EXHIBIT 10.16
LICENSE AGREEMENT
This Agreement is made and entered
into as of March 31, 1997 (the “Effective Date”) by and
between the University of Iowa Research Foundation (hereinafter
“UIRF”) having offices at 214 Technology Innovation
Center, Iowa City, Iowa 52242-5000 and CpG ImmunoPharmaceuticals,
Inc. (hereinafter “Licensee”), a Delaware
corporation.
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 is, therefore, owner
by assignment from Arthur M. Krieg (inventor/s) of his entire
right, title and interest in United States Patent Application
Serial No. [**********] filed [*************] titled
“[*****************************],” (UIRF #[*****] and
in the foreign patent applications corresponding thereto, and in
the inventions described and claimed herein;
WHEREAS, Licensee wishes to obtain
an exclusive world-wide license in order to practice the
above-referenced invention 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; and
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 1.
DEFINITIONS
1.1 PARENT RIGHTS shall mean U.S.
patent application Serial No. [**********] filed [************],
the inventions described and claimed therein, and any divisions,
continuations, continuations-in-part to the extent the claims are
directed to subject matter specifically described in USSN
[**********], 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.
1.2 LICENSED PRODUCTS shall mean any
product the sale, use or manufacture of which would infringe a
pending or issued claim of the PATENT RIGHTS but for the license
granted hereunder.
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.
1.3 LICENSED PROCESSES shall mean
the processes claimed in PATENT RIGHTS or some portion
thereof.
1.4 NET SALES shall mean the amount
billed or invoiced 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; (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; and/or (d)
Shipping and insurance charges.
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 , then “NET SALES,” for
purposes of determining royalty payments on the combination, shall
be calculated using one of the following methods:
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(e)
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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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(f)
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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 determined using criteria to be mutually agreed upon by the
parties. Such estimates shall be reported to UIRF with the reports
to be provided to UIRF pursuant to Section 4.3 hereof.
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1.5 AFFILIATE shall mean any
company, corporation, or business in which the entity in question
owns or controls at-least fifty percent (50%) of the voting
stock.
1.6 AGREEMENT YEAR shall mean the
annual period commencing upon an anniversary of the Effective
Date.
1.7 QIAGEN shall mean QIAGEN GmbH, a
German corporation, having its principal address at Max-Volmer-Str.
4, 40724 Hilden, Germany.
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.
2
ARTICLE 2.
GRANT
2.1 UIRF hereby grants to Licensee
and Licensee hereby accepts, subject to the terms and conditions
hereof a worldwide exclusive license under the PATENT RIGHTS 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 to sell
and have sold the LICENSED PRODUCTS, and to practice the LICENSED
PROCESSES. Such license shall include the right to grant
sublicenses, provided, however, that Licensee shall provide UIRF
with a copy of any sublicense agreement promptly upon its execution
and that such sublicense agreement must contain terms that do not
diminish any of the legal or financial rights of UIRF hereunder,
including but not limited to the indemnification and insurance
provided under this Agreement. In recognition of the exclusive
nature of this license, UIRF agrees that it will not grant licenses
under PATENT RIGHTS to others except as required by UIRF’s
obligations in Paragraph 2.3(a) and that it will not provide any
proprietary materials relating to the PATENT RIGHTS to any
commercial entity for any purpose or to entities other than
commercial entities for any commercial purpose unless otherwise
approved by Licensee.
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 PATENT RIGHTS or for a period of fifteen years,
whichever is longer.
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 and Public Law 98-620.
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 shall have
the right to make and to use for research purposes only and not for
any commercial purpose unless otherwise approved by Licensee, the
subject matter described and claimed in PATENT RIGHTS. UIRF shall
not disclose any confidential information or proprietary materials
relating to the PATENT RIGHTS to any other party without prior
written consent of Licensee and without use of a confidentiality
agreement in the form of Appendix B or a material transfer
agreement in the form of Appendix C, an executed copy of which
shall be provided to Licensee.
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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 government 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,
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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.
3
consistent with sound and reasonable
business practices and judgement; 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 if
Licensee shall not be capitalized with an aggregate investment of
at least [***** ******] U.S. dollars (US $[*********]) prior to the
first anniversary of the Effective Date.
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(f)
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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 Effective Date 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 practice and judgment
and shall take into account the reports provided hereunder by
Licensee.
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(g)
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All sublicenses
granted by Licensee hereunder shall include a requirement that the
sublicensee 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 judgement and shall bind the sublicensee to meet
Licensee’s obligations to UIRF under this Agreement and a
copy of this Agreement shall be attached to such sublicense
agreements. Copies of all sublicense agreements shall be provided
to UIRF.
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2.4 Upon expiration of the period of
exclusivity of this license, Licensee shall receive a fully paid up
perpetual license 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 to sell and have sold the LICENSED PRODUCTS, and to
practice the LICENSED PROCESSES.
