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UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION and GTx, INC. CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT

License Agreement

UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION 
and 
GTx, INC. 
CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT | Document Parties: Genotherapeutics, Inc | GTx, Inc | Ohio State University | Tennessee Research Corporation | TENNESSEE RESEARCH FOUNDATION You are currently viewing:
This License Agreement involves

Genotherapeutics, Inc | GTx, Inc | Ohio State University | Tennessee Research Corporation | TENNESSEE RESEARCH FOUNDATION

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Title: UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION and GTx, INC. CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT
Governing Law: Tennessee     Date: 11/9/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION 
and 
GTx, INC. 
CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT, Parties: genotherapeutics  inc , gtx  inc , ohio state university , tennessee research corporation , tennessee research foundation
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Exhibit  10.40
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION
and
GTx, INC.
CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT
     THIS CONSOLIDATED, AMENDED, AND RESTATED LICENSE AGREEMENT made and entered into this 24 th day of July, 2007, having an effective date of August 23, 2000 (the “ Effective Date ”) by and between University of Tennessee Research Foundation (formerly known as The University of Tennessee Research Corporation), a Tennessee corporation having an office at 1534 White Avenue, Knoxville, Tennessee 37996. (hereinafter “UTRF”), and GTx, Inc. (formerly known as Genotherapeutics, Inc.), a Delaware corporation, located at 3 N. Dunlap St., Memphis, Tennessee 38163 (hereinafter “GTx”), hereinafter sometimes referred to individually as a “ Party ” and collectively as the “ Parties ”.
RECITALS
      WHEREAS , UTRF owns, in whole or in part, certain Licensed Patents (as defined herein) and Licensed Technology (as defined herein), the subject matter of which was initially developed by one or more of the UT Contributors (as defined herein) in the course of their employment with The University of Tennessee (“UT”);
      WHEREAS , the UT Contributors submitted to UT multiple invention disclosure forms pertaining to SARMS (as defined herein), including (i) [ * ] , designated by UTRF as file number PD [ * ] ; (ii) [ * ] , designated by UTRF as file number PD [ * ] ; (iii) [ * ] , designated by UTRF as file number PD [ * ] ; (iv) [ * ] , designated by UTRF as file number PD [ * ] ; and (v) [ * ] designated by UTRF as file number PD [ * ] (individually, an “ Initial SARMS Disclosure ” and, collectively, the “ Initial SARMS Disclosures ”);
      WHEREAS, UTRF and GTx have previously entered into two separate agreements, each being titled “Amended and Restated Exclusive License Agreement” and made effective as of August 23, 2000, whereby GTx was granted exclusive licenses to Licensed Patents (as defined therein) and Licensed Technology (as defined therein) which arose out of the technology described in the Initial SARMS Disclosures (collectively, the “ Prior License Agreements ”);
      WHEREAS , after submission of the Initial SARMS Disclosures to UT, Dr. James T. Dalton, a UT Contributor, left the employ of UT, accepted employment as a faculty member at The Ohio State University (“ OSU ”) and in the capacity of an OSU researcher, continued to perform research at OSU relating to the subject matter of the Initial SARMS Disclosures with the assistance of other staff and students of OSU working under his supervision, said research being funded by various sponsors, including the United States government and GTx;
      WHEREAS, a number of the UT Contributors (excluding Dr. Dalton as an OSU employee), subsequently submitted to UT an invention disclosure form titled [ * ] designated by UTRF as file number PD [ * ] (the “ Third Generation SARMS Disclosure ”), a copy of which is attached hereto as Exhibit A;

 


