[ * ] = 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.
EXHIBIT 10.2
AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT
THIS AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT (this
"Agreement") is entered into and made effective as of this 1st day of January,
2005 (the "Restatement Date") by and between ORION CORPORATION, a corporation
organized and existing under the laws of Finland and having its principal office
at Orionintie 1 FIN-02200 Espoo, Finland ("Orion"), and GTX, INC., (fka
Genotherapeutics, Inc.) a corporation organized and existing under the laws of
the State of Delaware, U.S.A. and having its principal office at 3 North Dunlap
Avenue, Van Vleet Building, Third Floor, Memphis, Tennessee 38163, USA ("GTX").
WHEREAS, Orion and GTX entered into a Toremifene License and Supply
Agreement effective as of March 30, 2000 (the "Effective Date"), to govern the
Parties' rights and obligations with respect to the research, development,
commercialization and manufacture of Product (as defined in said agreement) (the
"Original Agreement");
WHEREAS, Orion and GTX amended and restated the Original Agreement on
October 22, 2001 (the "Amendment Date"), and then amended the Original Agreement
on March 5, 2003 (the "First Amendment"), and on December 29, 2003 (the "Second
Amendment");
WHEREAS, Shire and Orion have entered into an agreement wherein Orion
will acquire all of Shire's rights and interests to Toremifene for the breast
cancer indication in the United States;
WHEREAS, GTX desires to expand its license to include all of Orion's
other rights and interests in Toremifene for human use, except for the use of
Toremifene for the prevention and treatment of breast cancer in countries
outside of the United States and use of Toremifene in the animal health field
worldwide, and Orion desires to grant to GTX such licenses;
WHEREAS, the Parties desire with this Agreement to supercede and
replace the Original Agreement, First Amendment and Second Amendment effective
as of the Restatement Date to provide that GTX shall have the sole
responsibility for researching, developing, registering and commercializing the
Product (as defined below) within the Field (as defined below) worldwide, except
for the use of Toremifene either for the prevention and treatment of breast
cancer in countries outside of the United States or for animal health; and
WHEREAS, Orion shall have no monetary or other responsibilities for
researching, developing, registering or commercializing Product, but shall
remain responsible for manufacturing Orion Product (as defined below), as agreed
herein;
1.
NOW THEREFORE for and in consideration of the mutual covenants
contained herein, the receipt and sufficiency of which are hereby acknowledged,
Orion and GTX (hereinafter individually a "Party"; and collectively the
"Parties") hereto agree as follows:
1. DEFINITIONS
For purposes of this Agreement, the following terms shall be defined as
set forth below. Additional terms used in specific Sections of this Agreement
shall be defined in such Sections.
1.1 "ADDITIONAL PRODUCT" shall have the meaning set forth in Section
2.1.5.
1.2 "AFFILIATE" shall mean any business entity controlled by a Party,
or which controls a Party, or which is under common control with a Party.
"Control" herein means the direct or indirect ownership of more than fifty
percent (50%) of the authorized issued voting shares in such entity, or such
other relationship as in fact legally results in effective control over the
management, business and affairs of such entity or Party, as the case may be.
1.3 "ANNUAL NET SALES" shall mean Net Sales (as defined below) in any
calendar year.
1.4 "BREAST CANCER FIELD" shall mean the prevention and treatment of
breast cancer.
1.5 "CALENDAR QUARTER" shall mean each of the three (3) month periods
beginning on January 1, April 1, July 1 and October 1 of each year during the
Term (as defined below).
1.6 "COMPETING PRODUCT" shall mean any pharmaceutical product
containing a SERM as a therapeutically active ingredient as well as any salt
thereof, which product is licensed, sold and/or marketed for use in the Field,
including, but not limited to, other dosage forms licensed, sold and/or marketed
for use in the Field. Competing Product does not include Orion Product, but
includes any generic form of the Product.
1.7 "CORRECTION FACTOR" shall have the meaning set forth in Section
3.1.3(b).
1.8 "DMF" shall have the meaning provided in Section 7.5.
1.9 "EUROPEAN UNION" shall include Austria, Belgium, Denmark, Finland,
France, Germany, Greece, Ireland, Italy, Luxembourg, The Netherlands, Portugal,
Spain, Sweden, United Kingdom, Cyprus, Czech Republic, Estonia, Hungary, Latvia,
Lithuania, Malta, Poland, Slovakia, Slovenia, and any such other country or
territory that may become part of the European Union after the Restatement Date.
1.10 "FARESTON PRODUCT" shall mean the Orion Product in 60 mg tablet
form containing Toremifene that was promoted in the USA under the brand name
"Fareston" by Shire prior to the Restatement Date for use in the Breast Cancer
Field.
[ * ] = 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.
1.11 "FARESTON REPURCHASE AGREEMENT" shall mean the Repurchase
Agreement entered by and between Shire and Orion dated December 13, 2004.
1.12 "FARESTON U.S. WEB PAGES" shall have the meaning set forth in
Article 9.
1.13 "FIELD" shall mean all uses of a Product in humans. The Parties
expressly acknowledge that the use of Product in the field of animal health is
excluded from the scope of this Agreement.
1.14 "FIRST COMMERCIAL SALE" means in each country, the date the
Product is first sold, marketed, or publicly made available for sale for use in
a given portion of the Field by GTX, its Affiliate or a GTX Unaffiliated
Sublicensee. Product for use in a given portion of the Field, distributed or
used for clinical trial purposes shall not be considered sold, marketed or made
publicly available for sale and shall not constitute First Commercial Sale.
1.15 "GENERIC PRODUCT" shall mean a generic pharmaceutical product for
human use containing Toremifene as an active ingredient sold by an entity other
than GTX, its Affiliate or its Unaffiliated Sublicensee and which can be
substituted by the prescriber or dispenser for a Product for use in the Field
(excluding Products sold by or on behalf of Orion, in the Orion Territory in the
Orion Field or outside the Field).
1.16 "GTX FINAL DEVELOPMENT AND REGISTRATION PLAN" shall mean the final
product development and registration plan for each Product in the Prostate
Cancer Field prepared by GTX, its Affiliate or a GTX Unaffiliated Sublicensee,
as the same may be modified from time to time pursuant to Section 7.4.
1.17 "GTX KNOW-HOW" shall mean such non-patented and unpublished
non-clinical, pre-clinical and clinical documentation, information, and data
including information and data in U.S. IND [ * ], U.S. IND [ * ], and all
resulting marketing applications worldwide relating to the use of Toremifene or
any SERM in the Field, that is owned or controlled by, and disclosable by and
available to, GTX and its Affiliates as of the Effective Date or at any time
during the Term, including but not limited to all registration materials for the
Product developed, acquired or compiled by GTX and/or its Affiliates as of the
Effective Date or at any time during the Term, and all non-patented and
unpublished documentation, information and data relating to the formulation,
manufacture and/or quality control of the Product that is owned or controlled by
GTX and/or its Affiliates as of the Effective Date or at any time during the
Term.
1.18 "GTX PATENTS" shall mean the patents issued from GTX Patent
Applications as of the Effective Date and other patents owned or controlled by
GTX and its Affiliates that are issued at any time during the Term, and that
claim technology used for the manufacture, sale or use of any SERM for use in
the Prostate Cancer Field (including any divisions, continuations,
continuations-in-part, re-examinations, reissues, additions, renewals and
extensions thereof). GTX Patents in existence as of the Restatement Date are set
forth in Part I of Schedule A. For purposes of this Agreement, the Parties
acknowledge that GTX Patents shall include United States Patents as set forth on
Schedule A, which claims the use of Product in the Prostate Cancer Field, which
patents are in the name of and owned by The University of Tennessee Research
Foundation. GTX represents and warrants that it has acquired sufficient
[ * ] = 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.
rights and licenses from The University of Tennessee Research Foundation to said
patents for the purpose of performing its obligations under this Agreement.
1.19 "GTX PATENT APPLICATIONS" shall mean patent applications of the
University of Tennessee Research Foundation or GTX, as applicable, and/or
Affiliates of GTX pending as of the Effective Date, and patent applications
owned or controlled by the University of Tennessee Research Foundation and/or
GTX, as applicable, and/or Affiliates of GTX, that are filed at any time during
the Term, in each case that claim technology used for the manufacture, sale or
use of any SERM for use in the Prostate Cancer Field (including any divisions,
continuations, continuations-in-part, re-examinations, reissues, additions,
renewals and extensions thereof). GTX Patent Applications in existence as of the
Restatement Date are set forth in Part II of Schedule A.
1.20 "GTX PATENT RIGHTS" shall mean GTX Patents and GTX Patent
Applications.
1.21 "GTX PRELIMINARY DEVELOPMENT AND REGISTRATION PLAN" shall mean the
preliminary product development plan for the development of the Product in the
Prostate Cancer Field prepared by GTX which has been provided to Orion prior to
Effective Date, and which was attached to the Original Agreement.
1.22 "GTX TERRITORY" shall mean all countries or territories worldwide.
1.23 "GTX UNAFFILIATED SUBLICENSEE" shall mean any sublicensee of GTX
other than a GTX Affiliate. For avoidance of doubt, Orion shall not be a GTX
Unaffiliated Sublicensee.
1.24 "MAJOR COUNTRY" shall mean the United States of America including
its fifty states, the District of Columbia, Puerto Rico, and all other USA
territories and possessions ("USA"), Canada, Japan, Great Britain, France,
Germany, Spain and Italy.
1.25 "MANUFACTURING COSTS" shall have the meaning set forth in Section
7.3.
1.26 "MANUFACTURING PATENTS" shall have the meaning provided in Section
7.7.
1.27 "MAT NET SALES OF FARESTON PRODUCT" shall mean the certain moving
annual total sales of the Fareston Product as defined in Section 3.1.3(b).
1.28 "NET SALES" shall mean the invoiced gross sales of the Product to
a Third Party which is not a GTX Unaffiliated Sublicensee, less: (A) credits and
allowances or adjustments (consistent with generally accepted accounting
principles), granted to such customers on account of rejections, recalls or
returns of the Product previously sold; (B) any customary and reasonable trade
and cash discounts, rebates, including government rebates, granted in connection
with sale of Product to such customers; (C) sales, tariff duties and/or use
taxes directly imposed and with reference to particular sales; and (D) outbound
transportation prepaid or allowed, amounts allowed or credited on returns,
export licenses, import duties, value added tax, and prepaid freight.
[ * ] = 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.
1.29 "ORION FIELD" shall mean the use of Toremifene in the Breast
Cancer Field.
1.30 "ORION KNOW-HOW" shall mean such non-patented and unpublished
non-clinical, pre-clinical and clinical documentation, information, and data
relating to the Orion Product that is owned or controlled by, and disclosable by
and available to, Orion and its Affiliates as of the Effective Date or at any
time during the Term which is necessary for the development by GTX of Product
for use in the Field (including without limitation filing an application for
Regulatory Approval for the Product for use in the Field), including information
and data in the Orion Product NDA relating to Fareston Product, registration
materials for the Orion Product, documentation, information and data relating to
the formulation and/or quality control of the Orion Product. Except as otherwise
provided in Sections 7.7, 14.9, 16.1, 17.3.2, 17.4 and 21.2, Orion Know-How
shall exclude information relating to Orion's manufacture of Toremifene (as
defined below) and Orion Product (as defined below).
1.31 "ORION PATENTS" shall mean the patents owned or controlled by
Orion that are directed to the compound Toremifene per se, and relate to the use
or sale of Toremifene and all other patents issued from Orion Patent
Applications during the Term (including any divisions, continuations,
continuations-in-part, re-examinations, reissues, additions, renewals and
extensions thereof). Orion Patents in existence as of the Restatement Date are
set forth in Part I of Schedule B. Schedule B shall be amended by Orion from
time to time during the Term to include future Orion Patents.
1.32 "ORION PATENT APPLICATIONS" shall mean patent applications owned
or controlled by Orion and its Affiliates that are pending as of the Effective
Date, and patent applications owned or controlled by Orion and its Affiliates
that are filed at any time during the Term, in each case that are directed to
the compound Toremifene per se and relate to the use or sale of Toremifene
(including any divisions, continuations, continuations-in-part, re-examinations,
reissues, additions, renewals and extensions thereof). Orion Patent Applications
in existence as of the Restatement Date are set forth in Part II of Schedule B.
Schedule B shall be amended by Orion from time to time during the Term to
include future Orion Patent Applications.
1.33 "ORION PATENT RIGHTS" shall mean Orion Patents and Orion Patent
Applications.
1.34 "ORION PRODUCT" shall mean tablets containing [ * ] of Toremifene
respectively, that are manufactured by Orion and are commercially available as
of the Restatement Date, and such other dosage strength or formulation of
Toremifene as a therapeutically active ingredient as Orion may agree to
manufacture pursuant to Section 17.4.
1.35 "ORION PRODUCT NDA" shall mean U.S. NDA [ * ].
1.36 "ORION TERRITORY" shall mean all countries and territories
worldwide, except for the USA.
[ * ] = 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.
1.37 "ORION UNAFFILIATED SUBLICENSEE" shall mean any licensee or
sublicensee under the Orion Patent Rights, other than an Orion Affiliate, GTX, a
GTX Affiliate or a GTX Unaffiliated Sublicensee.
1.38 "OTHER PRODUCT" shall have the meaning set forth in Section 17.4.
1.39 "PREMIUM" shall mean, with respect to an equity investment by a
Third Party in GTX, an amount equal to the difference between the total
consideration paid for the purchase of shares of GTX stock and the fair market
value of such stock, as defined herein. Such fair market value shall be equal to
the trading price of a share of GTX common stock on the date such Third Party
investment is made (or, if such date is not a trading day, the price of a share
of GTX common stock on the most recent trading day prior to the date of such
investment, and if such Third Party investment occurs concurrent with the
initial public offering, then the price per share at which stock is offered to
the public), multiplied by the number of shares issued to such Third Party
investor.
1.40 "PRODUCT" shall mean any pharmaceutical product for human use
within the Field containing Toremifene as a therapeutically active ingredient.
1.41 "PRODUCT ROYALTY ADJUSTMENT DATE" shall have the meaning set forth
in Section 3.1.3(a).
1.42 "PROSTATE CANCER FIELD" shall mean the prevention and treatment of
prostate cancer, which shall mean for the purposes of hereof: preventing
prostate carcinogenesis; suppressing or inhibiting prostate cancer; reducing the
risk of developing prostate cancer; increasing the survival rate of a subject
with prostate cancer; and treating prostate cancer. Furthermore, the Prostate
Cancer Field shall include the prevention and/or treatment of osteoporosis,
gynecomastia, hot flashes, and other side effects induced by chemical or
surgical androgen deprivation therapy in the treatment of prostate cancer.
1.43 "PURCHASE AGREEMENT" shall mean the agreement between Orion and
GTX dated December 13, 2004.
1.44 "REGULATORY APPROVAL" shall mean all governmental approvals
required to import, market, promote and sell the Product for use in the Field in
any given country or territory in the GTX Territory, including but not limited
to, product registrations, medical approvals and price and marketing approvals.
1.45 "ROYALTY INCOME" shall have the meaning set forth in Section
3.1.5.
1.46 "SALES OF GENERIC PRODUCT" shall mean the documented sale and use
of a Generic Product.
1.47 "[ * ]" shall have the meaning set forth in Section 3.1.6.
1.48 "SERM" shall mean Toremifene (as described in the Orion Patent
Rights), including its isomers, metabolites, derivatives or analogs having
either antiestrogenic or estrogenic pharmacological properties.
[ * ] = 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.
1.49 "SHIRE" shall mean Shire US, Inc., a corporation duly organized
and existing under the laws of New Jersey, USA, and having its principal offices
in Wayne, Pennsylvania, which had rights to Product in the USA in the Breast
Cancer Field prior to the Restatement Date.
1.50 "SPECIFICATIONS" shall mean the current specifications (as of the
Restatement Date) for the Orion Product, as such specifications are, with regard
to [ * ] containing Toremifene, set forth in the Orion Product NDA, and with
regard to [ * ] and [ * ] tablet of Orion Product set forth in Schedule C
(Copies of such current specifications are set forth in Schedule C attached
hereto and made a part hereof.) The Specifications shall also include any other
modified or additional specifications applicable to Orion Product which may be
manufactured by Orion, pursuant to Section 17.3 or 17.4. Schedule C may be
amended from time to time as necessary to reflect modifications to the
Specifications that may be implemented pursuant to Section 17.3 or to include
Specifications for any Other Product that Orion may agree to manufacture
pursuant to Section 17.4.
1.51 "TERM" shall mean the period commencing on the effective date of
the Original Agreement and continuing, on a country by country basis until the
later of (a) the date of expiration or invalidation of the last to expire or be
invalidated of the GTX Patent Rights, or (b) the expiration or termination of
the last to expire of the marketing or regulatory exclusivity granted by the
FDA, the European Medicines Agency or other equivalent regulatory authority for
Product, each of (a) and (b) herein as subject to earlier termination under
Article 21.
1.52 "THIRD PARTY" or "THIRD PARTIES" shall mean any party or parties
other than GTX, Orion, an Affiliate of GTX, or an Affiliate of Orion.
1.53 "TOREMIFENE" shall mean [ * ].
1.54 "TRADEMARKS" shall mean the trademarks GTX selects and registers
for the Product in the GTX Territory in accordance with Article 10 of this
Agreement, and the trademark Fareston(R) in the USA used by Shire prior to the
Restatement Date for the Fareston Product.
1.55 "USA" shall mean the United States of America including its fifty
states, the District of Columbia, Puerto Rico, and all its territories and
possessions.
1.56 "U.S. FDA" shall mean the United States Food and Drug
Administration and any successor regulatory agency.
1.57 "U.S. IND" shall mean an Investigational New Drug Application
filed with the U.S. FDA.
1.58 "U.S. NDA" shall mean a New Drug Application filed with the U.S.
FDA.
1.59 "UPFRONT AND MILESTONE INCOME" shall have the meaning provided in
Section 3.1.1(c).
[ * ] = 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.
1.60 "VALID CLAIM" shall mean 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.
2. GRANT AND SCOPE OF RIGHTS GRANTED
2.1 ORION GRANTS TO GTX.
2.1.1 LICENSE GRANTS. Orion hereby grants to GTX for the Term:
(I) an exclusive right and license, with the right to
grant sublicenses as provided in Section 2.1.4, under Orion Patent Rights and
Orion Know-How, to develop, use, have used, sell, have sold, import, market and
distribute the Product in the Field in the GTX Territory, except in the Orion
Field in the Orion Territory; and
(II) a non-exclusive right and license, with the right to
grant sublicenses as provided in Section 2.1.4, under the Orion Patents and
Orion Know-How, to perform research and preclinical development activities in
accordance with Section 2.5 using the Powder (as defined in Section 14.6.2) to
be provided to GTX pursuant to Section 14.6.2, except in the Orion Field in the
Orion Territory.
For the avoidance of doubt, nothing herein shall limit or restrict or
be construed to limit or restrict Orion from using, and GTX acknowledges that
Orion may use, Toremifene and Product (i) as a reference compound and reference
product in its research and development activities for the Field and for uses
outside the Field, and (ii) in conducting business activities in the Orion Field
in and for the Orion Territory, as well as in the field of animal health.
Licenses under Section 2.1.1(i) may be expanded to include the right to
make and have made Products as provided in Sections 7.7, 14.9, 16.1, 17.3.2,
17.4 and 21.2.2 on such terms as are set forth in such Sections.
2.1.2 MANUFACTURING RIGHTS RESERVED. Except as otherwise provided
in Sections 7.7, 14.9, 16.1, 17.3.2, 17.4 and 21.2.2, Orion retains the
exclusive right to manufacture or have manufactured Toremifene, Orion Product
and Product including, without limitation, any Toremifene and Orion Product to
be supplied to GTX under this Agreement and subject to Sections 7.7, 14.9, 16.1,
17.3.2, 17.4 and 21.2.2 herein, during the Term GTX undertakes to purchase all
its requirement of Product exclusively from Orion.
2.1.3 USE OF ORION KNOW-HOW. Under the license granted pursuant to
Section 2.1.1(i), GTX shall, subject to the terms and conditions of this
Agreement, including without limitation Article 8, have the right to use and
reference Orion Know-How in support of GTX's clinical trials and applications
for Regulatory Approval within the Field for the Product in the GTX Territory.
Subject to the license rights granted hereunder, Orion retains full ownership
rights to all Orion Know-How.
[ * ] = 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.
2.1.4 SUBLICENSING. GTX shall have the right to sublicense its
rights received under this Agreement in the GTX Territory to any Third Party,
except that GTX shall not have the right to grant sublicenses to any Third Party
to market, sell or offer for sale the Fareston Product for use in the Breast
Cancer Field in the USA. For any permitted sublicense granted by GTX, GTX shall
notify Orion within fifteen (15) days after execution of an agreement between
GTX and a GTX Unaffiliated Sublicensee. GTX shall endeavor to include in its
agreement with each GTX Unaffiliated Sublicensee a provision stating that, upon
termination of this Agreement, such Unaffiliated Sublicensee and Orion shall
discuss, and as appropriate, negotiate the terms and conditions under which
Orion and such sublicensee would be willing to collaborate with regard to the
further development and/or commercialization of the Product for use in the field
in which GTX and such sublicensee were previously developing and/or
commercializing Products, provided that any such further development and/ or
commercialization of the Product by Orion and such sublicensee shall be subject
to and conditioned by a definite written agreement, if any, accepted and signed
by duly authorized representatives of Orion. GTX shall forward to Orion a
complete copy of each sublicense agreement. No sublicense shall relieve GTX of
any of its obligations or commitments under this Agreement and GTX shall cause
its Affiliates and GTX Unaffiliated Sublicensees to comply with all of GTX
obligations and commitments under this Agreement.
GTX shall remain jointly and severally liable to Orion with its
Affiliate(s) and GTX Unaffiliated Sublicensee(s) that obtain a sublicense under
the licenses granted to GTX pursuant to Section 2.1.1 for performance of GTX's
obligations under this Agreement. GTX shall be responsible for complying and
ensuring that such of its Affiliates and GTX Unaffiliated Sublicensees, as
applicable, comply with all relevant laws, regulations and requirements relating
to the importation, packaging, distribution, marketing, promotion, sale and use
of Product in the GTX Territory.
