<PAGE>
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.
<PAGE>
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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<PAGE>
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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<PAGE>
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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<TABLE>
<CAPTION>
Milestone
Milestone
Payment
---------
---------
<S>
<C>
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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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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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
decision-making au