Exhibit
10.40
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION
and
GTx, INC.
CONSOLIDATED, AMENDED, AND RESTATED LICENSE
AGREEMENT
THIS CONSOLIDATED, AMENDED, AND
RESTATED LICENSE AGREEMENT made and entered into this 24
th day
of July, 2007, having an effective date of August 23, 2000
(the “ Effective Date ”) by and between
University of Tennessee Research Foundation (formerly known as The
University of Tennessee Research Corporation), a Tennessee
corporation having an office at 1534 White Avenue, Knoxville,
Tennessee 37996. (hereinafter “UTRF”), and GTx, Inc.
(formerly known as Genotherapeutics, Inc.), a Delaware corporation,
located at 3 N. Dunlap St., Memphis, Tennessee 38163 (hereinafter
“GTx”), hereinafter sometimes referred to individually
as a “ Party ” and collectively as the “
Parties ”.
RECITALS
WHEREAS , UTRF owns, in whole
or in part, certain Licensed Patents (as defined herein) and
Licensed Technology (as defined herein), the subject matter of
which was initially developed by one or more of the UT Contributors
(as defined herein) in the course of their employment with The
University of Tennessee (“UT”);
WHEREAS , the UT Contributors
submitted to UT multiple invention disclosure forms pertaining to
SARMS (as defined herein), including (i) [ * ] , designated
by UTRF as file number PD [ * ] ; (ii) [ * ] ,
designated by UTRF as file number PD [ * ] ; (iii) [ *
] , designated by UTRF as file number PD [ * ] ; (iv)
[ * ] , designated by UTRF as file number PD [ * ] ;
and (v) [ * ] designated by UTRF as file number PD [ *
] (individually, an “ Initial SARMS Disclosure
” and, collectively, the “ Initial SARMS
Disclosures ”);
WHEREAS, UTRF and GTx have
previously entered into two separate agreements, each being titled
“Amended and Restated Exclusive License Agreement” and
made effective as of August 23, 2000, whereby GTx was granted
exclusive licenses to Licensed Patents (as defined therein) and
Licensed Technology (as defined therein) which arose out of the
technology described in the Initial SARMS Disclosures
(collectively, the “ Prior License Agreements
”);
WHEREAS , after submission of
the Initial SARMS Disclosures to UT, Dr. James T. Dalton, a UT
Contributor, left the employ of UT, accepted employment as a
faculty member at The Ohio State University (“ OSU
”) and in the capacity of an OSU researcher, continued to
perform research at OSU relating to the subject matter of the
Initial SARMS Disclosures with the assistance of other staff and
students of OSU working under his supervision, said research being
funded by various sponsors, including the United States government
and GTx;
WHEREAS, a number of the UT
Contributors (excluding Dr. Dalton as an OSU employee),
subsequently submitted to UT an invention disclosure form titled
[ * ] designated by UTRF as file number PD [ * ] (the
“ Third Generation SARMS Disclosure ”), a copy
of which is attached hereto as Exhibit A;
WHEREAS , with the consent of
GTx, UTRF entered into that certain agreement titled “Bridged
SARMS Inter-Institutional Agreement” with OSU effective
December 22, 2004 (hereinafter “ OSU IIA#1
”), attached hereto and incorporated by reference herein as
Exhibit B;
WHEREAS, pursuant to the
provisions of OSU IIA#1, UTRF holds a license, with the right to
sublicense, to the interest of OSU in EXISTING INVENTIONS (defined
below) pertaining to BRIDGED SARMS the subject matter of which was
conceived, created, developed, designed, invented, or reduced to
practice in whole or in part by OSU researcher Dr. Dalton
and/or other OSU research staff and students under
Dr. Dalton’s direction before December 22,
2004;
WHEREAS , pursuant to the
provisions of OSU IIA#1, UTRF holds an option to a license, with
the right to sublicense, to OSU’s interest in IMPROVEMENT
INVENTIONS (defined below) pertaining to BRIDGED SARMS conceived,
created, developed, designed, invented, or reduced to practice, in
whole or in part by OSU faculty researchers, research staff, or
students after December 22, 2004.
WHEREAS , UTRF also entered
into that certain agreement entitled “New SARM Inventions
Inter-Institutional Agreement” with OSU effective as of
December 22, 2004 (“ OSU IIA#2 ”), attached
hereto and incorporated by reference herein as
Exhibit C;
WHEREAS , pursuant to the
provisions of OSU IIA#2, UTRF holds an option to a license, with
the right to sublicense, to OSU’s interest in NEW INVENTIONS`
(defined below) pertaining to certain SARMS conceived, created,
developed, designed, invented, or reduced to practice, in whole or
in part, by Dr. Dalton, or other OSU research staff, or
students and not otherwise subject to OSU IIA#1;
WHEREAS , the Parties now
desire to enter into this “Consolidated, Amended, and
Restated License Agreement” for the purpose of
(i) consolidating the Prior License Agreements into one
agreement; (ii) granting GTx an exclusive license in
UTRF’s interest in EXISTING INVENTIONS and IMPROVEMENT
INVENTIONS that were not previously licensed to GTx under the Prior
License Agreements, if any; (iii) granting GTx an exclusive
license, subject to the provisions of OSU IIA#1, in OSU’s
interest in all LICENSED INVENTIONS (as defined in OSU IIA#1), to
the extent licensed to UTRF; (iv) granting GTx an exclusive
license, subject to the provisions of OSU IIA#2, in OSU’s
interest in all LICENSED INVENTIONS (as defined in OSU IIA#2), to
the extent licensed to UTRF, and in UTRF’s interest in NEW
INVENTIONS; and (v) making certain other changes regarding the
rights and obligations of the Parties, including but not limited to
those changes that are necessary for UTRF to comply with the
provisions of OSU IIA#1 and OSU IIA#2; and
WHEREAS , the Parties intend
that this Agreement shall supersede the Prior License Agreements
and render them null and void.
NOW, THEREFORE , for and in
consideration of the premises and other good and valuable
consideration, including a payment in the amount of Two Hundred
Ninety Thousand Dollars ($290,000; the “Consideration
Fee”),which is paid by GTx in consideration of UTRF’s
execution of this Agreement, the Parties hereto expressly agree as
follows:
SECTION 1
Definitions
1.1 “ Actions ”
shall have the meaning set forth in Section 17.1 hereof.
1.2 “ Active Ingredient
” means the material(s) in a pharmaceutical product which
provide its
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
2
pharmacological activity (excluding formulation components such as
coatings, stabilizers or controlled release technologies).
1.3 “ Affiliate ”
shall mean any corporation, partnership, or other entity that at
any time during the Term of this Agreement, directly or through one
or more intermediaries, Controls or is Controlled by or is under
common Control with a Party to this Agreement or a Sublicensee, but
only for so long as the relationship exists. A corporation or other
entity shall no longer be an Affiliate when through loss,
divestment, dilution or other reduction of ownership, the requisite
Control no longer exists.
1.4 “ Agreement ”
shall mean this Consolidated, Amended and Restated License
Agreement.
1.5 “ BRIDGED SARMS
” shall have the meaning set forth in OSU IIA#1.
1.6 “ Claims ”
shall have the meaning set forth in Section 8.1 hereof.
1.7 “ Combination
Product ” means either (i) any pharmaceutical
product that consists of a SARM and at least one other Active
Ingredient that is not a SARM, or (ii) any combination of a
SARM and another pharmaceutical product that contains at least one
other Active Ingredient that is not a SARM where such products are
not formulated together but are sold together as a single product
and invoiced as one product.
1.8 “ Confidential
Information ” shall have the meaning set forth in
Section 18.2 hereof.