Orion shall have the right to propose to GTX one or more potential
sub-licensees under GTX's rights to the Product for use in the Field (other than
in the Orion Field) in South Korea and China (including, for the purpose of this
Agreement, the People's Republic of China and Taiwan). GTX shall consider such
proposal(s) in good faith when appointing such a sub-licensee for the Product
for use in the Field (other than in the Orion Field) for South Korea and China.
2.1.5 GTX RIGHTS OF FIRST NEGOTIATION. Orion grants GTX, on a
country by country basis, the right of first negotiation to negotiate further
agreements under commercially reasonable terms and conditions regarding the
further development, registration, promotion, marketing, sales and distribution
of a pharmaceutical product for human use within the Prostate Cancer Field
containing SERMs as the active ingredient (a) which is covered by a Valid Claim
within the GTX Patent Rights in such country; and (b) for which Orion has both a
license or other right to develop and commercialize such products and has
commenced, within five (5) years after the Amendment Date, a Phase I clinical
trial for such product anywhere in the world for a primary indication falling
within the Prostate Cancer Field (a product fulfilling (a) and (b), hereinafter
referred to as "Additional Product"). If Orion decides to offer to any Third
Party the opportunity to participate in the development or commercialization of
such Additional Product, or if Orion commences Phase I clinical trials for such
Additional Product, it shall so notify GTX in writing. [ * ] after GTX's receipt
of such notice from Orion regarding commercially
[ * ] = 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.
reasonable terms and conditions for obtaining rights in and to such Additional
Product, GTX shall notify Orion in writing if it wishes to enter into
negotiations with respect to such Additional Product. Should GTX elect to
exercise such right, the Parties agree to negotiate in good faith the
commercially reasonable terms and conditions for a letter of intent to be
completed [ * ] of receipt by Orion of such notification from GTX. Any deadlines
may be extended by mutual written agreement. Should GTX fail to provide written
notification to Orion by the end of [ * ], or GTX notifies Orion that it does
not wish to enter into negotiations; or the Parties, despite conducting good
faith negotiations, are unable to finalize the commercial terms of the letter of
intent [ * ], GTX shall have no further rights in the SERM, and Orion shall be
free to contract with a Third Party concerning same or itself further pursue the
development, registration, promotion, marketing, sales and distribution of such
Additional Product.
2.1.6 GTX RIGHTS TO NEGOTIATE FOR RIGHTS IN THE ORION FIELD IN THE
ORION TERRITORY. With respect to the development and commercialization of
Products in the Orion Field in the Orion Territory, GTX shall have the following
rights:
(A) As of the Restatement Date, Orion has Third Party
licensees that have rights to develop and/or commercialize the Product in the
Orion Field and in the Orion Territory. If any such sublicense terminates at any
time during the Term after the Restatement Date, and if Orion desires to seek
another Third Party sublicensee under such rights, then Orion shall so notify
GTX and GTX shall have a right to negotiate with Orion the terms under which GTX
may obtain such rights to such Product in the Orion Field and in the Orion
Territory, on the following basis:
(B) If GTX is interested in negotiating with Orion for such
rights to Product in the Orion Field and in the Orion Territory, it shall notify
Orion thereof in writing within thirty (30) days of receiving Orion's notice.
The Parties shall negotiate in good faith for a period of ninety (90) days after
Orion receives GTX's notice of interest on the terms of an agreement governing
such rights and during said period Orion shall not grant such rights to any
Third Party. If the Parties fail within such ninety (90) day period to execute
such an agreement, then Orion shall thereafter be free to contract with any
Third Party with respect to the rights in question.
2.2 NO IMPLIED LICENSES. Any rights not expressly granted by either
Party to the other Party in this Agreement are expressly reserved by the Party
owning or controlling such rights and, accordingly, no licenses other than those
specified herein shall be deemed granted by this Agreement by implication,
estoppel or otherwise.
2.3 UNITED STATES GOVERNMENT RIGHTS. In the event it is determined that
any GTX Patent Rights were developed with the support of the United States
Government or any agency thereof (the "Government"), the Government will retain
rights in the GTX Patent Rights as set forth in Title 35 U.S.C. Section 200 et
seq. All rights herein granted to GTX are subject to any such rights held by the
Government and further subject to any restrictions or obligations that may be
imposed by the Government pursuant to such rights, at such time that it is
determined.
2.4 ORION'S RIGHT OF FIRST NEGOTIATION.
[ * ] = 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.
2.4.1 Whereas Orion has considerable knowledge and experience in
the marketing, sales and distribution of pharmaceutical products in, inter alia,
Scandinavia (which term shall for purpose of this Section 2.4 comprise the
countries of Denmark, Finland, Norway and Sweden), GTX undertakes to regard
Orion as its preferential partner for the marketing, sales and distribution of
the Product in Scandinavia for use in the Field (other than in the Orion Field
in the Orion Territory), subject to this Section 2.4.1. Consequently, GTX
grants, and shall cause its Affiliates and Unaffiliated Sublicensees who receive
a sublicense under the license granted to GTX pursuant to Section 2.1.1 in
Scandinavia to grant, to Orion a right of first negotiation to negotiate in good
faith an agreement(s) under commercially reasonable terms and conditions
regarding the marketing, sales and/or distribution by Orion of the Product in
Scandinavia for use in the Field (other than in the Orion Field in the Orion
Territory), with the express understanding that such commercially reasonable
terms and conditions shall not comprise an obligation to develop and register
the Product for use in the Field in any country of Scandinavia.
2.4.2 Within thirty (30) days after Orion's receipt of a first
written offer from GTX regarding commercially reasonable terms and conditions
governing such rights, Orion shall notify GTX in writing if it wishes to
negotiate the terms and conditions under which Orion could obtain the rights
contemplated in this Section 2.4. Should Orion so exercise such right, the
Parties shall negotiate exclusively with each other and in good faith the
commercially reasonable terms and conditions for a license and distribution
agreement for the marketing, sales and distribution by Orion of the Product in
Scandinavia for use in the Field (excluding the Orion Field in the Orion
Territory), such negotiations to be completed within one hundred and eighty
(180) days from the date of Orion's notification to GTX. Any deadlines may be
extended by mutual agreement upon reasonable request. If Orion fails to provide
written notification to GTX by the end of the thirty (30) day period; Orion
notifies GTX that it does not wish to enter into negotiations; or the Parties,
despite conducting good faith negotiations, are unable to finalize the material
commercial terms of agreement within such one hundred and eighty (180) day
period (any such event, a "Termination of the Orion Right"), Orion shall have no
further right under this Agreement to market, sell and distribute the Product in
Scandinavia and GTX shall be free to offer to or enter into an agreement with
any Third Party or any GTX Affiliate with respect to such activities after the
Termination of the Orion Right occurs.
2.4.3 In the event that GTX's Unaffiliated Sublicensee for Product
for use in the Field in the USA does not obtain the right and license to sell,
have sold, import, market and distribute the Product in the Field in Europe at
the time of execution of the sublicense agreement for the Product for use in the
Field in the USA, then Orion shall, on the terms and conditions of Sections
2.4.1 and 2.4.2, have a right of first negotiation to negotiate in good faith an
agreement(s) under commercially reasonable terms and conditions regarding the
marketing, sales, and/or distribution of the Product for use in the Field in
Europe.
2.5 USE OF TOREMIFENE BY GTX FOR RESEARCH. Subject to Sections
2.1.1(ii) and 14.6.2, GTX may use the Powder provided to it pursuant to Section
14.6.2 to perform stability studies and other activities with respect to
Products for use in the Field that are necessary for supporting Regulatory
Approval of Products or expanding the indications for Products within the Field.
GTX shall, upon Orion's request therefor, provide Orion with written updates of
any and all activities undertaken by or on behalf of it pursuant to this Section
2.5, and with the results thereof in reasonable detail.
[ * ] = 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.
2.6 PROHIBITED ACTIONS. During the Term of this Agreement, Orion shall
not grant any rights to any Third Party that are inconsistent with the licenses
granted to GTX pursuant to Section 2.1.1.
3. PAYMENTS
3.1 TYPES OF PAYMENTS. For the rights, privileges and licenses granted
hereunder, GTX shall pay Orion in the manner provided as follows:
3.1.1 In the event GTX or its Affiliate receives Upfront and
Milestone Income (as defined in Section 3.1.1(c)), GTX shall pay Orion as
follows:
(A) Any Upfront and Milestone Income for the sublicensing of
Product rights in the Prostate Cancer Field shall first be applied to [ * ] both
prior to and after the Effective Date with respect to the [ * ] and also for the
[ * ].
(B) Upon full reimbursement of such [ * ] pursuant to Section
3.1.1(a), any remaining Upfront and Milestone Income (the "Net Upfront and
Milestone Income") shall then be paid by GTX to Orion as follows:
(I) GTX shall pay Orion [ * ] of the portion of Net
Upfront and Milestone Income that is [ * ]; and
(II) [ * ] of the portion of the Net Upfront and
Milestone Income that is [ * ].
(C) For the purposes of this Agreement, "Upfront and
Milestone Income" shall mean any bona fide consideration (either in cash or
non-cash form) received by GTX or its Affiliate from a GTX Unaffiliated
Sublicensee for sublicensing GTX's rights in and to the Product for use in the
Prostate Cancer Field in the GTX Territory excluding: (i) Royalty Income (as
defined in Section 3.1.5); (ii) cost of goods payments for supply of Product
manufactured by Orion and supplied at the prices set forth in Article 14 herein
below, or payments to reimburse GTX's fully burdened costs of manufacturing or
having manufactured Product by or on behalf of GTX as permitted under this
Agreement; (iii) in the form of a loan; or (iv) for the purchase of an equity
interest in GTX (except to the extent such purchase price is a Premium over the
fair market value of such stock, in which case the Premium, but not the portion
of such price that is at the fair market value of such stock, shall be included
in Upfront and Milestone Income). Notwithstanding the foregoing, if GTX receives
Upfront and Milestone Income received in the form described in (ii) or (iii)
[ * ]. For example and without limitation, [ * ].
3.1.2 If GTX is Acquired prior to the first Regulatory Approval of
Product for use in the Prostate Cancer Field, then GTX shall pay to Orion an
amount equal to the lesser of one million dollars ($1,000,000) or one percent
(1%) of the fair market value of GTX at the time of such acquisition. "Acquired"
means that GTX either (i) sells all or substantially all of its assets to a
Third Party, or (ii) is merged with or consolidated or reorganized into a Third
Party, or becomes a subsidiary of a Third Party, and, as a result of such
transaction, the stockholders of
[ * ] = 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.
GTX immediately prior to such transaction own less than fifty percent (50%) of
the surviving parent entity.
3.1.3 ROYALTIES PAYABLE ON COMMERCIAL SALES OF FARESTON PRODUCT
UNTIL PRODUCT ROYALTY ADJUSTMENT DATE.
(A) For commercial sales of the Fareston Product by GTX or
its Affiliates after the Restatement Date, until the earlier to occur of (y) the
[ * ] or (z) the [ * ] of a Product for use in the Prostate Cancer Field (any
such Product in the Prostate Cancer Field, hereinafter referred to as a "New
Product", and the date that is the earlier to occur of (y) or (z), hereinafter
referred to as the "Product Royalty Adjustment Date"), GTX shall pay to Orion a
running royalty on Net Sales of Fareston Product by GTX, its Affiliate or its
Unaffiliated Sublicensee, as follows:
(I) Up until the end of the calendar month immediately
preceding the month in which the [ * ] occurs, the royalty due to Orion with
respect to Net Sales of the Fareston Product by GTX, its Affiliates and/or
Unaffiliated Sublicensees in the USA shall be [ * ] of Net Sales of Fareston
Product.
(II) Commencing upon the first day of the calendar month
in which the [ * ] occurs, and for the [ * ] the royalty due to Orion with
respect to Net Sales of the Fareston Product shall be [ * ] of Net Sales of
Fareston Product by GTX, its Affiliates and/or Unaffiliated Sublicensees during
such period of time, or (B) [ * ] of the MAT Net Sales of Fareston Product (as
calculated and defined in Section 3.1.3(b)).
(III) Upon the first day of the [ * ] occurs, and for the
[ * ] the royalty due to Orion with respect to Net Sales of Fareston Product by
GTX, its Affiliates and Unaffiliated Sublicensees shall be [ * ] of Net Sales of
Fareston Product by GTX, its Affiliates and Unaffiliated Sublicensees during
such period of time, or (B) [ * ] of [ * ] MAT Net Sales of Fareston Product.
(B) The Parties have agreed to use a moving annual total
("MAT") of sales of Fareston Product in the USA in calculating royalties due on
Net Sales of Fareston Product in the USA during [ * ] of the first New Product,
which MAT takes into account and reflects [ * ] during such period of time. Such
MAT shall be based upon (i) the [ * ] of such New Product and (ii) the actual
Net Sales of the Fareston Product in the USA during the [ * ] as follows: First,
the "Correction Factor" shall be calculated, which shall be equal to the Net
Sales of Fareston Product by GTX, its Affiliates and/or Unaffiliated
Sublicensees in the USA during the [ * ] occurs, divided by the Net Sales of
Fareston Product during the [ * ] occurs in the USA, provided that in no event
will the Correction Factor be [ * ]. Then, the "MAT Net Sales of Fareston
Product" shall be calculated, which shall be equal to the Correction Factor
multiplied by actual Net Sales of the Fareston Product during [ * ] occurs.
(C) For example and without limitation, if the Net Sales of
the Fareston Product have been [ * ] for [ * ] prior to the [ * ] occurs, and
[ * ] for [ * ] preceding the beginning of the [ * ] occurs, then the Correction
Factor would be [ * ]. Accordingly, the MAT
[ * ] = 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.
Net Sales of Fareston Product would be [ * ] of the actual Net Sales of the
Fareston Product during the [ * ].
(D) Commencing upon the Product Royalty Adjustment Date, the
royalty for Fareston Product shall be paid pursuant to Section 3.1.4 and shall
no longer be due pursuant to Sections 3.1.3(a) and (b).
(E) For clarity, sales of any New Product shall not be
included in the calculation of Net Sales of Fareston Product under this Section
3.1.3, but shall instead be subject to the royalty due pursuant to Section
3.1.4, no matter when such sales occur.
3.1.4 ROYALTIES PAYABLE ON OTHER COMMERCIAL SALES OF PRODUCT.
Except as provided for the Fareston Product prior to the Product Royalty
Adjustment Date in Section 3.1.3, GTX shall pay to Orion a royalty on Net Sales
of Product by GTX or its Affiliates, equal to [ * ] of Net Sales of such
Products, on a country by country basis, subject to the provisions of Sections
3.1.8 and 21.2.2.
3.1.5 Subject to the provisions of Sections 3.1.8 and 21.2.2, and
except as provided for the Fareston Product prior to the Product Royalty
Adjustment Date in Section 3.1.3, in the event GTX receives running royalty
income from GTX Unaffiliated Sublicensees for sublicensing GTX's rights in and
to any Product and/or based upon sales by GTX Unaffiliated Sublicensees of any
Product in the GTX Territory ("Royalty Income"), GTX shall pay Orion the lesser
of, on a country by country basis, either (a) [ * ] of such Royalty Income; or
(b) [ * ] of such Product by such GTX Unaffiliated Sublicensees provided,
however, that in no event shall the amounts due to Orion pursuant to this
Section 3.1.5 be [ * ] of Net Sales of such Product by such GTX Unaffiliated
Sublicensees.
3.1.6 Notwithstanding Sections 3.1.3 through 3.1.5, if GTX enters
into an agreement with a Third Party to [ * ] and GTX is [ * ] (a [ * ]), then
in lieu of the payments to Orion under Sections 3.1.3 through 3.1.5, GTX shall
pay to Orion [ * ] of [ * ] Additionally, GTX shall not be obligated to pay
Orion any amounts under Sections 14.4 or 14.6 for Product supplied to GTX for
the purpose of [ * ], as the Parties have agreed that the amounts due to Orion
pursuant to this Section 3.1.6 shall be in lieu of any payments that would
otherwise be due to Orion for the supply of such Product if this Section 3.1.6
were not applicable.
3.1.7 As of December 31, 2000, an upfront license fee of four
hundred thousand dollars ($400,000) (the "Upfront License Fee"), was paid in
full by GTX to Orion. This payment shall be creditable by GTX against fees or
payments due to Orion with respect to Upfront and Milestone Income pursuant to
Section 3.1.1.
3.1.8 If a Generic Product is sold in any Major Country of the GTX
Territory, and, for two (2) succeeding Calendar Quarters the Sales of Generic
Product in that country [ * ] of the sales of Product (calculated on a unit
basis) in that country by GTX, its Affiliates and Unaffiliated Sublicensees,
then the royalty on Net Sales owed by GTX to Orion under Section 3.1.4 and the
payments due to Orion on Royalty Income pursuant to Section 3.1.5, respectively,
shall be reduced to [ * ] of the amount otherwise due to Orion pursuant to
either
[ * ] = 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 3.1.4 or 3.1.5, as applicable, with regard to such country with such
reduction to be applicable to the immediately succeeding Calendar Quarter only.
3.1.9 For clarity, in no event shall a royalty be due with respect
to the sale of a given unit of Fareston Product pursuant to more than one of
Sections 3.1.3, 3.1.4 or 3.1.5.
3.2 NON-REFUNDABILITY. All milestone payments GTX makes to Orion
pursuant to Section 3.1.1 shall be non-refundable once paid. However, if this
Agreement is terminated for any reason prior to a given milestone payment
becoming due or if the events specified for a given milestone payment do not
occur, then GTX shall have no obligation to make such milestone payment.
3.3 ROYALTY REPORTS AND PAYMENTS. Commencing with the first Calendar
Quarter in which GTX, its Affiliates or a GTX Unaffiliated Sublicensees make the
First Commercial Sale of a Product, GTX shall provide Orion with a written
report of Net Sales and Royalty Income on a country-by-country basis within
forty-five (45) days after the last day of March, June, September and December
for Royalty Income accruing on Net Sales during the three (3) preceding calendar
months. Concurrently with the submission of each such written report, GTX shall
pay or cause to be paid to Orion the total amount of royalties shown to be due
thereon.
3.4 CURRENCY. GTX shall make all Upfront and Milestone Income and
royalty payments to Orion pursuant to Section 3.1 in U.S. Dollars except that
GTX shall make all cost of goods payments to Orion pursuant to Article 14 in
euros. Where royalty payments are made, payments earned shall be first
determined by GTX in the currency of the country where the Net Sales on the
sales giving rise to payments were made and then converted directly to its
equivalent in U.S. dollars. The rates of exchange for converting the currencies
involved to U.S. dollars shall be the Foreign Exchange Rates quoted in the Wall
Street Journal rate on the last business day of the quarterly period in which
the royalty payments were earned.
3.5 NO ROYALTIES PAYABLE BETWEEN AFFILIATES. No royalties shall be
payable to a Party on sales between the other Party, its Affiliates or between
the Party's Affiliates.
3.6 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable
because the Product, its manufacture, use or sale is or shall be covered by
multiple patents.
4. LIAISON
Representatives of the Parties shall meet bi-annually or as otherwise
agreed to review the development, sales and marketing activities for Product
conducted by GTX, its Affiliates or its Unaffiliated Sublicensees for use in the
Field in the GTX Territory, with the exact dates and locations of such meetings
to be mutually agreed upon. Such meetings shall alternate between GTX's and
Orion's offices or be at other mutually agreed upon locations, with each Party
to be responsible for the travel and living costs and expenses of its own
representatives attending such meetings.
[ * ] = 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.
15.
5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS
5.1 METHOD OF PAYMENT. In the event of any required tax withholding,
the paying Party will provide the receiving Party with any relevant certificates
or documents required for national, state or local tax credit and reporting
purposes. Payments hereunder shall not be creditable against any other amounts
payable by a Party under this Agreement, except as otherwise expressly stated
herein. All payments shall be made by bank wire transfer (e.g., "SWIFT" or other
comparable electronic transfer method) to such account(s) as the receiving Party
shall designate beforehand in writing to the paying Party. Payments shall be
deemed paid once funds are freely available to the receiving Party at such
account(s).
5.2 LATE PAYMENTS. The Party entitled to payment hereunder reserves the
right to charge the paying Party interest on any amounts owing from the paying
Party which are overdue by more than fourteen (14) business days at a rate of
[ * ] per annum, or the maximum rate allowed by law, whichever is lower,
calculated from the date any payment was due and payable.
5.3 RECORD KEEPING AND AUDIT RIGHTS. Each Party shall keep or cause to
be kept accurate records relating to Net Sales, royalties, development and any
other costs and expenses subject to payment, deduction or reimbursement by
either Party to the other Party in sufficient detail to enable the amounts
payable hereunder to be determined. Upon the written request of either Party
(but not more frequently than once in any calendar year), the requesting Party
may retain an independent certified public accountant, subject to approval by
the other Party (which approval shall not be unreasonably withheld), to review
such records to verify the accuracy of the payments made or payable hereunder.
Such accountant shall be required to execute a confidentiality agreement in a
form reasonably acceptable to the audited Party and shall report to the auditing
Party only the amount of any underpayment or overcharge. Within ten (10)
business days after completion of such review, the Parties shall reconcile any
underpayment or overcharge. The auditing Party shall pay the cost of any review
of records conducted at its request under this Section. However, if the review
establishes underpayment or overcharge by the audited Party of over three
percent (3%) during the period of the review, the audited Party shall promptly
reimburse the auditing Party for the fees and expenses of the accountant. Such
audit rights may be exercised by the Parties only with respect to records for
the current calendar year and the preceding two (2) calendar years.
6. GTX PRODUCT MARKETING AND SALES ACTIVITIES
6.1 MINIMUM SALES REQUIREMENTS FOR USA.
6.1.1 LEVELS OF MSRS. GTX shall have annual minimum sales
requirements for Product for use in the Prostate Cancer Field ("MSRs") in the
second year and fourth year after Product Launch in the USA for the Prostate
Cancer Field equal to [ * ] of GTX's annual Product Sales Projections (as
defined below) in the USA for the Prostate Cancer Field. To establish such
projections for the purpose of the foregoing sentence, GTX shall provide to
Orion quarterly Product Sales Projections in the USA for the Prostate Cancer
Field, within ninety (90) days after GTX, its Affiliate or Unaffiliated
Sublicensee completes the last pivotal clinical trial as provided in the GTX
Final Development and Registration Plan for Product in the Prostate Cancer Field
in
[ * ] = 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.
the USA. The Parties shall set forth in Schedule D GTX's MSR obligations within
sixty (60) days after GTX provides such projections, and such MSRs shall be made
a part hereof. Beginning with the [ * ] year after Product Launch in USA for use
in the Prostate Cancer Field until the end of the Term, GTX shall have an annual
MSR equal to [ * ] of the average of GTX's Actual Product Sales (as defined
below) in the USA for Product in the Prostate Cancer Field for the [ * ].
