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EXHIBIT 10.1
Confidential treatment has been requested for portions of this
Exhibit. The copy
filed herewith omits the information subject to the
confidentiality request.
Omissions are designated by ***. A complete version of this
exhibit has been
filed separately with the Securities and Exchange
Commission.
LICENSE AGREEMENT
BY AND BETWEEN
CHICAGO LABS, INC.
AND
SPECTRUM PHARMACEUTICALS, INC.
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LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this "AGREEMENT"), entered into as of
February
18, 2005 (the "EFFECTIVE DATE"), by and between CHICAGO LABS,
INC., an Illinois
corporation ("CHICAGO LABS"), and SPECTRUM PHARMACEUTICALS,
INC., a Delaware
corporation ("SPECTRUM"). Chicago Labs and Spectrum may each be
referred to
herein individually as a "PARTY" and collectively as the
"PARTIES."
RECITALS
A. Whereas, Chicago Labs is the exclusive worldwide licensee
under the
University License Agreement (defined below) for the patent
rights and know-how
owned by University to an invention (the "Invention") entitled
"Evidence for
prevention and therapeutic use of endothelin ET-B receptor
antagonists in breast
tumor" and has developed additional know-how concerning the
Invention.
B. Whereas, the Invention is the subject of United States
patent
application entitled "Method and composition for preventing and
treating solid
tumors," US Patent application publication number US
2004/0138121A1, publication
date July 15, 2004; and the international application published
under the Patent
Cooperation Treaty, international publication number WO
2004/037235 A2,
international publication date May 6, 2004; both owned by the
Board of Trustees
of the University of Illinois.
C. Whereas, Spectrum is engaged in the development and
eventual
marketing, sale and licensing of pharmaceutical products and
desires to have
access to the Invention and Chicago Labs' proprietary
discoveries and
technologies relating to the Invention.
D. Whereas, Chicago Labs and Spectrum desire to enter into a
license
agreement whereby Spectrum shall obtain the right to use the
Invention and
Chicago Labs' proprietary discoveries and technologies relating
to the Invention
to develop and commercialize products or methods for the
prevention and/or
treatment of cancer.
NOW, THEREFORE, in consideration of the mutual covenants and
conditions
set forth herein, Chicago Labs and Spectrum hereby agree as
follows:
AGREEMENT
1. DEFINITIONS. Capitalized terms shall have the meaning set
forth below.
1.1 AFFILIATE. The term "Affiliate" shall mean any entity
which
directly or indirectly controls, is controlled by, or is under
common control
with Spectrum or Chicago Labs, as applicable. The term "control"
as used in this
definition means having (i) more than fifty percent (50%)
ownership of the
assets,
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profit interest or outstanding voting securities or (ii) the
power to direct or
cause the direction of the management and the policies of an
entity, whether by
contract or otherwise.
1.2 CHICAGO LABS KNOW-HOW. The term "Chicago Labs Know-how"
shall mean
Chicago Labs methods, processes, techniques and data that relate
to the Chicago
Labs Patent Rights or the Chicago Labs Materials which are
necessary or useful
for researching, developing, manufacturing, using or selling a
Product, now or
in the future owned or Controlled by Chicago Labs, whether or
not: (i) the same
is eligible for protection under the patent laws of the United
States or
elsewhere; (ii) enforceable as a trade secret; or (iii) the
copying of which
would be enjoined or restrained by a court as constituting
unfair competition.
The Chicago Labs Know-how in existence as of the Effective Date
is contained in
the documents listed in the attached Exhibit A.
1.3 CHICAGO LABS MATERIALS. The term "Chicago Labs Materials"
shall
mean the materials provided by Chicago Labs to Spectrum under
this Agreement as
set forth in Exhibit B, as the same may be amended by the
Parties from time to
time.
1.4 CHICAGO LABS PATENT RIGHTS. The term "Chicago Labs Patent
Rights"
shall mean United States patent application entitled "Method and
composition for
preventing and treating solid tumors," US Patent application
publication number
US 2004/0138121A1, publication date July 15, 2004; and the
international
application published under the Patent Cooperation Treaty,
international
publication number WO 2004/037235 A2, international publication
date May 6,
2004; all rights (including without limitation all US and
foreign Patents)
arising out of or resulting from such patent applications; and
any other U.S.
and foreign Patents now or in the future owned or Controlled by
Chicago Labs
having claims covering or directed to the Inventions, the
Chicago Labs Know-how,
the Chicago Labs Materials or the preventative and/or
therapeutic use of
endothelin ET-B receptor antagonists and/or agonists in cancer
related
applications.
