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

License Agreement

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

Genotherapeutics, Inc | GTx, Inc | Ipsen Limited | Tennessee Research Corporation

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Title: UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION and GTx, INC. 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. 
AMENDED AND RESTATED LICENSE AGREEMENT, Parties: genotherapeutics  inc , gtx  inc , ipsen limited , tennessee research corporation
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Exhibit 10.41
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
UNIVERSITY OF TENNESSEE RESEARCH FOUNDATION
and
GTx, INC.
AMENDED AND RESTATED LICENSE AGREEMENT
     THIS AMENDED AND RESTATED LICENSE AGREEMENT made and entered into this 24 th day of September, 2007, having an effective date of July 24, 1998 (the “ Effective Date ”) by and between University of Tennessee Research Foundation (formerly known as The University of Tennessee Research Corporation), a Tennessee corporation having an office at 1534 White Avenue, Knoxville, Tennessee 37996. (hereinafter “ UTRF ”), and GTx, Inc. (formerly known as Genotherapeutics, Inc.), a Delaware corporation, located at 3 N. Dunlap St., Memphis, Tennessee 38163 (hereinafter “ GTx ”), hereinafter sometimes referred to individually as a “ Party ” and collectively as the “ Parties ”.
RECITALS
      WHEREAS , UTRF owns, in whole or in part, certain Licensed Patents (as defined herein) and Licensed Technology (as defined herein), the subject matter of which was initially developed by one or more of the UT Contributors (as defined herein) in the course of their employment with The University of Tennessee (“ UT ”);
      WHEREAS , the UT Contributors submitted to UT the invention disclosure form [ * ] designated by UTRF as file number PD [ * ] (“ Initial SERM Disclosure ”);
      WHEREAS, UTRF and GTx have previously entered into a separate agreement, titled “Amended and Restated Exclusive License Agreement” and made effective as of July 24, 1998, whereby GTx was granted an exclusive license to Licensed Patents (as defined therein) and Licensed Technology (as defined therein) which arose out of the technology described in the Initial SERM Disclosure (the “ Prior License Agreement ”);
      WHEREAS , GTx entered into a Collaboration and License Agreement dated September 7, 2006 (the “ Ipsen Sublicense ”) with Ipsen Limited (“ Ipsen ”) to grant Ipsen exclusive rights in the European Territory (as defined in the Ipsen Sublicense) to GTx’s product candidate, Acapodene ® , and other products containing toremifene citrate, for methods of use that include those encompassed within the Licensed Patents;
      WHEREAS , GTx provided UTRF with a copy of the Ipsen Sublicense in accordance with the provisions of the Prior License Agreement;
      WHEREAS , the Parties now desire to enter into this “Amended and Restated License Agreement” for the purpose of making certain changes regarding the rights and obligations of the Parties; and
      WHEREAS , the Parties intend that this Agreement shall supersede the Prior License Agreement and render it null and void.
      NOW, THEREFORE , for and in consideration of the premises and other good and valuable consideration, including a payment in the amount of Two Hundred Ninety Thousand Dollars ($290,000; the “ Consideration Fee ”), which is paid by GTx in consideration of UTRF’s execution of this Agreement, the Parties hereto expressly agree as follows:

 


