[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT 10.15
TOREMIFENE LICENSE AND SUPPLY AGREEMENT
BY AND BETWEEN
ORION CORPORATION
ESPOO, FINLAND
AND
GTX INC.,
TENNESSEE, U.S.A.
TABLE OF CONTENTS
PAGE
1. DEFINITIONS..................................................................1
1.1 "Affiliate"............................................................1
1.2 "Annual Net Sales".....................................................1
1.3 "Calendar Quarter".....................................................2
1.4 "Competing Product"....................................................2
1.5 "DMF"..................................................................2
1.6 "Field"................................................................2
1.7 "First Commercial Sale"................................................2
1.8 "Generic Product"......................................................2
1.9 "GTX Final Development and Registration Plan"..........................2
1.10 "GTX Know-How".........................................................2
1.11 "GTX Patents"..........................................................2
1.12 "GTX Patent Applications"..............................................3
1.13 "GTX Patent Rights"....................................................3
1.14 "GTX Preliminary Development and Registration Plan"....................3
1.15 "GTX Territory"........................................................3
1.16 "GTX Unaffiliated Sublicensee".........................................3
1.17 "Major Country"........................................................3
1.18 "Manufacturing Patents"................................................3
1.19 "Net Sales"............................................................3
1.20 "North American Territory".............................................3
1.21 "Orion Know-How".......................................................4
1.22 "Orion Patents"........................................................4
1.23 "Orion Patent Applications"............................................4
1.24 "Orion Patent Rights"..................................................4
1.25 "Orion Product"........................................................4
1.26 "Orion Unaffiliated Sublicensee".......................................4
1.27 "Premium"..............................................................4
1.28 "Product"..............................................................5
1.29 "Regulatory Approval"..................................................5
-i-
TABLE OF CONTENTS
(CONTINUED)
PAGE
1.30 "ROW Territory"........................................................5
1.31 "Sales of Generic Product".............................................5
1.32 "Specifications".......................................................5
1.33 "Term".................................................................5
1.34 "Third Party"..........................................................5
1.35 "Toremifene"...........................................................5
1.36 "Trademarks"...........................................................5
1.37 "U.S. FDA".............................................................6
1.38 "U.S. IND".............................................................6
1.39 "U.S. NDA".............................................................6
1.40 "Upfront and Milestone Income".........................................6
1.41 "Valid Claim"..........................................................6
2. GRANT AND SCOPE OF RIGHTS GRANTED............................................6
2.1 Orion Grants to GTX....................................................6
2.2 No Implied Licenses...................................................10
2.3 United States Government Rights.......................................10
2.4 Orion's Right of First Negotiation....................................11
2.5 Use of Toremifene by GTX for Research.................................12
2.6 Prohibited Actions....................................................12
3. PAYMENTS....................................................................12
3.1 Types of Payments.....................................................12
3.2 Non-Refundability.....................................................13
3.3 Royalty Reports and Payments..........................................13
3.4 Currency..............................................................14
3.5 No Royalties Payable Between Affiliates...............................14
3.6 No Multiple Royalties.................................................14
4. LIAISON.....................................................................14
5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS....................................14
5.1 Method of Payment.....................................................14
5.2 Late Payments.........................................................15
-ii-
TABLE OF CONTENTS
(CONTINUED)
PAGE
5.3 Record Keeping and Audit Rights.......................................14
6. GTX PRODUCT MARKETING AND SALES ACTIVITIES..................................15
6.1 Minimum Sales Requirements for USA....................................15
6.2 No Minimum Sales Requirements Outside of USA..........................16
6.3 Marketing and Sales Efforts in the Major Countries....................16
6.4 Product Launch........................................................17
6.5 Marketing Costs and Expenses..........................................18
6.6 Marketing Plans and Reports...........................................18
7. GTX PRODUCT DEVELOPMENT AND REGISTRATIONS...................................18
7.1 GTX Development and Registration Activities...........................18
7.2 Development and Registration Costs....................................19
7.3 GTX Development and Registration Plan.................................20
7.4 Orion Documentation and Data..........................................21
7.5 GTX Registration and Marketing Approval Applications..................22
7.6 Failure to File or Extend.............................................22
7.7 Reimbursement of Orion Costs..........................................23
8. CONFIDENTIALITY AND PUBLICITY...............................................23
8.1 Confidentiality Obligation............................................23
8.2 Permitted Disclosures.................................................23
8.3 Confidential Information..............................................23
8.4 Duration of Confidentiality Obligation................................24
8.5 Publicity and Announcements...........................................24
9. TRADEMARKS..................................................................25
9.1 Use of Trademarks.....................................................25
9.2 Trademark Filing and Maintenance......................................25
9.3 Worldwide Trademark Enforcement.......................................25
10. PATENT OWNERSHIP AND WARRANTIES.............................................25
10.1 Patent Ownership......................................................25
10.2 Orion Patent Warranties...............................................25
10.3 GTX Patent Warranties.................................................25
-iii-
TABLE OF CONTENTS
(CONTINUED)
PAGE
11. PATENT PROSECUTION AND INFRINGEMENT.........................................26
11.1 Orion Patent Filing and Prosecution...................................26
11.2 GTX Patent Filing and Prosecution.....................................26
11.3 Notification of Infringement..........................................26
11.4 Infringement of Third Parties Rights by Orion.........................26
11.5 Infringement of Third Parties Rights by GTX...........................27
11.6 Infringement Indemnification..........................................27
11.7 Termination for Infringement of Third Party Rights....................27
11.8 Third Party Infringement of Orion Patent Rights.......................27
11.9 Third Party Infringement of GTX Patent Rights and Trademark...........29
11.10 Mutual Cooperation....................................................29
11.11 Patent Challenges.....................................................29
11.12 Activities During Infringement Litigation.............................29
12. COMPETING PRODUCTS..........................................................30
12.1 Obligations With Respect to Competing Products........................30
13. PRODUCT ORDERS, SUPPLY AND PAYMENTS.........................................31
13.1 Orion Supply Obligations..............................................31
13.2 Orion Affiliates and Subcontractors...................................31
13.3 GTX Forecasts.........................................................31
13.4 Prices and Payment....................................................32
13.5 Resale Prices.........................................................33
13.6 Product Supply for Testing and Registration; Supply of Toremifene.....33
13.7 Agreement Terms Govern................................................34
13.8 Price Adjustment for Commercial Supply................................34
13.9 Termination of Product Supply.........................................35
14. PRODUCT WARRANTIES AND INDEMNIFICATION......................................35
14.1 Product Warranties and Limitations....................................35
14.2 Certificate of Analysis...............................................36
14.3 Product Inspections...................................................36
14.4 Product Storage.......................................................36
-iv-
TABLE OF CONTENTS
(CONTINUED)
PAGE
14.5 GTX Responsibilities in GTX Territory.................................37
14.6 Reciprocal Indemnification Provisions.................................37
14.7 Conditions for Indemnification........................................38
14.8 Liability Insurance...................................................38
15. STANDBY MANUFACTURING RIGHTS................................................38
15.1 Inability to Manufacture or Supply....................................38
16. MANUFACTURING INSPECTIONS AND CHANGES.......................................39
16.1 Regulatory Inspections................................................39
16.2 Orion-initiated Manufacturing Changes.................................39
16.3 GTX-Initiated Manufacturing Changes...................................39
16.4 New Dosage Strengths and Formulations.................................40
17. PRODUCT RECALLS.............................................................41
17.1 Recall Notification...................................................42
17.2 Recall Implementation in GTX Territory................................42
17.3 Recall Costs and Expenses in GTX Territory............................42
18. ADVERSE DRUG EXPERIENCES....................................................42
18.1 Adverse Events........................................................42
19. REPRESENTATIONS AND WARRANTIES..............................................42
19.1 Representations and Warranties of the Parties.........................42
20. TERM AND EARLY TERMINATION RIGHTS...........................................43
20.1 Term..................................................................43
20.2 Termination for Cause.................................................43
20.3 Termination by Mutual Agreement.......................................44
20.4 Other Termination by Orion............................................44
20.5 Other Termination by GTX..............................................45
20.6 Effect of Termination.................................................45
21. NOTICES.....................................................................45
21.1 Manner of Giving Notices..............................................45
21.2 Addresses for Notices.................................................46
22. INTEGRATION.................................................................47
-v-
TABLE OF CONTENTS
(CONTINUED)
PAGE
23. ASSIGNMENT..................................................................47
24. GOVERNING LAW AND DISPUTE RESOLUTION........................................47
24.1 Governing Law.........................................................47
24.2 Dispute Resolution....................................................47
24.3 Effect of Commencing Dispute Resolution...............................48
25. LIMITATION OF DAMAGES.......................................................48
26. FORCE MAJEURE...............................................................48
27. RELATIONSHIP OF PARTIES.....................................................49
28. SEVERABILITY................................................................49
29. NON-WAIVER..................................................................49
30. HEADINGS....................................................................49
31. GOVERNING LANGUAGE..........................................................49
32. EXECUTION...................................................................49
-vi-
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 22nd day of October, 2001 (the
"Amendment Date") by and between ORION CORPORATION, a corporation organized and
existing under the laws of Finland and having its principal office at ▇▇▇▇▇▇▇▇▇▇
▇ ▇▇▇-▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇ ("Orion"), and GTX INC., (fka Genotherapeutics, Inc.)
