NON-EXCLUSIVE LICENSE
AGREEMENT
This Agreement,
effective as of January 10, 2007 (the “Effective
Date”), is between the University of Massachusetts
(“University”), a public institution of higher
education of the Commonwealth of Massachusetts as represented by
its Worcester campus, and, RXi Pharmaceuticals Corporation
(“Company”), a Delaware corporation.
WHEREAS,
University owns intellectual property rights which relate to
therapeutic applications of RNAi, as described in
University’s invention disclosures numbered UMMC 06-08,
entitled “Methods of Synthesis and Formulation of New
Reagents for Efficient Nucleic Acids Delivery in Cells and
Animals” and UMMC 07-08 entitled “Microwave Assisted
Method of Synthesis of New Cationic Reagents for Efficient Drug
Delivery in Cells and Animals”;
WHEREAS, Company
is engaged in business relating to the development and
commercialization of products that use or incorporate
University’s intellectual property rights and has the
capability of developing commercial applications of the
intellectual property;
WHEREAS, Company
desires to obtain a non-exclusive license to University’s
intellectual property rights, and University is willing to grant a
non-exclusive license to its intellectual property rights under the
following conditions so that these intellectual property rights may
be developed to their fullest and the benefits enjoyed by the
general public; and
WHEREAS, the
license that is granted in this Agreement promotes the development
of publicly funded intellectual property to practical application
for the public good.
THEREFORE,
University and Company agree as follows:
1.1 “
Affiliate ” means an entity that controls, is
controlled by, or is under common control with a party to this
Agreement. The term “control” as used in the preceding
sentence means possession of the power to direct or call for the
direction of the management and policies of an entity, whether
through ownership of a majority of the outstanding voting
securities, by contract, or otherwise.
1.2 “
Companion UMass License Agreements ” means this
Agreement and the license agreements with University that are
executed on the same date as this Agreement for University
technologies, UMMC 03-75, UMMC 03-68, UMMC 06-38, UMMC 06-39, and
UMMC 06-21, collectively.
1.3. “
Confidential Information ” means any confidential or
proprietary information furnished by one party (the
“Disclosing Party”) to the other party (the
“Receiving Party”) in
Page 1 of 17
connection with
this Agreement that is specifically designated as confidential, as
further described in Article 7.
1.4. “
Field ” means Primary Field and Secondary Field
collectively. Any commercial sale of research reagents covered by
the Patent Rights is specifically excluded from the Field. The
foregoing shall not be interpreted to prevent Company or its
Affiliates from performing research related to discovery or
development of Licensed Products for itself or any Affiliate. (a)
“ Primary Field ” means therapeutic,
prophylactic, or diagnostic health care applications for
amyotrophic lateral sclerosis (ALS), diabetes, and obesity, in
humans. (b) “ Secondary Field ” means
therapeutic, prophylactic, or diagnostic health care applications
in humans that are not included in the Primary Field.
1.5. “
Licensed Product ” means any product that cannot be
developed, manufactured, used, or sold without infringing one or
more Valid Claims.
1.6. “
Net Sales ” means the gross amount billed or invoiced
on sales of Licensed Products by Company and its Affiliates less
the following: (a) customary trade, quantity, or cash
discounts 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; and (d) outbound
transportation costs prepaid or allowed and costs of insurance in
transit.
In any transfers
of Licensed Products between any of Company and Affiliates Net
Sales are calculated based on the final sale of the Licensed
Product to an independent third party. If Company or an Affiliate
receives non-monetary consideration for any Licensed Products, Net
Sales are calculated based on the fair market value of that
consideration. If Company or its Affiliates use or dispose of a
Licensed Product in the provision of a commercial service, the
Licensed Product is sold and the Net Sales are calculated based on
the sales price of the Licensed Product to an independent third
party during the same Royalty Period or, in the absence of sales,
on the fair market value of the Licensed Product as determined by
the parties in good faith.
1.7. “
Patent Rights ” means the United States patent
applications listed in Exhibit A, patent applications covering
invention disclosures listed in Exhibit A, and any divisional,
continuation, or continuation-in-part of those patent applications
to the extent the claims are directed to subject matter
specifically described therein as well as any patents issued on
these patent applications and any reissues or reexaminations or
extensions of the patents, and any foreign counterparts to any of
the foregoing.
1.8. “
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.
Page 2 of 17
1.9. “
Valid Claim ” means (a) a claim of an issued and
unexpired patent covering the Patent Rights which has not been
permanently revoked or held unenforceable or invalid by an
unappealable or unappealed decision of a court or government agency
of competent jurisdiction or (b) a claim of a pending patent
application within the Patent Rights that has not been abandoned or
finally disallowed without the possibility of appeal or
refiling.