2.5 Licensee agrees during the
exclusive period 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 unless any waiver
of such requirement is obtained. UIRF shall, at Licensee’s
request and expense, assist Licensee in attempting to obtain such a
waiver, should Licensee determine to do so.
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.
4
2.6 UIRF hereby grants to Licensee
the right to extend the licenses granted in Paragraph 2.1 to an
AFFILIATE subject to the terms and conditions hereof.
2.7 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 3.
ROYALTIES, PAYMNTS
3.1 Licensee shall pay to UIRF a
non-refundable license fee in the sum of $[*******] as
follows:
$[******] payable within thirty days
of the Effective Date
$[******] payable six months after
the Effective Date
$[******] payable twelve months
after the Effective Date
$[******] payable eighteen months
after the Effective Date
$[******] payable twenty-four months
after the Effective Date
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3.2
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(a) Licensee
shall pay UIRF within forty-five (45) days after the end of each
calendar quarter, during the term of the license of Paragraph 2.1,
royalties on NET SALES of all LICENSED PRODUCTS sold by Licensee
and its AFFILIATES or sublicensees as follows:
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In the human field:
[*]%, if total royalty being paid on
the LICENSED PRODUCT to all parties, other than by Licensee to
[******] and its AFFILIATES for anything other than licenses under
issued patents, is less than [*]%
[****]%, if total royalty being paid
on the LICENSED PRODUCT to all parties, other than by Licensee to
[******] and its AFFILIATES for anything other than licenses under
issued patents, is greater than or equal to [*]%, but less than
[*]%
[*]%, if total royalty being paid on
the LICENSED PRODUCT to all parties, other than by Licensee to
[******] and its AFFILIATES for anything other than licenses under
issued patents, is greater than or equal to [*]%
In the animal field:
[***]% on NET SALES of LICENSED
PRODUCTS
(b) On sales between Licensee and
its AFFILATES or sublicensees for resale, the royalty shall be paid
on the resale.
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3.3
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Commencing in
the fifth AGREEMENT YEAR, an annual license maintenance
fee
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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.
5
payment of $[*******] shall be payable to the
UIRF, payable within forty-five (45) days of the end of each
AGREEMENT YEAR. This payment shall be reduced by the amount of any
milestones, royalties or non-royalty sub-license income accrued to
the UIRF solely during that AGREEMENT YEAR but shall not be reduced
by (a) any royalties accruing in any other AGREEMENT YEAR or (b)
contract research funding payable to the University of Iowa
pursuant to the terms of any Sponsored Research
Agreement.
3.4 Licensee shall pay to UIRF the
following sums within thirty (30) days of the achievement of the
indicated milestones;
$[******] payable upon the
[******************************************************************]
LICENSED PRODUCTS in the animal field in the United
States
$[******] payable upon
[****************************************************************************]
LICENSED PRODUCTS in the human field
$[******] payable upon
[*****************************************************************]
LICENSED PRODUCTS in the human field in
[**********************************]
3.5 In the case of sublicenses,
Licensee shall also pay to UIRF [***********] percent [**]% of all
license issue fees and license maintenance fees, excluding equity
investments in Licensee and any funds received by Licensee for the
conduct of research.
ARTICLE 4.
REPORTING,
CONFIDENTIALITY
4.1 Prior to signing this Agreement,
Licensee has provided to UIRF a written business plan pertaining to
the subject matter of the licenses granted hereunder. UIRF hereby
acknowledges receipt of such business plan.
4.2 Licensee shall provide brief
written annual reports within sixty (60) days after each
anniversary of the Effective Date which shall include but not be
limited to: summaries of progress on research and development,
regulatory approvals, manufacturing, sublicensing, marketing and
sales during the preceding twelve (12) months as well as plans for
the coming year. If progress differs from that anticipated in the
plan provided under 4.1, or in the previous annual report, Licensee
shall explain the reasons for the differences and propose a
modified plan for UIRF’s review and approval. Licensee shall
also provide any reasonable additional data UIRF requires to
evaluate Licensee’s performance.
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4.3
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(a) Commencing
upon the first sale of LICENSED PRODUCTS, Licensee agrees to submit
to UIRF within forty-five (45) days after the calendar quarters
ending
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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.
6
March 31, June 30, September 30, and
December 31, reports setting forth for the preceding three (3)
month period at least the following information:
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i)
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the number of
LICENSED PRODUCTS sold by Licensee, its AFFILIATES and
sublicensees;
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ii)
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total billings
for each LICENSED PRODUCT;
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iii)
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an accounting
for all LICENSED PROCESSES used or sold;
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iv)
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deductions
applicable to determine the NET SALES thereof
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v)
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the amount of
royalty due thereon;
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and with each such royalty report to
pay the amount of royalty due. Such report shall be certified as
correct by an officer of Licensee and shall include a detailed
listing of all deductions from royalties as specified herein. If no
royalties are due to UIRF for any reporting period, the written
report shall so state.