1.5 CHICAGO LABS TECHNOLOGY. The term "Chicago Labs Technology"
shall
mean the Chicago Labs Patent Rights, Chicago Labs' rights
arising out of or
resulting from Patents to Joint Inventions and Improvements,
Chicago Labs
Know-how and Chicago Labs Materials.
1.6 CONFIDENTIAL INFORMATION. The term "Confidential
Information" shall
mean all know-how, trade secrets and other proprietary or
confidential
information of a disclosing Party or held by the disclosing
Party under an
obligation of confidentiality to a Third Party, which may be
disclosed from one
Party to the other Party at any time and from time to time
during the term of
this Agreement. "Confidential Information" shall include the
terms of this
Agreement as well as any proprietary or confidential information
that is jointly
owned by the Parties. Information shall not be considered
Confidential
Information to the extent such information:
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(a) 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;
(b) is properly in the public domain;
(c) is subsequently disclosed to the receiving Party by a
Third
Party who may lawfully do so and is not under an obligation
of
confidentiality to the disclosing Party; or
(d) is developed by the receiving party independently of
Confidential lnformation received from the disclosing Party,
as documented by research and development records.
Nothing in this definition shall preclude a Party from use or
disclosure of any
proprietary or Confidential Information owned by that Party
where the other
Party has no rights of ownership.
1.7 CONTROLLED. The term "Controlled" shall mean possessing the
ability
to grant a license or sublicense without violating (i) any
applicable law or
governmental regulation or (ii) the terms of an agreement with a
Third Party
that has an effective date which predates the Effective Date
hereof.
1.8 DEVELOPMENT COMMITTEE. The term "Development Committee"
shall have
the meaning given such term in Section 2.1.
1.9 EMEA. The term "EMEA" shall mean the European Agency for
the
Evaluation of Medicinal Products, any successor agency thereto
(European
Medicines Agency) or any equivalent replacement agency having
substantially the
same functions.
1.10 EVENT OF DEFAULT. The term "Event of Default" shall have
the
meaning set forth in Section 11.4.1 of this Agreement.
1.11 FDA. The term "FDA" shall mean the United States Food and
Drug
Administration, or any successor agency thereto.
1.12 FIRST COMMERCIAL SALE. The term "First Commercial Sale"
shall
mean, with respect to any Product, the first sale for end use or
consumption of
such Product in a country after all required approvals,
including marketing and
pricing approvals, have been granted by the governing Regulatory
Authority of
such country.
1.13 GAAP. The term "GAAP" shall mean generally accepted
accounting
principles in the United States or International Accounting
Standards outside
the United States, in each case as consistently applied by
Spectrum, its
Affiliates, its sublicensees or its distributors in their
respective financial
statements, audited if applicable.
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1.14 IMPROVEMENTS. The term "Improvements" shall mean one or
more
enhancements, improvements or modifications in the manufacture,
formulation,
conjugations, ingredients, preparation, dosage, administration
or packaging of a
Product or the Chicago Labs Technology.
1.15 IND. The term "IND" shall mean (i) an Investigational New
Drug
application as defined in the United States Food, Drug &
Cosmetic Act and
applicable regulations promulgated thereunder, as amended from
time to time or
(ii) an equivalent application or filing with the applicable
Regulatory
Authority in any country other than the United States allowing
the commencement
of human clinical trials.
1.16 INVENTION. The term "Invention" is defined in Recital A
above.
1.17 JOINT INVENTIONS. The term "Joint Inventions" shall have
the
meaning set forth in Section 5.1 of this Agreement.
1.18 JOINT PATENT. The term "Joint Patent" shall mean any Patent
filed
with respect to a Joint Invention.
1.19 LICENSED FIELD. The term "Licensed Field" shall mean
the
prevention and/or treatment of cancer.
1.20 MILESTONE PAYMENT. The term "Milestone Payment" shall mean
the
payments from Spectrum to Chicago Labs under Section 4.4.
1.21 NDA. The term "NDA" shall mean a New Drug Application, as
defined
in the United States Food, Drug & Cosmetic Act and
applicable regulations
promulgated thereunder, as amended from time to time, to obtain
approval from
the FDA for commercial sale of a Product, or an equivalent
application or filing
with the applicable Regulatory Authority in any country other
than the United
States.