 
      WHEREAS , with the consent of GTx, UTRF entered into that certain agreement titled “Bridged SARMS Inter-Institutional Agreement” with OSU effective December 22, 2004 (hereinafter “ OSU IIA#1 ”), attached hereto and incorporated by reference herein as Exhibit B;
      WHEREAS, pursuant to the provisions of OSU IIA#1, UTRF holds a license, with the right to sublicense, to the interest of OSU in EXISTING INVENTIONS (defined below) pertaining to BRIDGED SARMS the subject matter of which was conceived, created, developed, designed, invented, or reduced to practice in whole or in part by OSU researcher Dr. Dalton and/or other OSU research staff and students under Dr. Dalton’s direction before December 22, 2004;
      WHEREAS , pursuant to the provisions of OSU IIA#1, UTRF holds an option to a license, with the right to sublicense, to OSU’s interest in IMPROVEMENT INVENTIONS (defined below) pertaining to BRIDGED SARMS conceived, created, developed, designed, invented, or reduced to practice, in whole or in part by OSU faculty researchers, research staff, or students after December 22, 2004.
      WHEREAS , UTRF also entered into that certain agreement entitled “New SARM Inventions Inter-Institutional Agreement” with OSU effective as of December 22, 2004 (“ OSU IIA#2 ”), attached hereto and incorporated by reference herein as Exhibit C;
      WHEREAS , pursuant to the provisions of OSU IIA#2, UTRF holds an option to a license, with the right to sublicense, to OSU’s interest in NEW INVENTIONS` (defined below) pertaining to certain SARMS conceived, created, developed, designed, invented, or reduced to practice, in whole or in part, by Dr. Dalton, or other OSU research staff, or students and not otherwise subject to OSU IIA#1;
      WHEREAS , the Parties now desire to enter into this “Consolidated, Amended, and Restated License Agreement” for the purpose of (i) consolidating the Prior License Agreements into one agreement; (ii) granting GTx an exclusive license in UTRF’s interest in EXISTING INVENTIONS and IMPROVEMENT INVENTIONS that were not previously licensed to GTx under the Prior License Agreements, if any; (iii) granting GTx an exclusive license, subject to the provisions of OSU IIA#1, in OSU’s interest in all LICENSED INVENTIONS (as defined in OSU IIA#1), to the extent licensed to UTRF; (iv) granting GTx an exclusive license, subject to the provisions of OSU IIA#2, in OSU’s interest in all LICENSED INVENTIONS (as defined in OSU IIA#2), to the extent licensed to UTRF, and in UTRF’s interest in NEW INVENTIONS; and (v) making certain other changes regarding the rights and obligations of the Parties, including but not limited to those changes that are necessary for UTRF to comply with the provisions of OSU IIA#1 and OSU IIA#2; and
      WHEREAS , the Parties intend that this Agreement shall supersede the Prior License Agreements and render them null and void.
      NOW, THEREFORE , for and in consideration of the premises and other good and valuable consideration, including a payment in the amount of Two Hundred Ninety Thousand Dollars ($290,000; the “Consideration Fee”),which is paid by GTx in consideration of UTRF’s execution of this Agreement, the Parties hereto expressly agree as follows:
SECTION 1
Definitions
     1.1 “ Actions ” shall have the meaning set forth in Section 17.1 hereof.
     1.2 “ Active Ingredient ” means the material(s) in a pharmaceutical product which provide its
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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pharmacological activity (excluding formulation components such as coatings, stabilizers or controlled release technologies).
     1.3 “ Affiliate ” shall mean any corporation, partnership, or other entity that at any time during the Term of this Agreement, directly or through one or more intermediaries, Controls or is Controlled by or is under common Control with a Party to this Agreement or a Sublicensee, but only for so long as the relationship exists. A corporation or other entity shall no longer be an Affiliate when through loss, divestment, dilution or other reduction of ownership, the requisite Control no longer exists.
     1.4 “ Agreement ” shall mean this Consolidated, Amended and Restated License Agreement.
     1.5 “ BRIDGED SARMS ” shall have the meaning set forth in OSU IIA#1.
     1.6 “ Claims ” shall have the meaning set forth in Section 8.1 hereof.
     1.7 “ Combination Product ” means either (i) any pharmaceutical product that consists of a SARM and at least one other Active Ingredient that is not a SARM, or (ii) any combination of a SARM and another pharmaceutical product that contains at least one other Active Ingredient that is not a SARM where such products are not formulated together but are sold together as a single product and invoiced as one product.
     1.8 “ Confidential Information ” shall have the meaning set forth in Section 18.2 hereof.
     1.9 “ Control ” or “ Controls ” or “ Controlled ” shall mean: (i) in the case of a corporation, ownership or control, directly or indirectly, of at least fifty one percent (51%) of the shares of stock entitled to vote for the election of directors; or (ii) in the case of an entity other than a corporation, ownership or control, directly or indirectly, of at least fifty one percent (51%) of the assets of such entity.
     1.10 “ Effective Date ” shall have the meaning set forth in the introductory paragraph hereof.
     1.11 “ Exception Countries ” shall have the meaning set forth in Section 6.6 hereof.
     1.12 “ EXISTING INVENTION ” shall have the meaning set forth in OSU IIA#1.
     1.13 “ Federal Policy ” shall have the meaning set forth in Section 2.3 hereof.
     1.14 “ Generic Product ” shall mean a product that is derived from, made with, uses, or incorporates, in whole or in part, Licensed Technology, but is not covered or claimed in whole or in part by a Valid Claim of the Licensed Patents in the country of manufacture, use, or sale or import.
     1.15 “ GTx ” shall mean GTx, Inc. and its Affiliate(s) (unless such Affiliates are clearly excluded from the referencing provision(s) at issue), provided that in no instance shall GTx, Inc. be relieved of any duty or obligation hereunder by the inclusion of its Affiliates in the definition of “GTx”.
     1.16 “ IMPROVEMENT INVENTION ” shall have the meaning set forth in OSU IIA#1.
     1.17 “ Independent SARM Invention ” shall have the meaning set forth in Section 2.8 hereof.
     1.18 “ Initial SARMS Disclosure ” and “ Initial SARMS Disclosures ” shall have the meaning set forth in the Recitals.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     1.19 “ IP RIGHTS ” shall have the meaning set forth in OSU IIA#1 when referring to an EXISTING INVENTION or an IMPROVEMENT INVENTION and the meaning set forth in OSU IIA#2 when referring to a NEW INVENTION.
     1.20 “ License Maintenance Fee ” shall have the meaning set forth in Section 4.1A. hereof.
     1.21 “ License Year ” shall mean a 12-month period beginning on August 20 of one year and ending on August 19 of the following year.
     1.22 “ Licensed Patent ” or “ Licensed Patents ” shall mean any or all of the (a) the patents set forth on Appendix A, attached hereto and incorporated herein by reference, (b) the patent applications set forth on Appendix A and any patents issuing therefrom, and (c) any other patent applications that may in the future be filed pursuant to Section 6.1 of this Agreement by GTx, whether in the United States of America or any other country, and any patents issuing therefrom, including, as they pertain to patents and patent applications described in (a)-(c) hereof, any and all substitutions for and divisional applications, continuation applications, continuation-in-part applications, provisional applications, and non-provisional applications, renewal applications, reissue applications, any foreign patent applications and divisional, continuation and continuation-in-part applications therefrom or national phase applications which claim priority from any of the pending patent applications set forth on Appendix A.
     1.23 “ Licensed Product ” or “ Licensed Products ” shall mean any Patented Product or Generic Product, provided that in the case of a Combination Product (as defined under Section 1.7), Licensed Product shall mean only that portion of the Combination Product containing a SARM or SARMS, and Net Sales for such Licensed Product contained within a Combination Product shall be determined as set forth under Section 1.29.
     1.24 “ Licensed Subject Matter ” shall mean Licensed Patents and Licensed Technology.
     1.25 “ Licensed Technology ” shall mean, except to the extent published or otherwise generally known to the public:
  A.   any know-how that is (i) related to an EXISTING INVENTION and/or an IMPROVEMENT INVENTION licensed by UTRF from OSU under OSU IIA#1; or (ii) related to a NEW INVENTION licensed by UTRF from OSU under OSU IIA#2; and
 
  B.   any technology, trade secrets, methods, processes, know-how, show-how, data, information, or results (except technology, trade secrets, methods, processes, know-how, show-how, data, information, or results solely related to NON-TGS NEW INVENTIONS to the extent not published or otherwise generally known to the public) that are (i) developed by any one or more of the UT Contributors in the course of employment by UT or developed by any other UT employee directly from his or her research or clinical investigation of SARMs utilizing any Proprietary SARM Know-How; and (ii) owned solely or in part by UTRF (but, if owned in part by UTRF, only to the extent of the part owned by UTRF); and (iii) necessary or reasonably useful for the practice of any of the Licensed Patent(s), including (for purposes of explaining, and without expanding, the meaning of Sections 1.25B. (i) through (iii)) any: (1) SARMs, and compositions and compounds containing SARMS, and analogs or isomers of SARMS, including without limitation radiolabeled SARMS, fluorescent labeled SARMS, and SARMS with radioisotopes incorporated therein, and SARMS comprising small molecules of R-bicalutamide; (2) methods of making, developing, or characterizing such SARMs, agents, compositions, and compounds of (1); and (3) any therapeutic, diagnostic, and prognostic methods of use of (1), including but not limited to methods of treating prostate cancer,
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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      methods of imaging, or methods related to fertility, contraceptive, andropause, muscle wasting, bone loss and muscle or bone mass uses.
     1.26 “ Major Countries ” shall have the meaning set forth in Section 6.6 hereof.
     1.27 “ Major Markets ” shall mean and include the United States, Great Britain, France, Germany, and Japan.
     1.28 “ Negotiation Period ” shall have the meaning set forth in Section 2.8D. hereof.
     1.29 “ Net Sales ” shall mean the gross amount actually received by GTx or any Sublicensee for the use, sale or distribution (hereinafter “ Sale ”) of a Licensed Product (hereinafter “ Gross Receipts ”), less the following:
  A.   refunds, credits, and/or discounts actually given in connection with a particular Sale in amounts customary in the trade for quantity purchases, cash payments, and prompt payments, but only if such refunds, credits, and/or discounts constitute a return of amounts already included in Gross Receipts;
 
  B.   refunds, credits and/or discounts actually given for Licensed Products that are rejected, recalled, returned, or destroyed by customers, but only if such refunds, credits and/or discounts constitute a return of amounts already included in Gross Receipts;
 
  C.   sales, tariff duties and/or use taxes directly imposed and with reference to a particular Sale, to the extent included in Gross Receipts;
 
  D.   outbound transportation expenses (including insurance relating thereto) directly related to a particular Sale, to the extent included in Gross Receipts;
 
  E.   the cost of export licenses, import duties, value added tax, and prepaid freight directly related to a particular Sale, to the extent included in Gross Receipts;
 
  F.   sales commissions paid by GTx to individuals who are not employees of GTx, a Sublicensee, or their respective Affiliates, to the extent such commissions are directly related to a particular Sale;
 