 
SECTION 1
Definitions
     1.1 “ Actions ” shall have the meaning set forth in Section 17.1 hereof.
     1.2 “ Active Ingredient ” means the material(s) in a pharmaceutical product which provide its pharmacological activity (excluding formulation components such as coatings, stabilizers or controlled release technologies).
     1.3 “ Affiliate ” shall mean any corporation, partnership, or other entity that at any time during the Term of this Agreement, directly or through one or more intermediaries, Controls or is Controlled by or is under common Control with a Party to this Agreement or a Sublicensee, but only for so long as the relationship exists. A corporation or other entity shall no longer be an Affiliate when through loss, divestment, dilution or other reduction of ownership, the requisite Control no longer exists.
     1.4 “ Agreement ” shall mean this Amended and Restated License Agreement.
     1.5 “ Claims ” shall have the meaning set forth in Section 8.1 hereof.
     1.6 “ Combination Product ” means either (i) any pharmaceutical product that consists of at least one SERM and at least one other Active Ingredient that is not a SERM, or (ii) any combination of a SERM and another pharmaceutical product that contains at least one other Active Ingredient that is not a SERM where such products are not formulated together but are sold together as a single product and invoiced as one product.
     1.7 “ Confidential Information ” shall have the meaning set forth in Section 18.2 hereof.
     1.8 “ Control ” or “ Controls ” or “ Controlled ” shall mean: (i) in the case of a corporation, ownership or control, directly or indirectly, of at least fifty one percent (51%) of the shares of stock entitled to vote for the election of directors; or (ii) in the case of an entity other than a corporation, ownership or control, directly or indirectly, of at least fifty one percent (51%) of the assets of such entity.
     1.9 “ Effective Date ” shall have the meaning set forth in the introductory paragraph hereof.
     1.10 “ Federal Policy ” shall have the meaning set forth in Section 2.3 hereof.
     1.11 “ Generic Product ” shall mean a product that is derived from, made with, uses, or incorporates, in whole or in part, Licensed Technology, but is not covered or claimed in whole or in part by a Valid Claim of the Licensed Patents in the country of manufacture, use, or sale or import.
     1.12 “ GTx ” shall mean GTx, Inc. and its Affiliate(s) (unless such Affiliates are clearly excluded from the referencing provision(s) at issue), provided that in no instance shall GTx, Inc. be relieved of any duty or obligation hereunder by the inclusion of its Affiliates in the definition of “GTx”.
     1.13 “ Independent SERM Invention ” shall have the meaning set forth in Section 2.8 hereof.
     1.14 “ Initial SERM Disclosure ” shall have the meaning set forth in the Recitals.
     1.15 “ Ipsen ” shall have the meaning set forth in the Recitals.
     1.16 “ Ipsen Sublicense ” shall have the meaning set forth in the Recitals.
     1.17 “ License Maintenance Fee ” shall have the meaning set forth in Section 4.1A. hereof.
     1.18 “ License Year ” shall mean a 12-month period beginning on July 24 th of one year and ending on July 23 rd of the following year.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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     1.19 “ Licensed Patent ” or “ Licensed Patents ” shall mean any or all of the (a) the patents set forth on Appendix A, attached hereto and incorporated herein by reference, (b) the patent applications set forth on Appendix A and any patents issuing therefrom, and (c) any other patent applications that may in the future be filed pursuant to Section 6.1 of this Agreement by GTx, whether in the United States of America or any other country, and any patents issuing therefrom, including, as they pertain to patents and patent applications described in (a)-(c) hereof, any and all substitutions for and divisional applications, continuation applications, continuation-in-part applications, provisional applications, and non-provisional applications, renewal applications, reissue applications, any foreign patent applications and divisional, continuation and continuation-in-part applications therefrom or national phase applications which claim priority from any of the pending patent applications set forth on Appendix A.
     1.20 “ Licensed Product ” or “ Licensed Products ” shall mean any Patented Product or Generic Product, provided that in the case of a Combination Product (as defined under Section 1.6), Licensed Product shall mean only that portion of the Combination Product containing a SERM or SERMS, and Net Sales for such Licensed Product contained within a Combination Product shall be determined as set forth under Section 1.25.
     1.21 “ Licensed Subject Matter ” shall mean Licensed Patents and Licensed Technology.
     1.22 “ Licensed Technology ” shall mean, except to the extent published or otherwise generally known to the public any technology, trade secrets, methods, processes, know-how, show-how, data, information, or results (except technology, trade secrets, methods, processes, know-how, show-how, data, information, or results solely related to Independent SERM Inventions to the extent not published or otherwise generally known to the public) that are (i) developed by any one or more of the UT Contributors in the course of employment by UT or developed by any other UT employee directly from his or her research or clinical investigation of SERMs utilizing any Proprietary SERM Know-How; and (ii) owned solely or in part by UTRF (but, if owned in part by UTRF, only to the extent of the part owned by UTRF); and (iii) necessary or reasonably useful for the practice of any of the Licensed Patent(s), including (for purposes of explaining, and without expanding, the meaning of Sections 1.22 (i) through (iii)) the chemoprevention of prostate cancer and any methods of which the primary purpose is to administer to a subject an effective dose of a chemopreventive agent, toremifene, and analogs or metabolites thereof, to prevent recurrence of, suppress or inhibit prostate carcinogenesis.
     1.23 “ Major Markets ” shall mean and include the United States, Great Britain, France, Germany, and Japan.
     1.24 “ Negotiation Period ” shall have the meaning set forth in Section 2.8D. hereof.
     1.25 “ Net Sales ” shall mean the gross amount actually received by GTx or any Sublicensee for the use, sale or distribution (hereinafter “ Sale ”) of a Licensed Product (hereinafter “ Gross Receipts ”), less the following:
  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;
[ * ] = 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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  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
 
