Exhibit
10.41
[ * ]
= 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.
AMENDED AND RESTATED LICENSE AGREEMENT
THIS AMENDED AND RESTATED LICENSE
AGREEMENT made and entered into this 24 th day of
September, 2007, having an effective date of July 24, 1998
(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 the invention disclosure form [ * ]
designated by UTRF as file number PD [ * ] (“
Initial SERM Disclosure ”);
WHEREAS, UTRF and GTx have
previously entered into a separate agreement, titled “Amended
and Restated Exclusive License Agreement” and made effective
as of July 24, 1998, whereby GTx was granted an exclusive
license to Licensed Patents (as defined therein) and Licensed
Technology (as defined therein) which arose out of the technology
described in the Initial SERM Disclosure (the “ Prior
License Agreement ”);
WHEREAS , GTx entered into a
Collaboration and License Agreement dated September 7, 2006
(the “ Ipsen Sublicense ”) with Ipsen Limited
(“ Ipsen ”) to grant Ipsen exclusive rights in
the European Territory (as defined in the Ipsen Sublicense) to
GTx’s product candidate, Acapodene ® , and other
products containing toremifene citrate, for methods of use that
include those encompassed within the Licensed Patents;
WHEREAS , GTx provided UTRF
with a copy of the Ipsen Sublicense in accordance with the
provisions of the Prior License Agreement;
WHEREAS , the Parties now
desire to enter into this “Amended and Restated License
Agreement” for the purpose of making certain changes
regarding the rights and obligations of the Parties; and
WHEREAS , the Parties intend
that this Agreement shall supersede the Prior License Agreement and
render it 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 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 Amended and Restated License Agreement.
1.5 “ Claims ”
shall have the meaning set forth in Section 8.1 hereof.
1.6 “ Combination
Product ” means either (i) any pharmaceutical
product that consists of at least one SERM and at least one other
Active Ingredient that is not a SERM, or (ii) any combination
of a SERM and another pharmaceutical product that contains at least
one other Active Ingredient that is not a SERM where such products
are not formulated together but are sold together as a single
product and invoiced as one product.
1.7 “ Confidential
Information ” shall have the meaning set forth in
Section 18.2 hereof.
1.8 “ 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.
1.9 “ Effective Date
” shall have the meaning set forth in the introductory
paragraph hereof.
1.10 “ Federal Policy
” shall have the meaning set forth in Section 2.3
hereof.
1.11 “ 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.
1.12 “ 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”.
1.13 “ Independent SERM
Invention ” shall have the meaning set forth in
Section 2.8 hereof.
1.14 “ Initial SERM
Disclosure ” shall have the meaning set forth in the
Recitals.
1.15 “ Ipsen ”
shall have the meaning set forth in the Recitals.
1.16 “ Ipsen Sublicense
” shall have the meaning set forth in the Recitals.
1.17 “ License Maintenance
Fee ” shall have the meaning set forth in
Section 4.1A. hereof.
1.18 “ License Year
” shall mean a 12-month period beginning on July 24
th of
one year and ending on July 23 rd of the
following year.
[ * ]
= 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
1.19 “ 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.
1.20 “ 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 1.6), Licensed
Product shall mean only that portion of the Combination Product
containing a SERM or SERMS, and Net Sales for such Licensed Product
contained within a Combination Product shall be determined as set
forth under Section 1.25.
1.21 “ Licensed Subject
Matter ” shall mean Licensed Patents and Licensed
Technology.
1.22 “ Licensed
Technology ” shall mean, except to the extent published
or otherwise generally known to the public 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
Independent SERM 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
SERMs utilizing any Proprietary SERM 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 1.22 (i) through
(iii)) the chemoprevention of prostate cancer and any methods of
which the primary purpose is to administer to a subject an
effective dose of a chemopreventive agent, toremifene, and analogs
or metabolites thereof, to prevent recurrence of, suppress or
inhibit prostate carcinogenesis.
1.23 “ Major Markets
” shall mean and include the United States, Great Britain,
France, Germany, and Japan.
1.24 “ Negotiation
Period ” shall have the meaning set forth in
Section 2.8D. hereof.
1.25 “ 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. |
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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. |
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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. |
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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. |
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outbound transportation expenses (including insurance relating
thereto) directly related to a particular Sale, to the extent
included in Gross Receipts; |
[ * ]
= 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
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E. |
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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. |
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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. |
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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. |
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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 |
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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 SERM 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 1.25I.) from the use, sale, or distribution of
Licensed Products containing such SERM 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.
[ * ]
= 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
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.
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.
1.26 “ Option ”
shall have the meaning set forth in Section 2.8 hereof.
