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EXCLUSIVE LICENSE AGREEMENT

 

Exhibit 10.12
     This Agreement, effective as of April 15, 2003 (the “Effective Date”), is between the University of Massachusetts Medical School (“Medical School”), a public institution of higher education of the Commonwealth of Massachusetts having an address of 00 Xxxx Xxxxxx Xxxxx, Xxxxxxxxx, XX 00000, and CytRx Corporation (“Company”), a Delaware corporation having an address of11726 Xxx Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000.
R E C I T A L S
     1.1. “Affiliate” means any legal entity (such as a corporation, partnership, or limited liability company) that is controlled by Company. For the purposes of this definition, the term “control” means (a) beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities or (b) a fifty percent (50%) or greater interest in the net assets or profits of a partnership or other business organization without voting securities.
     1.2. “Biological Materials” means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.
     1.3. “Combination Product” means a product that contains a Licensed Product component and at least one other essential functional component.

 

 

     1.4. “Confidential Information” means any confidential or proprietary information furnished by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in connection with this Agreement, provided that such information is specifically designated as confidential. Such Confidential Information shall include, without limitation, any diligence reports furnished to Medical School under Section 3.1. and royalty reports furnished to Medical School under Section 5.2.
     1.5. “Field” means inhibition of mutant superoxide dismutase (SOD1) gene expression for the treatment of amyotrophic lateral sclerosis (ALS) including therapeutics, prophylactics and diagnostics.
     1.6. “Licensed Product” means any product that cannot be developed, manufactured, used, or sold without (a) infringing one or more claims under the Patent Rights, (b) using or incorporating some portion of one or more Biological Materials, or (c) using some portion of the Related Technology.
     1.7. “Net Sales” means the gross amount billed or invoiced on sales by Company and its Affiliates and Sublicensees of Licensed Products, less the following: (a) customary trade, quantity, or cash discounts and commissions to non-affiliated brokers or agents to the extent actually allowed and taken; (b) amounts repaid or credited by reason of rejection or return; (c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, delivery, or use of a Licensed Product which is paid by or on behalf of Company; (d) outbound transportation costs prepaid or allowed and costs of insurance in transit; and (e) allowance for bad debt that is customary and reasonable for the industry and in accordance with generally accepted accounting principles. Notwithstanding anything to the contrary in this Section 1.7, Net Sales does not include sales of Licensed Products at or below the fully burdened cost of manufacturing solely for research or clinical testing or for indigent or similar public support or compassionate use programs.
     In any transfers of Licensed Products between Company and an Affiliate or Sublicensee, Net Sales shall be calculated based on the final sale of the Licensed Product to an independent third party. In the event that Company or an Affiliate or Sublicensee receives non-monetary consideration for any Licensed Products, Net Sales shall be calculated based on the fair market value of such consideration. .
     In the case of Combination Products, Net Sales means the gross amount billed or invoiced on sales of the Combination Product less the deductions set forth above, multiplied by a proration factor that is determined as follows:
     (i) If all components of the Combination Product were sold separately during the same or immediately preceding Royalty Period, the proration factor shall be determined by the formula [A / (A+B)], where A is the aggregate gross sales price of all Licensed Product components during such period when sold separately from the other essential functional components, and B is the aggregate gross sales price of the other essential functional components during such period when sold separately from the Licensed Product Components; or

