Exhibit 10.57
***Text Omitted and Filed
Separately
with the Securities and Exchange
Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections
200.80(b)(4)
and 240.24b-2.
LICENSE AGREEMENT
University of Michigan File 0867p1
This Agreement is
effective as of 14 th of February, 2006 (the
“Effective Date”), between Vical Incorporated
(“LICENSEE”) having the address in Article 13 below,
and the Regents of the University of Michigan, a constitutional
corporation of the State of Michigan (“MICHIGAN”).
LICENSEE and MICHIGAN agree as follows:
BACKGROUND
MICHIGAN and LICENSEE are assignees
of the inventions covered by the PATENT RIGHTS (as defined
below).
LICENSEE desires to obtain, and
MICHIGAN desires to grant to LICENSEE, a license of the PATENT
RIGHTS on the terms and conditions set forth below.
ARTICLE 1 –
DEFINITIONS
1.1 “FIELD OF USE” means
all fields.
1.2 “FIRST COMMERCIAL
SALE” means the first sale, rental, or lease of any LICENSED
PRODUCT or first commercial use of any LICENSED PROCESS by LICENSEE
or a SUBLICENSEE, other than sale of a LICENSED PRODUCT or use of a
LICENSED PROCESS for use in trials, such as field trials or
clinical trials, being conducted to obtain FDA or other
governmental approvals to market LICENSED PRODUCTS or otherwise
commercially use LICENSED PROCESSES.
1.3 “LICENSED
PROCESS(ES)” means any process or method that, but for access
to rights to practice the PATENT RIGHTS, comprises an infringement
(including contributory or inducement) of an issued, unexpired
claim or a pending claim contained in the PATENT RIGHTS or uses a
LICENSED PRODUCT.
1.4 “LICENSED
PRODUCT(S)” means any product the manufacture, use, import,
offer for sale or sale of which, but for access to rights to
practice the PATENT RIGHTS, comprises an infringement (including
contributory or inducement) of an issued, unexpired claim or a
pending claim contained in the PATENT RIGHTS in the country in
which any such product or product part is made, used, imported,
offered for sale or sold.
1.5 “NET SALES” means
the amount billed or invoiced, and if any amount is not billed or
invoiced, the amounts received, on sales, rental or lease, however
characterized, by LICENSEE and/or SUBLICENSEES of LICENSED PRODUCTS
and uses of LICENSED PROCESSES, less the following deductions (so
long as such deductions are not obtained in view of other
consideration received by LICENSEE):
(a) trade, quantity and cash
discounts actually granted to customers in such invoices for sales,
rental or lease of LICENSED PRODUCTS;- or uses of LICENSED
PROCESSES, including without limitation, discounts provided by
means of chargebacks, rebates and administrative fees charged by
customers or health care organizations determined based upon sales,
but only in amounts customary in the trade;
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(b) sales, tariff duties and/or use
taxes separately stated in such bills or invoices with reference to
particular sales and actually paid by LICENSEE or SUBLICENSEE to a
governmental unit and shipping, handling and insurance charges
actually paid by LICENSEE or SUBLICENSEE;
(c) actual freight expenses between
LICENSEE or SUBLICENSEE and customers, to the extent such expenses
are not charged to or reimbursed by customers; or
(d) rebates and amounts actually
refunded or credited on returns.
Where LICENSEE receives any
consideration other than cash for such transactions, fair market
cash value for such consideration, to be agreed upon by the parties
hereto, shall be included in NET SALES.
1.6 “PATENT RIGHTS”
means MICHIGAN’S legal rights under the patent laws of the
United States or relevant foreign countries for all of the
following:
(a) the following United States and
foreign patents and/or patent applications, and divisionals,
continuations (except continuations-in-part), and foreign
counterparts of the same: US. 5,910,488, “Plasmids suitable
for gene therapy” and CA2164088, JP3636187 and
EP0702722.
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1.7
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“ROYALTY
PERIOD(S)” means the six-month periods ending on the last
days of June and December each year.
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1.8 “SUBLICENSEE(S)”
means any person or entity sublicensed, or granted an option for a
sublicense, under the PATENT RIGHTS under this
Agreement.