a corporation organized and existing under the laws of the State of Tennessee,
U.S.A. and having its principal office at 3 North ▇▇▇▇▇▇ Avenue, Van Vleet
Building, Third Floor, Memphis, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇ ("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, the Parties desire with this Agreement to supercede the Original
Agreement as of the Amendment 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, and
that Orion shall have no monetary or other responsibilities for researching,
developing, registering and commercializing Product, but shall remain
responsible for manufacturing Orion Product (as defined below), as agreed
herein;
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 "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.
1.2 "ANNUAL NET SALES" shall mean Net Sales (as defined below) in any
calendar year.
1.
1.3 "CALENDAR QUARTER" shall mean each of the three (3) month periods
beginning on January 1, April 1, July I and October 1 of each year during the
Term (as defined below).
1.4 "COMPETING PRODUCT" shall mean any pharmaceutical product containing
an anti-estrogen and/or 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 same Field as the Product. Competing Product does not
include Orion Product, its Affiliate or subcontractor, but includes any generic
form of the Product.
1.5 "DMF" shall have the meaning provided in Section 7.4.
1.6 "FIELD" shall mean the prevention and treatment of prostate cancer,
which shall mean for purposes 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.
1.7 "FIRST COMMERCIAL SALE" means in each country, the date the Product is
first sold, marketed, or publicly made available for sale for use in the Field
by GTX, its Affiliate or a GTX Unaffiliated Sublicensee. Product for use in 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.
1.8 "GENERIC PRODUCT" shall mean a generic pharmaceutical product for
human use containing Toremifene as an active ingredient and which can be
substituted by the prescriber or dispenser for a Product for use in the Field.
1.9 "GTX FINAL DEVELOPMENT AND REGISTRATION PLAN" shall mean the final
product development and registration plan for each Product in the Field prepared
by GTX, its Affiliate or a GTX Unaffiliated Sublicensee, as the same may be
modified from time to time pursuant to Section 7.3.
1.10 "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 the US IND [ * ] relating to the use of any
anti-estrogen and/or 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.
1.11 "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
relate to the manufacture, sale or use of any anti-estrogen and/or SERM for use
in the Field (including any divisions, continuations, continuations-
2.
in-part, re-examinations, reissues, additions, renewals and extensions thereof).
GTX Patents in existence as of the Effective Date are set forth in Part I of
Schedule A.
1.12 "GTX PATENT APPLICATIONS" shall mean patent applications of GTX
and/or its Affiliates pending as of the Effective Date and patent applications
owned or controlled by GTX and/or its Affiliates that are filed at any time
during the Term, in each case that relate to the manufacture, sale or use of any
anti-estrogen and/or SERM for use in the Field (including any divisions,
continuations, continuations-in-part, re-examinations, reissues, additions,
renewals and extensions thereof). GTX Patent Applications in existence as of the
Effective Date are set forth in Part II of Schedule A. For purposes of this
Agreement, the Parties acknowledge that GTX Patent Applications shall include
patent application U.S. Serial No. [ * ] which claims the use of Product in the
Field, which application is in the name of and owned by The University of
Tennessee Research Corporation. GTX represents and warrants that it has acquired
sufficient rights and licenses from The University of Tennessee Research
Corporation to said application for the purpose of performing its obligations
under this Agreement.
1.13 "GTX PATENT RIGHTS" shall mean GTX Patents and GTX Patent
Applications.
1.14 "GTX PRELIMINARY DEVELOPMENT AND REGISTRATION PLAN" shall mean the
preliminary product development plan for the development of the Product in the
Field prepared by GTX which has been provided to Orion prior to Effective Date,
and which was attached to the Original Agreement.
1.15 "GTX TERRITORY" shall mean all countries or territories worldwide.
1.16 "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.
1.17 "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.
1.18 "MANUFACTURING PATENTS" shall have the meaning provided in Section
7.6.
1.19 "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.
1.20 "NORTH AMERICAN TERRITORY" shall mean (i) the USA (ii) Mexico, and
(iii) Canada.
3.
1.21 "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 U.S. NDA [ * ] relating to the Orion 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 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2, Orion Know-How
shall exclude information relating to Orion's manufacture of Toremifene (as
defined below) and Orion Product (as defined below).
1.22 "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 Effective 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.
1.23 "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 Amendment Date are set forth in Part II of Schedule C.
Schedule C shall be amended by Orion from time to time during the Term to
include future Orion Patent Applications.
1.24 "ORION PATENT RIGHTS" shall mean Orion Patents and Orion Patent
Applications.
1.25 "ORION PRODUCT" shall mean tablets containing [ * ] of Toremifene
respectively, that are manufactured by Orion and are commercially available as
of the Amendment Date, and such other dosage strength or formulation of
Toremifene as a therapeutically active ingredient as Orion may agree to
manufacture pursuant to Section 16.4.
1.26 "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.
1.27 "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 either (i) if
GTX has not had an initial public offering of its stock prior to the date of
such investment by such Third Party, and does not conduct such a public offering
concurrently with such investment, the average price per share of GTX stock
offered in GTX's two (2) most recent rounds of equity financing, multiplied by
the number of shares of GTX stock
4.
issued to such Third Party investor, also on an as-warranted basis, or (ii) if
GTX has had an initial public offering of its stock prior to the date of such
investment by such Third Party, or is then conducting such a public offering
concurrently with such Third Party investment, 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.
1.28 "PRODUCT" shall mean any pharmaceutical product for human use within
the Field containing Toremifene as a therapeutically active ingredient.
1.29 "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.
1.30 "ROW TERRITORY" shall mean the GTX Territory except the North
American Territory and Japan.