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     (ii) If all components of the Combination Product were not sold separately during the same or immediately preceding Royalty Period, the proration factor shall be determined by the formula [C / (C+D)], where C is the aggregate fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles.
     1.8. “Patent Rights” means the U.S. patent applications listed on Exhibit A, and any divisional, continuation, or continuation-in-part of such patent applications to the extent the claims are directed to subject matter specifically described therein, as well as any patent issued thereon and any reissue or reexamination of such patent, and any foreign counterparts to such patents and patent applications. Exhibit A shall be periodically amended to include any additional Patent Rights that may arise. “Medical School Patent Rights” means Patent Rights assigned solely to Medical School (and other academic institutions, if any). “Joint Patent Rights” means Patent Rights assigned to both Medical School and Company.
     1.9. “Related Technology” means any know-how, technical information, research and development information, test results, and data necessary for the effective exercise of the Patent Rights.
     1.10. “Royalty Period” means the partial calendar quarter commencing on the date on which the first Licensed Product is sold or used and every complete or partial calendar quarter thereafter during which either (a) this Agreement remains in effect or (b) Company has the right to complete and sell work-in-progress and inventory of Licensed Products pursuant to Section 8.5.
     1.11. “Sublicense Income” means any payments that Company receives from a Sublicensee in consideration of the sublicense of the rights granted Company under Section 2.1., including without limitation license fees, royalties, milestone payments, and license maintenance fees, but excluding the following payments: (a) payments made in consideration for the issuance of equity or debt securities of Company at fair market value, and (b) payments specifically committed to the development of Licensed Products.
     1.12. “Sublicensee” means any permitted sublicensee of the rights granted Company under this Agreement, as further described in Section 2.2.

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          (c) Subject to applicable law or the rights of research sponsors, the Medical School shall use its best efforts to make any improvements to the Patent Rights available to Company.
          (b) Federal Government. To the extent that any invention claimed in the Patent Rights has been partially funded by the federal government, this Agreement and the grant of any rights in such Patent Rights are subject to and governed by federal law as set forth in 35 U.S.C. §§ 201-211, and the regulations promulgated thereunder, as amended, or any successor statutes or regulations. Company acknowledges that these statutes and regulations reserve to the federal government a royalty-free, non-exclusive, non-transferable license to practice any government-funded invention claimed in any Patent Rights. If any term of this Agreement fails to conform with such laws and regulations, the relevant term shall be deemed an invalid provision and modified in accordance with Section 10.11. Upon execution of this Agreement, the Medical School shall disclose in writing to Company any funding that would be subject to this Section 2.3(b).

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     (a) Within ninety (90) days after the Effective Date, Company shall furnish Medical School with a written research and development plan under which Company intends to develop Licensed Products.
     (b) Within sixty (60) days after each anniversary of the Effective Date, Company shall furnish Medical School with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.
     (c) Company shall endeavor to obtain all necessary governmental approvals for the manufacture, use and sale of Combination Product and Licensed Product. Specifically, Company shall:
     (i) Within eight (8) years after the Effective Date, file an Investigational New Drug Application (“IND”) or its equivalent covering at least one Combination Product or Licensed Product with the U.S. Food and Drug Administration (“FDA”);
     (ii) Within thirteen (13) years after the Effective Date, file a New Drug Application (“NDA”) with the FDA covering at least one Combination Product or Licensed Product;
     (iii) Within eighteen (18) months after receiving FDA approval of the NDA for a Combination Product or Licensed Product, market at least one Combination Product or Licensed Product in the U.S. ; and
     (iv) reasonably fill the market demand for any Combination Product or Licensed Product following commencement of marketing of such product at any time during the exclusive period of this Agreement.
     (d) Within eighteen (18) months after the Effective Date, Company shall successfully undertake a public or private offering of raising ten million dollars ($10,000,000).
Company shall have the responsibility to finance its obligations in this Section 3.1, and the Medical School shall provide reasonable cooperation to Company in this regard. In the event that Medical School determines that Company (or an Affiliate or Sublicensee) has not fulfilled its obligations under this Section 3.1., Medical School shall furnish Company with written notice of such determination. Within sixty (60) days after receipt of such notice, Company shall either

