EXHIBIT 10.161
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
KNOW-HOW LICENSE
AGREEMENT
by and between
INDEVUS PHARMACEUTICALS,
INC.
and
NOVEXEL SA
THIS KNOW-HOW LICENSE AGREEMENT
(“ Agreement ”) is effective as of
December 4 th , 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 NOVEXEL SA, a corporation
organized and existing under the laws of France and having its
principal office at Parc Biocitech, 102, route de Noisy, F-93230
Romainville France (“ Novexel ”). Indevus and
Novexel are collectively referred to herein as the “
Parties ”, and individually, as a “ Party
”.
W I T N E S S E T
H:
WHEREAS, effective April 18,
2003, Indevus entered into that certain License Agreement with
Aventis Pharma SA (“ Aventis ”) (as amended, the
“ 2003 License ”) under which, among other
things, Indevus was granted an exclusive license under AVENTIS
Intellectual Property (as defined in the 2003 License) to develop
and commercialize Compound and Product (each as defined
below);
WHEREAS, pursuant to the Assignment
Agreement (as defined below) effective as of December 1, 2004,
Aventis assigned to Novexel all of Aventis’s right, title and
interest in and to all intellectual property rights relating to
Compound and Product;
WHEREAS, pursuant to the Assignment
Agreement, effective as of December 1, 2004, Aventis also
assigned to Novexel the 2003 License and Aventis’s rights and
obligations thereunder (except for the right to manufacture and
supply Nucleus (as defined below) that was retained by Aventis) and
Novexel assumed all such rights and obligations
thereunder;
WHEREAS, under the 2003 License,
Indevus, through its efforts to develop Product, has generated the
Indevus Know-how (as defined below);
WHEREAS, Indevus has made a
strategic corporate decision to search for a partner to pursue
development and commercialization of Compound and Product and
Novexel wishes to have an exclusive right to pursue such
activities, Indevus and Novexel have agreed, and mutually desire,
to simultaneously execute three agreements which will, together,
allow Novexel to exclusively pursue development and
commercialization of Compound and Product; and
WHEREAS the three agreements Indevus
and Novexel have agreed to simultaneously execute include
(i) a Termination Agreement terminating the 2003 License,
(ii) this Know-How License Agreement under which Indevus will
grant Novexel an exclusive license to Indevus Know-How (the
“Know-How License”), and (iii) a letter agreement
assigning Indevus’ rights and obligations relative to Aventis
in the manufacture and supply of Nucleus to Novexel, to which
Aventis is also a party (the “Side
Agreement”).
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:
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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:
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1.1
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“
Affiliate ” means (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 or
(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.
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1.2
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“
Assignment Agreement ” means the Subscription
Agreement in relation to Novexel SA dated as of 25 October
2004 by and among Aventis, Novexel and the other parties listed on
the signature page thereto, a redacted form of which has been
previously provided to Indevus.
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1.3
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“
Aventis ” means Sanofi-aventis, the successor to
Aventis Pharma SA.
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1.4
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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
or a day that is a bank holiday in France (which days are set forth
on Schedule 1.4 ).
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1.5
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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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1.6
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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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1.7
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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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1.8
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“
Compound ” means the chemical compound known under the
International Non-proprietary name aminocandin and the code
name HMR-3270 and diagrammed on Schedule 1.8 , and any other
compounds disclosed or covered or included in the Novexel Patent
Assets or any compound that is part of the aminocandin family of
compounds or any derivative, homolog, or analog of any of the
foregoing, and any isomer, salt, hydrate, solvate, amide, ester,
metabolite, or prodrug of any of the foregoing
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1.9
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“ Dominating Patent
” shall mean an unexpired patent which has not been
invalidated by a court or other governmental agency of competent
jurisdiction which is owned by a Third Party and which Novexel or
its sublicensees reasonably believe they have no
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alternative to obtaining a
royalty-bearing license under such patent in order to commercialize
a Product under this Agreement without infringing such patent. Any
Third Party patent that (i) [*] and (ii) becomes
subject to the preceding sentence after the Effective Date, shall
be deemed a Dominating Patent.
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1.10
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“
EMEA ” means 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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1.11
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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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1.12
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“
First Commercial Sale ” means the date of the first
commercial sale of Product in the Territory by Novexel or its
Affiliates, or their sublicensee(s) after all required Regulatory
Approvals in the country of sale have been obtained.
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1.13
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“
Indevus Know-How” means any and all information and
materials, including but not limited to, discoveries, Inventory,
information, processes, formulae, data, inventions (whether
patentable or not), invention disclosures, know-how and trade
secrets, patentable or otherwise, that relate to Compound or
Product, including without limitation, all chemical,
pharmaceutical, toxicological, biochemical, and biological,
technical and non technical data, and information relating to the
results of tests, assays, methods, and processes, and
specifications and/or other documents containing information and
related data, and any preclinical, clinical, assay control,
manufacturing, regulatory, and any other data or information used
or useful for the development, manufacturing, regulatory filing or
application and/or regulatory approval of Compound or Product that
are immediately prior to the Effective Date, owned or controlled by
Indevus. A list of the principal components of the Indevus Know-How
is attached as Schedule 1.13 .
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1.14
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“
Inventory ” means the materials set forth on
Schedule 1.14 attached hereto and incorporated by reference
herein that as of the Effective Date are stored and held by or on
behalf of Indevus.
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1.15
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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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1.16
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“
Material Adverse Change ” means a serious adverse
condition or event relating to the clinical safety, efficacy,
toxicity or side effects of Compound or Product that (i) was
not included in the Indevus Know-How; (ii) was in the Indevus
Know-How or was known to Novexel, but after the Effective date and
reasonably diligent efforts by Novexel is determined by Novexel to
be a condition or event that cannot be reasonably overcome;
(iii) was not, as of the Effective Date, known to Novexel,
including any action by any Regulatory Authority significantly
limiting the development or commercialization of Compound or
Product.
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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1.17
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“
NDA ” means a new drug application or other submission
filed with the applicable Regulatory Authority in any regulatory
jurisdiction in the Territory to obtain Regulatory Approval of a
Product in such regulatory jurisdiction, and any amendments and
supplements thereto.
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1.18
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“ Net
Sales ” means the actual gross amount invoiced by
Novexel, its Affiliates or its sublicensees for the commercial sale
of all Products in the Territory to a Third Party, commencing upon
the date of First Commercial Sale, after deducting 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, credits, reimbursements
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 Territory;
(f) retroactive price reductions;
and
(g) write-offs or allowances for bad
debt, not to exceed two percent (2%) of Net Sales.
If Novexel or its Affiliates or
sublicensees sells Product together with other products to Third
Parties in a particular country and the price attributable to the
Product is less than the average price of “arms length”
sales of the Product alone in the particular country for the
reporting period in which sales occur (such sales to be excluded
from the calculation of the average price of “arms
length” sales), Net Sales for any such sales shall be the
average price of “arms length” sales by Novexel or its
Affiliates or sublicensees of the Product alone and in the country
during the reporting period in which such sales occur. If the
average price of “arms length” sale of the Product
cannot be determined in any given country, Net Sales will be
determined by the value of the Product sold to similar customers in
countries with similar pricing and reimbursement structures and for
similar quantities. Any dispute as to the determination of value
shall be resolved under the dispute procedure in accordance with
the provisions of Section 10.6.
If a Product contains one or more
therapeutically active ingredients in addition to Compound
(“Combination Product”), the Net Sales from the
Combination Product, for
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the purposes of determining royalty
payments, shall be determined by multiplying the Net Sales of the
Combination Product during the applicable royalty reporting period,
by the fraction, A/A+B, where A is the weighted average per unit
sale price of Product when sold in finished form with the Compound
as the only active ingredient in the country in which the
Combination Product is sold, and B is the weighted average per unit
sale price of an active ingredient other than Compound (it being
understood that if there are multiple other active ingredients they
shall be designated as B-1, B-2, etc.) contained in the Combination
Product when sold separately in finished form in the country in
which the Combination Product is sold multiplied by the number of
units of such active ingredient(s) in the Combination Product, in
each case during the applicable royalty reporting period or, if
sales of the Product alone did not occur in such period, then in
the most recent royalty reporting period in which arm’s
length fair market sales of such Product occurred. In the event
that such weighted average sale price cannot be determined for
either the Product or all other product(s) included in the
Combination Product, Net Sales for the purpose of determining
royalty payments due on a Combination Product shall be mutually
agreed upon by the Parties based on the relative value contributed
by each component, such agreement not to be unreasonably withheld,
conditioned or delayed.
Use of Products for promotional or
sampling purposes or for use in clinical trials contemplated under
this Agreement shall not be considered in determining Net Sales. In
the case of any sale of a Product between Novexel and its
Affiliates or sublicensees for resale, Net Sales shall be
calculated as above only on the first arm’s length sale
thereafter to a Third Party.
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1.19
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“
Novexel Know-How ” means any and all information and
materials, including but not limited to, discoveries, improvements,
information, processes, formulae, data, inventions (whether
patentable or not), invention disclosures, know-how and trade
secrets, patentable or otherwise, that relate to Compound or
Product, including without limitation, all chemical,
pharmaceutical, toxicological, biochemical, and biological,
technical and non technical data, and information relating to the
results of tests, assays, methods, and processes, and
specifications and/or other documents containing information and
related data, and any preclinical, clinical, assay control,
manufacturing, regulatory, and any other data or information used
or useful for the development, manufacturing, regulatory filing or
application and/or regulatory approval of Compound or Product that
are as of the Effective Date or at any time during the Term of this
Agreement become, owned or controlled by Novexel (other than
pursuant to the license granted by Indevus under this Agreement)
and as to which Novexel has the right to license or
sublicense.