1.31 "SALES OF GENERIC PRODUCT" shall mean the documented sale and use of
a Generic Product.
1.32 "SPECIFICATIONS" shall mean the current specifications (as of the
Amendment Date) for the Orion Product, as such specifications are, with regard
to [ * ] containing Toremifene, set forth in the Orion NDA [ * ] approved by the
U.S. FDA, 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 16.3 or 16.4. Schedule C
may be amended from time to time as necessary to reflect modifications to the
Specifications that may be implemented pursuant to Section 16.3 or to include
Specifications for any Other Product that Orion may agree to manufacture
pursuant to Section 16.4.
1.33 "TERM" shall mean the period commencing on the Amendment Date and
continuing, on a country by country basis until the date of expiration or
invalidation of the last to expire or be invalidated of the GTX Patent Rights,
subject to earlier termination under Section 20 as provided herein.
1.34 "THIRD PARTY" or "Third Parties" shall mean any party or parties
other than GTX, Orion, an Affiliate of GTX, or an Affiliate of Orion.
1.35 "TOREMIFENE" shall mean [ * ].
1.36 "TRADEMARKS" shall mean the trademarks GTX selects and registers for
the Product in the Territory in accordance with Section 9 of this Agreement.
5.
1.37 "U.S. FDA" shall mean the United States Food and Drug Administration
and any successor regulatory agency.
1.38 "U.S. IND" shall mean an Investigational New Drug Application filed
with the U.S. FDA.
1.39 "U.S. NDA" shall mean a New Drug Application filed with the U.S. FDA.
1.40 "UPFRONT AND MILESTONE INCOME" shall have the meaning provided in
Section 3.1.1(c).
1.41 "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:
(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 North American Territory and in Japan in the
Field;
(II) a non-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 ROW Territory for exclusive use in the Field;
(III) a non-exclusive license, 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 13.6.2) to
be provided to GTX pursuant to Section 13.6.2; and
Licenses under Sections 2.1.1 (i) and (ii) may be expanded to include the
right to make and have made Products as provided in Sections 7.6, 13.9, 15.1,
16.3.2, 16.4 and 20.2.2 on such terms as are set forth in such Sections.
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 as a reference compound and/or product in its R&D
and business activities.
2.1.2 MANUFACTURING RIGHTS RESERVED. Except as otherwise provided in
Sections 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2.2, Orion retains the exclusive
right to manufacture
6.
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 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2.2
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 licenses granted pursuant to
Sections 2.1.1 (i)-(ii), GTX shall, subject to the terms and conditions of this
Agreement, including without limitation Section 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.
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,
provided that 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 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 for the Product for use in the Field in Japan, 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 a sub-licensee for the Product for use in the Field for Japan, South
Korea and China. After the Amendment Date, Orion may disclose to its current
licensee for Toremifene in the breast cancer field in the USA, Japan, South
Korea and China the existence of this Agreement and the fact that it pertains to
the development and commercialization of Toremifene in the Field, [ * ].
2.1.5 GTX RIGHTS OF FIRST NEGOTIATION
7.
(A) 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 Field containing anti-estrogens and/or SERMs, including
analogs, metabolites, and/or derivatives thereof, 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 within five (5) years after the Amendment Date,
Orion has commenced Phase I clinical trials for such product anywhere in the
world for a primary indication falling within the Field (a product fulfilling
(a) and (b), hereinafter referred to as "Additional Product"). Within thirty
(30) days after GTX's receipt in writing of a first offer from Orion regarding
commercially 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 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 within ninety (90)
days 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 the thirty (30) day period, 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 within the ninety day (90) period, GTX shall have no
further rights in the anti-estrogens and/or SERM including analogs, metabolites,
and/or derivatives thereof, and Orion shall be free to contract with a Third
Party concerning same or itself pursue the development, registration, promotion,
marketing, sales and distribution of such Additional Product.
(B) During the term of any Orion Patent or pendency of Orion
Patent Application in the relevant country, Orion grants GTX, on a country by
country basis and as set forth in this Section 2.1.5 (b), a right of first
negotiation to negotiate with Orion an agreement under which GTX would, on
commercially reasonable terms and conditions, develop, register, promote,
market, sell and distribute pharmaceutical products containing Toremifene for
use outside the Field ("Other Activities"), provided, however, that such right
of first negotiation described in this Section 2.1.5(b) shall not extend to
breast cancer indications.
(I) If after the Amendment Date, a Third Party
(including without limitation an Orion Unaffiliated Sublicensee or a GTX
Unaffiliated Sublicensee) approaches Orion in writing and indicates its desire
to obtain a license and/or other rights from Orion to conduct Other Activities,
or if an Orion Affiliate refers such a Third Party having such interest to
Orion, then Orion shall advise such Third Party to approach GTX and discuss such
Other Activity with GTX. Orion shall for a period of two hundred and ten (210)
days from the date that Orion notifies GTX in writing that a Third Party has an
interest in an Other Activity, refrain from granting such Third Party such
license and/or other rights to conduct such Other Activities. If GTX desires to
obtain a license and other support from Orion to conduct such Other Activities
(alone or together with such Third Party) GTX shall notify Orion in writing
thereof. If GTX so notifies Orion, then the Parties shall negotiate exclusively
with each other the terms of a binding, commercially reasonable license
agreement under which Orion would grant GTX a license to conduct such Other
Activities and provide other related support to GTX, provided that GTX's right
to conduct such Other Activity shall be subject to and conditioned by, and
become effective only upon the execution by the Parties of a separate, mutually
acceptable written
8.
agreement, if any, with respect thereto. Such negotiations, if any, shall
continue for up to one hundred and eighty (180) days after Orion receives such
notification from GTX or until the expiry of said period of two hundred and ten
(210) days, which ever is earlier (hereinafter referred to as "Negotiation
Period"). If the Parties, despite conducting good faith negotiations, if any,
are unable to or do not finalize and execute a binding license agreement within
the Negotiation Period, then GTX shall have no rights with respect to such Other
Activities, and Orion and/or its Affiliate shall have the right to conduct such
Other Activities alone or together with a Third Party(ies) or grant a Third
Party a license and/or other rights from Orion to conduct Other Activities
without any obligation to GTX.
(II) If after the Amendment Date a Third Party
(including without limitation an Orion Unaffiliated Sublicensee or a GTX
Unaffiliated Sublicensee) approaches GTX or a GTX Affiliate and indicates its
desire to obtain a license and/or other rights to conduct Other Activities, then
GTX shall Promptly notify Orion in writing. Within thirty (30) days after GTX
provides any such notice to Orion, GTX shall inform Orion if GTX desires to
negotiate the terms and conditions under which GTX would be willing to obtain a
license from Orion to conduct the Other Activities that are the subject of such
notice. If GTX so notifies Orion of its interest, then the Parties shall
negotiate exclusively with each other a letter of intent providing for the
material, commercially reasonable terms and conditions under which Orion would
be willing to grant GTX a license to conduct such Other Activities and provide
other related support to GTX. Such negotiations shall continue for up to one
hundred and eighty (180) days after Orion receives such notification from GTX.
