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EXHIBIT 10.7
LICENSE AGREEMENT
THIS AGREEMENT is made as of January 11, 2000 between:
1. SANGAMO BIOSCIENCES, INC. incorporated in Delaware, United States of
America, having an office at Point Richmond Tech Center, 000 Xxxxx Xxxx.
Xxxxx X000, Xxxxxxxx, Xxxxxxxxxx 00000 (SANGAMO); and
2. XXXXXX HEALTHCARE CORPORATION incorporated in Delaware, United States of
America, having an office at 00000 Xxx Xxxx Xxxxxx, Xxxxxx, Xxxxxxxxxx,
00000-0000 (BAXTER).
RECITALS
A. SANGAMO is the owner or licensee of the Technology and Patent Rights (as
defined in Clause 1.1. herein).
X. XXXXXX wishes to received an exclusive license to use and exploit the
Technology and Patent Rights to develop and commercialize zinc finger DNA
binding protein and gene therapy products for activation of all vascular
endothelial growth factors ("VEGF") and VEGF receptors for the treatment of
ischemic cardiovascular and vascular disease in humans, and SANGAMO is
willing to xxxxx XXXXXX such a license on the terms and conditions
contained in this Agreement.
C. SANGAMO wishes to undertake research relating to the further development of
its proprietary zinc finger binding protein and gene therapy technology and
BAXTER wishes to fund such research to facilitate SANGAMO's ability to
license such technology to BAXTER under the License Agreement. Therefore,
BAXTER and SANGAMO have entered into a Research Funding Agreement,
contemporaneously herewith.
IT IS AGREED as follows.
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1. DEFINITIONS
The following definitions apply unless the context requires otherwise.
1.1 AFFILIATE with respect to an entity, means a person or entity which owns,
is owned by or is under common ownership with the first-named entity. For
the purposes of this definition, the term "owns" as used with respect to
any person or entity means ownership (directly or indirectly) of at least
fifty percent (50%) of the outstanding voting securities of a corporation
or a comparable equity interest in another form of entity.
1.2 AGREEMENT means this License Agreement.
1.3 BAXTER INVENTIONS shall mean those Inventions independently conceived
and/or reduced to practice, or written (as determined by United States
patent or copyright law) solely by BAXTER or by an employee, consultant,
agent or representative of BAXTER or by some other person obligated to
assign their rights to such Invention to BAXTER or otherwise owned by
BAXTER.
1.4 CONVERTIBLE DEBENTURES means a debenture issued by SANGAMO, substantially
in the form of Schedule 3 hereto, accruing interest at the Prime Rate as
published in the United States Western Edition of The Wall Street Journal
under the heading "Money Rates" on the date of issuance, maturing on the
fifth anniversary of the date of issuance, and convertible in accordance
with its terms into capital stock of SANGAMO.
1.5 CROSS LICENSED PRODUCT shall mean product or device for which BAXTER or its
Affiliate receives a (sub)license or other rights to commercialize in
connection with the grant of a sublicense or other rights to commercialize
a Licensed Product.
1.6 DEVELOPMENT COSTS shall mean, with respect to a Licensed Product, the sum
of (a) the aggregate cash consideration actually paid by BAXTER to Third
Parties to acquire licenses under pending patent applications or issued
patents necessary in order to manufacture, having manufactured, import,
use, sell and offer for sale such Licensed Product, plus (b) the aggregate
out-of-pocket amounts (if any) actually paid by BAXTER to Third Parties to
research and develop such Licensed Product for commercial sale, or to
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acquire or develop the facilities, equipment, materials and processes
needed for GMP manufacture of such Licensed Product. Whether or not a
pending patent application, issued patent, facility, equipment, materials
or process is needed for purposes of this Clause 1.5 shall be determined by
the Steering Committee: provided, however, if the Steering Committee cannot
reach agreement, the disagreement shall be resolved pursuant to Clause 12.
1.7 EFFECTIVE DATE means the date set forth on page 1, line 1 of this
Agreement.
1.8 ELA means Establishment License Approval to manufacture any Licensed
Product by USFDA, or its foreign equivalent in a Major Country.
1.9 FIELD means the use of zinc finger DNA binding proteins and nucleic acids
that encode zinc finger DNA binding proteins for the activation of VEGF and
VEGF receptors for the treatment and prevention of ischemic cardiovascular
and vascular disease in humans.
1.10 FIELD OF RESEARCH shall mean the development of zinc finger DNA binding
proteins and nucleic acids that encode zinc finger DNA binding proteins for
the activation of VEGF and VEGF receptors for the treatment and prevention
of ischemic cardiovascular and vascular disease in humans.
1.11 FIRST COMMERCIAL SALE means the initial arms length transfer in a Major
Country by BAXTER or XXXXXX'X sub-licensee of a Licensed Product to a
purchaser that is not an Affiliate after the date of receiving the
applicable regulatory approval to market the Licensed Product in such Major
Country, in exchange for cash or some equivalent to which value can be
assigned for the purpose of determining Net Sales.
1.12 GROSS PROFITS means the Net Sales of Licensed Products, less the sum of (a)
the actual cost of raw materials and (b) the other production costs
(allocated in accordance with generally accepted accounting principles
consistently applied to all products produced by the producer) incurred in
bringing the Licensed Products to the point of sale.
1.13 IND means Investigational New Drug application in the United States or its
foreign equivalent in a Major Country, and a reference to the submission
thereof is a reference to
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the submission of such application with the USFDA or the equivalent
submission with the applicable foreign regulatory authority of a
Major Country.
1.14 INVENTION(S) as used herein shall include, without restriction or
limitation, any and all devices, products, compositions or matter,
chemical formulations, computer software, or processes (including
without limitation processes for making or using devices or
compositions of matter), whether patentable or unpatentable, and any
and all written materials or other works which may be subject to
copyright, which are reduced to practice, conceived or written during
the term of the Research Funding Agreement and for ninety (90) days
after it expires, and result from the performance of the Sponsored
Research.
1.15 INVENTION PATENTS as used herein shall include any patent or patent
application covering an Invention in any country (including any
additions, divisions, continuations, continuations-in-part, reissues,
re-examinations, inventors' certificates, registrations or extensions
of the said patents or patent applications and any supplementary
protection certificates issued in connection with any of the said
patents or patent applications).
1.16 JOINT INVENTIONS shall mean those Inventions jointly conceived and/or
reduced to practice, or written (as determined by United States
patent or copyright law) by, on the one hand, either an employee,
consultant, agent, or representative of SANGAMO or some other person
obligated to assign their rights to such invention to SANGAMO, and,
on the other hand, BAXTER or an employee, consultant, agent, or
representative of BAXTER or by some other person obligated to assign
their rights to such Invention to BAXTER, or otherwise jointly owned
by SANGAMO and BAXTER.
1.17 JOINTLY INVENTED LICENSED PRODUCT shall mean a pharmaceutical product
(in final dosage, packaged and labeled form) comprising a ZFP, the
manufacture, use, offer for sale, sale or import of which falls
within the scope of one or more claims of a pending patent
application or issued and unexpired patent within the Inventions
Patents covering Joint Inventions which has not been permanently
revoked, held unenforceable or invalid by a decision of a court or
other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been
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admitted to be invalid or unenforceable through reissue or disclaimer
or otherwise, provided that such product is not otherwise a Licensed
Product.
1.18 JOINTLY INVENTED LICENSE COMBINATION PRODUCT shall mean any
pharmaceutical product (in final dosage, packaged and labeled form)
that consists of a Jointly Invented Licensed Product and parts of
other products such as, for example, biological or mechanical drug
delivery systems or vehicles, including but not limited to devices or
biological systems for enhancing the performance of the Jointly
Invented Licensed Product, the local delivery of the Jointly Invented
Licensed Product, or the sustained expression of the Jointly Invented
Licensed Product.
1.19 LICENSE FEE means any amount payable by BAXTER to SANGAMO pursuant to
this Agreement.
1.20 LICENSED PRODUCT means any of a Jointly Invented Licensed ZFP
Product, Jointly Invented Licensed ZFP Combination Product, Licensed
ZFP Product or Licensed ZFP Combination Product. For clarification
purposes, a Subsequent Licensed Product shall be a Licensed Product.
1.21 LICENSED ZFP PRODUCT means any pharmaceutical product (in final
dosage, packaged and labeled form) comprising a ZFP, the manufacture,
use, offer for sale, sale or import of which falls within the scope
of one or more claims of a pending patent application or issued and
unexpired patent within the Patent Rights, which has not been
permanently revoked, held unenforceable or invalid by a decision of a
court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise.