"Product Sales Projections" means GTX's good faith estimates of the target
patient population in a given year for Products in the Prostate Cancer Field in
the USA, multiplied by the price per tablet of Product for use in the Prostate
Cancer Field in the USA that GTX plans to be able to charge during the [ * ]
after Product Launch. "Actual Product Sales" means GTX's, its Affiliate's or a
GTX Unaffiliated Sublicensee's actual Net Sales of Product in the Prostate
Cancer Field during a given year in the USA.
For example, in year [ * ] if the target patient population in the USA
is [ * ] subjects in the Prostate Cancer Field and the Product would be consumed
by such patients [ * ] for the Prostate Cancer Field at a hypothetical price of
[ * ], GTX's Product Sales Projections for the USA would [ * ]. The hypothetical
price for a tablet set forth above is hypothetical and was only used for the
sole purpose of explaining the mechanism for calculating the Product Sales
Projections and MSRs. Nothing contained in such example shall be so construed to
deny the right of GTX to freely set its resale price of the Product.
6.1.2 PRODUCT LAUNCH DATE. "Product Launch in USA" shall be
determined by the date on which the Product has received Regulatory Approval and
is commercially available in the USA as follows: (i) if such date occurs during
the first six (6) months of any calendar year (i.e., January 1-June 30), Product
Launch in USA shall be deemed to have occurred on January 1 of such calendar
year, and (ii) if such date occurs during the last six (6) months of any
calendar year (i.e., July 1-December 31), Product Launch in USA shall be deemed
to have occurred on January 1 of the following calendar year.
6.1.3 ADJUSTMENT. GTX's annual Product Sales Projections for the
Prostate Cancer Field in the USA shall be subject to adjustment by written
agreement of the Parties, with a corresponding adjustment in the MSRs, in the
event of government intervention in given markets (including, but not limited
to, government mandated health care reforms, rebates or regulatory changes),
failure to obtain (or delay in obtaining) approval for a Product indication in
the Prostate Cancer Field, or other events or causes affecting the market for
the Product for use in the Prostate Cancer Field beyond the control of GTX,
including but not limited to lower than anticipated pricing approvals measured
on an aggregate basis throughout USA; GTX Patent Rights and/or Orion Patent
Rights invalidation, infringement or expiration; Product safety and/or efficacy
issues and/or major therapeutic advances materially affecting the market
potential for the Product for use in the Prostate Cancer Field (including but
not limited to new surgical procedures or introduction of new competitive
products with superior safety and/or efficacy profiles); or a Force Majeure
event (as described in Article 27).
6.1.4 FAILURE TO ACHIEVE MSRS. If GTX's annual Product Sales in USA
for the Prostate Cancer Field are less than the MSRs in any applicable calendar
year, GTX shall, without prejudice to its payment obligations under Section 3.1,
pay Orion royalties corresponding to the "shortfall" between the actual
royalties paid by GTX for such year and the royalties which would have been
payable pursuant to Section 3.1 had GTX achieved the MSRs during such 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.
17.
subject to Section 6.1.3. GTX's payment of such "shortfall" hereunder shall be
Orion's sole and exclusive remedy for GTX's failure to achieve MSRs in USA for
such year. However, if GTX fails to pay such "shortfall," then Orion may,
without prejudice to its right to such shortfall, also terminate this Agreement
pursuant to Section 21.2.2.
6.2 NO MINIMUM SALES REQUIREMENTS OUTSIDE OF USA; NO MINIMUM SALES
REQUIREMENTS FOR SALES OF FARESTON PRODUCT. GTX shall not have any minimum sales
requirements with respect to sale of Product in any countries in the GTX
Territory outside of the USA. GTX shall not have any MSRs with respect to any
sales of Fareston Product or for any Product for use outside the Prostate Cancer
Field. GTx agrees that it will continue to sell Fareston Product in the Breast
Cancer Field in the USA until at least the Royalty Adjustment Date. If GTX
desires, after such date, to cease commercialization of the Fareston Product in
the Breast Cancer Field in the USA, then it may so notify Orion in writing. In
such case, the Parties shall discuss the reasons why GTX desires to cease such
commercialization activities. If Orion approves such proposal by GTX to cease
commercializing the Fareston Product in the Breast Cancer Field in the USA (such
approval not to be unreasonably withheld), then GTX may cease such activities.
Without limiting the foregoing, Orion may not withhold its approval of a
proposal by GTX under this Section 6.2 if GTX would be incurring, or based on
GTX's reasonable projections would be likely to incur, a loss if it continues to
commercialize Fareston Product in the Breast Cancer Field in the USA.
6.3 MARKETING AND SALES EFFORTS IN THE MAJOR COUNTRIES.
6.3.1 COMMERCIALLY REASONABLE OBLIGATION. On a country by country
basis, subject to Sections 6.3 and 6.4, during the period commencing with
Regulatory Approval in a Major Country, and for the remainder of the Term, GTX,
its Affiliate and/or a GTX Unaffiliated Sublicensee shall use commercially
reasonable efforts to promote, market, distribute and sell the Product for use
in the Prostate Cancer Field in such Major Country. For purposes of this Section
6.3, "commercially reasonable" shall mean using, in the relevant Major
Countries, an equivalent degree of effort as GTX, its Affiliate or a GTX
Unaffiliated Sublicensee would use to promote, market, distribute and sell a
product of its own that is of comparable market potential in such Major Country
during the same time period (as determined by consideration of, without
limitation, potential market, patent protection, and availability of competitive
products), including but not limited to, engaging in the following activities
(subject to any applicable U.S. FDA restrictions or other applicable legal
restrictions):
(A) Using reasonable diligence to establish and maintain good
business relationships with hospitals, health systems, doctors and other medical
professionals in accordance with standard and customary practices in such Major
Country;
(B) Using commercially reasonable efforts to establish and
maintain an adequate capacity of sales personnel consisting of reasonably
qualified personnel who have been certified, as trained by GTX, its Affiliate or
a GTX Unaffiliated Sublicensee, to promote and market the Product for use in the
Prostate Cancer Field in such Major Country, and to provide such sales force
with adequate sales and promotional materials for the Product;
[ * ] = 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.
18.
(C) Promoting and detailing the Product for use in the
Prostate Cancer Field throughout such Major Country, provided that GTX, its
Affiliate or a GTX Unaffiliated Sublicensee may, in its discretion use
relatively greater promotional and detailing efforts (i) in some Major Countries
than it uses in other of such countries, and (ii) in some parts of each Major
Country than in other parts thereof, consistent with its overall marketing plan;
and further provided, however, that the foregoing shall in no event be deemed to
limit GTX's its Affiliate or a GTX Unaffiliated Sublicensee overall obligations
under the first paragraph of this Section 6.3.1.
(D) Advertising the Product for use in the Prostate Cancer
Field in professional journals and publications and sponsoring or attending
appropriate symposia, trade exhibitions and medical education programs in a
manner equivalent to that used for GTX's, its Affiliate's or a GTX Unaffiliated
Sublicensee's, as applicable, own products of comparable market potential in
such Major Country; and
(E) Formulating and using reasonable efforts to implement
annual sales and marketing plans for the Product for use in the Prostate Cancer
Field in such Major Country and providing copies of such plans to Orion for
review and comment, provided that Orion shall not have approval rights with
respect to such plans.
6.3.2 SALES OBJECTIVES AND OTHER FACTORS FOR THE USA. GTX and Orion
shall agree in writing upon annual target sales objectives for the Product for
use in the Prostate Cancer Field in the USA, commencing with the fourth calendar
year after First Commercial Sale of the Product for use in the Prostate Cancer
Field in the USA, provided that such annual target sales objectives shall not be
considered MSRs for any purposes, but instead shall be used by the Parties for
informational and planning purposes and shall be one (1) factor, among others,
to be considered in assessing whether GTX has complied with its commercially
reasonable obligations hereunder. GTX's level of sales and marketing expenses
for the Product for use in the Prostate Cancer Field in the USA and events or
causes affecting the market for the Product for use in the Prostate Cancer Field
beyond the control of GTX shall also be among the factors to be considered in
assessing whether GTX has complied with its commercially reasonable obligations
hereunder.
6.4 PRODUCT LAUNCH.
6.4.1 TIMING OF LAUNCH. GTX shall use commercially reasonable
efforts to launch the Product for use in a given indication in the Prostate
Cancer Field as soon as practical in every Major Country of the GTX Territory
where GTX, its Affiliates and/or GTX Unaffiliated Sublicensees have obtained
Regulatory Approval for such indication. Notwithstanding the foregoing, GTX, its
Affiliate or a GTX Unaffiliated Sublicensee may, acting in good faith in the
exercise of its reasonable business judgment, determine either to delay the
launch of the Product for use in a given indication in the Prostate Cancer Field
or not to launch the Product for use in a given indication in the Field in any
given country in the GTX Territory other than a Major Country, which decision to
delay or not to launch shall not be deemed a failure to use commercially
reasonable efforts. Further, GTX's, its Affiliates' or a GTX Unaffiliated
Sublicensee's decision to delay the launch of the Product for use in the
Prostate Cancer Field in any Major Country for up to six (6) months after GTX or
its Affiliates have obtained Regulatory
[ * ] = 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.
19.
Approval in such country, shall not be deemed a failure to use commercially
reasonable efforts pursuant to Section 6.3 to the extent that GTX can
demonstrate that such delay was attributable to bona fide business reasons
affecting the Product.
6.4.2 DECISIONS NOT TO LAUNCH. GTX shall promptly notify Orion in
writing if GTX, its Affiliate or a GTX Unaffiliated Sublicensee, as applicable,
determines to delay the launch of the Product for use in a given indication in
the Prostate Cancer Field in any Major Country after obtaining Regulatory
Approval of Product therefor. If such decision is due to any reasons other than
the potential for, or the existence of, adverse business effects in such Major
Country, then such decision shall be deemed a material breach of this Agreement
pursuant to Section 21.2.2 and GTX shall be subject to the provisions of such
Section within thirty days (30) after GTX's decision not to launch in such Major
Country.
6.5 MARKETING COSTS AND EXPENSES. Except as otherwise provided herein
or as otherwise mutually agreed by the Parties, GTX, its Affiliate or a GTX
Unaffiliated Sublicensee shall bear all costs and expenses connected with its
marketing and sales activities for the Product for use in the Field and its
performance under this Agreement.
6.6 MARKETING PLANS AND REPORTS.
6.6.1 MARKETING PLANS. GTX shall develop and provide to Orion by
October 31 of each year during the Term marketing and sales plans for the
Product for each Major Country for the following calendar year, commencing with
the calendar year in which Regulatory Approval is obtained in each respective
country. Such plans shall include the projected Annual Net Sales and the
projected advertising and promotion budgets for such year, and shall not be
applicable to the calculation of MSRs in connection with the sale of Products in
the Prostate Cancer Field in the USA pursuant to Section 6.1, for which GTX
shall separately provide information.
6.6.2 MARKETING AND SALES REPORTS FOR PRODUCT. GTX shall provide to
Orion, within forty-five (45) days after the end of each calendar year, a
written marketing activities and sales report for each of the Major Countries in
which Product is launched. The report shall include at least a description of
sales, marketing and promotion activities and a list of scientific conferences
or other events involving the particular Product or its therapeutic area,
accompanied by a general description of the nature and extent of GTX's
participation in such conferences or events.
7. GTX PRODUCT DEVELOPMENT AND REGISTRATIONS
7.1 GTX DEVELOPMENT AND REGISTRATION ACTIVITIES.
7.1.1 GTX ACTIVITIES. In accordance with the GTX Preliminary
Development and Registration Plan and the GTX Final Development and Registration
Plan, GTX shall undertake development and registration activities for the
Product for use in the Prostate Cancer Field in the GTX Territory, including but
not limited to, conducting or sponsoring, and completing or having completed in
accordance with U.S. FDA regulations and Good Clinical Practice regulations
under the European Union legislation and directives requirements, all
[ * ] = 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.
20.
clinical studies and other activities required for Regulatory Approval under the
GTX Final Development and Registration Plan. Without limiting the provisions of
Section 7.7, GTX shall use its commercially reasonable efforts to pursue such
development and registration activities under the GTX Final Development and
Registration Plan with the objective of filing applications for Regulatory
Approval in all Major Countries throughout the GTX Territory in the Prostate
Cancer Field according to the anticipated filing dates set forth in the GTX
Final Development and Registration Plan timetable [ * ]. GTX's Regulatory
Approvals in the GTX Territory shall be owned solely by GTX.
7.1.2 ORION ACTIVITIES.
(A) Orion shall use its commercially reasonable efforts to
assist GTX in obtaining and maintaining the U.S. FDA Regulatory Approval of
Products in the Prostate Cancer Field and of the Fareston Product in the Breast
Cancer Field in the USA (including obtaining and/or maintaining the Orion
Product NDA and all related U.S. INDs filed with the U.S. FDA for such Products,
and any other required Regulatory Approvals in the Major Countries of the GTX
Territory relating to the manufacture, use, marketing or sale of Product for use
in the Prostate Cancer Field or of Fareston Product in the Breast Cancer Field
in the USA (by providing to GTX relevant information, documents and data in its
possession in relation to regulatory inquiries during the Regulatory Approval
process for Products, necessary additional letters of cross-reference or
authorization equivalent to those described in Section 7.5 to its registrations
for Product in the Orion Field in the Orion Territory, and other similar
assistance). Orion shall maintain the DMF filed with the U.S. FDA and all
equivalent regulatory authorities outside of the USA for Product as well as its
registrations for Product in the Orion Field in the Orion Territory during the
Term, provided that Orion may notify GTX that Orion intends to cease maintenance
of any such DMF and/or registration, in which case GTX shall have the right to
maintain such filing, at GTX's expense, by notifying Orion in writing within
thirty (30) days after it receives Orion's notice hereunder that it desires to
maintain such filing. If GTX elects to maintain such filing, Orion shall
cooperate reasonably with GTX to effect the transfer of such DMF and/or
registration to GTX.
(B) Orion shall perform any stability testing for the bulk
Orion Product to be manufactured and supplied by Orion to GTX that is required
by regulatory authorities in any Major Country. Such testing shall be provided
at no cost to GTX, except that GTX will reimburse Orion's direct costs of
performing any such stability testing that must be conducted solely for the [ *
] tablet of the Orion Product. Orion employees shall, at Orion's cost and
expense, have the right to participate in all FDA and other regulatory agency
meetings regarding the use of the Product in the Field.
(C) Orion shall have no obligation to research, develop,
register, commercialize any Product or carry out any studies or testing in
relation to Products, including without limitation with respect to any new or
additional strength, dosage form, formulation or route of administration of the
Orion Product or the Product, or provide any documentation, information or data
relating to the foregoing, except as expressly provided in Section 7.1.2(a) or
otherwise set forth in this Agreement, unless the Parties expressly mutually
agree otherwise in writing after the Restatement Date. Other than as expressly
agreed in this Agreement, Orion shall have no obligation to fund or pay for any
of the costs and expenses of such activities. All
[ * ] = 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.
21.
studies, trials, tests, activities, documentation, data and information required
by any regulatory or other governmental agency or which is necessary or useful
for the research, development, registration or commercialization of the Product
shall, unless otherwise expressly agreed to herein as between the Parties, be
for the sole cost and responsibility of GTX.
7.1.3 AUTHORIZATION LETTERS. Any regulatory filings (including
without limitation any DMFs that GTX may develop if it obtains the right to
manufacture Product) compiled and filed by or on behalf of GTX shall remain the
property of GTX, but GTX shall, upon request therefor by Orion, negotiate with
Orion the terms under which GTX would provide appropriate authorization letters
to relevant regulatory bodies to enable Orion to reference such regulatory
filings for purposes of applying for and supporting Orion's applications for
Regulatory Approval of products containing Toremifene outside the Field.
7.2 FDA FILE. As of the Restatement Date, Orion shall have transferred
the Orion Product NDA and all Investigational New Drug Applications (as defined
in 21 C.F.R. Section 212) for Products filed with the FDA to the name of GTX, as
set forth in the Purchase Agreement.
7.3 DEVELOPMENT AND REGISTRATION COSTS. Except as otherwise expressly
provided in this Agreement or otherwise mutually agreed in writing by the
Parties after the Restatement Date, GTX shall bear all costs and expenses
related to Product registration and regulatory activities (other than for
Product for the Orion Field in the Orion Territory), including without
limitation costs of filing, obtaining and maintaining all such Regulatory
Approvals throughout the GTX Territory, as well as all costs and expenses for
the research and development of the Product for use in the Field (other than for
Product for the Orion Field in the Orion Territory), provided that GTX shall not
be responsible for any costs related to the manufacture of the Orion Product
(except for payments that GTX must make to Orion pursuant to Section 7.1.2(b) or
Article 14 (such costs collectively referred to herein as "Manufacturing
Costs"). Except for the Manufacturing Costs or as otherwise expressly provided
in this Article 7, Orion shall bear no responsibility for any costs or expenses
related to Product registration, regulatory, research or development activities
in relation to the Product.
7.3.1 DEVELOPMENT AND REGISTRATION COSTS PRIOR TO RESTATEMENT DATE.
The Parties agree that GTX shall, notwithstanding anything to the contrary in
the Original Agreement or otherwise, also bear all costs and expenses related to
Product research, development, registration, regulatory compliance and other
activities relating to the development of Product that were incurred prior to
the Amendment Date by GTX (excluding any Manufacturing Costs) (hereinafter
referred to as "Incurred Costs"). Consequently, except as set forth in Section
3.1.1, GTX shall forever release and discharge Orion of any and all claims that
it purports to have at the Amendment Date or may have thereafter against Orion
with respect to Incurred Costs.
7.4 GTX DEVELOPMENT AND REGISTRATION PLAN.
7.4.1 COMPLETION OF GTX FINAL DEVELOPMENT AND REGISTRATION PLAN.
The GTX Preliminary Development and Registration Plan for development and
registration of Product in the Prostate Cancer Field was attached to the
Original Agreement as Schedule B. GTX will prepare a GTX Final Development and
Registration Plan for such activities for each
[ * ] = 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.
22.
Major Country in a timely fashion upon receiving approval from the appropriate
regulatory authority in each Major Country of a plan for regulatory approval in
that country. Immediately upon completion of the GTX Final Development and
Registration Plan for each Major Country, [ * ] GTX shall provide a copy of such
plan to Orion.
7.4.2 ORION'S RIGHT TO COMMENT ON AND OBJECT TO PLAN. Orion shall
have the right to comment on each GTX Final Development and Registration Plan
for Product for the Prostate Cancer Field for each Major Country. Additionally,
Orion shall have the right to object to each GTX Final Development and
Registration Plan for each Major Country to the extent such plan could
reasonably be deemed to affect adversely Orion's development, commercialization,
sales or registration of Toremifene in the Orion Field in the Orion Territory or
outside the Field. GTX undertakes to change and/or amend the GTX Final
Development and Registration Plan for Product for the Prostate Cancer Field for
each Major Country to the extent Orion has so objected thereto as necessary to
alleviate or obviate such adverse effect. Orion shall provide GTX with such
comments and/or objections within thirty (30) days from Orion's receipt of the
GTX Final Development and Registration Plan.
7.4.3 CHANGES TO SUCH PLAN. GTX may modify the GTX Final
Development and Registration Plan, as GTX deems necessary and consistent with
Section 7.4.1, but shall notify Orion of such changes. Any changes to the GTX
Final Development and Registration Plan for each Major Country shall also be
subject to Section 7.4.2.
7.5 ORION DOCUMENTATION AND DATA.
7.5.1 GTX ACCESS TO ORION KNOW-HOW. Orion has provided and shall
continue to provide GTX with copies of the Orion Know-How, documentation,
information and data listed or referenced in the GTX Preliminary Development and
Registration Plan, and GTX shall be authorized to use and reference the same in
its applications for Regulatory Approval and regulatory compliance activities in
relation to such Regulatory Approvals. Any Product Drug Master Files ("DMFs")
compiled or owned by Orion shall remain the property of Orion, but Orion shall,
upon reasonable request therefor by GTX, provide appropriate authorization
letters to relevant regulatory bodies in the GTX Territory within forty-five
(45) days from such request to enable GTX to reference such DMFs for purposes of
GTX's applications for Regulatory Approval and regulatory compliance activities
in the GTX Territory as provided for in Section 7.1. For the avoidance of doubt,
neither Party is obligated to disclose the contents of its DMFs to the other
Party.
7.5.2 GTX ACCESS TO DATA. During the Term, Orion shall provide GTX,
within forty-five (45) days of receipt of a written request from GTX specifying
in detail the documentation, information and/or data requested, access to Orion
Know-How in Orion's control and possession (and freely disclosable) that GTX
reasonably requires for regulatory filings for the use of Product in the Field
in the GTX Territory, including any Orion Know-How concerning the use of the
Product in the Orion Field in the Orion Territory to the extent such information
may be reasonably required by GTX for such regulatory filings. In instances
where documentation, information and/or data requested are required by the U.S.
FDA or other regulatory agency to be submitted in a time frame shorter than
forty-five (45) days, GTX shall notify Orion, and GTX and Orion shall agree on a
shorter time frame for provision of such
[ * ] = 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.
23.
materials within the time required by the FDA. In the event any of such Orion
Know-How is not in the control or possession of Orion but is controlled by a
Third Party, Orion and GTX shall discuss in good faith commercially reasonable
efforts that Orion may, at its discretion, decide to take to assist GTX in
accessing such Orion Know-How, provided that nothing herein shall obligate Orion
to take steps to arrange, or incur costs, to access such Orion Know-How from
such Third Party, and provided further that if requested by GTX, Orion will
grant GTX the necessary authorizations to approach any such Third Party for such
access. Upon GTX's request, Orion shall provide GTX with copies of such Orion
Know-How referenced in the preceding sentences only in such form and content as
is available to Orion, provided that, upon Orion's request, GTX shall reimburse
Orion for Orion's direct out-of-pocket cost of making such copies and providing
GTX with such Orion Know-How.
GTX shall also provide to Orion quarterly reports summarizing GTX's
development activities for Products in the Field (excluding the Orion Field in
the Orion Territory).