  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 SERM licensed to GTx hereunder; and (2) the purpose of such royalty is for licensing of or acquiring such issued patent; and (3) the dollar amount of the [ * ] deduction for any calendar quarter shall not exceed the dollar amount of Net Sales in the same calendar quarter (computed without the application of this Section 1.25I.) from the use, sale, or distribution of Licensed Products containing such SERM in the country(ies) where such Third Party owns or controls such issued patent, it being agreed, however, that GTx may carry forward to future quarter(s) the amount by which the dollar amount of the [ * ] deduction exceeds the cumulative dollar amount of the actual deductions taken; and (4) GTx has not entered into such patent license agreement as of the date of execution of this Agreement.
For avoidance of doubt, no deductions shall be made for sales commissions paid to individuals who are employees of GTx, a Sublicensee, or their respective Affiliates, or for cost of collections. Notwithstanding the foregoing, Net Sales shall not include the amount received by GTx for the transfer of Licensed Product to a GTx Affiliate or a Sublicensee or the amount received by a Sublicensee for transfer or distribution of Licensed Product to GTx or a GTx Affiliate. Sales of Licensed Product for use in conducting clinical trials of a Licensed Product candidate in a country shall be excluded from Net Sales calculations for all purposes. Net Sales shall be determined in a consistent manner for all products sold by or on behalf of GTx and its Sublicensees and in accordance with applicable U.S. generally accepted accounting principles for GTx and any U.S. based Sublicensee.
Combination Product . In the event one or more Licensed Products are sold as part of a Combination Product in a particular country, the Net Sales of such Licensed Product(s), for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country, during the applicable Net Sales reporting period, by the fraction, A/(A+B), where:
A is the average sale price of the Licensed Product(s) by GTx or Sublicensees when sold separately in finished form in such country and B is the average sale price by GTx or Sublicensees, or, if they have no such right of sale, by a Third Party of the other product(s) included in the Combination Product when sold separately in finished form in such country, in each case during the applicable Net Sales reporting period.
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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In the event one or more Licensed Products are sold as part of a Combination Product and are sold separately in finished form in such country, but the other product(s) included in the Combination Product are not sold separately in finished form in such country, the Net Sales of the Licensed Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction C/D where:
C is the average sale price, in such country, of the Licensed Product(s) contained in such Combination Product when sold separately and D is the average sale price, in such country, for the Combination Product, in each case during the applicable Net Sales reporting period. Under no circumstances can C/D exceed one hundred percent (100%).
In the event that one or more of the Licensed Product(s) are not sold separately in finished form in the country, but all of the other product(s) included in the Combination Product in such country are sold separately, the Net Sales of the Licensed Product, for the purposes of determining payments based on Net Sales, shall be determined by multiplying the Net Sales of the Combination Product in such country by the fraction (D-E)/D, where:
D is the average sale price, in such country, of the Combination Product, and E is the average sale price of the other product(s) included in the Combination Product in finished form in such country, in each case during the applicable Net Sales reporting period.
In the event that the Net Sales of the Licensed Product(s) when included in a Combination Product cannot be determined using the methods above, Net Sales for the purposes of determining payments based on Net Sales shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of F/(F+G) where:
F is the fair market value of the Licensed Product(s) and G is the fair market value of all other pharmaceutical product(s) included in the Combination Product, as reasonably determined in good faith by the Parties.
     1.26 “ Option ” shall have the meaning set forth in Section 2.8 hereof.
     1.27 “ Option Period ” shall have the meaning set forth in Section 2.8A. hereof.