If GTX fails to provide written notice to Orion of GTX's interest in conducting
such Other Activities by the end of such thirty (30) day period, or if the
Parties, despite conducting good faith negotiations, are unable to finalize such
a letter of intent within such one hundred and eighty (180) day period, then GTX
shall have no further rights with respect to such Other Activities, and Orion
shall have the right to grant to such Third Party a license and/or other rights
to conduct such Other Activities without further obligation to GTX with respect
to such Other Activities. If the Parties finalize a letter of intent pursuant to
this subsection (ii) providing for the material terms and conditions under which
GTX would obtain a license conduct Other Activities within such one hundred and
eighty (180) day period, then the Parties shall promptly thereafter meet to
negotiate an agreement setting forth more fully the terms and conditions
contained in such letter of intent as well as other applicable terms and
conditions typically contained in agreements of similar nature, provided that
GTX's right to conduct such Other Activity shall be subject to and conditioned
by, and become effective only upon the execution by the Parties of a separate,
mutually acceptable written agreement, with respect thereto, if any, and further
provided that neither GTX nor Orion shall either itself conduct such Other
Activities or grant any Third Party the right to do so unless (I) GTX has
provided Orion notice that it is not interested in conducting such Other
Activity, or (II) GTX has failed to provided Orion with such notice of its
interest in conducting such Other Activity within such thirty (30) day period,
or (III) the Parties fail to agree upon the terms of a letter of intent or
execute such agreement within the applicable one hundred eighty (180) day
period, which ever of items (I)-(III) occur first.
(III) If after the Amendment Date Orion or an Orion
Affiliate desires to initiate the conduct of Other Activities, then Orion shall
promptly so notify GTX in writing. Within thirty (30) days after GTX receives
any such notification from Orion, GTX shall inform Orion if GTX desires to
negotiate the terms and conditions under which Orion would be
9.
willing to grant GTX a license and other support from Orion to conduct the Other
Activities that are the subject of such notice. If GTX so notifies Orion of its
interest, then the Parties shall negotiate exclusively with each other on a
binding, commercially reasonable license agreement under which Orion would grant
GTX a license to conduct such Other Activities and Orion would provide other
related support to GTX, provided that GTX's right to conduct such Other Activity
shall be subject to and conditioned by, and become effective only upon the
execution by the Parties of a separate, mutually acceptable written agreement,
if any, with respect thereto. Such negotiations shall continue for up to one
hundred and eighty (180) days after Orion receives such notification from GTX.
If GTX fails to provide written notice to Orion of GTX's interest in conducting
such Other Activities by the end of such thirty (30) day period, or if the
Parties, despite conducting good faith negotiations, are unable to finalize and
execute a binding license agreement within such one hundred and eighty (180) day
period, then GTX shall have no rights with respect to such Other Activities, and
Orion or its Affiliate shall have the right to conduct such Other Activities
alone or together with a Third Party(ies) without any obligation to GTX. Orion
shall not grant a license to any Third Party to commercialize products
containing Toremifene for such Other Activities unless and until (I) GTX has
provided Orion notice that it is not interested in conducting such Other
Activity, or (II) GTX has failed to provide Orion with such notice of its
interest in conducting such Other Activity within such thirty (30) day period,
or (III) the Parties fail to execute such binding license agreement within such
one hundred eighty (180) day period, which ever of items (I)-(III) occur first.
(IV) If GTX desires to conduct Other Activities, then
GTX shall promptly notify Orion in writing of GTX's desire to conduct such Other
Activity and the terms and conditions under which GTX would be willing to obtain
a license to conduct such Other Activities and other related support from Orion,
provided that any such license to GTX to conduct such Other Activity shall be
subject to and conditioned by, and become effective only upon the execution by
the Parties of a separate, mutually acceptable written agreement, if any
("Additional Agreement"). If GTX so notifies Orion of its interest, then the
Parties shall discuss, and as appropriate, negotiate exclusively with each other
with regard to an Additional Agreement for up to one hundred and eighty (180)
days after Orion receives such notification from GTX. If the Parties are unable
to or do not finalize and execute such Additional Agreement within such one
hundred and eighty (180) day period, then GTX shall have no rights with respect
to such Other Activities, and Orion or its Affiliate shall have the right to
itself conduct such Other Activities or to grant to such Third Party a license
and/or other right to conduct such Other Activities without further obligation
to GTX with respect thereto.
(V) Any deadlines provided in this Section 2.1.5(b) may
be extended by mutual written agreement of the Parties. GTX's rights under this
Section 2.1.5(b) shall apply on an indication by indication basis.
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
10.
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.
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. 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, 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, 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.
11.
2.5 USE OF TOREMIFENE BY GTX FOR RESEARCH. Subject to Sections 2.1.1 (iii)
and 13.6.2, GTX may use the Powder provided to it pursuant to Section 13.6.2 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.
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 shall first be applied to
[ * ] both prior to and after the Amendment Date, 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 Field in the GTX
Territory excluding: (i) Royalty Income (as defined in Section 3.1.4); (ii) cost
of goods payments for supply of Product manufactured by Orion and supplied at
the prices set forth in Section 13 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, if [ * ].
12.
3.1.2 If GTX is Acquired prior to the first Regulatory Approval of
Product for use in the Field, then GTX shall pay to Orion an amount equal to
[ * ] or [ * ] 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 GTX immediately prior to such
transaction own less than fifty percent (50%) of the surviving parent entity.
3.1.3 For commercial sales of each Product by GTX, or its Affiliates
in a country of GTX Territory commencing on the First Commercial Sale of
Product, GTX shall during the Term pay Orion a running royalty in the amount of
[ * ] of Net Sales of Product on a country by country basis, subject to the
provisions of Sections 3.1.6 and 20.2.2.
3.1.4 Subject to the provisions of Sections 3.1.6 and 20.2.2, in the
event GTX receives running royalty income from GTX Unaffiliated Sublicensees for
sublicensing GTX's rights in and to the Product for use in the Field and/or
based upon sales by GTX Unaffiliated Sublicensees of Product for use in the
Field in the Territory ("Royalty Income"), GTX shall during the Term pay Orion
the lesser of, on a country by country basis, either (i) [ * ] of such Royalty
Income; or (ii) [ * ] of such GTX Unaffiliated Sublicensees, provided, however,
that in no event shall the amounts due to Orion pursuant to this Section 3.1.4
be [ * ] of Net Sales of such GTX Unaffiliated Sublicensees.
3.1.5 As of December 31, 2000, an upfront license fee of [ * ] (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.
3.1.6 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, then the royalty on Net Sales owed by GTX to Orion under
Section 3.1.3 and the payments due to Orion on Royalty Income pursuant to
Section 3.1.4, respectively, shall be reduced to [ * ] of the amount otherwise
due to Orion pursuant to either Section 3.1.3 or 3.1.4, as applicable, with
regard to such country with such reduction to be applicable to the immediately
succeeding calendar quarter only.
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 the 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)
13.
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 Section 13 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 development, sales and marketing activities for the Product 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.
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
14.
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 Field ("MSRs") in the second year and
fourth year after Product Launch in the USA equal to [ * ] of GTX's annual
Product Sales Projections (as defined below) in the USA. To establish such
projections for the purpose of the foregoing sentence, GTX shall provide to
Orion annual Product Sales Projections in the USA 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 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 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 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 Field, multiplied by the price per tablet of
Product for use in the Field 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 Field
during a given year in the USA.
For example, in year [ * ] if the target patient population is [ * ]
subjects in the Field and the Product would be consumed [ * ] for the Field at a
hypothetical price of [ * ], GTX's Product Sales Projections 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)
15.
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
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 Field, or other
events or causes affecting the market for the Product for use in the 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 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 Section 26).
6.1.4 FAILURE TO ACHIEVE MSRS. If GTX's annual Product Sales in USA
for the 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. 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 20.2.2.
