LIMITED LICENSE
AGREEMENT
This Limited
License Agreement (this “ Agreement ”),
effective the 10th day of June, 2009 (the “ Effective
Date ”), is by and between Sorrento Therapeutics, Inc., a
California corporation (“ STI ”), having its
principal place of business at San Diego, California, U.S.A. and
OPKO Health, Inc., a Delaware corporation (“ OPKO
”), having its principal place of business at Miami, Florida,
U.S.A. As used herein, each of OPKO and STI are referred to
individually as a “Party” and collectively as
the “Parties” .
WHEREAS, OPKO
is purchasing a certain number of shares of STI’s stock
pursuant to a stock purchase agreement entered into concurrently
with this Agreement (the “Stock Purchase
Agreement” );
WHEREAS, STI
owns certain patent rights relating to the manufacture of human
antibody libraries;
WHEREAS, OPKO
is desirous of acquiring an exclusive license under such patent
rights for the development, manufacture, use, sale, offer for sale,
import and export of certain products within the OPKO Field (as
defined below); and
WHEREAS, STI is
willing to grant OPKO such an exclusive license in the OPKO Field
in accordance with the terms and conditions set forth in this
Agreement;
NOW, THEREFORE,
in consideration of mutual covenants and conditions set forth
herein and the Stock Purchase Agreement and other good and valuable
consideration the adequacy, sufficiency and receipt of which is
hereby acknowledged by the Parties, STI and OPKO hereby agree as
follows:
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1.1
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Affiliate . The term “ Affiliate
” shall mean any corporation, company, partnership, joint
venture and/or firm which controls, is controlled by, or is under
common control with a Party. For purposes hereof,
“control” shall mean (a) in the case of corporate
entities, direct or indirect ownership of at least fifty percent
(50%) of the stock or shares having the right to vote for the
election of directors, and (b) in the case of non-corporate
entities, direct or indirect ownership of at least fifty percent
(50%) of the equity interest with the power to direct the
management and policies of such non-corporate entities.
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1.2
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Licensed Library
. The term “
Licensed Library ” shall mean any population of
distinct molecules, including but not limited to, peptides,
polypeptides, proteins or polynucleotides, the manufacture, use,
sale, or importation of which is covered by any claim of the STI
Patents or which is derived by use of any process or method covered
by any claim of the STI Patents.
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1.3
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OPKO Field . The term “ OPKO Field
” shall mean development, manufacture, marketing, and sale of
drugs for ophthalmological indications.
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1.4
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OPKO Patent . The term “OPKO
Patent” shall mean any patent or patent application (i)
owned or controlled by OPKO or any of its Affiliates, including any
patent application filed by or on behalf of OPKO or any of its
Affiliates, and (ii) which has at least one claim that covers
any use, manufacture, sale, offer for sale, or importation of a
Selected Product, such as any patent or patent application directed
to the composition of matter for a Selected Product.
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1.5
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Selected Product
. The term “
Selected Product ” shall mean any molecule, including
but not limited to any peptide, polypeptide, protein or
polynucleotide, which is identified and selected through the use of
a Licensed Library.
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1.6
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STI Field . The term “STI
Field” shall mean any field of use, other than the OPKO
Field.
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1.7
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STI Patents . The term “ STI
Patents ” shall mean all United States and foreign
patents and patent applications owned or controlled by STI or its
Affiliate at any time during the term of this Agreement, which has
at least one claim that covers (i) any use, manufacture, sale,
offer for sale, or importation of a Selected Product, such as any
patent or patent application directed to the composition of matter
for a Selected Product, or (ii) the manufacture or creation of
the Licensed Library, including but not limited to, a) U.S. Patent
Number 7,405,062, entitled “Method for cloning variable
domain sequences of immunological gene repertoire”, all other
patents and patent applications listed in Exhibit A and
all corresponding or related inventor certificates, (b) any
and all continuations, continuations-in-part, continuing
prosecution applications, and divisionals based on any patent or
patent application referenced herein, (c) any and all patents
issuing from any applications referenced herein, (d) any
reissues, renewals, reexaminations and extensions based on any
patents referenced herein, and (e) all corresponding foreign
counterparts and foreign patent applications and issued patents in
any country throughout the world.
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1.8
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Territory. The term “ Territory
” shall mean worldwide.
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Article 2 - License
Grant
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2.1
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Exclusive License for Selected
Products .
Subject to the terms and conditions of this Agreement, STI hereby
grants to OPKO an exclusive, royalty-free, fully-paid, worldwide,
non-transferable (except as permitted under Section 9.1) right
and license, under the STI Patents: (i) to develop, use, make
and have made Selected Products within the OPKO Field and in the
Territory; and (ii) to market, promote, sell, offer to sell,
transfer, distribute, import and export Selected Products within
the OPKO Field and in the Territory.
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2.2
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Exclusive License for Licensed
Library . To
the extent STI provides to OPKO the Licensed Library pursuant to
Section 3.1, subject to the terms and conditions of this
Agreement, STI hereby grants to OPKO an exclusive, royalty-free,
fully-paid, worldwide, non-transferable (except as permitted under
Section 9.1) right and license, under the STI Patents, to use
and screen the Licensed Library to identify, select and
commercialize one or more Selected Products within the OPKO Field
and in the Territory.
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2.3
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Sublicensing Right
. OPKO will have the
right to sublicense any of the rights granted under
Sections 2.1 and 2.2, provided that OPKO enters into a
sublicense agreement with the sublicensee in writing and the
sublicense agreement (i) conforms in all respects to the
applicable terms and conditions of this Agreement, including all
restrictions and limitations provided herein, (ii) specifies
that such sublicense does not include any rights outside the OPKO
Field, and (iii) includes a covenant by the sublicensee not to
practice the STI Patents outside the OPKO Field.