     1.28 “ Patented Product ” shall mean any product whose manufacture, use, sale or import is covered in whole or in part by a Valid Claim of the Licensed Patents in the country of manufacture, use, sale or import.
     1.29 “ Party ” and “ Parties ” shall have the meaning set forth in the introductory paragraph hereof.
     1.30 “ Prior License Agreement ” shall have the meaning set forth in the Recitals.
     1.31 “ Proprietary SERM Know-How ” shall mean know-how pertaining to a SERM that is obtained from GTx or a UT Contributor and is not published or otherwise generally known to the public.
     1.32 “ Regulatory Approval ” shall mean any approvals granted by a governmental authority in a particular regulatory jurisdiction (with the exception of conditional approvals) that are necessary for the commercial manufacture, use, storage, importation, export, transport or sale of Licensed Products in that regulatory jurisdiction.
     1.33 “ Running Royalty ” shall have the meaning set forth in Section 4.1B. hereof.
     1.34 “ SERM ” or “ SERMS ” shall mean toremifene, and analogs or metabolites thereof.
     1.35 “ Sublicense ” shall mean a direct grant of right, license, or option to any Licensed Subject Matter from GTx to a GTx Affiliate or a Third Party, including the Ipsen Sublicense, and any further such grant at any tier.
     1.36 “ Sublicense Revenue ” shall mean all payments actually received by GTx pursuant to each Sublicense, including, without limitation, up-front license fees, milestone payments, license maintenance fees, election fees, and all other fees and payments paid to GTx under each Sublicense agreement, excluding running royalties received by GTx that are calculated as a percentage of Sublicensee’s Net Sales, and excluding the up-front fee GTx has already received from Ipsen in October 2006 upon its entering into the Ipsen Sublicense. GTx may deduct from Sublicense Revenue attributable to a particular Sublicense agreement payments received by GTx as
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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reimbursement for actual, otherwise unreimbursed, out-of-pocket expenses as set out in such Sublicense agreement, provided that only reimbursements for expenses incurred in the development of one or more Licensed Products covered by such Sublicense may be deducted from Sublicense Revenue and then only to the extent of expenses incurred from and after the date of the Sublicense for pre-clinical or clinical research and development, including development of the formulation and manufacturing process, manufacturing of preclinical and clinical supplies and analytical and stability testing as required by the Food and Drug Administration to support a New Drug Application (NDA) filing for the Licensed Product. For the avoidance of doubt, Sublicense Revenue will not include any payments made to Third Parties by or on behalf of a Sublicensee for conducting clinical trials, filing new drug applications, commercially launching a product and/or marketing and selling a product, since these are not payments received by GTx from a Sublicensee on account of the Sublicense.
     1.37 “ Sublicense Royalty ” shall have the meaning set forth in Section 4.1C. hereof.
     1.38 “ Sublicensee ” shall mean and include any recipient of a Sublicense, including Ipsen.
     1.39 “ Sublicensee Patent Rights ” shall have the meaning set forth in Section 6.2 hereof.
     1.40 “ Term ” shall have the meaning set forth in Section 12.1 hereof.
     1.41 “ Third Party ” or “ Third Parties ” shall mean any person, party or entity other than GTx, its Affiliates, UTRF, or UT.
     1.42 “ UT ” shall mean The University of Tennessee.
     1.43 “ UT Contributor ” and “ UT Contributors ” shall mean one or more of Mitchell S. Steiner and Sharan Raghow, and any other UT employee who contributed, either before or after the Effective Date, to the development of the Licensed Subject Matter.
     1.44 “ Valid Claim ” shall mean (a) a claim of an issued patent which has not expired and which has not been held revoked, invalid or unenforceable by decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed with the time allowed for appeal having expired, and which has not been admitted to be invalid through reissue or disclaimer or otherwise; or (b) any claim of a pending patent application, which (i) was filed in good faith; and (ii) has not been pending for more than eight (8) years.
SECTION 2
Grant
     2.1 During the Term hereof, and subject to the terms and conditions of this Agreement, UTRF hereby grants to GTx for the purpose of developing, making, having made, using, marketing, selling, having sold, importing, distributing, and offering for sale the Licensed Product:
  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; and
 
