Exhibit 10.53
Confidential treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as [***]. A complete version of this
exhibit has been filed separately with the Securities and Exchange
Commission.
OPTION and LICENSE
AGREEMENT
This Option and License Agreement
(this “Agreement”), is entered into as of
July 5, 2001 (the “Effective Date”) by and
between Sanquin Blood Supply Foundation for the purpose of this
agreement acting through her division CLB-Research and Development,
formed under the laws of the Netherlands (hereinafter referred to
as “CLB”) and Seattle Genetics, Inc., a Delaware
corporation (hereinafter referred to as
“SGI”).
RECITALS
A. CLB owns intellectual property
rights relating to certain antibodies directed toward CD70
described in this Agreement;
B. SGI desires to acquire access to
the antibodies for research and development purposes and an option
to a worldwide exclusive license to the antibodies.
C. CLB is willing to provide SGI
with access to the antibodies and to grant SGI an option to acquire
a worldwide exclusive license in accordance with the terms and
conditions set forth in this Agreement.
AGREEMENT
The parties hereto agree as
follows:
1.
Definitions
“ Affiliate ”
shall mean any corporation or other business entity controlled by,
controlling, or under common control with another entity, with
“control” meaning direct or indirect beneficial
ownership of more than fifty percent (50%) of the voting stock
of such corporation, or more than a fifty percent
(50%) interest in the decision-making authority of such other
unincorporated business entity; and a corporation in which the
maximum amount of stock permitted by law to be held by another
entity is beneficially owned by such other entity.
“ Antibodies ”
shall mean the antibodies identified on Exhibit A and any
other antibodies directed toward human and murine CD70 that are
owned or controlled by CLB now or in the future.
“ Antibody Technology
” shall mean all rights to the Antibodies including, but not
limited to:
(a) the patents and patent
applications currently existing or filed hereafter covering the
Antibodies, including any addition, continuation,
continuation-in-part or division thereof or any substitute
application therefor; and
(b) all trade secrets and other
information , including but not limited to present and future
techniques, inventions, discoveries, developments, practices,
methods, formulations, specifications, processes, apparatus,
knowledge, know-how, skill, biological materials, design data,
pharmacological, toxicological and clinical test data, sequence
data, analytical and quality control data, manufacturing data and
all other information and data relating to the Antibodies
including, the hybridoma cell line expressing each
Antibody;
provided, however, that Antibody
Technology shall not include trade secrets and other information
that is specifically and solely related to the Reagents
Programme.
“ Approval ”
shall mean all approvals, licenses, registrations and
authorizations of all governmental agencies in a country necessary
for the manufacture, use or sale of a Licensed Product in the
applicable country.
“ Confidential
Information ” shall have the meaning assigned thereto in
Section 11.
“ First Commercial Sale
” shall mean, with respect to any Licensed Product, the first
sale for use or consumption by the general public of such product
in any country following Approval, or otherwise permitted, by the
governing health authority of such country. “First Commercial
Sale” shall not include the sale of any Licensed Product for
use in clinical trials or research.
“ License ” shall
have the meaning assigned thereto in Section 4.2.
“ Licensed Products
” shall mean any product incorporating the Antibodies or
derived from the Antibodies or their sequences.
“ Net Sales ”
shall mean the amount actually received by SGI or its Affiliates or
sublicensees for the sale to an unaffiliated third party of a
Licensed Product, less the following deductions for amounts
actually incurred related to the sale:
(a) [***]
(b) [***].
In the event that a Licensed Product
is sold as part of a Combination Product (as defined below), the
Net Sales from the Combination Product, for the purposes of
determining royalty payments, shall be determined by
[***].
As used above, the term “
Combination Product ” shall mean any pharmaceutical
product which comprises a Licensed Product and any other active
compounds and/or ingredients.
Net Sales shall not include transfer
of Licensed Products at or below cost by or on behalf of SGI in
connection with research or clinical trials.
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Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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“ Option ” means
the option granted by CLB to SGI pursuant to the provisions of
Section 4.1 hereof to obtain the licenses under
Section 4.2 hereof.
“ Option Period ”
means, the period commencing as of the Effective Date and
continuing for a period of [***] unless terminated earlier pursuant
to the provisions of Section 4.1 below.
“ Phase II Clinical
Trial ” shall mean a human clinical trial for which a
primary endpoint is a preliminary determination of efficacy in
patients with the disease being studied as required in 21 C.F.R.
