University
of Pennsylvania
This Agreement
(this “ Agreement ”) is between The Trustees of
the University of Pennsylvania, a Pennsylvania nonprofit
corporation (“ Penn ”), and Acuity
Pharmaceuticals, Inc., a Delaware corporation (“
Company ”). This Agreement is being signed on
March 31, 2003. This Agreement will become effective on
March 31, 2003 (the “ Effective Date
”).
Penn owns
certain intellectual property developed by Dr. Michael J.
Tolentino, Mr. Samuel J. Reich and Mr. Enrico M. Surace
of Penn’s School of Medicine, Department of Ophthalmology,
relating to the body of work known as RNA interference (the “
RTS Intellectual Property ”). Penn also owns certain
applications for United States letters patent relating to the RTS
Intellectual Property. Company desires to obtain an exclusive
license under the patent rights to exploit the RTS Intellectual
Property. Company also desires to fund further research by
Dr. Tolentino and Dr. Jean Bennett and their respective
groups under a separate agreement. Penn has determined that the
exploitation of the RTS Intellectual Property by Company is in the
best interests of Penn and is consistent with its educational and
research missions and goal.
Simultaneously
with the execution of this Agreement, Penn and Company are
executing an exclusive license agreement for certain intellectual
property developed by Dr. Alan Gewirtz (together with the RTS
Intellectual Property, the “ Intellectual Property
”), also relating to the body of work known as RNA
interference (the “ Gewirtz License Agreement
”).
In
consideration of the mutual obligations contained in this
Agreement, and intending to be legally bound, the parties agree as
follows:
1.1. License
Grant . Penn grants to Company an exclusive, world-wide license
(the " License ”) to make, have made, use, import,
sell and offer for sale Licensed Products during the Term (as such
terms may be defined in Sections 1.2 and 6.1). The License
includes the right to sublicense as permitted by this Agreement. No
other rights or licenses are granted by Penn.
1.2. Related
Definitions .
The term “
Licensed Products ” means products that are made, made
for, used, imported, sold or offered for sale by Company or its
Affiliates or sublicensees and that
either
(i) in the absence of this Agreement, would infringe at least
one claim of the Penn Patent Rights or (ii) use a process or
machine covered by a claim of Penn Patent Rights.
The term “
Sale ” means any bona fide transaction for which
consideration is received or expected for the sale, use, lease,
transfer or other disposition of a Licensed Product, and a Sale is
deemed completed at the time that Company or its Affiliate or
sublicensee invoices, ships or receives payment for a Licensed
Product, whichever occurs first.
The term “
Penn Patent Rights ” means all patent rights
represented by or issuing from: (i) the United States patent
applications and/or Penn docket numbers listed in Exhibit A;
(ii) any continuation, divisional and re-issue applications of
(i); and (ii) any foreign counterparts and extensions of
(i) or (ii).
The term “
Affiliate ” means a legal entity that is controlling,
controlled by or under common control with Company and that has
executed either this Agreement or a written Joinder Agreement
agreeing to be bound by all of the terms and conditions of this
Agreement. For purposes of this Section 1.2, the word “
control ” means (i) the direct or indirect
ownership of more than fifty percent (50%) of the outstanding
voting securities of a legal entity, (ii) the right to receive
fifty percent (50%) or more of the profits or earnings of a legal
entity or (iii) the right to determine the policy decisions of
a legal entity.
The term “
Significant Transaction ” shall mean a single
transaction or series of related transactions consisting of or
resulting in any of the following: (i) an assignment of the
License, (ii) an exclusive worldwide sublicense of all or
substantially all of the intellectual property rights granted to
Company under this Agreement and a non-exclusive or exclusive, in
either case, worldwide sublicense of all or substantially all of
the intellectual property rights granted to Company under the
Gewirtz License Agreement, (iii) an initial public offering of
securities by Company or other transaction resulting in either:
(a) Company becoming a public company or (b) any of
Company’s securities being traded on a nationally recognized
stock exchange or automated quotation system, (iv) a sale,
license or other disposition of all or substantially all of
Company’s assets, or (v) a reorganization, consolidation
or merger of Company, or sale or transfer of the securities of
Company, where the holders of Company’s outstanding voting
securities before the transaction beneficially own less than fifty
percent (50%) of the outstanding voting securities, or hold less
than fifty percent (50%) of the voting power of the voting
securityholders of the surviving entity after the transaction.
Notwithstanding anything above to the contrary, a Significant
Transaction shall not be deemed to occur as a result of a bona
fide, arms-length equity financing for cash in which Company issues
securities representing more than fifty percent (50%) of the voting
power of its securityholders to venture capital or other similar
investors who do not actively manage day-to-day operations of
Company.
1.3.
Reservation of Rights by Penn . Penn reserves the right to
use, and to permit other non-commercial entities to use, the Penn
Patent Rights for educational and research purposes
only.
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1.4. U.S.