6.2 NO MINIMUM SALES REQUIREMENTS OUTSIDE OF USA. GTX shall not have any
MSRs with respect to sale of the Product in any countries in GTX Territory
outside of 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 Field in the Major Countries. For purposes of this Section 6.3,
"commercially reasonable" shall mean using, in each of the 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 it
own that is of comparable market potential in the respective Major Countries
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 the Major
Countries;
16.
(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
Field in the Major Countries, and to provide such sales force with adequate
sales and promotional materials for the Product;
(C) Promoting and detailing the Product for use in the Field
throughout the Major Countries, 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 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 Field in the
Major Countries 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 Field in the USA, commencing with the fourth calendar year after
First Commercial Sale of the Product for use in the 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 Field in the USA and events or causes affecting the market for the
Product for use in the 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 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 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
17.
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 Field in any Major
Country for up to six (6) months after GTX or its Affiliates have obtained
Regulatory 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 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
20.2.2 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 other-wise 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 pursuant to Section 6.1, for which GTX
shall separately provide information.
6.6.2 MARKETING AND SALES REPORTS. 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. 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
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 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 clinical studies and other
18.
activities required for Regulatory Approval under the GTX Final Development and
Registration Plan. Without limiting the provisions of Section 7.6, 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 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 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 Field (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 7.4, assistance in
obtaining free sales certificates, and other similar assistance).
(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 Amendment 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 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, be for the sole cost and responsibility of
GTX.
7.1.3 FDA FILE. 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.
19.
7.2 DEVELOPMENT AND REGISTRATION COSTS. Except as otherwise expressly
provided in this Agreement or otherwise mutually agreed in writing by the
Parties after the Amendment Date, GTX shall bear all costs and expenses related
to Product registration and regulatory activities, including without limitation
costs of filing, obtaining and maintaining all Regulatory Approvals throughout
GTX Territory, as well as all costs and expenses for the research and
development of the Product for use in the Field, 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
Section 13 (such costs collectively referred to herein as "Manufacturing
Costs"). Except for the Manufacturing Costs or as otherwise expressly provided
in this Section 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.
7.2.1 DEVELOPMENT AND REGISTRATION COSTS PRIOR TO AMENDMENT 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, 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.
7.3 GTX DEVELOPMENT AND REGISTRATION PLAN.
7.3.1 COMPLETION OF GTX FINAL DEVELOPMENT AND REGISTRATION PLAN. The
GTX Preliminary Development and Registration Plan was attached to the Original
Agreement as Schedule B. GTX will prepare a GTX Final Development and
Registration Plan for each 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, a copy of
such Plan shall be provided to Orion.
7.3.2 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 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 Orion's proprietary
product Fareston(R) outside the Field or Toremifene outside the Field. GTX
undertakes to change and/or amend the GTX Final Development and Registration
Plan 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.
7.3.3 CHANGES TO SUCH PLAN. GTX may modify the GTX Final Development
and Registration Plan, as GTX deems necessary and consistent with Section 7.3.1,
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
7.3.2.
20.
7.4 ORION DOCUMENTATION AND DATA
7.4.1 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.
7.4.2 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 data requested, access to Orion
Know-How that GTX reasonably requires for regulatory filings for the use of
Product in the Field in the GTX Territory. Upon GTX's request, Orion shall
provide GTX with copies of such Orion Know-How referenced in the preceding
sentence 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
progress under the GTX Preliminary Development and Registration Plan and the GTX
Final Development and Registration Plan.
7.4.3 LETTER OF CROSS REFERENCE. Orion agrees that the Cross
Reference letter dated December 10, 1999 from Orion to GTX shall remain in
effect and 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, Orion's existing U.S. NDA [ * ] and all other
applications or filings for Regulatory Approval for Orion Products for use in
the breast cancer indication 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 referring 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).
21.
7.4.4 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.
7.5 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.
7.6 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 twenty (120) days prior written notice
to GTX, if either (I) Regulatory Approval has not been granted for the Product
for use in the Field in the USA by December 31, 2007, or (II) the last Valid
Claim included in the Orion Patent Rights in the USA expires (which the Parties
currently anticipate to occur in 2009) or is invalidated. Any such notice
hereunder shall be given no later than sixty (60) days after the occurrence of
the applicable event giving rise to such right, provided that GTX shall inform
Orion in writing by December 31, 2007, whether or not Regulatory Approval has
been granted for the Product for use in the 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 in item (I) 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 with regard to the
event described in item (I) if Orion finds out, 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, 2007. Effective upon the date that
GTX receives any notice from Orion pursuant to this Section 7.6 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. Such license shall be
exclusive with respect to Products for use in the Field and in the North
American Territory and Japan, and nonexclusive with respect to Products for
exclusive use in the Field in the ROW Territory. Orion shall as soon as
practically possible after providing any notice to GTX pursuant to this Section
7.6 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 7.6 (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.
At any time prior to December 31, 2007, GTX may propose to discuss
whether Orion would be willing either to commit to manufacture and supply to GTX
Orion Product for a certain amount of time to allow GTX to have uninterrupted
supply during critical Product development or commercialization periods, or to
allow GTX to locate and qualify a Third Party manufacturer of Orion Product for
such purpose. Upon such request, the Parties shall promptly discuss whether or
not Orion is interested in supplying GTX with such needs of Orion Product.
Nothing in this
22.
paragraph shall be deemed to require Orion to take any action or to impose an
obligation for, or constitute a commitment by Orion in relation to such subject
matter.
7.7 REIMBURSEMENT OF ORION COSTS. Except as provided for otherwise in this
Section 7, GTX shall reimburse Orion for all costs and expenses incurred by
Orion in fulfilling its obligations under this Section 7. Orion shall issue an
invoice for all such reasonable costs and expenses so incurred 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 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 Section 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, Confidential Information shall not include
any information:
(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;
23.
(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 Finnish equivalent thereof to the
extent that such information cannot be treated confidential.
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 Amendment 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. 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 (I) fall within the scope of Section 8.5.1; or (II)
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. TRADEMARKS
24.
9.1 USE OF TRADEMARKS. GTX shall market and sell the Product for use in
the Field in GTX Territory only under Trademarks selected by GTX. GTX shall not
select a Trademark which is confusingly similar to the Orion trademark
Fareston(R). GTX shall own and control all Trademarks excluding, for the
avoidance of doubt Fareston(R). GTX shall notify Orion if GTX decides to change,
alter, modify or replace the Trademark initially selected by it for the Product
without the express written prior approval thereof by Orion.
9.2 TRADEMARK FILING AND MAINTENANCE. GTX shall be responsible for filing,
maintaining, prosecuting and defending the Trademarks in the GTX Territory.
9.3 WORLDWIDE TRADEMARK ENFORCEMENT. GTX shall be responsible for and
control Trademark prosecution, maintenance, and/or enforcement worldwide. 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.
10. PATENT OWNERSHIP AND WARRANTIES
10.1 PATENT OWNERSHIP.
10.1.1 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
Section 11.
10.1.2 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
Section 11.
10.2 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
Amendment Date which are directed to the composition of matter, use or sale of
the compound Toremifene per se; (B) 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 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/or (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,
and (D) the use and 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 Amendment Date, Orion has not received any written claims from any Third
Party alleging that the use of Toremifene in the Field infringes such Third
Party's patent rights.