1.9 “SUBLICENSE INCOME”
means any revenue that LICENSEE receives from SUBLICENSEES or
assignees in consideration for rights under the PATENT RIGHTS,
including, without limitation, license issue fees, maintenance fees
and milestone payments, but excluding (a) all royalties and
other payments based on NET SALES, (b) all amounts paid to
support research and/or development by LICENSEE, (c) all
payments for equity or debt securities of LICENSEE (except that, to
the extent such payments exceed the fair market value of such
securities upon date of receipt, such excess shall be included in
SUBLICENSE INCOME), (d) all payments tied to the provision of
goods and/or services by LICENSEE, and (e) any bona fide loan
except to the extent such loan is forgiven without repayment. For
clarification, SUBLICENSE INCOME does not include any revenue that
LICENSEE receives from SUBLICENSEES or assignees in consideration
for rights to any intellectual property of LICENSEE other than the
PATENT RIGHTS.
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1.10
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“TERRITORY” means
worldwide.
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ARTICLE 2 – GRANT OF
LICENSE
2.1 MICHIGAN hereby grants to
LICENSEE an exclusive license with the right to grant sublicenses
(with the right to grant further sublicenses), both subject to the
terms and conditions of this Agreement, in the FIELD OF USE and the
TERRITORY to make, have made, import, use, market, offer for sale
and sell LICENSED PRODUCTS and to practice LICENSED
PROCESSES.
2.2 MICHIGAN reserves the right to
practice the PATENT RIGHTS for research and/or educational
purposes, and the right to grant the same limited rights to other
non-profit research institutions (with no right of such non-profit
research institution to grant further rights).
2.3 This Agreement shall extend
until expiration of the last to expire of the licensed PATENT
RIGHTS, unless sooner terminated as provided in another specific
article of this Agreement.
2.4 LICENSEE agrees that LICENSED
PRODUCTS used, leased or sold in the United States shall be
manufactured substantially in the United States to the extent
required by law.
2.5 LICENSEE acknowledges that it
has been informed that the licensed PATENT RIGHTS were developed,
at least in part, by employees of the Howard Hughes Medical
Institute (“HHMI”) and that HHMI has a paid-up,
non-exclusive, irrevocable license to use the licensed PATENT
RIGHTS for HHMI’s research purposes, but with no right to
assign or sublicense (the “HHMI License”). This license
is explicitly made subject to the HHMI License.
2.6 To the extent that the following
grant may be required by research funding agreements between
MICHIGAN and the United States Government, MICHIGAN reserves the
right to grant to the United States Government nonexclusive,
nontransferable, irrevocable, paid-up licenses to practice or have
practiced for or on behalf of the United States PATENT RIGHTS
throughout the world.
ARTICLE 3 -
CONSIDERATION
3.1 LICENSEE shall pay to MICHIGAN
the following:
(a) A license issue fee of [***].
Such license issue fee shall be nonrefundable and is due fourteen
days (14) from the complete execution of this
Agreement.
(b) Running royalties according to
the following schedule from the FIRST COMMERCIAL SALE until the
expiration date of the last to expire of the PATENT RIGHTS or until
this Agreement is terminated:
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(i)
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[***] of annual
NET SALES up to and including [***]
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(ii)
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[***] of annual
NET SALES over [***] and up to and including [***]
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(iii)
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[***] of annual
NET SALES over [***]
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Confidential
Treatment Requested
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If LICENSEE makes any NET SALES to
any party controlled by, controlling, or under common control with
LICENSEE (where “control” means the direct or indirect
ownership of more than 30% of the voting stock or other ownership
interests of that entity, or the power, directly or indirectly to
cause the direction of the management and policies of such entity)
at a price less than the price charged to-independent third
parties, the running royalties payable to MICHIGAN shall be
computed on the basis of the price charged to independent third
parties in an arm’s length transaction.
(c) [***] of SUBLICENSE
INCOME.
(d) Until the [***], an annual
license maintenance fee (“Annual Fee”) of [***]. This
Annual Fee is accrued on June 30 beginning [***] and is
payable with the semi-annual report for the ROYALTY PERIOD in which
the Annual Fee accrues.