  B.   an exclusive, worldwide right and license, with the right to grant Sublicenses, to utilize the Licensed Technology.
Subject to the other provisions of this Agreement, the Parties hereby agree that the term “exclusive” means that to the extent of UTRF’s rights in the Licensed Subject Matter and subject to Federal Policy, UTRF shall not grant any other license under Licensed Subject Matter to any Third Party or take any action inconsistent with the rights granted to GTx under this Agreement. The Parties further acknowledge and agree that to the extent UTRF owns any Licensed Subject Matter “in part”, the license herein granted to GTx will not give GTx or its Sublicensees the right to exclude UTRF’s co-owner(s) from exercising any rights attendant to such co-ownership, whether such rights arise by law or contract, provided that UTRF agrees that it will not negotiate or enter into a license agreement or
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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sublicense agreement, or otherwise grant any option or licenses or other rights with respect to such Licensed Subject Matter (whether in whole or in part), except as required by Federal Policy. For avoidance of doubt, the exercise by GTx of its right to grant Sublicenses will not serve to restrict GTx’s exercising of its right, as granted above, to practice under the Licensed Patents and/or to utilize the Licensed Technology.
     2.2 GTx agrees that UT and those persons who, as of the date of signature hereto on behalf of UTRF, are named UT Contributors shall have the royalty-free non-exclusive right to practice under the Licensed Patents and to utilize the Licensed Technology for non-commercial educational, research, and academic purposes only.
     2.3 To the extent that any research pertaining to inventions included in Licensed Technology and/or claimed in Licensed Patents has been or is in the future funded in whole or in part by the United States government, the United States government retains certain rights and requires certain obligations concerning such inventions as set forth in 35 U.S.C. §§200-212 and all regulations promulgated thereunder, as amended, and any successor statutes and regulations and applicable policies of such United States government sponsors, including, without limitation, to the extent applicable, the utilization and capability requirements found in the National Institutes of Health (NIH) Grants Policy Statement; “Developing Sponsored Research Agreements: Considerations for Recipients of NIH Research Grants and Contracts”, Federal Register, Vol. 59, No. 215, Tuesday, November 8, 1994, pp. 55675-55679 (collectively, “ Federal Policy ”). GTx acknowledges that all rights herein granted to GTx may be subject to any such rights held by the United States government and further subject to any restrictions or obligations that may be imposed by the United States government pursuant to such rights. GTx shall materially comply with all aspects of Federal Policy applicable to a licensee pertaining to Licensed Technology and/or Licensed Patents and shall include and require its Sublicensees to include a provision in each Sublicense agreement, at any tier, that requires the Sublicensee to materially comply with all applicable aspects of Federal Policy. In the event UTRF or GTx shall receive notice of any action or notification by the United States government with respect to any rights and/or obligations under Federal Policy pertaining to any rights licensed hereunder to GTx, the Party receiving such notice shall provide prompt written notice thereof to the other Party.
     2.4 Intentionally omitted.
     2.5 GTx shall have the right to enter into Sublicenses and to permit further sublicensing by Sublicensees through multiple tiers with respect to the Licensed Subject Matter, subject to notifying UTRF of the identity and address of each Sublicensee within thirty (30) days after execution of such agreement by the parties thereto. No GTx Affiliate or Third Party shall have the right to practice under the Licensed Patents or utilize the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, or offer for sale any Licensed Product in the absence of a written Sublicense agreement. Any grant of rights by GTx or a Sublicensee to practice under the Licensed Patents or to utilize the Licensed Technology to make, have made, use, market, sell, have sold, import, distribute, or offer for sale any Licensed Product shall constitute a Sublicense. All Sublicenses shall be subject to this Agreement in all respects and shall include provisions that such Sublicensee is being granted a license under the Licensed Subject Matter as defined herein and subject to the terms hereof. Notwithstanding anything to the contrary in this Agreement (including, without limitation, this Section 2.5), UTRF hereby agrees that all provisions of the Ipsen Sublicense, as executed on September 7, 2006, are in full compliance with the terms and conditions of this Agreement. GTx agrees that it will not modify or otherwise amend the Ipsen Sublicense in any manner that would deviate from any of the requirements of a Sublicense set forth herein without obtaining UTRF’s prior written approval, which approval will not unreasonably be withheld. The Parties agree that unless a modification or amendment shall affect any requirement of a Sublicense as described in the immediately preceding sentence, GTx and Ipsen shall have the right and discretion to negotiate and enter into such amendments and modifications to the Ipsen Sublicense as they shall from time to time determine without first obtaining the approval of UTRF, and GTx will furnish a copy of any such amendment or modification to UTRF within thirty (30) days of the execution of such an instrument as required herein.
     2.6 GTx shall be responsible for its Affiliates and Sublicensees and, except as set forth above as it pertains to Ipsen, shall not grant any rights that are inconsistent with the rights granted to and obligations of GTx hereunder. Each Sublicense agreement shall include a requirement that the Sublicensee use its commercially reasonable efforts to bring the subject matter of the Sublicense into commercial use. In addition, each Sublicense agreement shall include an acknowledgement that the ownership of the Licensed Patents are and shall remain in the
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

