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 03-68,
entitled “Methods of Efficient siRNA Delivery in Human Cells
— New Approaches for the Development of siRNA
Therapeutics”; UMMC 06-38, entitled “Design, Synthesis,
and Formulation of Nanotransporters for Efficient Nucleic Acids and
other Pharmaceutics Delivery in Cells and Animals”; and UMMC
06-39, entitled “Therapeutic Silencing of Genes Involved in
Cholesterol Biosynthesis and Other Metabolic Disorders by
Chemically Modified siRNA and New Delivery
Agents”;
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 an exclusive license to University’s
intellectual property rights, and University is willing to grant an
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 06-08, UMMC 07-08, 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 21
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, its
Affiliates or corporate partners from performing research related
to discovery or development of Licensed Products for itself or any
Affiliate or Sublicensee. (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, its Affiliates and
Sublicensees, 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 and
Sublicensees, Net Sales are calculated based on the final sale of
the Licensed Product to an independent third party. If Company or
an Affiliate or Sublicensee 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 or
Sublicensees 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 21
1.9. “
Sublicense Agreement ” means any agreement in which
Company grants rights to the Patent Rights pursuant to
Section 2.2.
1.10. “
Sublicense Income ” means payments or other value 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, equity, 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,
(b) payments specifically committed to the development of
Licensed Products, (c) reimbursements of patent expenses for
the Patent Rights, and (d) royalties.
1.11. “
Sublicensee ” means any permitted sublicensee of the
rights granted Company under this Agreement, as further described
in Section 2.2.
1.12. “
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 an exclusive, worldwide,
royalty-bearing license 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.
2.2.
Sublicenses . Company may grant sublicenses of its rights
under Section 2.1. with the consent of University, which
consent may not be unreasonably withheld or delayed. All Sublicense
Agreements executed by Company pursuant to this Section 2.2
shall expressly bind the Sublicensee to the terms of this
Agreement. Company shall promptly furnish University with a fully
executed copy of any Sublicense Agreement.
(a)
University . University retains the right to use the Patent
Rights for academic research, teaching, and non-commercial patient
care, without payment of compensation to Company. University may
license its retained rights under this Subsection 2.3(a) to
research collaborators of University faculty members, post-doctoral
fellows, and students.
(b)
Federal Government . If the federal government has funded
any invention claimed in the Patent Rights, this Agreement and the
grant of any rights in Patent Rights are subject to the federal law
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-transferrable license to practice any
government-funded invention claimed in the Patent
Page 3 of 21
Rights. If any
term of this Agreement fails to conform to those laws and
regulations, the relevant term is invalid, and the parties shall
modify the term pursuant to Section 10.11.
(c)
Other Organizations . University represents that all
inventions claimed in the Patent Rights have been funded only by
the federal government or University funds.
2.4. 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 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 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) Within
three years after the Effective Date, Company shall enter into a
bona fide collaboration or strategic alliance with a third party
commercial entity having a market capitalization greater than that
of Company, such as, a large pharmaceutical or biotechnology
company for research and/or development of Licensed Products in the
Secondary Field. If Company does not satisfy the diligence
obligation set forth in this Subsection 3.1(b) within three years
after the Effective Date, University may convert the license for
the Secondary Field to a non-exclusive license and offer licenses
in the Secondary Field to the Patent Rights to third parties,
unless Company pays University One Million Dollars ($1,000,000)
within 30 days after
Page 4 of 21
the third
anniversary of the Effective Date. If Company pays the one million
dollar fee under this Subsection 3.1(b), Company has an additional
three years to fulfill this diligence obligation, failing which
University may convert the license for the Secondary Field to a
non-exclusive license or terminate the license for the Secondary
Field.
(c)
Development of Licensed Products .
(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
five (5) years after the Effective Date, Company, its
Affiliate or Sublicensee shall file an IND or its equivalent with
the FDA covering at least one (1) Licensed Product.
(iv) Within
thirteen (13) 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, its Affiliate or
Sublicensee shall market the approved Licensed Product in the
United States.
(vi) Company
or its partner shall spend at least {***} per calendar year for
development of Licensed Products until the earlier of three years
after the Effective Date or the commencement of a Phase II clinical
trial on a Licensed Product.
(vii) Within
three years after the Effective Date, Company shall enter into a
bona fide collaboration or strategic alliance with a third party
commercial entity having a market capitalization greater than that
of Company, such as, a large pharmaceutical or biotechnology
company, for research and development of Licensed Products in a
field that includes the Primary Field.
3.2. If University
determines that Company has not fulfilled its obligations under
Subsection 3.1(c), 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
Page 5 of 21
obligations,
failing which University may, immediately upon written notice to
Company, terminate this Agreement or convert the exclusive license
into a non-exclusive license.
(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.
(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, its Affiliate or Sublicensee
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 and Sublicensees 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 and Sublicensees to mark all
Licensed Products that are manufactured or sold under
this
Page 6 of 21
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 and Sublicensees 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 foreign governmental authorities in which Company or
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 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 and Sublicensees to comply with all
United States export control laws and regulations, that it bears
sole responsibility for any violation of those laws and regulations
by itself or its Affiliates or Sublicensees, 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 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
Page 7 of 21
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 Licens
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