Exhibit 10.1
NOTE: Portions of this Exhibit
are the subject of a Confidential Treatment Request by the
Registrant to the Securities and Exchange Commission (the
“Commission”). Such portions have been redacted and are
marked with a “[***]” in place of the redacted
language. The redacted information has been filed separately with
the Commission.
L ICENSE A GREEMENT
T HIS L ICENSE A GREEMENT (the “ Agreement ”) is made
and entered into effective as of April 2, 2008 (the “
Effective Date ”) by and between S
ANGAMO B IO S CIENCES , I NC . , a
Delaware corporation with offices at 501 Canal Blvd., Suite A100,
Richmond, California 94804 (“ Sangamo ”), and
O PEN
M ONOCLONAL T ECHNOLOGY , I NC . , a
Delaware corporation with offices at 2747 Ross Road, Palo Alto, CA
94303 (“ OMT ”). Sangamo and OMT may be referred
to herein individually as a “Party”, and collectively
as the “Parties.”
R ECITALS
W HEREAS , Sangamo has expertise in and owns or controls
proprietary technology relating to zinc finger nucleases and their
use to alter the genomes and/or protein expression capabilities of
organisms and cells, including animals and animal cells;
W HEREAS , pursuant to an exclusive license from Sangamo,
Sigma-Aldrich Co. (“ Sigma ”) has the right to
offer products and services based on Sangamo’s proprietary
zinc finger nuclease technology for research use only;
W HEREAS , OMT and Sigma have entered into a Research
Products Agreement, of even date herewith (the “ Sigma
Agreement ”), under which Sigma and OMT agreed to
undertake research program for the purpose of generating a
genetically modified [***] using zinc finger nuclease
technology;
W HEREAS , pursuant to the Sigma Agreement, Sigma has
granted OMT a license to use such genetically modified [***] for
research purposes; and
W HEREAS , OMT
further desires a license from Sangamo to use such genetically
modified [***] for clinical and commercial purposes, and
Sangamo is willing to provide such license under the terms and
conditions of this Agreement.
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N OW T HEREFORE , in
consideration of the foregoing and the covenants and promises
contained herein, the Parties agree as follows:
ARTICLE 1
D EFINITIONS
As used in this Agreement, the
following capitalized terms shall have the following
meanings:
1.1
“Affiliate” means, with respect to a particular Party, any
other person or entity that directly or indirectly controls, is
controlled by, or is in common control with such Party. As used in
this Section 1.1, the term “controls” (with
correlative meanings for the terms “controlled by” and
“under common control with”) means the ownership,
directly or indirectly, of more than fifty percent (50%) of
the voting securities or other ownership interest of entity, or the
possession, directly or indirectly, of the power to direct the
management or policies of the entity, whether through the ownership
of voting securities, by contract, or otherwise.
1.2 “Confidential
Information” means
each Party’s confidential information, inventions, non-public
know-how or non-public data disclosed pursuant to this Agreement
and shall include, without limitation, manufacturing, marketing,
financial, personnel and other business information and plans,
whether in oral, written, graphic or electronic form.
1.3 “Control”
means, with respect to an item of
Information or intellectual property right, that a Party owns or
has a license to such item or right and has the ability to disclose
such item and/or grant a license or sublicense as provided for in
this Agreement under such item or right without violating the terms
of any agreement or other arrangement with any Third
Party.
1.4 “Decision
Date” means
[***] days after the date that OMT achieves the milestone
set forth in Section 3.2 of the Sigma Agreement.
1.5 “Drug Approval
Application” means
(a) in the U.S., a Biologics License Application (as such term
is defined under United States statutes or regulations, as amended)
for an OMT Product, or any equivalent or successor application for
regulatory approval required before commercial sale of an OMT
Product for use in humans in the United States and (b) in the
rest of the Territory, an equivalent application for regulatory
approval required before commercial sale of an OMT Product for use
in humans in a regulatory jurisdiction.
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2.
1.6 “Executive
Officer” means the
Chief Executive Officer of the applicable Party, or another senior
executive officer of such Party who has been duly appointed by the
Chief Executive Officer to act as the representative of the
Party.
1.7 “Field”
means use of Modified [***] to
produce antibodies for clinical or commercial purposes.
1.8 “First
Commercial Sale” means, with respect to a country in the
Territory, the first sale to a Third Party of an OMT Product in
such country by or on behalf of OMT or any of its Affiliates or
licensees after the granting of Regulatory Approval with respect to
such country.