1.27 “ Option Period
” shall have the meaning set forth in Section 2.8A.
hereof.
1.28 “ 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.
1.29 “ Party ” and
“ Parties ” shall have the meaning set forth in
the introductory paragraph hereof.
1.30 “ Prior License
Agreement ” shall have the meaning set forth in the
Recitals.
1.31 “ Proprietary SERM
Know-How ” shall mean know-how pertaining to a SERM that
is obtained from GTx or a UT Contributor and is not published or
otherwise generally known to the public.
1.32 “ 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.
1.33 “ Running Royalty
” shall have the meaning set forth in Section 4.1B.
hereof.
1.34 “ SERM ” or
“ SERMS ” shall mean toremifene, and analogs or
metabolites thereof.
1.35 “ 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, including the Ipsen Sublicense, and any further such grant
at any tier.
1.36 “ 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 excluding the up-front fee GTx
has already received from Ipsen in October 2006 upon its
entering into the Ipsen Sublicense. GTx may deduct from Sublicense
Revenue attributable to a particular Sublicense agreement payments
received by GTx 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.
5
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.
1.37 “ Sublicense
Royalty ” shall have the meaning set forth in
Section 4.1C. hereof.
1.38 “ Sublicensee
” shall mean and include any recipient of a Sublicense,
including Ipsen.
1.39 “ Sublicensee Patent
Rights ” shall have the meaning set forth in
Section 6.2 hereof.
1.40 “ Term ”
shall have the meaning set forth in Section 12.1 hereof.
1.41 “ Third Party
” or “ Third Parties ” shall mean any
person, party or entity other than GTx, its Affiliates, UTRF, or
UT.
1.42 “ UT ” shall
mean The University of Tennessee.
1.43 “ UT Contributor
” and “ UT Contributors ” shall mean one
or more of Mitchell S. Steiner and Sharan Raghow, and any other UT
employee who contributed, either before or after the Effective
Date, to the development of the Licensed Subject Matter.
1.44 “ 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.
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:
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A. |
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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; and |
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B. |
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an exclusive, worldwide right and license, with the right to
grant Sublicenses, to utilize the Licensed Technology. |
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, 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
[ * ]
= 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
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.
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. Notwithstanding anything to the contrary in this
Agreement (including, without limitation, this Section 2.5),
UTRF hereby agrees that all provisions of the Ipsen Sublicense, as
executed on September 7, 2006, are in full compliance with the
terms and conditions of this Agreement. GTx agrees that it will not
modify or otherwise amend the Ipsen Sublicense in any manner that
would deviate from any of the requirements of a Sublicense set
forth herein without obtaining UTRF’s prior written approval,
which approval will not unreasonably be withheld. The Parties agree
that unless a modification or amendment shall affect any
requirement of a Sublicense as described in the immediately
preceding sentence, GTx and Ipsen shall have the right and
discretion to negotiate and enter into such amendments and
modifications to the Ipsen Sublicense as they shall from time to
time determine without first obtaining the approval of UTRF, and
GTx will furnish a copy of any such amendment or modification to
UTRF within thirty (30) days of the execution of such an
instrument as required herein.
2.6 GTx shall be responsible for its
Affiliates and Sublicensees and, except as set forth above as it
pertains to Ipsen, 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
[ * ]
= 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
name of
UTRF, 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 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 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, or UT Contributors, compliance with
Federal Policy, 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 upon becoming aware of any
SERM invention owned solely or in part by UTRF which is not
(a) based on or developed from Proprietary SERM Know-How or
(b) developed at UT from grants or research payments made to
UT by GTx (each invention described above herein being an “
Independent SERM Invention ”). Subject to the rights
of Third Parties (in the event UTRF co-owns such Independent SERM
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
SERM Invention (“ Option ”), provided that the
grant of such Option does not violate Federal Policy and further
subject to the following:
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A. |
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The Option shall commence upon UTRF’s written notice to
GTx of the existence of such Independent SERM 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 ”). |
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B. |
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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. |
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C. |
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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 SERM
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 |
[ * ]
= 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
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with non-economic terms that are substantially similar to those
contained herein, to the extent applicable. |
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D. |
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In the event GTx does not exercise the Option for a particular
Independent SERM 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 SERM 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 SERM Invention. In the absence of a
license agreement granting GTx rights to such Independent SERM
Invention, GTx agrees that it will not use such Independent SERM
Invention for any commercial or non-commercial purpose. |
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E. |
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During the Option Period and the Negotiation Period, if any,
UTRF will confer with GTx concerning proper protection of such
Independent SERM 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 SERM 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 SERM
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 SERM Invention, which intellectual property
rights shall be assigned solely to UTRF or jointly to UTRF and its
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