10.3 GTX PATENT WARRANTIES. GTX warrants and represents that, to the best
of its management's knowledge 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 Field and that it had
25.
full right and authority to grant to Orion and Orion Affiliate the rights
granted to it under the Original Agreement; (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) the United States Government or any agency thereof should not 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
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 that might be infringed by the marketing, promotion,
distribution, importation, offer for sale or sale of the Product by GTX, its
Affiliates and GTX Unaffiliated Sublicensees.
11. PATENT PROSECUTION AND INFRINGEMENT
11.1 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 obtain extensions in the Major
Countries in the GTX Territory in which such extensions are available.
11.2 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.
11.3 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.
11.4 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,
excluding actions and proceedings covered by Section 11.5. 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
26.
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.
11.5 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 11.4.
11.6 INFRINGEMENT INDEMNIFICATION.
11.6.1 ORION INFRINGEMENT INDEMNIFICATION. Orion shall indemnify,
defend and hold GTX (including for purposes of this Section 11.6.1, GTX
Affiliates and GTX 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 Onion harmless pursuant to Section 11.6.2, and further subject to the
conditions of indemnification set forth in Section 14.7.
11.6.2 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 the 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 11.6.1, and further subject to the conditions of indemnification set
forth in Section 14.7.
11.7 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 or territory 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.
11.8 THIRD PARTY INFRINGEMENT OF ORION PATENT RIGHTS.
27.
11.8.1 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) and, if such infringement does
not cease, commence a legal proceeding to enforce Orion Patent Rights, if any,
against 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. 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 11.6.
11.8.2 GTX ENFORCEMENT.
(A) ORION PATENT RIGHTS. If within a reasonable period of time
from the date Orion becomes aware of any alleged Third Party infringement of the
Orion Patent Rights relating to the manufacture, use, sale, offer for sale, or
import of Products containing Toremifene for use in the Field, either by notice
from GTX or otherwise, Orion has not commenced a legal proceeding pursuant to
Section 11.8.1, or if at any time Orion discontinues the pursuit of such
proceeding, 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 in the GTX Territory, 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's rights hereunder are
subject and secondary to any rights that Orion has granted to any Third Party
prior to the Amendment 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.
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 11.6.
11.9 THIRD PARTY INFRINGEMENT OF GTX PATENT RIGHTS AND TRADEMARK.
28.
11.9.1 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 11.6.
11.10 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 the 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.
11.11 PATENT CHALLENGES
11.11.1 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 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.
11.11.2 If Orion challenges the validity of any GTX Patent Rights in
any Major Country in GTX Territory other than 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.
11.12 ACTIVITIES DURING INFRINGEMENT LITIGATION
11.12.1 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, 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
29.
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 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 14.6.1.
11.12.2 In the event of any patent or trademark or other proprietary
right infringement litigation involving the Orion Product in the GTX Territory
in which Orion defends or prosecutes such litigation, 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 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 indemnification
obligation to GTX pursuant to Section 14.6.2. If GTX elects to comply with such
request, such compliance shall be considered a suspension of GTX's marketing and
sales obligations, notwithstanding Section 6.
11.12.3 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.
12. COMPETING PRODUCTS
12.1 OBLIGATIONS WITH RESPECT TO COMPETING PRODUCTS
12.1.1 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.
30.
12.1.2 However, nothing contained in this Section 12.1 shall be
construed as preventing either Party from conducting research and development
activities relating to a Competing Product during such period or thereafter.
13. PRODUCT ORDERS, SUPPLY AND PAYMENTS
13.1 ORION SUPPLY OBLIGATIONS
13.1.1 PRODUCT SUPPLY. During the Term, Orion shall, subject to the
terms of this Section 13, supply GTX and GTX Affiliates with their requirements
of Orion Product. Orion shall supply the Product in bulk tablet form.
13.1.2 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 13.2, 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 F.O.B. Espoo, Finland to a carrier
designated by GTX. GTX shall pay shipping costs and shall assume title to and
risk of loss for Orion Product purchased hereunder upon delivery to GTX's
designated carrier.
13.1.3 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.
13.2 ORION AFFILIATES AND SUBCONTRACTORS. Orion may satisfy its supply
obligations under this Agreement either directly or through any Orion Affiliate,
whether located inside or outside GTX Territory (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.
13.3 GTX FORECASTS
13.3.1 ROLLING FORECASTS. Not later than ninety (90) days prior to
GTX's first commercial order of Orion Product from Orion for GTX's Product
launch anywhere in the GTX Territory, GTX shall inform Orion in writing of GTX's
bona fide, good faith estimated requirements of Orion Product in the GTX
Territory during the remainder of the calendar year of said Product launch.
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 fifteen (15) month period beginning with October 1 of the
then current year, allocated for each calendar month of such period. GTX shall
update its purchase estimates to Orion on a monthly basis by indicating by the
end of each month revised estimates or confirming
31.
that no revisions are necessary, which shall provide Orion with GTX's rolling
fifteen (15) month forecasts.
13.3.2 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.
13.3.3 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 Section 13 of what the size of a full batch of Orion Product
is at such time.
13.4 PRICES AND PAYMENT
13.4.1 COMMERCIAL PRICING FORMULA. Orion's annual price of bulk
Orion Product to GTX for commercial purposes, delivered F.O.B., Espoo, Finland,
shall be:
[ * ]
13.4.2 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.
13.4.3 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,
32.
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.
13.5 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.
13.6 PRODUCT SUPPLY FOR TESTING AND REGISTRATION; SUPPLY OF TOREMIFENE.
13.6.1 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 with such quantities of [ * ] tablets of bulk
Product as GTX may require of Orion Product and/or placebos for GTX's use in
clinical trials referenced in the GTX Preliminary Development and Registration
Plan or the GTX Final Development and Registration Plan. 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 may require of Orion Product and/or placebos for GTX's use in clinical
trials referenced in the GTX Preliminary Development and Registration Plan or
the GTX Final Development and Registration Plan. The price for the [ * ] tablet
of bulk Orion Product for clinical trials shall be [ * ] per tablet. Orion shall
supply GTX with such quantities as GTX may require of [ * ] tablets of Orion
Product and/or placebos for GTX's use in clinical trials referenced in the GTX
Preliminary Development and Registration Plan or the GTX Final Development and
Registration Plan. 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 13.6 shall be provided in bulk packaging.
13.6.2 SUPPLY OF TOREMIFENE.
For the sole purpose of aiding GTX 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
undertakes to use such Powder only for studies necessary to support Regulatory
Approval for Product for use in the Field. 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 agreeing 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
33.
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. 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, 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 (hereinafter referred to as "Other Use"), 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.
13.7 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 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.
13.8 PRICE ADJUSTMENT FOR COMMERCIAL SUPPLY. It is agreed upon by the
Parties that the price of the [ * ] tablet of Orion Product to GTX 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 13.8, then the
adjusted price shall apply to the entire amount of the relevant tablets
purchased during the relevant year.
34.
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 13.8.
13.9 TERMINATION OF PRODUCT SUPPLY. Orion shall, at its sole discretion,
have the right upon providing twenty-four (24) months prior written notice
thereof, to terminate its obligations under this Section 13 relating to the
manufacture and supply of Orion Product and/or Toremifene (pursuant to Section
13.6.2) in the event that Orion permanently ceases the manufacture of Toremifene
and/or Orion Product. 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 during the Term, with such license to be
exclusive with respect to Products for use in the Field and in the North
American Territory, and non-exclusive for exclusive use in the Field in the ROW
Territory. Such license shall become effective upon GTX's receipt of notice from
Orion under this Section 13.9. Orion shall during such twenty-four (24) month
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 13.9, 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.