2.1. License
Grant . University grants to Company a nonexclusive, worldwide,
royalty-bearing license (without the right to sublicense ) in the
Patent Rights to make, have made, use, offer to sell, sell, have
sold and imported Licensed Products in the Field, including
research for development of Licensed Products.
2.3. Assignment
of UMass/CytRx Licenses . On or before March 31, 2007,
Company shall obtain assignment from CytRx Corporation of the
license agreements that cover the following RNAi technologies that
CytRx has licensed from University and the Carnegie Institution,
UMMC 01-36, UMMC 02-01, UMMC 03-17, UMMC 03-33, UMMC 03-60, and
UMMC 98-22, in a manner compliant with the relevant license
agreements. University shall consent to any assignment as
necessary. If Company does not obtain assignment of those license
agreements on or before March 31, 2007, this Agreement
immediately terminates.
3. Company
Obligations Relating to Commercialization .
3.1. Diligence
Requirements . Company shall use diligent efforts or cause its
Affiliates to use diligent efforts to develop Licensed Products and
to introduce Licensed Products into the commercial market.
Thereafter, Company or its Affiliates shall make Licensed Products
reasonably available to the public. Specifically, Company shall
fulfill the following obligations:
(a)
Financing the Company . On or before March 31, 2007,
Company shall raise at least Fifteen Million Dollars ($15,000,000)
from investors which may include CytRx Corporation (the
“Initial Financing”) or this Agreement automatically
terminates, and Company shall pay University Seventy-Five Thousand
Dollars ($75,000) due April 1, 2007 (payable only once under
the Companion UMass License Agreements). However, if Company
demonstrates to the reasonable satisfaction of University that, on
March 31, 2007, investors are performing due diligence for,
or, in the case of CytRx Corporation, is otherwise taking actions
that are reasonably likely to result in, the financing of Company
of at least $15,000,000, University grants Company a thirty
(30) day extension from March 31, 2007, to fulfill the
financing obligation set forth in this Subsection 3.1(a). If
Company can demonstrate to the reasonable satisfaction of
University that investors are performing due diligence for, or, in
the case of CytRx Corporation, is otherwise taking actions that are
reasonably likely to result in, the financing of Company of at
least $15,000,000, Company shall be granted up to two additional
thirty (30) day extensions to fulfill the financing obligation
by paying to University Twenty-Five Thousand Dollars ($25,000) each
on the last day of the previous extension. The extension fees are
non-refundable but creditable to the upfront license
fee.
(b)
Development of Licensed Products .
Page 3 of 17
(i)
On or before execution of this Agreement, Company shall furnish
University with a written business plan under which Company intends
as of the Effective Date to develop Licensed Products. University
acknowledges that this business plan is a statement of
Company’s current intention regarding the development of
Licensed Product and that Company’s plans regarding the
development of Licensed Products may change.
(ii)
Within sixty (60) days after the start of each calendar year,
beginning on January 1, 2008, Company shall furnish University
with a written report on progress during the prior year to develop
and commercialize Licensed Products, including without limitation
research and development, efforts to obtain regulatory approval,
marketing, and sales figures. The Company shall also include in the
report a discussion of its intended development and
commercialization efforts and sales projections for the current
year.
(iii)
Within four (4) years after the Effective Date, Company or its
Affiliate shall file an IND or its equivalent with the FDA covering
at least one (1) Licensed Product.
(iv)
Within twelve (12) years after the Effective Date, Company,
its Affiliate or Sublicensee shall file an NDA or BLA with the FDA
covering at least one (1) Licensed Product.
(v)
Within three (3) months after receiving FDA approval of the
NDA or BLA for each Licensed Product, Company or its Affiliate
shall market the approved Licensed Product in the United
States.
3.2. If University
determines that Company has not fulfilled its obligations under
Subsection 3.1(b), University shall furnish Company with written
notice of the determination. Within sixty (60) days after
receipt of the notice, Company shall either (a) fulfill the
relevant obligation or (b) negotiate with University a
mutually acceptable schedule of revised diligence obligations,
failing which University may, immediately upon written notice to
Company, terminate this Agreement.
(a)
Indemnity . Company shall indemnify, defend, and hold
harmless University 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 the 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. However, indemnification does not
apply to any liability, damage, loss, or expense to the extent
directly attributable to (i) the gross negligence 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.