1.22 LICENSED ZFP COMBINATION PRODUCT means any pharmaceutical product (in
final dosage, packaged and labeled form) that consists of the
Licensed ZFP Product and parts of other products such as, for
example, biological or mechanical drug delivery systems or vehicles,
including but not limited to devices or biological systems for
enhancing the
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performance of the Licensed ZFP Product, the local delivery of the
Licensed ZFP Product, or the sustained expression of the Licensed ZFP
Product.
1.23 MAJOR COUNTRY means either the United States of American or any three
countries of the European Union.
1.24 MARKETING APPROVAL means the granting of marketing approval for any
Licensed Product by the USFDA or the applicable foreign regulatory
authority in a Major Country.
1.25 NET SALES means gross invoiced sales price from sales of any Licensed
Product by BAXTER, its Affiliate or sub-licensee of BAXTER to a
purchaser that is not an Affiliate (other than to an Affiliate that
is an end user), less reasonable and customary deductions for (a)
transportation charges, including insurance relating thereto; (b)
sales and excise taxes or customs duties paid by the party selling or
distributing such Licensed Product or any other governmental charges
imposed upon the sale or distribution of such Licensed Product; and
(c) returns, or allowances in lieu of returns, quantity discounts,
cash discounts or chargebacks actually granted, allowed or incurred
in the ordinary course of business in connection with the sale or
distribution of such Licensed Product. Notwithstanding the foregoing,
if BAXTER does not receive in the ordinary course of business, from
an Affiliate to whom BAXTER sells or otherwise transfers a Licensed
Product for resale in any country, the foregoing itemized gross sales
and deductions data regarding a Licensed Product, then "Net Sales"
shall mean, with respect to such Affiliate and such Licensed Product
(on a per unit basis) sold in such country, the average per unit
sales price, less the above types of deductions (the "average net
sales price"), by such Affiliate of such Licensed Product in such
country (if reported) or otherwise in the geographic region in which
such country is located; provided, however, that the average net
sales price shall be calculated in accordance with generally accepted
accounting principles consistently applied in the United States,
shall be the same as the average net sales price by such Affiliate in
such country or region (as applicable) used for purposes of preparing
XXXXXX'x consolidated financial statements, and shall not materially
differ from the calculation of Net Sales by BAXTER itemized above.
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1.26 NET SUBLICENSE REVENUES shall mean, with respect to a Licensed Product, the
Sublicense Revenues for such Licensed Product, less the sum of (a) fifty
percent (50%) of the aggregate milestone payments actually paid to SANGAMO
pursuant to Clauses 4.2.1(b) and 4.2.1(c) for such Licensed Product, (b)
two hundred percent (200%) of the aggregate royalties actually paid to
SANGAMO pursuant to Clause 4.3.1 for such Licensed Product, and (c) fifty
percent (50%) of the Development Costs for such Licensed Product.
1.27 PATENT RIGHTS means (i) the SANGAMO Patent Applications, (ii) any patent or
patent application owned by or licensed to SANGAMO which discloses or
claims a ZFP or methods of producing or using ZFP in the Field, and (iii)
any patent subsequently issued on any or all of (i) or (ii) in any country
(including any additions, divisions, continuations, continuations-in-part,
reissues, re-examinations, inventors' certificates, registrations or
extensions of the said patents or patent applications and any supplementary
protection certificates issued in connection with any of the said patents
or patent applications), in each case that are owned by SANGAMO or licensed
to SANGAMO with the right to grant sublicenses during the term of this
Agreement.
1.28 PHASE 1 CLINICAL TRIALS has the same meaning as the term has in the United
States Code of Federal Regulations or its foreign equivalent in a Major
Country.
1.29 PHASE 2 CLINICAL TRIALS has the same meaning as that term in the United
States Code of Federal Regulations or its foreign equivalent in a Major
Country.
1.30 PHASE 3 CLINICAL TRIALS has the same meaning as that term has in the United
States Code of Federal Regulations or its foreign equivalent in a Major
Country.
1.31 RESEARCH FUNDING AGREEMENT shall mean the Research Funding Agreement
entered into between BAXTER and SANGAMO contemporaneously herewith (as
amended or restated from time to time).
1.32 SANGAMO INVENTIONS shall mean those Inventions independently conceived
and/or reduced to practice, or written (as determined by United States
patent or copyright law) solely by SANGAMO or by an employee, consultant,
agent or representative of
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SANGAMO or by some other person obligated to assign their rights so such
Inventions to SANGAMO or otherwise owned by SANGAMO.
1.33 SANGAMO PATENT APPLICATIONS means any patents and patent applications
described in Schedule 1.
1.34 SPONSORED RESEARCH shall mean those research activities to be performed
within the Field Of Research, and in accordance with a Research Plan
specifically set forth in Exhibit A to the Research Funding Agreement.
1.35 STEERING COMMITTEE means the Committee appointed pursuant to clause 7.2.1.
1.36 SUBLICENSE REVENUES shall mean, with respect to a Licensed Product, the
aggregate cash consideration, plus the fair market value of the aggregate
cash equivalents and securities, owing to BAXTER and its Affiliates in
connection with the grant of such sublicense or other rights to
commercialize such Licensed Product. If the parties fail to reach mutually
acceptable agreement on the fair market value of any such cash equivalents
or securities, the disagreement shall be resolved in accordance with Clause
12.
1.37 SUBSEQUENT LICENSED PRODUCT shall mean a Licensed Product that comprises a
ZFP intended for use in the treatment or prevention of a clinical
indication in the Field, other than coronary or peripheral vascular
disease, and that is different than any Licensed Product which previously
reached the point of First Commercial Sale.
1.38 TECHNOLOGY means any and all technical data, information, materials,
know-how and trade secrets (including but not limited to, the biological
materials and other materials used by SANGAMO for purifying or producing
ZFPs), regarding ZFPs or methods of purifying, producing, or using ZFPs in
the Field, which is owned by SANGAMO or licensed to SANGAMO with the right
to grant sublicenses during the term of this Agreement.
1.39 TERRITORY means the entire world.
1.40 THIRD PARTY means any party other than SANGAMO or XXXXXX.
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1.41 USFDA means the Food and Drug Administration of the United States of
America.
1.42 ZFP means any zinc finger DNA binding protein, or any nucleic acid that
encodes for a zinc finger DNA binding protein, that is developed,
licensed or acquired by SANGAMO for use in the Field pursuant to the
Research Funding Agreement or this Agreement.
2. REPRESENTATIONS AND WARRANTIES
2.1 PATENT MATTERS
(a) As of the Effective Date:
(i) SANGAMO warrants and represents that, except as SANGAMO
otherwise has advised BAXTER in writing prior to the
Effective Date, it has not received written notice from any
Third Party that any composition, process or use claimed by
the Patent Rights infringes an issued patent of such Third
Party;
(ii) SANGAMO warrants and represents that (A) it has conducted
searches of public databases for issued patents and
published Third Party patent applications that contain the
words "zinc finger" or "nucleic acid binding proteins" in
the title or abstract, and (B) that it has disclosed to
BAXTER all issued patents and published Third Party patent
applications that have been disclosed to SANGAMO in the
results of such searches.
(iii) SANGAMO warrants and represents that it has no actual
knowledge (without any duty of inquiry) of any current
action conducted by a Third Party which is or would
constitute an infringement of the Patent Rights in the
Field;
(iv) BAXTER has had the opportunity to review such materials and
to ask such questions of SANGAMO and its advisors, as XXXXXX
xxxxx necessary or appropriate, regarding the Patent Rights.
SANGAMO warrants and represents that such materials provided
to BAXTER and responses to such inquiries did not contain
any untrue statement of a
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material fact or omit to state any material fact necessary
in order to make the statements made therein, in light of
the circumstances under which they were made, not
misleading; and
(v) SANGAMO warrants and represents that it has reviewed its
intellectual property portfolio and believes that there
are no other patents or patent applications owned by
SANGAMO or licensed to SANGAMO with the right to grant
sublicenses which would be infringed in the practice of the
Patent Rights in the Field in the Territory. Should it
later eventuate that any patent or patent application, that
as of the Effective Date is owned by SANGAMO or licensed to
SANGAMO with the right to grant sublicenses, would be
infringed in the practice of the Patent Rights in the Field
in the Territory, then that patent or patent application
shall be deemed to be licensed to XXXXXX as part of the
Patent Rights under this Agreement but only to the extent
necessary for BAXTER to exercise the license rights granted
to it under this Agreement.