1.9 “ Control ” or
“ Controls ” or “ Controlled
” shall mean: (i) in the case of a corporation,
ownership or control, directly or indirectly, of at least fifty one
percent (51%) of the shares of stock entitled to vote for the
election of directors; or (ii) in the case of an entity other
than a corporation, ownership or control, directly or indirectly,
of at least fifty one percent (51%) of the assets of such
entity.
1.10 “ Effective Date
” shall have the meaning set forth in the introductory
paragraph hereof.
1.11 “ Exception
Countries ” shall have the meaning set forth in
Section 6.6 hereof.
1.12 “ EXISTING
INVENTION ” shall have the meaning set forth in OSU
IIA#1.
1.13 “ Federal Policy
” shall have the meaning set forth in Section 2.3
hereof.
1.14 “ Generic Product
” shall mean a product that is derived from, made with, uses,
or incorporates, in whole or in part, Licensed Technology, but is
not covered or claimed in whole or in part by a Valid Claim of the
Licensed Patents in the country of manufacture, use, or sale or
import.
1.15 “ GTx ” shall
mean GTx, Inc. and its Affiliate(s) (unless such Affiliates are
clearly excluded from the referencing provision(s) at issue),
provided that in no instance shall GTx, Inc. be relieved of any
duty or obligation hereunder by the inclusion of its Affiliates in
the definition of “GTx”.
1.16 “ IMPROVEMENT
INVENTION ” shall have the meaning set forth in OSU
IIA#1.
1.17 “ Independent SARM
Invention ” shall have the meaning set forth in
Section 2.8 hereof.
1.18 “ Initial SARMS
Disclosure ” and “ Initial SARMS Disclosures
” shall have the meaning set forth in the Recitals.
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
3
1.19 “ IP RIGHTS ”
shall have the meaning set forth in OSU IIA#1 when referring to an
EXISTING INVENTION or an IMPROVEMENT INVENTION and the meaning set
forth in OSU IIA#2 when referring to a NEW INVENTION.
1.20 “ License Maintenance
Fee ” shall have the meaning set forth in
Section 4.1A. hereof.
1.21 “ License Year
” shall mean a 12-month period beginning on August 20 of
one year and ending on August 19 of the following year.
1.22 “ Licensed Patent
” or “ Licensed Patents ” shall mean any
or all of the (a) the patents set forth on Appendix A,
attached hereto and incorporated herein by reference, (b) the
patent applications set forth on Appendix A and any patents
issuing therefrom, and (c) any other patent applications that
may in the future be filed pursuant to Section 6.1 of this
Agreement by GTx, whether in the United States of America or any
other country, and any patents issuing therefrom, including, as
they pertain to patents and patent applications described in
(a)-(c) hereof, any and all substitutions for and divisional
applications, continuation applications, continuation-in-part
applications, provisional applications, and non-provisional
applications, renewal applications, reissue applications, any
foreign patent applications and divisional, continuation and
continuation-in-part applications therefrom or national phase
applications which claim priority from any of the pending patent
applications set forth on Appendix A.
1.23 “ Licensed Product
” or “ Licensed Products ” shall mean any
Patented Product or Generic Product, provided that in the case of a
Combination Product (as defined under Section 1.7), Licensed
Product shall mean only that portion of the Combination Product
containing a SARM or SARMS, and Net Sales for such Licensed Product
contained within a Combination Product shall be determined as set
forth under Section 1.29.
1.24 “ Licensed Subject
Matter ” shall mean Licensed Patents and Licensed
Technology.
1.25 “ Licensed
Technology ” shall mean, except to the extent published
or otherwise generally known to the public:
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A. |
|
any know-how that is (i) related to an EXISTING INVENTION
and/or an IMPROVEMENT INVENTION licensed by UTRF from OSU under OSU
IIA#1; or (ii) related to a NEW INVENTION licensed by UTRF
from OSU under OSU IIA#2; and |
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B. |
|
any technology, trade secrets, methods, processes, know-how,
show-how, data, information, or results (except technology, trade
secrets, methods, processes, know-how, show-how, data, information,
or results solely related to NON-TGS NEW INVENTIONS to the extent
not published or otherwise generally known to the public) that are
(i) developed by any one or more of the UT Contributors in the
course of employment by UT or developed by any other UT employee
directly from his or her research or clinical investigation of
SARMs utilizing any Proprietary SARM Know-How; and (ii) owned
solely or in part by UTRF (but, if owned in part by UTRF, only to
the extent of the part owned by UTRF); and (iii) necessary or
reasonably useful for the practice of any of the Licensed
Patent(s), including (for purposes of explaining, and without
expanding, the meaning of Sections 1.25B. (i) through (iii))
any: (1) SARMs, and compositions and compounds containing
SARMS, and analogs or isomers of SARMS, including without
limitation radiolabeled SARMS, fluorescent labeled SARMS, and SARMS
with radioisotopes incorporated therein, and SARMS comprising small
molecules of R-bicalutamide; (2) methods of making,
developing, or characterizing such SARMs, agents, compositions, and
compounds of (1); and (3) any therapeutic, diagnostic, and
prognostic methods of use of (1), including but not limited to
methods of treating prostate cancer, |
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
4
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|
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methods of imaging, or methods related to fertility,
contraceptive, andropause, muscle wasting, bone loss and muscle or
bone mass uses. |
1.26 “ Major Countries
” shall have the meaning set forth in Section 6.6
hereof.
1.27 “ Major Markets
” shall mean and include the United States, Great Britain,
France, Germany, and Japan.
1.28 “ Negotiation
Period ” shall have the meaning set forth in
Section 2.8D. hereof.
1.29 “ Net Sales ”
shall mean the gross amount actually received by GTx or any
Sublicensee for the use, sale or distribution (hereinafter “
Sale ”) of a Licensed Product (hereinafter “
Gross Receipts ”), less the following:
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A. |
|
refunds, credits, and/or discounts actually given in connection
with a particular Sale in amounts customary in the trade for
quantity purchases, cash payments, and prompt payments, but only if
such refunds, credits, and/or discounts constitute a return of
amounts already included in Gross Receipts; |
| |
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B. |
|
refunds, credits and/or discounts actually given for Licensed
Products that are rejected, recalled, returned, or destroyed by
customers, but only if such refunds, credits and/or discounts
constitute a return of amounts already included in Gross
Receipts; |
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C. |
|
sales, tariff duties and/or use taxes directly imposed and with
reference to a particular Sale, to the extent included in Gross
Receipts; |
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D. |
|
outbound transportation expenses (including insurance relating
thereto) directly related to a particular Sale, to the extent
included in Gross Receipts; |
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E. |
|
the cost of export licenses, import duties, value added tax,
and prepaid freight directly related to a particular Sale, to the
extent included in Gross Receipts; |
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F. |
|
sales commissions paid by GTx to individuals who are not
employees of GTx, a Sublicensee, or their respective Affiliates, to
the extent such commissions are directly related to a particular
Sale; |
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G. |
|
out-of-pocket service fees consistent with normal industry
practice paid to distributors or wholesalers of drug product in
payment for distribution of Licensed Product, provided that
(a) such distributors and wholesalers are not Affiliates of
GTx; (b) if any such distributor or wholesaler is an Affiliate
of a Sublicensee, such fees are no more than that which such
distributor/wholesaler actually and contemporaneously charges
unaffiliated third party pharmaceutical companies for the same or
similar service; (c) such fees may not be deducted more than
once; (d) if a Sublicense shall be in effect, the fees paid by
a Sublicensee may be deducted from Net Sales under this Agreement
only if such fees are deducted from the equivalent of Net Sales
under the relevant Sublicense agreement for purposes of calculating
the royalty owed to GTx; |
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H. |
|
retroactive price reductions, chargeback payments and rebates
actually granted in connection with a particular Sale to managed
health care organizations or to federal, state and local
governments, their agencies, purchasers, and reimbursers, but only
if such reductions, chargeback payments, and rebates constitute a
return of amounts already included in or calculated as part of
Gross Receipts; and |
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
5
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I. |
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[ * ] of any royalty (including a lump-sum payment) that
is paid to a Third Party by GTx pursuant to a patent license
agreement between GTx and such Third Party, provided that at the
time of such payment (1) such Third Party owns or controls an
issued patent containing a Valid Claim that, in the absence of such
patent license agreement, would be infringed by the use, sale, or
distribution of the composition of matter of a SARM licensed to GTx
hereunder; and (2) the purpose of such royalty is for
licensing of or acquiring such issued patent; and (3) the
dollar amount of the [ * ] deduction for any calendar
quarter shall not exceed the dollar amount of Net Sales in the same
calendar quarter (computed without the application of this
Section 1.29I.) from the use, sale, or distribution of
Licensed Products containing such SARM in the country(ies) where
such Third Party owns or controls such issued patent, it being
agreed, however, that GTx may carry forward to future quarter(s)
the amount by which the dollar amount of the [ * ] deduction
exceeds the cumulative dollar amount of the actual deductions
taken; and (4) GTx has not entered into such patent license
agreement as of the date of execution of this Agreement. |
For
avoidance of doubt, no deductions shall be made for sales
commissions paid to individuals who are employees of GTx, a
Sublicensee, or their respective Affiliates, or for cost of
collections. Notwithstanding the foregoing, Net Sales shall not
include the amount received by GTx for the transfer of Licensed
Product to a GTx Affiliate or a Sublicensee or the amount received
by a Sublicensee for transfer or distribution of Licensed Product
to GTx or a GTx Affiliate. Sales of Licensed Product for use in
conducting clinical trials of a Licensed Product candidate in a
country shall be excluded from Net Sales calculations for all
purposes. Net Sales shall be determined in a consistent manner for
all products sold by or on behalf of GTx and its Sublicensees and
in accordance with applicable U.S. generally accepted accounting
principles for GTx and any U.S. based Sublicensee.