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b)
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All payments
due hereunder shall be payable in United States dollars.
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Conversion of foreign currency to
US, dollars shall be made at the conversion rate existing in the
United States (as reported in the Wall Street Journal) on the last
working day of each royalty period. Such payments shall be without
deduction of exchange, collection or other charges.
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(c)
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All such
reports shall be maintained in confidence by UIRF, except as
required by law, including Public Law 96-517 and 98-620.
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(d)
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Late payments
shall be subject to an interest charge of [****************]
percent ([*****]%) per month.
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4.4 UIRF shall not disclose the
contents of the business plan or any report provided by Licensee
hereunder to any third party without the prior written consent of
Licensee, which consent shall not be unreasonably withheld, except
to the extent that disclosure of any such information shall be
required by government agencies.
ARTICLE 5.
RECORD KEEPING
Licensee shall keep, and shall
require its AFFILIATES and sublicensees to keep, accurate and
correct records of LICENSED PRODUCTS made, used, imported or sold
under this Agreement, appropriate to determine the amount of
royalties due hereunder to UIRF. Such records shall be retained for
at least three (3) years following a given reporting period. They
shall be available during normal business hours for inspection at
the expense of UIRF by UIRF’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.
7
Internal Audit Department or by a Certified
Public Accountant selected by UIRF and approved by Licensee for the
sole purpose of verifying reports and payments hereunder. Such
accountant shall not disclose to UIRF any information other than
information relating to accuracy of reports and payments made under
this Agreement. In the event that any such inspection shows an
underreporting and underpayment in excess of [****] percent ([*]%)
for any twelve (12) month period, then Licensee shall pay the cost
of such examination as well as any additional sum that would have
been payable to UIRF had the Licensee reported correctly, plus
interest.
ARTICLE 6.
FILING, PROSECUTION AND
MAINTENANCE OF PATENTS
6.1 Licensee shall reimburse UIRF
for all reasonable expenses heretobefore incurred by UIRF for the
preparation, filing, prosecution and maintenance of PATENT RIGHTS
and not previously reimbursed by or on behalf of Licensee promptly
upon execution of this Agreement and shall reimburse UIRF for all
such ongoing expenses within thirty (30) days of receipt of
invoices from UIRF. Late payment of these invoices shall be subject
to interest charges of [*****************] percent ([***]%) per
month. UIRF shall take responsibility for the preparation, filing,
prosecution and maintenance of any and all patent applications and
patents included in PATENT RIGHTS using patent counsel approved by
Licensee, such approval to not be unreasonably withheld. UIRF shall
promptly inform Licensee regarding all matters directly pertaining
to prosecution of LICENSED PATENTS, and shall seek Licensee’s
counsel concerning all proposed courses of action affecting the
LICENSED PATENTS, including but not limited to in which countries
patent prosecution should be obtained and all proposed courses of
action in any interference proceedings. UIRF shall cause its patent
counsel to provide Licensee with copies of all correspondence
regarding PATENT RIGHTS and UIRF shall provide Licensee sufficient
opportunity to comment on any document that UIRF intends to file or
to cause to be filed with the relevant intellectual property or
patent office.
6.2 UIRF and Licensee shall
cooperate fully in the preparation, filing, prosecution and
maintenance of PATENT RIGHTS and of all patents and patent
applications licensed to Licensee hereunder, executing all papers
and instruments or requiring members of UIRF to execute such papers
and instruments as to enable UIRF to apply for, to prosecute and to
maintain patent applications and patents in UIRF’s name in
any country. Each party shall provide to the other prompt notice as
to all matters which come to its attention and which may affect the
preparation, filing, prosecution or maintenance of any such patent
applications or patents.
6.3 If Licensee elects to no longer
pay the expenses of prosecution or maintenance of a patent
application or patent included with PATENT RIGHTS, Licensee shall
notify UIRF not less than sixty (60) days prior to such action and
shall thereby surrender its rights hereunder to such patent or
patent application.
ARTICLE 7.
MARKING
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.
8
7.1 If a PATENT RIGHT has been or is
subsequently issued to UIRF covering any feature or features of the
LICENSED PRODUCTS, Licensee agrees to mark each and every package
or container in which the LICENSED PRODUCTS are used or sold by or
for Licensee with marking complying with the provisions of Title
35, U.S. Code, Section 287, if required, or any future equivalent
provisions of the United States relating to the marking of patented
devices, or with marking complying with the law of the country
where the LICENSED PRODUCTS are shipped, used or sold.