1.9 “Information”
means information, results and data
of any type whatsoever, in any tangible or intangible form
whatsoever, including without limitation, databases, inventions,
practices, methods, techniques, specifications, formulations,
formulae, knowledge, know-how, skill, experience, test data
including pharmacological, biological, chemical, biochemical,
toxicological and clinical test data, analytical and quality
control data, stability data, studies and procedures, and patent
and other legal information or descriptions.
1.10 “Modified
[***]” means a
[***] having a genomic modification that results from the
use of the ZFN Deliverable created in the course of work performed
under the Sigma Agreement, and any progeny or components thereof or
any biological material derived therefrom (other than OMT
Products).
1.11 “Net
Sales” means the
gross amounts actually received for OMT Products sold or otherwise
disposed of for consideration by or on behalf of OMT or its
Affiliates to unrelated Third Parties, reduced by the following
amounts, to the extent allocable to sales or other disposition of
OMT Products: (a) the amounts actually allowed as volume,
quantity, trade and/or cash discounts; (b) credits actually
given in connection with retroactive price reductions, or as a
result of returns or rejections; (c) transportation and
insurance charges, and (d) import, export, sales, excise and
turnover taxes and customs duties imposed directly on and actually
paid by OMT or its Affiliates (and not reimbursed), all of the
foregoing calculated in accordance with United States Generally
Accepted Accounting Principles consistently applied across
OMT’s organization.
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3.
When calculating the Net Sales, the
amount of such sales in foreign currencies shall be converted into
United States Dollars at the spot rate for buying United States
Dollars published in the Wall Street Journal as of last day of the
applicable measurement or activity period (e.g., calendar quarter,
month, etc.). OMT shall provide reasonable documentation of the
calculation and reconciliation of the conversion figures on a
country-by-country basis as part of its report of Net Sales for the
period covered under the report.
If OMT or its Affiliates receive
non-cash consideration in place of cash consideration for an OMT
Product sold or otherwise transferred to an unrelated Third Party,
the Net Sales for such OMT Product shall be deemed to be the gross
invoice price that OMT or its Affiliate (as applicable) currently
charges unrelated Third Parties for such OMT Product, in either
case reduced by any applicable amounts in subsections
(a) through (d) above. For clarity, each OMT Product
shall be subject to only one royalty payment, and amounts received
by OMT with respect to OMT Products as Sublicensee Income shall not
be included in the calculation of Net Sales.
1.12 “OMT
Product” means any
product that is created or produced directly or indirectly by or on
behalf of OMT, its Affiliates, or its licensees or sublicensees
through use or practice of Sangamo Technology, including, without
limitation, any Modified [***] or any antibodies created or
produced through the use of a Modified [***] .
1.13 “Patents”
means (a) all patents and
patent applications (including provisional applications),
(b) any substitutions, divisions, continuations,
continuations-in-part, reissues, renewals, registrations,
confirmations, re-examinations, extensions, supplementary
protection certificates and the like of the foregoing, and
(c) any foreign or international equivalents of any of the
foregoing.
1.14 “Phase I
Trial” means a
human clinical trial of an OMT Product that would satisfy the
requirements of 21 C.F.R. Part 312.21(a) (as amended from time to
time) or other comparable regulation imposed by an applicable
regulatory authority in any country other than the United States,
the principal purpose of which is to determine safety, metabolism
and pharmacokinetic properties and clinical pharmacology of such
product.
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4.
1.15 “Phase II
Trial” means a
human clinical trial of an OMT Product that would satisfy the
requirements of 21 C.F.R. Part 312.21(b) (as amended from time to
time) or other comparable regulation imposed by an applicable
regulatory authority in any country other than the United States,
the principal purposes of which are to make a preliminary
determination that such OMT Product is safe for its intended use
and to obtain sufficient information about such product’s
efficacy to permit the design of further clinical trials. A Phase
II Trial shall be deemed initiated upon the enrollment of the first
patient.
1.16 “Phase III
Trial” means a
pivotal human clinical trial of an OMT Product that would satisfy
the requirements of 21 C.F.R. Part 312.21(c) (as amended from time
to time) or other comparable regulation imposed by an applicable
regulatory authority in any country other than the United States,
the results of which could be used to evidence efficacy of the OMT
Product in a target population and to obtain expanded evidence of
safety for such OMT Product as a basis for submission of an
application for Regulatory Approval. For clarity, a phase II/III
trial designed to support a filing for Regulatory Approval shall be
deemed a Phase III Trial. A Phase III Trial shall be deemed
initiated upon the enrollment of the first patient.