Combination Product . In the event one or more Licensed
Products are sold as part of a Combination Product in a particular
country, the Net Sales of such Licensed Product(s), for the
purposes of determining payments based on Net Sales, shall be
determined by multiplying the Net Sales of the Combination Product
in such country, during the applicable Net Sales reporting period,
by the fraction, A/(A+B), where:
A is the
average sale price of the Licensed Product(s) by GTx or
Sublicensees when sold separately in finished form in such country
and B is the average sale price by GTx or Sublicensees, or, if they
have no such right of sale, by a Third Party of the other
product(s) included in the Combination Product when sold separately
in finished form in such country, in each case during the
applicable Net Sales reporting period.
In the
event one or more Licensed Products are sold as part of a
Combination Product and are sold separately in finished form in
such country, but the other product(s) included in the Combination
Product are not sold separately in finished form in such country,
the Net Sales of the Licensed Product, for the purposes of
determining payments based on Net Sales, shall be determined by
multiplying the Net Sales of the Combination Product in such
country by the fraction C/D where:
C is the
average sale price, in such country, of the Licensed Product(s)
contained in such Combination Product when sold separately and D is
the average sale price, in such country, for the Combination
Product, in each case during the applicable Net Sales reporting
period. Under no circumstances can C/D exceed one hundred percent
(100%).
In the
event that one or more of the Licensed Product(s) are not sold
separately in finished form in the country, but all of the other
product(s) included in the Combination Product in such country are
sold separately, the Net Sales of the Licensed Product, for the
purposes of determining payments based on Net Sales, shall be
determined by multiplying the Net Sales of the Combination Product
in such country by the fraction (D-E)/D, where:
D is the
average sale price, in such country, of the Combination Product,
and E is the average sale price of the other product(s) included in
the Combination Product in finished form in such country, in each
case during the applicable Net Sales reporting period.
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
6
In the
event that the Net Sales of the Licensed Product(s) when included
in a Combination Product cannot be determined using the methods
above, Net Sales for the purposes of determining payments based on
Net Sales shall be calculated by multiplying the Net Sales of the
Combination Product by the fraction of F/(F+G) where:
F is the
fair market value of the Licensed Product(s) and G is the fair
market value of all other pharmaceutical product(s) included in the
Combination Product, as reasonably determined in good faith by the
Parties.
1.30 “ NEW INVENTION
” shall have the meaning set forth in OSU IIA#2, but limited
for purposes of this Agreement to invention(s) described in the
Third Generation SARMS Disclosure.
1.31 “ NON-TGS NEW
INVENTION ” shall have the meaning set forth for NEW
INVENTION in OSU IIA#2, but excluding for purposes of this
Agreement invention(s) described in the Third Generation SARMS
Disclosure.
1.32 “ Option ”
shall have the meaning set forth in Section 2.8 hereof.
1.33 “ Option Period
” shall have the meaning set forth in Section 2.8A.
hereof.
1.34 “ OSU ” shall
mean The Ohio State University, except that where it is used in
reference to OSU IIA#1 or OSU IIA#2 in which case it shall mean The
Ohio State University and OSURF, as set forth therein.
1.35 “ OSU Contributors
” shall mean Dr. James T. Dalton and/or other research
staff and students at OSU.
1.36 “ OSU IIA#1 ”
shall have the meaning set forth in the Recitals.
1.37 “ OSU IIA#2 ”
shall have the meaning set forth in the Recitals.
1.38 “ OSURF ”
shall mean The Ohio State University Research Foundation.
1.39 “ Patented Product
” shall mean any product whose manufacture, use, sale or
import is covered in whole or in part by a Valid Claim of the
Licensed Patents in the country of manufacture, use, sale or
import.
1.40 “ Party ” and
“ Parties ” shall have the meaning set forth in
the introductory paragraph hereof.
1.41 “ Prior License
Agreements ” shall have the meaning set forth in the
Recitals.
1.42 “ Proprietary SARM
Know-How ” shall mean know-how pertaining to an EXISTING
INVENTION, IMPROVEMENT INVENTION or NEW INVENTION that is obtained
from GTx or a UT Contributor and is not published or otherwise
generally known to the public.
1.43 “ Regulatory
Approval ” shall mean any approvals granted by a
governmental authority in a particular regulatory jurisdiction
(with the exception of conditional approvals) that are necessary
for the commercial manufacture, use, storage, importation, export,
transport or sale of Licensed Products in that regulatory
jurisdiction.
1.44 “ Running Royalty
” shall have the meaning set forth in Section 4.1B.
hereof.
1.45 “ SARM ” or
“ SARMS ” shall mean selective androgen receptor
modulator(s) whose primary pharmacologic effect at any dose
observed in vivo is mediated by the androgen receptor.
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
7
1.46 “ Sublicense
” shall mean a direct grant of right, license, or option to
any Licensed Subject Matter from GTx to a GTx Affiliate or a Third
Party and any further such grant at any tier.
1.47 “ Sublicense
Revenue ” shall mean all payments actually received by
GTx pursuant to each Sublicense, including, without limitation,
up-front license fees, milestone payments, license maintenance
fees, election fees, and all other fees and payments paid to GTx
under each Sublicense agreement, excluding running royalties
received by GTx that are calculated as a percentage of
Sublicensee’s Net Sales and up-front fees paid by Ortho
Biotech Products L.P. pursuant to the Joint Collaboration and
License Agreement entered into with GTx effective as of
March 16, 2004. GTx may deduct from Sublicense Revenue
attributable to a particular Sublicense agreement payments received
by GTx as reimbursement for actual, otherwise unreimbursed,
out-of-pocket expenses as set out in such Sublicense agreement,
provided that only reimbursements for expenses incurred in the
development of one or more Licensed Products covered by such
Sublicense may be deducted from Sublicense Revenue and then only to
the extent of expenses incurred from and after the date of the
Sublicense for pre-clinical or clinical research and development,
including development of the formulation and manufacturing process,
manufacturing of preclinical and clinical supplies and analytical
and stability testing as required by the Food and Drug
Administration to support a New Drug Application (NDA) filing
for the Licensed Product. For the avoidance of doubt, Sublicense
Revenue will not include any payments made to Third Parties by or
on behalf of a Sublicensee for conducting clinical trials, filing
new drug applications, commercially launching a product and/or
marketing and selling a product, since these are not payments
received by GTx from a Sublicensee on account of the
Sublicense.