14. PRODUCT WARRANTIES AND INDEMNIFICATION
14.1 PRODUCT WARRANTIES AND LIMITATIONS
14.1.1 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 agree that, except as expressly provided
for in Section 10.2, 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 7.6, 13.9, 15.1, 16.3.2, 16.4 or 20.2.2.
14.1.2 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
35.
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.
14.2 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.
14.3 PRODUCT INSPECTIONS
14.3.1 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.
14.3.2 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 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 14.3.1 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 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.
14.4 PRODUCT STORAGE. Each Party shall properly store Orion Product under
conditions that will not adversely affect the quality or normal shelf life
thereof.
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14.5 GTX RESPONSIBILITIES IN GTX TERRITORY
14.5.1 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 sold by GTX under license from Orion. 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 14.5. 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.
14.5.2 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.
14.6 RECIPROCAL INDEMNIFICATION PROVISIONS
14.6.1 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 14.1, 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 14.6.2.
14.6.2 GTX INDEMNIFICATION IN GTX TERRITORY. 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) the negligence, fault, willful wrongdoing or any other act or omission, or
material breach of this Agreement by GTX, its Affiliates or Unaffiliated
37.
Sublicensees or (B) the manufacture, use, sale, importation, distribution,
and/or marketing of the Product in the Field in 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 (A)
and (B) to the extent that such Losses are caused by activities for which Orion
must defend, indemnify and hold harmless GTX pursuant to Section 14.6.1.
14.7 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.
14.8 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
14.8 shall survive the termination expiration of this Agreement for ten (10)
years for whatsoever reason.
15. STANDBY MANUFACTURING RIGHTS
15.1 INABILITY TO MANUFACTURE OR SUPPLY. If Orion is unable to supply or
manufacture Orion Product, as ordered pursuant to Sections 13.1.2 and 13.3.2,
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 13.1.2 and 13.3.2,
then GTX may, at its option, responsibility and expense, elect to manufacture or
have a Third Party manufacture Toremifene for use in manufacturing and selling
the Product for use in the Field anywhere in the GTX 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 Product for use in the
Field in the GTX Territory. Such license shall be exclusive with respect to
Products for use in the Field and in the North American Territory, and
38.
nonexclusive for exclusive use in the Field in the ROW Territory, 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 15.1, 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 15.1 shall
be GTX's sole and exclusive remedy for Orion's failure to manufacture or have
manufactured Orion Product for supply to GTX under Section 13.
16. MANUFACTURING INSPECTIONS AND CHANGES
16.1 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. 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.
16.2 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 and 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
16.3 GTX-INITIATED MANUFACTURING CHANGES
16.3.1 GTX REQUEST FOR MANUFACTURING CHANGES. Prior to Orion
providing GTX with notice pursuant to Section 13.9, GTX may, from time to time
during the Term and as agreed in this Section 16.3, make a written and detailed
request for changes in Orion's manufacturing operations, or the Specifications,
for Toremifene and 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 shall be deemed "Other Manufacturing
Changes".
39.
16.3.2 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, condition 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 15.1 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.
16.3.3 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 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.
16.4 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
Amendment 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 16.4.
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 such Other Product, including
without limitation the supply price of such Other Product. Upon execution of
such amendment, such Other Product shall be
40.
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, 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 Amendment 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
pursuant to this Section 16.4 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 have made the relevant Other Product for use in the Field
in the GTX Territory. Such license shall be exclusive with respect to Products
for use in the Field and in the North American Territory, and nonexclusive for
exclusive use in the Field in the ROW Territory, and shall become effective only
under the circumstances specified in this Section 16.4.
17. PRODUCT RECALLS
17.1 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 (collectively, "Recall").
17.2 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.
17.3 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
41.
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 14.1.
18. ADVERSE DRUG EXPERIENCES
18.1 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, post-authorization safety updates) upon
public release thereof concerning the Product; and (ii) Orion will provide to
GTX Periodic Safety Update Reports upon public release thereof prepared in
accordance with ICH E2C guidelines covering Orion's Toremifene indication for
breast cancer. In addition, any safety information which may negatively affect
the benefit-risk ratio of Toremifene 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 with respect to its
own Regulatory Approval applications and regulatory requirements according to
applicable laws, rules and regulations. If the FDA requires that reports of
adverse events must be exchanged between the Parties, and submitted to the FDA
in connection with both Parties' regulatory filings for Toremifene products, the
details of the Parties' exchange of such information will be modified
accordingly and documented as an Exhibit to this Agreement.
(B) The intent of Section 18.1(a) is to enable each Party to
comply with regulatory requirements for Toremifene products. If either Party
learns that the foregoing exchange of information is not sufficient for such
Party to meet regulatory requirements with respect to Toremifene products that
it has the right to commercialize, it may so note by the other Party. Promptly
thereafter, the Parties shall discuss and agree upon a mutually acceptable
modification to the foregoing procedure that enables the Party providing such
notice to conform with such regulatory requirements with respect to such
Toremifene products. Specifically and without limitation, to the extent
regulatory authorities outside of the United States require reporting or other
obligations with respect to adverse drug experiences in addition to those stated
in Section 18.1(a) above, the Parties shall, promptly after the Amendment Date,
meet and negotiate in good faith mutually agreeable procedures to meet such
obligations.
This Section 18 shall survive the expiration or termination of this
Agreement.
19. REPRESENTATIONS AND WARRANTIES
19.1 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;
42.
(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; and
(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.
(G) NEGATIVE DATA OR INFORMATION. Each Party has, to the
best of its management 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.
20. TERM AND EARLY TERMINATION RIGHTS
20.1 TERM. The Term shall be as stated in Section 1.33.
20.2 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 20.2 as
follows.
20.2.1 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 is filed 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.
43.
20.2.2 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 24.2 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 Section 11.11.1), or, if
such breach is by GTX and is described in Section 6.4.2 or 11.11.1 terminate the
license granted to GTX pursuant to Section 2.1 with respect to the Major Country
in relation to which such material breach occurred. 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, then GTX shall grant to Orion a
nonexclusive, royalty-bearing license, with the right to grant sublicenses,
under the GTX Patent Rights, the Trademark and the GTX Know-How to make have
made, use, sell, offer for sale, market and promote, and import Products in the
country(ies) in which GTX's license terminates (if such breach is a material
breach described in Section 6.4.2) or, for any other material breach, throughout
the GTX Territory; or
if Orion is the breaching Party, then the license granted to GTX shall be
expanded to include a 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 during the Term, with such license to be exclusive with respect to
Products for use in the Field and in the North American Territory, and
nonexclusive for exclusive use in the Field in the ROW Territory, and 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.
If a non-breaching Party obtains a license under this Section 20.2.2
above, it shall pay to the other Party a running royalty equal to [ * ] of such
non-breaching Party's Net Sales of Product in the territory in which such
license applies. 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.
20.3 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.
20.4 OTHER TERMINATION BY ORION
20.4.1 Orion shall have the right to terminate this Agreement upon
thirty (30) days prior written notice to GTX if any business entity which is a
direct competitor of Orion for
44.
Toremifene should any time during the Term acquire control over the business
affairs of GTX by purchase or acquisition of a fifty percent (50%) or greater
interest in GTX's issued and outstanding stock, all or substantially all of
GTX's assets, or the GTX business unit or division dealing with the Product. If
Orion after the thirty (30) days from receipt of notification (such notification
to be furnished by GTX to Orion at the latest by such purchase or acquisition
becoming public knowledge), does not exercise its rights to terminate this
Agreement, Orion shall irrevocably lose and forfeit such right.