  G.   out-of-pocket service fees consistent with normal industry practice paid to distributors or wholesalers of drug product in payment for distribution of Licensed Product, provided that (a) such distributors and wholesalers are not Affiliates of GTx; (b) if any such distributor or wholesaler is an Affiliate of a Sublicensee, such fees are no more than that which such distributor/wholesaler actually and contemporaneously charges unaffiliated third party pharmaceutical companies for the same or similar service; (c) such fees may not be deducted more than once; (d) if a Sublicense shall be in effect, the fees paid by a Sublicensee may be deducted from Net Sales under this Agreement only if such fees are deducted from the equivalent of Net Sales under the relevant Sublicense agreement for purposes of calculating the royalty owed to GTx;
 
  H.   retroactive price reductions, chargeback payments and rebates actually granted in connection with a particular Sale to managed health care organizations or to federal, state and local governments, their agencies, purchasers, and reimbursers, but only if such reductions, chargeback payments, and rebates constitute a return of amounts already included in or calculated as part of Gross Receipts; and
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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  I.   [ * ] of any royalty (including a lump-sum payment) that is paid to a Third Party by GTx pursuant to a patent license agreement between GTx and such Third Party, provided that at the time of such payment (1) such Third Party owns or controls an issued patent containing a Valid Claim that, in the absence of such patent license agreement, would be infringed by the use, sale, or distribution of the composition of matter of a SARM licensed to GTx hereunder; and (2) the purpose of such royalty is for licensing of or acquiring such issued patent; and (3) the dollar amount of the [ * ] deduction for any calendar quarter shall not exceed the dollar amount of Net Sales in the same calendar quarter (computed without the application of this Section 1.29I.) from the use, sale, or distribution of Licensed Products containing such SARM in the country(ies) where such Third Party owns or controls such issued patent, it being agreed, however, that GTx may carry forward to future quarter(s) the amount by which the dollar amount of the [ * ] deduction exceeds the cumulative dollar amount of the actual deductions taken; and (4) GTx has not entered into such patent license agreement as of the date of execution of this Agreement.
For avoidance of doubt, no deductions shall be made for sales commissions paid to individuals who are employees of GTx, a Sublicensee, or their respective Affiliates, or for cost of collections. Notwithstanding the foregoing, Net Sales shall not include the amount received by GTx for the transfer of Licensed Product to a GTx Affiliate or a Sublicensee or the amount received by a Sublicensee for transfer or distribution of Licensed Product to GTx or a GTx Affiliate. Sales of Licensed Product for use in conducting clinical trials of a Licensed Product candidate in a country shall be excluded from Net Sales calculations for all purposes. Net Sales shall be determined in a consistent manner for all products sold by or on behalf of GTx and its Sublicensees and in accordance with applicable U.S. generally accepted accounting principles for GTx and any U.S. based Sublicensee.
Combination Product . In the event one or more Licensed Products are sold as part of a Combination Product in a particular country, the Net Sales of such Licensed Product(s), for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country, during the applicable Net Sales reporting period, by the fraction, A/(A+B), where:
A is the average sale price of the Licensed Product(s) by GTx or Sublicensees when sold separately in finished form in such country and B is the average sale price by GTx or Sublicensees, or, if they have no such right of sale, by a Third Party of the other product(s) included in the Combination Product when sold separately in finished form in such country, in each case during the applicable Net Sales reporting period.
In the event one or more Licensed Products are sold as part of a Combination Product and are sold separately in finished form in such country, but the other product(s) included in the Combination Product are not sold separately in finished form in such country, the Net Sales of the Licensed Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction C/D where:
C is the average sale price, in such country, of the Licensed Product(s) contained in such Combination Product when sold separately and D is the average sale price, in such country, for the Combination Product, in each case during the applicable Net Sales reporting period. Under no circumstances can C/D exceed one hundred percent (100%).
In the event that one or more of the Licensed Product(s) are not sold separately in finished form in the country, but all of the other product(s) included in the Combination Product in such country are sold separately, the Net Sales of the Licensed Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction (D-E)/D, where:
D is the average sale price, in such country, of the Combination Product, and E is the average sale price of the other product(s) included in the Combination Product in finished form in such country, in each case during the applicable Net Sales reporting period.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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In the event that the Net Sales of the Licensed Product(s) when included in a Combination Product cannot be determined using the methods above, Net Sales for the purposes of determining payments based on Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of F/(F+G) where:
F is the fair market value of the Licensed Product(s) and G is the fair market value of all other pharmaceutical product(s) included in the Combination Product, as reasonably determined in good faith by the Parties.
     1.30 “ NEW INVENTION ” shall have the meaning set forth in OSU IIA#2, but limited for purposes of this Agreement to invention(s) described in the Third Generation SARMS Disclosure.
     1.31 “ NON-TGS NEW INVENTION ” shall have the meaning set forth for NEW INVENTION in OSU IIA#2, but excluding for purposes of this Agreement invention(s) described in the Third Generation SARMS Disclosure.
     1.32 “ Option ” shall have the meaning set forth in Section 2.8 hereof.
     1.33 “ Option Period ” shall have the meaning set forth in Section 2.8A. hereof.
     1.34 “ OSU ” shall mean The Ohio State University, except that where it is used in reference to OSU IIA#1 or OSU IIA#2 in which case it shall mean The Ohio State University and OSURF, as set forth therein.
     1.35 “ OSU Contributors ” shall mean Dr. James T. Dalton and/or other research staff and students at OSU.
     1.36 “ OSU IIA#1 ” shall have the meaning set forth in the Recitals.
     1.37 “ OSU IIA#2 ” shall have the meaning set forth in the Recitals.
     1.38 “ OSURF ” shall mean The Ohio State University Research Foundation.
     1.39 “ Patented Product ” shall mean any product whose manufacture, use, sale or import is covered in whole or in part by a Valid Claim of the Licensed Patents in the country of manufacture, use, sale or import.
     1.40 “ Party ” and “ Parties ” shall have the meaning set forth in the introductory paragraph hereof.
     1.41 “ Prior License Agreements ” shall have the meaning set forth in the Recitals.
     1.42 “ Proprietary SARM Know-How ” shall mean know-how pertaining to an EXISTING INVENTION, IMPROVEMENT INVENTION or NEW INVENTION that is obtained from GTx or a UT Contributor and is not published or otherwise generally known to the public.
     1.43 “ Regulatory Approval ” shall mean any approvals granted by a governmental authority in a particular regulatory jurisdiction (with the exception of conditional approvals) that are necessary for the commercial manufacture, use, storage, importation, export, transport or sale of Licensed Products in that regulatory jurisdiction.
     1.44 “ Running Royalty ” shall have the meaning set forth in Section 4.1B. hereof.
     1.45 “ SARM ” or “ SARMS ” shall mean selective androgen receptor modulator(s) whose primary pharmacologic effect at any dose observed in vivo is mediated by the androgen receptor.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     1.46 “ Sublicense ” shall mean a direct grant of right, license, or option to any Licensed Subject Matter from GTx to a GTx Affiliate or a Third Party and any further such grant at any tier.
     1.47 “ Sublicense Revenue ” shall mean all payments actually received by GTx pursuant to each Sublicense, including, without limitation, up-front license fees, milestone payments, license maintenance fees, election fees, and all other fees and payments paid to GTx under each Sublicense agreement, excluding running royalties received by GTx that are calculated as a percentage of Sublicensee’s Net Sales and up-front fees paid by Ortho Biotech Products L.P. pursuant to the Joint Collaboration and License Agreement entered into with GTx effective as of March 16, 2004. GTx may deduct from Sublicense Revenue attributable to a particular Sublicense agreement payments received by GTx as reimbursement for actual, otherwise unreimbursed, out-of-pocket expenses as set out in such Sublicense agreement, provided that only reimbursements for expenses incurred in the development of one or more Licensed Products covered by such Sublicense may be deducted from Sublicense Revenue and then only to the extent of expenses incurred from and after the date of the Sublicense for pre-clinical or clinical research and development, including development of the formulation and manufacturing process, manufacturing of preclinical and clinical supplies and analytical and stability testing as required by the Food and Drug Administration to support a New Drug Application (NDA) filing for the Licensed Product. For the avoidance of doubt, Sublicense Revenue will not include any payments made to Third Parties by or on behalf of a Sublicensee for conducting clinical trials, filing new drug applications, commercially launching a product and/or marketing and selling a product, since these are not payments received by GTx from a Sublicensee on account of the Sublicense.
     1.48 “ Sublicense Royalty ” shall have the meaning set forth in Section 4.1C. hereof.
     1.49 “ Sublicensee ” shall mean and include any recipient of a Sublicense.
     1.50 “ Sublicensee Patent Rights ” shall have the meaning set forth in Section 6.2 hereof.
     1.51 “ Term ” shall have the meaning set forth in Section 12.1 hereof.
     1.52 “ Third Generation SARMS Disclosure ” shall have the meaning set forth in the Recitals.
     1.53 “ Third Party ” or “ Third Parties ” shall mean any person, party or entity other than GTx, its Affiliates, UTRF, or UT.
     1.54 “ UT ” shall mean The University of Tennessee.
     1.55 “ UT Contributo r” and “ UT Contributors ” shall mean one or more of James T. Dalton, Yali He, Dong-Jin Hwang, Leonid Kirkovsky, Craig Marhefka, Duane Miller, Michael Mohler, Arnab Mukherjee, Igor Rakov, Huiping Xu, Donghua Yin and any other UT employee who, while under the supervision of Duane Miller or James T. Dalton, contributed, either before or after the Effective Date, to the development of the Licensed Subject Matter.
     1.56 “ Valid Claim ” shall mean (a) a claim of an issued patent which has not expired and which has not been held revoked, invalid or unenforceable by decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed with the time allowed for appeal having expired, and which has not been admitted to be invalid through reissue or disclaimer or otherwise; or (b) any claim of a pending patent application, which (i) was filed in good faith; and (ii) has not been pending for more than eight (8) years.
      [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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SECTION 2
Grant
     2.1 During the Term hereof, and subject to the terms and conditions of this Agreement, UTRF hereby grants to GTx for the purpose of developing, making, having made, using, marketing, selling, having sold, importing, distributing, and offering for sale the Licensed Product:
  A.   an exclusive, worldwide right and license, with the right to grant Sublicenses, to practice under the Licensed Patents that are owned solely or in part by UTRF, excluding Licensed Patents to which a license is granted in Section 2.1B.; and
 
