EXCLUSIVE LICENSE AGREEMENT
Exhibit 10.11
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 of
00000 Xxx Xxxxxxx Xxxxxxxxx, Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000.
R E C I T A L S
WHEREAS, Medical School is owner by assignment of the invention claimed in the United States
Patent Application listed in Exhibit A pertaining to the Medical School’s invention disclosure
number UMMC 03-17 entitled “RNAi Targeting of Viruses”.
WHEREAS Company desires to obtain an exclusive license in the field of RNAi therapeutics
solely to inhibit human cytomegalovirus (HCMV) Immediate Early (IE) gene expression for the
development of retinitis prophylactics, treatments, and diagnostics, under the rights of Medical
School in any patent rights claiming those inventions; and
WHEREAS, Medical School is willing to grant Company an exclusive license on the terms set
forth in this Agreement.
NOW, THEREFORE, Medical School and Company hereby agree as follows:
1. Definitions.
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.
[***] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.
An unredacted version of this exhibit has been filed separately with the Commission.
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 the limited use of RNAi to inhibit human cytomegalovirus (HCMV) Immediate
Early (IE) gene expression for the development of retinitis prophylactics, therapeutics, 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
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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
(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 which
(a) has been developed by Xx. Xxxxxxx Xxxxxxx and his associates in his laboratory at the Medical
School as of the Effective Date and which is owned by Medical School.
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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2. Grant of Rights.
2.1. License Grants.
(a) Patent Rights and Biological Materials. Subject to the terms of this Agreement, Medical
School hereby grants to Company and its Affiliates an exclusive, worldwide, royalty-bearing license
(with the right to sublicense) under its commercial rights in the Patent Rights and Biological
Materials to develop, make, have made, use, and sell Licensed Products in the Field.
(b) Related Technology. Subject to the terms of this Agreement, Medical School hereby grants
to Company and its Affiliates a non-exclusive, royalty-bearing license (with the right to
sublicense) under its commercial rights in the Related Technology to develop, make, have made, use,
and sell Licensed Products in the Field.
(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.
2.2. Sublicenses. Company shall have the right to grant sublicenses of its rights under
Section 2.1. with the consent of Medical School, which consent shall not be unreasonably withheld
or delayed. All sublicense agreements executed by Company pursuant to this Article 2 shall
expressly bind the Sublicensee to the terms of this. Company shall promptly furnish Medical School
with a fully executed copy of any such sublicense agreement.
2.3. Retained Rights.
(a) Medical School. Medical School retains the right to make and use Licensed Products for
academic research, teaching, and non-commercial patient care, without payment of compensation to
Company. Medical School may license its retained rights under this Section to research
collaborators of Medical School faculty members, post-doctoral fellows, and students.
(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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(c) Other Organizations. To the extent that any invention claimed in the Patent Rights has
been partially funded by a non-profit organization or state or local agency, this Agreement and the
grant of any rights in such Patent Rights are subject to and governed by the terms and conditions
of the applicable research grant. If any term of this Agreement fails to conform with such terms
and conditions, the relevant term shall be deemed an invalid provision and modified by the parties
pursuant to 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(c).
3. Company Obligations Relating to Commercialization.
3.1. Diligence Requirements. Company shall use diligent efforts, or shall cause its
Affiliates and Sublicensees to use diligent efforts, to develop Licensed Products and to introduce
Licensed Products into the commercial market; thereafter, Company or its Affiliates or Sublicensees
shall make Licensed Products reasonably available to the public. Specifically, Company or
Affiliate or Sublicensee shall fulfill the following obligations:
(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
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(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).
(e) Within three months of Effective Date, Company shall commit to fund basic research in the
laboratory of Xx. Xxxxxxx Xxxxxxx at an amount of at least {***} in direct Medical School costs in
the first year, {***} in direct Medical School costs in the second year, and {***} in direct
Medical School costs in the third year towards in support of licensed Patent Rights and/or related
technology. In addition to direct Medical School costs, Company sponsored research is subject to
indirect cost rates, currently fifty percent (50%) for basic research. Company shall enter into a
formal sponsored research agreement with Medical School in a separate agreement. During the term
of any agreement covering funding described in this Section 3.1(e), if a lower indirect cost rate
is afforded to any other industrial sponsor by the Office of Technology Management of the Medical
School or if the federal indirect cost rate is reduced, the indirect cost rate charged to the
Company shall prospectively be reduced to that lower rate.