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1.20
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“
Novexel Patent Assets ” means the United States
patents and patent applications and any foreign counterparts
thereof listed on Schedule 1.20 or which as of the Effective
Date are, or at any time during the Term of this Agreement become,
owned or controlled by Novexel, and relate to Compound or Product
or any improvement, including all certificates of invention and
applications for certificates of invention and substitutions,
divisions, continuations, continuations-in-part, patents issuing
thereon or reissues or reexaminations thereof, supplementary
protection certificates or the like of any such patents and patent
applications.
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Page 5
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1.21
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“
Nucleus ” means deacylmulundocandin, the starting
material for the manufacture of the Compound, obtained by
biochemistry through a biosynthesis from an Aspergillus strain, the
first step of which leads to deoxymulundocandin and the second step
of which leads to deacylmulundocandin.
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1.22
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“
Product ” means any product in final form (or where
the context so indicates, the product being tested) which contains
Compound as at least one of the therapeutically active
ingredients.
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1.23
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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 is being provided by that Party to the
other Party in connection with this Agreement. For purposes of the
confidentiality and non-use provisions of this Agreement, Novexel
Know-How and Reports are deemed Novexel Proprietary Information and
Indevus Know-How is deemed Indevus Proprietary
Information.
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1.24
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“Regulatory Approval
” means all authorizations and
approvals (including pricing and reimbursement approvals where
required for marketing), of all regional, federal, state or local
agencies, departments, bureaus or other governmental entities,
necessary for the manufacture, use, storage, import, export,
transport and sale of Product in a jurisdiction.
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1.25
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“
Regulatory Authority ” means the FDA in the United
States and any body in the European Union and any health regulatory
authority(ies) in any country(ies) in the Territory that is
equivalent to the FDA and holds responsibility for granting
Regulatory Approval for a Product in such country(ies), and any
successor(s) thereto having substantially the same
functions.
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1.26
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“
Royalty Year ” means, (i) for the year in which
the First Commercial Sale occurs, the period commencing with the
first day of the Calendar Quarter in which the First Commercial
Sale occurs and expiring on the last day of the Calendar Year in
which the First Commercial Sale occurs and (ii) for each
subsequent year, each successive Calendar Year.
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1.27
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“
SEC ” means the US Securities and Exchange Commission
or any successor agency.
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1.28
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“ Side
Agreement ” means the agreement entered into by and among
Novexel, Indevus and Aventis on even date herewith and attached as
Exhibit A which provides inter alia , for
Indevus’ rights and obligations under Sections 3.1.2 and 3.8
of the 2003 License to be assigned to Novexel, and that in the
event of a termination of this agreement where Indevus will
reacquire the rights consistent with the 2003 License, the rights
and obligations under Sections 3.1.2 and 3.8 shall be reassigned
back to Indevus.
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Page 6
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1.29
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“
Termination Agreement ” means the agreement entered
into between the Parties on even date herewith, and attached as
Exhibit B, which provides, inter alia , for
the termination of the 2003 License in consideration of the Parties
entering into this Agreement and Novexel, Indevus and Aventis
entering into the Side Agreement.
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1.30
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“
Territory ” means all of the countries in the
world.
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1.31
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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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ARTICLE II
LICENSE;
SUBLICENSES
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2.1
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License
Grant . Indevus hereby
grants to Novexel an exclusive license, with the right to
sublicense in accordance with the terms of this Agreement (with the
right of sublicensees to further sublicense), to use and practice
the Indevus Know-How for any purpose in connection with Compound
and/or Product, including to develop, make, have made, use, import,
offer for sale, sell, market, promote, commercialize, distribute,
or otherwise dispose of Compound and Product for any and all uses
in the Territory.
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2.2
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Delivery of
Indevus Know-How . Within
thirty (30) days after the Effective Date, Indevus shall
deliver to Novexel, at Indevus’s expense, all tangible items
(except Inventory) within the Indevus Know-How in a form(s) to be
agreed upon and to a place designated in writing by Novexel. The
Parties shall agree on a mutual place and time within thirty
(30) days after the Effective Date, to arrange for a delivery
to Novexel’s personnel, at Indevus’s expense, all of
the Indevus Know-How not available in tangible form. Such transfer
shall be made by qualified Indevus personnel who understand, have
used and are familiar with such Indevus Know-How.
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2.3
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Sublicenses . Subject to the terms and conditions of this
Agreement, Novexel shall have the right to grant sublicenses of any
of the rights granted to Novexel under Section 2.1 to
Affiliates or any Third Party, provided, however , that any
sublicense shall be consistent with Novexel’s obligations
under this Agreement, including under Section 9.4. Novexel
shall remain responsible for the performance by the sublicensee of
such obligations. Novexel shall notify Indevus of any sublicense
granted in the US, Japan and/or Europe.
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2.4
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Inventory . Effective as of the Effective Date, Indevus
hereby assigns and transfers to Novexel all of Indevus’s
right, title and interest in the Inventory. The Inventory shall be
delivered for the account of Novexel, at Novexel’s expense,
in accordance with and as soon as reasonably practicable after
receipt by Indevus of written instructions from Novexel,
provided , however , that prior to any such delivery,
the Inventory shall be held from and after the Effective Date, for
the account of Novexel and, from and after the Effective Date,
Novexel shall bear all risk of partial or total deterioration or
loss of any Inventory through no fault of Indevus, without any
recourse against Indevus in relation thereto. To the best of
Indevus’ knowledge, the Inventory at all times while held for
the account of Indevus has been stored in accordance with cGMPs and
all other applicable laws and regulations.
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2.5
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Non-Use/Non-Disclosure . From and after the Effective Date, Indevus
agrees and covenants to Novexel that Indevus shall not disclose any
Indevus Know-How to any Third Party without the prior written
consent of Novexel. From and after the Effective Date (except if
the provisions of Section 9.4.3 or 9.4.4 become applicable),
Indevus agrees and covenants to Novexel that Indevus shall not use
any Indevus Know-How for any purpose whatsoever. To implement the
provision of this Section 2.5, Indevus shall make reasonable
efforts to notify all of its employees who have used or have access
to Indevus Know-How of the provisions of this Section 2.5, and
in accordance with Indevus’ standard procedures, collect all
documents and things containing Indevus Know-How and maintain them
in a locked file.
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2.6
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Technical
Assistance .
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2.6.1 Access to Indevus’s
Records . Upon Novexel’s request, within the six
(6) month period after the Effective Date, Novexel personnel
shall be permitted access to Indevus’s facility where the
original documents and things within Indevus Know-How are
maintained to inspect and copy, if desired, such original documents
and things. Any such access shall be during normal business hours
and upon at least five (5) Business Days advance
notice.
2.6.2 Assistance. Within the
one (1) year period after the Effective Date, Indevus shall
make available to Novexel at Novexel’s designated facility,
Indevus’ qualified personnel familiar with the Indevus
Know-How to provide reasonable training and assistance to Novexel
with its use of the Indevus Know-How, upon Novexel’s
reasonable written request and at such times and for such periods
as may be mutually agreed to in good faith, subject to the terms of
this Section 2.6.2. Novexel shall bear all out of pocket
expenses associated with such assistance. Such assistance shall be
limited to [*]. Thereafter, if Novexel requests additional training
or assistance, and Indevus agrees to provide such assistance,
Novexel shall pay Indevus at the rate of [*] and bear all out of
pocket expenses in the manner set forth above. Any such additional
assistance shall be limited to [*].
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2.7
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Regulatory
Filings . Within thirty
(30) days after the Effective Date, Indevus, at its expense,
shall transfer ownership to Novexel of any and all regulatory
applications, filings and submissions with respect to Compound and
Product so that Novexel can continue clinical development of
Compound and Product in its own name, and in accordance with
Section 3.2.
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ARTICLE III
DEVELOPMENT AND
COMMERCIALIZATION
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3.1
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Development
and Commercialization .
Novexel shall control and shall be solely responsible for
development, manufacture and commercialization of Compound
and
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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the Products conducted or
performed after the Effective Date. Novexel shall comply with all
applicable laws and regulations in the development and
commercialization of Product. A summary of Novexel’s progress
and results of such development and commercialization will be
reported to Indevus at least on an annual basis. Such progress
reports and the information, data and results contained therein
(“ Reports ”) shall be deemed Proprietary
Information of Novexel and shall remain the property of Novexel.
Only those employees of Indevus who administer this Agreement shall
have access to such Reports.
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3.2
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Regulatory
Matters . Novexel shall
own, control and retain primary legal and financial responsibility
for the preparation, filing, prosecution and maintenance of all
filings and regulatory applications required to obtain and maintain
authorization to develop, manufacture, sell and use Product in the
Territory. Novexel shall notify Indevus of the dates of First
Commercial Sale in each country in the Territory. Novexel shall be
solely responsible for filing all reports required to be filed in
order to maintain Regulatory Approvals for Product in the
Territory, and for all interactions with Regulatory Authorities in
the Territory regarding such Regulatory Approvals. Novexel shall
have sole responsibility for, bear all costs and expenses
associated with and make all decisions with respect to any recall,
withdrawal or seizure of the Product. Novexel shall notify Indevus
with respect to any material changes or material problems that may
arise in connection with its Regulatory Approvals in any country in
the Territory.