  B.   subject to the provisions of OSU IIA#1 and OSU IIA#2, as applicable, an exclusive, worldwide right and license, with the right to grant Sublicenses, to practice under the Licensed Patents and the IP RIGHTS that are owned jointly by UTRF and OSU or owned solely by OSU and that cover an EXISTING INVENTION, an IMPROVEMENT INVENTION or a NEW INVENTION, provided that OSU’s interest is licensed to UTRF with the right to grant sublicenses pursuant to the provisions of OSU IIA#1 or OSU IIA#2, as the case may be; and
 
  C.   subject to the provisions of OSU IIA#1 and OSU IIA#2, as applicable, an exclusive, worldwide right and license, with the right to grant Sublicenses, of the non-exclusive rights received by UTRF from OSU under OSU IIA#1 and OSU IIA#2 to utilize the Licensed Technology described in Section 1.25A.; and
 
  D.   subject to the provisions of OSU IIA#1 and OSU IIA#2, as applicable, an exclusive, worldwide, right and license, with the right to grant sublicenses, to utilize the Licensed Technology described in Section 1.25B.
Subject to the other provisions of this Agreement, the Parties hereby agree that the term “exclusive” means that to the extent of UTRF’s rights in the Licensed Subject Matter and subject to Federal Policy and the provisions of OSU IIA#1 and OSU IIA#2, UTRF shall not grant any other license under Licensed Subject Matter to any Third Party or take any action inconsistent with the rights granted to GTx under this Agreement. The Parties further acknowledge and agree that to the extent UTRF owns any Licensed Subject Matter “in part”, the license herein granted to GTx will not give GTx or its Sublicensees the right to exclude UTRF’s co-owner(s) from exercising any rights attendant to such co-ownership, whether such rights arise by law or contract, provided that UTRF agrees that it will not negotiate or enter into a license agreement or sublicense agreement, or otherwise grant any option or licenses or other rights with respect to such Licensed Subject Matter (whether in whole or in part), except as required by Federal Policy. For avoidance of doubt, the exercise by GTx of its right to grant Sublicenses will not serve to restrict GTx’s exercising of its right, as granted above, to practice under the Licensed Patents and/or to utilize the Licensed Technology.
     2.2 GTx agrees that UT and those persons who, as of the date of signature hereto on behalf of UTRF, are named UT Contributors shall have the royalty-free non-exclusive right to practice under the Licensed Patents and to utilize the Licensed Technology for non-commercial educational, research, and academic purposes only. GTx acknowledges and agrees that OSU retains the non-exclusive right to use EXISTING INVENTIONS and IMPROVEMENT INVENTIONS and associated IP RIGHTS under OSU IIA#1, as well as NEW INVENTIONS and associated IP RIGHTS under OSU IIA#2, to the extent of any of its respective rights therein, solely for non-commercial educational, research (including non-commercial clinical research), and academic purposes, but that OSU has contractually acknowledged that it has no rights for clinical research using a UTRF or GTx proprietary BRIDGED SARMS compound or to refer to any GTx regulatory filing without prior written approval from UTRF or GTx. UTRF agrees that during the Term hereof, it will not, without obtaining GTx’s prior written consent, enter
      [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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into a modification of OSU IIA#1 or OSU IIA#2 that (i) grants any additional ownership rights to OSU in an EXISTING INVENTION, IMPROVEMENT INVENTION, or NEW INVENTION; or (ii) places any additional obligations on GTx.
     2.3 To the extent that any research pertaining to inventions included in Licensed Technology and/or claimed in Licensed Patents has been or is in the future funded in whole or in part by the United States government, the United States government retains certain rights and requires certain obligations concerning such inventions as set forth in 35 U.S.C. §§200-212 and all regulations promulgated thereunder, as amended, and any successor statutes and regulations and applicable policies of such United States government sponsors, including, without limitation, to the extent applicable, the utilization and capability requirements found in the National Institutes of Health (NIH) Grants Policy Statement; “Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts”, Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55675-55679 (collectively, “ Federal Policy ”). GTx acknowledges that all rights herein granted to GTx may be subject to any such rights held by the United States government and further subject to any restrictions or obligations that may be imposed by the United States government pursuant to such rights. GTx shall materially comply with all aspects of Federal Policy applicable to a licensee pertaining to Licensed Technology and/or Licensed Patents and shall include and require its Sublicensees to include a provision in each Sublicense agreement, at any tier, that requires the Sublicensee to materially comply with all applicable aspects of Federal Policy. In the event UTRF or GTx shall receive notice of any action or notification by the United States government with respect to any rights and/or obligations under Federal Policy pertaining to any rights licensed hereunder to GTx, the Party receiving such notice shall provide prompt written notice thereof to the other Party.
     2.4 Intentionally omitted.
     2.5 GTx shall have the right to enter into Sublicenses and to permit further sublicensing by Sublicensees through multiple tiers with respect to the Licensed Subject Matter, subject to notifying UTRF of the identity and address of each Sublicensee within thirty (30) days after execution of such agreement by the parties thereto. No GTx Affiliate or Third Party shall have the right to practice under the Licensed Patents or utilize the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, or offer for sale any Licensed Product in the absence of a written Sublicense agreement. Any grant of rights by GTx or a Sublicensee to practice under the Licensed Patents or to utilize the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, or offer for sale any Licensed Product shall constitute a Sublicense. All Sublicenses shall be subject to this Agreement in all respects and shall include provisions that such Sublicensee is being granted a license under the Licensed Subject Matter as defined herein and subject to the terms hereof.
     2.6 GTx shall be responsible for its Affiliates and Sublicensees and shall not grant any rights that are inconsistent with the rights granted to and obligations of GTx hereunder. Each Sublicense agreement shall include a requirement that the Sublicensee use its commercially reasonable efforts to bring the subject matter of the Sublicense into commercial use. In addition, each Sublicense agreement shall include an acknowledgement that the ownership of the Licensed Patents are and shall remain in the name of UTRF and/or OSU, as set forth in OSU IIA#1 or OSU IIA#2, as the case may be, with the exception of Licensed Patents that are properly assigned to GTx, and, except as set forth in Section 6.2 hereof, an obligation on the part of the Sublicensee to assign, transfer and convey ownership of Licensed Patents to UTRF and/or, as UTRF may direct, to OSU, OSURF, or GTx. Upon termination of this Agreement, each Sublicensee’s rights under any Sublicense agreement shall also terminate, provided that if UTRF terminates this Agreement for default by GTx, a Sublicensee’s rights under a Sublicense agreement shall terminate only if UTRF has given such Sublicensee notice of default at least thirty (30) days prior to the effective date of termination and the Sublicensee shall have failed to cure such default, as provided in Section 12.3. UTRF shall have discharged its obligation to give notice of such default to a Sublicensee by sending (through any means contemplated under Section 15) a copy of GTx’s notice of default to the Sublicensee’s most recent street address of which UTRF has received written notice from GTx or the Sublicensee. No Sublicense shall relieve GTx of any of its
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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obligations under this Agreement, except that a Sublicensee shall have the right to cure a default of GTx as set out in Section 12.3. GTx shall forward to UTRF a complete copy of each Sublicense agreement (including, without limitation, all amendments and addenda) granted hereunder within thirty (30) days after execution of such agreement by the parties thereto, provided that each such Sublicense agreement (and any amendments and addenda related thereto) shall be deemed GTx’s Confidential Information and UTRF shall receive such information and documents in confidence and shall not publicly disclose, discuss or release such information or document to Third Parties (other than such information as may be reasonably necessary to be disclosed to UT Contributors and those persons within UT who have a need to know such information, provided that only such information concerning the Sublicense that is necessary to explain any payments to be made to a UT Contributor will be shared with the UT Contributors) without the prior written approval of GTx except for the purposes of enforcement of UTRF’s rights, defense of any claim against UTRF, UT, UT Contributors, OSU, OSURF, or OSU Contributors, compliance with Federal Policy, compliance with OSU IIA#1 or OSU IIA#2, or compliance with applicable law, regulation, or court order. GTx shall be responsible for payment of royalties from Sublicensees’ Net Sales provided, however, that GTx may arrange for such payments to be made to UTRF by a Sublicensee, with the understanding that the amount paid to UTRF shall not be decreased thereby and that UTRF’s acceptance of such payments from a Sublicensee does not relieve GTx of the ultimate responsibility for any other or future payment required hereunder. Each such Sublicense agreement shall include an audit right by UTRF of the same scope as provided in Section 5.1 herein with respect to UTRF’s audit of GTx’s books of account.
     2.7 Any act or omission of an Affiliate or Sublicensee, which would constitute a breach of this Agreement if performed by GTx, shall be deemed to be a breach by GTx of this Agreement, subject however to the same cure provisions in favor of GTx, an Affiliate, or Sublicensee as are otherwise provided herein for breach by GTx.
     2.8 During the Term hereof, UTRF shall promptly notify GTx in writing (i) upon becoming aware of any SARM invention owned solely or in part by UTRF which is not (a) based on or developed from Proprietary SARM Know-How or (b) developed at UT from grants or research payments made to UT by GTx; or (ii) upon acquiring from OSU a license pursuant to OSU IIA#2, with the right to sublicense, to a NON-TGS NEW INVENTION (each invention described in subsection (i) and subsection (ii) herein being an “ Independent SARM Invention ”). Subject to the rights of Third Parties (in the event UTRF co-owns such Independent SARM Invention with a Third Party), GTx will have an exclusive option to acquire, to the extent possible, a worldwide, exclusive (as defined in Section 2.1), royalty-bearing license to such Independent SARM Invention (“ Option ”), provided that the grant of such Option does not violate Federal Policy and further subject to the following:
  A.   The Option shall commence upon UTRF’s written notice to GTx of the existence of such Independent SARM Invention and shall terminate upon the earlier of (i) the expiration of six (6) calendar months from the date of such notice; or (ii) the giving of written notice to UTRF by GTx that it does not intend to exercise the Option; or (iii) the termination of this Agreement (“ Option Period ”)
 
  B.   GTx may exercise the Option during the Option Period by giving written notice of same to UTRF, provided that GTx is not then in default or breach of any of its obligations under this Agreement.
 
  C.   Upon proper exercise of the Option by GTx, UTRF and GTx shall negotiate in good faith in an effort to reach agreement on the economic terms of a license to GTx of the Independent SARM Invention that is the subject of such Option, it being the intent that upon agreement of the Parties as to such economic terms, they will be expeditiously incorporated into a new license agreement with non-economic terms that are substantially similar to those contained herein, to the extent applicable.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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  D.   In the event GTx does not exercise the Option for a particular Independent SARM Invention within the Option Period or the Parties do not execute a license agreement within six (6) months after exercise of the Option for a particular Independent SARM Invention by GTx, which time period may be extended by written agreement of the Parties (the “ Negotiation Period ”), UTRF shall have no further obligation to GTx under this Agreement with regard to such Independent SARM Invention. In the absence of a license agreement granting GTx rights to such Independent SARM Invention, GTx agrees that it will not use such Independent SARM Invention for any commercial or non-commercial purpose.
 