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 (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.
3.2. Indemnification.
(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.
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(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.
3.4. Marking of Licensed Products. To the extent commercially feasible and consistent with
prevailing business practices, Company shall xxxx, and shall cause its Affiliates and Sublicensees
to xxxx, all Licensed Products that are manufactured or sold under this Agreement with the number
of each issued patent under the Patent Rights that applies to such Licensed Product.
3.5. Compliance with Law. Company shall comply with, and shall ensure that its Affiliates and
Sublicensees (to the extent commercially feasible) comply with, all local, state, federal, and
international laws and regulations relating to the development, manufacture, use, and sale of
Licensed Products. Company expressly agrees to comply with the following:
(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
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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.
4. Consideration for Grant of Rights.
4.1. License Fee. In partial consideration of the rights granted Company under this
Agreement, Company shall pay to Medical School on the Effective Date (a) a license fee of {***},
and (b) a payment in the amount of {***} to reimburse Medical School for its actual expenses
incurred as of January 31, 2003 in connection with obtaining the Patent Rights. These license fee
payments are nonrefundable and are not creditable against any other payments due to Medical School
under this Agreement.
4.2. Equity. In partial consideration of the license granted to Company under this Agreement,
on or about April 18, 2003, Company shall issue to Medical School a total number 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.
4.3. License Maintenance Fee. Beginning on the first anniversary of the Effective Date, and
on each anniversary of the Effective Date thereafter during the term of the Agreement, Company
shall pay to Medical School {***}, as long as Company has a funding agreement in place with the
Medical School at the levels described in Section 3.1(e), after which time the annual maintenance
fee shall be {***}. This annual license maintenance fee is nonrefundable and is not creditable
against any other payments due to Medical School under this Agreement.
4.4. Milestone Payments. Company shall pay Medical School the following milestone payments
within thirty (30) days after the occurrence of each event:
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| 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.
4.5. Royalties.
(a) Base Royalty. In partial consideration of the rights granted Company under this
Agreement, Company shall pay to Medical School a royalty of {***} of Net Sales of Licensed Products
by Company and its Affiliates (but not Sublicensees).
(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.
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(iv) Company shall pay Medical School {***} of Net Sales of commercial clinical laboratory
services by Company and its Affiliates.
(b) Royalty Reduction. If Medical School grants additional licenses to third parties pursuant
to Section 3.1., the royalty rates set forth in Subsection 4.5.(a) shall be adjusted, if necessary,
so as not to exceed the royalty rates charged any other licensee of the Patent Rights during the
term of the non-exclusive license.
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.
4.7. Sublicense Income. Company shall pay Medical School {***} of all Sublicense Income.
Such amounts shall be due and payable within sixty (60) days after Company receives the relevant
payment from the Sublicensee.
4.8. Third-Party Royalties. In the event that Company is legally required to make
royalty payments to Medical School under any agreement other than this Agreement or to one or more
third parties in order to make, use, or sell Licensed Products or have it’s Sublicensee make, use,
or sell Licensed Products, Company may offset a total of fifty percent (50%) of such other Medical
School and third-party payments against any royalty payments that are due to Medical School in the
same Royalty Period under this agreement, provided that in no event shall the royalty payments
under Sections 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.
5. Royalty Reports; Payments; Records.
5.1. First Sale. Company shall report to Medical School the date of first commercial sale of
each Licensed Product within thirty (30) days of occurrence in each country.
5.2. Reports and Payments. Within sixty (60) days after the conclusion of each Royalty Period,
Company shall deliver to Medical School a report containing the following information:
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(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.
5.3. Payments in U.S. Dollars. All payments due under this Agreement shall be payable in
United States dollars. Conversion of foreign currency to U.S. dollars shall be made at the
conversion rate existing in the United States (as reported in the Wall Street Journal) on the last
working day of the calendar quarter preceding the applicable Royalty Period. Such payments shall
be without deduction of exchange, collection, or other charges.