1.22 NET SALES. The term "Net Sales" shall mean the amount
received by
Spectrum, its Affiliates, its sublicensees or distributors on
account of sales
of a Product to Third Parties in the Territory, less the
following deductions to
the extent actually allowed or specifically allocated to the
Product by the
selling party using GAAP and not separately invoiced: (i) sales
and excise taxes
and duties paid or allowed by the selling party and any other
governmental
charges imposed upon the production, importation, use or sale of
such Product;
(ii) customary trade, quantity and cash discounts allowed on
Product; (iii)
allowances or credits to customers on account of rejection or
return of Product
or on account of retroactive price reductions affecting such
Product; (iv)
freight and insurance costs; (v) rebates, chargebacks and other
amounts paid on
sale or dispensing of the Product; and (vi) the booked cost of
devices or
systems used for delivering a Product into the patient where the
Product when
sold is a
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combination of the active pharmaceutical ingredient and the
device or system.
For the avoidance of doubt, for each Product the Net Sales shall
be calculated
only once for the first sale of such Product by either Spectrum,
its Affiliate,
its sublicensee or its distributor, as the case may be, to a
Third Party which
is neither an Affiliate, sublicensee or distributor of Spectrum.
A sale of
Products by Spectrum, its Affiliate, its sublicensee or its
distributor to a
wholesaler shall be regarded as the first sale of the Product
for the purpose of
calculating Net Sales unless such sale is made by one of them
directly to a
hospital, pharmacy, physician, retailer or other entity which
provides the
Product to the patient in which case the first sale shall be the
sale to such
hospital, pharmacy, physician, retailer or other entity. Net
Sales shall not
include the amount received on account of sales of a Product or
of sales of a
Product in a particular country for which the term of this
Agreement has expired
in accordance with Section 11.1 on or before the date of the
invoice for such
sales.
1.23 PATENT. The term "Patent" shall mean any and all unexpired
patent
applications, provisional patent applications and any patent
issuing therefrom
worldwide, together with any extensions, registrations,
confirmations, reissues,
continuations, divisions, continuations-in-part, reexamination
certificates,
confirmations, registrations, revalidations, additions,
supplementary protection
certificates, substitutions or renewals thereof and any patents
anywhere in the
world, claiming the priority date of any of the foregoing.
1.24 PHASE I CLINICAL TRIAL. The term "Phase I Clinical Trial"
shall
mean those further and lawful studies of a Product conducted
anywhere in the
Territory that the applicable Regulatory Authority requires to
be performed on a
sufficient number of healthy human patients to generate
sufficient data to
establish the safety and biological activity of that Product,
and to permit
commencement of a Phase II Clinical Trial.
1.25 PHASE II CLINICAL TRIAL. The term "Phase II Clinical Trial"
shall
mean those further and lawful studies of a Product conducted
anywhere in the
Territory that the applicable Regulatory Authority requires to
be performed on a
sufficient number of human patients with the condition treated
by the Product to
generate sufficient data to establish the safety, and biological
activity of
that Product for its intended use and to permit commencement of
a Phase III
Clinical Trial.
1.26 PHASE III CLINICAL TRIAL. The term "Phase III Clinical
Trial"
shall mean those controlled and lawful studies of a Product
conducted anywhere
in the Territory on sufficient numbers of patients with the
condition treated by
the Product that are prospectively designed, using predetermined
endpoints, to
demonstrate clinically and statistically the efficacy and safety
of that Product
for one or more indications as a pivotal study intended to lead
to regulatory
approval of such Product for such indication or indications.
1.27 PRODUCT. The term "Product" shall mean any product,
including
products under
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development and products approved by a Regulatory Authority,
that includes, is
based upon or is derived from the Chicago Labs Technology. The
term "Products"
shall mean more than one Product.
1.28 PRODUCT LICENSE. The term "Product License" shall have the
meaning
set forth in Section 3.1.
1.29 REGULATORY AUTHORITY. The term "Regulatory Authority" shall
mean
the principal governmental organization or agency that has the
right to approve
the sale and, if applicable price, of Products in a given
country, including,
without limitation, the FDA, the EMEA and the Ministry of
Health, Labour and
Welfare in Japan.
1.30 ROYALTY TERM. The term "Royalty Term" shall have the
meaning set
forth in Section 4.5.5.
1.31 SUBLICENSE. The terms "Sublicense" and "Sublicenses" shall
have
the meanings set forth in Section 3.2.