  E.   During the Option Period and the Negotiation Period, if any, UTRF will confer with GTx concerning proper protection of such Independent SARM Invention, but UTRF will have sole authority regarding decisions concerning such protection, including patent activities, provided that if GTx exercises the Option, UTRF shall coordinate all decisions regarding patent protection with GTx and shall take no actions with regard to intellectual property protection for such Independent SARM Invention that are contrary to GTx’s advice unless UTRF reasonably believes rights may be lost unless it acts to protect those rights. From and after the commencement of the Option Period, whether or not GTx exercises the Option and whether or not the Parties subsequently execute a license agreement for GTx to secure rights to the Independent SARM Invention prior to the end of the Negotiation Period, GTx shall, within thirty (30) days after receipt of each invoice, reimburse UTRF for all reasonable and documented out-of-pocket expenses incurred by UTRF during the Option Period and the Negotiation Period, if any, for filing, prosecution, and maintenance of United States and foreign patent applications, issued patents, and other forms of intellectual property protection for such Independent SARM Invention, which intellectual property rights shall be assigned solely to UTRF or jointly to UTRF and its co-owner(s), if any, provided that UTRF shall have consulted with GTx regarding such proposed patent protection and UTRF shall have undertaken to make those filings that are reasonably necessary to protect and preserve its rights in the Independent SARM Invention to reasonably minimize the expenses GTx may be required to reimburse in accordance with this Section 2.8E until the Option Period and Negotiation Period shall have expired. If GTx shall fail to enter into a license agreement with UTRF for such Independent SARM Invention, it shall be entitled to receive a dollar for dollar reduction against Running Royalties and/or Sublicense Revenue (in the same manner as the reduction is to be applied in Section 4.1D) for the total amount of costs it shall have reimbursed to UTRF for the expenses incurred by UTRF under this Section 2.8E.
SECTION 3
Diligence
     3.1 GTx shall use its commercially reasonable efforts to develop and commercialize Licensed Products through a commercially reasonable program for exploitation of the Licensed Patents and the Licensed Technology.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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SECTION 4
Payments and Royalties
     4.1 For the rights, privileges and license granted hereunder, GTx shall pay to UTRF, in addition to the Consideration Fee, the following fees and royalties in the manner hereinafter provided until this Agreement expires or is terminated.
  A.   License Maintenance Fee . GTx shall pay UTRF a license maintenance fee in the amount of [ * ] on [ * ] and on [ * ] thereafter during the Term of this Agreement (“ License Maintenance Fee ”). The License Maintenance Fee actually paid for a particular License Year shall reduce, dollar for dollar, the Running Royalty (defined below) payable in the same License Year. License Maintenance Fees paid in excess of the Running Royalty payable in the same License Year shall not be creditable to the Running Royalty for future years. The Parties acknowledge and agree that there are no License Maintenance Fees due and owing to UTRF by GTx under the Prior License Agreements.
 
  B.   Running Royalty . For the purposes of this Section 4.1(B), royalties on Net Sales of all Patented Products and Generic Products incorporated in Combination Products shall be subject to the calculation of Net Sales with respect to Combination Products, as applicable, as set forth in Section 1.29.
  (1)   GTx shall pay UTRF [ * ] of Net Sales of all Patented Products; and
 
  (2)   GTx shall pay UTRF a percentage of Net Sales attributable to the use, sale or distribution of Generic Products, which percentage shall be determined on a Generic Product-by-Generic Product, country-by-country, and calendar quarter-by-calendar quarter basis. In each country the percentage shall be calculated as the [ * ] during the applicable calendar quarter divided by the [ * ] during the same calendar quarter [ * ] (provided that in no event shall the resulting percentage [ * ] ). Furthermore, until such time as this Agreement shall expire in accordance with Section 12.1, should there be no sales in the Major Markets by GTx or Sublicensees of the same Licensed Product covered by a Valid Claim of Licensed Patents during the same calendar quarter, the percentage shall be [ * ] ;
(the royalty under 4.1B.(1) and 4.1B.(2) being the “ Running Royalty ”). Notwithstanding the foregoing, in the event that, for a particular Licensed Product in a given License Year under a specific Sublicense agreement, the running royalty (as a percentage of Net Sales) owed to GTx (including the Running Royalty owed to UTRF, if to be paid by the Sublicensee) is less than [ * ] of Sublicensee’s Net Sales after deduction of running royalties (calculated as a percentage of Net Sales) owed and actually paid by or on behalf of GTx to one or more Third Parties as consideration for the grant by such Third Party(ies) of a license to technology incorporated in such Licensed Product, the Running Royalty owed to UTRF shall be [ * ] of the amount owed to GTx (including the Running Royalty owed to UTRF, if to be paid by the Sublicensee) for that License Year. By way of example only, in the event that during a particular License Year GTx is entitled to receive a running royalty equal to [ * ] of its Sublicensee’s Net Sales of a particular Licensed Product in the EU and is in turn required to pay, and does actually pay, [ * ] of Sublicensee’s Net Sales of that Licensed Product in the EU to a Third Party, then UTRF’s Running Royalty would be [ * ] of Sublicensee’s Net Sales of that Licensed Product in the EU.
  C.   Sublicense Royalty . GTx shall pay UTRF [ * ] of Sublicense Revenue (“ Sublicense Royalty ”)
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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  D.   Reduction . GTX shall be entitled to reduce dollar-for-dollar the Running Royalties and/or the Sublicense Royalties (such reduction to be applied at GTx’s sole discretion) which are otherwise payable to UTRF by a total of [ * ] to reimburse GTx for certain shared legal expenses previously borne by GTx in connection with the negotiation of OSU IIA#1.
     4.2 In the event that any taxes are required by law or regulation to be levied in any foreign country by a foreign taxing authority on any Running Royalty or Sublicense Royalty payable in UTRF’s name under this Agreement and GTx determines in good faith that it or its Sublicensee must withhold such taxes:
  A.   GTx or its Sublicensee shall have the right to withhold and pay such taxes withheld on the Running Royalty and/or Sublicense Royalty to the local tax authorities in UTRF’s name;
 
  B.   GTx or its Sublicensee shall pay the net amount of Running Royalty and/or Sublicense Royalty due after reduction by the amount of such taxes that are actually withheld and paid;
 
  C.   GTx or its Sublicensee shall provide UTRF with appropriate documentation and receipts supporting such withholding; and
 