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.
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
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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.
5.6. Late Payments. Any payments by Company that are not paid on or before the date such
payments are due under this Agreement shall bear interest, to the extent permitted by law, at two
percentage points above the Prime Rate of interest as reported in the Wall Street Journal on the
date payment is due, with interest calculated based on the number of days that payment is
delinquent.
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.
5.8. Withholding and Similar Taxes. Royalty payments and other payments due to Medical School
under this Agreement shall be reduced by reason of any withholding or similar taxes applicable to
such payments to Medical School, which shall be paid by Company as required by applicable law and
reported by Company to the Medical School.
6. Patents and Infringement.
6.1. Responsibility for Medical School Patent Rights. Medical School shall have primary
responsibility, at the expense of Company, for the preparation, filing, prosecution, and
maintenance of all Medical School Patent Rights, using patent counsel reasonably acceptable to
Company. Medical School shall consult with Company 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 Company with copies of all
relevant documents reasonably in advance of such consultation.
6.2. Responsibility for Joint Patent Rights. Company shall have primary responsibility, at
its expense, for the preparation, filing, prosecution, and maintenance of all Joint Patent Rights,
using patent counsel reasonably acceptable to Medical School. Company shall consult with 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.
6.3. Cooperation. Medical School and Company shall cooperate fully in the preparation,
filing, prosecution, and maintenance of all Patent Rights. Such cooperation includes, without
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limitation, (a) promptly executing all papers and instruments or requiring employees of Medical
School or Company to execute such papers and instruments as reasonable and appropriate so as to
enable Medical School or Company to file, prosecute, and maintain such Patent Rights in any
country; and (b) promptly informing the other party of matters that may affect the preparation,
filing, prosecution, or maintenance of any such Patent Rights (such as becoming aware of an
additional inventor who is not listed as an inventor in a patent application).
6.4. Payment of Expenses. Within thirty (30) days after Medical School invoices Company,
Company shall reimburse Medical School for all reasonable patent-related expenses incurred by
Medical School pursuant to Section 6.1. Company may elect, upon sixty (60) days written notice to
Medical School, to cease payment of the expenses associated with obtaining or maintaining patent
protection for one or more Patent Rights in one or more countries. In such event, Company shall
lose all rights under this Agreement with respect to such Patent Rights in such countries for which
it has elected not to pay.
6.5. Abandonment. In the event that a party desires to abandon any patent or patent
application within the Patent Rights for which it has primary responsibility, such party shall
provide the other party with reasonable prior written notice of such intended abandonment or
decline of responsibility, and the other party shall have the right, at its expense, to prepare,
file, prosecute, and maintain the relevant Patent Rights.
6.6. Grant back: The Company agrees that for any patent rights, as defined in the sponsored
research agreement that implements Company’s obligation in Section 3.1(e) that it has not licensed,
the Company grants back to the Medical School, without limiting in any way its rights under this
Agreement, a non-exclusive license to the Patent Rights in order that the Medical School may
license the patent rights from the sponsored research to third parties. Medical School shall pay
Company {***} of any revenues or other consideration received by Medical School with respect to any
patent rights granted back by Company pursuant to this Section 6.6.
6.7. Infringement.
(a) Notification of Infringement. Each party agrees to provide written notice to the other
party promptly after becoming aware of any infringement of the Patent Rights.
(b) Company Right to Prosecute. So long as Company remains the only licensee of the Patent
Rights and Biological Materials in the Field, Company shall have the right, under its own control
and at its own expense, to prosecute any third party infringement of the Patent Rights in the Field
or, together with licensees of the Patent Rights in other fields (if any), to defend the Patent
Rights in any declaratory judgment action brought by a third party which alleges invalidity,
unenforceability, or non-infringement of the Patent Rights. Prior to commencing any such action,
Company shall consult with Medical School and shall consider the views of Medical School regarding
the advisability of the proposed action and its effect on the 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.
- 13 -
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.
(c) Medical School as Indispensable Party. Medical School shall permit any action under this
Section to be brought in its name if required by law, provided that Company shall hold Medical
School harmless from, and if necessary indemnify Medical School against, any costs, expenses, or
liability that Medical School may incur in connection with such action.