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(i) fulfill the relevant obligation or (ii) negotiate with Medical School a mutually acceptable schedule of revised diligence obligations, failing which Medical School shall have the right, immediately upon written notice to Company, to terminate this Agreement or to grant additional licenses to third parties to the Patent Rights and Biological Materials in the Field. The Medical School may not unreasonably withhold acceptance of Company’s revised diligence obligations.
          (a) Indemnity. Company shall indemnify, defend, and hold harmless Medical School and its trustees, officers, faculty, students, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss, or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon any of the Indemnitees in connection with any claims, suits, actions, demands or judgments arising out of any theory of liability (including without limitation actions in the form of tort, warranty, or strict liability and regardless of whether such action has any factual basis) concerning any product, process, or service that is made, used, or sold pursuant to any right or license granted under this Agreement; provided, however, that such indemnification shall not apply to any liability, damage, loss, or expense to the extent directly attributable to (i) the negligent activities or intentional misconduct of the Indemnitees or (ii) the settlement of a claim, suit, action, or demand by Indemnitees without the prior written approval of Company.
          (b) Procedures. The Indemnitees agree to provide Company with prompt written notice of any claim, suit, action, demand, or judgment for which indemnification is sought under this Agreement. Company agrees, at its own expense, to provide attorneys reasonably acceptable to Medical School to defend against any such claim. The Indemnitees shall cooperate fully with Company in such defense and will permit Company to conduct and control such defense and the disposition of such claim, suit, or action (including all decisions relative to litigation, appeal, and settlement); provided, however, that any Indemnitee shall have the right to retain its own counsel, at the expense of Company, if representation of such Indemnitee by the counsel retained by Company would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other party represented by such counsel. Company agrees to keep Medical School informed of the progress in the defense and disposition of such claim and to consult with Medical School with regard to any proposed settlement.
          (c) Insurance. Company shall maintain insurance or self-insurance that is reasonably adequate to fulfill any potential obligation to the Indemnitees, but in any event not less than one million dollars ($1,000,000) for injuries to any one person arising out of a single occurrence and five million dollars ($5,000,000) for injuries to all persons arising out of a single occurrence. Company shall provide Medical School, upon request, with written evidence of such insurance or self-insurance. Company shall continue to maintain such insurance or self-insurance after the expiration or termination of this Agreement during any period in which Company or any Affiliate or Sublicensee continues to make, use, or sell a product that was a Licensed Product under this Agreement and thereafter for a period of two (2) years.
     3.3. Use of Medical School Name. In accordance with Section 7.3., Company and its Affiliates and Sublicensees shall not use the name “University of Massachusetts Medical School” or any variation of that name in connection with the marketing or sale of any Licensed Products.

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     (a) Company or its Affiliates or Sublicensees shall obtain all necessary approvals from the United States Food & Drug Administration and any similar governmental authorities of any foreign jurisdiction in which Company or an Affiliate or Sublicensee intends to make, use, or sell Licensed Products.
     (b) Company and its Affiliates and Sublicensees shall comply with all United States laws and regulations controlling the export of certain commodities and technical data, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit, or require a license for, the export of certain types of commodities and technical data to specified countries. Company hereby gives written assurance that it will comply with, and will cause its Affiliates and Sublicensees to comply with, all United States export control laws and regulations, that it bears sole responsibility for any violation of such laws and regulations by itself or its Affiliates or Sublicensees, and that it will indemnify, defend, and hold Medical School harmless (in accordance with Section 3.2.) for the consequences of any such violation.
     (c) To the extent that any invention claimed in the Patent Rights has been partially funded by the United States government, and only to the extent required by applicable laws and regulations, Company agrees that any Licensed Products used or sold in the United States will be manufactured substantially in the United States or its territories. Current law provides that if domestic manufacture is not commercially feasible under the circumstances, Medical School may seek a waiver of this requirement from the relevant federal agency on behalf of Company.

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of shares of Common Stock of Company, ($.01 par value per share) equal to {***} of the outstanding shares of Company. Company shall register the shares that are issued to the Medical School within ninety (90) days after their issuance and those shares will then be unrestricted.
     