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3.3
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Diligence;
Development and Commercialization . Novexel shall use commercially reasonable
efforts to develop and commercialize Product. As used herein,
“commercially reasonable efforts” shall mean efforts
and resources normally used by Novexel for a product owned by it or
to which it has exclusive rights, which is of similar market
potential at a similar stage in its development or product life,
taking into account issues of safety and efficacy, product profile,
the competitiveness of the marketplace, the proprietary position of
the compound or product, the regulatory and reimbursement structure
involved, the profitability of the concerned products, and other
relevant factors if any.
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3.4
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Trademark . Novexel shall have the right to select, own
and maintain trademarks for Product in the Territory.
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3.5
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Agreements . Schedule 3.5 sets forth a list of all
contracts, agreements and other arrangements in effect as of the
Effective Date between Indevus and any Third Parties relating to
the research, development or storage of the Compound and Product.
Indevus shall use commercially reasonable efforts to assign to
Novexel, and Novexel shall assume all of Indevus’s
obligations under, the contracts and agreements listed on
Schedule 3.5 which Novexel shall specifically request, and
Indevus shall terminate any such other contracts, agreements or
other arrangements. From and after the Effective Date, Indevus
shall have no obligations under any of the contracts or agreements
assigned to Novexel except for payment obligations that accrued
prior to the Effective Date.
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3.6
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Manufacturing and Supply.
During the Term of this Agreement,
and subject to the following sentence, Novexel shall have all
rights and responsibility relating to chemistry, manufacturing and
control for clinical and commercial use of Compound or Product. The
Parties hereby acknowledge that pursuant to the 2003 License,
Aventis retained the right to manufacture and supply or have
manufactured or have supplied, the Nucleus under the terms and
conditions set forth therein and that as of the Effective Date,
Indevus and Aventis have not entered into the manufacturing and
supply agreement referred to therein, but have extended the time
period for entering into such an agreement through July 1,
2007, as established by the correspondence between Indevus and
Aventis included in Exhibit C , which shall also include any
amendments to the 2003 License.
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ARTICLE IV
PAYMENTS AND
REPORTS
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4.1
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License and
Transfer Fees . In
partial consideration of the rights granted by Indevus hereunder,
Novexel shall pay Indevus the following non-refundable and
non-creditable license fees by wire transfer of immediately
available funds to a bank account or bank accounts designated by
Indevus:
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4.1.1 one million five hundred
thousand dollars (US$1,500,000) payable within five
(5) Business days after the Effective Date ;
and
4.1.2 two hundred fifty thousand
dollars (US$250,000) on a quarterly basis, commencing twenty-four
(24) months from the Effective Date, provided that such
obligation shall expire on the commencement of the first Phase 2
clinical trial (first dosing of first patient) and payment of the
milestone referred to in Section 4.2.1. Such payments may be
temporarily suspended in the event of, and for the duration of, a
Material Adverse Change, provided, that Novexel shall have provided
Indevus with written notice and evidence of such Material Adverse
Change prior to the date any quarterly payment required by this
Section 4.1.2 would otherwise have been payable.
|
|
4.2
|
Milestone
Payments . In further
consideration of the rights granted by Indevus hereunder, Novexel
shall pay Indevus the following non-refundable and non-creditable
milestone payments, contingent upon occurrence of the specified
event, with each milestone payment to be made no more than once
with respect to the achievement of such milestone and no amounts
payable for any subsequent or repeated achievement of such
milestones, regardless of the number of Products for which such
milestone may be achieved (but payable the first time such
milestone is achieved):
|
4.2.1 For the first IV
formulation of the first Product :
|
|
(a)
|
US $2,000,000
upon commencement (first dosing of the first patient) of first
Phase 2 clinical trial;
|
|
|
(b)
|
US $750,000
upon the commencement (first dosing of the first patient) of the
first Phase 3 clinical trial;
|
Page 10
|
|
(c)
|
US $1,500,000
upon the FDA’s acceptance for filing of the first
NDA;
|
|
|
(d)
|
US $750,000
upon the first acceptance for filing of an NDA with the
EMEA;
|
|
|
(e)
|
US $750,000
upon the first acceptance for filing of an NDA in Japan;
|
|
|
(f)
|
US $3,500,000
upon receipt of first written Regulatory Approval in the United
States by the FDA;
|
|
|
(g)
|
US $2,000,000
upon receipt of written Regulatory Approval by the EMEA;
|
|
|
(h)
|
US $2,000,000
upon receipt of written Regulatory Approval by the Regulatory
Authority in Japan;
|
|
|
(i)
|
US $750,000
upon the achievement of cumulative Net Sales of US $100,000,000
;
|
|
|
(j)
|
US $750,000
upon the achievement of cumulative Net Sales of US
$200,000,000;
|
|
|
(k)
|
US $750,000
upon the achievement of cumulative Net Sales of US $300,000,000;
and
|
|
|
(l)
|
US $750,000
upon the achievement of cumulative Net Sales of US
$400,000,000.
|
4.2.2 For the first oral
formulation of the first Product :
|
|
(a)
|
US $2,250,000
upon the commencement (first dosing of the first patient) of the
first Phase 3 Clinical Trial;
|
|
|
(b)
|
US $2,625,000
upon the FDA’s acceptance for filing of the first
NDA;
|
|
|
(c)
|
US $1,875,000
upon the first acceptance for filing of an NDA by the
EMEA;
|
|
|
(d)
|
US $1,500,000
upon the first acceptance for filing of an NDA in Japan;
|
|
|
(e)
|
US $5,000,000
upon receipt of first written Regulatory Approval in the United
States by the FDA;
|
|
|
(f)
|
US $4,000,000
upon receipt of written Regulatory Approval by the EMEA;
|
|
|
(g)
|
US $2,000,000
upon receipt of written Regulatory Approval by the Regulatory
Authority in Japan;
|
Page 11
|
|
(h)
|
US $1,500,000
upon the achievement of cumulative Net Sales of US
$200,000,000;
|
|
|
(i)
|
US $1,500,000
upon the achievement of cumulative Net Sales of US
$400,000,000;
|
|
|
(j)
|
US $1,500,000
upon the achievement of cumulative Net Sales of US
$600,000,000;
|
|
|
(k)
|
US $1,500,000
upon the achievement of cumulative Net Sales of US $800,000,000;
and
|
|
|
(l)
|
US $1,500,000
upon the achievement of cumulative Net Sales of US
$1,000,000,000.
|
Novexel shall notify Indevus in
writing within fifteen (15) Business Days after the
achievement of each milestone (thirty (30) days for the
milestones set forth in Section 4.2.1 (i), (j), (k) and
(l), and Section 4.2 (h), (i), (j), (k) and (l)), and
payment shall be made concurrent with such notice by wire transfer
of immediately available funds to a bank account or bank accounts
designated by Indevus.
4.3.1 In further consideration of
the rights granted by Indevus hereunder, Novexel shall pay to
Indevus in each Royalty Year royalties on Net Sales in the
Territory at the following rates:
|
|
|
|
|
Annual Net Sales in all countries
in the Territory:
|
|
Royalty Rate
|
|
|
Less than US$500,000,000
|
|
5
|
%
|
|
Greater than or equal to US$500,000,000 and
less than US$1,000,000,000
|
|
6
|
%
|
|
Greater than or equal to US$
1,000,000,000
|
|
7.5
|
%
|
4.3.2 Royalties shall accrue as of
the date of First Commercial Sale of Product in the Territory and
shall continue and accrue on Net Sales in each country in the
Territory until the later of in any such country, (a) the
expiration of the last to expire Novexel Patent Asset that exists
as of the Effective Date in such country and is listed on
Schedule 1.20 , or (b) [*] from the date of First
Commercial Sale of Product in such country. After the expiration of
the applicable royalty term in any country, Novexel shall be
relieved of any royalty payment in that country.
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 12
4.3.3 The payment of royalties
hereunder shall be subject to the following:
|
|
(a)
|
No royalties
shall accrue on the disposition of Product by Novexel, Affiliates
or sublicensees as samples or as donations (for example, to
non-profit institutions or government agencies);
|
|
|
(b)
|
In the event
Novexel, a Novexel Affiliate or sublicensee sells Compound or bulk
drug product rather than Product in finished packaged form to a
Third Party, other than a sublicensee, and is unable to determine
Net Sales as defined in this Agreement, then the royalty
obligations shall apply to the Compound or bulk drug product sold;
and
|
|
|
(c)
|
Novexel shall
be responsible for any royalties or other amounts payable to Third
Parties in order to make, have made, use, sell or import Compound
or Product in any country in the Territory, including pursuant to
any license agreement with any Third Party. Notwithstanding the
foregoing, except with respect to any payments required to be made
in connection with the Nucleus, including the manufacture or rights
to manufacture the Nucleus, if Novexel, its Affiliates,
sublicensees or their co-promotion partners would be prevented from
developing, making, having made, using, selling or importing
Product in any country of the Territory on the grounds that by
doing so they would infringe a Dominating Patent or other patent
rights held by a Third Party in said country, and any of them enter
into an agreement with a Third Party pursuant to which an actual
royalty on Compound or Product is paid to such Third Party, then
Novexel shall be entitled to a credit against future royalties
otherwise payable to Indevus hereunder in an amount equal to [*] of
the amount of such royalty payments paid to such Third Parties;
provided that the credit for any given year will not exceed [*] of
the royalties payable to Indevus for such year; and provided
further that in such event Indevus has been informed of the
Dominating Patent or other patent rights and has had an opportunity
to provide input on any related discussion.
|
4.3.4 In the event that Novexel or
any Novexel Affiliate or sublicensee determines to commercialize
Product as an Over-the-Counter Product, the Parties shall negotiate
in good faith a royalty payable to Indevus on Net Sales of
Over-the-Counter Products in countries where the manufacture, use
or sale of such Over-the-Counter Product wouldinfringe any of the
Novexel Patent Assets in such country.