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name of UTRF, with the exception of Licensed Patents that are properly assigned to GTx, and, except as set forth in Section 6.2 hereof, an obligation on the part of the Sublicensee to assign, transfer and convey ownership of Licensed Patents to UTRF and/or, as UTRF may direct, to GTx. Upon termination of this Agreement, each Sublicensee’s rights under any Sublicense agreement shall also terminate, provided that if UTRF terminates this Agreement for default by GTx, a Sublicensee’s rights under a Sublicense agreement shall terminate only if UTRF has given such Sublicensee notice of default at least thirty (30) days prior to the effective date of termination and the Sublicensee shall have failed to cure such default, as provided in Section 12.3. UTRF shall have discharged its obligation to give notice of such default to a Sublicensee by sending (through any means contemplated under Section 15) a copy of GTx’s notice of default to the Sublicensee’s most recent street address of which UTRF has received written notice from GTx or the Sublicensee. No Sublicense shall relieve GTx of any of its obligations under this Agreement, except that a Sublicensee shall have the right to cure a default of GTx as set out in Section 12.3. GTx shall forward to UTRF a complete copy of each Sublicense agreement (including, without limitation, all amendments and addenda) granted hereunder within thirty (30) days after execution of such agreement by the parties thereto, provided that each such Sublicense agreement (and any amendments and addenda related thereto) shall be deemed GTx’s Confidential Information and UTRF shall receive such information and documents in confidence and shall not publicly disclose, discuss or release such information or document to Third Parties (other than such information as may be reasonably necessary to be disclosed to UT Contributors and those persons within UT who have a need to know such information, provided that only such information concerning the Sublicense that is necessary to explain any payments to be made to a UT Contributor will be shared with the UT Contributors) without the prior written approval of GTx except for the purposes of enforcement of UTRF’s rights, defense of any claim against UTRF, UT, or UT Contributors, compliance with Federal Policy, or compliance with applicable law, regulation, or court order. GTx shall be responsible for payment of royalties from Sublicensees’ Net Sales provided, however, that GTx may arrange for such payments to be made to UTRF by a Sublicensee, with the understanding that the amount paid to UTRF shall not be decreased thereby and that UTRF’s acceptance of such payments from a Sublicensee does not relieve GTx of the ultimate responsibility for any other or future payment required hereunder. Each such Sublicense agreement shall include an audit right by UTRF of the same scope as provided in Section 5.1 herein with respect to UTRF’s audit of GTx’s books of account.
     2.7 Any act or omission of an Affiliate or Sublicensee which would constitute a breach of this Agreement if performed by GTx, shall be deemed to be a breach by GTx of this Agreement, subject however to the same cure provisions in favor of GTx, an Affiliate, or Sublicensee as are otherwise provided herein for breach by GTx.
     2.8 During the Term hereof, UTRF shall promptly notify GTx in writing upon becoming aware of any SERM invention owned solely or in part by UTRF which is not (a) based on or developed from Proprietary SERM Know-How or (b) developed at UT from grants or research payments made to UT by GTx (each invention described above herein being an “ Independent SERM Invention ”). Subject to the rights of Third Parties (in the event UTRF co-owns such Independent SERM Invention with a Third Party), GTx will have an exclusive option to acquire, to the extent possible, a worldwide, exclusive (as defined in Section 2.1), royalty-bearing license to such Independent SERM Invention (“ Option ”), provided that the grant of such Option does not violate Federal Policy and further subject to the following:
  A.   The Option shall commence upon UTRF’s written notice to GTx of the existence of such Independent SERM Invention and shall terminate upon the earlier of (i) the expiration of six (6) calendar months from the date of such notice; or (ii) the giving of written notice to UTRF by GTx that it does not intend to exercise the Option; or (iii) the termination of this Agreement (“ Option Period ”).
 