Milestone   Payment
Filing of IND or equivalent for each product
   ${***}
Entry into Phase I Clinical trial or equivalent for each Licensed Product
   ${***} for first product and ${***} for each subsequent product
Entry into Phase II clinical trial or equivalent for each Licensed Product
   ${***} for first product and ${***} for each subsequent product
Entry into Phase III clinical trial or equivalent for each Licensed Product
   ${***} for first product and ${***} for each subsequent product
Filing for market approval (NDA or equivalent) in any country besides the United States
   ${***} for first product and ${***} for each subsequent product
Commencement of product marketing in the United States
   ${***}
First market approval for first three European countries in total
   ${***}
These milestone payments are nonrefundable and are not creditable against any other payments due to University under this Agreement.
Company shall pay Medical School a one-time bonus in the amount of {***} in the event that cumulative gross sales of Licensed Products by Company and its Affiliates or Sublicense Income exceed {***} in one calendar year in the United States. Company shall pay Medical School a one-time bonus in the amount of {***} in the event that cumulative gross sales of Licensed Products by Company and its Affiliates or Sublicense Income exceed {***} in one calendar year in Japan and Europe.

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               (i) If a particular Licensed Product is within the definition of “Licensed Product” solely because it uses or incorporates Related Technology, the royalty rate applicable to such Licensed Product shall be reduced by {***}.
               (ii) If there is a competing product in the marketplace, no royalties are due for a Licensed Product that is within the definition of “Licensed Product” because it uses or incorporates only Related Technology or Biological Materials.
               (iii) If during the Royalty Period, patents under the Patent Rights have expired or have been abandoned in a particular country, (I) no royalty is payable by Company, if there is a competing product in that country, and (II) if Company reduces its prices for Licensed Products in that country, even if there is no competing product in that country, Company and Medical School shall negotiate in good faith a reduction in the royalty rate to reflect the reduction in Company’s gross margins caused by the price reduction.
               (iv) Company shall pay Medical School {***} of Net Sales of commercial clinical laboratory services by Company and its Affiliates
     4.6. Minimum Royalty. At the beginning of each calendar year during the term of this Agreement, beginning January 1, 2016, Company shall pay to Medical School a minimum royalty of {***}. If the actual royalty payments to Medical School in any calendar year are less than the minimum royalty payment required for that year, Company shall have the right to pay Medical School the difference between the actual royalty payment and the minimum royalty payment in full satisfaction of its obligations under this Section, provided such minimum payment is made to Medical School within sixty (60) days after the conclusion of the calendar year. Waiver of any minimum royalty payment by Medical School shall not be construed as a waiver of any subsequent minimum royalty payment. If Company fails to make any minimum royalty payment within the sixty-day period, such failure shall constitute a material breach of its obligations under this Agreement, and Medical School shall have the right to terminate this Agreement in accordance with Section 8.3.

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4.7., when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than fifty percent (50%) in any Royalty Period.
     (a) the number of Licensed Products sold to independent third parties in each country;
     (b) the gross sales price for each Licensed Product sold by Company and its Affiliates during the applicable Royalty Period in each country;
     (c) calculation of Net Sales for the applicable Royalty Period in each country, including a listing of applicable deductions;
     (d) total royalty payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and
     (e) the portion of royalty-based Sublicense Income due to Medical School for the applicable Royalty Period from each Sublicensee.
All such reports shall be considered Company Confidential Information. If no royalties are due to Medical School for any Royalty Period, the report shall so state. Concurrent with this report, Company shall remit to Medical School any payment due for the applicable Royalty Period.
     5.4. Payments in Other Currencies. If by law, regulation, or fiscal policy of a particular country, conversion into United States dollars or transfer of funds of a convertible currency to the United States is restricted or forbidden, Company shall give Medical School prompt written notice of such restriction, which notice shall satisfy the sixty-day payment deadline described in Section 5.2. Company shall pay any amounts due Medical School through whatever lawful methods Medical School reasonably designates; provided, however, that if Medical School fails to designate such payment method within thirty (30) days after Medical School is notified of the restriction, Company may deposit such payment in local currency to the credit of Medical School in a recognized banking institution selected by Company and identified by written notice to Medical School, and such deposit shall fulfill all obligations of Company to Medical School with respect to such payment.