  D.   GTx or its Sublicensee shall inform UTRF in writing within thirty (30) days of being notified that taxes will be or have been required by a taxing authority to be withheld on the Running Royalty and/or Sublicense Royalty.
     4.3 In the event that a Running Royalty is payable to UTRF on the same Net Sales revenue or a Sublicense Royalty is payable to UTRF on the same Sublicense Revenue under this Section 4 and under one or more other UTRF/GTx license agreements, GTx shall only be required to pay UTRF such royalty under one such license agreement, subject to the provisions of Section 5.2 and provided that if the amount due varies from one such license agreement to another, GTx shall pay the highest amount.
     4.4 Within [ * ] following the close of each calendar quarter in which Net Sales revenue is received by GTx or a Sublicensee, or Sublicense Revenue is received by GTx, payment of all amounts due to UTRF, including but not limited to Running Royalty and Sublicense Royalty, shall be made to UTRF or its designee in United States dollars in Knoxville, Tennessee, or at such other place as UTRF may reasonably designate consistent with the laws and regulations controlling in any foreign country, provided that the [ * ] period may be extended for up to [ * ] after the close of each calendar quarter if a Sublicensee under a Sublicense requires more time than [ * ] to make its sales and royalty calculation and its royalty payment available to GTx. In the event GTx arranges for any payment under this Section 4.4 to be made to UTRF by a Sublicensee pursuant to Section 2.6, if such payment is not received by UTRF within the [ * ] period set forth herein (or within up to [ * ] extension period as stated above), GTx shall be deemed to be in breach of this Agreement, subject to the same cure provisions in favor of GTx as set forth in Section 12. If any currency conversion shall be required in connection with the payment of royalties hereunder, such conversion shall be made by using the exchange rate procedure listed in a Sublicense, if applicable, or in the absence of an applicable Sublicense provision addressing this issue, using the exchange rate listed in the Wall Street Journal for major New York banks on the last business day of the calendar quarter during which the royalty-bearing revenue was received by GTx or its Sublicensees, as the case may be.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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SECTION 5
Reports and Records
     5.1 No more often than once each License Year, UTRF or its accounting agents shall have the right to inspect the books of account of GTx. GTx shall keep full, true and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to UTRF hereunder. Said books of account shall be kept at GTx’s principal place of business or the principal place of business of the appropriate division of GTx to which this Agreement relates. Said books and the supporting data shall be open at all reasonable times for [ * ] following the end of the License Year to which they pertain, to the inspection of UTRF or its accounting agents for the purpose of verifying GTx’s royalty statements. If any examination reveals a shortage in amounts paid to UTRF, GTx shall promptly reimburse UTRF for the shortage, together with interest thereon as provided in Section 5.4, and if the shortage is equal to or greater than [ * ] of the total amount due in the period under audit, GTx shall reimburse UTRF for the cost of the examination as well. If the examination reveals an overpayment to UTRF, GTx may deduct the amount of such overpayment from future amounts owed to UTRF hereunder.
     5.2 GTx shall deliver to UTRF true and accurate reports to confirm a royalty accounting hereunder within [ * ] after the close of each calendar quarter (provided that the [ * ] period may be extended for up to [ * ] after the close of each calendar quarter if a Sublicensee under a Sublicense requires more time than [ * ] to make such information and its royalty payment available to GTx) and a summary of GTx’s activities during such quarter to develop and commercialize Licensed Products. These reports shall be deemed GTx’s Confidential Information and shall include at least the following, on a Licensed Product-by-Licensed Product, country-by-country, and Sublicensee-by-Sublicensee basis:
  A.   The number/amount of Licensed Product used, sold, or imported by and/or for GTx and Sublicensees and other information that is reasonably necessary to allow UTRF to properly calculate royalties due to OSU under OSU IIA#1 and, if applicable, OSU IIA#2 (e.g., the number/amount of BRIDGED SARMS or other SARMS sold);
 
  B.   The total amounts invoiced and received by GTx and Sublicensees for Licensed Products used or sold by GTx and/or Sublicensees including (i) an accounting of Net Sales for Running Royalty payments due to UTRF under Section 4.1B. above, with separate calculations for Patented Products, Generic Products, and Combination Products reflecting the type and amount of all deductions from Gross Receipts; and (ii) an accounting of Sublicense Revenue for Sublicense Royalty payments due to UTRF under Section 4.1C above reflecting the type and amount of all amounts deducted or excluded from Sublicense Revenue;
 
  C.   The Running Royalty and Sublicense Royalty due, showing the application of any reduction pursuant to Section 4.1D and Section 2.8E., if applicable;
 
  D.   For all royalties due to UTRF pursuant to Section 4.1, the report shall include (i) the manner in which such royalties were calculated and the amount allocable to each Licensed Product; and (ii) if any such royalties are payable to UTRF under this Agreement and under one or more other UTRF/GTx license agreements, GTx shall set out in its report the amount of such royalties covered by multiple license agreements and identify all such license agreements to which such royalties apply, notwithstanding that GTx is required to pay such royalties under only one such license agreement;
 