4.3.5 Upon the expiration of the
obligation of Novexel to make the royalty payments required by
Section 4.3.1 in any country in the Territory, Novexel shall
have a fully paid-up, royalty free, transferable license in such
country to use the Indevus Know-How for any purpose
whatsoever.
|
|
4.4
|
Reports; Payment of
Royalties. Novexel shall
furnish to Indevus by not later than twenty (20) days
following the end of each Calendar Quarter a written report for
such Calendar quarter showing: (i) gross sales and Net Sales
of Product or Compound
|
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 13
|
|
during such Calendar Quarter
(including a detailing of all deductions taken in the calculation
of Net Sales and, where available, the number of units sold) in
each country’s currency, (ii) the formulas used in the
calculation of the royalties owed thereon, (iii) the
applicable exchange rate to convert from each country’s
currency to United States Dollars, and (iv) the royalties
payable to Indevus. Royalty payments shall first be calculated in
the currency in which sales took place and then converted to United
States Dollars using the arithmetic averages of the closing
conversion rates on the first and last Business Day of such
Calendar Quarter, as published by The Wall Street Journal, Eastern
edition (if available), or any other publication as agreed to by
the Parties. The royalties shown to have accrued by each report, if
any, shall be due and payable on the date such report is due.
Novexel shall keep, and shall require its Affiliates and
sublicensees to keep, complete and accurate records in sufficient
detail to enable the royalties payable hereunder to be
determined.
|
|
|
4.5
|
In order for
Indevus to receive compensation on a quarterly basis, Novexel shall
pay to Indevus, on a quarterly basis, royalties based on the
cumulative Net Sales for the applicable Royalty Year to date, less
royalties previously paid to Indevus on account of Net Sales for
the previous Calendar Quarters in such Royalty Year. Any change in
the amount that would have been payable from Novexel to Indevus
under this Agreement which results from any restatements to a prior
period’s financial results due to errors, omissions, or any
other misstatements, shall be added to or deducted from, as
applicable, the amount of the next payment due under this
Agreement.
|
|
|
4.6
|
Financial
Audits . Upon the written
request of Indevus and not more than once in each Calendar Year,
Novexel shall permit an independent certified public accounting
firm selected by Indevus and reasonably acceptable to Novexel to
have access during normal business hours, upon ten-days notice to
Novexel, to such of the records of Novexel, its Affiliates and
sublicensees, as applicable, as may be reasonably necessary to
verify the accuracy of the reports under Section 4.4 for any
Royalty Year ending not more than [*]prior to the date of such
request. The accounting firm shall disclose to Indevus only whether
the reports are correct or incorrect and the specific details
concerning any discrepancies.
|
4.6.1 If such accounting firm
concludes that additional amounts were owed by Novexel for such
Royalty Year, Novexel shall pay the additional amounts within
thirty (30) days of the date Indevus delivers to Novexel such
accounting firm’s written report so concluding. In the event
such accounting firm concludes that amounts were overpaid by
Novexel during such period, Indevus shall repay Novexel the amount
of such overpayment within thirty (30) days of the date
Indevus delivers to Novexel such accounting firm’s written
report so concluding. The fees charged by such accounting firm
shall be paid by Indevus; provided , however , that
if an error in favor of Indevus of more than the greater of
(i) [*] or (ii) [*] of the amounts due hereunder for the
period being reviewed is discovered, then the fees and expenses of
the accounting firm shall be paid by Novexel.
4.6.2 Upon the expiration of
thirty-six (36) months following the end of any Royalty Year
the calculation of royalties or other payments payable with respect
to such
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 14
Royalty Year shall be binding and
conclusive upon Indevus, and Novexel shall be released from any
liability or accountability with respect to royalties for such
Royalty Year.
4.6.3 Indevus shall treat all
financial information subject to review under this Section 4.6
in accordance with the confidentiality provisions of this Agreement
and shall cause its accounting firm to enter into a reasonable and
mutually satisfactory confidentiality agreement with Novexel
obligating it to retain all such financial information in
confidence pursuant to such confidentiality agreement.
|
|
4.7
|
Payments . All payments to Indevus under this Agreement
shall be made in United States dollars.
|
|
|
4.8
|
Late
Payment . In case of any
late payment due hereunder by Novexel, Novexel shall pay to Indevus
interest on the unpaid amount until such payment is paid in full,
at the LIBOR Rate (as defined below), [*] but in no event in excess
of the maximum rate permitted by applicable law. “LIBOR
Rate” means an interest rate per annum equal to the rate of
interest per annum at which deposits in United States dollars are
offered by the principal office of Citibank, N.A. in London,
England, to prime banks in the London interbank market at
11:00 a.m. (London time) on the Business Day immediately
preceding the commencement of such interest period.
|
|
|
4.9
|
Tax
Withholding If
withholding taxes are payable with respect to any payments to
Indevus hereunder, Novexel shall pay such withholding taxes and
deduct the amount thereof from the amounts otherwise due to Indevus
hereunder. Novexel shall provide Indevus with a certificate
evidencing payment of any withholding taxes hereunder, together
with a written statement of any such taxes paid with respect to
Indevus’s tax liability. Novexel shall provide Indevus with
both a written statement of any such withholding taxes and a
certificate evidencing payment of such taxes. Novexel will use
commercially reasonable efforts consistent with its usual business
practices and reasonably cooperate with Indevus to ensure that any
withholding taxes imposed are reduced as far as possible under the
provisions of the current or any future taxation treaties or
agreements between foreign countries. In the event that Novexel is
legally required to file such forms for the benefit of Indevus,
Indevus shall provide fully completed forms for verification and
subsequent filing by Novexel.
|
|
|
4.10
|
Restrictions
on Payment . If by law,
regulations or fiscal policy of a particular country, remittance of
royalties in United States Dollars is restricted or forbidden,
notice thereof will be promptly given to Indevus, and payment of
the royalties shall be made by the deposit thereof in local
currency to the credit of Indevus in a recognized banking
institution designated by Indevus. When in any country the law or
regulations prohibit both the transmittal and deposit of royalties
on sales in such a country, royalty payments shall be suspended for
as long as such prohibition is in effect and as soon as such
prohibition ceases to be in effect, all royalties that Novexel
would have been under obligation to transmit or deposit but for the
prohibition, shall forthwith be deposited or transmitted promptly
to the extent allowable.
|
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 15
ARTICLE V
CONFIDENTIALITY AND
PUBLICITY
|
|
5.1
|
Non-Disclosure and Non-Use
Obligations . All
Proprietary Information disclosed by one Party to the other Party
hereunder shall be maintained in confidence and shall not be
disclosed to any Third Party or used for any purpose except as
expressly permitted herein without the prior written consent of the
Party that disclosed the Proprietary Information to the other Party
during the Term of this Agreement and for a period of five years
thereafter, except that with respect to the Indevus Know-How,
Indevus’s obligation hereunder shall continue throughout the
Term of this Agreement. The foregoing non-disclosure and non-use
obligations shall not apply to the extent that such Proprietary
Information:
|
5.1.1 is known by the receiving
Party at the time of its receipt, and not through a prior
disclosure by the disclosing Party, as documented by business
records;
5.1.2 is or becomes properly in the
public domain or knowledge, but not by any action of the receiving
Party;
5.1.3 is subsequently disclosed to a
receiving Party by a Third Party who may lawfully do so and is not
under an obligation of confidentiality to the disclosing Party;
or
5.1.4 is developed by the receiving
Party independently of Proprietary Information received from the
other Party, as documented by research and development
records.
|
|
5.2
|
Permitted
Disclosure of Proprietary Information . Notwithstanding Section 5.1,
|
5.2.1 Novexel may disclose Indevus
Proprietary Information:
|
|
(a)
|
to governmental
or other regulatory agencies in order to obtain patents, or to gain
approval to conduct clinical trials or to market Product, but such
disclosure may be only to the extent reasonably necessary to obtain
such patents or authorizations;
|
|
|
(b)
|
to its
respective agents, consultants, Affiliates, sublicensees and/or
other Third Parties for the development and/or marketing of Product
(or for such parties to determine their interests in performing
such activities) on the condition that such Third Parties agree to
be bound by the confidentiality obligations consistent with this
Agreement; or
|
|
|
(c)
|
if required to
be disclosed by law or court order, provided that notice is
promptly delivered to the non-disclosing Party in order to provide
an opportunity to challenge or limit the disclosure obligations;
and
|
5.2.2 Indevus may disclose Novexel
Proprietary Information if required to be disclosed by law or court
order, provided that notice is promptly delivered to the
non-disclosing Party in order to provide an opportunity to
challenge or limit the disclosure obligations.
Page 16
|
|
5.3
|
Return of
Proprietary Information .
Upon termination of this Agreement, the Party to which Proprietary
Information has been disclosed pursuant to this Agreement shall,
upon request, promptly return within thirty (30) days all such
information, including any copies thereof, and cease its use or, at
the request of the Party transmitting such Proprietary Information,
shall promptly destroy the same and certify such destruction to the
transmitting party; except for a single copy thereof which may be
retained for the sole purpose of determining the scope of the
obligations incurred under this Agreement. Upon termination of this
Agreement, Novexel shall return to Indevus or destroy, as provided
in Section 9.4, the Indevus Know-How, including any unused
Inventory.
|
|
|
5.4
|
Public
Disclosure .