(d) Medical School Right to Prosecute. In the event that Company fails to initiate an
infringement action within a reasonable time after it first becomes aware of the basis for such
action, or to answer a declaratory judgment action within a reasonable time after such action is
filed, Medical School shall have the right to prosecute such infringement or answer such
declaratory judgment action, under its sole control and at its sole expense, and any recovery
obtained shall be given to Medical School.
(e) Cooperation. Each party agrees to cooperate fully in any action under this Section 6.7.
which is controlled by the other party, provided that the controlling party reimburses the
cooperating party promptly for any costs and expenses incurred by the cooperating party in
connection with providing such assistance.
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
Confidential Information to its directors, officers, employees, consultants, and advisors who are
- 14 -
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
- 15 -
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.
8. Term and Termination.
8.1. Term. This Agreement shall commence on the Effective Date and shall remain in effect
until (a) the expiration of all issued patents within the Patent Rights or (b) for a period of ten
(10) years after the Effective Date if no such patents have issued within that ten-year period,
unless earlier terminated in accordance with the provisions of this Agreement.
8.2. Termination for Default. In the event that either party commits a material breach of its
obligations under this Agreement and fails to cure that breach within sixty (60) days after
receiving written notice thereof, the other party may terminate this Agreement immediately upon
written notice to the party in breach. If the alleged breach involves nonpayment of any amounts
due Medical School under this Agreement, Company shall have only one opportunity to cure a material
breach for which it receives notice as described above; any subsequent material breach by Company
will entitle Medical School to terminate this Agreement immediately upon written notice to Company,
without the sixty-day cure period.
8.3. Force Majeure. Neither party will be responsible for delays resulting from causes beyond
the reasonable control of such party, including without limitation fire, explosion, flood, war,
strike, or riot, provided that the nonperforming party uses commercially reasonable efforts to
avoid or remove such causes of nonperformance and continues performance under this Agreement with
reasonable dispatch whenever such causes are removed.
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.
9. Dispute Resolution.
9.1. Procedures Mandatory. The parties agree that any dispute arising out of or relating to
this Agreement shall be resolved solely by means of the procedures set forth in this Article, and
that such procedures constitute legally binding obligations that are an essential provision of this
Agreement; provided, however, that all procedures and deadlines specified in this Article may be
modified by written agreement of the parties. If either party fails to observe the procedures of
this Article, as modified by their written agreement, the other party may bring an action for
specific performance in any court of competent jurisdiction.
- 16 -
9.2. Dispute Resolution Procedures.
(a) Negotiation. In the event of any dispute arising out of or relating to this Agreement,
the affected party shall notify the other party, and the parties shall attempt in good faith to
resolve the matter within ten (10) days after the date of such notice (the “Notice Date”). Any
disputes not resolved by good faith discussions shall be referred to senior executives of each
party, who shall meet at a mutually acceptable time and location within thirty (30) days after the
Notice Date and attempt to negotiate a settlement.
(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.
(c) Trial Without Jury. If the parties fail to resolve the dispute through mediation, or if
neither party elects to initiate mediation, each party shall have the right to pursue any other
remedies legally available to resolve the dispute, provided, however, that the parties expressly
waive any right to a jury trial in any legal proceeding under this Section.
9.3. Preservation of Rights Pending Resolution.
(a) Performance to Continue. Each party shall continue to perform its obligations under this
Agreement pending final resolution of any dispute arising out or relating to this Agreement;
provided, however, that a party may suspend performance of its obligations during any period in
which the other party fails or refuses to perform its obligations.
(b) Provisional Remedies. Although the procedures specified in this Article are the sole and
exclusive procedures for the resolution of disputes arising out of relating to this Agreement,
either party may seek a preliminary injunction or other provisional equitable relief if, in its
reasonable judgment, such action is necessary to avoid irreparable harm to itself or to preserve
its rights under this Agreement.
(c) Statute of Limitations. The parties agree that all applicable statutes of limitation and
time-based defenses (such as estoppel and laches) shall be tolled while the procedures set forth in
Subsections 9.2.(a) and 9.2(b) are pending. The parties shall take any actions necessary to
effectuate this result.