1.48 “ Sublicense
Royalty ” shall have the meaning set forth in
Section 4.1C. hereof.
1.49 “ Sublicensee
” shall mean and include any recipient of a Sublicense.
1.50 “ Sublicensee Patent
Rights ” shall have the meaning set forth in
Section 6.2 hereof.
1.51 “ Term ”
shall have the meaning set forth in Section 12.1 hereof.
1.52 “ Third Generation
SARMS Disclosure ” shall have the meaning set forth in
the Recitals.
1.53 “ Third Party
” or “ Third Parties ” shall mean any
person, party or entity other than GTx, its Affiliates, UTRF, or
UT.
1.54 “ UT ” shall
mean The University of Tennessee.
1.55 “ UT Contributo
r” and “ UT Contributors ” shall mean one
or more of James T. Dalton, Yali He, Dong-Jin Hwang, Leonid
Kirkovsky, Craig Marhefka, Duane Miller, Michael Mohler, Arnab
Mukherjee, Igor Rakov, Huiping Xu, Donghua Yin and any other UT
employee who, while under the supervision of Duane Miller or James
T. Dalton, contributed, either before or after the Effective Date,
to the development of the Licensed Subject Matter.
1.56 “ Valid Claim
” shall mean (a) a claim of an issued patent which has
not expired and which has not been held revoked, invalid or
unenforceable by decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed with the time
allowed for appeal having expired, and which has not been admitted
to be invalid through reissue or disclaimer or otherwise; or
(b) any claim of a pending patent application, which
(i) was filed in good faith; and (ii) has not been
pending for more than eight (8) years.
[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
8
SECTION 2
Grant
2.1 During the Term hereof, and
subject to the terms and conditions of this Agreement, UTRF hereby
grants to GTx for the purpose of developing, making, having made,
using, marketing, selling, having sold, importing, distributing,
and offering for sale the Licensed Product:
| |
A. |
|
an exclusive, worldwide right and license, with the right to
grant Sublicenses, to practice under the Licensed Patents that are
owned solely or in part by UTRF, excluding Licensed Patents to
which a license is granted in Section 2.1B.; and |
| |
| |
B. |
|
subject to the provisions of OSU IIA#1 and OSU IIA#2, as
applicable, an exclusive, worldwide right and license, with the
right to grant Sublicenses, to practice under the Licensed Patents
and the IP RIGHTS that are owned jointly by UTRF and OSU or owned
solely by OSU and that cover an EXISTING INVENTION, an IMPROVEMENT
INVENTION or a NEW INVENTION, provided that OSU’s interest is
licensed to UTRF with the right to grant sublicenses pursuant to
the provisions of OSU IIA#1 or OSU IIA#2, as the case may be;
and |
| |
| |
C. |
|
subject to the provisions of OSU IIA#1 and OSU IIA#2, as
applicable, an exclusive, worldwide right and license, with the
right to grant Sublicenses, of the non-exclusive rights received by
UTRF from OSU under OSU IIA#1 and OSU IIA#2 to utilize the Licensed
Technology described in Section 1.25A.; and |
| |
| |
D. |
|
subject to the provisions of OSU IIA#1 and OSU IIA#2, as
applicable, an exclusive, worldwide, right and license, with the
right to grant sublicenses, to utilize the Licensed Technology
described in Section 1.25B. |
Subject
to the other provisions of this Agreement, the Parties hereby agree
that the term “exclusive” means that to the extent of
UTRF’s rights in the Licensed Subject Matter and subject to
Federal Policy and the provisions of OSU IIA#1 and OSU IIA#2, UTRF
shall not grant any other license under Licensed Subject Matter to
any Third Party or take any action inconsistent with the rights
granted to GTx under this Agreement. The Parties further
acknowledge and agree that to the extent UTRF owns any Licensed
Subject Matter “in part”, the license herein granted to
GTx will not give GTx or its Sublicensees the right to exclude
UTRF’s co-owner(s) from exercising any rights attendant to
such co-ownership, whether such rights arise by law or contract,
provided that UTRF agrees that it will not negotiate or enter into
a license agreement or sublicense agreement, or otherwise grant any
option or licenses or other rights with respect to such Licensed
Subject Matter (whether in whole or in part), except as required by
Federal Policy. For avoidance of doubt, the exercise by GTx of its
right to grant Sublicenses will not serve to restrict GTx’s
exercising of its right, as granted above, to practice under the
Licensed Patents and/or to utilize the Licensed Technology.
2.2 GTx agrees that UT and those
persons who, as of the date of signature hereto on behalf of UTRF,
are named UT Contributors shall have the royalty-free non-exclusive
right to practice under the Licensed Patents and to utilize the
Licensed Technology for non-commercial educational, research, and
academic purposes only. GTx acknowledges and agrees that OSU
retains the non-exclusive right to use EXISTING INVENTIONS and
IMPROVEMENT INVENTIONS and associated IP RIGHTS under OSU IIA#1, as
well as NEW INVENTIONS and associated IP RIGHTS under OSU IIA#2, to
the extent of any of its respective rights therein, solely for
non-commercial educational, research (including non-commercial
clinical research), and academic purposes, but that OSU has
contractually acknowledged that it has no rights for clinical
research using a UTRF or GTx proprietary BRIDGED SARMS compound or
to refer to any GTx regulatory filing without prior written
approval from UTRF or GTx. UTRF agrees that during the Term hereof,
it will not, without obtaining GTx’s prior written consent,
enter
[ * ] = CERTAIN CONFIDENTIAL
INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS
BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF
1934, AS AMENDED.
9
into a
modification of OSU IIA#1 or OSU IIA#2 that (i) grants any
additional ownership rights to OSU in an EXISTING INVENTION,
IMPROVEMENT INVENTION, or NEW INVENTION; or (ii) places any
additional obligations on GTx.
2.3 To the extent that any research
pertaining to inventions included in Licensed Technology and/or
claimed in Licensed Patents has been or is in the future funded in
whole or in part by the United States government, the United States
government retains certain rights and requires certain obligations
concerning such inventions as set forth in 35 U.S.C.
§§200-212 and all regulations promulgated thereunder, as
amended, and any successor statutes and regulations and applicable
policies of such United States government sponsors, including,
without limitation, to the extent applicable, the utilization and
capability requirements found in the National Institutes of Health
(NIH) Grants Policy Statement; “Developing Sponsored
Research Agreements: Considerations for Recipients of NIH Research
Grants and Contracts”, Federal Register, Vol. 59,
No. 215, Tuesday, November 8, 1994, pp. 55675-55679
(collectively, “ Federal Policy ”). GTx
acknowledges that all rights herein granted to GTx may be subject
to any such rights held by the United States government and further
subject to any restrictions or obligations that may be imposed by
the United States government pursuant to such rights. GTx shall
materially comply with all aspects of Federal Policy applicable to
a licensee pertaining to Licensed Technology and/or Licensed
Patents and shall include and require its Sublicensees to include a
provision in each Sublicense agreement, at any tier, that requires
the Sublicensee to materially comply with all applicable aspects of
Federal Policy. In the event UTRF or GTx shall receive notice of
any action or notification by the United States government with
respect to any rights and/or obligations under Federal Policy
pertaining to any rights licensed hereunder to GTx, the Party
receiving such notice shall provide prompt written notice thereof
to the other Party.
2.4 Intentionally
omitted.