Notwithstanding the provisions of this Article V, it is understood
that the Parties may make disclosure of this Agreement and the
terms hereof in any filings required by the SEC, other governmental
authority or securities exchange, may file this Agreement as an
exhibit to any filing with the SEC, other governmental authority or
securities exchange, and may distribute any such filing in the
ordinary course of its business. Except as set forth in this
Agreement or as required by law, neither Party shall make any press
release or other public announcement or other disclosure to a Third
Party concerning the existence of or terms of this Agreement
without the prior written consent of the other Party, which consent
shall not be unreasonably withheld or delayed. Each Party agrees to
provide to the other Party a copy of any public announcement as
soon as reasonably practicable under the circumstances prior to its
scheduled release. Each party shall have the right to expeditiously
(but in any event within one Business Day of receipt) review any
press release or announcement regarding this Agreement or the
subject matter of this Agreement; provided , however
, that such right of review shall only apply for the first time
that specific information is to be disclosed, and shall not apply
to the subsequent disclosure of substantially similar information
that has previously been disclosed unless there have been material
changes in the disclosure since the date of the previous
disclosure.
|
ARTICLE VI
REPRESENTATIONS AND
WARRANTIES
|
|
6.1
|
General
Representations . Each
Party hereby represents and warrants to the other Party as of the
Effective Date as follows:
|
6.1.1 Such Party is a corporation
duly organized, validly existing and in good standing under the
laws of the jurisdiction in which it is incorporated;
6.1.2 Such Party has the corporate
power and authority and the legal right to enter into this
Agreement, the Termination and the Side Agreement and to perform
its obligations hereunder and thereunder and the execution,
delivery and performance by such party of this Agreement, the
Termination and the Side Agreement has been duly authorized by all
necessary corporate action;
Page 17
6.1.3 Each of this Agreement, the
Termination and the Side Agreement has been duly executed and
delivered on behalf of such party, and each constitutes a legal,
valid, binding obligation, enforceable against such Party in
accordance with its terms except as enforceability may be limited
by (a) any applicable bankruptcy, insolvency, reorganization,
moratorium or similar law affecting creditor’s rights
generally, or (b) general principles of equity, whether
considered in a proceeding in equity or at law;
6.1.4 All necessary consents,
approvals and authorizations of all governmental authorities and
other persons required to be obtained by such Party in connection
with this Agreement, the Termination and the Side Agreement have
been obtained; and
6.1.5 The execution and delivery of
this Agreement, the Termination and the Side Agreement and the
performance of such Party’s obligations hereunder and
thereunder does not conflict with or violate any requirement of
applicable laws or regulations or any judgment, injunction, decree,
determination or award presently in effect having applicability to
it.
|
|
6.2
|
Indevus
Representations and Warranties . Indevus represents and warrants to Novexel
that as of the Effective Date:
|
6.2.1 Indevus has not received any
written notice alleging that the practice of the subject matter of
the Indevus Know-How or the making, using or selling of Compound or
Product in the Territory would infringe any Third Party patents and
Indevus is not aware of any facts or circumstances that would
support a claim of infringement;
6.2.2 there are no claims, judgments
or settlements against or owed by Indevus relating to the Indevus
Know-How;
6.2.3 Indevus has not previously
assigned, transferred, conveyed or otherwise encumbered any right,
title and interest in the Indevus Know-How, or entered into any
agreement with any Third Party which is in conflict with the rights
granted to Novexel pursuant to this Agreement;
6.2.4 No Third Party has claimed or
threatened to claim ownership, control or the right to use Indevus
Know-How and Indevus is not aware of any facts or circumstances
that would support such a claim;
6.2.5 Indevus has not filed, and
shall not file during the Term of this Agreement, any application
for patent, copyright, trademark or other form of intellectual
property right disclosing or claiming any Indevus
Know-How;
6.2.6 Indevus does not own, control
or otherwise possess any information or technology related to
Compound or Product that is not included in Indevus Know-How;
and
Page 18
6.2.7 All of the information
concerning Inventory set forth in Schedule 1.14 , including
the amount of each material listed, is true and accurate in all
material respects; Indevus does not own or control any additional
such materials; from and after the time such Inventory has been
held for the account of Indevus, to the best of Indevus’
knowledge, the Inventory has been held and stored in accordance
with cGMPs and all applicable laws and regulations.
|
|
6.3
|
Novexel
Representations and Warranties. Novexel represents and warrants to
Indevus that:
|
6.3.1 in accordance with the
Assignment Agreement, effective as of December 1, 2004 , the
2003 License, and all of Aventis’ rights thereunder, other
than with respect to the Nucleus, have been assigned by Aventis to
Novexel, and Novexel has assumed all of Aventis’ obligations
thereunder; the Assignment Agreement is in full force and effect
and no party thereto is in breach or default thereof;
and
6.3.2 as of the Effective Date,
Novexel owns all right, title and interest in and to the Novexel
Patent Assets, all of which are listed on Schedule 1.20 ,
and has not assigned, transferred, conveyed or otherwise encumbered
its right, title or interest in the Novexel Patent
Assets;
|
|
6.4
|
THE LIMITED
WARRANTIES SET FORTH IN THIS SECTION 6 ARE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF
MERCHANTABILITY, WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY OF
FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTIES
EXPRESSED IN THIS SECTION 6, NEITHER PARTY MAKES ANY OTHER
WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE COMPOUND
OR THE PRODUCT.
|
ARTICLE VII
INDEMNIFICATION AND
INSURANCE
|
|
7.1
|
Indemnification by Indevus
. Indevus will indemnify, defend and
hold harmless Novexel, its Affiliates, directors, officers,
employees, agents, successors, and assigns (each, a “
Novexel Indemnitee ”) from and against any and all
Losses arising out of, attributable to or resulting from any claim,
suit, action or proceedings (collectively, “Claims”),
that are brought by a Third Party against a Novexel Indemnitee that
are attributable to a breach by Indevus of any of its
representations, warranties or covenants under this Agreement;
provided , however , that Indevus shall not be
obligated under this Section 7.1 to the extent any Losses
(A) arose out of the negligence or wrongdoing on the part of
Novexel; (B) arose out of any breach by Novexel of any of its
representations, warranties and/or covenants hereunder; or
(C) are Losses subject to indemnification by Novexel under
Section 7.2.
|
|
|
7.2
|
Indemnification by
Novexel . Novexel shall
indemnify, defend and hold harmless Indevus and its Affiliates,
directors, officers, employees, agents, successors and
|
Page 19
|
|
assigns (each a “
Indevus Indemnitee ”) from and against any and all
Losses arising out of, attributable to or resulting from any Claims
that are brought by a Third Party against an Indevus Indemnitee
that are attributable to (i) the development, manufacture,
use, marketing, promotion or sale of Compound or Product;
(ii) Novexel’s negligence, recklessness or willful
misconduct in exercising or performing any of its rights or
obligations under this Agreement; or (iii) a breach by Novexel
of any of its representations, warranties or covenants under this
Agreement; provided , however , that Novexel shall
not be obligated under this Section 7.2 to the extent any
Losses (A) arose out of any breach by Indevus of any of its
representations, warranties and/or covenants hereunder; or
(B) are Losses subject to indemnification by Indevus under
Section 7.1.
|
|
|
7.3
|
Procedure . In the event that any Indemnitee intends to
claim indemnification under this Article VII it shall promptly
notify the other Party (the “ Indemnitor ”) in
writing of such Claim. Failure to provide prompt notice shall not
relieve any Party of the duty to defend or indemnify unless such
failure materially prejudices the defense of any matter. The
Indemnitor shall have the sole right to control the defense and
settlement thereof provided , however , that an
Indemnitor shall not, without the written consent of the other
Party, as part of any settlement or compromise (i) admit to
liability on the part of the other Party; (ii) agree to an
injunction against the other Party; or (iii) settle any matter
in a manner that separately apportions fault to the other Party.
The Parties shall have a reasonable opportunity to participate in
decision-making with respect to the strategy of such defense, and
shall reasonably cooperate with each other in connection with the
implementation thereof. An Indemnitee shall not, except at its own
cost, voluntarily make any payment or incur any expense with
respect to any Claim without the prior written consent of the
Indemnitor, which the Indemnitor shall not be required to
give.
|
|
|
7.4
|
Insurance . Novexel shall maintain, during the Term of
this Agreement and for a period of three (3) years after any
expiration of termination of this Agreement, a Commercial General
Liability Insurance policy or policies (including coverage for
Product Liability, Contractual Liability, Bodily Injury, Property
Damage and Personal Injury), with minimum limits per occurrence and
in the aggregate customary for the stage of development and
commercial activity of the aminocandin program, but in any event
shall not be less than [*] total per year. Such insurance shall
insure against liability arising out of the manufacture, use, sale,
or marketing of Product in the Territory as appropriate for the
stage and extent of development and commercial activity of the
aminocandin program. During the Term, Novexel shall not permit such
insurance to be reduced, expired or canceled without reasonable
prior written notice to Indevus. Upon request Novexel shall provide
Certificates of Insurance to Indevus evidencing the coverage
specified herein.
|
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 20
ARTICLE VIII
PATENT MATTERS
|
|
8.1
|
Novexel shall
be responsible in its sole discretion for all filing, prosecution,
maintenance, enforcement and defense (including interference and
opposition proceedings) of the Novexel Patent Assets.