  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 SERM Invention that is the subject of such Option, it being the intent that upon agreement of the Parties as to such economic terms, they will be expeditiously incorporated into a new license agreement
[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

8


 
      with non-economic terms that are substantially similar to those contained herein, to the extent applicable.
 
  D.   In the event GTx does not exercise the Option for a particular Independent SERM Invention within the Option Period or the Parties do not execute a license agreement within six (6) months after exercise of the Option for a particular Independent SERM Invention by GTx, which time period may be extended by written agreement of the Parties (the “ Negotiation Period ”), UTRF shall have no further obligation to GTx under this Agreement with regard to such Independent SERM Invention. In the absence of a license agreement granting GTx rights to such Independent SERM Invention, GTx agrees that it will not use such Independent SERM Invention for any commercial or non-commercial purpose.
 
  E.   During the Option Period and the Negotiation Period, if any, UTRF will confer with GTx concerning proper protection of such Independent SERM Invention, but UTRF will have sole authority regarding decisions concerning such protection, including patent activities, provided that if GTx exercises the Option, UTRF shall coordinate all decisions regarding patent protection with GTx and shall take no actions with regard to intellectual property protection for such Independent SERM Invention that are contrary to GTx’s advice unless UTRF reasonably believes rights may be lost unless it acts to protect those rights. From and after the commencement of the Option Period, whether or not GTx exercises the Option and whether or not the Parties subsequently execute a license agreement for GTx to secure rights to the Independent SERM Invention prior to the end of the Negotiation Period, GTx shall, within thirty (30) days after receipt of each invoice, reimburse UTRF for all reasonable and documented out-of-pocket expenses incurred by UTRF during the Option Period and the Negotiation Period, if any, for filing, prosecution, and maintenance of United States and foreign patent applications, issued patents, and other forms of intellectual property protection for such Independent SERM Invention, which intellectual property rights shall be assigned solely to UTRF or jointly to UTRF and its c

 
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