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Exhibit
10.26
LICENSE
AGREEMENT
This Agreement is made and entered into
by and between the University of Iowa Research Foundation
(hereinafter “UIRF”) having offices at 214 Technology
Innovation Center, Iowa City, Iowa 52242-5000 and Coley
Pharmaceutical Group, having a principal place of business at 93
Worcester Road, Suite 101, Wellesley, Massachusetts, 02481
(hereinafter “LICENSEE”).
WHEREAS, under the patent policy of The
University of Iowa (“UI”), all inventions and
technology arising during the normal course of research and
teaching at the UI are assigned and entrusted to the UIRF to obtain
patent or other appropriate intellectual property protection and
license said technology;
WHEREAS, UIRF, the
[*********************************] (hereinafter
“[**]”), The [***********]
[**********************************] (hereinafter
“[*********]”) and the [************************],
(hereinafter “[***]”) are the joint owners by
assignment (hereinafter “CO-OWNERS”) from their
respective inventors of certain PATENT RIGHTS as defined
below;
WHEREAS, UIRF is co-owner, with [**], by
assignment from [**********************] of his entire right, title
and interest in United States Patent No. [***********], issued
[***********], titled
“[************************************************************************************]”,
the associated Divisional Patent, U.S. [*******] (issued
[*********]), and the second Divisional Patent, U.S. [*******]
(issued [******************]), and the third Divisional
Application, filed [*************], (UIRF #[*******]), and is
co-owner, along with [**], [*******], and [***] of United States
Patent [*******], issued [************] based on U. S. Patent
Application Serial No. [**********] and International Patent
Application No. [**********************] filed [*******], and the
associated European and Canadian Patent Applications, titled
“[**********************************************************************************************************
******************************]” (UIRF # [*******]), the
inventions described and claimed therein, and any divisions, to the
extent the claims are directed to subject matter specifically
described therein, patents issuing thereon or reissues thereof;
which will be automatically incorporated in and added to the
Agreement;
WHEREAS, the development of these
inventions was sponsored in part by grants and/or fellowships from
the Department of the Army, and as a consequence this license is
subject to overriding obligations to the Federal Government under
35 U.S.C. §200-212 and applicable regulations;
WHEREAS, UIRF, [*******] and [***]
entered into an Inter-Institutional Agreement dated February 26,
2002 whereby UIRF is appointed as the sole licensing agent and
manager of PATENT RIGHTS on behalf of UIRF, [*******] and [***], a
copy of which is attached at Appendix B;
WHEREAS, UIRF and [**] entered into an
Inter-Institutional Agreement dated September 18, 2001 whereby UIRF
is appointed as the sole licensing agent and manager of PATENT
RIGHTS on behalf of [**], a copy of which is attached at Appendix
C;
WHEREAS, LICENSEE wishes to obtain an
exclusive world-wide license in order to practice the above
referenced inventions covered by patent rights in the United States
and in certain foreign countries, and to manufacture, use and sell
in the commercial market the products made in accordance therewith;
also
WHEREAS, UIRF wishes to grant such a
license to LICENSEE in accordance with the terms of this
Agreement.
NOW THEREFORE, in consideration of the
foregoing premises, the parties agree as follows:
ARTICLE I —
DEFINITIONS
1.1 PATENT RIGHTS shall mean United
States Patent No. [**********], issued [**********], titled
“[**********************************************]”, the
associated Divisional Patent, U.S.
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
[*********] (issued [**************]),
the second associated Divisional Patent, U.S. [*********] (issued
[****************]), and the third Divisional Application, filed
[**************] (UIRF #[******]). [************************] is
the sole inventor in United States Patent [*******] and the
associated divisional filings.
PATENT RIGHTS shall also mean
United States Patent [*********], issued [*****************], based
on United States Patent Application Serial No. [*********], and
International Patent Application No. [***************] filed
[*********], and the associated European and Canadian Patent
Applications, titled
“[**********************************************************************************************************
**” (UIRF # [*****]), the inventions described and claimed
therein, and any divisions, to the extent the claims are directed
to subject matter specifically described therein, patents issuing
thereon or reissues thereof; and any and all foreign patents and
patent applications corresponding thereto; which will be
automatically incorporated in and added to this Agreement and shall
periodically be added to Appendix A attached to this Agreement and
made part thereof. Inventorship of the U.S. Patent Application
[************] is as follows: University of Iowa
inventor(s)-[**************]; [**************] inventor(s)-
[**************] [*************] and [********************]
inventor(s)-[*************************] (assigning to
[******************************************];[*********************************************]
inventor(s) [****************************] (assigning to the UIRF);
[******************************]
inventor(s)-[*****************************].