§312, or a similar clinical study prescribed by the regulatory
authorities in a country other than the United States. Any
well-controlled study intended to provide the substantial evidence
of efficacy necessary to support the filing of an approvable
marketing applications (such as a combined Phase II Clinical Trial/
Phase III Clinical Trial, or any Phase III Clinical Trial in lieu
of a Phase II Clinical Trial) (a “ Pivotal Study
”) shall automatically be deemed to have reached Phase II
status. A Phase II Clinical Trial shall be deemed to have commenced
when the first patient in the study has been enrolled.
“ Phase III Clinical
Trial ” shall mean a human clinical trial, the principal
purpose of which is to establish safety and efficacy in patients
with the disease being studied as required in 21 C.F.R. §312,
or similar clinical study prescribed by the regulatory authorities
in a country other than the United States. A Phase III Clinical
Trial shall also include any other human clinical trial intended as
a Pivotal Study, whether or not such study is a traditional Phase
III Clinical Trial. A Phase III Clinical Trial shall be deemed to
have commenced when the first patient has been enrolled in a
Pivotal Study.
“ Reagents Programme
” shall mean any kits or reagents for in vitro diagnostic and
research use, currently and prospectively listed and offered for
sale in CLB’s standard Immune Reagents Product
List.
2. Delivery of Antibodies and
Hybridomas . CLB
shall deliver to SGI 5 mg of each of the Antibodies, and hybridomas
for each within [***] following the Effective Date.
3. Use of Antibodies
. As of the Effective
Date, CLB grants to SGI a non-exclusive, non-sublicensable,
worldwide license to use the Antibodies solely for research
purposes. SGI shall use the Antibodies in compliance with all
applicable federal, state and local laws and regulations. No other
license with regards to the Antibodies shall be granted or implied
unless and until the Option is exercised by SGI.
4. Option and License
Grant .
4.1 Option Grant and Exercise
. Subject to the terms of this Agreement, CLB hereby grants to SGI
and its Affiliates an Option to acquire the License set forth in
Section 4.2 below with respect to the Antibodies and Antibody
Technology. At any time during the Option Period, SGI may provide
written notice to CLB that it wishes to acquire such License for
the
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Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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Antibodies and Antibody Technology.
SGI shall be able to terminate the Option for any reason by giving
[***] advance written notice to CLB during the Option
Period.
4.2 License Grant . If
(i) SGI elects to exercise its Option to acquire a License
with respect to the Antibody Technology pursuant to
Section 4.1 and (ii) SGI pays the Option exercise fee
pursuant to Section 6.1.2 below, then subject to the terms and
conditions of this Agreement, and commencing as of the date that
SGI has both (i) so informed CLB in writing of such Option
exercise and (ii) paid the Option exercise fee, CLB is
automatically deemed to grant, and in such event hereby grants, to
SGI, a worldwide, exclusive, non-transferable, royalty-bearing
license, with the right to sublicense, to develop, make, have made,
import, have imported, use, offer for sale, sell or otherwise
distribute Licensed Products (a “License”). The date
upon which a License is granted with respect to the Antibody
Technology under this Section 4.2 is referred to herein as the
“ License Date ”.
5. Reservation
. The License granted in
Section 4.2 is subject to rights reserved by CLB to
[***] .
6. Payments
6.1 Option Fees .
6.1.1. SGI shall pay CLB a fee of
[***].
6.1.2. SGI shall pay CLB a fee of
[***].
6.1.3. SGI shall pay CLB a
maintenance fee of [***].
6.2 License Fee . SGI shall
pay CLB a license fee of [***].
6.3 Milestone Payments .
Within [***] following the occurrence of each of the events
specified below for the first Licensed Product only, SGI shall pay
to CLB the following amounts:
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Payment
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1. [***]
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[***]
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2. [***]
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[***]
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3. [***]
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[***]
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Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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6.4 Royalties
6.4.1 SGI shall pay CLB a royalty
equal to [***] on Net Sales of Licensed Products, commencing with
the First Commercial Sale of a Licensed Product.
6.4.2 Royalties shall be calculated
on a [***] basis and shall be due and payable within [***] after
the end of such calendar quarter. Such royalties shall be
calculated on the Net Sales in the local currency of each country,
and converted into U.S. Dollars and paid in U.S. Dollars, on the
basis of the [***]. SGI shall withhold any taxes on such royalties
as required by law.
6.4.3 SGI shall furnish to CLB a
written report which includes financial information relevant
to the calculation of royalties, including the relevant, current
standard list prices. Such reports shall be due together with the
royalty payments under