7.5.3 LETTER OF CROSS REFERENCE. Orion agrees that the Cross
Reference letter dated December 10, 1999 from Orion to GTX shall remain in
effect to the extent it enables GTX or its Affiliates to reference regulatory
filings for the Orion Product in all countries outside of the USA. Such Cross
Reference letter may not be revoked by Orion unless this Agreement is
terminated. During the Term, Orion shall permit GTX, its Affiliates and the GTX
Unaffiliated Sublicensees to reference, and shall provide GTX with an
appropriate authorization letter to enable GTX, its Affiliates and the GTX
Unaffiliated Sublicensees to reference, all applications or filings for
Regulatory Approval for Orion Products for use in the Orion Field and related
DMFs that are identified in Schedule E hereof (hereinafter "Orion Product
Approvals") for the purpose of applying for and supporting Regulatory Approval
of Products for use in the Field within the GTX Territory. Orion shall update
Schedule E from time to time during the Term to set forth all Orion Product
Approvals and DMFs that are owned and controlled by Orion. GTX recognizes that
Orion has obtained the Orion Product Approvals solely for the purpose of its
proprietary product Fareston(R), and that nothing herein shall be construed so
as to obligate Orion to maintain or cause to be maintained any Orion Product
Approvals solely for allowing GTX, its Affiliates and/or GTX Unaffiliated
Sublicensees to refer thereto, provided that during the Term, Orion shall not
withdraw such Orion Product Approvals in the absence of commercially justifiable
reasons in relation to Fareston(R). Orion shall, prior to withdrawing such Orion
Product Approvals, offer to GTX the right to maintain such approvals, at GTX's
expense. If GTX elects to maintain such approvals, Orion shall reasonably
cooperate with GTX to enable GTX to assume such responsibility.
7.5.4 ADDRESS. All requests by GTX to Orion for documentation,
information or data, as agreed herein, shall be addressed only to the attention
of such person(s) as is/are designated in writing or in electronic form by Orion
from time to time.
7.6 GTX REGISTRATION AND MARKETING APPROVAL APPLICATIONS. GTX, its
Affiliates and/or GTX Unaffiliated Sublicensees shall have the responsibility
and the right to submit registration applications for Regulatory Approval and
marketing and price approval of the Product for use in the Field within the GTX
Territory; provided, however, that GTX shall not have the responsibility to
submit such applications for approval of the Product for use in the Orion Field
in the Orion Territory.
[ * ] = 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.
24.
7.7 FAILURE TO FILE OR EXTEND. Orion shall have the right to terminate
its obligations under Section 7.1.2(a) and its obligations to manufacture and
supply to GTX Orion Product upon one hundred and eighty (180) days prior written
notice to GTX, if Regulatory Approval has not been granted for the Product for
use in the Prostate Cancer Field in the USA by December 31, 2009. Any such
notice hereunder shall be given no later than sixty (60) days after December 31,
2009, provided that GTX shall inform Orion in writing by December 31, 2009,
whether or not Regulatory Approval has been granted for the Product for use in
the Prostate Cancer Field in the USA by such date. The time for Orion to provide
notice to GTX of its decision to exercise its right with regard to the event
described above shall be deemed to commence upon the receipt by Orion of such
notice from GTX, provided that nothing shall be construed so as to prevent Orion
from exercising its right hereunder if Orion discovers, either by itself or
through a Third Party, that Regulatory Approval has not been granted for the
Product for use in the Field in the USA by December 31, 2009. Effective upon the
date that GTX receives any notice from Orion pursuant to this Section 7.7 and
during the Term, Orion hereby grants GTX a contingent license under the Orion
Patent Rights and Orion Know-How and all other patents and patent applications
owned or controlled by Orion during the Term that relate to the manufacture, use
or sale of Toremifene or Orion Product ("Manufacturing Patents") to make and
have made Product for use in the Field in the GTX Territory (except in the Orion
Field in the Orion Territory). Such license shall be exclusive and sublicensable
(but only for the purposes of having manufactured the Products for GTX, its
Affiliates or Unaffiliated Sublicensees). Orion shall as soon as practically
possible after providing any notice to GTX pursuant to this Section 7.7 provide
GTX with such then-existing manufacturing, process and quality control
procedures, documentation and other relevant know-how and information to the
extent reasonably necessary to enable GTX to exercise its manufacturing right
pursuant to this Section 7.7 (hereinafter "Product Manufacturing Know-How"),
including without limitation providing up to ten (10) person-days of technology
transfer assistance at GTX's site of manufacture of Product using Orion
personnel skilled in such manufacturing operations, at no charge to GTX.
7.8 REIMBURSEMENT OF ORION COSTS. Except as provided for otherwise in
this Article 7, GTX shall reimburse Orion for all costs and expenses incurred by
Orion in fulfilling its obligations under this Article 7 with respect to
Products in the Field, subject to the following: (a) such reimbursable amounts
shall include costs of assistance provided by Orion for activities relating to
the Prostate Cancer Field only to the extent such costs (i) are incurred by
Orion after [ * ] or (ii) have been invoiced to GTX prior to [ * ]; (b) such
reimbursable amounts shall include costs of assistance provided by Orion for
activities outside of the Prostate Cancer Field and the Breast Cancer Field,
with the amounts described in this subsection (b) including Orion's [ * ]; (c)
such reimbursable amounts shall not include [ * ] and (d) such reimbursable
amounts shall not include [ * ]. Orion shall issue an invoice for all such
reasonable costs and expenses so incurred that are reimbursable hereunder during
each Calendar Quarter, and GTX shall effect payment of such invoice within
thirty (30) days from the date of the invoice.
8. CONFIDENTIALITY AND PUBLICITY
8.1 CONFIDENTIALITY OBLIGATION. Each Party shall hold the other Party's
Confidential Information (as defined below) of which it becomes informed in
connection with this Agreement or the Original Agreement in strictest confidence
and shall not disclose such Confidential Information to Third Parties or
otherwise use it, except to the extent such use 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.
25.
disclosure is expressly permitted by the terms of this Agreement or is
reasonably necessary for the performance of this Agreement.
8.2 PERMITTED DISCLOSURES. Permitted disclosures of Confidential
Information hereunder include, but are not limited to: (A) disclosures to
regulatory agencies to the extent required for Regulatory Approval, including
but not limited to, GTX Product registrations and applications in the GTX
Territory (to the extent expressly permitted hereunder), and (B) disclosures to
the Parties' Affiliates, employees, agents and independent contractors
(including clinical investigators, consultants and contract research
organizations) who have a bona fide "need to know", and GTX Unaffiliated
Sublicensees, and prospective sublicensees, provided that for such permitted
disclosures under subsection (B) the disclosing Party shall obligate the
recipients to maintain the confidentiality of Confidential Information under
terms substantially similar to those contained in this Article 8.
8.3 CONFIDENTIAL INFORMATION. "Confidential Information" includes, but
is not limited to, any information relating to the terms of this Agreement, the
Original Agreement, the Product, the Orion Product, GTX Know-How, GTX Patent
Rights, Orion Patent Rights, Orion Know-How, GTX Preliminary Development and
Registration Plan, GTX Final Development and Registration Plan, clinical and
non-clinical studies involving the Product, and all sales and marketing plans
for the Product, as well as information concerning all other products and the
business affairs, manufacturing processes and other activities of the disclosing
Party that are designated as confidential in writing or orally disclosed,
provided such oral disclosure is confirmed as confidential in writing within
thirty (30) days thereafter. However, such obligations shall not apply to
Confidential Information to the extent such information is:
(A) PUBLICLY AVAILABLE INFORMATION. Which at the time of
disclosure is or later comes into public domain by publication or otherwise
through no fault of the receiving Party;
(B) PREVIOUSLY KNOWN INFORMATION. Which can be demonstrated
by documentation or other competent proof to have been in the receiving Party's
possession prior to disclosure;
(C) SUBSEQUENTLY RECEIVED INFORMATION. Which is subsequently
received by the receiving Party from a Third Party who is not bound by any
confidentiality undertaking to the disclosing Party or to any of its Affiliates
with respect to said information;
(D) INDEPENDENTLY DEVELOPED INFORMATION. Which is
independently developed by or for the receiving Party without reference to the
disclosing Party's Confidential Information; or
(E) LEGALLY REQUIRED DISCLOSURES OF INFORMATION. Which is
legally required to be disclosed pursuant to any statute or regulation or any
judicial or administrative order, including any material or information
requested by the Securities and Exchange Commission (or any equivalent
securities exchange) or Finnish equivalent thereof to the extent that such
information cannot be treated confidential.
[ * ] = 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.
26.
8.4 DURATION OF CONFIDENTIALITY OBLIGATION. The confidentiality
obligations of the Parties hereunder shall remain in effect during the Term and
shall survive the termination or expiration of this Agreement for any reason and
be effective until the later of five (5) years after such termination or
expiration, or ten (10) years after the Restatement Date.
8.5 PUBLICITY AND ANNOUNCEMENTS.
8.5.1 With regard to the existence and content of commercial terms
and conditions of this Agreement, unless agreed upon by the Parties, neither
Party shall originate any publicity, news release or other public announcement,
written or oral, whether to the public press, stockholders or otherwise,
relating to this Agreement or any amendment hereto, without the approval of the
other Party, except as required by law, including, without limitation,
provisions regarding the disclosure requirement for publicly quoted companies,
and then only to the minimum extent so required, in which event such Party shall
give the other Party a reasonable opportunity to review the form and content of
the announcement before such legally required announcement is made.
8.5.2 GTX may originate any publicity, news release or other public
announcement, written or oral, whether to the public press, stockholders or
otherwise, relating to the use of the Product in the Field provided that GTX
forwards to Orion such publicity, news release or other public announcement
fourteen (14) days prior to such publicity, news release or other public
announcement, except as otherwise required by law or regulation, including
without limitation disclosure requirements promulgated by the Securities and
Exchange Commission. It is agreed that such publicity, news release or other
public announcement does not require the approval of Orion, unless Orion
considers such publicity, news release or other public announcement to (a) fall
within the scope of Section 8.5.1; or (b) be misleading or incorrect, in which
case Orion shall, within five (5) business days after receiving such publicity,
news release or other public announcement, so notify GTX and provide written
comments specifying changes that Orion reasonably believes will correct such
inaccuracy, except as otherwise required by law or regulation. If requested by
Orion, such publicity, news release or other public announcement shall include
wording to the effect that Toremifene is a proprietary compound of Orion, and
that Toremifene has been licensed by Orion to GTX for use in the Field.
9. FARESTON PRODUCT WEBSITE FOR USA
9.1 FARESTON WEBSITE. During the Term of this Agreement or as long as
the Fareston Product is sold in USA (whichever period is shorter), Orion shall
maintain, (including, without limitation, by renewing the applicable domain
name(s)), and operate, either itself or via Third Party subcontractor(s), the
internet site with the domain name www.fareston.com (or any successor site or
domain name thereof). Promptly following the execution of this Agreement, Orion
and GTX shall mutually agree upon a process or means whereby Orion shall provide
GTX with a means to access said website in order to update and maintain web
pages for the Fareston Product that are directed towards residents of the USA
(the "FARESTON U.S. WEB PAGES"). The Parties acknowledge and agree that GTX
shall have sole control over, and responsibility for, the content of the
Fareston U.S. Web Pages, including, without limitation, the "look and feel"
thereof. Orion hereby grants GTX a non-exclusive, sublicenseable license in the
GTX Territory under such intellectual property rights owned or controlled by
Orion during the Term that are
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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.
27.
strictly necessary for GTx, its Affiliates and Unaffiliated Sublicensees to
exercise the rights granted to GTX pursuant to this Section 9.1 with respect to
the Fareston U.S. Web Pages. It is understood and agreed that nothing herein
shall obligate Orion to perform the foregoing tasks [ * ] GTX shall be
responsible for ensuring that the Fareston U.S. Web Pages conform with all
applicable laws and regulations. To the extent allowed by applicable laws and
regulations, Orion shall have a right to build on and join and/or establish a
link to the foregoing site for the Fareston Product in connection with its
retained rights for Fareston Product, and to grant to its Affiliates and
Unaffiliated Sublicensees such rights, at any time, at its sole discretion, with
the reasonable costs thereof payable by the supplier of such link or contents.
GTX shall reasonably cooperate with Orion in regard to any additions to such
site. Such additions, if any, will be placed in an easily visible location on
such site as agreed between the Parties.
10. TRADEMARKS
10.1 TRADEMARKS.
10.1.1 GTX shall market and sell the Product for use in the Field
in the GTX Territory under the Trademarks. GTX shall own and control all
Trademarks (including, as provided in the Purchase Agreement, the trademark
Fareston(R) in the USA). For avoidance of doubt, GTX shall not have any rights
to use the trademark Fareston(R) outside of the USA. GTX shall notify Orion if
GTX decides to change, alter, modify or replace the Trademark initially selected
by it for a given Product.
10.1.2 If GTX exercises its right of first negotiation to obtain
rights to sell Orion Product in the Orion Field under Section 2.1.6, then the
Parties agree that any letter of intent and final agreement governing the terms
under which GTX would obtain such rights shall provide for Orion to grant to GTX
an exclusive, sublicensable license under the trademark Fareston(R) in the
relevant country outside the USA (or any counterpart to such trademark that
Orion is then using to market, promote, and commercialize Orion Products in the
relevant country or countries) to advertise, promote, market or sell such Orion
Product.
10.2 TRADEMARK FILING AND MAINTENANCE. GTX shall be responsible for
filing, maintaining, prosecuting and defending the Trademarks in the GTX
Territory (including, for the avoidance of doubt, the trademark Fareston(R) in
the USA).
10.3 TRADEMARK DOCUMENTATION. If requested by Orion, GTX shall provide
Orion with copies of all documents relating to the maintenance of the Trademark
in the GTX Territory, at Orion's expense.
11. PATENT OWNERSHIP AND WARRANTIES
11.1 PATENT OWNERSHIP.
11.1.1 Subject to the license rights granted to GTX hereunder,
Orion retains full ownership of all Orion Patent Rights and shall be responsible
for filing, prosecuting, and maintaining Orion Patent Rights as provided for in
Article 12.
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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.
28.
11.1.2 Subject to the license rights granted to Orion hereunder,
GTX retains full ownership of all GTX Patent Rights and shall be responsible for
filing, prosecuting, and maintaining GTX Patent Rights as provided for in
Article 12.
11.2 ORION PATENT WARRANTIES. Orion warrants and represents that, to
the best of its management's knowledge as of the Effective Date: (A) Schedule B
sets forth all of the Orion Patent Rights as of the Effective Date and as of the
Restatement Date which are directed to the composition of matter, use or sale of
the compound Toremifene per se; (B) except for the Orion Field in the Orion
Territory, Orion has not and will not grant, license, convey, assign, and/or
transfer to any Third Party any rights to Orion Patent Rights for use in the
Field, or any rights to manufacture the Product or Toremifene for use in the
Field, or other rights to any Third Party, in each case inconsistent with the
licenses and other rights granted to GTX hereunder, (C) based upon Orion's
reasonably diligent investigation, the Orion Patent Rights are (i) valid, in
full force, and enforceable, and (ii) there are no existing valid Third Party
patents in the GTX Territory that might be infringed by the manufacture or sale
of the Orion Product by Orion to GTX under this Agreement for the Prostate
Cancer Field, or in the USA for the Breast Cancer Field, and (D) the use and/or
sale of Products in the Field and in the GTX Territory by GTX, its Affiliates or
Unaffiliated Sublicensees pursuant to this Agreement will not, in the absence of
a license from Orion, infringe any patents owned or controlled by Orion other
than the Orion Patent Rights. Additionally, Orion represents and warrants to GTX
that to the best of its management's knowledge as of the Restatement Date, Orion
has not received any written claims or assertions from any Third Party alleging
that the use of Toremifene in the Field (other than as may be for use and/or
sale of Products in the Orion Field in the Orion Territory) infringes such Third
Party's patent rights.
11.3 GTX PATENT WARRANTIES. GTX warrants and represents that [ * ] as
of the Effective Date: (A) Schedule A sets forth all of the GTX Patent Rights as
of the Effective Date which cover the Product for use in the Prostate Cancer
Field and that it had full right and authority to grant to Orion and Orion
Affiliate the rights granted to it under Section 2.4; (B) subject to Section
2.1.4, GTX has not and will not grant to any Third Party any rights under the
Orion Patent Rights or Orion Know-How inconsistent with GTX's licenses under
this Agreement, and (C) there are no circumstances existing that render it
likely that the United States Government or any agency thereof to exercise such
rights as set forth and/or referenced to in Section 2.3, if GTX's development,
registration and commercialization of the Product for use in the Prostate Cancer
Field will be carried out as agreed herein; and (D) (i) the GTX Patent Rights
are valid, in full force, and enforceable and (ii) upon GTX's reasonably
diligent investigation, there are no existing valid and enforceable Third Party
patents in the GTX Territory (other than any that may be owned or controlled by
Shire) that might be infringed by the marketing, promotion, distribution,
importation, offer for sale or sale of the Product in the Prostate Cancer Field
by GTX, its Affiliates and GTX Unaffiliated Sublicensees.
12. PATENT PROSECUTION AND INFRINGEMENT; TRADEMARKS
12.1 ORION PATENT FILING AND PROSECUTION. Orion shall, at its sole
expense, prosecute, maintain and defend Orion Patent Rights in the GTX Territory
and Orion shall control all Orion Patent Rights filings and actions. Orion shall
use its commercially reasonable efforts to
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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.
29.
obtain extensions in the Major Countries in the GTX Territory in which such
extensions are available.
12.2 GTX PATENT FILING AND PROSECUTION. GTX shall, as its sole expense,
file, prosecute, maintain and defend GTX Patent Rights in the GTX Territory and
GTX shall control all GTX Patent Rights filings and actions. GTX shall use its
commercially reasonable efforts to obtain GTX Patent Rights protection and
commercially reasonable efforts to obtain GTX Patent Rights extensions in any
countries in the GTX Territory in which such extensions are available.
12.3 NOTIFICATION OF INFRINGEMENT. The Parties shall promptly inform
each other of any information that comes to their attention involving actual or
apparent infringements or misappropriations of Orion Patent Rights, Orion
Know-How, GTX Patent Rights, GTX Know-How, or Trademarks by any Third Party, or
claims of alleged infringement made by any Third Party in the GTX Territory
against Orion, its Affiliates, or Orion Unaffiliated Sublicensees, GTX, its
Affiliates, or GTX Unaffiliated Sublicensees, resulting from the manufacture,
importation, marketing, sale or use of the Product in the Field.
12.4 INFRINGEMENT OF THIRD PARTIES RIGHTS BY ORION. Orion shall, at its
sole discretion, direct or defend in its own name and at its own expense any
legal or other action or proceeding, including any settlement or negotiation,
with respect to any alleged infringement of a Third Party patent or other
proprietary right as a result of Orion's, its Affiliates', or Orion Unaffiliated
Sublicensees' manufacture of Toremifene or Orion Product for use in the Field,
or the use or sale of Product in the Orion Field in the Orion Territory
excluding actions and proceedings covered by Section 12.5. During the time any
such proceeding or any appeal thereof is pending, Royalty Income payable by GTX
under Section 3.1 in the country in which such proceeding is pending shall be
paid by GTX into an interest-bearing escrow account pending the outcome of such
proceeding. Upon a favorable final resolution of such proceeding or any appeal
thereof, GTX shall resume paying Orion the full royalties in such country, and
all funds in such escrow account shall be paid to Orion. Upon an unfavorable
final resolution of such proceeding or any appeal thereof, the funds in such
escrow account shall be applied toward the damage award in such action, if any,
and the balance, if any, shall be paid to Orion. If Orion fails to defend such
proceeding or discontinues the defense, all funds in such escrow account shall
be returned to GTX and GTX shall have no further obligation to pay Royalty
Income in such country.
12.5 INFRINGEMENT OF THIRD PARTIES RIGHTS BY GTX. GTX shall, at its
sole discretion, direct or defend in its own name and at GTX's own expense in
the GTX Territory any legal or other action or proceeding, including any
settlement or negotiation, with respect to any alleged infringement of a Third
Party patent, trademark or other proprietary right as a result of GTX's, its
Affiliates', or GTX Unaffiliated Sublicensees' making, having made, importing,
marketing, distributing, using or selling the Product in GTX Territory for use
in the Field, excluding actions and proceedings covered by Section 12.4.
12.6 INFRINGEMENT INDEMNIFICATION.
12.6.1 ORION INFRINGEMENT INDEMNIFICATION. Orion shall indemnify,
defend and hold GTX (including for purposes of this Section 12.6.1, GTX
Affiliates and GTX
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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.
30.
Unaffiliated Sublicensees), its and their officers, directors, and employees,
and permitted successors and assigns, harmless from and against any and all
liabilities, damages, claims, demands, costs and/or expenses (including
reasonable attorneys' fees) (collectively, "Losses") claimed by any Third Party
in any patent or proprietary right infringement suit or action which may be
brought as a result of Orion's, its Affiliates', or Orion Unaffiliated
Sublicensees' manufacture of Toremifene or Orion Product, except to the extent
such Losses arise out of claims for which GTX shall defend, indemnify and hold
Orion harmless pursuant to Section 12.6.2, and further subject to the conditions
of indemnification set forth in Section 15.7.
12.6.2 GTX INFRINGEMENT INDEMNIFICATION. GTX shall indemnify,
defend and hold Orion (including for purposes of this Section, Orion's
Affiliates and Unaffiliated Sublicensees) its and their officers, directors, and
employees, and permitted successors and assigns, harmless from and against any
and all Losses claimed by any Third Party in any suits or actions relating to
patent, trademark or other proprietary right infringements as a result of GTX's,
its Affiliates', or GTX Unaffiliated Sublicensees' making or having made,
importing, marketing, using or selling the Product or Other Product under a
Trademark in GTX Territory for use in the Field, except to the extent such
Losses arise out of claims for which Orion shall indemnify, defend and hold GTX
harmless pursuant to Section 12.6.1, and further subject to the conditions of
indemnification set forth in Section 15.7.
12.7 TERMINATION FOR INFRINGEMENT OF THIRD PARTY RIGHTS. Should either
Party be prevented by reason of an adverse, non-appealable court or
administrative proceeding, order or judgment or arbitral award against it from
manufacturing, making, using or selling the Orion Product and/ or Product in any
country within the GTX Territory as required or permitted under this Agreement,
then, as to such country so affected, the other Party may, upon sixty (60) days
prior written notice thereof to the other Party, terminate this Agreement upon
written notice to the other Party with respect to such country, and the Parties
shall make a final transition accounting and settlement for outstanding bona
fide costs, payments and expenses to which each Party is entitled hereunder with
respect to such country.