3.2 LICENSEE shall be responsible
for the payment of all taxes, duties, levies, and other charges
imposed by any taxing authority with respect to the royalties
payable to MICHIGAN under this agreement. Should LICENSEE be
required under any law or regulation of any government entity or
authority to withhold or deduct any portion of the payments on
royalties due to MICHIGAN, then the sum payable to MICHIGAN shall
be increased by the amount necessary to yield to MICHIGAN an amount
equal to the sum it would have received had no withholdings or
deductions been made. MICHIGAN shall cooperate reasonably with
LICENSEE in the event LICENSEE elects to assert, at its own
expense, MICHIGAN’s exemption from any such tax or
deduction.
3.3 LICENSEE is not obligated to pay
multiple royalties if any LICENSED PRODUCT or LICENSED PROCESS is
covered by more than one claim of PATENT RIGHTS or the same
LICENSED PRODUCT is covered by claims in two or more
countries.
3.4 Royalty payments shall be paid
to the “Regents of the University of Michigan” in
United States dollars in Ann Arbor, Michigan, sent as provided in
Article 13. In computing royalties, LICENSEE shall convert any
revenues it receives in foreign currency into its equivalent in
United States dollars at the most recent exchange rate published in
the Wall Street Journal on the last business day of the ROYALTY
PERIOD during which such payments are received by LICENSEE, or at
such other exchange rate as the parties may agree to in
writing.
3.5 Royalty payments shall be made
on a semi-annual basis with submission of the reports required by
Article 4. All amounts due under this Agreement shall, if overdue,
be subject to a charge of interest compounded monthly until
payment, at a per annum rate of five percent (5%) above the
prime rate in effect at the JP Morgan Chase & Co. or its
successor bank on the due date (or at the highest allowed rate if a
lower rate is required by law) or $250, whichever is greater. The
payment of such interest shall not foreclose MICHIGAN from
exercising any other rights it may have resulting from any late
payment. LICENSEE shall reimburse MICHIGAN for the costs, including
reasonable attorney fees, for expenses paid in order to collect any
amounts overdue more than 120 days unless there is a good faith
dispute regarding whether such payment is due.
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Confidential
Treatment Requested
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ARTICLE 4 -
REPORTS
4.1 Until the FIRST COMMERCIAL SALE,
LICENSEE shall provide to MICHIGAN a written annual report on or
before July 30 of each year. The annual report shall include:
reports of progress on research and development, regulatory
approvals, manufacturing and sublicensing with respect to LICENSED
PRODUCTS and LICENSED PROCESSES during the preceding twelve
(12) months, and plans for the coming year. LICENSEE also
shall report to MICHIGAN the date of FIRST COMMERCIAL SALE in each
country within thirty (30) days of occurrence.
4.2 After the FIRST COMMERCIAL SALE,
LICENSEE shall provide semi-annual reports to MICHIGAN. By each
July 30 and January 31 (i.e., within one month after each
ROYALTY PERIOD closes, including the close of the ROYALTY PERIOD
immediately following any termination of this Agreement), LICENSEE
shall report to MICHIGAN for that ROYALTY PERIOD:
(a) number of LICENSED PRODUCTS
sold, leased or distributed by LICENSEE and each
SUBLICENSEE.
(b) NET SALES, excluding the
deductions provided therefor, of LICENSED PRODUCTS sold by LICENSEE
and all SUBLICENSEES.
(c) accounting for all LICENSED
PROCESSES used or sold by LICENSEE and all SUBLICENSEES, including
NET SALES, excluding the deductions therefor.
(d) deductions applicable as
provided in the definition for NET SALES above.
(e) royalties due on INCOME under
Paragraph 3.1(c) above, including supporting figures.
(f) foreign currency conversion rate
and calculations (if applicable) pursuant to Paragraph 3.4 and
total royalties due under Paragraph 3.1(b).
(g) names and addresses of all
SUBLICENSEES granted a sublicense or option therefor under the
PATENT RIGHTS any time during the particular ROYALTY
PERIOD.
(h) for each sublicense or amendment
thereto completed in the particular ROYALTY PERIOD, the date of
each agreement and amendment, the territory of the sublicense, the
scope of the sublicense, and the nature, timing and amounts of all
fees and royalties to be paid thereunder.