PATENT RIGHTS shall not
include European Application No. [*********], filed on
[*****************],
“[***************************************************************]”,
the inventions described and claimed therein, patents issuing
thereon or reissues thereof; and any and all foreign patents and
patent applications corresponding thereto. [**************] is the
sole inventor in European Application No. [**********], which is
based on a PCT application corresponding to United States Patent
[*********]
1.2 LICENSED PRODUCTS shall mean
products claimed in PATENT RIGHTS and any product, the making,
selling or using of which would infringe PATENT RIGHTS but for this
Agreement or which are made in accordance with or be means of
LICENSED PROCESSES.
1.3 LICENSED PROCESSES shall mean the
processes claimed in PATENT RIGHTS or some portion
thereof.
1.4 MAJOR MARKET shall mean Germany, the
United Kingdom or the United States.
1.5 NET SALES shall mean the amount
billed or invoiced by LICENSEE, AFFILIATES, or sub-licensees on
sales of LICENSED PRODUCTS less: (a) Customary trade, quantity or
cash discounts and non-affiliated brokers’ or agents’
commissions actually allowed and taken; (b) Amounts repaid or
credited by reason of rejection or return; and/or (c) To the extent
separately stated on purchase orders, invoices or other documents
of sale, taxes levied on and/or other governmental charges made as
to production, sale, transportation, delivery or use and paid by or
on behalf of LICENSEE.
In the event that a LICENSED
PRODUCT under this Agreement is sold in combination with another
active ingredient or component having independent therapeutic
effect or diagnostic utility, the “NET SALES”, for
purposes of determining royalty payments on the combination, shall
be calculated using one of the following methods:
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(a) |
By multiplying the NET SALES of the combination by the fraction
A/A+B, where A is the gross selling price, during the royalty
paying period in question, of the LICENSED PRODUCT sold separately,
and B is the gross selling price, during the royalty period in
question, of the other active ingredients or components sold
separately; or |
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(b) |
In the event that no such separate sales are made of the
LICENSED PRODUCT or any of the active ingredients or components in
such combination package during the royalty paying period in
question, NET SALES, for the purposes of determining royalty
payments, shall be calculated using the above formula where A is
the reasonably estimated commercial value of the LICENSED PRODUCT
sold separately and B is the reasonably estimated commercial value
of the other active ingredients or components sold separately. Any
such estimates shall be reported to UIRF with the reports provided
to UIRF pursuant to section 4.3 hereof. |
Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
1.8 AFFILIATES shall mean any company,
corporation, or business in which LICENSEE owns or controls at
least fifty percent (50%) of the voting stock.
1.9 FIELD shall include all
fields
ARTICLE II —
GRANT
2.1 UIRF on behalf of itself and
CO-OWNERS hereby grants to LICENSEE and LICENSEE accepts, subject
to the terms and conditions hereof, a worldwide exclusive license
in the FIELD under PATENT RIGHTS to make and have made, to use and
have used, to sell and have sold the LICENSED PRODUCTS, and to
practice LICENSED PROCESSES. Such license shall include the right
to grant sublicenses, subject to UIRF’s approval, which
approval shall not be unreasonably withheld In order to provide
LICENSEE with a period of exclusivity, UIRF agrees it will not
grant licenses under PATENT RIGHTS in the FIELD to others except as
required by UIRF’s obligations in paragraph 2.3 (a) or as
permitted in paragraph 2.3 (b). LICENSEE agrees during the period
of exclusivity of this license in the United States that any
LICENSED PRODUCT produced for sale in the United States will be
manufactured substantially in the United States.
2.2 The term of this agreement and the
exclusive license set forth in Paragraph 2.1 shall be from the
effective date of this Agreement until the expiration of the last
to expire of the LICENSED PATENTS.