2.2 OTHER SANGAMO REPRESENTATIONS AND WARRANTS
(a) SANGAMO warrants and represents regarding the Patent Rights and
Technology, that it owns or has a license to the Patent Rights and
Technology, that it has the legal power to extend the rights
granted to BAXTER under this Agreement, that this Agreement
constitutes a binding agreement enforceable against SANGAMO in
accordance with its terms, and that it has not made any
commitments to others regarding ZFP in respect of the Patent
Rights and/or Technology in the Field that would conflict with
such rights.
(b) SANGAMO warrants and represents that it has disclosed to BAXTER all
technical data and other information owned or known by SANGAMO as
of the Effective Date regarding the safety and efficacy of zinc
finger DNA binding proteins in the Field.
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2.3 BAXTER REPRESENTATIONS AND WARRANTIES
BAXTER warrants and represents that it has the legal power to enter into
this Agreement, that this Agreement constitutes a binding agreement
enforceable against BAXTER in accordance with its terms, and that is has
not made any commitments to others that would conflict with its
obligations under this Agreement.
3. LICENSE AND OPTION
3.1 GRANT OF LICENSE AND OPTION
(a) The parties hereby acknowledge that, pursuant to the Research
Funding Agreement, BAXTER has assigned to SANGAMO any and all of
its rights to BAXTER Inventions and to Joint Inventions, including
all rights under the patent, copyright and other intellectual
property laws of the United States or any other country.
(b) SANGAMO hereby grants to BAXTER an exclusive license including the
right to sub-license pursuant to Clause 3.2 under the Patent
Rights, the Technology, and under Invention Patents and Inventions
(other than Inventions Patents to the extent they claim BAXTER
Inventions, and other than BAXTER Inventions) to manufacture, have
manufactured, import, use, sell and offer for sale Licensed
Products for use in the Field throughout the Territory for the term
of this Agreement. During the term of this Agreement, SANGAMO shall
not grant to any Third Party any license under the Patent Rights,
technology, Invention Patents or Inventions for use in the Field in
the Territory.
(c) SANGAMO hereby grants to BAXTER an exclusive, perpetual,
royalty-free license, including the exclusive right to sub-license,
under the Invention Patents to the extent they claim BAXTER
Inventions and under BAXTER Inventions for all purposes throughout
the Territory; provided, however, that SANGAMO reserves the right
thereunder to conduct its obligations and exercise its rights under
this Agreement.
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(d) SANGAMO hereby grants to BAXTER a non-exclusive, perpetual,
royalty-free license, including the right to sub-license, under the
Invention Patents to the extent they claim Joint Inventions and under
Joint Inventions for all purposes throughout the Territory for the
term of this Agreement, other than to manufacture, have manufactured,
import, use, sell and offer for sale Licensed Products for use in the
Field throughout the Territory for the term of this Agreement.
(e) SANGAMO hereby grants to BAXTER the exclusive option, exercisable for
a period of eighteen (18) months after the Effective Date, to purchase
a Convertible Debenture having a face amount of Seven Million Five
Hundred Thousand Dollars ($7,500,000) pursuant to a Convertible
Debenture Purchase Agreement substantially in the form of the similar
agreement between the parties entered into concurrently herewith. Such
option is exercisable by BAXTER giving express written notice to
SANGAMO of its desire to exercise such option, and paying to SANGAMO
the sum of Seven Million Five Hundred Thousand Dollars ($7,500,000)
prior to the expiration of such option. If BAXTER timely exercises
such option and purchases such Convertible Debenture, SANGAMO shall
grant to BAXTER a right of first refusal, for a period of three (3)
years after the date of the issuance of such Convertible Debenture, to
obtain an exclusive license under the Patent Rights and the Technology
for use throughout the Territory in the field of treatment and
prevention of any and all cardiovascular and vascular disease in
humans, including, but not limited to, pro-angiogenic therapies,
anti-restenosis and congestive heart failure.
(f) BAXTER shall not use the Patent Rights, Technology, Invention Patents
or Inventions for any purpose for which it is not expressly licensed
hereunder.
(g) Except as otherwise expressly set forth in this Agreement, neither
party grants to the other party any license, immunity or other right
under the such party's patent rights, other intellectual property
rights or technology, whether by implication or otherwise, for any
purpose.
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(h) If BAXTER becomes aware of any pending patent applications or issued
patents of a Third Party that claim ZFPs or their use in the Field,
BAXTER promptly shall advise SANGAMO thereof. As between BAXTER and
SANGAMO, SANGAMO shall have the first right, but not the obligation
(at its option in its sole discretion), to obtain a license from such
Third Party under such pending patent applications and issued
patents, and shall use its commercially reasonable efforts to obtain
a license (with the right to grant a sublicense to BAXTER) for use in
the Field, in each case on terms and conditions acceptable to
SANGAMO. If SANGAMO obtains such a license (with the right to grant a
sublicense to BAXTER) for use in the Field, then such pending patent
applications and issued patents shall be subject to this Agreement.
If SANGAMO elects not to seek, or fails to obtain, such a license
(with the right to grant a sublicense to BAXTER) for use in the
Field, then BAXTER shall have the right, but not the obligation (at
its option in its sole discretion), to obtain a license from such
Third Party under such pending patent applications and issued patents
on terms and conditions acceptable to BAXTER.
3.2 CERTAIN RESTRICTIONS ON SUB-LICENSES
XXXXXX'x right to sublicense the rights granted under Clauses 3.1 to a
Third Party shall be subject to the following:
(a) BAXTER shall inform SANGAMO of any sublicense under Clauses 3.1 and
shall provide SANGAMO, after the grant of such sublicense, a copy of
such sublicense subject to the confidentiality provisions of this
Agreement; and
(b) Any sublicense granted under Clauses 3.1 shall be subject to the
terms and conditions of this Agreement and shall have terms and
conditions which are consistent with the terms and conditions of this
Agreement.
3.3 DESIGN OF ZFPS AFTER THE SPONSORED RESEARCH
(a) At any time during the term of this Agreement after the termination
of the Research Funding Agreement, upon the reasonable request of
BAXTER,
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SANGAMO shall design, assemble and characterize (or cause to be designed,
assembled or characterized) one or more zinc finger DNA binding proteins
for the activation of VEGF or VEGF receptors for the treatment or
prevention of ischemic cardiovascular and vascular disease in humans, in
addition to those developed under the Sponsored Research, and shall deliver
to BAXTER such zinc finger DNA binding protein and/or the nucleic acid that
encodes therefor. On or after delivery of such zinc finger DNA binding
protein and/or the nucleic acid, SANGAMO shall invoice BAXTER an amount not
to exceed * * * * * * of the fully-burdened cost
to SANGAMO therefor, and BAXTER shall pay such invoice promptly following
receipt of such invoice.
(b) The parties hereto expressly acknowledge and agree that the intellectual
property licensed to BAXTER by this Agreement is unique and unavailable
from any source other than SANGAMO and that in the event of SANGAMO's
breach of its obligations under Paragraph 3.3 or of the exclusivity of the
rights granted to BAXTER hereunder, money damages will not adequately
compensate BAXTER for the losses that it would sustain due to XXXXXX'x
inability to then realize the benefit of this Agreement. Therefore, the
parties expressly acknowledge and agree that, in the event of such uncured
breach, BAXTER shall be entitled to equitable relief in the form of
specific performance or other mandatory or prohibitory injunction in order
to allow BAXTER to enforce such terms of this Agreement to either require
SANGAMO to design, assemble and characterize (or cause to be designed,
assembled or characterized) one or more zinc finger DNA binding proteins
for the activation of VEGF or VEGF receptors for the treatment or
prevention of ischemic cardiovascular and vascular disease in humans, or,
at XXXXXX'x option, the right of XXXXXX itself to design, assemble and
characterize one or more zinc finger DNA binding proteins for the
activation of VEGF or VEGF receptors for the treatment or prevention of
ischemic cardiovascular and vascular disease in humans; provided, however,
that the subsequent making, using, offering for sale, selling or importing
of such zinc finger DNA binding proteins shall be limited to the scope of
the license granted hereunder. If the event of such uncured breach, upon
the written request of
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the Commission. Confidential treatment has been requested with respect to the
omitted portions.