Government Rights . The parties acknowledge that the United
States government retains rights in intellectual property funded
under any grant or similar contract with a Federal agency. The
License is expressly subject to all applicable United States
government rights, including, but not limited to, any applicable
requirement that products, which result from such intellectual
property and are sold in the United States, must be substantially
manufactured in the United States as conditioned by 37 CFR
401.
1.5. Sublicense
Conditions . The Company’s right to sublicense granted by
Penn under the License is subject to each of the following
conditions:
(a) In
each sublicense agreement, Company will prohibit the sublicensee
from further sublicensing and require the sublicensee to comply
with the terms and conditions of this Agreement.
(b) Within
thirty (30) days after Company enters into a sublicense
agreement, Company will deliver to Penn an executed copy of the
entire sublicense agreement written in the English language.
Penn’s receipt of the sublicense agreement, however, will not
constitute a waiver of any right of Penn or obligation of Company
under this Agreement.
(c) In
the event that Company causes or experiences a Trigger Event (as
defined in Section 6.4), all payments due to Company and its
Affiliates or sublicensees under the sublicense agreement will,
upon notice from Penn to such Affiliate or sublicensee, become
payable directly to Penn for the account of Company. Upon receipt
of any such funds, Penn will remit to Company the amount by which
such payments exceed the amounts owed by Company to
Penn.
(d) Company’s
execution of a sublicense agreement will not relieve Company of any
of its obligations under this Agreement. Company is primarily
liable to Penn for any act or omission of an Affiliate or
sublicensee of Company that would be a breach of this Agreement if
performed or omitted by Company, and Company will be deemed to be
in breach of this Agreement as a result of such act or
omission.
2.1.
Development Plan . Company will deliver to Penn, within
ninety (90) days after the Effective Date, a copy of an
initial development plan for the Penn Patent Rights (the "
Development Plan ”). The purpose of the Development
Plan is (a) to demonstrate Company’s capability to bring
the Penn Patent Rights to commercialization, (b) to project
the timeline for completing the necessary tasks, and (c) to
measure Company’s progress against the projections.
Thereafter, Company will deliver to Penn an annual updated
Development Plan no later than December 1 of each year during the
Term. The Development Plan will include, at a minimum, information
to be mutually agreed upon by the parties hereto.
2.2.
Company’s Efforts . Company will use commercially
reasonable efforts to
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develop,
commercialize, market and sell Licensed Products in a manner
consistent with the Development Plan.
2.3. Diligence
Events . The Company will use commercially reasonable efforts
to achieve each of the diligence events by the applicable
completion date listed in the table below for the first product to
be commercialized by the Company pursuant to this Agreement or the
Gewirtz License Agreement.
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DILIGENCE EVENT
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COMPLETION DATE
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Delivery to
Penn of a preliminary business plan
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June 30, 2003
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Raising at
least an aggregate of $5 Million in equity investment capital from
qualified investors
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December 31, 2004
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Filing of IND
for first Licensed Product
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January 31, 2005
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Initiation of
Phase II clinical trials for first Licensed Product
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December 31, 2007
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Initiation of
Phase III clinical trials for first Licensed Product
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December 31, 2010
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First
commercial Sale of first Licensed Product
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December 31, 2013
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3.1. Equity
Issuance . In partial consideration of the License, Company
will issue to Penn on the Effective Date such number of shares of
Common Stock of the Company as will cause Penn to own at least
twenty six and eight tenths percent (26.8%) of the capital stock of
Company on a fully diluted basis, assuming the exercise, conversion
and exchange of all outstanding securities of Company for or into
shares of Common Stock. The issuance of equity to Penn will be
pursuant to a Stock Purchase Agreement and a Stockholders Agreement
between Company and Penn, the forms of which are attached as
Exhibits C and D (the “ Equity Documents
”).
3.2. Dilution
Protection . In partial consideration of the License, through
the closing of the equity financing round at which Company has
raised cumulatively at least an aggregate of seven hundred and
fifty thousand dollars ($750,000) in net proceeds to Company of
equity financing from qualified investors, Company will issue to
Penn, from time to time and at no additional consideration, such
additional number of shares of Common Stock of Company as will
cause Penn to continue to hold in the aggregate twenty six and
eight tenths percent (26.8%) of the capital stock of Company on a
fully diluted basis, assuming the exercise, conversion and exchange
of all outstanding securities of Company for or into shares of
Common Stock.
3.3. Milestone
Payments . In partial consideration of the License, Company
will pay to Penn the applicable milestone payment listed in the
table below after achievement of each milestone event for the first
product commercialized and sold by the Company or its Affiliates
pursuant to this Agreement or the Gewirtz License
Agreement.