20.5 OTHER TERMINATION BY GTX
20.5.1 CHANGE OF CONTROL OF ORION. GTX shall have the right to
terminate this Agreement upon thirty (30) days prior written notice to Orion if
any business entity which is a direct competitor of GTX for Toremifene for use
in the Field should any time during the Term acquire control over the business
affairs of Orion by purchase or acquisition of a fifty percent (50%) or greater
interest in Orion's issued and outstanding stock, all or substantially all of
Orion's assets, or the Orion business unit or division dealing with the Product.
If GTX after the thirty (30) days from receipt of notification, such
notification to be furnished by Orion to GTX at the latest by such purchase or
acquisition becoming public knowledge, does not exercise its rights to terminate
this Agreement, GTX shall irrevocably lose and forfeit such right.
20.5.2 SAFETY OR EFFICACY. 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 20.5.2 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.
20.6 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.
21. NOTICES
21.1 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
45.
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.
21.2 ADDRESSES FOR NOTICES
Notices to Orion shall be sent to:
Orion Corporation
Orion Pharma
Attn: President of Orion Pharma
▇▇▇▇▇▇▇▇▇▇ ▇, ▇.▇. ▇▇▇ ▇▇
▇▇▇-▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇
Facsimile: 358-9-429-3044
With a copy to:
Orion Corporation
Orion Pharma
Attn: Legal Counsel
▇▇▇▇▇▇▇▇▇▇ ▇, ▇.▇. ▇▇▇ ▇▇
▇▇▇-▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇
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 ▇▇▇▇▇▇ Avenue,
Van Vleet Building, Third Floor
Memphis, Tennessee 38163
U.S.A.
Telephone: ▇-▇▇▇-▇▇▇-▇▇▇▇ ▇▇▇▇
Facsimile: ▇-▇▇▇-▇▇▇-▇▇▇▇
▇▇▇▇▇▇ Godward LLP
Five Palo Alto Square
▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Attention: ▇▇▇▇▇▇ ▇▇▇▇▇, Esq.
46.
Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Facsimile: (▇▇▇) ▇▇▇-▇▇▇▇
22. 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.
23. 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 to an Affiliate in
accordance with the terms of this Agreement, in which case notification thereof
shall be provided to the other Party no later than thirty (30) days prior to
such assignment to an Affiliate. Neither Party shall unreasonably withhold its
consent which shall be provided within thirty (30) days, to such 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.
24. GOVERNING LAW AND DISPUTE RESOLUTION
24.1 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.
24.2 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:
24.2.1 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 24.2.1, to the following corporate officers of
the Parties for resolution:
For GTX: President and Chief Executive Officer (or his or her designee)
47.
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.
24.2.2 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 24.2.1 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.
24.3 EFFECT OF COMMENCING DISPUTE RESOLUTION. If either Party in good
faith commences dispute resolution proceedings under Section 24.2, (A) any
applicable notice periods or cure periods hereunder (including but not limited
to the periods referenced in Sections 20.2 and 20.4) 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.
25. LIMITATION OF DAMAGES
Except for indirect damages resulting from breach of Section 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.
26. 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
48.
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.
27. 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.
28. 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.
29. 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.
30. HEADINGS
The headings in this Agreement are for convenience of reference only and
shall not be used in the interpretation of any provisions hereof.
31. 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.
32. 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
49.
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 Amendment Date.
ORION CORPORATION GTX, INC.
By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇ MD
------------------------------ --------------------------
▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, M.D.
Title: President Title: Vice-Chairman and CEO
Orion Corporation Orion Pharma GTx, Inc.
By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ By: /s/ ▇▇▇▇ ▇▇▇▇▇▇▇
------------------------------ ----------------
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇
Title: Senior Vice President Title: President and COO
Business Development & Finance 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
50.
SCHEDULE A: PART I
COUNTRY/JURISDICTION TITLE INVENTORS PATENT NO. ISSUE DATE STATUS
-------------------- ------------------ ----------------------- ---------- ------------- ------
1. UNITED STATES METHOD FOR 1. MITCHELLS ▇. ▇▇▇▇▇▇▇ 6,265,448 July 24, 2001 Issued
CHEMOPREVENTION OF
PROSTATE CANCER 2. ▇▇▇▇▇▇ ▇▇▇▇▇▇
▇.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE A: PART II
APPLICATIONS FILED IN THE UNITED STATES
[ * ]
2.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
APPLICATIONS FILED IN FOREIGN JURISDICTIONS
[ * ]
3.
SCHEDULE B: PART I. ORION PATENTS
TITLE: Novel Alkane and Alkene Derivatives and their
Preparation and Use (Toremifene)
Country Patent No. Expiry
------------------- ---------- -------------------
AU Australia ▇▇▇▇▇▇ May 25, 2008*
BG Bulgaria 98379 May 20, 2003
CA Canada 1185977 ▇▇▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇▇▇ 170927 December 21, 2003*
EP Europe 95875 December 21, 2003*
▇▇ ▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ May 19, 2008*
IT Italy 95875 February 14, 2008*
SE Sweden 95875 May 20, 2008*
FI Finland 77839 December 21, 2003*
HK Hong Kong ▇▇/▇▇ ▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇▇▇ 193536 May 26, 2003
HU Hungary 200742 May 26, ▇▇▇▇
▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇ December 21, 2003*
IL Israel 68784 ▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇, ▇▇▇▇*
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇▇ 5066 May 26, 2003
NO Norway 156164 December 21, 2003*
▇▇ ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ May 25, ▇▇▇▇
▇▇ ▇▇▇▇▇▇▇▇▇ 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 ▇▇▇▇▇▇▇▇ ▇▇, ▇▇▇▇
▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇ 833803 May 25, 2003
Germany, Belgium, Austria, Italy, Sweden, Netherlands, Switzerland,
EP= Liechtenstein, Luxembourg, Great Britain, France
* patent term extension
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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE B: PART II. ORION PATENT APPLICATIONS
TITLE: [ * ]
Country Patent No.
-------------- ----------
CN China [ * ]
RO Romania [ * ]
* Administrative protection based on [ * ]
** Pipe-line protection based on [ * ]
2.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE C: SPECIFICATIONS
SPECIFICATIONS FOR [ * ] TABLETS
TEST SPECIFICATION
---------- -------------------------
[ * ] [ * ] [ * ]
----- ----- -----
CHARACTERS
Colour [ * ] [ * ] [ * ]
Shape [ * ] [ * ] [ * ]
Score [ * ] [ * ] [ * ]
Code [ * ] [ * ] [ * ]
Coating [ * ] [ * ] [ * ]
[ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
[ * ] [ * ] [ * ] [ * ]
3.
SCHEDULE D: GTS'S MSR OBLIGATION
(TO BE COMPLETED PURSUANT TO SECTION 6.1.1)
4.
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
SCHEDULE E: ORION PRODUCT APPROVALS
REGISTRATION STATUS 27.9.2001
ORION PHARMA
Status: Approved, Pending
Submission types: Marketing authorisations
(2 PAGES)
Sent Date Appl. Date Product Country Decision 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
5.
Sent Date Appl. Date Product Country Decision Date Decision M.A. holder
--------- ---------- --------------------- -------------- ------------- -------- -----------------
19.12.94 03.01.95 Fareston 60 mg tablet United States 29.05.97 Approved Orion Corporation
of America
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
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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
6.