LICENSEE shall include the amount of
all payments due, and the various calculations used to arrive at
those amounts, including the quantity, description (nomenclature
and type designation as described in Paragraph 4.3 below), country
of manufacture and country of sale of LICENSED PRODUCTS and
LICENSED PROCESSES. LICENSEE shall direct its authorized
representative to certify that all information regarding payments
due to MICHIGAN contained in reports required hereunder is correct
to the best of LICENSEE’s knowledge and information and all
other information contained in
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reports required hereunder is correct in all
material respects to the best of LICENSEE’s knowledge and
information. Failure to provide reports as required under this
Article 4 shall be a material breach of this Agreement.
If no payment is due, LICENSEE shall
so report to MICHIGAN that no payment is due.
4.3 LICENSEE shall promptly
establish and consistently employ a system of specific nomenclature
and type designations for LICENSED PRODUCTS and LICENSED PROCESSES
to permit identification and segregation of various types where
necessary. LICENSEE shall consistently employ, and shall require
SUBLICENSEES to consistently employ, the system when rendering
invoices thereon and shall inform MICHIGAN, or its auditors, when
requested, as to the details concerning such nomenclature system,
all additions thereto and changes therein.
4.4 LICENSEE shall keep, and shall
require SUBLICENSEES to keep, true and accurate records containing
data reasonably required for the computation and verification of
payments due under this Agreement. LICENSEE shall, and it shall
require all SUBLICENSEES to: (a) open such records for
inspection upon reasonable notice during business hours by either
MICHIGAN auditor(s) or an independent certified accountant selected
by MICHIGAN, for the purpose of verifying the amount of payments
due; and (b) retain such records for six (6) years from
date of origination.
The terms of this Article shall
survive any termination of this Agreement. MICHIGAN is responsible
for all expenses of such inspection, except that if any inspection
reveals an underpayment greater than [***] of royalties due
MICHIGAN, then LICENSEE shall pay all expenses of that inspection
and the amount of the underpayment and interest to MICHIGAN within
twenty-one (21) days of written notice thereof. LICENSEE shall
also reimburse MICHIGAN for reasonable expenses required to collect
the amount underpaid.
4.5 All of the payment terms in this
Agreement and all information contained in reports provided
hereunder may be designated confidential under the terms of the
Non-Disclosure Agreement of even date herewith.
ARTICLE 5 -
DILIGENCE
5.1 LICENSEE (itself or through its
SUBLICENSEES) shall use commercially reasonable efforts to bring
LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to
commercial use and to continue active, diligent marketing efforts
for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout
the life of this Agreement. LICENSEE (itself or through its
SUBLICENSEES) has the responsibility to do all that is necessary to
obtain and retain any governmental approvals to manufacture and/or
sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all
relevant activities of LICENSEE and SUBLICENSEES.
ARTICLE 6 -
SUBLICENSING
6.1 LICENSEE shall notify MICHIGAN
in writing of every sublicense agreement and each amendment thereto
within thirty (30) days after their execution, and indicate
the name of the
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SUBLICENSEE, the territory of the sublicense,
the scope of the sublicense, and the nature, timing and amounts of
all fees and royalties to be paid thereunder. Upon request,
LICENSEE shall provide MICHIGAN with a copy of sublicense
agreements (provided that confidential information in any such
sublicense agreement that is not required to be provided to
MICHIGAN hereunder may be redacted).
6.2 Each sublicense granted by
LICENSEE under this Agreement shall provide for its termination
upon termination of this Agreement provided, however, that a
sublicense granted to any SUBLICENSEE may permit such SUBLICENSEE,
by written notice to MICHIGAN within sixty (60) days of the
SUBLICENSEE’s receipt of written notice of such termination,
to elect to continue the sublicense of rights under this Agreement
granted to such SUBLICENSEE on the condition that the sublicense
conforms to the requirements of Paragraph 6.3 and the SUBLICENSEE
agrees in writing at the time of election to be subject to the
obligations contained in this Agreement to be performed or becoming
due and payable by LICENSEE from and after the time of election as
if SUBLICENSEE were LICENSEE hereunder, subject to any limitations
on the grant of rights (such as field limitations) to such
SUBLICENSEE c