2.3 The granting and acceptance of this
license is subject to the following conditions:
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(a) |
The UI Patent Policy approved in 1983, Public Law 96-517,
Public Law 98-620 and UIRF’s obligations under agreements
with other sponsors of research. Any right granted in this
Agreement greater than that permitted under Public Law 96-517 or
Public Law 98-620 shall be subject to modification as may be
required to conform to the provision of that statute. |
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(b) |
UIRF, [**********] and CO-OWNERS shall have the right to make
and to use and to grant non-exclusive licenses to make and to use,
for research purposes only and not for any commercial purpose the
subject matter described and claimed in PATENT RIGHTS. |
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(c) |
LICENSEE shall pay all future costs connected with the
commercial development of the LICENSED PRODUCTS, including but not
limited to the costs of complying with applicable governmental
testing, approvals and regulations. |
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(d) |
LICENSEE shall use reasonable efforts to effect introduction of
the LICENSED PRODUCTS into the commercial market as soon as
practicable, consistent with sound and reasonable business
practices and judgment; thereafter, until the expiration of this
Agreement, LICENSEE shall endeavor to keep LICENSED PRODUCTS
reasonably available to the public. |
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(e) |
UIRF shall have the right to terminate or render this license
non-exclusive at any time after three (3) years from the date of
license if, in UIRF’s reasonable judgment,
LICENSEE: |
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(i) |
has not put the licensed subject matter into commercial use in
the country or countries where licensed, directly or through a
sublicense, and is not keeping the licensed subject matter
reasonably available to the public, or |
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(ii) |
is not demonstrably engaged in a research, development,
manufacturing, marketing, or licensing program, as appropriate,
directed toward this end. |
In making this determination UIRF shall
take into account the normal course of such programs conducted with
sound and reasonable business practices and judgment and shall take
into account the reports provided hereunder by LICENSEE.
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(f) |
All
sublicenses granted by LICENSEE hereunder shall include a
requirement that the sublicensee use its best efforts to bring the
subject matter of the sublicenses into commercial use as quickly as
is reasonably possible and shall bind the sublicensee to meet
LICENSEE’s obligations to UIRF and co-owning
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Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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parties under this Agreement
and a copy of this Agreement shall be attached to such sublicense
agreements. Royalties charged for sublicenses by LICENSEE shall not
be in excess of normal trade practice. Copies of all sublicense
agreements shall be provided to UIRF and co-owning
parties.
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(g) |
In accordance with the rights reserved to the Government of the
United States of America under the laws set forth in 37 CFR Part
401 et. al., 35 U.S.C. §§200-212 and succeeding statutes,
the Government shall have the nonexclusive, nontransferable,
irrevocable, royalty-free, paid-up right to practice or have
practiced the Patent Rights throughout the world by or on behalf of
the Government and on behalf of any foreign government or
international organization pursuant to any existing or future
treaty or agreement to which the Government is a
signatory. |
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(h) |
In accordance with the rights reserved to the Government under
35 U.S.C. §203 and succeeding statutes, the Government shall
retain the right to require University or its LICENSEE(s) to grant
a sublicense to a responsible applicant on terms that are
reasonable under the circumstances. The Government may exercise its
rights retained herein only in exceptional circumstances and only
if the Government determines that (i) the action is necessary to
meet health or safety needs that are not reasonably satisfied by
UIRF; (ii) the action is necessary to meet requirements for public
use specified by Federal regulations, and such requirements are not
reasonably satisfied by UIRF, or (iii) UIRF has failed to comply
with any agreement containing provisions described in 35 U.S.C. 204
or 15 U.S.C. 3710a(c)(4)(B), whichever is appropriate. |
2.4 UIRF on behalf of itself and
CO-OWNERS, hereby grants to LICENSEE the right to extend the
licenses granted or to be granted in paragraphs 2.1 and 2.3 to an
AFFILIATE subject to the terms and conditions hereof.
2.5 All rights reserved to the United
States Government and others under Public Law 96-517 and 98- 620
shall remain and shall in no way be affected by this
Agreement.
ARTICLE III —
ROYALTIES, PAYMENTS
3.1 LICENSEE shall pay to UIRF a
non-refundable license fee in the sum of $[******] execution of
this Agreement. UIRF shall distribute said fee according to its
Inter-Institutional Agreement with CO-OWNERS.
3.2 LICENSEE shall pay UIRF within
thirty (30) days after the end of each calendar quarter, during the
term of the license of paragraph 2.1, the following royalties,
based on the NET SALES of all LICENSED PRODUCTS sold by LICENSEE
and its AFFILIATES.