1.17 “Regulatory
Approval” means the
approval of a Drug Approval Application by the applicable
regulatory authority in a regulatory jurisdiction.
1.18 “Sangamo
Patents” means all
Patents that (a) are Controlled by Sangamo or its Affiliates
as of the Effective Date or anytime during the term of this
Agreement; and (b) claim or cover the Modified [***] or
the use of the Modified [***] .
1.19 “Sangamo
Technology” means
the Sangamo Patents.
1.20 “Sublicensee
Income” means all
cash consideration actually received by OMT or its Affiliates from
licensees in connection with (a) the grant or maintenance of a
license or other right to commercially research or develop,
manufacture or sell OMT Products, or (b) the sale or other
disposition of OMT Products, including without limitation upfront
license fees, annual license payments, milestone payments,
royalties received from the licensee and other similar
license-related payments; provided, however, that amounts received
with respect of the following items are expressly excluded:
(i) the purchase of OMT’s or its Affiliate’s stock
(but
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5.
solely to the extent that such payment is at a
price equal to or less than 100% of the fair market value of such
stock at the date of purchase, it being understood that, for so
long as OMT is a private company, a stock price set in and paid by
at least one professional, non-strategic investor shall be deemed
to be the fair market price of such stock), (ii) reasonable
research and development support, (iii) reasonable patent
prosecution and/or litigation, or (iv) the manufacturing or
supply of Modified [***] for research purposes, where such
manufacturing or supply is billed at cost or with a reasonable
manufacturing markup (not to exceed [***] ).
When calculating the Sublicensee
Income, the amount of cash consideration received by OMT or its
Affiliates in foreign currencies shall be converted into United
States Dollars at the spot rate for buying United States Dollars
published in the Wall Street Journal as of last day of the
applicable measurement or activity period (e.g., calendar quarter,
month, etc.
1.21 “Target”
has the meaning given to such term
in the Sigma Agreement.
1.22 “Third
Party” means any
individual or entity other than the Parties or their respective
Affiliates.
1.23 “Territory”
means the entire world.
1.24 “ZFN
Deliverable” has
the meaning given to such term in the Sigma Agreement.
1.25 “ZFPs”
means zinc-finger proteins
(including a zinc-finger transcription factor or a zinc-finger
nuclease), or a nucleic acid encoding and capable of expressing
such protein in a cell or tissue.
ARTICLE 2
L ICENSE G RANT
2.1 Licenses to
OMT. Subject to the terms
and conditions of this Agreement, Sangamo agrees to grant to OMT a
royalty-bearing, worldwide, non-exclusive license under the Sangamo
Technology to use, distribute, reproduce, modify (without the use
of ZFN Deliverables) and sell Modified [***] solely for the
purpose of making, using and selling OMT Products. Notwithstanding
anything to the contrary in this Agreement, such license
(a) does not
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6.
include a license with respect to any genomic
modifications that may be present in a Modified [***] that
do not arise from or relate to a modification of the Target and
(b) does not include any rights to any ZFPs. Sangamo shall not
(nor shall it authorize or assist any Third Party to) develop, use
or transfer a ZFN Deliverable for the benefit of itself or any
Third Party for use in connection with (whether directly or
indirectly) inactivation of [***] expression in [***]
cells, tissues or whole animals for any purpose other than
non-commercial research purposes provided, however, that
OMT’s sole remedy for any material breach of this covenant by
Sangamo or its Affiliates shall be [***] .
2.2 Restrictions on
Exercise of License. OMT
shall have no right to exercise the license granted in
Section 2.1 unless and until OMT pays Sangamo in full the
amount set forth in Section 3.1. Prior to OMT making such
payment in full, OMT shall not use Modified [***] for any
purpose other than as permitted under the Sigma
Agreement.
2.3 Sublicensing.
After OMT pays Sangamo in full the
amount set forth in Section 3.1, OMT may freely sublicense the
rights granted under Section 2.1 or transfer any Modified
[***] to any Third Party or OMT Affiliate, provided that OMT
shall require each licensee to be bound in writing by (and shall
cause each licensee to similarly bind any sublicense to) provisions
that are as protective of Sangamo as the terms of Sections 2.4,
7.2, 7.3 and 8.4(b) (in each case, as if such licensee were OMT) .