2.5 GTx shall have the right to enter
into Sublicenses and to permit further sublicensing by Sublicensees
through multiple tiers with respect to the Licensed Subject Matter,
subject to notifying UTRF of the identity and address of each
Sublicensee within thirty (30) days after execution of such
agreement by the parties thereto. No GTx Affiliate or Third Party
shall have the right to practice under the Licensed Patents or
utilize the Licensed Technology to make, have made, use, market,
sell, have sold, import, distribute, or offer for sale any Licensed
Product in the absence of a written Sublicense agreement. Any grant
of rights by GTx or a Sublicensee to practice under the Licensed
Patents or to utilize the Licensed Technology to make, have made,
use, market, sell, have sold, import, distribute, or offer for sale
any Licensed Product shall constitute a Sublicense. All Sublicenses
shall be subject to this Agreement in all respects and shall
include provisions that such Sublicensee is being granted a license
under the Licensed Subject Matter as defined herein and subject to
the terms hereof.
2.6 GTx shall be responsible for its
Affiliates and Sublicensees and shall not grant any rights that are
inconsistent with the rights granted to and obligations of GTx
hereunder. Each Sublicense agreement shall include a requirement
that the Sublicensee use its commercially reasonable efforts to
bring the subject matter of the Sublicense into commercial use. In
addition, each Sublicense agreement shall include an
acknowledgement that the ownership of the Licensed Patents are and
shall remain in the name of UTRF and/or OSU, as set forth in OSU
IIA#1 or OSU IIA#2, as the case may be, with the exception of
Licensed Patents that are properly assigned to GTx, and, except as
set forth in Section 6.2 hereof, an obligation on the part of
the Sublicensee to assign, transfer and convey ownership of
Licensed Patents to UTRF and/or, as UTRF may direct, to OSU, OSURF,
or GTx. Upon termination of this Agreement, each
Sublicensee’s rights under any Sublicense agreement shall
also terminate, provided that if UTRF terminates this Agreement for
default by GTx, a Sublicensee’s rights under a Sublicense
agreement shall terminate only if UTRF has given such Sublicensee
notice of default at least thirty (30) days prior to the
effective date of termination and the Sublicensee shall have failed
to cure such default, as provided in Section 12.3. UTRF shall
have discharged its obligation to give notice of such default to a
Sublicensee by sending (through any means contemplated under
Section 15) a copy of GTx’s notice of default to the
Sublicensee’s most recent street address of which UTRF has
received written notice from GTx or the Sublicensee. No Sublicense
shall relieve GTx of any of its
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
10
obligations under this Agreement, except that a Sublicensee shall
have the right to cure a default of GTx as set out in
Section 12.3. GTx shall forward to UTRF a complete copy of
each Sublicense agreement (including, without limitation, all
amendments and addenda) granted hereunder within thirty
(30) days after execution of such agreement by the parties
thereto, provided that each such Sublicense agreement (and any
amendments and addenda related thereto) shall be deemed GTx’s
Confidential Information and UTRF shall receive such information
and documents in confidence and shall not publicly disclose,
discuss or release such information or document to Third Parties
(other than such information as may be reasonably necessary to be
disclosed to UT Contributors and those persons within UT who have a
need to know such information, provided that only such information
concerning the Sublicense that is necessary to explain any payments
to be made to a UT Contributor will be shared with the UT
Contributors) without the prior written approval of GTx except for
the purposes of enforcement of UTRF’s rights, defense of any
claim against UTRF, UT, UT Contributors, OSU, OSURF, or OSU
Contributors, compliance with Federal Policy, compliance with OSU
IIA#1 or OSU IIA#2, or compliance with applicable law, regulation,
or court order. GTx shall be responsible for payment of royalties
from Sublicensees’ Net Sales provided, however, that GTx may
arrange for such payments to be made to UTRF by a Sublicensee, with
the understanding that the amount paid to UTRF shall not be
decreased thereby and that UTRF’s acceptance of such payments
from a Sublicensee does not relieve GTx of the ultimate
responsibility for any other or future payment required hereunder.
Each such Sublicense agreement shall include an audit right by UTRF
of the same scope as provided in Section 5.1 herein with
respect to UTRF’s audit of GTx’s books of
account.
2.7 Any act or omission of an
Affiliate or Sublicensee, which would constitute a breach of this
Agreement if performed by GTx, shall be deemed to be a breach by
GTx of this Agreement, subject however to the same cure provisions
in favor of GTx, an Affiliate, or Sublicensee as are otherwise
provided herein for breach by GTx.
2.8 During the Term hereof, UTRF
shall promptly notify GTx in writing (i) upon becoming aware
of any SARM invention owned solely or in part by UTRF which is not
(a) based on or developed from Proprietary SARM Know-How or
(b) developed at UT from grants or research payments made to
UT by GTx; or (ii) upon acquiring from OSU a license pursuant
to OSU IIA#2, with the right to sublicense, to a NON-TGS NEW
INVENTION (each invention described in subsection (i) and
subsection (ii) herein being an “ Independent SARM
Invention ”). Subject to the rights of Third Parties (in
the event UTRF co-owns such Independent SARM Invention with a Third
Party), GTx will have an exclusive option to acquire, to the extent
possible, a worldwide, exclusive (as defined in Section 2.1),
royalty-bearing license to such Independent SARM Invention (“
Option ”), provided that the grant of such Option does
not violate Federal Policy and further subject to the
following:
| |
A. |
|
The Option shall commence upon UTRF’s written notice to
GTx of the existence of such Independent SARM Invention and shall
terminate upon the earlier of (i) the expiration of six
(6) calendar months from the date of such notice; or
(ii) the giving of written notice to UTRF by GTx that it does
not intend to exercise the Option; or (iii) the termination of
this Agreement (“ Option Period ”) |
| |
| |
B. |
|
GTx may exercise the Option during the Option Period by giving
written notice of same to UTRF, provided that GTx is not then in
default or breach of any of its obligations under this
Agreement. |
| |
| |
C. |
|
Upon proper exercise of the Option by GTx, UTRF and GTx shall
negotiate in good faith in an effort to reach agreement on the
economic terms of a license to GTx of the Independent SARM
Invention that is the subject of such Option, it being the intent
that upon agreement of the Parties as to such economic terms, they
will be expeditiously incorporated into a new license agreement
with non-economic terms that are substantially similar to those
contained herein, to the extent applicable. |
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
11
| |
D. |
|
In the event GTx does not exercise the Option for a particular
Independent SARM Invention within the Option Period or the Parties
do not execute a license agreement within six (6) months after
exercise of the Option for a particular Independent SARM Invention
by GTx, which time period may be extended by written agreement of
the Parties (the “ Negotiation Period ”), UTRF
shall have no further obligation to GTx under this Agreement with
regard to such Independent SARM Invention. In the absence of a
license agreement granting GTx rights to such Independent SARM
Invention, GTx agrees that it will not use such Independent SARM
Invention for any commercial or non-commercial purpose. |
| |
| |
E. |
|
During the Option Period and the Negotiation Period, if any,
UTRF will confer with GTx concerning proper protection of such
Independent SARM Invention, but UTRF will have sole authority
regarding decisions concerning such protection, including patent
activities, provided that if GTx exercises the Option, UTRF shall
coordinate all decisions regarding patent protection with GTx and
shall take no actions with regard to intellectual property
protection for such Independent SARM Invention that are contrary to
GTx’s advice unless UTRF reasonably believes rights may be
lost unless it acts to protect those rights. From and after the
commencement of the Option Period, whether or not GTx exercises the
Option and whether or not the Parties subsequently execute a
license agreement for GTx to secure rights to the Independent SARM
Invention prior to the end of the Negotiation Period, GTx shall,
within thirty (30) days after receipt of each invoice,
reimburse UTRF for all reasonable and documented out-of-pocket
expenses incurred by UTRF during the Option Period and the
Negotiation Period, if any, for filing, prosecution, and
maintenance of United States and foreign patent applications,
issued patents, and other forms of intellectual property protection
for such Independent SARM Invention, which intellectual property
rights shall be assigned solely to UTRF or jointly to UTRF and its
co-owner(s), if any, provided that UTRF shall have consulted with
GTx regarding such proposed patent protection and UTRF shall have
undertaken to make those filings that are reasonably necessary to
protect and preserve its rights in the Independent SARM Invention
to reasonably minimize the expenses GTx may be required to
reimburse in accordance with this Section 2.8E until the
Option Period and Negotiation Period shall have expired. If GTx
shall fail to enter into a license agreement with UTRF for such
Independent SARM Invention, it shall be entitled to receive a
dollar for dollar reduction against Running Royalties and/or
Sublicense Revenue (in the same manner as the reduction is to be
applied in Section 4.1D) for the total amount of costs it
shall have reimbursed to UTRF for the expenses incurred by UTRF
under this Section 2.8E. |
SECTION 3
Diligence
3.1 GTx shall use its commercially
reasonable efforts to develop and commercialize Licensed Products
through a commercially reasonable program for exploitation of the
Licensed Patents and the Licensed Technology.