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(a) |
[***]% royalties on Net Sales of Licensed Products sold by
Licensee and its AFFILIATES, if total royalties being paid on the
LICENSED PRODUCT to all parties, other than by LICENSEE to QIAGEN
and its AFFILIATES for anything other than licenses under issued
patents, is less than or equal to [***]%; |
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(b) |
[****]% royalties on Net Sales of Licensed Products sold by
Licensee and its AFFILIATES, if total royalties being paid on the
LICENSED PRODUCT to all parties, other than by LICENSEE to QIAGEN
and its AFFILIATES for anything other than licenses under issued
patents, is greater than [***]%, but less than or equal to
[***]%; |
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(c) |
[***]% royalties on Net Sales of Licensed Products sold by
Licensee and its AFFILIATES, if total royalties being paid on the
LICENSED PRODUCT to all parties, other than by LICENSEE to QIAGEN
and its AFFILIATES for anything other than licenses under issued
patents, is greater than [***]% but less than or equal to
[****]%; |
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(d) |
[*]%
royalties on Net Sales of Licensed Products sold by Licensee and
its AFFILIATES, if total royalties being paid on the LICENSED
PRODUCT to all parties, other than by LICENSEE to
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Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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QIAGEN and its Affiliates for
anything other than licenses under issued patents, is greater than
[****]%;
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(e) |
[***]% royalties on Net Sales of Licensed Products sold by
Licensee and its AFFILIATES in the animal field. |
3.3 In the case of sublicense, options
to sublicense, and similar agreements to exploit PATENT RIGHTS,
LICENSEE shall also pay to UIRF [********] percent ([**]%) of any
royalty or non-royalty SUBLICENSE REVENUES. SUBLICENSEE shall mean
any third party that is not an AFFILIATE of LICENSEE to whom
LICENSEE, or an AFFILIATE of LICENSEE, grants a sublicense or an
option to sublicense under the PATENT RIGHTS pursuant to Section
2.1 hereof to make and have made, to use and have used, to import
and have imported, to offer for sale and have offered for sale,
and/or to sell and have sold the LICENSED PRODUCTS, and/or to
practice the LICENSED PROCESSES. SUBLICENSE REVENUES shall mean all
revenues received by LICENSEE or an AFFILIATE from a SUBLICENSEE
pursuant to a sublicense under the PATENT RIGHTS, an option for a
sublicense under the PATENT RIGHTS, or a similar agreement
providing for the exploitation of the PATENT RIGHTS, in each case
granted pursuant to Section 2.1 hereof, including license issue
fees, license maintenance fees, milestone fees and royalties, but
excluding equity investments in LICENSEE, any funds received by
LICENSEE for the conduct of research and development, payments
received for manufacturing, and the reimbursement of costs and
expenses.
3.4 If this license is converted to a
non-exclusive one and if other non-exclusive licenses are granted,
the above royalties shall not exceed the royalty being paid by
other licensees during the term of the non-exclusive
license.
3.5 Royalties shall not apply to sales
among LICENSEE, its AFFILIATES and their respective sublicensees
for resale. On sales between LICENSEE and its AFFILIATES for
resale, the royalty shall be paid on the resale.
3.6 A payment of
[**********************] dollars ($[*******]) for each of the first
four (4) Licensed Products to successfully complete Phase I FDA, or
equivalent European governmental body, trials. Such payment shall
accrue for each Licensed Product upon approval by FDA for the
product to proceed to Phase II FDA trials and shall be payable
within thirty (30) days of accrual. This payment would accrue and
be payable regardless of the date of execution of this Agreement.
If such milestone event has occurred and associated payment has
accrued prior to the execution of this Agreement, Licensee shall
pay such amount(s) immediately to UIRF upon execution of this
Agreement.
3.7 A payment of
[**********************] dollars ($[*******]) for each of the first
four (4) Licensed Products to receive FDA, or equivalent European
governmental body, approval for marketing. Such a payment for each
Licensed Product shall accrue upon receipt of FDA approval for the
product and shall be payable within thirty (30) days of accrual.
This payment would accrue and be payable regardless of the date of
execution of this Agreement. If such milestone event has occurred
and associated payment has accrued prior to the execution of this
Agreement, Licensee shall pay such amount(s) immediately to UIRF
upon execution of this Agreement.
3.8 A payment of [**************]
dollars ($[******]) for each of the Licensed Products that do not
require FDA approval upon execution of the first corporate
partnership agreement for product marketing. Such payment shall
accrue for each Licensed Product upon execution of said marketing
agreement. This payment would accrue and be payable regardless of
the date of execution of this Agreement. If such
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