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XXXXXX, SANGAMO shall promptly deliver to XXXXXX any intellectual property
and/or know-how or any other information which is in the control of SANGAMO and
which XXXXXX reasonably needs or requires to allow XXXXXX itself to design,
assemble and characterize zinc finger DNA binding proteins and/or the nucleic
acid that encodes therefor; provided, however, that the subsequent making,
using, offering for sale, selling or importing of such zinc finger DNA binding
proteins shall be limited to the scope of the licenses granted hereunder. XXXXXX
shall be relieved from any payment obligation to SANGAMO under Paragraph 3.3 for
zinc finger DNA binding proteins which XXXXXX designs, assembles or
characterizes after such uncured breach.
3.4 TRANSFER OF CERTAIN MATERIALS
Upon request, SANGAMO shall deliver to XXXXXX the materials (including
but not limited to biological materials such as cell lines, master cell
banks, transformed vectors and antibodies) and information that (a) are
owned by SANGAMO or licensed to SANGAMO with the right to grant
sublicenses, and (b) are needed for GMP production and/or purification of
ZFP, or improve the yield of production, increase the purity or decrease
the cost of production of ZFP (based on SANGAMO's then current state of
the art). Such materials and information shall be included within the
definition of Technology and shall be subject to the licenses granted by
SANGAMO to XXXXXX hereunder.
4. PAYMENTS BY XXXXXX
4.1 METHOD OF PAYMENT
All payments due by XXXXXX to SANGAMO pursuant to this Agreement shall be
payable in the currency of the United States of America and shall be paid
by wire transfer into such accounts as SANGAMO may direct.
4.2 CONVERTIBLE DEBENTURE AND MILESTONE PAYMENTS
4.2.1 In consideration for the rights acquired under this Agreement:
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(a) On or before January 21, 2000, XXXXXX shall pay to SANGAMO the sum
of Five Million Dollars ($5,000,000) in consideration for the
purchase of a Convertible Debenture having a face amount of Five
Million Dollars ($5,000,000).
(b) Within thirty (30) days of the first achievement of each of the
following events or the respective date described, XXXXXX shall pay
SANGAMO the following milestone payments:
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17
* * * * * * * * * *
* * * * * * * * * *
* * * * * * * * * *
(c) With respect to each Subsequent Licensed Product, within thirty
(30) days of achievement of each of the following events or the
respective date described, XXXXXX shall pay to SANGAMO the
following milestone payments:
* * * * * * * * * * * *
* * * * * * * * * * *
* * * * * * * * * * * *
* * * * * * * * * * *
* * * * * * * * * * *
4.2.2 For purposes of this Agreement, * * * * *
* * * * * * * * * * * *
* * * * * * * * * * * *
* * * * * * * * * * * *
* * * * * * * * * * * *
* * * * * * * * * * * *
4.2.3 In the event that XXXXXX must license from a Third Party one or
more pending patent applications or issued patents in order to
manufacture, have manufactured, import, use, sell and offer for sale
a Licensed Product in any country for use in the Field, XXXXXX
shall have the right to credit all up-front license payments and
milestone payments actually paid to such Third Party against up to
* * * * of each milestone payment owing to SANGAMO
under Clause 4.2.1(b)(iv), (v) and (vi) and Clause 4.2.1(c) with
respect to such Licensed Product. If the parties disagree whether
or not a pending patent application or issued patent is consistent
with the requirement set forth in this Clause 4.2.3, the
disagreement shall be resolved pursuant to Clause 12.
4.2.4 The calendar dates described in Clauses 4.2.1(b)(i), (ii), (iii)
and (iv) will be subject to review, and revision if appropriate, by
the Steering Committee as follows. The Steering Committee shall
determine the appropriateness of such
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calendar dates for the achievement of the applicable milestone events in
light of the technical and commercial feasibility of the particular ZFP
molecule being pursued at the time, and if appropriate, shall adjust such
calendar dates as agreed by the Steering Committee.
4.3 LICENSE FEE - ROYALTY
4.3.1 In addition to the payments set out in Clause 4.2, and subject to Clause
4.4, XXXXXX shall pay to SANGAMO the following royalties based on Net
Sales:
(a) A royalty equal to * * * of Net Sales of Licensed ZFP
Product, and a royalty equal to * * * of Net Sales of
Licensed ZFP Combination Product.
(b) A royalty equal to * * * of Net Sales of Jointly Invented
Licensed Product and a royalty equal * * * of Net Sales of
Jointly Invented Licensed Combination Product.
(c) In addition to the royalties set out in Clauses 4.2.1(a) and (b), for a
period of five (5) years after the First Commercial Sale of each
Subsequent Licensed Product, an additional royalty equal * * *
* of Net Sales of such Subsequent Licensed Product.
4.3.2 In addition to the payments set out in Clauses 4.2 and 4.3.1, if XXXXXX
grants to a Third Party a sublicense or other rights to commercialize a
Licensed Product prior to the first administration of such Licensed
Product to the first enrolled and evaluable patient in the first Phase 3
Clinical Trial for such Licensed Product, XXXXXX shall pay to SANGAMO the
following royalties:
(a) A royalty equal to * * * of Net Sublicense Revenues of such
Licensed Product.
(b) A royalty equal to * * * of Net Sales of any Cross Licensed
Product for which XXXXXX or its Affiliate receives any (sub)license or
other rights to commercialize in connection with the grant of such
sublicense or other rights to
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commercialize such Licensed Product. Xxxxxx shall calculate, report and
pay the royalties for such Cross Licensed Product hereunder in the same
manner as if such Cross Licensed Product were a Licensed Product
hereunder.
4.3.3 The payments due by XXXXXX to SANGAMO pursuant to Clauses 4.3.1 and 4.3.2
shall be made to SANGAMO within sixty (60) days of the end of each
calendar quarter, and each such payment shall be accompanied by a
reasonably detailed written report containing the calculation of the
payment due to SANGAMO for said calendar quarter. With respect to sales
of Licensed Products invoiced in United States dollars, the Net Sales,
Net Sublicense Revenues and royalties payable shall be expressed in
United States dollars. With respect to sales of Licensed Products
invoiced in a currency other than United States dollars, the Net Sales,
Net Sublicense Revenues and royalties payable shall be expressed in the
domestic currency of the party making the sale together with the United
States dollar equivalent of the royalty payable, calculated using the
average closing buying rate for such currency quoted in the United States
Western Edition of The Wall Street Journal under the heading "Currency
Trading -- Exchange Rates" on last day of each month during said calendar
quarter.
4.4 ROYALTY ADJUSTMENTS
(a) In the event that XXXXXX must license from a Third Party one or more
pending patent applications or issued patents that claim a ZFP or the
method of making or using a ZFP in any country in the Field, XXXXXX shall
have the right to credit one hundred percent (100%) of such Third Party
royalty payments based upon sales of such Licensed Product in such
country against the royalties owing to SANGAMO under Clause 4.3.1(a)
above with respect to sales of such Licensed Product in such country;
provided, however, that XXXXXX shall not reduce, pursuant to Clauses
4.4(a) and (b), the amount of the royalties paid to SANGAMO under Clause
4.3.1(a) above, with respect to sales of such Licensed Product in such
country, to less than * * * of Net Sales of such Licensed
Product in such country.
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(b) In the event that XXXXXX must license from a Third Party one or
more pending patent applications or issued patents (other than
those described in Clause 4.4(a)) in order to manufacture, have
manufactured, import, use, sell and offer for sale a Licensed
Product in any country for use in the Field. XXXXXX shall have
the right to credit fifty percent (50%) of such Third Party
royalty payments based upon sales of such Licensed Product in
such country against the royalties owing to SANGAMO under Clause
4.3.1(a) above with respect to sales of such Licensed Product in
such country; provided, however, that XXXXXX shall not reduce,
pursuant to Clauses 4.4(a) and (b), the amount of the royalties
paid to SANGAMO under Clause 4.3.1(a) above, with respect to
sales of such Licensed Product in such country, to less than *
* * of Net Sales of such Licensed Product in such
country.
(c) XXXXXX shall allow representatives of SANGAMO to examine any
licenses that XXXXXX asserts justify the adjustment of royalties
to verify that any adjustments made pursuant to this Clause 4.4
are consistent with the requirement set forth in this Clause
4.4. SANGAMO's representatives shall not copy the license or
licenses and must keep confidential all information, including
royalty rates, pertaining to the license or licenses. If the
parties disagree whether or not a pending patent application or
issued patent is consistent with the requirement set forth in
this Clause 4.4, the disagreement shall be resolved pursuant to
Clause 12.
