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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:
Page 1
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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Page 2
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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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Page 3
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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):
|
|
|
(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.
|
|
|
(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.
| |
|
|
|
|
Annual Net Sales in all countries in the
Territory:
|
|
Royalty Rate
|
|
|
|
|
5
|
%
|
-
Greater than or equal to US$500,000,000 and less
than US$1,000,000,000
|
|
6
|
%
|
|
|
|
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
|
|
(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,
|
|
|
(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
|
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
|
|
[*]
|
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.
|
|
|
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.
|
|
[*]
|
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
|
|
[*]
|
CONFIDENTIAL TREATMENT
REQUESTED
|
Page 23
|
|
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
|
|
|
(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.
|
|
|
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.
|
Page 25
|
|
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.
|
|
|
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
|
[*]
|
CONFIDENTIAL TREATMENT
REQUESTED
|
Page 26
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-
-
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.
|
|
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.
|
|
[*]
|
CONFIDENTIAL TREATMENT
REQUESTED
|
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.
|
|
|
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.
|
|
|
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.
|
|
|
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.
|
-
-
-
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
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-
-
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:
|
|
/s/ Glenn L. Cooper, M.D.
|
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Name:
|
|
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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/s/ Iain Buchanan
|
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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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Wednesday
|
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January 1 (*)
|
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New Year Day
|
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Monday
|
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April 9 (**)
|
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Easter Monday
|
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|
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Thursday
|
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May 1 (*)
|
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Labour Day
|
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Thursday
|
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May 8 (*)
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End of World War II
|
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Thursday
|
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May 17 (**)
|
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Ascension
|
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Monday
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May 28 (**)
|
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Whit Monday
|
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Monday
|
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July 14 (*)
|
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National Day
|
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Friday
|
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August 15 (**)
|
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Assumption
|
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|
|
Saturday
|
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November 1 (*)
|
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All Saints’ Day
|
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Tuesday
|
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November 11 (*)
|
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End of World War I
|
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Thursday
|
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December 25 (*)
|
|
Christmas
|
|
(*)
|
Every year on same date
|
|
(**)
|
Dates are for 2007 , but for following
years, since they are catholic religious feasts , they are
worldwide identical dates.
|
SCHEDULE 1.8
COMPOUND
[*]
|
[*]
|
CONFIDENTIAL TREATMENT
REQUESTED
|
SCHEDULE 1.13
INDEVUS KNOW-HOW
|
|
1.
|
Complete reports of all clinical trials
undertaken including all adverse events identified by clinical
investigators
|
|
|
a.
|
Phase-I single dose study
|
|
|
b.
|
Phase I multi-dose study (terminated due to
injection site irritation issues)
|
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|
c.
|
Phase I multi-dose study with modified
administration (terminated due to injection site irritation
issues)
|
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|
2.
|
Complete reports and data from all formulation
work including animal studies
|
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|
3.
|
All records (including batch records and GMP
certifications) relating to synthesis, storage and transport of
Inventory listed in Schedule 1.14
|
|
|
4.
|
All correspondence with regulatory agencies
relating to Compound
|
|
|
5.
|
All correspondence with ethics committees and
clinical investigators relating to Compound
|
|
|
6.
|
Copies of all publications relating to
Compound
|
SCHEDULE 1.14
INVENTORY
[*]
|
[*]
|
CONFIDENTIAL TREATMENT
REQUESTED
|
SCHEDULE 1.20
NOVEXEL PATENT ASSETS
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CONFIDENTIAL TREATMENT
REQUESTED
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SCHEDULE 3.5
AGREEMENTS
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Facility and Address
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Task/Agreement Type
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Dates
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CONFIDENTIAL TREATMENT
REQUESTED
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EXHIBIT A
SIDE AGREEMENT
[SEE ATTACHED]
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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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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.
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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
containing mutually acceptable terms within ninety (90) days
after the Effective Date, which shall set forth the terms and
conditions of the manufacturing and supply of the Nucleus.
(b) Other Manufacturing. In connection with any other
manufacturing and supply of Compound and/or Product, INDEVUS will
consider AVENTIS in priority to any Third Party, as such
manufacturer and supplier.
If you are in agreement with these changes, please acknowledge
by having this letter signed by an authorized member of your
company.
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Best regards,
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For Novexel S.A.
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For Indevus Pharmaceuticals Inc.
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