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MILESTONE
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PAYMENT
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Initiation of Phase II clinical trials for first
Licensed Product
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$
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50,000
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Initiation of Phase III clinical trials for
first Licensed Product
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$
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300,000
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First commercial Sale of first Licensed
Product
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$
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600,000
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3.4. Earned
Royalties . In partial consideration of the License, Company
will pay to Penn a royalty of two percent (2%) of Net Sales of a
Licensed Product sold by Company or its Affiliates (but not
sublicensees) during each Quarter following the occurrence of a
Significant Transaction. In partial consideration of the License,
Company will pay to Penn a royalty of one percent (1%) of Net Sales
of each Licensed Product sold by sublicensees of the Company (and
not the Company or its Affiliates) during each Quarter following
the occurrence of a Significant Transaction. The term “
Quarter ” means each three-month period beginning on
January 1, April 1, July 1 and October 1. The term
“ Net Sales ” means the consideration received
from, or fair market value attributable to, each Sale of a Licensed
Product, less Qualifying Costs directly attributable to a Sale and
borne by Company or its Affiliates or sublicensees. For purposes of
determining Net Sales, the words “fair market value”
mean the cash consideration that Company or its Affiliates or its
sublicensees would realize from an unrelated buyer in an arms
length sale of an identical item sold in the same quantity and at
the time and place of the transaction. The term “
Qualifying Costs ” means: (a) customary discounts
in the trade for quantity purchased, prompt payment or wholesalers
and distributors; (b) credits or refunds for claims or returns
that do not exceed the original invoice amount; (c) prepaid
outbound transportation expenses and transportation insurance
premiums; and (d) sales and use taxes and other fees imposed
by a governmental agency.
3.5. Reduction
of Royalty . If Company is required to pay royalties to Penn
and third parties that, in the aggregate, exceed four percent (4%)
of Net Sales (the “ Total Royalty ”) to
commercialize a Licensed Product, the royalties due to Penn for
such time, with respect to such a Licensed Product shall be reduced
by two tenths of one percent (0.2%) for every one percent (1%) the
aggregate royalty exceeds four percent (4%) of Net Sales. To
clarify, Company shall pay to Penn a royalty of 2% —
(0.2*(Total Royalty — 4%)) of the Net Sales. In no event
shall the royalties due to Penn be reduced below one percent (1%)
of Net Sales.
3.6. Sublicense
Fees . Except as otherwise provided below, in partial
consideration of the License, Company will pay to Penn a sublicense
fee of two percent (2%) of all payments and the fair value of all
other consideration of any kind received by Company from
sublicensees.
Notwithstanding
anything above to the contrary, no sublicense fee under this
Section 3.6 will be due to Penn with respect to any of the
following consideration received by Company: (i) consideration
received by the Company from sublicensees before the earlier of
(a) the third anniversary of the Effective Date and
(b) the occurrence of a Significant Transaction as long as
such fees are reinvested in the development of the Intellectual
Property, (ii) royalties paid to Company by a sublicensee
based upon sales or net sales of Licensed Products by the
sublicensee; (iii) equity investments in Company by a
sublicensee, up to the amount of the fair market value of the
equity purchased on the date of the investment as reasonably
determined under the circumstances; (iv) sponsored research
funding paid to Company by a sublicensee in a bona fide transaction
for future
5
research to be
performed by Company; (v) payments for consulting services
actually performed by Company in a bona fide transaction at arms
length rates; and (vi) intellectual property rights received
by Company from a sublicensee, including, but not limited to,
licenses or sublicenses to intellectual property rights, covenants
not to compete against Company, or agreements not to assert claims
against Company.
3.7.
Non-Assertion and Non-Duplication . Net Sales of any
Licensed Product, including, but not limited to, Licensed Products
pursuant to any other License Agreement executed by Company, shall
not be subject to more than one assessment of any scheduled royalty
or fee payable to Penn pursuant to this Agreement and the Gewirtz
License Agreement; such assessment shall be the lowest applicable
royalty and/or fee payable to Penn. Penn shall not assert any right
to royalties or fees for any other Licensed Product other than the
one with the lesser royalty.
3.8.
Transaction Fee . In partial consideration of the License,
Company will pay to Penn, within ninety (90) days after the
execution of this Agreement, a one-time, non-refundable,
non-creditable transaction fee of up to $10,000 with respect to
Penn’s licensing and legal expenses in connection with this
Agreement, the Gewirtz License Agreement and the Equity
Documents.
4.1. Royalty
Reports . Within forty-five (45) days after the end of
each Quarter, Company will deliver to Penn a report, certified by
the chief financial officer of Company, detailing the calculation
of all royalties and fees due to Penn for such Quarter. Unless
otherwise included on a form provided to Company by Penn or
otherwise agreed to by Penn, this report will include, at a
minimum: (a) the number of Licensed Products involved in
Sales, listed by product, by country; (b) gross consideration
invoiced, billed or received for Sales in the Quarter; (c)
Qualifying Costs, listed by category of cost; (d) Net Sales,
listed by product, by country; (e) sublicense fees and other
consideration received by Company from sublicensees, listed by
product, by country; and (f) royalties and fees owed to Penn,
listed by category, by product, by country.
4.2.
Payments . Company will pay all royalties and fees due to
Penn under Article 3, that have not been paid in advance,
within forty-five (45) days after the end of the Quarter in
which the royalties or fees accrue.
4.3.
Records . Company will maintain, and will cause its
Affiliates and sublicensees to maintain, adequate books and records
to verify Sales, Net Sales, and all of the royalties, fees, and
other payments due under this Agreement. The records for
ea
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