ARTICLE 8.
INFRINGEMENT
8.1 With respect to any PATENT
RIGHTS under which Licensee is exclusively licensed pursuant to
this Agreement, Licensee or its sublicensee shall have the right to
prosecute in its own name and at its own expense any infringement
of such patent, so long as such license is exclusive at the time of
the commencement of such action. UIRF agrees to notify Licensee
promptly of each infringement of such patents of which UIRF is or
becomes aware, Before Licensee or its sublicensees commences an
action with respect to any infringement of such patents, Licensee
shall give careful consideration to the views of UIRF and to
potential effects on the public interest in making its decision
whether or not to sue and in the case of a Licensee sublicense,
shall report such views to the sublicensee.
8.2 If Licensee elects to sue for
patent infringement, UIRF agrees to be named as nominal third party
plaintiff if necessary to the commencement of any such action, and
further agrees to provide any information available to UIRF and
needed by Licensee in prosecuting such action. Licensee shall
reimburse UIRF for any costs it incurs as part of an action brought
by Licensee or its sublicensee, irrespective of whether UIRF shall
become a co-plaintiff.
8.3 If Licensee or its sublicensee
elects to commence an action as described above, Licensee may
reduce, by up to [*****] percent ([**]%), the royalty due to UIRF
earned under the patent subject to suit by [*****] percent ([**]%)
of the amount of the expenses and costs of such action, including
attorney fees. In the event that such [*****] percent ([**]%) of
such expenses and costs exceed the amount of royalties withheld by
Licensee for any calendar year, Licensee may to that extent reduce
the royalties due to UIRF from Licensee in succeeding calendar
years, but never by more than [*****] percent ([**]%) of the
royalty otherwise due in any one year.
8.4 No settlement, consent judgment
or other voluntary final disposition of the suit may be entered
into without the consent of UIRF, which consent shall not be
unreasonably withheld.
8.5 Recoveries or reimbursements
from such action shall first be applied to reimburse Licensee and
UIRF for litigation costs not paid from royalties and then to
reimburse UIRF for royalties withheld. Any remaining recoveries or
reimbursements shall be divided [**]% to Licensee and [**]% to
UIRF.
8.6 In the event that Licensee and
its sublicensee, if any, elect not to exercise their
right
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.
9
to prosecute an infringement of the PATENT
RIGHTS pursuant to the above paragraphs, UIRF may do so at its own
expense, controlling such action and retaining all recoveries
therefrom.
8.7 If a declaratory judgment action
alleging invalidity of any of the PATENT RIGHTS shall be brought
against Licensee or UIRF, then UIRF, at its sole option, shall have
the right to intervene and take over the sole defense of the action
at its own expense.
8.8 UIRF shall have no obligation to
defend any action for infringement brought against Licensee by a
third party. In the event Licensee is sued by a third party, and as
a result of the settlement of such suit is required to pay a
royalty to a third party on a LICENSED PRODUCT, the amount of
royalty paid will be deducted from the royalty payment due to the
UIRF for that LICENSED PRODUCT. In the event the settlement
prevents the Licensee from continuing sales of a LICENSED PRODUCT,
no additional royalties and/or minimum royalties will apply for
that LICENSED PRODUCT.
ARTICLE 9.
TERMINATION OF
AGREEMENT
9.1 Upon any termination of this
Agreement, and except as provided herein to the contrary, all
rights and obligations of the Parties hereunder shall cease, except
as follows:
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(a)
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UIRF’s
right to receive or recover and Licensee’s obligation to pay
royalties accrued or accruable for payment at the time of any
termination;
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(b)
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Licensee’s obligation to maintain records
and UIRF’s right to conduct a final audit as provided in
Article 5 of this Agreement; and
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(c)
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Any cause of
action or claim of either party, accrued or to accrued because of
any breach or default by the other party.
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9.2 In the event Licensee fails to
make payments due hereunder, UIRF shall have the right to terminate
this Agreement upon forty-five (45) days’ written notice,
unless Licensee makes such payments plus interest within the
forty-five (45) day notice period or unless any such payment is
contested in good faith, in which event UIRF shall not have the
right to terminate this Agreement until the matter is resolved and
Licensee still fails to make any such payment. If payments are not
so made, UIRF may immediately terminate this Agreement.
9.3 In the event that Licensee shall
be in default in the performance of any obligations under this
Agreement (other than as provided in 9.2 above which shall take
precedence over any other default), and if the default has not been
remedied within ninety (90) days after the date of notice in
writing of such default, UIRF may terminate this Agreement
immediately by written notice, unless any such obligation is
contested in good faith, in which event UIRF shall not have the
right to terminate this Agreement until the matter is resolved and
Licensee still fails to perform any such obligation.
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.
10
9.4 In the event that Licensee shall
becom