Notwithstanding the foregoing, Novexel shall prosecute, maintain,
enforce and defend the Novexel Patent Assets in the US, Europe and
Japan covering Compound.
|
ARTICLE IX
TERM AND
TERMINATION
|
|
9.1
|
Term and
Expiration . This
Agreement shall be effective as of the Effective Date and unless
terminated earlier under Section 9.2, the term of this
Agreement shall extend for a period (the “ Term
”) which shall expire and terminate, on a country-by country
basis, on the expiration of all royalty obligations with respect to
such country under Section 4.3.
|
9.2.1 By Notice . Novexel
shall have the right to terminate this Agreement (a) at any
time upon [*] advance written notice to Indevus upon the occurrence
of a Material Adverse Change, or (b) after the earlier of
(i) the commencement of the first Phase 2 clinical trial, or
(ii) [*] after the Effective Date, for any or no reason, upon
[*] advance written notice to Indevus.
In the event of any termination
under this Section 9.2.1, the provisions of Section 9.4.3
shall be applicable, provided, that any amounts payable pursuant to
Section 4.1.2 that become due during the period commencing
from the date of the termination notice until the effective date of
termination shall not be payable.
9.2.2 Termination of Agreement
for Cause . Either Party may terminate this Agreement by notice
to the other Party at any time during the Term as
follows:
|
|
(a)
|
if the other
Party is in breach of any material obligation hereunder by causes
and reasons within its control, or has breached, in any material
respect, any representations or warranties set forth herein, and
has not cured such breach within (i) [*] Business Days in case
the breach is a non payment of any amount due under this Agreement,
and (ii) within [*] for other cases of breach, after notice
requesting cure of the breach, provided , however ,
that if a breach other than a non payment is not capable of being
cured within [*] of such written notice, the Agreement may not be
terminated sooner than [*] of such written notice so long as the
breaching Party commences and is taking commercially reasonable
actions to cure such breach as promptly as practicable;
or
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|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 21
|
|
(b)
|
upon the filing
or institution of bankruptcy, reorganization, liquidation or
receivership proceedings, or upon an assignment of a substantial
portion of the assets for the benefit of creditors by the other
Party; provided , however , in the case of any
involuntary bankruptcy, reorganization, liquidation, receivership
or assignment proceeding such right to terminate shall only become
effective if the Party consents to the involuntary proceeding or
such proceeding is not dismissed within [*] after the filing
thereof.
|
|
|
9.3
|
Rights not
Affected . All rights and
licenses granted pursuant to this Agreement are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of
the Bankruptcy Code licenses of rights to “intellectual
property” as defined under Section 101(35A) of the
Bankruptcy Code. The Parties agree that Novexel and Indevus shall
retain and may fully exercise all of their respective rights,
remedies and elections under the Bankruptcy Code. The Parties
further agree that, in the event of the commencement of a
bankruptcy or reorganization case by or against a Party under the
Bankruptcy Code, the other Party shall be entitled to all
applicable rights under Section 365 (including 365(n)) of the
Bankruptcy Code. Upon rejection of this Agreement by a Party or a
trustee in bankruptcy for such Party, pursuant to
Section 365(n), the other Party may elect (i) to treat
this Agreement as terminated by such rejection or (ii) to
retain its rights (including any right to enforce any exclusivity
provision of this Agreement) to intellectual property (including
any embodiment of such intellectual property) under this Agreement
and under any agreement supplementary to this Agreement for the
duration of this Agreement and any period for which this Agreement
could have been extended by such other Party, subject, however, to
the continued payment of all amounts owing under this Agreement,
all of which amounts shall be deemed to be royalties for purposes
of Section 365(n) of the Bankruptcy Code. Upon written request
to the trustee in bankruptcy or bankrupt Party, the trustee or
Party, as applicable, shall (i) provide to the other Party any
intellectual property (including such embodiment) held by the
trustee or the bankrupt Party and shall provide to the other Party
a complete duplicate of (or complete access to, as appropriate) any
such intellectual property and all embodiments of such intellectual
property and (ii) not interfere with the rights of the other
Party to such intellectual property as provided in this Agreement
or any agreement supplementary to this Agreement, including any
right to obtain such intellectual property (or such embodiment or
duplicates thereof) from a Third Party.
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|
|
9.4
|
Effect of
Expiration or Termination . Upon termination of this Agreement, all rights
and licenses granted to Novexel hereunder shall terminate upon the
effective date of such termination and the Parties shall arrange
for an orderly return to Indevus (or, at Indevus’ request,
destruction by Novexel) of any Indevus Know-How in Novexel’s
possession including any remaining Inventory. Expiration or
termination of this Agreement shall not relieve the Parties of any
obligation accruing prior to such expiration or
termination.
|
9.4.1 Outstanding Payment .
Payments of amounts owing to Indevus under this Agreement as of its
expiration or termination shall be due and payable within the later
of (i) to the extent such amounts can be calculated and a
fixed sum determined at the time of
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 22
expiration or termination of this
Agreement, thirty (30) after the date of such expiration or
termination, or (ii) ten (10) days after the date in
which such amounts can be calculated and a fixed sum
determined.
9.4.2 Sale of Remaining
Product . Upon termination of this Agreement (but not its
expiration), Novexel shall notify Indevus of the amount of Product
Novexel, its Affiliates and their sublicensees then have on hand or
have committed to purchase or sell. For a period ending upon the
earlier of: (i) Novexel, its Affiliates and their sublicensees
sale of all Product in their possession on the date of termination
of this Agreement, or (ii) the end of the six (6) month
period following such termination (the “ Trailing
Period ”), Novexel, its Affiliates and their sublicensees
shall be permitted to sell such Product and Indevus hereby grants
Novexel a non-exclusive license reasonably necessary to sell such
Product, subject to the payment of royalties at the same rates and
on the same terms and conditions as the royalties set forth in
Section 4.3, on any Net Sales of such Product during the
Trailing Period.
9.4.3 Termination by Novexel by
Notice . If Novexel terminates this Agreement pursuant to
Section 9.2.1, the following shall be applicable:
|
|
(a)
|
Indevus shall have a [*] period
to determine whether it wishes to obtain a license under the
Novexel Patent Assets and Novexel Know-How. Upon Indevus’
written request and expense, Novexel shall reasonably cooperate to
facilitate Indevus decision-making, including providing Indevus
with reasonable access to the Novexel Patent Assets and Novexel
Know-How. If Indevus decides to license the Novexel Patent Assets
and the Novexel Know-How, it shall so notify Novexel in writing and
the Parties shall then immediately execute a license (the “
Automatic License ”) identical, except for the
following changes, to the 2003 License: (i) Aventis shall be
replaced by Novexel as the licensor and in all other aspects
(except with respect to those provisions specifically not assigned
to Novexel by Aventis, in particular the commitment to supply
Nucleus or Nucleus intellectual property, which is addressed in
subsection (iv) below; (ii) any milestone events set
forth in the 2003 License already achieved as of the effective date
of the termination of this Agreement shall be deleted;
(iii) the License Fee in Section 5.1 of the 2003
Agreement shall be replaced by a payment equal to the amount of all
patent costs on the Novexel Patent Assets paid by Novexel during
the period commencing on the Effective Date and expiring on the
effective date of the termination of this Agreement, as evidenced
by appropriate back-up documentation, up to a maximum [*] per year
during such period; (iv) Novexel’s rights under the Side
Agreement shall be assigned to Indevus on and subject to the same
terms and conditions as set forth in the Side Agreement or any
supply agreement between Aventis and Novexel with respect to the
Nucleus then in effect; and (v) in the event Indevus advises
that it desires to include in the Automatic License any Novexel
Patent Asset that was acquired by Novexel from a Third Party after
the Effective Date (other than in connection with a royalty-bearing
license) (a “ New Novexel Patent
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|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
Page 23
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|
Asset ”), the Parties shall negotiate in good
faith any additional consideration to be payable by Indevus to
Novexel for the rights to such New Novexel Patent Asset. If Indevus
advises Novexel in writing that it does not wish to obtain the
Automatic License under the Novexel Patent Assets and Novexel
Know-How, then Indevus shall have no further rights with respect to
the Novexel Patent Assets and Novexel Know-How, and Novexel shall
have no further obligation to Indevus with respect to the Novexel
Patent Assets and Novexel Know-How; and
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|
|
(b)
|
In the event
Indevus elects to license the Novexel Patent Assets and Novexel
Know-How in accordance with Section 9.4.3(a), (i) Novexel
will, if requested by Indevus, cooperate with Indevus or
Indevus’ designee to transfer to Indevus or Indevus’
designee the supervision of any ongoing clinical trial in such a
way that no delay incurs in such clinical trial, if the termination
of such trial would materially adversely affect the development of
Product and Indevus has advised Novexel that it intends to continue
development of Product; (ii) Novexel will promptly upon having
sent such notice transfer to Indevus or Indevus’ designee all
data, files, INDs, Regulatory Approvals, if any, and information,
data, Novexel Know-how, etc in the possession of Novexel and
related to Compound or Product; (iii) Indevus will be entitled
to start negotiations with Third Parties in relation to Compound or
Product immediately upon receipt of such notice; and
(iv) Novexel will provide Indevus with reasonable assistance
that Indevus may request in responding to due diligence requests by
Third Parties that Indevus is negotiating with as potential
licensees for Compound or Product, provided that Novexel shall not
be required to disclose to such Third Parties Novexel Proprietary
Information that does not relate to Compound or Product.
|
9.4.4 Termination by Indevus for
Cause. If Indevus terminates this Agreement pursuant to
Section 9.2.2(a), the provisions of Section 9.4.3 shall
be applicable except that in the event that Indevus advises that it
desires to include in the Automatic License any Novexel Know-How
that was developed by Novexel after the Effective Date (other than
Novexel Know-How included in a New Novexel Patent Asset), the
Parties shall negotiate in good faith any additional consideration
to be payable by Indevus to Novexel for the rights to such new
Novexel Know-How, provided, however , that the nature of the
breach by Novexel shall be a principal component in determining the
amount of any such additional consideration.