12.8 THIRD PARTY INFRINGEMENT OF ORION PATENT RIGHTS.
12.8.1 ORION ENFORCEMENT. Orion shall have the first right but not
the obligation, to commence, at its own expense, appropriate measures to enforce
Orion Patent Rights [ * ] against infringement by Third Parties relating to the
manufacture, use, sale, offer for sale, or import of products containing
Toremifene for use in the Field within a reasonable period of time after Orion
becomes aware of such infringement (including, but not limited to, by notifying
the infringing Third Party of such infringement and demanding that such Third
Party cease and desist from such infringement). If such infringement does not
cease, Orion shall have the right to commence a legal proceeding to enforce
Orion Patent Rights, if any, against such Third Party infringements within a
reasonable period of time of the date Orion becomes aware of such infringement.
Orion shall notify GTX promptly after Orion becomes aware of such infringement,
and, upon request therefor by GTX, keep GTX reasonably informed regarding
Orion's intended strategy in such situation. Additionally, if within a
reasonable period of time from the date GTX becomes aware of any alleged Third
Party infringement of such Orion Patent Rights, either by notice from Orion or
otherwise, Orion has not commenced a legal proceeding against such infringement,
or if at any time Orion discontinues the pursuit of such proceeding,
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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.
31.
GTX may, at its option, commence, continue or intervene, as the case may be, in
such proceeding, provided, however, that with respect to any such proceedings in
any country, GTX shall first request Orion to notify GTX whether any Third Party
has a right to enforce the relevant Orion Patent Rights in the relevant
countries, in which event Orion shall promptly respond to such request, and
further provided that GTX' rights hereunder are subject and secondary to any
rights that Orion has granted to any Third Party prior to the Restatement Date
in such country with respect to enforcement of the relevant Orion Patent Rights.
During the time any such proceeding or any appeal thereof is pending, no Royalty
Income shall be payable under Section 3.1 in the country in which such
proceeding is pending. Upon a favorable final resolution of such proceeding or
any appeal thereof, GTX shall resume paying Orion the full royalties in such
country, and GTX shall also be liable for payment of any back royalties payable
for such period for which such a proceeding has been pending. Orion's
commencement of such proceeding shall be at Orion's own expense, provided that
Orion shall be entitled to retain all recoveries in such proceeding or any
appeal thereof. Such commencement by Orion shall not relieve either Party of its
obligations under Section 12.6.
12.8.2 GTX ENFORCEMENT.
(A) GTX shall have the first right but not the obligation,
to commence, at its own expense appropriate measures to enforce United States
Patent Nos. [ * ] against infringement by Third Parties, within a reasonable
period of time after GTX becomes aware of such infringement (including, but not
limited to, by notifying the infringing Third Party of such infringement and
demanding that such Third Party cease and desist from such infringement). If
such infringement does not cease, GTX shall have the right to commence a legal
proceeding to enforce said Orion Patent Rights, if any, against Third Party
infringements within a reasonable period of time of the date GTX becomes aware
of such infringement. GTX shall notify Orion promptly after GTX becomes aware of
such infringement, and, upon request therefor by Orion, keep Orion reasonably
informed regarding GTX's intended strategy in such situation. Additionally, if
within a reasonable period of time from the date GTX becomes aware of any
alleged Third Party infringement of said Orion Patent Rights, either by notice
from Orion or otherwise, GTX has not commenced a legal proceeding against such
infringement, or if at any time GTX discontinues the pursuit of such proceeding,
Orion may, at its option, commence, continue or intervene, as the case may be,
in such proceeding, provided, however, that with respect to any such proceedings
in the USA, Orion's right to commence, continue, or intervene in such proceeding
are subject to and secondary to any rights that GTX has granted to any Third
Party prior to the Restatement Date in such country with respect to enforcement
of the relevant patent rights. During the time any such proceeding or any appeal
thereof is pending, no Royalty Income shall be payable under Section 3.1 in the
country in which such proceeding is pending. Upon a favorable final resolution
of such proceeding or any appeal thereof, GTX shall resume paying Orion the full
royalties in such country, and GTX shall also be liable for payment of any back
royalties payable for such period for which such a proceeding has been pending.
GTX's commencement, continuation or intervention in such proceeding shall be at
GTX's own expense, provided that GTX shall be entitled to retain all recoveries
in such proceeding or any appeal thereof. Such commencement, continuation or
intervention by GTX shall not relieve either Party of its obligations under
Section 3.1 or 12.6.
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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.
32.
12.9 THIRD PARTY INFRINGEMENT OF GTX PATENT RIGHTS; THIRD PARTY
INFRINGEMENT OF TRADEMARKS AND THE TRADEMARK FARESTON(R).
12.9.1 GTX shall have the sole right, but not the obligation, at
its own expense, to commence appropriate measures to enforce GTX Patent Rights
and rights to Trademarks against Third Party infringements (including, but not
limited to, notifying the infringing Third Party of such infringement and
demanding that such Third Party cease and desist from such infringement) and, if
such infringement does not cease, commence a legal proceeding to enforce such
GTX Patent Rights or rights to Trademarks, if any, against Third Party
infringements. GTX's commencement of such proceeding shall be at GTX's own
expense, provided that GTX shall be entitled to retain all recoveries in such
proceeding or any appeal thereof. Such commencement by GTX shall not relieve
either Party of its obligations under Section 12.6.
12.10 MUTUAL COOPERATION. In the event of any infringement litigation
in the GTX Territory involving the Product or Orion Product or any Orion Patent
Rights or GTX Patent Rights or a Trademark, the non-prosecuting or non-defending
Party shall render such reasonable assistance as may be requested by the
prosecuting or defending Party in connection with such infringement actions. If
Orion requests GTX's assistance in connection with such infringement claims or
actions, Orion shall reimburse GTX for such direct, documented out-of-pocket
expenses as are reasonably incurred by GTX during the course of it providing
such requested assistance. If GTX requests Orion's assistance in connection with
such infringement claims or actions, GTX shall reimburse Orion for such direct,
documented out-of-pocket expenses as are reasonably incurred by Orion during the
course of it providing such requested assistance. Before incurring such
expenses, the Parties shall in good faith agree in writing on the nature and
extent of assistance to be rendered, and an estimate of the total expenses,
which expenses shall be monitored periodically.
12.11 PATENT CHALLENGES.
12.11.1 If GTX, its Affiliate, or GTX Unaffiliated Sublicensee,
either directly or through a contractor or agent, challenges the validity of any
Orion Patent Rights in any Major Country within the GTX Territory (other than in
a Major Country that is a member of the European Union) and does not cease such
challenge within thirty (30) days of receipt of written notice from Orion, then
such challenge shall be deemed a material breach of this Agreement and Orion
shall have the right to terminate this Agreement by written notice with
immediate effect, at Orion's sole discretion, in its entirety or with respect to
such country.
12.11.2 If Orion challenges the validity of any GTX Patent Rights
in any Major Country in the GTX Territory (other than in a Major Country that is
a member of the European Union) and does not cease such challenge within thirty
(30) days of receipt of written notice from GTX, then such challenge shall be
deemed a material breach of this Agreement and GTX shall be entitled to
terminate this Agreement by written notice with immediate effect, at GTX's sole
discretion, in its entirety or with respect to such country.
12.12 ACTIVITIES DURING INFRINGEMENT LITIGATION.
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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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12.12.1 In the event of any patent or trademark or other
proprietary right infringement litigation involving the Product in GTX Territory
in which GTX defends or prosecutes such litigation pursuant to Section 12.8 or
12.9, GTX may, at any time following one hundred eighty (180) days after the
commencement of such litigation, request in writing that Orion suspend the
manufacture of the Orion Product for use in the Field in the part of the GTX
Territory so affected pending resolution of such litigation if GTX reasonably
deems such action necessary or advisable to mitigate possible damages that may
be incurred during the pendency of such litigation. If Orion elects not to
comply with such request within thirty (30) days after receipt thereof, then all
damages resulting from Orion's continued manufacturing of the Product for use in
the Field in the part of the GTX Territory so affected (other than for the Orion
Field in the Orion Territory) after Orion's receipt of such request shall be
borne by Orion and be subject to Orion's indemnification obligation to GTX
pursuant to Section 15.6.1.
12.12.2 In the event of any patent or trademark or other
proprietary right infringement litigation involving the Product in the GTX
Territory in which Orion defends or prosecutes such litigation pursuant to
Section 12.8 or 12.9, Orion may, at any time following one hundred eighty (180)
days after the commencement of such litigation, request in writing that GTX
suspend the import, distribution, marketing, sale and use of the Product, and
suspend Orion's manufacture and supply of Orion Product for GTX hereunder, in
the part of the GTX Territory so affected pending resolution of such litigation
if Orion reasonably deems such action necessary or advisable to mitigate
possible damages that may be incurred during the pendency of such litigation. If
GTX elects not to comply with such request within thirty (30) days after receipt
thereof, then all damages resulting from GTX's continued importing,
distribution, marketing, sale and use of the Product in the part of the GTX
Territory so affected after GTX's receipt of such request shall be borne by GTX
and be subject to GTX's indemnification obligation to Orion pursuant to Section
15.6.2. If GTX elects to comply with such request, such compliance shall be
considered a suspension of GTX's marketing and sales obligations,
notwithstanding Article 6.
12.12.3 In the event either Party receives a written claim of any
alleged or actual infringement of a Third Party patent or trademark or other
proprietary right as a result of Orion's, its Affiliate(s) or Unaffiliated
Sublicensee(s') manufacturing of or selling Orion Product to GTX, or GTX, its
Affiliates, or GTX Unaffiliated Sublicensees making, having made, marketing,
using or selling the Product in GTX Territory for use in the Field, each Party
shall so notify the other Party and the Parties shall confer regarding the basis
for such claim, and discuss how the Parties may resolve the situation. Orion
shall have the right to suspend its manufacture and supply of the Orion Product
in and/or to the part of the GTX Territory so affected upon twenty (20) days
prior written notice to GTX pending resolution of such claim or any related
infringement litigation, if necessary to mitigate damages that may be incurred.
If Orion exercises its rights hereunder, the Parties shall thereafter discuss
from time to time whether the situation has been resolved and, accordingly,
whether Orion is in a position to resume the supply of Orion Product pursuant to
this Agreement.
13. COMPETING PRODUCTS
13.1 OBLIGATIONS WITH RESPECT TO COMPETING PRODUCTS.
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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.
34.
13.1.1 Beginning on the Effective Date and until the expiration of
the last of the Orion Patent Rights on a country by country basis in the Major
Countries, GTX and GTX Affiliates undertake not to market or sell a Competing
Product in such country, excluding those countries of the Major Countries within
the European Union, in which countries GTX and GTX Affiliates undertake not to
market or sell any Competing Product for a period of five (5) years from the
Amendment Date.
13.1.2 However, nothing contained in this Section 13.1 shall be
construed as preventing either Party from conducting research and development
activities relating to a Competing Product during such period or thereafter.
14. PRODUCT ORDERS, SUPPLY AND PAYMENTS
14.1 ORION SUPPLY OBLIGATIONS.
14.1.1 PRODUCT SUPPLY. During the Term, Orion shall, subject to
the terms of this Article 14 and Section 7.7, supply GTX and GTX Affiliates with
their requirements of Orion Product. Orion shall supply the Product in bulk
tablet form.
14.1.2 PRODUCT DELIVERY. Orion shall supply Orion Product to GTX
only against receipt of GTX's written purchase orders. Except as otherwise
provided herein or as otherwise expressly agreed in writing by the Parties,
delivery shall be within ninety (90) days from receipt and confirmation by Orion
of GTX's purchase order. Orion shall confirm the delivery dates within ten (10)
business days after receipt of GTX's purchase orders and, subject to the
provisions of Section 14.2, Orion shall use its best reasonable efforts to fill
such orders on the requested delivery dates, but shall in any event fill such
orders within ninety (90) days from receipt and confirmation of GTX's purchase
order. Orion shall deliver Orion Product [ * ] to a carrier designated by GTX
(with the foregoing being interpreted to effect [ * ]. GTX shall pay shipping
costs and shall assume title to and risk of loss for Orion Product purchased
hereunder after such delivery to GTX's designated carrier.
14.1.3 PRODUCT SHIPPING INSTRUCTIONS. GTX shall provide Orion with
appropriate instructions for each shipment of Orion Product hereunder
designating the desired carrier, destination and method of transport. If Orion
becomes aware that the designated carrier is unable to accept the desired
shipment within the requested delivery period, Orion shall promptly notify GTX
and GTX shall promptly designate another carrier or carriers.
14.2 ORION AFFILIATES AND SUBCONTRACTORS. Orion may satisfy its supply
obligations under this Agreement either directly or through any Orion Affiliate
(provided that such Orion Affiliate has a manufacturing site which has received
all required regulatory approvals and that Orion guarantees the performance of
such Affiliate), and such supply by Orion Affiliates shall not be deemed an
infringement of GTX's rights hereunder.
14.3 GTX FORECASTS.
14.3.1 ROLLING FORECASTS. Within ninety (90) days after the
Restatement Date, GTX shall inform Orion in writing of GTX's bona fide, good
faith estimated requirements of
[ * ] = 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.
35.
Fareston Product in the GTX Territory during the year 2005. Thereafter, for the
remainder of the Term, GTX shall provide to Orion by September 30 of each year a
purchase forecast of GTX's estimated requirements of Orion Product for the
twenty four (24) month period beginning with October 1 of the then current year,
allocated for each calendar month of such period, provided that if during any
calendar year GTX expects to order Product from Orion to support the launch of
Product for use in the Field but outside of the Breast Cancer Field, then not
later than ninety (90) days prior to GTX's anticipated first order of Orion
Product from Orion to support the launch of Product for such use, GTX shall
update the most recently provided purchase forecast to include GTX's good faith
estimated requirements of Orion Product to support such launch (if not already
included in the then-applicable forecast). GTX shall update its purchase
estimates to Orion on a monthly basis by indicating by the end of each month
revised estimates or confirming that no revisions are necessary, which shall
provide Orion with GTX's rolling twenty four (24) month forecasts.
14.3.2 EXCESS QUANTITIES. If GTX orders a quantity of Orion
Product in excess of one hundred twenty-five percent (125%) of GTX's purchase
forecast provided two (2) Calendar Quarters prior to such order, Orion shall
deliver the quantity in excess of one hundred twenty-five percent (125%) up to
one hundred fifty percent (150%) of such forecast within one hundred twenty
(120) days from receipt and confirmation of GTX's purchase order. If GTX orders
a quantity of Orion Product in excess of one hundred fifty percent (150%) of
GTX's purchase forecast provided two (2) Calendar Quarters prior to such order,
Orion shall use commercially reasonable efforts to supply the quantity in excess
of one hundred fifty percent (150%) up to two hundred percent (200%) of such
forecast as soon as practical, but in no event later than one hundred eighty
(180) days from receipt and confirmation of GTX's purchase order. If GTX orders
a quantity of Orion Product in excess of two hundred percent (200%) of GTX's
purchase forecast provided two (2) Calendar Quarters prior to such Order, Orion
shall use commercially reasonable efforts to supply the quantities in excess of
such forecast as soon as practical.
14.3.3 MINIMUM QUANTITIES. Of the amounts of Orion Product
indicated by GTX in its rolling monthly forecasts, GTX shall purchase at least
one hundred percent (100%) of its estimated requirement for Orion Product for
the first three (3) months of such forecast, eighty percent (80%) of its
estimated requirement of Orion Product for the fourth, fifth and sixth months of
such forecast, and fifty percent (50%) of its estimated requirement of Orion
Product for the seventh, eighth and ninth months of such forecast. All orders
and deliveries of Orion Product shall be in full batch sizes of Orion Product,
as determined by Orion from time to time. Orion shall notify GTX in writing
prior to the date upon which GTX must provide its first commercial order of
Orion Product under this Article 14 of what the size of a full batch of Orion
Product is at such time.
14.4 PRICES AND PAYMENT.
14.4.1 COMMERCIAL PRICING FORMULA. Orion's annual price of bulk
Orion Product to GTX, its Affiliates or its Unaffiliated Sublicensees for
commercial purposes, delivered [ * ] (with the foregoing being interpreted to
effect [ * ], shall 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.
36.
14.4.2 INVOICING AND PAYMENT. Orion shall invoice GTX for
commercial orders of Orion Product shipped, and GTX shall pay such invoice
within thirty (30) days of receipt.
14.4.3 PRICE CHANGES. GTX may, no more than once per year, request
that Orion determine whether the average cost of the raw materials set forth in
Schedule C used to manufacture Product during the immediately preceding year
has, in the aggregate, changed by more than five percent (5%) of the average
cost thereof that applied during the year immediately preceding the date that is
one year earlier than the date of GTX's request (any such change, a "Significant
Cost Change"). Reasonably promptly following any such request by GTX, Orion
shall make such determination and notify GTX of the result of such
determination. Additionally, if Orion determines that a Significant Cost Change
has occurred (other than in response to such a request by GTX), it shall so
notify GTX. If Orion determines that a Significant Cost Change has occurred upon
GTX's request or upon Orion's own investigation, then the Parties shall (no more
than once annually) adjust the price to reflect such Significant Cost Change.
Such price shall apply to Orion Products purchased by GTX following the date of
Orion's notice to GTX that a Significant Cost Change has occurred.
14.4.4 EXCEPTION. Notwithstanding the foregoing, GTX shall not owe
Orion any payment pursuant to this Section 14.4 for any Product that is sold to
a Third Party for development or commercialization of a [ * ] as to which GTX
owes Orion payments described in Section 3.1.6.
14.5 RESALE PRICES. GTX, its Affiliates and GTX Unaffiliated
Sublicensees shall be free to set their own resale prices for the Product sold
in the GTX Territory.
14.6 PRODUCT SUPPLY FOR TESTING AND REGISTRATION; SUPPLY OF TOREMIFENE.
14.6.1 PRODUCT SUPPLY FOR TESTING AND REGISTRATION. The supply
price for the [ * ] tablet of bulk Orion Product for clinical trials shall be
[ * ] per tablet. Orion shall supply GTX or its Affiliates with such quantities
of [ * ] tablets of bulk Product as GTX or its Affiliates may require of Orion
Product and/or placebos for use in clinical trials of Products. The price for
the [ * ] tablet of bulk Orion Product for clinical trials shall be [ * ] per
tablet. Orion shall supply GTX with such quantities of [ * ] tablets of bulk
Product as GTX or its Affiliates may require of Orion Product and/or placebos
for use in clinical trials of Products. The price for the [ * ] tablet of bulk
Product for clinical trials shall be [ * ] per tablet. Orion shall supply GTX
with such quantities as GTX or its Affiliates may require of [ * ] tablets of
Orion Product and/or placebos for use in clinical trials of Products. The price
for a [ * ] placebo for such clinical trials shall be [ * ], per tablet. All
Orion Product supplied for testing and registration pursuant to this Section
14.6 shall be provided in bulk packaging. Notwithstanding the foregoing, GTX
shall not owe Orion any payment pursuant to this Section 14.6 for any Product
that is sold to a Third Party for development or commercialization of a [ * ] as
to which GTX owes Orion payments described in Section 3.1.6.
14.6.2 SUPPLY OF TOREMIFENE. For the sole purpose of aiding GTX or
its Affiliates in its efforts to obtain Regulatory Approval for the Product for
use in the Field in the GTX Territory, Orion shall, during the Term, upon
written order thereof by GTX, provide GTX, free of charge, with up to [ * ] of
Toremifene in bulk powder form (the "Powder"). GTX
[ * ] = 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.
37.
undertakes to use such Powder only for studies necessary to support Regulatory
Approval for Product for use in the Field, excluding the Orion Field in the
Orion Territory. Upon ordering Powder from Orion, GTx shall provide Orion with a
detailed description of such study(ies) and the expected amount of Powder needed
for said study(ies).
As consideration for Orion's agreement to provide the Powder to GTX,
all results, data, information, inventions, memoranda, reports, discoveries,
work products and other results (including without limitation any patents(s)
granted thereon), which are conceived, derived, reduced to practice, made and/or
developed by or on behalf of GTX and arising out of or relating to the use of
the Powder (hereinafter referred to as "Results") shall be jointly owned by GTX
and Orion such that each Party shall have a one-half undivided interest in and
to such results, without a duty of accounting to the other Party. Orion's
interest in the Results, and any patent rights related thereto, shall be subject
to the licenses granted to GTX pursuant to Section 2.1 to the extent such
Results are included in the Orion Patent Rights or Orion Know-How. GTX hereby
grants to Orion an exclusive, royalty-free, worldwide license with the right to
grant sublicenses, under GTX's joint interest in the Results and any
intellectual property rights relating thereto for use in developing, using,
having used, selling, having sold, importing, marketing and distributing
products outside of the Field and in the Orion Field in the Orion Territory.
Orion hereby grants to GTX an exclusive, royalty-free, worldwide license, with
the right to grant sublicenses, under Orion's joint interest in the Results and
any intellectual property rights relating thereto, for use in developing, using,
having used, selling, having sold, importing, marketing and distributing
products in the Field (excluding in the Orion Field in the Orion Territory), to
the extent such rights are not otherwise included in the Orion Patent Rights or
Orion Know-How licensed to GTX pursuant to Section 2.1.1.
Any use of the Results by GTX other than for the purposes of this
Agreement shall not be permitted without the express written consent of Orion,
which Orion may withhold at its sole discretion.
Without prejudice to the foregoing, the Results shall be deemed both
Orion's and GTX's Confidential Information and shall be used and treated for
purposes of Section 8 of this Agreement as Confidential Information of the other
Party. GTX shall promptly disclose to Orion all Results immediately when such
Results are available.
GTX and Orion shall mutually determine whether or not any of the
Results provide the basis for any patentable inventions. If both Orion and GTX
consider that patents for any such inventions involving Results should be
sought, then such applications shall, in accordance with what has been stated
herein above, be filed in the Parties' joint name, and the Parties shall share
equally all costs of filing, prosecuting and maintaining relevant patent
applications and patents. The Parties shall negotiate in good faith on the
division of responsibilities with regard to drafting, filing, prosecuting and
maintaining the relevant patent applications and patents. If the Parties do not
decide that patent application(s) should be filed for any patentable inventions
included in the Results, then the Results shall continue to be treated as
Confidential Information of both Parties.