1.32 TERRITORY. The term "Territory" shall mean all of the
countries in
the world (including their territories and possessions).
1.33 THIRD PARTY. The term "Third Party" shall mean any person
or
entity other than a Party hereto or an Affiliate.
1.34 UNIVERSITY. The term "University" shall mean the Board of
Trustees
of the University of Illinois.
1.35 UNIVERSITY LICENSE AGREEMENT. The term "University
License
Agreement" shall mean the Exclusive License Agreement dated
August 15, 2003
between Chicago Labs and the University, a certified copy of
which has been
delivered to Spectrum concurrent with the execution of this
Agreement, as may be
amended from time to time as permitted by this Agreement.
1.36 VALID CLAIM. The term "Valid Claim" shall mean a claim in
any
unexpired, issued patent within the Chicago Labs Patent Rights
which has not
been held invalid and/or unenforceable in a decision by a court
or other body of
competent jurisdiction from which there is no appeal or, if
appealable, from
which no appeal has been taken.
2. RESEARCH AND DEVELOPMENT PROGRAM.
2.1 DEVELOPMENT COMMITTEE. After the Effective Date, Spectrum
shall
establish a committee (the "DEVELOPMENT COMMITTEE") to be
responsible for
planning, overseeing and directing the development and
commercialization of, and
regulatory filings relating to, Products. One representative
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from Chicago Labs shall be allowed to participate in all
meetings of the
Development Committee on a consultative basis and to receive
copies of all
minutes, if any, of the Development Committee's deliberations.
The Development
Committee shall meet at least quarterly until such time as the
first NDA for a
Product is filed and then as appropriate to keep the Parties'
representatives
informed thereafter. The President of Chicago Labs shall appoint
Chicago Labs'
representative and may change such representative from time to
time on written
notice to Spectrum.
3. PRODUCT LICENSE.
3.1 PRODUCT LICENSE. Chicago Labs hereby grants to Spectrum
an
exclusive (even as to Chicago Labs), right and license under
Chicago Labs'
rights to use the Chicago Labs Technology to develop, make, have
made, use,
offer for sale, sell, have sold, distribute, import, and export
Products in the
Licensed Field in the Territory (the "PRODUCT LICENSE").
Spectrum acknowledges
that (i) Chicago Labs' rights to use "Know How" under the
University License
Agreement are nonexclusive and (ii) the grant of rights under
the Chicago Labs
Patent Rights is qualified by the scope of the claims under the
Patents included
in such Chicago Labs Patent Rights. The Product License shall
not be construed
to confer any rights upon Spectrum by implication, estoppel or
otherwise as to
any technology not included in the Chicago Labs Technology.
Notwithstanding any
other provisions of this Agreement, Chicago Labs retains the
rights to use and
license Chicago Labs Know-how outside the Licensed Field. In
addition, Chicago
Labs hereby grants to Spectrum an exclusive (even as to Chicago
Labs),
perpetual, royalty-free, license to any Product that may be used
for the
diagnosis of cancer that was developed by Spectrum using the
Chicago Labs
Know-how. The use of the Chicago Labs Know-how to develop such a
Product shall
not be a breach by Spectrum of the terms of this Agreement.
3.2 SUBLICENSES. Spectrum shall have the right, but not the
obligation,
to grant sublicenses (one a "Sublicense; more than one
"Sublicenses") under the
Product License to its Affiliates and Third Parties, provided,
however, that any
such sublicense shall be subject to and in all material respects
consistent with
the material terms and conditions of this Agreement, including
but not limited
to the following:
3.2.1 Termination. Every Sublicense shall contain a
statement
describing the date upon which Chicago Lab's exclusive rights,
privileges and
license under the University License Agreement shall
terminate.
3.2.2 Binding Terms From University License Agreement.
Spectrum
shall be bound by the obligations of Chicago Labs of Articles 5,
7.1, 7.3, 8, 9,
10 and 15.4 of the University License Agreement as if it were a
party to the
University License Agreement. Spectrum acknowledges that Chicago
Labs has
provided it with a certified true copy of the University License
Agreement
containing such Articles. Further any Sublicenses granted by
Spectrum shall
provide that the obligations
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to Chicago Labs of such Articles shall be binding upon the
sublicensee as if it
were a party to the University License Agreement. Spectrum shall
attach copies
of such Articles to all Sublicenses or faithfully reproduce such
Articles within
such Sublicenses.