- 17 -
10. Miscellaneous.
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.
10.2. Compliance with Law and Policies. Company agrees to comply with applicable law and the
policies of Medical School in the area of technology transfer and shall promptly notify Medical
School of any violation that Company knows or has reason to believe has occurred or is likely to
occur. The Medical School policies currently in effect at the Worcester campus are listed on the
xxxx://xxx.xxxxxxxx.xxx web site.
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.
10.4. Counterparts. This Agreement 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.
10.5. Headings. All headings are for convenience only and shall not affect the meaning of any
provision of this Agreement.
10.6. Binding Effect. This Agreement shall be binding upon and inure to the benefit of the
parties and their respective permitted successors and assigns.
10.7. Assignment. This Agreement may not be assigned by either party without the prior
written consent of the other party, except that Company may assign this Agreement to an
- 18 -
Affiliate or to a successor in connection with the merger, consolidation, or sale of all or
substantially all of its assets or that portion of its business to which this Agreement relates.
10.8. Amendment and Waiver. This Agreement may be amended, supplemented, or otherwise
modified only by means of a written instrument signed by both parties. Any waiver of any rights or
failure to act in a specific instance shall relate only to such instance and shall not be construed
as an agreement to waive any rights or fail to act in any other instance, whether or not similar.
10.9. Governing Law. This Agreement shall be governed by and construed in accordance with the
laws of the Commonwealth of Massachusetts irrespective of any conflicts of law principles.
10.10. Notice. Any notices required or permitted under this Agreement shall be in writing,
shall specifically refer to this Agreement, and shall be sent by hand, recognized national
overnight courier, confirmed facsimile transmission, confirmed electronic mail, or registered or
certified mail, postage prepaid, return receipt requested, to the following addresses or facsimile
numbers of the parties:
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 | |||
| Chief Executive Officer | ||||
| 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.
- 19 -
10.11. Severability. In the event that any provision of this Agreement shall be held invalid
or unenforceable for any reason, such invalidity or unenforceability shall not affect any other
provision of this Agreement, and the parties shall negotiate in good faith to modify the Agreement
to preserve (to the extent possible) their original intent. If the parties fail to reach a
modified agreement within sixty (60) days after the relevant provision is held invalid or
unenforceable, then the dispute shall be resolved in accordance with the procedures set forth in
Article 9. While the dispute is pending resolution, this Agreement shall be construed as if such
provision were deleted by agreement of the parties.
10.12. Entire Agreement. Except for the Common Stock Purchase Agreement, this Agreement
constitutes the entire agreement between the parties with respect to its subject matter and
supersedes all prior agreements or understandings between the parties relating to its subject
matter.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives as of the Effective Date.
| UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL | CYTRX CORPORATION | |||||||||
By:
|
/s/ Xxxxxx F.X. XxXxxxx | By: | /s/ Xxxxxx X. Xxxxxxxxx | |||||||
| Xxxxxx F.X. XxXxxxx | Xxxxxx X. Xxxxxxxxx | |||||||||
| Executive Director, Office of Technology Management | Chief Executive Officer | |||||||||
- 20 -
EXHIBIT A
List of Patent Rights
UMMC 03-17:
|
“RNAi Targeting of Viruses” | |
Inventor:
|
Xxxxxxx Xxxxxxx |
Provisional Patent Application Filed on February 5, 2003
This AMENDMENT No. 1 to the Exclusive License Agreement covering UMMC 03-17 (“Amendment”) is
made effective as of January 7, 2004 (the “Amendment Date”), between 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, Xxxxxxxxxxxxx 00000, and CYTRX
CORPORATION (“Company”), a Delaware corporation having an address of 00000 Xxx Xxxxxxx Xxxxxxxxx,
Xxxxx 000, Xxx Xxxxxxx, Xxxxxxxxxx 00000.
Capitalized terms used in this Amendment that are not otherwise defined in this Amendment have
the same meanings as they are defined in the Agreement (as defined below).