(d) If the manufacture, use, offer for sale, sale or import of any
Licensed Product does not fall within the scope of one or more
claims of an issued and unexpired patent within the Patent
Rights or Inventions Patents (other than Inventions Patents to
the extent they claim only XXXXXX Inventions), then the
royalties owing under Clause 4.3.1 shall be reduced by one-half
and shall be payable only for a period of five (5) years after
the First Commercial Sale of such Licensed Product; provided,
however, at such later time as the manufacture, use, offer for
sale, sale or import of any Licensed Product falls within the
scope of one or more claims of an issued and unexpired patent
within the Patent Rights or Inventions Patents that was pending
on the date of the First Commercial Sale thereof (other
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omitted portions.
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than Inventions Patents to the extent they claim only XXXXXX
Inventions), then the royalties owing under Clause 4.3.1 shall resume in
full.
4.5 Records
(a) XXXXXX shall keep, and shall cause any person to whom it has
granted a sublicense pursuant to Clause 3.2 to keep, for a
minimum of five (5) years, complete records of all matters which
are relevant for determining the License Fees which are to be
paid to SANGAMO pursuant to this Agreement.
(b) Upon the written request of SANGAMO and not more than once in
each calendar year, XXXXXX shall permit an independent certified
public accounting firm of nationally recognized standing,
selected by SANGAMO and reasonably acceptable to BAXTER, at
SANGAMO's expense, to have access during normal business hours
to such of the records of XXXXXX as may be reasonably necessary
to verify the accuracy of the royalty reports hereunder for any
year ending nor more than thirty-six (36) months prior to the
date of such request. The accounting firm shall disclose to
SANGAMO only whether the records are correct or not and the
specific details concerning any discrepancies. No other
information shall be shared. If such accounting firm concludes
that additional royalties were owed during such period, XXXXXX
shall pay the additional royalties within thirty (30) days of
the date SANGAMO delivers to XXXXXX such accounting firm's
written report so concluding. The fees charged by such
accounting firm shall be paid by SANGAMO; provided, however, if
the audit discloses that the royalties payable by XXXXXX for the
audited period are more than one hundred five percent (105%) of
the royalties actually paid for such period, then XXXXXX shall
pay the reasonable fees and expenses charged by such accounting
firm.
5. OBLIGATIONS OF SANGAMO AND XXXXXX
5.1 SANGAMO OBLIGATIONS
SANGAMO undertakes the following obligations as part of entering this
Agreement:
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(a) To enter into a Research Funding Agreement with XXXXXX, which will
be executed contemporaneously with this Agreement and undertake the
activities described therein in a timely manner;
(b) To deliver to XXXXXX the ZFP product, molecule design, and package
design (as described in Schedule 2) and complete pre-clinical
testing to demonstrate the performance and activity of ZFP (as
described in Schedule 2), and to use its commercially reasonable
efforts to do so on or before April 1, 2001;
(c) To disclose to XXXXXX all technical data and other information owned
or known by SANGAMO, that was not previously disclosed to XXXXXX,
regarding the safety and efficacy of the ZFPs in the Field.
(d) To assist XXXXXX in assessing as to competency and price, and
recommend to the Steering Committee, the preferred manufacturer of
GMP grade ZFP for clinical trial and commercial purposes;
(e) To develop and deliver to XXXXXX processes for preclinical
production of ZFPs and procedures for the testing of ZFPs comprising
Licensed Products as are reasonably necessary for the clinical
development, the regulatory approval to manufacture and sell and the
commercial sale of Licensed Products hereunder.
(f) If requested by XXXXXX, (i) to transfer to a manufacturer, who is
acceptable to the Steering Committee, has the expertise to produce
GMP grade material and has been granted a manufacturing sublicense
from XXXXXX hereunder, such Technology as reasonably necessary for
the manufacture of GMP grade ZFP for clinical trial and commercial
purposes, and (ii) to provide such reasonable technical assistance
to such manufacturer regarding the use of such Technology to permit
such manufacturer to develop appropriate processes for the
manufacture of GMP grade ZFP for clinical trial and commercial
purposes;
(g) To produce and supply to XXXXXX ZFPs of appropriate quality and in
reasonably requested quantities sufficient to support XXXXXX'x
preclinical testing activities required by the appropriate
regulatory authorities; and
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(h) If requested by XXXXXX, to reasonably assist XXXXXX in the
preparation, filing and prosecution of all filings and submissions to
obtain Marketing Approval and ELA for Licensed Products.
5.2 XXXXXX OBLIGATIONS
XXXXXX undertakes the following obligations as part of entering this
Agreement:
(a) To enter into a Research Funding Agreement with SANGAMO, which will
be executed contemporaneously with this Agreement and to undertake
the activities described therein in a timely manner;
(b) To consult and collaborate with SANGAMO to determine the clinical and
regulatory requirements and strategy;
(c) To consult and collaborate with SANGAMO on the production and
manufacture of ZFP;
(d) To undertake, at its sole cost, the performance of all animal
pre-clinical testing, clinical development, regulatory activities and
manufacture as are required for the commercialization of Licensed
Products in the Territory for use in the Field in accordance with the
provisions of Clause 7.1; and
(e) To be primarily responsible, with the reasonable assistance of
SANGAMO, for the preparation, filing and prosecution of all filings
and submissions to obtain Marketing Approval and ELA for Licensed
Products.
6. INTELLECTUAL PROPERTY
6.1 INFRINGEMENT BY THIRD PARTIES
(a) A party shall promptly notify the other party in writing of any
alleged or threatened substantial and continuing infringement within
the Field of any patent included within the Patent Rights or
Invention Patents of which such party becomes aware.
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(b) XXXXXX shall have the right to bring and control any action or
proceeding with respect to such alleged or threatened infringement of
patents covering XXXXXX Inventions or Joint Inventions within the
Field, where such infringement does not also constitute
infringement of the Patent Rights (XXXXXX PROCEEDING) at its own
expense and represented by legal advisers of its own choice.
(i) In the event XXXXXX brings a XXXXXX Proceeding or in the event
an action is brought by a Third Party for a declaratory judgment
that any of the patents covering XXXXXX Inventions or Joint
Inventions are not infringed or invalid (XXXXXX ACTION), SANGAMO
shall co-operate reasonably with XXXXXX including, if required,
undertaking any action or agreeing to be joined as a party to
such XXXXXX Proceeding or XXXXXX Action, the reasonable costs of
which shall be at XXXXXX'x expense;
(A) SANGAMO shall retain the right to be represented by legal
advisers of its own choice at its expense.
(B) XXXXXX shall keep SANGAMO fully informed of the status of
such XXXXXX Proceeding or XXXXXX Action on a regular basis
or, as reasonably requested by SANGAMO, from time to time.
(C) In the event XXXXXX brings a XXXXXX Proceeding pursuant to
Clause 6.1(b), XXXXXX shall be entitled to retain *
* * * of the balance of any recovery, after
reimbursement of reasonable attorneys' fees and costs
incurred by XXXXXX (or for which XXXXXX is required to
reimburse SANGAMO) in such XXXXXX Proceeding, realized as a
result of such XXXXXX Proceeding, and shall remit to
SANGAMO the other * * * * .
(ii) In the event SANGAMO notifies XXXXXX in writing of any
infringement of patents covering Joint Inventions within the
Field referred to in
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Clause 6.1(b) and XXXXXX fails to commence a XXXXXX
Proceeding within a reasonable time of being so notified by
SANGAMO, provided that such time shall not, in any event,
exceed one hundred and eighty (180) days, SANGAMO may
commence a proceeding at its own expense and may be
represented by legal advisers of its own choice. In the event
SANGAMO brings such a proceeding, XXXXXX shall provide all
reasonable assistance to SANGAMO, at SANGAMO's expense, in
relation to such proceeding and the terms set out in Clause
6.1(b) shall apply as if XXXXXX were SANGAMO and SANGAMO were
XXXXXX.
(iii) In the event SANGAMO brings a proceeding pursuant to Clause
6.1(b)(ii), SANGAMO shall be entitled to retain * *
* * * of the balance of any recovery, after
reimbursement of reasonable attorneys' fees and costs
incurred by SANGAMO (or for which SANGAMO is required to
reimburse XXXXXX) in such proceeding, realized as a result of
such proceeding, and shall remit to XXXXXX the other *
* * * .
(c) SANGAMO shall have the right to bring and control any action or
proceeding with respect to such alleged or threatened infringement of
Patent Rights or patents covering SANGAMO Inventions within the Field
(SANGAMO PROCEEDING) at its own expense and represented by legal
advisers of its own choice.