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
12
SECTION 4
Payments and Royalties
4.1 For the rights, privileges and
license granted hereunder, GTx shall pay to UTRF, in addition to
the Consideration Fee, the following fees and royalties in the
manner hereinafter provided until this Agreement expires or is
terminated.
| |
A. |
|
License Maintenance Fee . GTx shall pay UTRF a license
maintenance fee in the amount of [ * ] on [ * ] and
on [ * ] thereafter during the Term of this Agreement
(“ License Maintenance Fee ”). The License
Maintenance Fee actually paid for a particular License Year shall
reduce, dollar for dollar, the Running Royalty (defined below)
payable in the same License Year. License Maintenance Fees paid in
excess of the Running Royalty payable in the same License Year
shall not be creditable to the Running Royalty for future years.
The Parties acknowledge and agree that there are no License
Maintenance Fees due and owing to UTRF by GTx under the Prior
License Agreements. |
| |
| |
B. |
|
Running Royalty . For the purposes of this
Section 4.1(B), royalties on Net Sales of all Patented
Products and Generic Products incorporated in Combination Products
shall be subject to the calculation of Net Sales with respect to
Combination Products, as applicable, as set forth in
Section 1.29. |
| |
(1) |
|
GTx shall pay UTRF [ * ] of Net Sales of all Patented
Products; and |
| |
| |
(2) |
|
GTx shall pay UTRF a percentage of Net Sales attributable to
the use, sale or distribution of Generic Products, which percentage
shall be determined on a Generic Product-by-Generic Product,
country-by-country, and calendar quarter-by-calendar quarter basis.
In each country the percentage shall be calculated as the [ *
] during the applicable calendar quarter divided by the [ *
] during the same calendar quarter [ * ] (provided that
in no event shall the resulting percentage [ * ] ).
Furthermore, until such time as this Agreement shall expire in
accordance with Section 12.1, should there be no sales in the
Major Markets by GTx or Sublicensees of the same Licensed Product
covered by a Valid Claim of Licensed Patents during the same
calendar quarter, the percentage shall be [ * ] ; |
(the royalty
under 4.1B.(1) and 4.1B.(2) being the “ Running
Royalty ”). Notwithstanding the foregoing, in the event
that, for a particular Licensed Product in a given License Year
under a specific Sublicense agreement, the running royalty (as a
percentage of Net Sales) owed to GTx (including the Running Royalty
owed to UTRF, if to be paid by the Sublicensee) is less than [ *
] of Sublicensee’s Net Sales after deduction of running
royalties (calculated as a percentage of Net Sales) owed and
actually paid by or on behalf of GTx to one or more Third Parties
as consideration for the grant by such Third Party(ies) of a
license to technology incorporated in such Licensed Product, the
Running Royalty owed to UTRF shall be [ * ] of the amount
owed to GTx (including the Running Royalty owed to UTRF, if to be
paid by the Sublicensee) for that License Year. By way of example
only, in the event that during a particular License Year GTx is
entitled to receive a running royalty equal to [ * ] of its
Sublicensee’s Net Sales of a particular Licensed Product in
the EU and is in turn required to pay, and does actually pay, [
* ] of Sublicensee’s Net Sales of that Licensed Product
in the EU to a Third Party, then UTRF’s Running Royalty would
be [ * ] of Sublicensee’s Net Sales of that Licensed
Product in the EU.
| |
C. |
|
Sublicense Royalty . GTx shall pay UTRF [ * ] of
Sublicense Revenue (“ Sublicense Royalty ”) |
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
13
| |
D. |
|
Reduction . GTX shall be entitled to reduce
dollar-for-dollar the Running Royalties and/or the Sublicense
Royalties (such reduction to be applied at GTx’s sole
discretion) which are otherwise payable to UTRF by a total of [
* ] to reimburse GTx for certain shared legal expenses
previously borne by GTx in connection with the negotiation of OSU
IIA#1. |
4.2 In the event that any taxes are
required by law or regulation to be levied in any foreign country
by a foreign taxing authority on any Running Royalty or Sublicense
Royalty payable in UTRF’s name under this Agreement and GTx
determines in good faith that it or its Sublicensee must withhold
such taxes:
| |
A. |
|
GTx or its Sublicensee shall have the right to withhold and pay
such taxes withheld on the Running Royalty and/or Sublicense
Royalty to the local tax authorities in UTRF’s name; |
| |
| |
B. |
|
GTx or its Sublicensee shall pay the net amount of Running
Royalty and/or Sublicense Royalty due after reduction by the amount
of such taxes that are actually withheld and paid; |
| |
| |
C. |
|
GTx or its Sublicensee shall provide UTRF with appropriate
documentation and receipts supporting such withholding; and |
| |
| |
D. |
|
GTx or its Sublicensee shall inform UTRF in writing within
thirty (30) days of being notified that taxes will be or have
been required by a taxing authority to be withheld on the Running
Royalty and/or Sublicense Royalty. |
4.3 In the event that a Running
Royalty is payable to UTRF on the same Net Sales revenue or a
Sublicense Royalty is payable to UTRF on the same Sublicense
Revenue under this Section 4 and under one or more other
UTRF/GTx license agreements, GTx shall only be required to pay UTRF
such royalty under one such license agreement, subject to the
provisions of Section 5.2 and provided that if the amount due
varies from one such license agreement to another, GTx shall pay
the highest amount.
4.4 Within [ * ] following the
close of each calendar quarter in which Net Sales revenue is
received by GTx or a Sublicensee, or Sublicense Revenue is received
by GTx, payment of all amounts due to UTRF, including but not
limited to Running Royalty and Sublicense Royalty, shall be made to
UTRF or its designee in United States dollars in Knoxville,
Tennessee, or at such other place as UTRF may reasonably designate
consistent with the laws and regulations controlling in any foreign
country, provided that the [ * ] period may be extended for
up to [ * ] after the close of each calendar quarter if a
Sublicensee under a Sublicense requires more time than [ * ]
to make its sales and royalty calculation and its royalty payment
available to GTx. In the event GTx arranges for any payment under
this Section 4.4 to be made to UTRF by a Sublicensee pursuant
to Section 2.6, if such payment is not received by UTRF within
the [ * ] period set forth herein (or within up to [ *
] extension period as stated above), GTx shall be deemed to be
in breach of this Agreement, subject to the same cure provisions in
favor of GTx as set forth in Section 12. If any currency
conversion shall be required in connection with the payment of
royalties hereunder, such conversion shall be made by using the
exchange rate procedure listed in a Sublicense, if applicable, or
in the absence of an applicable Sublicense provision addressing
this issue, using the exchange rate listed in the Wall Street
Journal for major New York banks on the last business day of the
calendar quarter during which the royalty-bearing revenue was
received by GTx or its Sublicensees, as the case may be.