14.7 AGREEMENT TERMS GOVERN. Except as otherwise agreed in writing by
the Parties, the terms and conditions of this Agreement shall govern Orion and
its Affiliates' sale of
[ * ] = 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.
38.
Orion Product to GTX, its Affiliates and GTX Unaffiliated Sublicensees during
the Term, notwithstanding any conflicting terms and conditions set forth in
GTX's forecast, order or purchase documents or in Orion's sale or acceptance
documents and any such conflicting terms are hereby expressly rejected.
14.8 PRICE ADJUSTMENT FOR COMMERCIAL SUPPLY. It is agreed upon by the
Parties that the price of the [ * ] tablet of Orion Product to GTX, its
Affiliates or Unaffiliated Sublicensees shall be reduced below [ * ] based upon
attaining certain milestone purchases of Product as follows: if GTX purchases
annually an aggregate amount of [ * ] of tablet [ * ] the price of the tablet
shall be [ * ] per [ * ] tablet. Similarly, (i) the price to GTX of the [ * ]
tablet of Orion Product shall be reduced if GTX purchases annually [ * ] of the
[ * ] tablets such that the price per [ * ] tablet of Orion Product shall be
[ * ] and (ii) the price to GTX of the [ * ] tablet of Orion Product shall be
reduced if GTX purchases annually [ * ] of the [ * ] tablets such that the price
per [ * ] tablet of Orion Product shall be [ * ]. If a price adjustment is
triggered under this Section 14.8, then the adjusted price shall apply to the
entire amount of the relevant tablets purchased during the relevant year. Orion
shall within thirty (30) days after the end of such year, pay to GTX an amount
equal to the number of relevant tablets actually purchased during such year,
multiplied by the difference between the price paid by GTX for supply of the
relevant tablets and the lower price that is actually applicable due to the
adjustment to be made pursuant to this Section 14.8.
14.9 TERMINATION OF PRODUCT SUPPLY. Orion shall, at its sole
discretion, have the right upon providing [ * ] prior written notice thereof, to
terminate its obligations under this Article 14 relating to the manufacture and
supply of Orion Product and/or Toremifene (pursuant to Section 14.6.2) in the
event that Orion permanently ceases the manufacture of Toremifene and/or Orion
Product. For the avoidance of doubt, the right of termination relating to the
manufacture and supply of Orion Product and/or Toremifene set forth in this
Section 14.9 shall not restrict or alter Orion's rights under Section 7.7. In
the event that Orion so terminates such obligations, Orion shall grant GTX a
contingent license under the Orion Patent Rights, Orion Know-How and the
Manufacturing Patents to make and have made Product for use in the Field in the
GTX Territory (except for use of the Product in the Orion Field in the Orion
Territory) during the Term, with such license to be exclusive in the Field (but
excluding the Orion Field in the Orion Territory) and sublicensable (but only
for the purpose of having Products manufactured for GTX, its Affiliates or
Unaffiliated Sublicensees). Such license shall become effective upon GTX's
receipt of notice from Orion under this Section 14.9. Orion shall during such
[ * ] notice period, and as soon as practically possible after GTX's written
request, provide GTX with Product Manufacturing Know-How to the extent
reasonably necessary to enable GTX to exercise its back-up manufacturing right
pursuant to this Section 14.9, including without limitation providing up to ten
(10) person-days of technology transfer assistance at GTX's site of manufacture
of Product using Orion personnel skilled in such manufacturing operations, at no
charge to GTX.
15. PRODUCT WARRANTIES AND INDEMNIFICATION
15.1 PRODUCT WARRANTIES AND LIMITATIONS.
[ * ] = 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.
39.
15.1.1 ORION WARRANTIES. Orion warrants and represents that the
Orion Product manufactured by Orion, its Affiliate(s) or subcontractor(s), as
the case may be, and delivered to GTX, its Affiliate(s) or GTX Unaffiliated
Sublicensee(s) hereunder for resale shall (i) from the date of shipment until
the end of the specified shelf-life conform to the Specifications (provided,
however, that Orion Product has after shipment been handled and stored properly
and been afforded sufficient protection against deterioration and damage) and
shall have been manufactured in accordance with U.S. FDA Good Manufacturing
Practices and equivalent Good Manufacturing Practices in Europe to the extent
applicable to Orion, its Affiliates or subcontractors as the manufacturer(s) of
Orion Product, and (ii) be transferred free and clear of any security interests,
liens and encumbrances. It is expressly agreed that, except as expressly
provided for in Section 11.2, no representation, warranty, commitment or
obligations given, made or undertaken by Orion in this Agreement shall apply
with regard to any Product manufactured by a party other than Orion, its
Affiliates or subcontractors, including without limitation any Product
manufactured by or on behalf of GTX under its stand-by and other manufacturing
rights pursuant to Section 7.7, 14.9, 16.1, 17.3.2, 17.4 or 21.2.2.
15.1.2 LIMITATIONS. Except as otherwise expressly stated herein,
no warranties or representations, express or implied are made or shall be deemed
to have been made by Orion, its Affiliate or subcontractor including without
limitation the warranties of fitness for a particular purpose and
merchantability, regarding any Product, including without limitation the Orion
Product and Other Product. Subject to Orion's warranty and indemnification
obligations under this Agreement for Orion Product, Orion shall have no
responsibility or liability for any Product, including without limitation Orion
Product and Other Product manufactured by Orion and/or used, supplied, marketed,
or sold by GTX, its Affiliates or GTX Unaffiliated Sublicensees.
15.2 CERTIFICATE OF ANALYSIS. Orion shall furnish GTX with one or more
certificates of analysis for each batch of Orion Product supplied hereunder, in
the form required by law in each country of GTX Territory where the Orion
Product is marketed, with shipment of each such batch.
15.3 PRODUCT INSPECTIONS.
15.3.1 GTX INSPECTION AND ANALYSIS. GTX shall inspect and analyze
a representative sample of Orion Product from batches supplied by Orion promptly
after receipt. If, after inspection, GTX reasonably believes the shipment does
not meet the Specifications, GTX shall notify Orion in writing within thirty
(30) days after GTX's receipt of any such goods. If GTX does not so notify
Orion, GTX shall be deemed to have waived all claims against Orion for said
quantity delivered, except for any latent defects that could not have been
reasonably discovered upon such inspection, which defects shall be notified by
GTX to Orion within fourteen (14) days from discovery of same. Any claims by GTX
regarding goods delivered shall specify in reasonable detail the nature and
basis for the claim and cite relevant Orion lot numbers or other information to
enable specific identification of the goods involved. GTX shall not be required
to accept Orion Product having a shelf life of less than eighty percent (80%) of
the stated expiration dating on the date of shipment by Orion.
15.3.2 ORION RESPONSE. Orion shall respond to all claims made by
GTX on a case-by-case basis and Orion shall have the right to first inspect any
goods involved before being
[ * ] = 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.
40.
required to take any action with respect thereto. Orion shall review any such
claim of nonconformity made by GTX within thirty (30) business days of receipt
of GTX's notice under Section 15.3.1 and conduct any required testing of the
goods involved as soon as possible, but in no event later than forty-five (45)
days after receipt thereof, or earlier if the U.S. FDA or any corresponding
regulatory authority in the GTX Territory requires an earlier response from
Orion. If such review and testing by Orion (or testing by an independent
laboratory as set forth below) confirms that a claimed quantity does not meet
the Specifications, then, at Orion's expense, GTX shall dispose of or return
such quantity involved as Orion shall direct in writing and Orion shall replace
such quantity with conforming goods as soon as possible, but in no event later
than sixty (60) days after testing is completed, which shall be GTX's sole and
exclusive remedy for such non-conformity. If the Parties fail to agree as to
whether a delivered quantity meets the Specifications, then the Parties shall
have the batch in dispute analyzed by a mutually agreed upon independent testing
laboratory located in the country in which Orion Product to which goods relate
is intended for resale, or, if the Parties agree, in Finland. Such laboratory's
determination shall be deemed final as to any dispute over the Specifications
and the nonprevailing Party shall bear the costs of such independent
laboratory's testing.
15.4 PRODUCT STORAGE. Each Party shall properly store Orion Product
under conditions that will not adversely affect the quality or normal shelf life
thereof.
15.5 GTX RESPONSIBILITIES IN GTX TERRITORY.
15.5.1 LABELING. GTX shall be responsible for packaging of the
Product, and for all labeling, inserts, packaging and promotional materials and
any other materials which accompany, are distributed, used or referred to in any
way by GTX, its Affiliate(s) or GTX Unaffiliated Sublicensee(s) in connection
with the Product and GTX shall ensure that same shall conform to all legal
requirements in each country of the GTX Territory in which the Product is sold.
Subject to applicable legal and regulatory requirements and space limitations,
all Product labeling, packaging, inserts and promotional materials shall
indicate that the Product is marketed by GTX. GTX shall, upon written request
therefore by Orion, provide Orion with copies of representative samples of
materials which GTX, its Affiliates and GTX Unaffiliated Sublicensees intend to
use in connection with the marketing, promotion and sale of the Product thirty
(30) days prior to their first use thereof, provided that nothing herein or
otherwise, including without limitation any request by Orion to be furnished
with such materials or review of same, shall be construed as Orion assuming any
liability or responsibility for such materials or their conformity to all legal
requirements in any country of the GTX Territory in which the Product is sold
and such request and/or review by Orion of such materials shall be without
prejudice to the first sentence of this Section 15.5. GTX, its Affiliates, or
GTX Unaffiliated Sublicensee shall register, promote, market and sell the
Product in the GTX Territory only for the indications for which relevant
Regulatory Approvals have been obtained and only in accordance with applicable
legal and governmental authority requirements.
15.5.2 NOTIFICATION. GTX shall also be responsible for notifying,
reporting or registering this Agreement or the business relationship created
hereby with any government authorities in the GTX Territory to the extent
legally required. Orion shall provide GTX with such assistance as GTX may
reasonably request in connection therewith.
[ * ] = 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.
41.
15.6 RECIPROCAL INDEMNIFICATION PROVISIONS.
15.6.1 ORION INDEMNIFICATION. Orion shall defend, indemnify and
hold GTX, its Affiliates, GTX Unaffiliated Sublicensees, and its and their
officers, directors and employees, harmless from and against any and all
liabilities, damages, claims, demands, costs, or expenses (including reasonable
attorneys' fees) Losses claimed by any Third Party for any property or other
economic loss or damage or injury or death suffered by it to the extent the same
is determined to have been caused by (A) the negligence, fault, willful
wrongdoing or any other act or omission in relation to the manufacture by Orion,
its Affiliates or subcontractor(s) of the Orion Product, or a material breach of
this Agreement by Orion, its Affiliate(s) or Unaffiliated Sublicensee(s), or (B)
or a breach by Orion of the warranties set forth in Section 15.1 and/or 20.1(i),
or (C) the manufacture, use, sale, importation, distribution and/or marketing of
the Product for use in the Orion Field and in the Orion Territory by Orion, its
Affiliates or Unaffiliated Sublicensees, except with respect to each of (A) and
(B) to the extent that such Losses are caused by activities for which GTX must
defend, indemnify and hold harmless pursuant to Section 15.6.2.
15.6.2 GTX INDEMNIFICATION. GTX shall defend, indemnify and hold
Orion, its Affiliates, and its and their the officers, directors and employees
harmless from and against any and all Losses claimed by any Third Party for any
property or other economic loss or damage, injury or death suffered by it to the
extent the same is determined to have been caused by (A) a breach by GTX of [ *
]; (B) the negligence, fault, willful wrongdoing or any other act or omission,
or material breach of this Agreement by GTX, its Affiliates or Unaffiliated
Sublicensees; (C) the manufacture, use, sale, importation, distribution, and/or
marketing of the Product by GTX, its Affiliates or Unaffiliated Sublicensees in
the Field in the GTX Territory, including without limitation any product
liability claim for property or other economic loss or damage, injury or death
suffered by a Third Party arising out of or relating to the Product or Other
Product or use thereof, except with respect to each of (B) and (C) to the extent
that such Losses are caused by activities for which Orion must defend, indemnify
and hold harmless GTX pursuant to Section 15.6.1.
15.7 CONDITIONS FOR INDEMNIFICATION. With respect to any
indemnification obligations of either Party to the other Party under this
Agreement, the following conditions must be met for such indemnification
obligations to become applicable: (A) the indemnified Party shall notify the
indemnifying Party promptly in writing of any claim which may give rise to an
obligation on the part of the indemnifying Party hereunder; (B) the indemnifying
Party shall be allowed to timely undertake the sole control of the defense of
any such action and claim, including all negotiations for the settlement, or
compromise of such claim or action at its sole expense; and (C) the indemnified
Party shall render reasonable assistance, information, cooperation and authority
to permit the indemnifying Party to defend such action, it being agreed that any
out-of-pocket expenses or other expenses incurred by the indemnified Party in
rendering the same shall be borne or reimbursed promptly by the indemnifying
Party. Neither Party shall consent to the entry of any judgment or settle or
otherwise compromise any such action or suit in a way that adversely affects the
other Party's intellectual property rights or other rights, obligations or
interests with respect to Products, or imposes obligations on such other Party,
without such other Party's prior written consent.
[ * ] = 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.
42.
15.8 LIABILITY INSURANCE. GTX shall procure and maintain insurance,
including product liability insurance, adequate to cover its obligations
hereunder and which are consistent with normal business practices of prudent
companies commercializing products of similar nature that present similar
liability risks. It is understood that such insurance shall not be construed to
create a limit of GTX's liability with respect to its any of its obligations
hereunder, including without limitation its indemnification and compensation
obligations under this Agreement. GTX shall provide Orion with written evidence
of such insurance (including without limitation financial information that
describes the amounts available under such insurance) upon request. This Section
15.8 shall survive the termination expiration of this Agreement for ten (10)
years for whatsoever reason.
16. STANDBY MANUFACTURING RIGHTS; INVENTORY MAINTENANCE
16.1 INABILITY TO MANUFACTURE OR SUPPLY. If Orion is unable to supply
or manufacture Orion Product, as ordered pursuant to Sections 14.1.2 and 14.3.2,
for ninety (90) or more consecutive days after the agreed delivery time for any
reason (including but not limited to a Force Majeure event), save as for reasons
arising from acts or omissions of GTX, its Affiliates and/or its Unaffiliated
Sublicensees, including without limitation failure by GTX, its Affiliates and/or
its Unaffiliated Sublicensees to notify Orion of Orion's failure to deliver
Orion Product ordered pursuant to Sections 14.1.2 and 14.3.2, then GTX may, at
its option, responsibility and expense, elect to manufacture or have a Third
Party manufacture Toremifene and/or Orion Product for use in manufacturing and
selling the Product for use in the Field anywhere in the GTX Territory (except
for use in the Orion Field in the Orion Territory) until such time as Orion can
demonstrate to GTX's reasonable satisfaction that Orion is capable of resuming
the manufacture of Toremifene and/or Orion Product, as applicable. To the extent
necessary to implement such standby manufacturing rights, Orion hereby grants
GTX a contingent license under the Orion Patent Rights, Orion Know-How and
Manufacturing Patents to make and have made Toremifene and/or Orion Product for
use in the Field in the GTX Territory (except for use in the Orion Field in the
Orion Territory). Such license shall be exclusive and sublicensable (but only
for the purpose of having Products manufactured for GTX, its Affiliates or
Unaffiliated Sublicensees), with such license to become effective only under the
circumstances specified in the preceding sentence. In such case, Orion shall as
soon as practically possible provide GTX with Product Manufacturing Know-How to
the extent reasonably necessary to enable GTX to exercise its back-up
manufacturing right pursuant to this Section 16.1, including without limitation
providing up to ten (10) person-days of technology transfer assistance at GTX's
site of manufacture of Product using Orion personnel skilled in such
manufacturing operations, at no charge to GTX. Orion shall promptly notify GTX
in writing of any circumstances rendering it unable to manufacture Product and
the estimated duration of such circumstances. GTX's standby-manufacturing rights
under this Section 16.1 shall be GTX's sole and exclusive remedy for Orion's
failure to manufacture or have manufactured Orion Product for supply to GTX
under Article 14.
16.2 BACK-UP MANUFACTURING RIGHT. GTX shall have the right to require
Orion to qualify and maintain the qualification for, at GTX's expense (as
described below), a back-up facility(ies) for use in manufacturing Product for
supply to GTX pursuant to Article 14 at any time after GTX's good faith
forecasted Net Sales of Products provided pursuant to Section 14.3 [ * ] in a
given Year, or actual Net Sales for Product in any given Year [ * ]. GTX shall
exercise
[ * ] = 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.
43.
such right by written notice to Orion. Promptly after receiving such notice,
Orion and GTX shall meet to discuss the manner in which Orion proposes to
qualify and maintain the qualification for such back-up manufacturing
facility(ies) (for example, by qualifying a site owned by Orion or by engaging a
Third Party manufacturer to qualify another facility), the timing for qualifying
such facility(ies), and Orion's estimated costs incurred directly in connection
with qualifying such facility(ies) (which costs may include, by way of example,
Orion's costs of obtaining Regulatory Approvals necessary to enable the sale in
the Territory of Product manufactured at such site). Orion shall promptly
thereafter, subject to agreement on reimbursement by GTX of Orion's related
costs and expenses, qualify such back-up facility and maintain the qualification
for such facility (including obtaining relevant Regulatory Approvals and making
appropriate regulatory filings) to assure continued supply of Product in the
event Orion is unable to supply Products in the amounts ordered pursuant to
Article 14. GTX shall reimburse Orion for [ * ] or [ * ] the Parties. Nothing in
this Section 16.2 shall be deemed to limit Orion's obligations under Article 14,
or to prevent GTX from seeking any remedies available to it under law or in
equity for any breach by Orion under such Sections.
16.3 MAINTENANCE OF INVENTORY. Orion shall, at all times during the
Term, maintain or have maintained, either itself or through a subcontractor, an
amount of Toremifene and other raw materials critical for the manufacture of
Products containing such Toremifene sufficient to manufacture the amount of
Product forecasted to be ordered by GTX pursuant to Section 14.3 during the
subsequent [ * ] period of time. The Parties will agree upon an appropriate
amount of reserve supplies to be maintained by Orion during the first [ * ]
following the First Commercial Sale of Product in the Prostate Cancer Field at
the time GTX provides an update to its forecasted requirements to support launch
of Product in such field pursuant to Section 14.1. Such supplies shall serve as
a reserve supply to be used by Orion solely to manufacture Product for GTX if
any shortfall in the amount of Product supplied by Orion pursuant to Article 14
occurs or is reasonably anticipated to occur. Nothing in this Section 16.3 shall
be deemed to limit Orion's obligations under Article 14.
17. MANUFACTURING INSPECTIONS AND CHANGES
17.1 REGULATORY INSPECTIONS. Each Party shall allow representatives of
the U.S. FDA and any other regulatory agency or authority with jurisdiction over
the manufacture, marketing and distribution of the Product to tour and inspect
all facilities utilized by such Party in the manufacture, testing, packaging,
storage, and shipment of Product sold under this Agreement, and shall co-operate
with such representatives in every reasonable manner. Upon notification by the
U.S. FDA or any other regulatory agency of such agency's intent to conduct an
inspection, the Party receiving such notification will immediately inform the
other Party of such inspection with such advance notice as to allow the other
Party to have representatives present during such inspection (to the extent such
presence is allowed by such regulatory agency). Each Party shall also provide
the other Party with a copy of any U.S. FDA Form 483 notices of adverse
findings, regulatory letters or similar notifications it receives from any other
governmental authority setting forth adverse findings or non compliance with any
applicable laws, regulations or standards relating to the Product within five
(5) days of its own receipt thereof. Each Party shall also provide the other
Party with a copy of its proposed written response to such governmental
authority before submission and shall incorporate any changes thereto which the
other Party may reasonably request.
[ * ] = 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.
44.
17.2 ORION-INITIATED MANUFACTURING CHANGES. Save as for changes
required under applicable laws and regulations or by any competent regulatory or
other authority, during the Term, Orion shall not make any material changes to
its manufacturing operations for Toremifene or Orion Product to be supplied to
GTX pursuant to this Agreement, without informing GTX prior to such changes;
provided that if such changes would require GTX to make additional filings with
regulatory authorities or to seek additional Regulatory Approvals for Orion
Product, then Orion shall not make such change without GTX's prior written
consent, such consent not to be unreasonably withheld, conditioned or delayed.
17.3 GTX-INITIATED MANUFACTURING CHANGES.
17.3.1 GTX REQUEST FOR MANUFACTURING CHANGES. Prior to Orion
providing GTX with notice pursuant to Section 14.9, GTX may, from time to time
during the Term and as agreed in this Section 17.3, make a written and detailed
request for changes in Orion's manufacturing operations, or the Specifications,
for Toremifene or Orion Product. Such changes that are required and mandatory
under applicable laws and regulations in a Major Country shall be deemed
"Required Manufacturing Changes", and such changes that are intended to promote
quality control/quality assurance, and/or to achieve greater efficiency or cost
savings in the manufacturing process but are not so required and mandatory shall
be deemed "Other Manufacturing Changes".
17.3.2 REQUIRED MANUFACTURING CHANGES. Provided that GTX furnishes
Orion with evidence of Required Manufacturing Changes, Orion shall commence the
implementation of Required Manufacturing Changes as soon as practicable, but in
no event later than (i) ninety (90) days after receipt of GTX's request (or
within such other longer time period as may be mutually agreed upon by the
Parties if implementation within ninety (90) days is impossible or reasonably
impractical, such agreement not to be unreasonably withheld, conditioned or
delayed by GTX) or (ii) earlier if required by the U.S. FDA or any corresponding
regulatory authority in a Major Country. If Orion does not commence the
implementation of Required Manufacturing Changes within the time period
referenced in the preceding sentence or does not notify GTX in writing that
Orion disputes whether GTX's requested changes are Required Manufacturing
Changes, then GTX shall have the option to exercise standby manufacturing rights
for Toremifene and Product pursuant to Section 16.1 until such time as Orion
implements such Required Manufacturing Changes. If Orion notifies GTX in writing
that Orion disputes whether GTX's requested changes are Required Manufacturing
Changes, the Parties shall resolve such dispute by reference to a mutually
agreed upon independent Third Party regulatory expert as soon as possible for a
binding determination of whether the requested changes are Required
Manufacturing Changes. If such independent Third Party regulatory expert
determines that GTX's requested changes are Required Manufacturing Changes,
Orion shall implement such changes as soon as possible. Any modification to the
Specifications that is necessary to implement or reflect a Required
Manufacturing Change shall be deemed to be included in the Specifications, and
any Products manufactured thereunder by Orion shall be deemed Orion Products.