9.4.5 Termination by Novexel for
Cause . If Novexel terminates this Agreement pursuant to
Section 9.2.2, effective as of the effective date of such
termination, if requested by Novexel, the Parties shall immediately
enter into a new, mutually agreeable agreement granting Novexel the
same rights and obligations that were granted by Indevus to and
assumed by Novexel under this Agreement, and providing for
compensation to Indevus which will be negotiated in good faith
between the Parties.
Page 24
9.4.6 Survival . In addition
to any other provisions of this Agreement which by their terms
continue after the expiration of this Agreement, the provisions of
Article VII shall survive the expiration or termination of this
Agreement and shall continue in effect for five (5) years from
the date of expiration or termination (subject to the changes
thereto as set forth in the Automatic License). In addition, any
other provision required to interpret and enforce the
Parties’ rights and obligations under this Agreement shall
also survive, but only to the extent required for the full
observation and performance of this Agreement.
9.4.7 Non-Exclusive Right .
Except as expressly set forth herein, the rights to terminate as
set forth herein shall be in addition to all other rights and
remedies available under this Agreement, at law, or in equity, or
otherwise.
ARTICLE X
MISCELLANEOUS
|
|
10.1
|
Force
Majeure . Neither Party
shall be held liable or responsible to the other Party nor be
deemed to have defaulted under or breached the Agreement for
failure or delay in fulfilling or performing any term of the
Agreement during the period of time when such failure or delay is
caused by or results from causes beyond the reasonable control of
the affected Party including, but not limited to, fire, flood,
embargo, war, acts of war (whether war be declared or not),
terrorism, insurrection, riot, civil commotion, strike, lockout or
other labor disturbance, factory shutdowns, failure of public
utilities or common carriers, act of God or act, omission or delay
in acting by any governmental authority or the other Party. The
affected Party shall notify the other Party of such force majeure
circumstances as soon as reasonably practicable.
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|
|
10.2
|
Assignment . The Agreement may not be assigned or otherwise
transferred without the prior written consent of the other Party;
provided , however , that either Party may assign
this Agreement to an Affiliate or in connection with the transfer
or sale of its business or all or substantially all of its assets
to which this Agreement relates or in the event of a merger,
consolidation, change in control or similar corporate transaction.
Any permitted assignee shall assume in writing all obligations of
its assignor under this Agreement.
|
|
|
10.3
|
Severability . In the event that any of the provisions
contained in this Agreement are held invalid, illegal or
unenforceable in any respect, the validity, legality and
enforceability of the remaining provisions contained herein shall
not in any way be affected or impaired thereby, unless the invalid
provisions are of such essential importance for this Agreement that
it is to be reasonably assumed that the Parties would not have
entered into this Agreement without the invalid provisions. In such
event, the Parties shall substitute such invalid provisions by
valid ones, which in their economic effect come so close to the
invalid provisions that it can be reasonably assumed that the
Parties would have entered into this Agreement also with those
substituted provisions.
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Page 25
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|
10.4
|
Notices . All notices or other communications which are
required or permitted hereunder shall be in writing and sufficient
if delivered personally, sent by facsimile (and promptly confirmed
by personal delivery, registered or certified mail or overnight
courier), sent by nationally-recognized overnight courier or sent
by registered or certified mail, postage prepaid, return receipt
requested, addressed as follows:
|
if to Novexel to:
Novexel SA
Parc Biocitech
102, route de Noisy
F-93230 Romainville
France
Attention: Chief Executive
Officer
Fax No: +33 1 48 46 39 26
if to Indevus to:
Indevus Pharmaceuticals,
Inc.
33 Hayden Avenue
Lexington, MA 02421
Attention: Chief Executive
Officer
Fax No.: 781-862-3859
or to such other address as the
Party to whom notice is to be given may have furnished to the other
Parties in writing in accordance herewith. Any such communication
shall be deemed to have been given when delivered if personally
delivered or sent by facsimile on a Business Day, upon confirmed
delivery by nationally-recognized overnight courier if so delivered
and on the third Business Day following the date of mailing if sent
by registered or certified mail.
|
|
10.5
|
Applicable
Law . The Agreement shall
be governed by and construed in accordance with the laws of the
United States of America and State of New York without reference to
any rules of conflict of laws, except matters of intellectual
property law, which shall be determined in accordance with the
national intellectual property laws relevant to the intellectual
property in question.
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|
|
10.6
|
Dispute
Resolution .
|
10.6.1 Except if a Party reasonably
determines that it must seek a preliminary injunction, temporary
restraining order or other provisional relief, the Parties shall
resolve all claims, disputes, or controversies arising under, out
of, or in connection with this Agreement (a “ Dispute
”) in accordance with the following procedure. The Parties
agree to attempt initially to solve Disputes by conducting good
faith negotiations. Any Disputes which cannot be resolved by good
faith negotiation within [*] Business Days, shall be referred, by
written notice from either Party to the other, to the Chief
Executive Officer of each Party. Such Chief Executive Officers
shall negotiate in good faith to achieve a resolution of the
Dispute referred to them within [*] Business Days after such notice
is received by the Party to whom the notice was sent. If the Chief
Executive
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[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
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Page 26
Officers are unable to settle the
Dispute between them within [*] Business Days, they shall so report
to the Parties in writing. The Dispute shall then be referred to
mediation as set forth in the following subsection
10.6.2.
10.6.2 Upon the Parties receiving
the Chief Executive Officers’ report that the Dispute
referred to them pursuant to subsection 10.6.1 has not been
resolved, the Dispute shall be referred to mediation by written
notice from either Party to the other. The mediation shall be
conducted pursuant to the LCIA Mediation Procedure. In the event
Indevus is the claimant, the mediation shall be held in London,
England; in the event Novexel is the claimant, the mediation shall
be held in Geneva, Switzerland. If the Parties have not reached a
settlement within twenty (20) Business Days of the date of the
notice of mediation, the Dispute shall be referred to arbitration
pursuant to subsection 10.6.3.
10.6.3 If after the procedures set
forth in subsections 10.6.1 and 10.6.2, the Dispute has not been
resolved, a Party shall decide to institute arbitration
proceedings, it shall give written notice to that effect to the
other Party. The Parties shall refrain from instituting the
arbitration proceedings for a period of sixty (60) days
following such notice. During such period, the Parties shall
continue to make good faith efforts to amicably resolve the dispute
without arbitration. If the Parties have not reached a settlement
during that period the arbitration proceedings shall go forward and
be governed by the LCIA Arbitration Rules then in force. Each such
arbitration shall be conducted by a panel of three arbitrators with
appropriate experience in the biotechnology or pharmaceutical
industry: one arbitrator shall be appointed by each of Novexel and
Indevus and the third arbitrator, who shall be the Chairman of the
tribunal, shall be appointed by the two Party-appointed
arbitrators. In the event Indevus is the claimant, the arbitration
shall be held in London, England; in the event Novexel is the
claimant, the arbitration shall be held in Geneva, Switzerland. The
arbitrators shall have the authority to grant specific performance.
Judgment upon the award so rendered may be entered in any court
having jurisdiction or application may be made to such court for
judicial acceptance of any award and an order of enforcement, as
the case may be. In no event shall a demand for arbitration be made
after the date when institution of a legal or equitable proceeding
based on such claim, dispute or other matter in question would be
barred by the applicable statute of limitations. Each Party shall
bear its own costs and expenses incurred in connection with any
arbitration proceeding and the Parties shall equally share the cost
of the mediation and arbitration levied by the LCIA. Any mediation
or arbitration proceeding entered into pursuant to this
Section 10.6 shall be conducted in the English
language.
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10.7
|
Entire
Agreement . This
Agreement, together with the Schedules and Exhibits hereto,
contains the entire understanding of the Parties with respect to
the subject matter hereof. All express or implied agreements and
understandings, either oral or written, heretofore made are
expressly merged in and made a part of this Agreement. This
Agreement may be amended, or any term hereof modified, only by a
written instrument duly executed by all Parties hereto.
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[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
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Page 27
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10.8
|
Independent
Contractors . It is
expressly agreed that the Parties shall be independent contractors
and that the relationship between the Parties shall not constitute
a partnership, joint venture or agency. Neither Party shall have
the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be
binding on the other Party, without the prior consent of such other
Party.
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10.9
|
Waiver . The waiver by a Party hereto of any right
hereunder or the failure to perform or of a breach by another Party
shall not be deemed a waiver of any other right hereunder or of any
other breach or failure by said other Party whether of a similar
nature or otherwise.
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10.10
|
Headings . The captions to the several Articles and
Sections hereof are not a part of the Agreement, but are merely
guides or labels to assist in locating and reading the several
Articles and Sections hereof.
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10.11
|
Counterparts . The Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same
instrument.
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10.12
|
Use of
Names . Except as
otherwise provided in this Agreement, neither Party shall use the
name of the other Party in relation to this transaction in any
public announcement, press release or other public document without
the consent of such other Party, which consent shall not be
unreasonably withheld or delayed; provided , however
, that either Party may use the name of the other Party in any
document required to comply with applicable laws, rules or
regulations.