Notwithstanding the grant of sublicense hereunder, OMT shall remain
fully responsible for performance of its obligations under this
Agreement. Any sublicense granted by OMT under this Agreement shall
be consistent with the terms and conditions of this Agreement
Within thirty (30) days prior to delivery of the first payment
to Sangamo with respect to a sublicense agreement, OMT shall
provide Sangamo with the name of the sublicense (provided that OMT
has the authority to disclose such name, which authority OMT agrees
to use commercially reasonable efforts to obtain) and a summary of
the relevant financial provision(s) relevant to any payments that
Sangamo might receive under Section 3.4 hereunder, which
information shall be deemed to be the Confidential Information of
OMT.
2.4 No
Non-Permitted Use. OMT
hereby covenants that it shall not, nor shall it permit any
Affiliate or licensee, to use or practice, directly or indirectly,
any Sangamo Technology for any purposes other than those expressly
permitted by this Agreement.
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7.
2.5 No
Prohibition on Sangamo. Except as set forth in Section 2.1, nothing
in this Agreement shall prevent Sangamo from making, using,
offering for sale, selling, or importing ZFPs for all purposes
(including for purposes in the Field), and to grant to Third
Parties the right to do the same.
2.6 Third
Party Licenses. OMT shall
be solely responsible for obtaining, at its sole expense, any other
licenses from Third Parties that OMT determines, in its sole
discretion, are required in order to lawfully make, use, sell,
offer for sale, or import OMT Products.
2.7 Compliance with
Law. Each party shall
comply, and shall ensure that its Affiliates, licensees and Third
Party contractors comply, with all applicable laws, regulations,
and guidelines, including without limitation those relating to the
transport, storage, and handling of Modified [***]
.
2.8 Diligence.
OMT shall use commercially
reasonable efforts to develop and obtain Regulatory Approval for
OMT Products and to commercialize any OMT Products for which
Regulatory Approval is obtained.
ARTICLE 3
C OMPENSATION
3.1 License
Fee. OMT shall pay
Sangamo [***] no later than the Decision Date. For clarity,
OMT may make such payment at any time prior to the Decision Date,
if it so elects. Any payment made under this Section 3.1 shall
be non-creditable and non-refundable.
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8.
3.2 Clinical Development
Milestone Payments. For
each OMT Product, OMT shall pay Sangamo the following
non-creditable and non-refundable milestone payments no later than
thirty (30) days after achievement of the corresponding
milestone event by OMT or any of its Affiliates:
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For a given OMT Product, each
milestone payment shall only be paid once, the first time the
applicable milestone event is reached for such OMT Product and
irrespective of the number of times such milestone event may be
subsequently reached for such OMT Product.
3.3 Royalties.
For each calendar quarter in which
there are Net Sales, OMT shall pay a royalty to Sangamo equal to
[***] of Net Sales in such quarter. OMT’s obligation
to pay royalties under this Section 3.3 with shall expire on a
country-by-country basis upon the later of (a) expiration of
the last to expire Sangamo Patent that would be infringed by use of
the ZFN Deliverable to create or generate a Modified [***]
and (b) ten (10) years after First Commercial Sale of the
first OMT Product.
3.4 Sublicensee
Income. OMT shall pay to
Sangamo an amount equal to [***] of Sublicensee Income
received by OMT or its Affiliates in such calendar quarter.
OMT’s obligation to pay Sublicensee Income under this
Section 3.4 with shall expire on a country-by-country basis
upon the later of (a) expiration of the last to expire Sangamo
Patent that would be infringed by use of the ZFN Deliverable to
create or generate a Modified [***] and (b) ten
(10) years after First Commercial Sale of the first OMT
Product.
3.5 Acknowledgement.
The Parties acknowledge and agree
that the royalty rate for OMT Products and sharing of Sublicensee
Income are in consideration for (a) the licenses granted by
Sangamo in Section 2.1 and (b) Sangamo entering into this
Agreement, absent which the Sigma Agreement would prohibit OMT from
using the Modified [***] for commercial purposes (including
clinical development). In addition, the parties acknowledge and
agree that the Sangamo Technology will be used by OMT to develop
Modified [***] for the purpose of directly and indirectly
making, using and selling OMT Products, but there is no assurance
that such Sangamo Technology would be required by OMT or its
Affiliates, licensees or sublicensees on an ong