17.3.3 OTHER MANUFACTURING CHANGES. Orion shall give due
consideration to making Other Manufacturing Changes proposed by GTX. Orion shall
within sixty (60) days from receipt of GTX's written request for Other
Manufacturing Changes provide GTX a written
[ * ] = 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.
45.
response to such request indicating whether it would be willing to discuss, and
as appropriate, negotiate the terms and conditions under which Orion would be
willing to implement such Other Manufacturing Changes.
17.4 NEW DOSAGE STRENGTHS AND FORMULATIONS. Upon written request by
GTX, the Parties shall meet in person or by teleconference to discuss, and as
appropriate, negotiate the terms under which Orion would be willing to
manufacture and supply to GTX any dosage strengths or formulations of the
Product other than those that are available as an Orion Product as of the
Restatement Date (including without limitation any combination Product
containing Toremifene and another active ingredient) or any Product otherwise
having specifications different from Orion Product Specifications (such
Products, collectively "Other Product(s)"), as provided in this Section 17.4.
The Parties shall conduct such discussions during a sixty (60) day
period following GTX's written request setting forth in sufficient detail the
changes proposed by GTX, or any mutually agreed extension of such time period
("Evaluation Period"). If Orion would be willing to manufacture such Other
Product, Orion shall within the Evaluation Period notify GTX of the terms and
conditions under which it would be willing to do so, and the Parties shall
negotiate a written amendment to this Agreement to include the applicable terms
and conditions under which Orion would manufacture and supply such Other
Product, including without limitation the supply price of such Other PRODUCT.
Upon execution of such amendment, such Other Product shall be deemed to be an
Orion Product. Such negotiation shall be conducted for up to one hundred twenty
(120) days following GTX's receipt of Orion's notice of such terms and
conditions ("Negotiation Period"). It is expressly agreed that Orion shall have
no obligation to manufacture and supply any Other Product unless a mutually
acceptable definitive written amendment to this Agreement, if any, in relation
to such Other Product is executed by duly authorized representatives of both
Parties.
In the event Orion notifies GTX within the Evaluation Period that it
will not be interested in supplying such Other Product, or the Parties do not
amend this Agreement during the Negotiation Period to specify applicable terms
for, or execute another agreement governing, Orion's supply of such Other
Product for use in the Field (other than use in the Orion Field in the Orion
Territory), then if GTX has a good faith basis for requiring supply of such
Other Product, including but not limited to its desire to develop a dosage
strength of Product other than one which is in clinical development by or on
behalf of GTX as of the Restatement Date and in which an Orion Product is
available, or a formulation of Product that incorporates a new technology or
another active ingredient in order to optimize the pharmacokinetic properties of
Product, improve the competitive position of Product in the market, or to
increase the efficiency or safety of Products, GTX shall have the right to
manufacture, or engage a Third Party subcontractor to manufacture, such Other
Product for sale and use in the Field only. GTX shall exercise such right to
manufacture or have manufactured an Other Product for sale and use in the Field
(except for use in the Orion Field in the Orion Territory) pursuant to this
Section 17.4 in good faith only, and not for the purpose of obtaining the right
to manufacture Product by, for example, proposing minor changes to the Product
formulation that do not present a commercially reasonable basis for development.
To the extent reasonably necessary to implement such manufacturing right, Orion
hereby grants GTX a contingent license under Orion's Patent Rights, Orion
Know-How, Manufacturing Patents, and Product Manufacturing Know-How to make 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.
46.
have made the relevant Other Product for use in the Field in the GTX Territory
(except for use in the Orion Field in the Orion Territory). Such license shall
be exclusive and sublicensable but only for the purpose of having Products
manufactured for GTX, its Affiliates and Unaffiliated Sublicensees), and shall
become effective only under the circumstances specified in this Section 17.4.
18. PRODUCT RECALLS
18.1 RECALL NOTIFICATION. Each Party shall promptly notify the other
Party in writing of any facts relating to the advisability of the recall,
destruction or withholding from the market of the Product anywhere in the GTX
Territory (any of the foregoing, a "Recall").
18.2 RECALL IMPLEMENTATION IN GTX TERRITORY. If at any time (A) any
governmental or regulatory authority in the GTX Territory issues a request,
directive or order for a Recall; (B) a court of competent jurisdiction orders a
Recall in the GTX Territory; or (C) GTX determines, following consultation with
Orion (except in emergency situations in which there is insufficient time for
such consultation), that a Recall in the GTX Territory is necessary or
advisable, GTX shall take all appropriate corrective actions to effect the
Recall and Orion shall provide GTX with such cooperation in connection with the
Recall as GTX may reasonably request.
18.3 RECALL COSTS AND EXPENSES IN GTX TERRITORY. GTX shall bear the
costs and expenses of any Recall in the GTX Territory, provided that Orion shall
bear all costs and expenses of any Recall in the GTX Territory to the extent
such Recall is the result of a breach in the warranties set forth in Section
15.1.
19. ADVERSE DRUG EXPERIENCES
19.1 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS.
(A) To ensure that all relevant safety information for
Toremifene is shared between the Parties, the following information will be
exchanged: (i) GTX will provide to Orion all regulatory safety updates (e.g.
120-day safety updates, annual reports, and post-authorization safety updates)
concerning Product and information regarding all serious adverse events from
clinical studies and all spontaneous adverse reactions, including reports from
literature concerning the Product coming to the knowledge of GTX; and (ii) Orion
will provide to GTX Periodic Safety Update Reports prepared in accordance with
ICH E2C or equivalent guidelines as adopted by the European Medicines Evaluation
Agency (EMEA) relevant to Product for use in the Orion Field in the Orion
Territory, and information regarding all serious adverse events from clinical
studies and all spontaneous adverse reactions, including reports from literature
concerning Product, coming to the knowledge of Orion. All of the above mentioned
safety information shall be exchanged reasonably in advance of any applicable
regulatory deadlines or upon release of such information. In addition, any
safety information which may negatively affect the benefit-risk ratio of
Products or that may have consequences regarding the product information (e.g.
labeling, data sheets, instruction leaflets) or may require immediate safety
measures to be taken by either Party shall be forwarded to the other Party
without any delay. Each Party is responsible for any regulatory safety reporting
requirements
[ * ] = 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.
47.
with respect to maintaining its own Regulatory Approval applications and
complying with regulatory requirements for Products that it has the right to
sell pursuant to this Agreement according to applicable laws, rules and
regulations.
(B) The intent of Section 19.1(a) is to enable each Party
to comply with regulatory requirements for Toremifene products, which
requirements may change from time to time. Concurrently with the execution of
this Agreement, the Parties shall execute an agreement setting forth a mutually
acceptable detailed procedure generally consistent with the intent of Section
19.1(a) that enables each Party to comply with such regulatory requirements with
respect to such Products. Under such agreement, from time to time after the
Restatement Date, the Parties shall meet upon request by either Party to discuss
and agree upon any modifications to such detailed procedure necessary to ensure
that each Party is in compliance with regulatory reporting requirements for
Products that it has the right to develop and sell pursuant to this Agreement.
This Article 19 shall survive the expiration or termination of this
Agreement.
20. REPRESENTATIONS AND WARRANTIES
20.1 REPRESENTATIONS AND WARRANTIES OF THE PARTIES. Each Party hereby
represents and warrants to the other Party as follows:
(A) CORPORATE STATUS. It is a corporation duly organized
and validly existing under the laws of its state or other jurisdiction of
incorporation or formation;
(B) AUTHORITY. It has the power and authority to execute
and deliver this Agreement, and to perform its obligations hereunder;
(C) NO CONFLICTS. The execution, delivery and performance
by it of this Agreement and its compliance with the terms and provisions hereof
does not and will not conflict with or result in a breach of any of the terms
and provisions of or constitute a default under (i) any loan agreement,
guaranty, financing agreement, agreement affecting a product or other agreement
or instrument binding or affecting it or its property; (ii) the provisions of
its charter documents or by-laws; or (iii) any order, whit, injunction or decree
of any court or governmental authority entered against it or by which any of its
property is bound;
(D) NO APPROVALS. Except for the regulatory filings and
approvals for the Product referenced herein, no authorization, consent or
approval of any governmental authority or Third Party is required for the
execution, delivery or performance by it of this Agreement, and the execution,
delivery or performance of this Agreement will not violate any law, rule or
regulation applicable to such party;
(E) ENFORCEABILITY. This Agreement has been duly
authorized, executed and delivered and constitutes its legal, valid and binding
obligation enforceable against it in accordance with its terms subject, as to
enforcement, to bankruptcy, insolvency, reorganization and other laws of general
applicability relating to or affecting creditors' rights and to the availability
of particular remedies under general equity principles;
[ * ] = 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.
48.
(F) COMPLIANCE WITH LAWS. It shall comply with all
applicable local, state, national, regional and governmental laws and
regulations relating to its activities under this Agreement; and
(G) NEGATIVE DATA OR INFORMATION. It has, to the best of
its management's knowledge, no knowledge of negative data or information
regarding the Product, which, to the best of its reasonable belief, would have a
material effect on the regulatory approval process and/or on the
commercialization of the Product in the Field.
(H) NO DEBARMENT. It has not been and will not be
debarred under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C.
335a(a) or (b). In the event that such Party becomes aware of, or receives
notice of, the debarment of any individual, corporation, partnership, or
association performing activities which relate to the Products, it shall notify
the other Party immediately and address the issue as directed by the other
Party.
(I) NO IMPROPER CONTENT ON FARESTON U.S. WEB PAGES. It
has not and will not place any links or information on the Fareston U.S. Web
Pages pursuant to Article 9 that would: (A) infringe on the intellectual
property rights of any Third Party; (B) violate any law, statute, ordinance or
regulation; (C) be defamatory, trade libelous, unlawfully threatening or
unlawfully harassing; or (D) contain any viruses or other computer programming
routines that damage, detrimentally interfere with, surreptitiously intercept or
expropriate any system, data or personal information.
20.2 REPRESENTATION BY ORION. Orion hereby represents and warrants to
GTX that:
(A) As of the Restatement Date, Orion has entered into
the Fareston Repurchase Agreement pursuant to which Orion has terminated its
agreement with Shire dated 6 September, 1999, as amended, under which Shire had
been granted licenses or other rights to develop and/or commercialize Products
in the USA in the Breast Cancer Field.
20.3 REPRESENTATION BY GTX. GTX hereby represents and warrants to Orion
that:
(A) As of the Restatement Date, GTX has acquired
sufficient rights and licenses from The University of Tennessee Research
Foundation to the patent applications included in the GTX Patent Rights that are
listed in Part II of Schedule A that are necessary for the purpose of performing
its obligations under this Agreement.
21. TERM AND EARLY TERMINATION RIGHTS
21.1 TERM. The Term shall extend for the period provided in Section
1.51.
21.2 TERMINATION FOR CAUSE. Either Party shall have the right, without
prejudice to any other rights or remedies available to it, either to terminate
this Agreement or the license rights granted to a Party under this Agreement on
a country-by-country basis for cause as described in this Section 21.2 as
follows:
[ * ] = 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.
49.
21.2.1 BANKRUPTCY. Either Party shall have the right to terminate
this Agreement and same shall terminate upon expiry of a sixty (60) days notice
period, if the other Party becomes insolvent, is adjudged bankrupt, applies for
judicial or extra-judicial settlement with its creditors, makes an assignment
for the benefit of its creditors, voluntarily files for bankruptcy or has a
receiver or trustee (or the like) in bankruptcy appointed by reason of its
insolvency, or in the event an involuntary bankruptcy action has been omitted
and filed separately against the other Party and not dismissed within ninety
(90) days, or if the other Party becomes the subject of liquidation or
dissolution proceedings or otherwise discontinues business.
21.2.2 MATERIAL BREACH. If either Party commits a material breach
of this Agreement and if the Party alleged to be in breach of this Agreement
fails to (i) cure such breach or (ii) commence bona fide dispute resolution
proceedings under Section 25.2 contesting whether a breach has occurred and/or
whether such breach is a material breach, in either case within sixty (60) days
after receipt of written notice from the Party asserting the breach, then the
Party asserting the breach may terminate this Agreement in its entirety (if such
breach is a material breach, other than as specified in Sections 6.4.2 and
12.11.1 or 12.11.2), or, if such breach is by GTX and is described in Section
6.4.2 or in Section 12.11.1, then Orion may terminate its supply obligations as
set forth under Article 14 and terminate the license granted to GTX pursuant to
Section 2.1, in each case with respect to the Major Country in relation to which
such material breach occurred under Section 6.4.2 or 12.11.1. If the Agreement
is terminated either in its entirety or with regard to a particular Major
Country, as the case may be, then if GTX is the breaching Party, GTX shall grant
to Orion a nonexclusive, royalty-bearing license, with the right to grant
sublicenses, under the GTX Patent Rights, the Trademarks, the Regulatory
Approvals (by means of assignment or transfer of, or authorization to
cross-reference, relevant Regulatory Approval(s)) and the GTX Know-How to make,
have made, develop, use, sell, offer for sale, market and promote, and import
Products in the country(ies) in which GTX's license terminates, or, if Orion is
the breaching Party, then the license granted to GTX shall be expanded to
include an exclusive, sublicensable license under the Orion Patent Rights, Orion
Know-How, and Manufacturing Patents to make and have made Products for use in
the Field in the GTX Territory, (except for use in the Orion Field in the Orion
Territory). In the event of termination of the Agreement due to Orion's breach,
Orion shall as soon as practically possible provide GTX with Product
Manufacturing Know-How to the extent reasonably necessary to enable GTX to
exercise its manufacturing right pursuant to this Section, including without
limitation providing up to ten (10) person-days of technology transfer
assistance at GTX's site of Manufacture or Product using Orion personnel skilled
in such manufacturing operations, at no charge to GTX.
(A) If the non-breaching Party obtains a license under this
Agreement as provided in Section 21.2.2, it shall pay to the other Party a
running royalty equal to [ * ] of Net Sales of Product by the non-breaching
Party, its Affiliates or Unaffiliated Sublicensees. Furthermore, if GTX is the
breaching Party, GTX shall promptly transfer to Orion, at GTX's expense, all
Regulatory Approvals and registration filings for the Product in the territory
in which Orion obtains such license, together with such documentation,
information and data in its possession as Orion may need for regulatory
compliance in the course of exercising its rights in such territory with respect
to Product.
[ * ] = 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.
50.
21.3 TERMINATION BY MUTUAL AGREEMENT. The Parties may terminate this
Agreement at any time by drafting and executing a mutually acceptable written
agreement. The written agreement shall specify the consequences of such
termination.
21.4 TERMINATION BY GTX FOR SAFETY OR EFFICACY REASONS. If at any time
during the Term: (i) GTX decides not to file an application for Regulatory
Approval in any country or decides to withdraw such application due to
documented adverse reactions or other safety issues with the Product or the
Product's lack of efficacy or limited efficacy (collectively, "Safety or
Efficacy Issues"); (ii) GTX's application(s) for Regulatory Approval in any
country is rejected due to Safety or Efficacy Issues; (iii) GTX's application(s)
for Regulatory Approval in any country is subsequently withdrawn because of
Safety or Efficacy Issues; or (iv) the Product is withdrawn or recalled from the
market in any country because of Safety or Efficacy Issues, then GTX may, at its
option, terminate this Agreement with respect to such country upon thirty (30)
days prior written notice to Orion. GTX must exercise this right of termination
within the later of (a) sixty (60) days of the occurrence of the event giving
rise to such right or (b) thirty (30) days of GTX's last meeting, if any, with
the relevant regulatory authorities, provided that GTX uses reasonable diligence
to schedule such meeting and that Orion is providing reasonable co-operation to
GTX in connection with such meeting. GTX may, at its option, exercise its right
of termination under this Section 21.4 on a country-by-country basis, and, if
GTX does so, GTX's termination notice shall specify the country or countries of
the GTX Territory affected. GTX shall transfer to Orion, at Orion's expense, all
Regulatory Approvals and registration filings for the Product in the country for
which it terminates its license, together with such documentation, information
and data in its possession as Orion may need for regulatory compliance in the
course of any further development of Product in such country Orion may elect to
conduct thereafter.
21.5 EFFECT OF TERMINATION. Termination or expiration of this Agreement
through any means and for any reason shall not relieve the Parties of any
obligations accruing prior thereto and shall be without prejudice to the rights
and remedies of either Party with respect to any prior breach of any of the
provisions of this Agreement.
22. NOTICES
22.1 MANNER OF GIVING NOTICES. All notices required or permitted in
connection with this Agreement shall be writing and may be given by personal
delivery, prepaid registered or certified airmail letter, courier, facsimile,
addressed to the Party to receive the same at its address set forth below, or to
such other address as it shall later designate by like notice to the other
Party. Notice of termination of this Agreement if given by facsimile shall be
confirmed by prepaid registered or certified airmail letter dated and posted
within twenty-four (24) hours. The effective date of receipt of any notice if
served by facsimile shall be deemed the first business day in the city of
destination following the transmission or dispatch thereof and, if served by
courier shall deemed the second business day in the city of destination
following the dispatch thereof unless earlier received. Notice by personal
delivery shall be effective as of the date of such delivery.
[ * ] = 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.
51.
22.2 ADDRESSES FOR NOTICES.
Notices to Orion shall be sent to:
Orion Corporation
Orion Pharma
Attn: President of Orion Pharma
Orionintie 1, P.O. Box 65
FIN-02101 Espoo
Finland
Facsimile: 358-9-429-3044
With a copy to:
Orion Corporation
Orion Pharma
Attn: Legal Counsel
Orionintie 1, P.O. Box 65
FIN-02101 Espoo
Finland
Facsimile: 358-9-429-4088
Notices to GTX shall be sent to:
GTx, Inc.
Attn: President, with a copy to the General Counsel
3 North Dunlap Avenue
Van Vleet Building, Third Floor
Memphis, Tennessee 38163
U.S.A.
Telephone: 1-901-523-9700 x107
Facsimile: 1-901-523-9772
With a copy to:
Cooley Godward LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, CA 94306-2155
Attention: Robert Jones, Esq.
Telephone: (650) 843-5034
Facsimile: (650) 849-7400
[ * ] = 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.
52.
23. INTEGRATION
This Agreement represents the entire Agreement between the Parties
relating to the subject matter hereof and supersedes all prior arrangements,
understandings, correspondence, notes, minutes and agreements between the
Parties (or their predecessors in interest) whether written or oral. No
supplement, modification or amendment of this Agreement shall be binding unless
executed by the Parties in writing and signed by the duly authorized
representatives of both Parties.
24. ASSIGNMENT
Neither Party may assign this Agreement or any of its rights hereunder,
nor delegate any of its duties or obligations hereunder, to any Third Party
without the prior written consent of the other Party, except (i) to an Affiliate
in accordance with the terms of this Agreement, in which case notification
thereof shall be provided to the other Party prior to such assignment to an
Affiliate, or (ii) in connection with a merger, consolidation or similar
reorganization. For clarity, this Agreement shall survive any such merger,
consolidation or reorganization of either Party with or into, another party and
no consent for such merger, consolidation or reorganization shall be needed.
Neither Party shall unreasonably withhold its consent (which shall be provided
promptly after a request is made) to any contemplated assignment if such
contemplated assignment is in connection with the sale by either Party of all or
substantially all of its assets to a Third Party. Any assignment of this
Agreement to an Affiliate of the assigning Party shall not relieve the assigning
Party of its responsibilities and obligations hereunder.
25. GOVERNING LAW AND DISPUTE RESOLUTION
25.1 GOVERNING LAW. This Agreement, including the validity,
construction, interpretation and performance thereof, shall be governed entirely
by the laws of Sweden. It is the specific intent and agreement of the Parties
that the United Nations Convention on the International Sale of Goods shall not
apply to this Agreement.
25.2 DISPUTE RESOLUTION. All disputes arising out of or in connection
with this Agreement (except those involving actions commenced by or involving
Third Parties and affecting or involving only one of the Parties) shall be
resolved with the following mechanism:
25.2.1 ATTEMPTED AMICABLE RESOLUTION. The Parties shall promptly
give each other written notice of any disputes requiring resolution hereunder,
which written notice shall specify the Section(s) of this Agreement the other
Party is alleged to have breached and shall briefly state the initiating Party's
claims, and the Parties shall use reasonable efforts to resolve any such
disputes in an amicable manner.
Any disputes arising in connection with this Agreement which cannot be
resolved in an amicable manner by representatives of the Parties shall be
referred, not later than thirty (30) days after initiation of dispute resolution
proceedings under this Section 25.2.1, to the following corporate officers of
the Parties for resolution:
For GTX: Chief Executive Officer (or his or her designee)
[ * ] = 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.
53.
For Orion: President of Orion-Pharma (or his or her designee)
Such officers (or their designees) shall attempt to resolve the dispute
and shall communicate with each other by facsimile or telephone or in personal
meetings in an effort to resolve the dispute.
25.2.2 ARBITRATION. Any disputes (excluding any dispute,
controversy or claim arising out of or relating to the validity, enforceability,
scope or infringement of patent or trademark rights) arising in connection with
this Agreement which cannot be resolved by the Parties within forty-five (45)
days after initiation of dispute resolution proceedings under Section 25.2.1
shall be finally settled by binding arbitration under the Rules of the
Arbitration Institute of the Stockholm Chamber of Commerce, Stockholm, Sweden in
accordance with said Rules then in effect with proceedings to be held in
Stockholm, Sweden in the English language. Reasonable submission of evidence
shall be permitted in any such proceeding to the extent permitted under and
consistent with such Rules. Judgment upon any award rendered by the
arbitrator(s) in such proceedings may be issued and enforced by any court having
competent jurisdiction. Any disputes arising out of or relating to the validity,
enforceability, scope or infringement of patent or trademark rights shall be
submitted for resolution by a court of competent jurisdiction.
25.3 EFFECT OF COMMENCING DISPUTE RESOLUTION. If either Party in good
faith commences dispute resolution proceedings under Section 25.2, (A) any
applicable notice periods or cure periods hereunder (including but not limited
to the periods referenced in Sections 21.2 and 21.4) shall be temporarily
suspended pending the outcome of such dispute resolution proceedings and (B) the
non-breaching Party may, at its option, pay any amounts payable to the other
Party that are in dispute into an interest-bearing escrow account pending the
outcome of such dispute resolution proceedings.