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2.4
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Reservation of Rights
. STI reserves all
rights in the STI Patents outside the OPKO Field and not expressly
granted under Sections 2.1 and 2.2, provided that in any
license, transfer or other assignment of rights under the STI
Patents to a third party, STI shall specify that such license,
transfer or assignment of rights under the STI Patents does not
include any rights to a Selected Product in the OPKO Field. STI
shall also use commercially reasonable efforts to negotiate a
covenant from such third party that such third party will not
enforce any patent claim that is directed to a composition of
matter against OPKO within the OPKO Field (“ Covenant Not
to Sue ”), provided that a failure by STI to obtain such
Covenant Not to Sue despite using its commercially reasonable
efforts shall not be considered a breach of this Agreement by STI.
OPKO will not practice the STI Patents outside the scope of the
licenses granted in Sections 2.1 and 2.2. Specifically, the
licenses granted under Sections 2.1 and 2.2 do not include the
right to manufacture or have manufactured the Licensed Library
under the STI Patents.
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Article 3 - Access to Licensed
Library
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3.1
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Licensed Library
. Upon reasonable
request of OPKO, STI will provide OPKO with access to the Licensed
Library. After OPKO has identified a target, STI will either
(i) provide an aliquot of the Licensed Library based on the
identified target, or (ii) screen the Licensed Library based
on the identified target on behalf of the OPKO. In consideration
for performing these services, OPKO will pay STI reasonable,
industry standard fees, to be mutually agreed to by the Parties.
STI may utilize a third party contractor reasonably acceptable to
OPKO to perform its obligations under this
Section 3.1.
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3.2
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Material Transfer
Agreement .
To the extent STI elects to provide an aliquot of the Licensed
Library as describe in Section 3.1, the Parties will enter
into an industry standard material transfer agreement for the
transfer of Licensed Library from STI to OPKO, and OPKO may use the
transferred Licensed Library solely as provided in
Section 2.2. In addition, OPKO will promptly notify STI in
writing, (i) which targets were screened using the Licensed
Library, and (ii) the identity of the Selected Products
identified and selected based on such screening.
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Article 4 - Grant Back of OPKO
Patents and Prosecution.
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4.1
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Grant Back to STI
. OPKO hereby grants to
STI an exclusive, royalty-free, fully-paid, worldwide,
non-transferable (except as permitted under Section 9.1) right
and license, under the OPKO Patents: (i) to develop, use, make
and have made Selected Products in the STI Field and in the
Territory; and (ii) to market, promote, sell, offer to sell,
transfer, distribute, import and export Selected Products in STI
Field and in the Territory. OPKO
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specifically reserves all rights in
the OPKO Patents and STI Patents in the OPKO Field, and STI will
not practice the OPKO Patents or STI Patents outside the STI
Field.
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4.2
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STI
will have the right to sublicense any of the rights granted under
this Section, provided that STI enters into a sublicense agreement
with the sublicensee in writing and the sublicense agreement
(i) conforms in all respects to the applicable terms and
conditions of this Agreement, including all restrictions and
limitations provided herein, (ii) specifies that such
sublicense does not include any rights outside the STI Field, and
(iii) includes a covenant by the sublicensee not to practice
the STI Patents outside the STI Field.
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4.3
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Notice of OPKO Patent
. Prior to filing any
OPKO Patent or promptly after acquiring ownership or exclusive
license rights in any OPKO Patent, OPKO will notify STI in writing
and provide a copy of the applicable draft application, pending
application, or issued patent.
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4.4
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Notice of STI Patent
. Prior to filing any
STI Patent or promptly after acquiring ownership or exclusive
license rights in any STI Patent, STI will notify OPKO in writing
and provide a copy of the applicable draft application, pending
application, or issued patent.
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4.5
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Prosecution of STI Patent
. As between the
Parties, STI will be responsible for and will control the filing,
prosecution and maintenance of the STI Patents, including all fees
and costs relating thereto. STI will notify OPKO periodically of
the status of any pending cases included in the STI Patents, and
will provide OPKO with copies of any office actions, notices of
allowance, and other material documents filed with or received from
any patent office concerning the STI Patents. OPKO will have the
opportunity to comment on any response to office actions for STI
Patents or amendments to claims in STI Patents related to the OPKO
Field prior to their filing and STI will consider and accommodate
all comments from OPKO in good faith, including filing any
divisional, continuation, or continuation-in-part application to
include claims that are directed to OPKO Field, provided that OPKO
shall be solely responsible for any patent expenses or costs
related to the OPKO Field. Any differences between the Parties with
respect to any STI Patent prosecution matters will be discussed and
the Parties will use good faith efforts to resolve such differences
to their mutual satisfaction. If STI decides not to continue the
prosecution of any pending case or not to maintain any issued
patent included in the STI Patents, STI will promptly notify OPKO
in writing at least thirty (30) days before the pending case
is abandoned or the issued patent is lapsed. If OPKO desires to
take over the prosecution of the pending case or the maintenance of
the issued patent, OPKO will notify STI of such desire and will
have the right to prosecute such pending case or to maintenance
such issued patent in the name of and on behalf of OPKO.
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4.6
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Prosecution of OPKO
Patent . As
between the Parties, OPKO will be responsible for and will control
the filing, prosecution, and maintenance of the OPKO Patents,
including all fees and costs relating thereto. OPKO will notify STI
periodically of the status of any pending cases included in the
OPKO Patents, and will provide STI with copies of any
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office actions,
notices of allowance, and other material documents filed with or
received from any patent office concerning the OPKO Patents. STI
will have the opportunity to comment on any response to office
actions
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