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. Alan Gewirtz of
Penn’s School of Medicine, Department of Medicine, relating
to the body of work known as RNA interference (the “
Gewirtz Intellectual Property ”). Penn also owns
certain applications for United States letters patent relating to
the Gewirtz Intellectual Property. Company desires to obtain an
exclusive license under the patent rights to exploit the Gewirtz
Intellectual Property. Penn has determined that the exploitation of
the Gewirtz 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. Michael J. Tolentino, Mr. Samuel J.
Reich and Mr. Enrico M. Surace (together with the Gewirtz
Intellectual Property, the “ Intellectual Property
”), also relating to the body of work known as RNA
interference (the “ RTS 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 the RTS License 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 this 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.
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
2
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, the
information listed in Exhibit B.
2.2.
Company’s Efforts . Company will use commercially
reasonable efforts to develop, commercialize, market and sell
Licensed Products in a manner consistent with the Development
Plan.
3
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
RTS License Agreement.
|
|
|
|
|
DILIGENCE EVENT
|
|
COMPLETION DATE
|
Delivery to
Penn of a preliminary business plan
|
|
June 30, 2003
|
Raising at
least an aggregate of $5 Million in equity investment capital from
qualified investors
|
|
December 31, 2004
|
Filing of IND
for first Licensed Product
|
|
January 31, 2005
|
Initiation of
Phase II clinical trials for first Licensed Product
|
|
December 31, 2007
|
Initiation of
Phase III clinical trials for first Licensed Product
|
|
December 31, 2010
|
First
commercial Sale of first Licensed Product
|
|
December 31, 2013
|
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 six
percent (6%) 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 six percent (6%) 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 RTS License Agreement.
|
|
|
|
|
|
|
MILESTONE
|
|
PAYMENT
|
Initiation of Phase II clinical trials for first
Licensed Product
|
|
$
|
50,000
|
|
Initiation of Phase III clinical trials for
first Licensed Product
|
|
$
|
300,000
|
|
First commercial Sale of first Licensed
Product
|
|
$
|
600,000
|
|
3.4. Earned
Royalties . In partial consideration of the License, Company
will
4
pay to Penn a
royalty of eight percent (8%) of Net Sales of a Licensed Product
sold by the Company or its Affiliates (but not sublicensees of the
Company) 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, less Qualifying Costs
directly attributable to a Sale and borne by Company or its
Affiliates For purposes of determining Net Sales, the words
“fair market value” mean the cash consideration that
Company or its Affiliates 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 eight percent (8%)
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 eight percent (8%) of Net Sales. To
clarify, Company shall pay to Penn a royalty of 8% —
(0.2*(Total Royalty — 8%)) of the Net Sales. In no event
shall the royalties due to Penn be reduced below four percent (4%)
of Net Sales by Company or its Affiliates.
3.6. Sublicense
Fees . Except as otherwise provided below, in partial
consideration of the License, Company will pay to Penn a sublicense
fee of six percent (6%) 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) 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; (iii) sponsored research funding paid to
Company by a sublicensee in a bona fide transaction for future
research to be performed by Company; (iv) payments for
consulting services actually performed by Company in a bona fide
transaction at arms length rates; and (v) 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
5
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 RTS 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.
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 each
Quarter will be maintained for at least four (4) years after
submission of the applicable report required under
Section 4.1.
4.4. Audit
Rights . Upon reasonable prior written notice to Company,
Company and its Affiliates and sublicensees will provide Penn and
its accountants with access to all of the books and records
required by Section 4.3 to conduct a review or audit of Sales,
Net Sales, and all of the royalties, fees, and other payments
payable under this Agreement. Access will be made available:
(a) during normal business hours; (b) in a manner
reasonably designated to facilitate Penn’s review or audit
w
|