3.2.3 Copy of Sublicenses. Spectrum shall forward to University
and
Chicago Labs a copy of any and all fully executed Sublicenses,
and shall forward
to Chicago Labs *** a copy of such reports received by Spectrum
from its
sublicensees during the preceding *** period under the
Sublicenses as shall be
pertinent to a royalty accounting under said Sublicenses.
Spectrum may redact
from such Sublicenses any terms that are not relevant to the
Products so long as
the terms that are relevant to the Products, including the terms
related to the
royalties payable on such Products thereunder, remain
comprehensible. In the
event that the terms of a Third Party agreement prevent Spectrum
from providing
a copy of Spectrum's Sublicense with the Third Party, Spectrum
shall provide a
summary in sufficient detail to enable Chicago Labs to calculate
and verify the
royalties payable to Chicago Labs with respect to such
Sublicense.
3.3 UNIVERSITY LICENSE AGREEMENT. Spectrum acknowledges that
under the
University License Agreement, University retained the right to
practice the
Chicago Labs Patent Rights and Know How (as defined in Articles
1.13 and 1.8
respectively of the University License Agreement) for its own
non-commercial
teaching and research activities, the results of which shall not
be used for any
commercial purpose without the prior consent of Chicago Labs.
Chicago Labs shall
not grant such consent to University without the prior written
consent of
Spectrum which shall not be unreasonably withheld, provided that
it shall not be
considered unreasonable for Spectrum to withhold its consent if
the commercial
purpose might compete with the Products or any products that
Spectrum develops
or markets, directly or indirectly.
3.4 MATERIAL TRANSFER.
3.4.1 Chicago Labs Materials. Chicago Labs shall transfer
those
Chicago Labs Materials, if any, described in Exhibit B to
Spectrum together with
the data related thereto on or about the delivery dates set
forth in Exhibit B.
Spectrum shall also have the right to further transfer the
Chicago Labs
Materials transferred hereunder to its Affiliates or
sublicensees, solely in
accordance with Sections 3.2 and 3.4, under a sublicense or
material transfer
agreement consistent with the terms of this Agreement.
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3.4.2 Transfer and Use. The Parties shall mutually agree on
the
method for packaging and delivering Chicago Labs Materials, and
Chicago Labs
transferring its materials to Spectrum which shall bear all
costs of generating,
preparing, packaging and delivering such materials. Each Party
understands and
agrees that Chicago Labs Materials may have unpredictable and
unknown biological
and/or chemical properties and that they are to be used with
caution. Spectrum,
its Affiliates and sublicensees will use Chicago Labs Materials
subject to the
terms of this Agreement, and in material compliance with
applicable laws and
regulations, including but not limited to, any laws or
regulations relating to
the research, testing, production, storage, transportation,
export, packaging,
labeling or other authorized use of such materials.
4. FINANCIAL TERMS AND CONDITIONS.
4.1 INITIAL FEE. Spectrum shall pay to Chicago Labs a fee of
One
Hundred Thousand Dollars ($100,000). Such payment shall be made
within *** days
after the Effective Date.
4.2 INITIAL RESEARCH AND DEVELOPMENT FUNDING ESTIMATES AND
ADDITIONAL
PAYMENTS. The Parties estimate that the development costs
required to complete a
work program consisting of completion of preclinical testing and
filing an IND
to be approximately *** to ***. Beginning on the date *** after
the Effective
Date, Spectrum shall pay to Chicago Labs ***. Furthermore,
***.
4.3 PRODUCT LICENSE FEE. Subject to Section 11.5(d) and provided
there
has been a U.S. Patent issued upon United States patent
application entitled
"Method and composition for preventing and treating solid
tumors," US Patent
application publication number US 2004/0138121A1; publication
date July 15,
2004, upon the enrollment of the first patient in a Phase II
Clinical Trial by
Spectrum, Spectrum shall pay to Chicago Labs *** in ***
installments of ***. The
first such payment shall be made not later than *** after the
enrollment of the
first patient in the Phase II Clinical Trial. If for any reason
a US Patent
issues after the enrollment of such first patient, Spectrum
shall pay to Chicago
Labs within *** of the issuance of the Patent all of the ***
installments that
would have been due and payable had a US Patent been issued at
the time of such
enrollment and shall thereafter continue such payments until
Spectrum has paid
Chicago Labs the full ***. Spectrum shall pay to Chicago Labs
each *** payment
before the *** in which the payment is due.