Page 4 of 17
(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 University to defend against any claim. The
Indemnitees shall cooperate fully with Company in the defense and
will permit Company to conduct and control the defense and the
disposition of the claim, suit, or action (including all decisions
relative to litigation, appeal, and settlement). However, any
Indemnitee may retain its own counsel, at the expense of Company,
if representation of the Indemnitee by the counsel retained by
Company would be inappropriate because of actual or potential
conflicts in the interests of the Indemnitee and any other party
represented by that counsel. Company agrees to keep University
informed of the progress in the defense and disposition of the
claim and to consult with University regarding 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 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 University, upon request, with written evidence of
insurance or self-insurance. Company shall continue to maintain the
insurance or self-insurance after the expiration or termination of
this Agreement while Company or its Affiliate continues to make,
use, or sell a Licensed Product and thereafter for five
(5) years.
3.4. Use of
University Name . In accordance with Section 7.2., Company
and its Affiliates may not use the name “University of
Massachusetts” or any variation of that name in connection
with the marketing or sale of any Licensed Products.
3.5. Marking of
Licensed Products . To the extent commercially feasible and
consistent with prevailing business practices, Company shall mark
and shall cause its Affiliates to mark 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 a
Licensed Product.
3.6. Compliance
with Law . Company shall comply with, and shall ensure that its
Affiliates 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 shall obtain all necessary approvals from the
United States Food & Drug Administration and any similar
foreign governmental authorities in which Company or Affiliate
intends to make, use, or sell Licensed Products.
(b) Company
and its Affiliates shall comply with all United States laws and
regulations controlling the export of 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 and foreign nationals.
Company hereby gives written assurance that it will comply with and
will cause its Affiliates to comply with all United States export
control laws and regulations, that it bears sole
responsibility
Page 5 of 17
for any
violation of those laws and regulations by itself or its
Affiliates, and that it will indemnify, defend, and hold University
harmless (in accordance with Section 3.3.) for the
consequences of any violation.
(c) If
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, University may seek
a waiver of this requirement from the relevant federal agency on
behalf of Company.
4.
Consideration for Grant of Rights .
(a) On
the Effective Date, Company shall pay to
University{***}.
(b) Within
thirty (30) days after the closing of the Initial Financing,
Company shall pay to University {***}.
The license
fees are nonrefundable and are not creditable against any other
payments due to University under this Agreement.
(a) Within
thirty (30) days after the closing of the Initial Financing,
Company shall issue to University that number shares of Common
Stock of Company having an aggregate valuation equal to {***}
according to the Company valuation at the Initial Financing. In
connection with the issuance of stock pursuant to this Subsection
4.2(a), the University agrees to become a party to other agreements
of Company to the same extent (except any limitations relating to
the University’s status as an agency of the Commonwealth of
Massachusetts, e.g., prohibition on indemnification) as holders of
more than five percent (5%) of the Common Stock of Company (such
as, voting agreement and stock restriction agreement). University
acknowledges that all certificates representing the shares
described in this Subsection 4.2(a) may bear customary legends that
require compliance with the Securities Act of 1933 and related
state securities laws upon any transfer of the shares. Company
shall use commercially reasonable efforts to register the stock
issued to University pursuant to this Subsection 4.2(a) as soon as
possible, subject to customary terms in connection with the
registration.
(b) Beginning
on the Effective Date, Company shall notify University reasonably
prior to each Company board of directors meeting and provide
University with related documentation to the same extent that is
supplied to the board of directors. Company shall permit one
representative of University to attend all board of director
meetings until the earlier of five (5) years after the
Effective Date or the commencement by the Company of a Phase II
clinical trial relating to a Licensed Product. The University
attendee may not be a voting member of the board. The University
attendee shall comply with restrictions to which other board
members are subject, such as, confidentiality requirements relating
to Board
Page 6 of 17
discussions and
shall execute any agreement reasonably required by Company to
effect those restrictions. The Company board of directors may
exclude University representative from those portions of board
meetings that pertain to compensation and personnel issues and as
deemed reasonably necessary for the board members to exercise their
fiduciary responsibilities and to comply with applicable laws and
regulations.
4.3. License
Maintenance Fee . At the beginning of each calendar year during
the term of this Agreement, commencing on January 1, 2008,
Company shall pay to University {***}. This annual license
maintenance fee is nonrefundable and is not creditable against any
other payments due to University under this Agreement.
4.4. Milestone
Payments . Company shall pay University the following milestone
payments within thirty (30) days after the occurrence of each
event for each Licensed Product: [IS THERE NO MILESTONE PAYMENT FOR
NDA?]
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Payment
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The first issuance of any claim under any Patent
Rights
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{***}
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Earlier of filing IND or 3 years after
Effective Date
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{***}
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Commencement of Licensed Product marketing in US
or 11 years after the Effective Date
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{***}
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