(i) In the event SANGAMO brings a SANGAMO Proceeding or in the
event an action is brought by a Third Party for a declaratory
judgment that any of the Patent Rights or patents covering
SANGAMO Inventions are not infringed or invalid (SANGAMO
ACTION), XXXXXX shall co-operate reasonably with SANGAMO
including, if required, undertaking any action or agreeing to
be joined as a party to such SANGAMO Proceeding or SANGAMO
Action, the reasonable costs of which shall be at SANGAMO's
expense;
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(A) XXXXXX shall retain the right to be represented by legal
advisers of its own choice at its own expense.
(B) SANGAMO shall keep XXXXXX fully informed of the status
of such SANGAMO Proceeding or SANGAMO Action on a
regular basis or, as reasonably requested by XXXXXX,
from time to time.
(C) In the event SANGAMO brings a SANGAMO Proceeding
pursuant to Clause 6.1(c), SANGAMO shall be entitled to
retain * * * * of the balance of any
recovery, after reimbursement of reasonable attorneys'
fees and costs incurred by SANGAMO (or for which SANGAMO
is required to reimburse XXXXXX) in such SANGAMO
Proceeding, realized as a result of such SANGAMO
Proceeding, and shall remit to XXXXXX the other *
* * * *.
(ii) In the event XXXXXX notifies SANGAMO in writing of any
infringement referred to in Clause 6.1(c) and SANGAMO fails to
commence a SANGAMO Proceeding within a reasonable time of
being so notified by XXXXXX, provided that such time shall
not, in any event, exceed one hundred and eighty (180) days,
XXXXXX may commence a proceeding at its own expense and may
be represented by legal advisers of its own choice. In the
event XXXXXX brings such a proceeding, SANGAMO shall provide
all reasonable assistance to XXXXXX, at XXXXXX'x expense, in
relation to such proceeding and the terms set out in Clause
6.1(c) shall apply as if SANGAMO were XXXXXX and XXXXXX were
SANGAMO.
(iii) In the event XXXXXX brings a proceeding pursuant to Clause
6.1(c)(ii), XXXXXX shall be entitled to retain * *
* of the balance of any recovery, after
reimbursement of reasonable attorneys' fees and costs
incurred by XXXXXX (or for which XXXXXX is required to
reimburse SANGAMO) in such proceeding, realized as a result
of such
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proceeding, and shall remit to SANGAMO the other * *
* * .
6.2 INFRINGEMENT OF THIRD PARTY RIGHTS
6.2.1 Each party shall promptly notify the other parties in writing in
the event that any allegation of infringement of any Third Party
patent is raised by reason of the exercise by XXXXXX or any of
its sublicensees of any rights pursuant to Clause 3.1 or 3.2
(ALLEGED THIRD PARTY PATENT RIGHTS). In the event that such an
action is brought by a Third Party against XXXXXX or any of its
sublicensees of any rights pursuant to Clause 3.1 or 3.2, BAXTER,
or any sub-licensee of XXXXXX, as may be determined by BAXTER,
shall have the right to control any defense of any such action,
at its own expense, and to be represented by legal advisers of
its own choice, and SANGAMO shall have the right, at its own
expense, to be represented in any such action by legal advisers
of its own choice. In the event of any infringement or alleged
infringement of any Alleged Third Party Patent Rights, SANGAMO
shall co-operate in good faith with BAXTER or any sublicensee of
XXXXXX (as the case may be) on a reasonable basis to negotiate
and settle any dispute with a Third Party in relation to such
infringement or alleged infringement of any Alleged Third Party
Patent Rights, and to otherwise resolve any such infringement or
alleged infringement and secure XXXXXX'x continued rights to the
Alleged Third Party Patent Rights, if necessary or desirable.
6.2.2 In the event that such an action is brought by a Third Party
against XXXXXX alleging the infringement by XXXXXX, its Affiliate
or sublicensee of any Third Party patent by reason of the
manufacture, import, use, sale or offer for sale of a Licensed
Product in any country for use in the Field, XXXXXX shall be
entitled to retain up to * * * of the license fees
to be paid to SANGAMO pursuant to Clauses 4.2.1(b)(iv), (v) and
(vi) and Clause 4.2.1(c) with respect to such Licensed Product,
and up to * * * of the royalties to be paid to
SANGAMO pursuant to Clause 4.3.1(a) with respect to
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omitted portions.
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such Licensed Product, and to use such monies to pay for, or defray,
the costs of defending such action for alleged infringement of such
Third Party patents and to pay damages, reasonable attorneys' fees, or
other costs resulting from such litigation until XXXXXX has recovered
all of its costs. During the pendency of such action for alleged
infringement of such Third Party patents, XXXXXX shall submit
quarterly written reports showing royalties accruing to SANGAMO and
the expenses of defending itself against such claims of alleged
infringement. Upon termination of all proceedings or actions
involving such defense, XXXXXX shall remit the unused balance, if
any, of the license fees and royalties accrued but not yet paid to
SANGAMO. Notwithstanding anything to the contrary in this Agreement,
(a) XXXXXX shall not be entitled to reduce the amount of any license
fee owing to SANGAMO under Clauses 4.2.1(b)(iv), (v) and (vi) or
Clause 4.2.1(c) with respect to such Licensed Product by more than
* * * in the aggregate under this Clause 6.2.2 and
Clause 4.2.3, and (b) XXXXXX shall not be entitled to reduce the
amount of any royalties owing to SANGAMO under Clause 4.3.1(a) with
respect to such Licensed Product to less than * * * of Net
Sales of such Licensed Product after giving effect to this Clause
6.2.2 and Clause 4.4.
6.3 PROSECUTION AND MAINTENANCE OF PATENT RIGHTS AND INVENTION PATENTS
(a) Except as further provided herein, SANGAMO shall be responsible, at
its sole cost, for filing and prosecuting to issuance patent
applications, for filing and prosecuting all patent re-issues and
re-examinations, for applying for and obtaining any patent term
extensions, and for paying all maintenance fees on all patents,
relating to the Patent Rights and the Inventions Patents (other than
Inventions Patents that claim XXXXXX Inventions). SANGAMO shall
promptly make available to XXXXXX copies of all relevant
patent-related documents, including all documents received from or
filed with a national or international patent office, and shall
consult with XXXXXX regarding the preparation and prosecution of
applications. XXXXXX shall have the right to comment upon preparation
and prosecution strategies and to request desired claims. SANGAMO
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shall consider in good faith all reasonable suggestions of XXXXXX.
SANGAMO shall provide XXXXXX a written update of the status of the
Patent Rights and such Inventions Patents, in the same form as the
Schedules hereto on at least an annual basis. If SANGAMO chooses not
to file, prosecute or maintain any patent applications within the
Patent Rights or Inventions Patents, then SANGAMO shall notify
XXXXXX prior to taking any action which would jeopardize such patent
rights. XXXXXX will then have the right (i) to file, prosecute or
maintain any patent applications within the Inventions Patents that
claim solely Joint Inventions at its own expense, and (ii) to pay
SANGAMO's reasonable expenses for SANGAMO's continued filing,
prosecution or maintenance of such Patent Rights or other Inventions
Patents (if SANGAMO determines in good faith that such continued
filing, prosecution or maintenance is strategically desirable for
the Licensed Products and is consistent with its patent prosecution
practices).
(b) XXXXXX shall be responsible, at its sole cost, for filing and
prosecuting to issuance patent applications, for filing and
prosecuting all patent re-issues and re-examinations, for applying
for and obtaining any patent term extensions, and for paying all
maintenance fees on all patents, relating to the Inventions Patents
that claim XXXXXX Inventions.
7. OBLIGATIONS OF THE PARTIES
7.1 DILIGENCE OBLIGATIONS
(a) SANGAMO shall use commercially reasonable efforts consistent with
international practice in the biotechnology industry, SANGAMO's
sound business judgment, and research, regulatory and market
conditions, to perform its obligations under this Agreement,
including, but not limited to, its obligations under Clause 5.1.
(b) XXXXXX and/or its sub-licensees shall use commercially reasonable
efforts consistent with international practice in the human-use
pharmaceutical industry, XXXXXX'x sound business judgment, and
clinical, regulatory and market
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conditions, to develop and commercialize Licensed Products in
the Territory for use in the Field.