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
14
SECTION 5
Reports and Records
5.1 No more often than once each
License Year, UTRF or its accounting agents shall have the right to
inspect the books of account of GTx. GTx shall keep full, true and
accurate books of account containing all particulars that may be
necessary for the purpose of showing the amounts payable to UTRF
hereunder. Said books of account shall be kept at GTx’s
principal place of business or the principal place of business of
the appropriate division of GTx to which this Agreement relates.
Said books and the supporting data shall be open at all reasonable
times for [ * ] following the end of the License Year to
which they pertain, to the inspection of UTRF or its accounting
agents for the purpose of verifying GTx’s royalty statements.
If any examination reveals a shortage in amounts paid to UTRF, GTx
shall promptly reimburse UTRF for the shortage, together with
interest thereon as provided in Section 5.4, and if the
shortage is equal to or greater than [ * ] of the total
amount due in the period under audit, GTx shall reimburse UTRF for
the cost of the examination as well. If the examination reveals an
overpayment to UTRF, GTx may deduct the amount of such overpayment
from future amounts owed to UTRF hereunder.
5.2 GTx shall deliver to UTRF true
and accurate reports to confirm a royalty accounting hereunder
within [ * ] after the close of each calendar quarter
(provided that the [ * ] period may be extended for up to
[ * ] after the close of each calendar quarter if a
Sublicensee under a Sublicense requires more time than [ * ]
to make such information and its royalty payment available to GTx)
and a summary of GTx’s activities during such quarter to
develop and commercialize Licensed Products. These reports shall be
deemed GTx’s Confidential Information and shall include at
least the following, on a Licensed Product-by-Licensed Product,
country-by-country, and Sublicensee-by-Sublicensee basis:
| |
A. |
|
The number/amount of Licensed Product used, sold, or imported
by and/or for GTx and Sublicensees and other information that is
reasonably necessary to allow UTRF to properly calculate royalties
due to OSU under OSU IIA#1 and, if applicable, OSU IIA#2 (e.g., the
number/amount of BRIDGED SARMS or other SARMS sold); |
| |
| |
B. |
|
The total amounts invoiced and received by GTx and Sublicensees
for Licensed Products used or sold by GTx and/or Sublicensees
including (i) an accounting of Net Sales for Running Royalty
payments due to UTRF under Section 4.1B. above, with separate
calculations for Patented Products, Generic Products, and
Combination Products reflecting the type and amount of all
deductions from Gross Receipts; and (ii) an accounting of
Sublicense Revenue for Sublicense Royalty payments due to UTRF
under Section 4.1C above reflecting the type and amount of all
amounts deducted or excluded from Sublicense Revenue; |
| |
| |
C. |
|
The Running Royalty and Sublicense Royalty due, showing the
application of any reduction pursuant to Section 4.1D and
Section 2.8E., if applicable; |
| |
| |
D. |
|
For all royalties due to UTRF pursuant to Section 4.1, the
report shall include (i) the manner in which such royalties
were calculated and the amount allocable to each Licensed Product;
and (ii) if any such royalties are payable to UTRF under this
Agreement and under one or more other UTRF/GTx license agreements,
GTx shall set out in its report the amount of such royalties
covered by multiple license agreements and identify all such
license agreements to which such royalties apply, notwithstanding
that GTx is required to pay such royalties under only one such
license agreement; |
| |
| |
E. |
|
The names and addresses of all Sublicensees for or on whose
account royalty payments are being made in accordance with the
terms hereof; and |
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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F. |
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Upon request by UTRF, any other information that may be
necessary for the purpose of showing the amounts payable to UTRF
hereunder, amounts payable to OSU pursuant to IIA#1 and/or IIA#2
and/or compliance by GTx with the diligence provisions of
Section 3. |
5.3 With each such report submitted,
GTx shall pay to UTRF the royalties due and payable under this
Agreement. If no royalties shall be due, GTx shall so report. UTRF
is hereby authorized to provide to OSU or OSURF a copy of any
written reports provided to UTRF by GTx, subject to the
confidentiality provisions of OSU IIA#1, and if applicable, OSU
IIA#2.
5.4 Any amount owed by GTx under this
Agreement that is not received by UTRF on or before the date due
shall bear interest at a per annum rate [ * ] above the
prime rate quoted in the Wall Street Journal for major New York
banks on the date due, or if not quoted on the date due, the rate
quoted on the first business day after the date due. GTx shall also
pay all reasonable collection costs at any time incurred by UTRF in
obtaining payment of amounts past due, including reasonable
attorneys fees. If the transfer or the conversion into United
States Dollar equivalents in any such instance is not lawful or
possible, the payment of such part of the royalties as is necessary
shall be made by the deposit thereof, in the currency of the
country where the sales were made on which the royalty was based,
to the credit and account of UTRF or its nominee in any commercial
bank or trust company of its choice located in that country, prompt
notice of which shall be given by GTx to UTRF.
SECTION 6
Patent Prosecution
6.1 During the Term and subject to
the terms hereof and the applicable provisions of OSU IIA#1 and OSU
IIA#2, GTx shall have (a) complete control of the prosecution
of the Licensed Patents listed on Appendix A and will be
responsible for maintaining any patents issuing therefrom and (b)
the exclusive right and responsibility to prepare, file, prosecute
and maintain all patent applications and patents claiming
(i) EXISTING INVENTIONS and IMPROVEMENT INVENTIONS that are
solely or partly owned by UTRF or licensed to UTRF under OSU IIA#1
with the right to sublicense; (ii) NEW INVENTIONS that are
licensed to UTRF under OSU IIA#2 with the right to sublicense;
(iii) inventions solely owned by UTRF that are described in the
Initial SARMS Disclosures; (iv) invention(s) disclosed in the Third
Generation SARMS Disclosure that are owned in whole or in part by
UTRF and are not covered by Section 6.1(ii); and
(v) Licensed Technology defined in Section 1.25B., and such
patent applications and patents shall be added to Appendix A.
GTx shall use patent counsel of its own choice, at its own expense.
GTx agrees to pay all costs incident to the United States and
foreign applications, patents and like protection relating to the
Licensed Subject Matter, including all costs incurred for filing,
prosecution, issuance and maintenance fees as well as any costs
incurred in filing continuations, continuations-in-part,
divisionals or related applications and any re-examination,
reissue, opposition, or interference proceedings. Subject to the
provisions of Section 6.4, GTx shall file and maintain patent
applications claiming Licensed Technology defined in
Section 1.25B. in such countries as GTx in its sole discretion
shall select. Except for Licensed Patents listed on Appendix A
that are assigned to GTx or Sublicensee Patent Rights as described
in Section 6.2, UTRF shall have the sole and exclusive right,
title and ownership in and to all Licensed Patents, including
Licensed Patents claiming Licensed Technology defined in
Section 1.25B., which now exist or may exist in the future,
including all United States and foreign patent applications filed
and patents issued pursuant to this Section 6, except Licensed
Patents claiming invention(s) made in whole or in part by one or
more OSU Contributors or other Third Parties as determined in
accordance with applicable patent laws, ownership of which shall be
subject to the provisions of Section 6.2.