  E.   The names and addresses of all Sublicensees for or on whose account royalty payments are being made in accordance with the terms hereof; and
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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  F.   Upon request by UTRF, any other information that may be necessary for the purpose of showing the amounts payable to UTRF hereunder, amounts payable to OSU pursuant to IIA#1 and/or IIA#2 and/or compliance by GTx with the diligence provisions of Section 3.
     5.3 With each such report submitted, GTx shall pay to UTRF the royalties due and payable under this Agreement. If no royalties shall be due, GTx shall so report. UTRF is hereby authorized to provide to OSU or OSURF a copy of any written reports provided to UTRF by GTx, subject to the confidentiality provisions of OSU IIA#1, and if applicable, OSU IIA#2.
     5.4 Any amount owed by GTx under this Agreement that is not received by UTRF on or before the date due shall bear interest at a per annum rate [ * ] above the prime rate quoted in the Wall Street Journal for major New York banks on the date due, or if not quoted on the date due, the rate quoted on the first business day after the date due. GTx shall also pay all reasonable collection costs at any time incurred by UTRF in obtaining payment of amounts past due, including reasonable attorneys fees. If the transfer or the conversion into United States Dollar equivalents in any such instance is not lawful or possible, the payment of such part of the royalties as is necessary shall be made by the deposit thereof, in the currency of the country where the sales were made on which the royalty was based, to the credit and account of UTRF or its nominee in any commercial bank or trust company of its choice located in that country, prompt notice of which shall be given by GTx to UTRF.
SECTION 6
Patent Prosecution
     6.1 During the Term and subject to the terms hereof and the applicable provisions of OSU IIA#1 and OSU IIA#2, GTx shall have (a) complete control of the prosecution of the Licensed Patents listed on Appendix A and will be responsible for maintaining any patents issuing therefrom and (b) the exclusive right and responsibility to prepare, file, prosecute and maintain all patent applications and patents claiming (i) EXISTING INVENTIONS and IMPROVEMENT INVENTIONS that are solely or partly owned by UTRF or licensed to UTRF under OSU IIA#1 with the right to sublicense; (ii) NEW INVENTIONS that are licensed to UTRF under OSU IIA#2 with the right to sublicense; (iii) inventions solely owned by UTRF that are described in the Initial SARMS Disclosures; (iv) invention(s) disclosed in the Third Generation SARMS Disclosure that are owned in whole or in part by UTRF and are not covered by Section 6.1(ii); and (v) Licensed Technology defined in Section 1.25B., and such patent applications and patents shall be added to Appendix A. GTx shall use patent counsel of its own choice, at its own expense. GTx agrees to pay all costs incident to the United States and foreign applications, patents and like protection relating to the Licensed Subject Matter, including all costs incurred for filing, prosecution, issuance and maintenance fees as well as any costs incurred in filing continuations, continuations-in-part, divisionals or related applications and any re-examination, reissue, opposition, or interference proceedings. Subject to the provisions of Section 6.4, GTx shall file and maintain patent applications claiming Licensed Technology defined in Section 1.25B. in such countries as GTx in its sole discretion shall select. Except for Licensed Patents listed on Appendix A that are assigned to GTx or Sublicensee Patent Rights as described in Section 6.2, UTRF shall have the sole and exclusive right, title and ownership in and to all Licensed Patents, including Licensed Patents claiming Licensed Technology defined in Section 1.25B., which now exist or may exist in the future, including all United States and foreign patent applications filed and patents issued pursuant to this Section 6, except Licensed Patents claiming invention(s) made in whole or in part by one or more OSU Contributors or other Third Parties as determined in accordance with applicable patent laws, ownership of which shall be subject to the provisions of Section 6.2.
     6.2 GTx and its Sublicensees shall assign, transfer and convey to UTRF all right, title and interest in and to all Licensed Patents, except (i) those claiming invention(s) made in whole or in part by one or more OSU Contributors or Third Parties, which Licensed Patents are to be assigned, in whole or in part, as the case may be, to OSU, OSURF, or in accordance with the instructions of such Third Party(ies); and (ii) those listed on Appendix A that, as of the Effective Date, have been assigned to GTx. GTx shall be responsible for recording an assignment, as
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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appropriate, to UTRF and/or OSU and/or OSURF and/or to such individual(s) or entity(ies) as such Third Party(ies) may direct, of patent applications filed pursuant to this Section 6 with the United States Patent and Trademark Office and with each foreign Patent Office in which such applications are filed. Notwithstanding the foregoing, GTx may permit its Sublicensees to retain ownership of patent applications or patents claiming invention(s) made by employee(s) or agent(s) of such Sublicensee which result from the Licensed Subject Matter (“ Sublicensee Patent Rights ”), provided that the pertinent Sublicense agreement shall include provision(s) granting to UTRF, UT, OSU, and OSURF a perpetual worldwide non-exclusive royalty-free right to practice, for non-commercial educational, research and academic purposes only (such right to exclude the practice of Licensed Patents for any fee-for-services arrangement or for sponsored research on behalf of any commercial entity), under Sublicensee Patent Rights claiming inventions necessary or reasonably useful in the practice of the Licensed Patents.
     6.3 GTx agrees to provide UTRF with reasonable (which the Parties agree generally means not less than two weeks) advance notice prior to filing of new patent applications containing new subject matter, including, without limitation, continuation-in-part applications, within Licensed Patents. Copies of applications that are divisional or continuation applications of Licensed Patents shall be furnished to UTRF and OSU or OSURF within thirty (30) days of their being initially filed with an appropriate patent office. GTx shall keep UTRF and OSU or OSURF informed, at GTx’s expense, of filing, prosecution, maintenance, and abandonment of applications and issued patents within Licensed Patents pursuant to this Section 6, including submitting to UTRF and OSU or OSURF copies of all patent applications in accordance with the previous sentence, and submitting to UTRF and OSU or OSURF copies of material, official actions and responses thereto, and other material written communications it or its patent counsel receives from or files with the U.S. Patent and Trademark Office and the equivalent foreign offices within forty-five (45) days of filing or receipt, as the case may be. Notwithstanding the foregoing, GTx shall submit information and copies of documents to OSU or OSURF only with regard to EXISTING INVENTIONS, IMPROVEMENT INVENTIONS, and NEW INVENTIONS. GTx shall consult with UTRF prior to the abandonment of applications or issued patents with the Licensed Patents.