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     5.5. Records. Company shall maintain, and shall cause its Affiliates and Sublicensees to maintain, complete and accurate records of Licensed Products that are made, used, sold, or performed under this Agreement and any amounts payable to Medical School in relation to such Licensed Products, which records shall contain sufficient information to permit Medical School to confirm the accuracy of any reports delivered to Medical School under Section 5.2. The relevant party shall retain such records relating to a given Royalty Period for at least three (3) years after the conclusion of that Royalty Period, during which time Medical School shall have the right, at its expense, to cause its internal accountants or an independent, certified public accountant to inspect such records during normal business hours for the sole purpose of verifying any reports and payments delivered under this Agreement. Such accountant shall not disclose to Medical School any information other than information relating to accuracy of reports and payments delivered under this Agreement. The parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of the audit. In the event that any audit performed under this Section reveals an underpayment in excess of the greater of (a) five thousand dollars ($5,000) or (b) ten percent (10%) in any Royalty Period, Company shall bear the full cost of such audit. Medical School may exercise its rights under this Section only once every year and only with reasonable prior notice to Company.
     5.7. Method of Payment. All payments under this Agreement should be made in the name of the “University of Massachusetts Medical School” and sent to the address identified below. Each payment should reference this Agreement and identify the obligation under this Agreement that the payment satisfies.

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Medical School as to the preparation, filing, prosecution, and maintenance of all such Patent Rights reasonably prior to any deadline or action with the U.S. Patent & Trademark Office or any foreign patent office and shall furnish Medical School with copies of all relevant documents reasonably in advance of such consultation.

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public interest. Company shall not enter into any settlement, consent judgment, or other voluntary final disposition of any infringement action under this Subsection without the prior written consent of Medical School, which consent shall not be unreasonably withheld or delayed. Any recovery obtained in an action under this Subsection shall be distributed as follows: (i) each party shall be reimbursed for any expenses incurred in the action (including the amount of any royalty payments withheld from Medical School as described below), (ii) as to ordinary damages, Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales (whichever measure of damages the court shall have applied), less a reasonable approximation of the royalties that Company would have paid to Medical School if Company had sold the infringing products and services rather than the infringer, and (iii) as to special or punitive damages, the parties shall share equally in any award. Company may offset a total of fifty percent (50%) of any expenses incurred under this Subsection against any royalty payments due to Medical School under this Agreement, provided that in no event shall the royalty payments under Section 4.5. and 4.7., when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than fifty percent (50%) in any Royalty Period.
7. Confidential Information; Publications; Publicity.
     7.1. Confidential Information.
          (a) Designation. Confidential Information that is disclosed in writing shall be marked with a legend indicating its confidential status (such as “Confidential” or “Proprietary”). Confidential Information that is disclosed orally or visually shall be documented in a written notice prepared by the Disclosing Party and delivered to the Receiving Party within thirty (30) days of the date of disclosure; such notice shall summarize the Confidential Information disclosed to the Receiving Party and reference the time and place of disclosure.
          (b) Obligations. For a period of five (5) years after disclosure of any portion of Confidential Information, the Receiving Party shall (i) maintain such Confidential Information in strict confidence, except that the Receiving Party may disclose or permit the disclosure of any