(c) Notwithstanding the foregoing, XXXXXX shall be deemed to have
satisfied its diligence obligations under this Clause 7.1 upon
timely payment of the license fees under Clauses 4.2.1(b) and
(c).
7.2 STEERING COMMITTEE
7.2.1 SANGAMO and XXXXXX will appoint a Steering Committee comprising
up to three (3) named representatives from each party and up to
four (4) ex-officio members from each party as required to meet
at least four (4) times per year or with less frequency if
mutually agreed by the Steering Committee at mutually agreed
locations. SANGAMO and XXXXXX shall have the right to approve
the other Party's nominated Steering Committee members, which
approval shall not be unreasonably withheld, with the sole
objective of avoiding the appearance of conflict among
nominated representatives. Where matters of conflict of interest
arise subsequent to a member joining the Steering Committee, the
Steering Committee shall have the right to remove such member
and the Party who such member represents will nominate a
replacement.
7.2.2 The Steering Committee shall design, manage, review and direct
the status and operation of the scientific and technical
activities and obligations to be performed under this Agreement
and the Research Funding Agreement, including, but not limited
to, (i) the selection of the appropriate ZFP molecule to be
pursued for pre-clinical testing, and (ii) reviewing and
approving entry into each phase of clinical development. The
Steering Committee may be further called upon to assist in
establishing or revising the workplans associated with and/or
the requirements for the preclinical testing needed for the IND
submission or the manufacturing process development to be
performed under this Agreement and the Research Funding
Agreement. The Steering Committee shall also provide a forum for
the parties to disclose any additional research data relating to
improvements,
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31
modifications, enhancements or variations to the ZFP arising
under this Agreement or the Research Funding Agreement.
7.2.3 Decisions, recommendations, or approval of the Steering
Committee shall require an affirmative vote of two-thirds of the
seated members (i.e., four of six). Meetings or convenings of
the Steering Committee shall require the participation or
attendance of at least five (5) members of the Steering
Committee.
7.2.4 Each party will be responsible for the costs of their
representative's attendance, unless otherwise agreed. The
Steering Committee shall appoint a secretary who shall keep
written records of its meetings.
7.2.5 At any time after the date of First Commercial Sale of a
Licensed Product, the Steering Committee may disband by mutual
agreement.
7.3 APPOINTMENT OF PROJECT MANAGER
In addition to the appointment of the Steering Committee above, SANGAMO
and XXXXXX shall each appoint a designated project manager who will be
responsible for keeping the other party informed of activities under
this Agreement.
8. CONFIDENTIALITY
8.1 OBLIGATIONS
This Clause 8 applies, except as otherwise provided in this Clause 8,
during the term of this Agreement, and thereafter for a period of five
(5) years. Both SANGAMO and XXXXXX shall maintain in confidence, not
disclose to any Third Party and use only for the purposes of this
Agreement information and data which is not generally known and which
(a) results from the use or development of the Technology and Inventions
pursuant to this Agreement or the Research Funding Agreement, or (b) is
supplied by SANGAMO or XXXXXX after April 13, 1999 in connection with
this Agreement or the Research Funding Agreement (or discussions leading
up to them) and is marked, identified or otherwise acknowledged to be
confidential (INFORMATION).
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8.2 PERMITTED DISCLOSURES
To the extent it is reasonably necessary to fulfill their obligations or
exercise their rights pursuant to this Agreement, XXXXXX and SANGAMO may
disclose Information they are otherwise obligated pursuant to this Clause
8 not to disclose, to its Affiliates, its bona fide proposed sublicensees
and its permitted sublicensees, and shall limit disclosure of such
Information to its and their respective officers, directors, employees
and consultants on a need-to-know basis, in each case provided that such
persons and entities agree to keep the Information confidential for the
same time periods and to the same extent as the disclosing party is
required to keep the Information confidential. XXXXXX and SANGAMO may
also disclose such information to government or other regulatory
authorities to the extent that such disclosure is required to be
disclosed to obtain a patent or authorization to conduct a clinical
trial or to commercially market any product arising out of the Technology
or is otherwise required by applicable law, regulation or court order, in
each case provided that the disclosing party shall provide written notice
to the other party and sufficient opportunity to object to such
disclosure or to request confidential treatment thereof. The obligation
not to disclose Information shall not apply to any part of such
Information that:
(a) is or becomes patented, published or otherwise part of the public
domain other than by acts of the person obligated not to disclose
such Information in contravention of this Agreement;
(b) is disclosed to the receiving party by a Third Party, provided such
Information was not obtained from such Third Party directly or
indirectly from SANGAMO or XXXXXX (as the case may be);
(c) prior to disclosure pursuant to this Agreement, was already in the
possession of the receiving party, provided such Information was not
obtained directly or indirectly from SANGAMO or XXXXXX (as the case
may be);
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(d) is developed independently of the Information obtained from SANGAMO
or XXXXXX (as the case may be), by persons without access to or use
of the Information, as demonstrated by written evidence; or
(e) is disclosed by either SANGAMO or XXXXXX with the prior written
consent of the other.
8.3 TERMS OF THIS AGREEMENT
SANGAMO and XXXXXX agree to not disclose the existence of or the
financial terms or conditions of this Agreement or the Research Funding
Agreement to any Third Party without the prior written consent of the
other, except as required by applicable law or regulatory authority.
8.4 PUBLIC ANNOUNCEMENTS
Notwithstanding the provisions of Clause 8, neither XXXXXX nor SANGAMO
shall release any media release or other oral or written announcement for
dissemination to the media concerning or arising from this Agreement or
the Research Funding Agreement without the written consent of the other
party.
8.5 SURVIVAL OF OBLIGATIONS
This Clause 8 survives the termination of this Agreement.
9. LIMITATION OF LIABILITY AND INDEMNITY
9.1 XXXXXX agrees to indemnify, hold harmless and defend SANGAMO, its
directors, trustees, officers, employees and agents, and the inventors of
the patent and patent applications included in the Patent Rights or in
SANGAMO Inventions or Joint Inventions against any and all losses,
liabilities, damages and expenses (including reasonable attorneys' fees
and costs) incurred as a result of any Third Party claims, suits,
demands, causes of action or other proceedings to the extent arising out
of XXXXXX'x and its sublicensees' use of the Patent Rights, Technology,
Inventions Patents or Inventions or the manufacture, use, offer for sale
or sale of Licensed Products (without
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regard to culpable conduct), except to the extent arising from the
negligence or willful misconduct of SANGAMO, or its directors, officers,
employees, and agents, or the failure of SANGAMO (as the case may be) to
disclose relevant information pursuant to Section 2.1, 2.2 or 5.1(c) of
this Agreement.
9.2 SANGAMO agrees to indemnify, hold harmless and defend XXXXXX, its
directors, trustees, officers, employees and agents, against any and all
losses, liabilities, damages and expenses (including reasonable
attorneys' fees and costs) incurred as a result of any Third Party
claims, suits, demands, causes of action or other proceedings to the
extent arising out of the negligence or willful misconduct of SANGAMO, or
its directors, officers, employees and agents, or the failure of SANGAMO
to disclose relevant information pursuant to Section 2.1, 2.2 or 5.1(c)
of this Agreement.
9.3 This Clause 9 survives the termination of this Agreement.
10. INSURANCE
(a) XXXXXX shall maintain insurance, including product liability
insurance, with respect to the use and exploitation of the Patent Rights,
Technology, Inventions Patents and Inventions, and the research,
development, production, distribution and use of Licensed Products in
such amount as is customarily maintained in accordance with good practice
for the pharmaceutical industry. XXXXXX shall maintain such insurance for
so long as it continues to use and exploit any of the Patent Rights,
Technology, Inventions Patents or Inventions, or to conduct the research,
development, production, distribution or use of Licensed Products, and
thereafter for so long as XXXXXX maintains insurance for itself covering
supply of Licensed Products. The liability insurance requirement of this
Section may be satisfied through self-insurance with reserves consistent
with industry practices.
(b) XXXXXX shall, upon the request of SANGAMO:
(i) produce evidence of the currency of such insurance; and
(ii) note the interest of SANGAMO on the policy in respect of such
insurance.
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11. TERM AND TERMINATION
11.1 TERM
Unless terminated earlier pursuant to Clause 11.2, this Agreement shall
continue in force in each country of the Territory until the date of
expiration of the last to expire of any patent within the Patent Rights
or the Invention Patents in such country, at which time XXXXXX will have
a fully paid up license, including the right to sublicense, to the ZFPs,
Inventions and the Technology as provided herein.