     6.4 UTRF agrees to reasonably cooperate with GTx, at GTx’s request and expense, to whatever extent is reasonably necessary but not inconsistent with OSU IIA#1 or OSU IIA#2, when applicable, to procure patent protection for Licensed Technology, including execution of all appropriate documents to provide GTx the full benefit of the licenses granted herein.
     6.5 In the event that GTx decides not to continue prosecution of any United States or foreign patent application within Licensed Patents to issuance or not to maintain any United States or foreign patent within Licensed Patents in a particular jurisdiction, GTx shall timely notify UTRF in writing in order that UTRF may continue said prosecution or maintenance of such patent applications or patents at its option and at its own expense in such jurisdiction. GTx’s right under this Agreement to practice the invention(s) under such patents and patent applications shall immediately terminate in such jurisdiction upon UTRF’s assuming said costs provided that the application for which GTx decides not to continue prosecution, or the patent which GTx decides not to maintain, is before the patent office of a country that is a Major Market. Subject to the provisions of Section 6.6 below, GTx shall not be considered in default and this Agreement shall not terminate as to any particular jurisdiction merely due to the fact that GTx decides not to continue prosecution of a patent application to issuance, or not to maintain any patent in any country that is not a Major Market. If GTx fails to notify UTRF in sufficient time for UTRF to reasonably continue prosecution, or the maintenance of, a patent or patent application in a Major Market, GTx shall be considered in default of this Agreement.
     6.6 If (a) GTx and UTRF decide not to file a patent application claiming an EXISTING INVENTION or an IMPROVEMENT INVENTION or a NEW INVENTION, which is licensed to GTx hereunder, or (b) if GTx allows a pending patent application in Licensed Patents claiming an EXISTING INVENTION or an IMPROVEMENT INVENTION or a NEW INVENTION licensed to GTx hereunder to go abandoned without filing a continuation, division, re-issue or other application having the same priority and without issuance of a patent
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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having the same priority and UTRF does not assume said costs pursuant to Section 6.5, or (c) GTx decides not to maintain a previously-filed patent application or issued patent claiming an EXISTING INVENTION or IMPROVEMENT INVENTION or a NEW INVENTION licensed to GTx hereunder and UTRF does not assume said costs pursuant to Section 6.5, in each such case in the United States, England, France, Germany, Italy, Spain, Canada, Australia, China, India, Russia, Switzerland, and Japan (collectively, the “ Major Countries ”), OSU or OSURF may elect to file, prosecute, and/or maintain, as the case may be, such application or patent in any Major Country in which GTx did not file, prosecute, or maintain (collectively, the “ Exception Countries ”), at its sole expense. In that event, GTx agrees that OSU or OSURF will be free to exploit and to assign or license its interest in such patent application and/or patent to Third Parties in the Exception Countries, provided that any such assignment or license will be limited to domestic manufacture and sale in the Exception Countries, with no right to export or sell products or otherwise to compete with GTx or Sublicensees in the rest of the world. In the event GTx believes that any exploitation, assignment or license of OSU’s or OSURF’s interests in the Exception Countries competes with or interferes with GTx’s exclusive commercialization and exploitation of Licensed Technology licensed hereunder in any Major Country other than the Exception Countries, GTx agrees to so notify OSU or OSURF. GTx acknowledges that OSU or OSURF has contractually committed to take all reasonable measures to preclude such competition or interference, including without limitation terminating any license in the Exception Countries and taking enforcement action.
     6.7 GTx agrees to forward in a timely manner all correspondence in need of signature by OSU Contributors to the Memphis office of UTRF (unless UTRF shall otherwise direct) in a timely manner. UTRF agrees, in turn, to promptly forward such correspondence to OSU or OSURF for signature, but UTRF shall have no responsibility for costs or other damages that may be incurred because of delay at OSU or OSURF in returning signed documents.
     6.8 UTRF agrees to use reasonable business efforts to promptly notify GTx of any option to license an IMPROVEMENT INVENTION or NEW INVENTION upon such option arising in favor of UTRF under either OSU IIA#1 or OSU IIA#2 and to take such actions as are necessary and appropriate to exercise any such option upon receiving notice from GTx that it wishes to file a Licensed Patent claiming such IMPROVEMENT INVENTION or NEW INVENTION.
     6.9 GTx and all its Sublicensees shall mark all products covered by Licensed Patents with patent numbers in accordance with the statutory requirements in the country(ies) of manufacture, use, and sale.
     6.10 UTRF and GTx agree that one or more senior administrator representing each of the Parties will meet at least on a semi-annual basis at a mutually agreeable time and place so that GTx may provide UTRF with an oral update on the current development, licensing, regulatory, and commercialization status of Licensed Products and to discuss any issues raised by either UTRF or GTx arising out of, under, or in connection with this Agreement. UTRF agrees to notify OSURF no less than 14 days in advance of any such meeting, and that a representative from OSURF shall have the right to attend if they agree to confidentiality terms no less stringent than described in Section 18.
SECTION 7
Infringement
     7.1 GTx shall inform UTRF and UTRF shall inform GTx promptly in writing of any alleged assertion and/or claim of infringement of the Licensed Patents by a Third Party and of any available evidence thereof.
     7.2 GTx shall have the first, sole and exclusive right, but shall not be obligated, to prosecute or defend at its own expense all infringements or opposition, interference a

 
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