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Confidential Information to its directors, officers, employees, consultants, and advisors who are obligated to maintain the confidential nature of such Confidential Information and who need to know such Confidential Information for the purposes of this Agreement; (ii) use such Confidential Information solely for the purposes of this Agreement; and (iii) allow its trustees or directors, officers, employees, consultants, and advisors to reproduce the Confidential Information only to the extent necessary for the purposes of this Agreement, with all such reproductions being considered Confidential Information.
          (c) Exceptions. The obligations of the Receiving Party under Subsection 7.1.(b) above shall not apply to the extent that the Receiving Party can demonstrate that certain Confidential Information (i) was in the public domain prior to the time of its disclosure under this Agreement; (ii) entered the public domain after the time of its disclosure under this Agreement through means other than an unauthorized disclosure resulting from an act or omission by the Receiving Party; (iii) was independently developed or discovered by the Receiving Party without use of the Confidential Information; (iv) is or was disclosed to the Receiving Party at any time, whether prior to or after the time of its disclosure under this Agreement, by a third party having no fiduciary relationship with the Disclosing Party and having no obligation of confidentiality with respect to such Confidential Information; or (v) is required to be disclosed to comply with applicable laws or regulations, or with a court or administrative order, provided that the Disclosing Party receives reasonable prior written notice of such disclosure.
          (d) Ownership and Return. The Receiving Party acknowledges that the Disclosing Party (or any third party entrusting its own information to the Disclosing Party) claims ownership of its Confidential Information in the possession of the Receiving Party. Upon the expiration or termination of this Agreement, and at the request of the Disclosing Party, the Receiving Party shall return to the Disclosing Party all originals, copies, and summaries of documents, materials, and other tangible manifestations of Confidential Information in the possession or control of the Receiving Party, except that the Receiving Party may retain one copy of the Confidential Information in the possession of its legal counsel solely for the purpose of monitoring its obligations under this Agreement.
     7.2. Publications. Medical School and its employees will be free to publicly disclose (through journals, lectures, or otherwise) the results of any research in the Field or relating to the subject matter of the Patent Rights, except as otherwise provided by written agreement between Medical School and Company (e.g., a sponsored research agreement).
     7.3. Publicity Restrictions. Company shall not use the name of Medical School or any of its trustees, officers, faculty, students, employees, or agents, or any adaptation of such names, or any terms of this Agreement in any promotional material or other public announcement or disclosure without the prior written consent of Medical School. The foregoing notwithstanding, Company shall have the right to disclose such information without the consent of Medical School in any prospectus, offering memorandum, or other document or filing required by applicable securities laws or other applicable law or regulation, provided that Company shall have given Medical School at least ten (10) days (or such prior shorter period in order to enable Company to make a timely announcement, while affording the Medical School the maximum feasible time to review the announcement) prior written notice of the proposed text for the purpose of giving Medical School the opportunity to comment on such text.

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     8.4. Effect of Termination. The following provisions shall survive the expiration or termination of this Agreement: Articles 1 and 9; Sections 3.2., 3.5., 5.2. (obligation to provide final report and payment), 5.5., 6.4., 7.1., 7.3., 8.4., and 10.9. Upon the early termination of this Agreement, Company and its Affiliates and Sublicensees may complete and sell any work-in-progress and inventory of Licensed Products that exist as of the effective date of termination, provided that (a) Company is current in payment of all amounts due Medical School under this Agreement, (b) Company pays Medical School the applicable royalty on such sales of Licensed Products in accordance with the terms and conditions of this Agreement, and (c) Company and its Affiliates and Sublicensees shall complete and sell all work-in-progress and inventory of Licensed Products within six (6) months after the effective date of termination.

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          (b) Mediation. If the matter remains unresolved within sixty (60) days after the Notice Date, or if the senior executives fail to meet within thirty (30) days after the Notice Date, either party may initiate mediation upon written notice to the other party, whereupon both parties shall be obligated to engage in a mediation proceeding under the then current Center for Public Resources (“CPR”) Model Procedure for Mediation of Business Disputes, except that specific provisions of this Section shall override inconsistent provisions of the CPR Model Procedure. The mediator will be selected from the CPR Panels of Neutrals. If the parties cannot agree upon the selection of a mediator within ninety (90) days after the Notice Date, then upon the request of either party, the CPR shall appoint the mediator. The parties shall attempt to resolve the dispute through mediation until one of the following occurs: (i) the parties reach a written settlement; (ii) the mediator notifies the parties in writing that they have reached an impasse; (iii) the parties agree in writing that they have reached an impasse; or (iv) the parties have not reached a settlement within one hundred and twenty (120) days after the Notice Date.