4.4 MILESTONE PAYMENTS. Spectrum shall pay to Chicago Labs
the
following one-time payments (one time regardless of the number
of Products)
within *** of the achievement of each of the following
events:
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Milestone
Milestone Payment
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A. First approval of an NDA for a Product by the FDA ***
B. First approval of an NDA for a Product by the EMEA ***
C. First Approval of an NDA for a Product by the Ministry of
Health, ***
Labour and Welfare in Japan
D. Approval of the *** for a Product by the FDA ***
E. Approval of the *** for a Product by the EMEA ***
F. Approval of the *** for a Product by the Ministry of Health,
Labour and ***
Welfare in Japan
G. Annual Net Sales of a Product in *** of *** ***
H. Annual Net Sales of a Product in *** of *** ***
I. Annual Net Sales of a Product in *** of *** ***
</TABLE>
4.5 PRODUCT ROYALTIES.
4.5.1 Patent Royalties. During the Royalty Term, Spectrum shall
pay
Chicago Labs the following royalties on the aggregate annual Net
Sales of each
Product sold by Spectrum, its Affiliates and any Third Party
sublicensees in the
Territory during each calendar year:
*** percent (***%) of annual Net Sales up to and including ***;
and
*** percent (***%) of annual Net Sales greater than ***.
The applicable royalty rate determined above shall be applied to
the Net Sales
in each country where there is a Valid Claim covering the
Product, as determined
on a Product-by-Product and country-by-country basis. Multiple
royalties shall
not be earned or paid on a particular Product if such Product or
its
manufacture, use, importation or sale is covered by more than
one Valid Claim.
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Securities and Exchange Commission. Confidential treatment has
been requested
with respect to the omitted portions.
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4.5.2 Step-Down Royalty. After the expiration of the Royalty
Term
for a country and in consideration of the grant by Chicago Labs
to Spectrum of
the rights under this Agreement to Chicago Labs Know-how, for a
period of *** or
until there is generic competition within such country,
whichever comes first,
Spectrum shall pay Chicago Labs the following royalties on the
aggregate annual
Net Sales of each such Product sold by Spectrum, its Affiliates
and any Third
Party sublicensees in the Territory during each calendar
year:
*** percent (***%) of annual Net Sales up to and including ***;
and
*** percent (***%) of annual Net Sales greater than ***.
The applicable royalty rate shall be determined on a
Product-by-Product and
country-by-country basis.
4.5.3 Know-How Royalties. For the period of *** from the
First
Commercial Sale of each Product in each country where there is
no Valid Claim
covering the Product or until there is generic competition in
such country,
whichever comes first, Spectrum shall pay Chicago Labs the
following royalties
on the aggregate annual Net Sales of each such Product sold by
Spectrum, its
Affiliates and any Third Party sublicensees in the Territory
during each
calendar year:
*** percent (***%) of annual Net Sales up to and including ***;
and
*** percent (***%) of annual Net Sales greater than ***.
The applicable royalty rate determined above shall be applied to
the Net Sales
in each country where there is no Valid Claim covering the
Product, as
determined on a Product-by-Product and country-by-country
basis.
4.5.4 ***
4.5.5 Royalty Term. The "ROYALTY TERM" shall begin on the
First
Commercial Sale of a particular Product in a particular country
and expire on
the expiration of the last Valid Claim covering such Product in
that country, as
determined on a Product-by-Product basis and a
country-by-country basis.
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Securities and Exchange Commission. Confidential treatment has
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with respect to the omitted portions.