6.2 GTx and its Sublicensees shall
assign, transfer and convey to UTRF all right, title and interest
in and to all Licensed Patents, except (i) those claiming
invention(s) made in whole or in part by one or more OSU
Contributors or Third Parties, which Licensed Patents are to be
assigned, in whole or in part, as the case may be, to OSU, OSURF,
or in accordance with the instructions of such Third Party(ies);
and (ii) those listed on Appendix A that, as of the
Effective Date, have been assigned to GTx. GTx shall be responsible
for recording an assignment, as
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
16
appropriate, to UTRF and/or OSU and/or OSURF and/or to such
individual(s) or entity(ies) as such Third Party(ies) may direct,
of patent applications filed pursuant to this Section 6 with
the United States Patent and Trademark Office and with each foreign
Patent Office in which such applications are filed. Notwithstanding
the foregoing, GTx may permit its Sublicensees to retain ownership
of patent applications or patents claiming invention(s) made by
employee(s) or agent(s) of such Sublicensee which result from the
Licensed Subject Matter (“ Sublicensee Patent Rights
”), provided that the pertinent Sublicense agreement shall
include provision(s) granting to UTRF, UT, OSU, and OSURF a
perpetual worldwide non-exclusive royalty-free right to practice,
for non-commercial educational, research and academic purposes only
(such right to exclude the practice of Licensed Patents for any
fee-for-services arrangement or for sponsored research on behalf of
any commercial entity), under Sublicensee Patent Rights claiming
inventions necessary or reasonably useful in the practice of the
Licensed Patents.
6.3 GTx agrees to provide UTRF with
reasonable (which the Parties agree generally means not less than
two weeks) advance notice prior to filing of new patent
applications containing new subject matter, including, without
limitation, continuation-in-part applications, within Licensed
Patents. Copies of applications that are divisional or continuation
applications of Licensed Patents shall be furnished to UTRF and OSU
or OSURF within thirty (30) days of their being initially
filed with an appropriate patent office. GTx shall keep UTRF and
OSU or OSURF informed, at GTx’s expense, of filing,
prosecution, maintenance, and abandonment of applications and
issued patents within Licensed Patents pursuant to this
Section 6, including submitting to UTRF and OSU or OSURF
copies of all patent applications in accordance with the previous
sentence, and submitting to UTRF and OSU or OSURF copies of
material, official actions and responses thereto, and other
material written communications it or its patent counsel receives
from or files with the U.S. Patent and Trademark Office and the
equivalent foreign offices within forty-five (45) days of
filing or receipt, as the case may be. Notwithstanding the
foregoing, GTx shall submit information and copies of documents to
OSU or OSURF only with regard to EXISTING INVENTIONS, IMPROVEMENT
INVENTIONS, and NEW INVENTIONS. GTx shall consult with UTRF prior
to the abandonment of applications or issued patents with the
Licensed Patents.
6.4 UTRF agrees to reasonably
cooperate with GTx, at GTx’s request and expense, to whatever
extent is reasonably necessary but not inconsistent with OSU IIA#1
or OSU IIA#2, when applicable, to procure patent protection for
Licensed Technology, including execution of all appropriate
documents to provide GTx the full benefit of the licenses granted
herein.
6.5 In the event that GTx decides not
to continue prosecution of any United States or foreign patent
application within Licensed Patents to issuance or not to maintain
any United States or foreign patent within Licensed Patents in a
particular jurisdiction, GTx shall timely notify UTRF in writing in
order that UTRF may continue said prosecution or maintenance of
such patent applications or patents at its option and at its own
expense in such jurisdiction. GTx’s right under this
Agreement to practice the invention(s) under such patents and
patent applications shall immediately terminate in such
jurisdiction upon UTRF’s assuming said costs provided that
the application for which GTx decides not to continue prosecution,
or the patent which GTx decides not to maintain, is before the
patent office of a country that is a Major Market. Subject to the
provisions of Section 6.6 below, GTx shall not be considered
in default and this Agreement shall not terminate as to any
particular jurisdiction merely due to the fact that GTx decides not
to continue prosecution of a patent application to issuance, or not
to maintain any patent in any country that is not a Major Market.
If GTx fails to notify UTRF in sufficient time for UTRF to
reasonably continue prosecution, or the maintenance of, a patent or
patent application in a Major Market, GTx shall be considered in
default of this Agreement.
6.6 If (a) GTx and UTRF decide
not to file a patent application claiming an EXISTING INVENTION or
an IMPROVEMENT INVENTION or a NEW INVENTION, which is licensed to
GTx hereunder, or (b) if GTx allows a pending patent
application in Licensed Patents claiming an EXISTING INVENTION or
an IMPROVEMENT INVENTION or a NEW INVENTION licensed to GTx
hereunder to go abandoned without filing a continuation, division,
re-issue or other application having the same priority and without
issuance of a patent
[ * ]
= CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF
THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
17
having
the same priority and UTRF does not assume said costs pursuant to
Section 6.5, or (c) GTx decides not to maintain a
previously-filed patent application or issued patent claiming an
EXISTING INVENTION or IMPROVEMENT INVENTION or a NEW INVENTION
licensed to GTx hereunder and UTRF does not assume said costs
pursuant to Section 6.5, in each such case in the United
States, England, France, Germany, Italy, Spain, Canada, Australia,
China, India, Russia, Switzerland, and Japan (collectively, the
“ Major Countries ”), OSU or OSURF may elect to
file, prosecute, and/or maintain, as the case may be, such
application or patent in any Major Country in which GTx did not
file, prosecute, or maintain (collectively, the “
Exception Countries ”), at its sole expense. In that
event, GTx agrees that OSU or OSURF will be free to exploit and to
assign or license its interest in such patent application and/or
patent to Third Parties in the Exception Countries, provided that
any such assignment or license will be limited to domestic
manufacture and sale in the Exception Countries, with no right to
export or sell products or otherwise to compete with GTx or
Sublicensees in the rest of the world. In the event GTx believes
that any exploitation, assignment or license of OSU’s or
OSURF’s interests in the Exception Countries competes with or
interferes with GTx’s exclusive commercialization and
exploitation of Licensed Technology licensed hereunder in any Major
Country other than the Exception Countries, GTx agrees to so notify
OSU or OSURF. GTx acknowledges that OSU or OSURF has contractually
committed to take all reasonable measures to preclude such
competition or interference, including without limitation
terminating any license in the Exception Countries and taking
enforcement action.
6.7 GTx agrees to forward in a timely
manner all correspondence in need of signature by OSU Contributors
to the Memphis office of UTRF (unless UTRF shall otherwise direct)
in a timely manner. UTRF agrees, in turn, to promptly forward such
correspondence to OSU or OSURF for signature, but UTRF shall have
no responsibility for costs or other damages that may be incurred
because of delay at OSU or OSURF in returning signed
documents.
6.8 UTRF agrees to use reasonable
business efforts to promptly notify GTx of any option to license an
IMPROVEMENT INVENTION or NEW INVENTION upon such option arising in
favor of UTRF under either OSU IIA#1 or OSU IIA#2 and to take such
actions as are necessary and appropriate to exercise any such
option upon receiving notice from GTx that it wishes to file a
Licensed Patent claiming such IMPROVEMENT INVENTION or NEW
INVENTION.
6.9 GTx and all its Sublicensees
shall mark all products covered by Licensed Patents with patent
numbers in accordance with the statutory requirements in the
country(ies) of manufacture, use, and sale.
6.10 UTRF and GTx agree that one or
more senior administrator representing each of the Parties will
meet at least on a semi-annual basis at a mutually agreeable time
and place so that GTx may provide UTRF with an oral update on the
current development, licensing, regulatory, and commercialization
status of Licensed Products and to discuss any issues raised by
either UTRF or GTx arising out of, under, or in connection with
this Agreement. UTRF agrees to notify OSURF no less than
14 days in advance of any such meeting, and that a
representative from OSURF shall have the right to attend if they
agree to confidentiality terms no less stringent than described in
Section 18.
SECTION 7
Infringement
7.1 GTx shall inform UTRF and UTRF
shall inform GTx promptly in writing of any alleged assertion
and/or claim of infringement of the Licensed Patents by a Third
Party and of any available evidence thereof.
7.2 GTx shall have the first, sole
and exclusive right, but shall not be obligated, to prosecute or
defend at its own expense all infringements or opposition,
interference a
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