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     10.1. Representations and Warranties. Medical School represents and warrants that its employees have assigned to Medical School their entire right, title, and interest in the Patent Rights, that it has authority to grant the rights and licenses set forth in this Agreement, and that, to its best knowledge, Medical School does not hold any other intellectual property rights that would be infringed by the exploitation of the Patent Rights. MEDICAL SCHOOL MAKES NO OTHER WARRANTIES CONCERNING THE PATENT RIGHTS, RELATED TECHNOLOGY, AND BIOLOGICAL MATERIALS, INCLUDING WITHOUT LIMITATION ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. Specifically, Medical School makes no warranty or representation (a) regarding the validity or scope of the Patent Rights, (b) that the exploitation the Patent Rights or any Licensed Product will not infringe any patents or other intellectual property rights of a third party, and (c) that any third party is not currently infringing or will not infringe the Patent Rights.
     10.3. Tax-Exempt Status. Company acknowledges that Medical School, as a public institution of the Commonwealth of Massachusetts, holds the status of an exempt organization under the United States Internal Revenue Code. Company also acknowledges that certain facilities in which the licensed inventions were developed may have been financed through offerings of tax-exempt bonds. If the Internal Revenue Service determines, or if counsel to Medical School reasonably determines, that any term of this Agreement jeopardizes the tax- exempt status of Medical School or the bonds used to finance Medical School facilities, the relevant term shall be deemed an invalid provision and modified in accordance with Section 10.11.

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If to Medical School:
Office of Technology Management
University of Massachusetts Medical School
000 Xxxxxxxxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, XX 00000
Attention:     Xxxxxx F.X. XxXxxxx
                      Executive Director
Tel: (000) 000-0000
Fax: (000) 000-0000
If to Company:
CytRx Corporation
00000 Xxx Xxxxxxx Xxxxxxxxx, Xxxxx 000
Xxx Xxxxxxx, Xxxxxxxxxx 00000
Attention:        Xxxxxx X. Xxxxxxxxx
Invoices to:      Xxxxxx X. Xxxxxxxxx
All notices under this Agreement shall be deemed effective upon receipt. A party may change its contact information immediately upon written notice to the other party in the manner provided in this Section.

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UNIVERSITY OF MASSACHUSETTS       CYTRX CORPORATION    
MEDICAL SCHOOL                
 
                    
By:
  /s/ Xxxxxx F. X. XxXxxxx
 
       By:   /s/ Xxxxxx X. Xxxxxxxxx
 
    
    Xxxxxx F.X. XxXxxxx       Xxxxxx X. Xxxxxxxxx    
    Executive Director, Office of       Chief Executive Officer    
 
  Technology Management                

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EXHIBIT A
List of Patent Rights
Patent Rights
Docket number: UMMC 03-60 Title: “Selective Silencing of a Dominant ALS Gene by RNAi”
Patent Application Serial number: 60/423,507, filed on November 4, 2002
Inventors: Xxxxxxxx Xx et al

 

 