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4.5.6 Royalty Offsets. In the event that royalty payments are
owed
by Spectrum to Third Parties with respect to licenses necessary
to use, develop,
manufacture or sell a Product and such royalty payments exceed
*** percent
(***%) of Net Sales, the royalties owed to Chicago Labs under
Section 4.5.1
shall be reduced by the amount of the royalty payments actually
paid by Spectrum
to such Third Parties provided that such reductions shall not
exceed *** of the
royalties due Chicago Labs under such Section in such country
for the reporting
period. ***
4.5.7 Sublicense Income. In case Spectrum grants sublicenses
under
Section 3.2 hereof, Spectrum shall pay to Chicago Labs (A) if
before ***, ***
percent (***%) or (B) if after ***, *** percent (***%), of any
lump sum,
periodic or other consideration (other than royalties based on
Net Sales)
received by Spectrum from sublicensees including, but not
limited to, any
upfront fees, sublicense fees, or other consideration paid for
the authorization
to use the Chicago Labs Technology to develop, make, have made,
use, offer for
sale, sell, have sold, distribute, import, and export Products
in the Licensed
Field in the Territory. Notwithstanding anything else contained
herein, upon
receipt by Spectrum of any payment from a sublicensee upon the
achievement of
any applicable milestone (a "SUBLICENSEE MILESTONE"), (i) if the
Sublicensee
Milestone is also a milestone described in Section 4.3 or 4.4,
Spectrum shall
make the applicable milestone payment under Section 4.3 or 4.4
to Chicago Labs
and (ii) the payment received by Spectrum from such sublicensee
shall be treated
as sublicense income and subject to the first sentence of this
Section 4.5.7;
provided that Spectrum may deduct any payment made pursuant to
clause (i) of
this from such sublicense income before calculating the
percentage owed to
Chicago Labs pursuant to this Section 4.5.7 in determining
Spectrum's obligation
under this Section. Spectrum may only deduct from such
sublicense income, under
clause (ii) of this Section, the amount actually paid by
Spectrum to Chicago
Labs pursuant to clause (i) of this Section. If Spectrum
receives as
Sublicensing Revenues anything of value in lieu of cash
payments, Spectrum shall
pay Chicago Labs royalties at the applicable rate under Section
4.5.1, 4.5.2, or
4.5.3 as applicable, above based on the fair market value of
such payment,
unless Chicago Labs waives in writing such payment
obligation.
4.5.8 *** Royalty Payments. Royalties owed to Chicago Labs
pursuant
to this Section 4.5 shall be payable by Spectrum within ***
after the *** (i.e.,
*** after ***) based upon the Net Sales of each Product during
such ***. Any
underpayment or overpayment of the *** royalty payments shall be
reconciled and
added or deducted to the royalty payment due in the *** in which
such
underpayment or overpayment is discovered. All payments to
Chicago Labs under
this Agreement shall be made in U. S. Dollars by bank wire
transfer in
immediately available funds to such bank account in the
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United States designated in writing by Chicago Labs from time to
time. In the
case of sales outside the United States, the rate of exchange to
be used in
computing the amount of currency equivalent in U. S. Dollars due
Chicago Labs
shall be made at the rate of exchange utilized by Spectrum in
its worldwide
accounting system under GAAP.
4.5.9 Income Tax Withholding. If laws, rules or regulations
require
withholding of income taxes or other rates imposed upon payments
set forth in
this Section 4, Spectrum may make such withholding payments as
required and
subtract such withholding payments from the payments set forth
in this Section
4. Spectrum shall submit appropriate proof of payment of the
withholding rates
to Chicago Labs within a reasonable period of time. Spectrum
shall use efforts
consistent with its usual business practices to ensure that any
withholding
taxes imposed are reduced as far as possible under the
provisions of the current
or any future double taxation treaties or agreements between
foreign countries,
and the Parties shall cooperate with each other with respect
thereto, with the
appropriate Party under the circumstances providing the
documentation required
under such treaty or agreement to claim benefits thereunder.
4.5.10 Reports. Spectrum shall furnish to Chicago Labs at the
same
time as each royalty payment is made by Spectrum, a written
report of Net Sales
of the Products on a Product by Product and country by country
basis and the
royalty due and payable thereon, for the *** period upon which
the royalty
payment is based. Net Sales made in currencies other than U.S.
Dollars will be
translated into U.S. Dollars as provided in Section 4.5.8 and
added to Net Sales
made in U.S. Dollars for purposes of determining aggregate Net
Sales and the
royalties due to Chicago Labs.
4.6 RECORDS. Spectrum shall keep full, complete and proper
records and
accounts of all sales of Products by Spectrum, its Affiliates,
and to the extent
it acquires rights to do so, its sublicensees and distributors,
in accordance
with GAAP, in sufficient detail and in the currencies in which
the sale was made
to enable the royalties payable on each Product to be
determined. All such
records, statements, reports and accounts referred to in this
Section 4.6 shall
be retained for a period of *** after the end of the period to
which they apply.