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10.13.1 Whenever any provision of
this Agreement uses the term “including” (or
“includes”), such term shall be deemed to mean
“including without limitation” and “including but
not limited to” (or “includes without
limitations” and “includes but is not limited
to”) regardless of whether the words “without
limitation” or “but not limited to” actually
follow the term “including” (or
“includes”);
10.13.2 “Herein”,
“hereby”, “hereunder”, “hereof”
and other equivalent words shall refer to this Agreement in its
entirety and not solely to the particular portion of this Agreement
in which any such word is used;
10.13.3 All definitions set forth
herein shall be deemed applicable whether the words defined are
used herein in the singular or the plural;
10.13.4 Wherever used herein, any
pronoun or pronouns shall be deemed to include both the singular
and plural and to cover all genders;
10.13.5 The recitals set forth at
the start of this Agreement, along with the Exhibits and Schedules
to this Agreement, and the terms and conditions incorporated in
such recitals, Exhibits and Schedules shall be deemed integral
parts of this Agreement and all
Page 28
references in this Agreement to this
Agreement shall encompass such recitals, Exhibits and Schedules and
the terms and conditions incorporated in such recitals, Exhibits
and Schedules, provided, that in the event of any conflict between
the terms and conditions of this Agreement and any terms and
conditions set forth in the Exhibits and Schedules, the terms of
this Agreement shall control;
10.13.6 In the event of any conflict
between the terms and conditions of this Agreement and any terms
and conditions that may be set forth on any order, invoice, verbal
agreement or otherwise, the terms and conditions of this Agreement
shall govern;
10.13.7 The Agreement shall be
construed as if both Parties drafted it jointly, and shall not be
construed against either Party as principal drafter;
10.13.8 Unless otherwise provided,
all references to Sections, Schedules and Exhibits in this
Agreement are to Sections, Schedules and Exhibits of and to this
Agreement;
10.13.9 All references to days,
months, quarters or years are references to calendar days, calendar
months, calendar quarters or calendar years unless otherwise
expressly provided;
10.13.10 Any reference to any
federal, national, state, local or foreign statute or law shall be
deemed to also refer to all rules and regulations promulgated
thereunder, unless the context requires otherwise;
10.13.11 Any requirements of notice
or notification by one Party to another shall be construed to mean
written notice in accordance with Section 10.4; and
10.13.12 Wherever used, the word
“shall” and the word “will” are each
understood to be imperative or mandatory in nature and are
interchangeable with one another.
[remainder of page intentionally
left blank]
Page 29
IN WITNESS WHEREOF, the Parties have
executed this Agreement as of the date first set forth
above.
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INDEVUS
PHARMACEUTICALS, INC.
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By:
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/s/ Glenn L. Cooper, M.D.
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Name:
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Glenn L.
Cooper, M.D.
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Title:
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Chairman and
Chief Executive Officer
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NOVEXEL
SA
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By:
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Name:
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Iain
Buchanan
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itle:
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Chief Executive
Officer
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Page 30
SCHEDULE 1.4
BANK
HOLIDAYS-FRANCE
|
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|
|
|
|
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Wednesday
|
|
January 1 (*)
|
|
New Year
Day
|
|
|
|
|
|
Monday
|
|
April 9 (**)
|
|
Easter
Monday
|
|
|
|
|
|
Thursday
|
|
May 1
(*)
|
|
Labour
Day
|
|
|
|
|
|
Thursday
|
|
May 8
(*)
|
|
End of World
War II
|
|
|
|
|
|
Thursday
|
|
May 17 (**)
|
|
Ascension
|
|
|
|
|
|
Monday
|
|
May 28 (**)
|
|
Whit
Monday
|
|
|
|
|
|
Monday
|
|
July 14
(*)
|
|
National
Day
|
|
|
|
|
|
Friday
|
|
August 15 (**)
|
|
Assumption
|
|
|
|
|
|
Saturday
|
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November 1 (*)
|
|
All
Saints’ Day
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|
|
|
|
|
Tuesday
|
|
November 11 (*)
|
|
End of World
War I
|
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|
|
|
|
Thursday
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December 25 (*)
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Christmas
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(*)
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Every year
on same date
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(**)
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Dates are
for 2007 , but for following years, since they are catholic
religious feasts , they are worldwide identical
dates.
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SCHEDULE 1.8
COMPOUND
[*]
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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SCHEDULE 1.13
INDEVUS KNOW-HOW
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1.
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Complete
reports of all clinical trials undertaken including all adverse
events identified by clinical investigators
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a.
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Phase-I single
dose study
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b.
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Phase I
multi-dose study (terminated due to injection site irritation
issues)
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c.
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Phase I
multi-dose study with modified administration (terminated due to
injection site irritation issues)
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2.
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Complete
reports and data from all formulation work including animal
studies
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3.
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All records
(including batch records and GMP certifications) relating to
synthesis, storage and transport of Inventory listed in Schedule
1.14
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4.
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All
correspondence with regulatory agencies relating to
Compound
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5.
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All
correspondence with ethics committees and clinical investigators
relating to Compound
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6.
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Copies of all
publications relating to Compound
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SCHEDULE 1.14
INVENTORY
[*]
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[*]
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CONFIDENTIAL
TREATMENT REQUESTED
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SCHEDULE 1.20
NOVEXEL PATENT
ASSETS
[*]
|
[*]
|
CONFIDENTIAL
TREATMENT REQUESTED
|
SCHEDULE 3.5
AGREEMENTS
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|
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|
|
|
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Task/Agreement Type
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|
Dates
|
[*]
|
[*]
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CONFIDENTIAL
TREATMENT REQUESTED
|
- 2 -
EXHIBIT A
SIDE AGREEMENT
[SEE ATTACHED]
- 3 -
NOVEXEL
novel therapies for infectious
disease
AVENTIS PHARMA SA
20 avenue Raymond Aron
92165 Antony
France
TO WHOM IT MAY CONCERN
This letter is to inform you that
Novexel is finalizing an agreement with Indevus whereby the rights
to aminocandins licensed to Indevus by Aventis Pharma SA
(“Aventis”) under the 18 April 2003 License
Agreement will be transferred to Novexel. As you are aware, the
rights and obligations of Aventis under this License Agreement were
transferred to Novexel as of December 1, 2004. However, the
part of the License Agreement that dealt with supply of Nucleus
remained with Aventis.
Novexel requests that the rights and
obligations of Indevus under the License Agreement in Sections
3.1.2 and 3.8 now be assigned to Novexel. In the event the
aforesaid agreement between Indevus and Novexel is terminated and
Indevus reacquires the rights consistent with the License
Agreement, these rights and obligations under Sections 3.1.2 and
3.8 shall be reassigned back to Indevus, upon joint notification by
Novexel and Indevus to Aventis, thereto. The text of these Sections
is reproduced below.
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3.1.2
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As long as AVENTIS manufactures
and supplies or, in accordance with the provisions of
Section 3.8 (a) hereof, AVENTIS’ permitted assignee
manufactures and supplies, INDEVUS with Nucleus, in each case in
accordance with the supply agreement contemplated by
Section 3.8 (a) hereof, AVENTIS shall not be required to
disclose or transfer to INDEVUS that portion of the AVENTIS
Intellectual Property specifically covering the manufacturing
process for the Nucleus, provided, however, that such information
and AVENTIS Intellectual Property shall at all times be included in
the Drug Master File relating to Compound and/or Product and
AVENTIS hereby grants INDEVUS all rights of reference thereto. In
the event that (i) AVENTIS and INDEVUS have not entered into
such supply agreement relating to the manufacture and supply of the
Nucleus by AVENTIS in the time period set forth in Section 3.8
hereto, or (ii) the Parties have entered into such supply
agreement but for any reason AVENTIS or AVENTIS’ permitted
assignee of such manufacturing right decides not to, or for any
other reason, does not manufacture and supply INDEVUS with the
Nucleus, AVENTIS shall promptly transfer to INDEVUS all AVENTIS
Intellectual Property relating to the manufacturing process for the
Nucleus and shall provide to INDEVUS in establishing a Third Party
manufacturer of the Nucleus such reasonable assistance as can be
expected to be needed by a manufacturer having a reasonably high
level of knowledge and experience in the manufacturing of
comparable products. Such assistance will be provided free of
charge to the extent
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- 4 -
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that information has to be
supplied, and on the basis of cost reimbursement if any employee of
AVENTIS has to come on the concerned manufacturing premise, which
in any case should be for a limited period of time, to be specified
in the aforesaid supply agreement.
|
3.8 Manufacturing and
Supply . INDEVUS shall
have all rights and responsibility relating to chemistry,
manufacturing and control for clinical and commercial use of
Compound or Product such as but not limited to process development,
scale up and manufacturing of Compound and Product, subject to the
following:
(a) Manufacture of Nucleus. AVENTIS
shall retain the right to manufacture and supply or, subject to the
provisions of this Section 3.8 (a), have manufactured or have
supplied the Nucleus for additional clinical trials and for
commercial use by INDEVUS, provided that (i) AVENTIS can
manufacture and supply, or any Third Party manufacturer that is a
permitted assignee of AVENTIS’ rights under this
Section 3.8 (a) can manufacture and supply, the Nucleus
in accordance with cGMP and other regulatory requirements; and
(ii) AVENTIS shall not have the right to assign its rights
under this Section 3.8 (a) to a Third Party manufacturer
or supplier of the Nucleus, without INDEVUS’ prior written
consent, except with a sale or other divesture of the manufacturing
site where the Nucleus is manufactured; and (iii) any such
manufacture and supply is in accordance with the terms of the
agreement referred to in the next sentence. INDEVUS and AVENTIS
shall negotiate in good faith to enter into a manufacturing and
supply agreement between the Parties
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