AMENDMENT NO. 1
TO
EXCLUSIVE LICENSE AGREEMENT
(UMMC 03-60)
     This Amendment No. 1, dated as of February  1, 2004 (the “Amendment”) is being made to the Exclusive License Agreement relating to UMMC 03-60 (the “License Agreement”), effective as of April 15, 2003, by and between the University of Massachusetts Medical School (“Medical School”), a public institution of higher education of the Commonwealth of Massachusetts having an address of 00 Xxxx Xxxxxx Xxxxx, Xxxxxxxxx, XX 00000, and CytRx Corporation (“Company”), a Delaware corporation having an address of 00000 Xxx Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000.
R E C I T A L S
     Section 4.8 of the License Agreement is hereby amended to read in full as follows:
     “4.8 Third-Party and Other Payments. If Company is legally required to make royalty or sublicense income payments to Medical School under any other license agreement, as well as this Agreement, or to one or more third parties, as well as this Agreement, in the same Royalty Period for which payments are due under Section 4.5 or 4.7 in order for Company to make, use or sell Licensed Products or have its Sublicensee make, use, or sell Licensed Products:
          (a) Other Medical School Payments. In the case of payments to Medical School under Sections 4.5 and 4.7 with respect to any Licensed Product, Company shall pay only the highest rate among this Agreement and any other Medical School licenses, and that one payment shall be deemed to satisfy the payment requirements for the applicable period under not only this Agreement but each of the other Medical School licenses.
          (b) Third Party Payments. In the case of payments to one or more third parties with respect to any Licensed Product under this Agreement, Company may reduce its

 

 

payment to Medical School under Section 4.5 or 4.7 of this Agreement for the applicable Royalty Period by fifty percent (50%) of the amount actually paid to third parties. However, in no event will the reductions made pursuant to this Section 4.8(b) result in more than a fifty percent (50%) reduction in the payments that would otherwise be payable to Medical School under Section 4.5 and 4.7 (after taking into account Section 4.8(a)).
          (c) Example: Royalty Reductions. By way of illustration for Section 4.5 royalty payment reductions, for a particular Licensed Product, assume a royalty of (***) of Net Sales under another Medical School license and a payment of (***) of Net Sales to a third party. The reduction calculation would be as follows: The total (***) royalty rate in this Agreement would apply, and Company would reduce that rate by 50% of the (***) due to the third party, resulting in a (***) royalty to Medical School under this Agreement, and no royalties payable to the Medical School under the other Medical School license.
          (d) Example: Sublicense Income Payments. By way of illustration for Section 4.7 Sublicense Income payment reductions, assume (i) the total Sublicense Income received by Company from the Sublicensee is (***), and (ii) Company paid a third party (***) in order to allow the sublicensee to make Licensed Products. Company would then be required to pay the Medical School under this Agreement (***) (Medical School receiving (***) of the (***) reduced by one-half of the (***) paid to the third party). If Company also sublicensed another Medical School license with respect to the Licensed Products, Company would not be required to make additional sublicense income payments.”
     Except for the amendment of Section 4.8 of the License Agreement provided for in Section 1 of this Amendment, all of the terms and conditions of the License Agreement shall continue in full force and effect.
     3.1 Dispute Resolution. The parties agree that any dispute arising out of or relating to this Amendment shall be resolved solely by means of the procedures set forth in Article 9 of the Agreement.
     3.2 Counterparts. This Amendment may be executed in one or more counterparts, each of which shall be deemed an original, and all of which together shall be deemed to be one and the same instrument.
     3.3 Headings. All headings are for convenience only and shall not affect the meaning of any provision of this Amendment.
     3.4 Binding Effect. This Amendment shall be binding upon and inure to the benefit of the parties and their respective permitted successors and assigns.

 

 

     3.5 Amendment. This Amendment may be amended, supplemented, or otherwise modified only by means of a written instrument signed by all of the parties.
     3.6 Governing Law. This Amendment shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts irrespective of any conflicts of law principles.
                     
UNIVERSITY OF MASSACHUSETTS       CYTRX CORPORATION    
MEDICAL SCHOOL                
 
                    
By:
  /s/ Xxxxxxx X. Xxxxxx
 
Acting Executive Director 		      By:   /s/ Xxxxxx X. Xxxxxxxxx
 
Xxxxxx X. Xxxxxxxxx 		   
 
  Office of Technology Management           Chief Executive Officer    

 

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Filed: November 19th, 2007

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