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)
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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)
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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.
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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.
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)
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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)
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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)
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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)
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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)
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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)
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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)
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is not
demonstrably engaged in a research, development, manufacturing,
marketing, or licensing program, as appropriate, directed toward
this end.
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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)
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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)
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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)
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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.
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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)
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[***]%
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)
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[****]%
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)
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[***]%
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)
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[*]% 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)
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[***]%
royalties on Net Sales of Licensed Products sold by Licensee and
its AFFILIATES in the animal field.
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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 ap