WHEREAS, the parties entered into an Exclusive License Agreement dated as of April 15, 2003
(the “Agreement”) under which Medical School granted Company an exclusive license in the field of
RNAi therapeutics for inhibiting human cytomegalovirus (HCMV) Immediate Early (IE) gene expression
for the development of retinitis prophylactics, therapeutics, and diagnostics, under the rights of
the Medical School in the Patent Rights and Biological Materials.
WHEREAS, the parties desire to amend the Agreement to expand the field covered by the
exclusive license to include all disease indications and not just retinitis.
THEREFORE, the parties agree as follows:
1. Amendment of the Agreement. The parties hereby agree to amend the terms of the Agreement as of
the Amendment Date as provided below.
| 1.1 | Amendment of Section 1.5. Section 1.5. of the Agreement is amended to change the field of the license to read in its entirety as follows: | ||
| “1.5. “Field” means the use of RNAi limited to the inhibition of human cytomegalovirus (HCMV) Immediate Early (IE) gene expression for the development of prophylactics, therapeutics, and diagnostics.” | |||
| 1.2 | Amendment of Section 4.1. Section 4.1. of the Agreement is amended to change the license fee from (***) to (***) to read in its entirety as follows: | ||
| “4.1. License Fee. In partial consideration of the rights granted Company under this Agreement, Company shall pay to Medical School on the Effective Date (a) a license fee of (***), and (b) a payment in the amount of (***) to reimburse Medical School for its actual expenses incurred as of January 31, 2003 in connection with obtaining the Patent Rights. These license fee payments are nonrefundable and are not creditable against any other payments due to Medical School under this Agreement.” |
| 1.3 | Amendment of Section 4.3. Section 4.3. of the Agreement is amended to change the maintenance fee from (***) to (***) in one instance and from (***) to (***) in the other instance to read in its entirety as follows: | ||
| “4.3. License Maintenance Fee. Beginning on the first anniversary of the Effective Date, and on each anniversary of the Effective Date thereafter during the term of the Agreement, Company shall pay to Medical School (***), as long as Company has a funding agreement in place with the Medical School at the levels described in Section 3.1(e), after which time the annual maintenance fee shall be (***). This annual license maintenance fee is nonrefundable and is not creditable against any other payments due to Medical School under this Agreement.” |
2. Miscellaneous.
| 2.1 | No Other Changes. Except as expressly provided in this Amendment, all terms of the Agreement remain in full force. | ||
| The parties have caused this Amendment to be executed by their respective authorized representatives as of the Amendment Date. |
| University of Massachusetts Medical School | CytRx Corporation | |||||||||
By:
|
/s/ Xxxxxxx X. Xxxxxx | By: | /s/ Xxxxxx X. Xxxxxxxxx | |||||||
Name:
|
Xxxxxxx Xxxxxx, Ph.D., X.X. | Name: | Xxxxxx X. Xxxxxxxxx | |||||||
Title:
|
Acting Director, OTM | Title: | Chief Executive Officer | |||||||
Date:
|
1/8/04 | Date: | 1/7/04 | |||||||
This Amendment No. 2, dated as of February 1, 2004 (the “Amendment”) is being made to the
Exclusive License Agreement relating to UMMC 03-17 (the “License Agreement”), effective as of April
15, 2003, and as amended by Amendment No. 1, effective as of October 30, 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
WHEREAS, Section 4.8 of the License Agreement provided for the calculation of payments payable
to Medical School under Section 4.5 and Section 4.7 of the License Agreement in the event Company
was required to make certain other payments to Medical School or third parties; and
WHEREAS, Medical School and Company wish to clarify the manner in which Section 4.8 of the
License Agreement shall operate;
NOW, THEREFORE, Medical School and Company hereby agree as follows:
1. Amendment to Section 4.8.
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.”
2. Continuation of All Other Terms of Agreement.
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. Miscellaneous.
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.
IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their duly
authorized representatives as of the date first above written.
| UNIVERSITY OF MASSACHUSETTS MEDICAL SCHOOL | CYTRX CORPORATION | |||||||||
By:
|
/s/ Xxxxxxx X. Xxxxxx | By: | /s/ Xxxxxx X. Xxxxxxxxx | |||||||
| Acting Executive Director | Xxxxxx X. Xxxxxxxxx | |||||||||
| Office of Technology Management | Chief Executive Officer | |||||||||