26. LIMITATION OF DAMAGES
Except for indirect damages resulting from breach of Article 8, in no
event shall either Party be liable to the other Party for any indirect,
consequential or punitive damages in connection with the performance of this
Agreement or any breach of this Agreement (excluding such damages payable to a
Third Party which are subject to the indemnification obligations of the Parties
set forth in this Agreement.
27. FORCE MAJEURE
Neither Party shall be held in breach of this Agreement for failure to
perform any of its obligations hereunder to the extent and for the time period
such performance is prevented in whole or in part by reason of any Force Majeure
event, including but not limited to industrial disputes, strikes, lockouts,
riots, mobs, fires, floods, and other natural disasters and Acts of God, wars
declared or undeclared, civil strife, embargo, delays in delivery or defects or
shortages of raw materials from suppliers, loss or breakdown of any production
equipment, losses or shortage of power, damage to or loss of goods in transit,
currency restrictions, or events caused by reason of laws, regulations or orders
by any government, governmental agency or instrumentality or by any other
supervening unforeseeable circumstances whatsoever beyond the control of the
Party
[ * ] = 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.
54.
so affected. The Party so affected shall (A) give prompt written notice to the
other Party of the nature and date of commencement of the Force Majeure event
and its expected duration and (B) use its reasonable efforts to avoid or remove
the Force Majeure event as soon as possible to the extent it is so able to do.
28. RELATIONSHIP OF PARTIES
The relationship of the Parties under this Agreement is that of
independent contractors. Nothing contained in this Agreement shall be construed
so as to constitute the Parties as partners, joint venturers or agents of the
other. Neither Party has any express or implied right or authority under this
Agreement to assume or create any obligations or make any warranties and
representations on behalf of or in the name of the other Party, or to bind the
other Party to any contract, agreement or undertaking with any Third Party, and
no conduct of the Parties pursuant to the terms of this Agreement shall be
deemed to establish such right or authority. Neither Party shall make any
representation to Third Parties that the relationship created hereby constitutes
a partnership, joint venture or agency relationship.
29. SEVERABILITY
In case one or more of the provisions contained in this Agreement
shall, for any reason, be held invalid, illegal or unenforceable in any respect,
such invalidity, illegality or unenforceability shall not affect any other
provisions of this Agreement, but this Agreement shall be construed by limiting
such invalid, illegal or unenforceable provision, if such is not possible, by
deleting such provision from this Agreement.
30. NON-WAIVER
The failure by either Party at any time to enforce any of the terms or
provisions or conditions of this Agreement or exercise any right hereunder shall
not constitute a waiver of the same or affect that Party's rights thereafter to
enforce or exercise the same. No waiver of any of the provisions of this
Agreement shall be deemed binding unless executed in writing by the Party to be
bound by it.
31. HEADINGS
The headings in this Agreement are for convenience of reference only
and shall not be used in the interpretation of any provisions hereof.
32. GOVERNING LANGUAGE
The English language version of this Agreement shall be controlling in
all respects regardless of whether any translations into any other languages are
made.
33. EXECUTION
This Agreement shall be executed by the Parties in two (2) original
counterparts, one (1) original counterpart being retained by each Party and
either of which shall be deemed sufficient to prove the existence and terms and
conditions hereof. This Agreement 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.
55.
executed by the Parties by the exchange of facsimile signature pages, with
signed original counterparts of the Agreement to be exchanged by the Parties
promptly thereafter.
IN WITNESS WHEREOF, the Parties' duly authorized representatives hereto
have executed this Agreement as of the Restatement Date.
ORION CORPORATION GTX, INC.
By: /s/ Pekka Kaivola By: /s/ Mitchell S. Steiner
------------------------------ -----------------------
Mitchell Steiner, M.D.
Title: Director Title: Vice-Chairman and CEO
------------------------------ GTx, Inc.
Orion Corporation Orion Pharma
By: /s/ Timo Lappalainen By: /s/ Marc Hanover
------------------------------ ----------------
Timo Lappalainen Marc Hanover
Title: Senior Vice President Title: President and COO
------------------------------ GTx, Inc.
Orion Corporation Orion Pharma
[ * ] = 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.
56.
SCHEDULE A: PART I
- ---------------------------------------------------------------------------------------------------------------------------------
COUNTRY/JURISDICTION TITLE INVENTORS PATENT NO. ISSUE DATE STATUS
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELLS S. STENIER 6,265,448 July 24, 2001 Issued
CHEMOPREVENTION OF
PROSTATE CANCER 2. SHARAN RAGHAW
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELLS S. STENIER 6,413,534 July 2, 2002 Issued
CHEMOPREVENTION OF
PROSTATE CANCER 2. SHARAN RAGHAW
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELLS S. STENIER 6,410,043 June 2, 2002 Issued
CHEMOPREVENTION OF
PROSTATE CANCER 2. SHARAN RAGHAW
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELLS S. STENIER 6,413,535 June 2, 2002 Issued
CHEMOPREVENTION OF
PROSTATE CANCER 2. SHARAN RAGHAW
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELL S. STEINER 6,413,533 July 2, 2002 Issued
CHEMOPREVENTION OF 2. SHARAN RAGHOW
PROSTATE CANCER (THE UNIVERSITY OF TENNESSEE
RESEARCH CORPORATION)
- ---------------------------------------------------------------------------------------------------------------------------------
UNITED STATES METHOD FOR 1. MITCHELL S. STEINER 6,632,447 Oct 14, 2003 Issued
CHEMOPREVENTION OF 2. SHARAN RAGHOW
PROSTATE CANCER (THE UNIVERSITY OF TENNESSEE
RESEARCH CORPORATION)
- ---------------------------------------------------------------------------------------------------------------------------------
[ * ] = 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.
1.
SCHEDULE A: PART II
APPLICATIONS FILED IN THE UNITED STATES
[ * ]
APPLICATIONS FILED IN FOREIGN JURISDICTIONS
[ * ]
[ * ] = 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.
SCHEDULE B: PART I. ORION PATENTS
TITLE: NOVEL ALKANE AND ALKENE DERIVATIVES AND THEIR PREPARATION AND USE
(TOREMIFENE)
Country Patent No Expiry
---------------------------------------------------------------------------
AU Australia 556608 May 25, 2008 *
BG Bulgaria 98379 May 20, 2003
CA Canada 1185977 May, 20, 2003
CN China A-FI96091019 December 20, 2003
DK Denmark 170927 December 21, 2003 *
EP Europe 95875 December 21, 2003 *
CH Switzerland 95875 May 19, 2008 *
IT Italy 95875 February 14, 2008 *
SE Sweden 95875 May 20, 2008 *
FI Finland 77839 December 21, 2003 *
HK Hong Kong 83/89 May 20, 2003
HU Hungary 193536 May 26, 2003
HU Hungary 200742 May 26, 2003
IE Ireland 55023 December 21, 2003 *
IL Israel 68784 May 25, 2003
JP Japan 2105540 May 25, 2003
JP Japan 1739006 June 29, 2005 *
JP Japan 1959197 May 25, 2003
JP Japan 1867986 May 25, 2003
LV Latvia 5066 May 26, 2003
NO Norway 156164 December 21, 2003 *
NZ New Zealand 204349 May 25, 2003
RO Romania C-20106 ** December 29, 2004
SG Singapore 654/88 May 20, 2003
SU Russia 1508955 May 26, 2003
US USA 4696949 September 29, 2009 *
US USA 5491173 September 29, 2004
US USA 4996225 February 17, 2008
ZA South Africa 833803 May 25, 2003
EP = Germany, Belgium, Austria, Italy, Sweden, Netherlands, Switzerland,
Lichtenstein, Luxemburg, Great Britain, France
* Patent term extension
** Pipe-line protection based on US 4696949
[ * ] = 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.
1.
SCHEDULE B: PART II. ORION PATENT APPLICATIONS
TITLE: NOVEL ALKANE AND ALKENE DERIVATIVES AND THEIR PREPARATION AND USE
(TOREMIFENE)
Country Patent Appln. No
--------------------------------------------------------------------------
[ * ]
[ * ] = 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.
SCHEDULE C: SPECIFICATIONS
SPECIFICATIONS FOR [ * ] TABLETS
- -------------------------------------------------------------------------------
TEST SPECIFICATION
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
CHARACTERS
- -------------------------------------------------------------------------------
Colour [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
Shape [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
Score [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
Code [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
Coating [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] [ * ] [ * ] [ * ]
- -------------------------------------------------------------------------------
[ * ] = 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.
SCHEDULE D: GTX'S MSR OBLIGATION
(TO BE COMPLETED PURSUANT TO SECTION 6.1.1)
[ * ] = 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.
SCHEDULE E: ORION PRODUCT APPROVALS
REGISTRATION STATUS 27.9.2001
ORION PHARMA
Status: Approved, Pending
Submission types: Marketing authorizations
(2 PAGES)
Decision
Sent Date Appl. Date Product Country Date Decision M.A. holder
- --------------------------------------------------------------------------------------------------------------------------------
N=39
[ * ] [ * ] [ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ] [ * ]
30.12.87 30.12.87 Fareston 20 mg tablet Finland 21.12.88 Approved Orion-yhtyma Oy
Farmos
27.12.88 Fareston 60 mg tablet Russia 12.12.89 Approved Orion Corporation
27.12.88 Fareston 20 mg tablet Russia 12.12.89 Approved Orion Corporation
26.02.93 Fareston 60 mg tablet Latvia 20.05.93 Approved Orion-yhtyma Oy
Farmos
26.02.93 Fareston 20 mg tablet Latvia 20.05.93 Approved Orion-yhtyma Oy
Farmos
26.05.92 Fareston 60 mg tablet Norway 31.07.95 Approved Orion Corporation
10.11.93 Fareston 60 mg tablet Ukraine 02.02.96 Approved Orion Corporation
10.11.93 Fareston 20 mg tablet Ukraine 02.02.96 Approved Orion Corporation
14.11.94 30.11.94 Fareston 60 mg tablet Sweden 14.02.96 Approved Orion Corporation
14.11.94 30.11.94 Fareston 60 mg tablet Finland 14.02.96 Approved Orion Corporation
27.11.94 30.11.94 Fareston 60 mg tablet United Kingdom 14.02.96 Approved Orion Corporation
27.11.94 30.11.94 Fareston 60 mg tablet Spain 14.02.96 Approved Orion Corporation
27.11.94 30.11.94 Fareston 60 mg tablet Portugal 14.02.96 Approved Orion Corporation
27.11.94 29.11.94 Fareston 60 mg tablet Netherlands 14.02.96 Approved Orion Corporation
27.11.94 29.11.94 Fareston 60 mg tablet Luxembourg 14.02.96 Approved Orion Corporation
27.11.94 28.11.94 Fareston 60 mg tablet Italy 14.02.96 Approved Orion Corporation
27.11.94 29.11.94 Fareston 60 mg tablet Ireland 14.02.96 Approved Orion Corporation
27.11.94 01.12.94 Fareston 60 mg tablet Greece 14.02.96 Approved Orion Corporation
27.11.94 28.11.94 Fareston 60 mg tablet Germany 14.02.96 Approved Orion Corporation
27.11.94 30.11.94 Fareston 60 mg tablet France 14.02.96 Approved Orion Corporation
27.11.94 30.11.94 Fareston 60 mg tablet Belgium 14.02.96 Approved Orion Corporation
17.11.92 Fareston 60 mg tablet Austria 14.02.96 Approved Orion Corporation
27.11.94 Fareston 60 mg tablet Denmark 14.02.96 Approved Orion Corporation
31.03.96 Fareston 60 mg tablet Uzbekistan 16.09.96 Approved Orion Corporation
31.03.96 Fareston 20 mg tablet Uzbekistan 16.09.96 Approved Orion Corporation
10.04.95 15.07.96 Fareston 60 mg tablet Hungary 14.01.98 Approved Orion Corporation
01.08.97 01.08..97 Fareston 60 mg tablet Cyprus 23.04.98 Approved Orion Corporation
[ * ] = 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.
Decision
Sent Date Appl. Date Product Country Date Decision M.A. holder
- --------------------------------------------------------------------------------------------------------------------------------
10.07.96 Fareston 60 mg tablet Taiwan, R.O.C. 29.09.98 Approved Orion Corporation
31.03.95 Fareston 60 mg tablet Dominican 29.12.98 Approved Orion Corporation
Republic
10.11.95 26.04.96 Fareston 60 mg tablet China 13.02.99 Approved Orion Corporation
30.07.01 Fareston 60 mg tablet Georgia 30.07.01 Approved Orion Corporation
30.07.01 Fareston 20 mg tablet Georgia 30.07.01 Approved Orion Corporation
[ * ] = 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.
TOREMIFENE LICENSE AND SUPPLY AGREEMENT
BY AND BETWEEN
ORION CORPORATION
ESPOO, FINLAND
AND
GTX INC.,
TENNESSEE, U.S.A.
[ * ] = 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.
1. DEFINITIONS.............................................................2
1.1 "Additional Product".............................................2
1.2 "Affiliate"......................................................2
1.3 "Annual Net Sales"...............................................2
1.4 "Breast Cancer Field"............................................2
1.5 "Calendar Quarter"...............................................2
1.6 "Competing Product"..............................................2
1.7 "Correction Factor"..............................................2
1.8 "DMF"............................................................2
1.9 "European Union".................................................2
1.10 "Fareston Product"...............................................2
1.11 "Fareston Repurchase Agreement"..................................3
1.12 "Fareston U.S. Web Pages"........................................3
1.13 "Field"..........................................................3
1.14 "First Commercial Sale"..........................................3
1.15 "Generic Product"................................................3
1.16 "GTX Final Development and Registration Plan"....................3
1.17 "GTX Know-How"...................................................3
1.18 "GTX Patents"....................................................3
1.19 "GTX Patent Applications"........................................4
1.20 "GTX Patent Rights"..............................................4
1.21 "GTX Preliminary Development and Registration Plan"..............4
1.22 "GTX Territory"..................................................4
1.23 "GTX Unaffiliated Sublicensee"...................................4
1.24 "Major Country"..................................................4
1.25 "Manufacturing Costs"............................................4
1.26 "Manufacturing Patents"..........................................4
1.27 "MAT Net Sales of Fareston Product"..............................4
1.28 "Net Sales"......................................................4
1.29 "Orion Field"....................................................5
1.30 "Orion Know-How".................................................5
1.31 "Orion Patents"..................................................5
-i-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.32 "Orion Patent Applications"......................................5
1.33 "Orion Patent Rights"............................................5
1.34 "Orion Product"..................................................5
1.35 "Orion Product NDA"..............................................5
1.36 "Orion Territory"................................................5
1.37 "Orion Unaffiliated Sublicensee".................................6
1.38 "Other Product"..................................................6
1.39 "Premium"........................................................6
1.40 "Product"........................................................6
1.41 "Product Royalty Adjustment Date"................................6
1.42 "Prostate Cancer Field"..........................................6
1.43 "Purchase Agreement".............................................6
1.44 "Regulatory Approval"............................................6
1.45 "Royalty Income".................................................6
1.46 "Sales of Generic Product".......................................6
1.47 "[ * ]"..........................................................6
1.48 "SERM"...........................................................6
1.49 "Shire"..........................................................7
1.50 "Specifications".................................................7
1.51 "Term"...........................................................7
1.52 "Third Party" or "Third Parties".................................7
1.53 "Toremifene".....................................................7
1.54 "Trademarks".....................................................7
1.55 "USA"............................................................7
1.56 "U.S. FDA".......................................................7
1.57 "U.S. IND".......................................................7
1.58 "U.S. NDA".......................................................7
1.59 "Upfront and Milestone Income"...................................7
1.60 "Valid Claim"....................................................8
-ii-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
2. GRANT AND SCOPE OF RIGHTS GRANTED.........................................8
2.1 Orion Grants to GTX................................................8
2.2 No Implied Licenses...............................................10
2.3 United States Government Rights...................................10
2.4 Orion's Right of First Negotiation................................10
2.5 Use of Toremifene by GTX for Research.............................11
2.6 Prohibited Actions................................................12
3. PAYMENTS.................................................................12
3.1 Types of Payments.................................................12
3.2 Non-Refundability.................................................15
3.3 Royalty Reports and Payments......................................15
3.4 Currency..........................................................15
3.5 No Royalties Payable Between Affiliates...........................15
3.6 No Multiple Royalties.............................................15
4. LIAISON..................................................................15
5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS.................................16
5.1 Method of Payment.................................................16
5.2 Late Payments.....................................................16
5.3 Record Keeping and Audit Rights...................................16
6. GTX PRODUCT MARKETING AND SALES ACTIVITIES...............................16
6.1 Minimum Sales Requirements for USA................................16
6.2 No Minimum Sales Requirements Outside of USA; No Minimum Sales
Requirements for Sales of Fareston Product........................18
6.3 Marketing and Sales Efforts in the Major Countries................18
6.4 Product Launch....................................................19
6.5 Marketing Costs and Expenses......................................20
6.6 Marketing Plans and Reports.......................................20
7. GTX PRODUCT DEVELOPMENT AND REGISTRATIONS................................20
7.1 GTX Development and Registration Activities.......................20
7.2 FDA File..........................................................22
7.3 Development and Registration Costs................................22
-iii-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
7.4 GTX Development and Registration Plan............................22
7.5 Orion Documentation and Data.....................................23
7.6 GTX Registration and Marketing Approval Applications.............23
7.7 Failure to File or Extend........................................25
7.8 Reimbursement of Orion Costs.....................................25
8. CONFIDENTIALITY AND PUBLICITY...........................................25
8.1 Confidentiality Obligation.......................................25
8.2 Permitted Disclosures............................................26
8.3 Confidential Information.........................................26
8.4 Duration of Confidentiality Obligation...........................27
8.5 Publicity and Announcements......................................27
9. FARESTON PRODUCT WEBSITE FOR USA........................................27
9.1 Fareston Website.................................................27
10. TRADEMARKS..............................................................28
10.1 Trademarks.......................................................28
10.2 Trademark Filing and Maintenance.................................28
10.3 Trademark Documentation..........................................28
11. PATENT OWNERSHIP AND WARRANTIES.........................................28
11.1 Patent Ownership.................................................28
11.2 Orion Patent Warranties..........................................29
11.3 GTX Patent Warranties............................................29
12. PATENT PROSECUTION AND INFRINGEMENT; TRADEMARKS.........................29
12.1 Orion Patent Filing and Prosecution..............................29
12.2 GTX Patent Filing and Prosecution................................30
12.3 Notification of Infringement.....................................30
12.4 Infringement of Third Parties Rights by Orion....................30
12.5 Infringement of Third Parties Rights by GTX......................30
12.6 Infringement Indemnification.....................................30
12.7 Termination for Infringement of Third Party Rights...............31
12.8 Third Party Infringement of Orion Patent Rights..................31
-iv-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
12.9 Third Party Infringement of GTX Patent Rights; Third Party
Infringement of Trademarks and the Trademark Fareston(R)..........33
12.10 Mutual Cooperation................................................33
12.11 Patent Challenges.................................................33
12.12 Activities During Infringement Litigation.........................33
13. COMPETING PRODUCTS.......................................................34
13.1 Obligations With Respect to Competing Products....................34
14. PRODUCT ORDERS, SUPPLY AND PAYMENTS......................................35
14.1 Orion Supply Obligations..........................................35
14.2 Orion Affiliates and Subcontractors...............................35
14.3 GTX Forecasts.....................................................35
14.4 Prices and Payment................................................36
14.5 Resale Prices.....................................................37
14.6 Product Supply for Testing and Registration; Supply of
Toremifene........................................................37
14.7 Agreement Terms Govern............................................38
14.8 Price Adjustment for Commercial Supply............................39
14.9 Termination of Product Supply.....................................39
15. PRODUCT WARRANTIES AND INDEMNIFICATION...................................39
15.1 Product Warranties and Limitations................................39
15.2 Certificate of Analysis...........................................40
15.3 Product Inspections...............................................40
15.4 Product Storage...................................................41
15.5 GTX Responsibilities in GTX Territory.............................41
15.6 Reciprocal Indemnification Provisions.............................42
15.7 Conditions for Indemnification....................................42
15.8 Liability Insurance...............................................43
16. STANDBY MANUFACTURING RIGHTS; INVENTORY MAINTENANCE......................43
16.1 Inability to Manufacture or Supply................................43
16.2 Back-up Manufacturing Right.......................................43
16.3 Maintenance of Inventory..........................................44
-v-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
17. MANUFACTURING INSPECTIONS AND CHANGES...................................44
17.1 Regulatory Inspections...........................................44
17.2 Orion-initiated Manufacturing Changes............................45
17.3 GTX-Initiated Manufacturing Changes..............................45
17.4 New Dosage Strengths and Formulations............................46
18. PRODUCT RECALLS.........................................................47
18.1 Recall Notification..............................................47
18.2 Recall Implementation in GTX Territory...........................47
18.3 Recall Costs and Expenses in GTX Territory.......................47
19. ADVERSE DRUG EXPERIENCES................................................47
19.1 Adverse Events and Serious Adverse Events........................47
20. REPRESENTATIONS AND WARRANTIES..........................................48
20.1 Representations and Warranties of the Parties....................48
20.2 Representation by Orion..........................................49
20.3 Representation by GTX............................................49
21. TERM AND EARLY TERMINATION RIGHTS.......................................49
21.1 Term.............................................................49
21.2 Termination for Cause............................................49
21.3 Termination by Mutual Agreement..................................51
21.4 Termination by GTX for Safety or Efficacy Reasons................51
21.5 Effect of Termination............................................51
22. NOTICES.................................................................51
22.1 Manner of Giving Notices.........................................51
22.2 Addresses for Notices............................................52
23. INTEGRATION.............................................................53
24. ASSIGNMENT..............................................................53
25. GOVERNING LAW AND DISPUTE RESOLUTION....................................53
25.1 Governing Law....................................................53
25.2 Dispute Resolution...............................................53
25.3 Effect of Commencing Dispute Resolution..........................54
-vi-
[ * ] = 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.
TABLE OF CONTENTS
(CONTINUED)
PAGE
26. LIMITATION OF DAMAGES.....................................................54
27. FORCE MAJEURE.............................................................54
28. RELATIONSHIP OF PARTIES...................................................55
29. SEVERABILITY..............................................................55
30. NON-WAIVER................................................................55
31. HEADINGS..................................................................55
32. GOVERNING LANGUAGE........................................................55
33. EXECUTION.................................................................55
vii
[ * ] = 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.