4.7 AUDIT
4.7.1 If Chicago Labs disagrees with a report provided by
Spectrum,
pursuant to Section 4.5.10, Chicago Labs, at its own expense,
shall have the
right, upon reasonable prior notice during regular business
hours, to meet with
Spectrum's independent auditor to inspect and discuss the
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books and accounts of Spectrum or its Affiliates, related to the
payment and
calculation of royalties arising under this Agreement. After
this inspection, if
Chicago Labs still disagrees with the report provided by
Spectrum, with
reasonable justification for such disagreement, Chicago Labs, at
its own
expense, shall have the right, upon reasonable prior notice
during regular
business hours, to appoint independent auditors reasonably
acceptable to
Spectrum and have them during normal business hours, inspect and
copy the books
and accounts of Spectrum or its Affiliates, related to the
payment and
calculation of royalties arising under this Agreement. Spectrum
shall cooperate
and cause Spectrum's Affiliates, to cooperate with such
auditors. The auditors
performing the audit shall disclose to Chicago Labs only
information relating to
the accuracy of records kept and the payments made, and shall be
under a duty to
keep confidential any other information obtained from such
records. Spectrum
shall audit the books and accounts of its sublicensees and/or
distributors, if
any, using its independent auditor or a comparable reputable
auditor. Spectrum
shall share the results of its audit with Chicago Labs.
4.7.2 If any such audit establishes that Spectrum has underpaid
or
overpaid the amount due, Spectrum shall promptly pay any
remaining amounts due
as established by such audit or Chicago Labs shall promptly
refund any over
payment. If the underpayment is by *** percent (***%) or more
during any
calendar year, Spectrum shall reimburse Chicago Labs for its
out-of-pocket
expense of such audit with interest at the rate specified in
Section 4.8 below
for late payments on any such overdue payment from the date due
until paid.
4.8 LATE PAYMENTS. Any payments or reimbursements due Chicago
Labs
under this Agreement that are not paid on the due date shall
accrue interest at
the lower of the rate of *** percent (***%) per annum, or the
maximum rate
allowed by law, from the due date until paid in full.
4.9 NO REFUNDS. No payments or reimbursements once received by
Chicago
Labs pursuant to Sections 4.1 through 4.4 above are refundable
in whole or in
part.
5. OWNERSHIP AND PATENT MATTERS.
5.1 OWNERSHIP. As between the parties, all Chicago Labs
Technology
shall be owned by Chicago Labs. Improvements that are made by an
employee, agent
or consultant of Spectrum, solely or jointly with a Third Party
other than an
employee, agent or consultant of Chicago Labs, shall be owned by
Spectrum.
Improvements that are made jointly by employees, agents or
consultants of
Spectrum and employees, agents or consultants of Chicago Labs
("JOINT
INVENTIONS") shall be jointly owned by
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Spectrum and Chicago Labs and treated as joint inventions under
U.S. laws
applicable to joint inventions. Chicago Labs shall, and hereby
does, grant
Spectrum the exclusive and unrestricted right (even as to
Chicago Labs) in the
Licensed Field to make, have made, use, sell, have sold, import,
export and
license all Improvements that are owned by Chicago Labs and all
Joint Inventions
for so long as Spectrum is prosecuting and maintaining the
Patents contained in
such Joint Inventions. Chicago Labs shall, and hereby does,
grant Spectrum a
perpetual, royalty-free license to use all Improvements owned by
Chicago Labs
and all information, know-how and other data pertaining to all
Improvements and
the Joint Inventions after Spectrum's royalty obligations under
Section 4.5 have
expired or been terminated by Spectrum due to a breach of this
Agreement by
Chicago Labs or due to the insolvency of Chicago Labs pursuant
to Section 11.4.5
and all royalties then owed Chicago Labs have been paid,
provided that Chicago
Labs has not previously terminated this Agreement prior to such
expiration.
Spectrum shall own any trademarks associated with the
Products.
5.2 PROSECUTION AND MAINTENANCE OF CHICAGO LABS PATENT
RIGHTS.
5.2.1 Patent Prosecution and Maintenance. Spectrum, at its
own
expense, shall direct and control the preparation, filing,
prosecution and
maintenance of all United States and foreign Patents within the
Chicago Labs
Patent Rights, including any interferences and foreign
oppositions. Spectrum
shall, in its sole discretion, select outside patent counsel
reasonably
acceptable to Chicago Labs to carry out such activities. ***
5.2.2 Chicago Labs Participation and Assistance. Spectrum
shall
consult with Chicago Labs with regard to the preparation,
filing, prosecution
and/or maintenance of the Patents within the Chicago Labs Patent
Rights and
Joint Patents and the scope of claims contained therein.
Notwithstanding the
preceding sentence, however, Spectrum shall in all events have
final
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