11.2 EARLY TERMINATION
(a) In addition to any rights it may have hereunder, a party may
terminate this Agreement upon (30) days prior written notice
following the occurrence of any of the following:
(1) the bankruptcy, insolvency, dissolution or winding up of the
other party (other than dissolution or winding up for the
purposes of a solvent reconstruction or amalgamation);
(2) the failure of the other party to cure the breach of any
provision of this Agreement for the payment of funds within
thirty (30) days after written notice thereof by the
non-breaching party; or
(3) the failure of the other party to cure the breach of any
material provision of this Agreement, except nonpayment of
funds, within sixty (60) days after written notice thereof by
the non-breaching party.
(b) XXXXXX has the right to terminate this Agreement at any time by
giving ninety (90) days prior written notice without cause.
(c) Upon early termination of this Agreement for any of the reasons set
forth in this Clause 11.2(a) and (b), XXXXXX shall have no
obligation to make any license fee payments that come due after the
effective date of termination.
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11.3 SURVIVAL
(a) Expiration or termination of this Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or
termination.
(b) The provisions of Clause 3.1(d) shall survive the expiration or
termination of this Agreement.
(c) Upon expiration or termination of this Agreement, SANGAMO shall
assign to XXXXXX all right, title and interest in the XXXXXX
Inventions and all patent rights and other intellectual property
rights therein.
12. RESOLUTION OF DISPUTES
12.1 DISPUTES COMMITTEE
Disputes arising between the Parties to this Agreement shall be referred
to a disputes committee which shall consist of the respective chief
executive of SANGAMO and the highest official of the CardioVascular Group
of XXXXXX or their delegates (DISPUTES COMMITTEE). The Disputes Committee
shall confer together in an endeavor to settle the dispute on some fair
and equitable commercial basis with regard to the basic legal rights of
SANGAMO and XXXXXX. Any discussions or proceedings of the Disputes
Committee shall be on a without prejudice basis.
12.2 USE OF EXPERT
Subject to agreement of all members of the Disputes Committee, the
Disputes Committee may, at its option, refer any dispute or difference to
an independent Third Party, who shall act as an expert and not as an
arbitrator in settling the same, on terms that the decision of such
independent Third Party shall be binding on SANGAMO and XXXXXX.
12.3 OTHER RIGHTS AND REMEDIES
If the parties are unable to resolve a dispute under this Clause 12 within
thirty (30) days after written notice from one party to the other of such
dispute, either party shall have the
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right to pursue all rights and remedies to which it is entitled at law, in
equity or otherwise. Nothing in this Agreement shall preclude either party
from seeking appropriate injunctive relief in any court of competent
jurisdiction, whether or not the applicable dispute has been submitted to
resolution under this Clause 12.
13. NOTICES
Any notice, demand, consent or other communication (NOTICE) given or made
under this Agreement:
(a) must be in writing and signed by a person duly authorized by the
sender;
(b) must either be delivered to the intended recipient as follows:
(i) to SANGAMO
BIOSCIENCES, INC.: Point Richmond Tech Center
000 Xxxxx Xxxx., Xxxxx X000
Xxxxxxxx, Xxxxxxxxxx 00000
Attention: President
Fax No: (000) 000-0000
(ii) to Xxxxxx Healthcare
Corporation: 00000 Xxx Xxxx Xxxxxx
Xxxxxx, Xxxxxxxxxx, 00000-0000
Attention: Group Vice President,
CardioVascular Group
Fax No: (000) 000-0000
(c) will be effective upon receipt by the intended recipient.
14. ENTIRE AGREEMENT
This Agreement and the Research Funding Agreement contain the entire
agreement between the parties with respect to its subject matter and
supersede all prior agreements and understandings between the parties in
connection with them.
15. AMENDMENT
No amendment or variation of this Agreement is valid or binding on a party
unless made in writing executed by all parties.
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16. ASSIGNMENT
16.1 NO ASSIGNMENT WITHOUT CONSENT
Except as provided in clause 16.2, neither XXXXXX nor SANGAMO may assign
or otherwise transfer this Agreement or any of its rights or obligations herein
without the prior written consent of the other party, which consent shall not
be unreasonably withheld.
16.2 PERMITTED ASSIGNMENTS
(a) Either party may assign this Agreement together with the Research
Funding Agreement, the Convertible Debenture Purchase Agreement and
the Convertible Debenture, without the prior written consent of the
other party in connection with the sale or transfer of all or
substantially all of its stock or assets to which this Agreement
relates, by merger, divestiture, spin-off or similar transaction,
provided that such assignee undertakes in writing to be bound by all
the terms and conditions in this Agreement and the other party is
notified within thirty (30) days of such assignment taking place; and
(b) SANGAMO or XXXXXX may assign this Agreement together with the
Research Funding Agreement, the Convertible Debenture Purchase
Agreement and the Convertible Debenture, to an Affiliate provided that
such Affiliate undertakes to be bound by the terms and conditions of
this Agreement.
17. NO WAIVER
No failure to exercise nor any delay in exercising any right, power or
remedy by a party operates as a continuing waiver. A single or partial
exercise of any right, power or remedy does not preclude any other or
further exercise of that or any other right, power or remedy. A waiver is
not valid or binding on the party granting that waiver unless made in
writing.
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18. FURTHER ASSURANCES
Each party agrees to do all things and execute all deeds, instruments,
transfers or other documents as may be necessary or desirable to give full
effect to the provisions of this Agreement and the transactions contemplated by
it.
19. RELATIONSHIP OF THE PARTIES
This Agreement does not constitute an employer/employee relationship,
partnership of any kind, an association or trust between the parties, each
party being individually responsible only for its obligations as set out in
this Agreement and in addition the parties agree that their relationship is one
of independent contractors. XXXXXX is not authorized or empowered to act as
agent on behalf of SANGAMO and XXXXXX shall not on behalf of SANGAMO enter into
any contract, warranty or representation as to any matter. SANGAMO shall not be
bound by the acts or conduct of XXXXXX. SANGAMO is not authorized or empowered
to act as agent on behalf of XXXXXX and SANGAMO shall not enter any contract,
warranty or representations as to any matter on behalf of XXXXXX. XXXXXX shall
not be bound by the acts or conduct of SANGAMO.
20. GOVERNING LAW AND JURISDICTION
This Agreement is governed by the laws of the State of California, USA.
21. COUNTERPARTS
This Agreement may be executed in any number of counterparts. All
counterparts together will be taken to constitute one instrument.
22. INSOLVENCY
(a) All rights and licenses granted under or pursuant to this Agreement
by SANGAMO to XXXXXX are, for all purposes of Section 365(n) of Title 11 of the
United Sates Code (together with its foreign equivalents, the "Insolvency
Statute"), licenses of rights to "intellectual property" as defined in the
Insolvency Statute. If an Insolvency Statute case is commenced by or against
SANGAMO,
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and this Agreement is rejected by SANGAMO (in any capacity, including
debtor-in-possession, its successors, assigns, or an Insolvency Statute
trustee), then notwithstanding such rejection XXXXXX shall retain all of
its rights, benefits, licenses, protections and privileges under this
Agreement and shall be entitled to all of the rights, benefits and
protections of a licensee under the Insolvency Statute. XXXXXX will have
the right and ability to cure any and all defaults by SANGAMO under this
Agreement and to take any other actions to oppose a rejection pursuant to
the Insolvency Statute of this Agreement, and to contract directly with
third parties, if any, involved in contracted arrangements with SANGAMO
with respect to performance of this Agreement. SANGAMO shall, upon written
request of XXXXXX, provide XXXXXX with complete access to all Patent
Rights, Technology, Inventions Patents and Inventions solely to the extent
necessary for XXXXXX to perform SANGAMO's obligations under this Agreement;
provided, however, that such rights of access shall only be exercisable if
SANGAMO fails to perform its obligations under this Agreement substantially
as contemplated herein. All rights, powers and remedies of XXXXXX provided
herein are in addition to and not in substitution for any and all other
rights, powers and remedies now or hereafter existing at law or in equity
(including, without limitation, the Insolvency Statute) in the event of the
commencement of an Insolvency Statute case by or against SANGAMO, and
XXXXXX shall be entitled to exercise all other such rights and powers and
resort to all other such remedies as may now or hereafter exist at law or
in equity in such event.
(b) In the event of a rejection in bankruptcy of this Agreement by SANGAMO
pursuant to the Insolvency Statute, then, in place of SANGAMO, Xxxxxx shall
itself have the right to design, assemble and characterize (or cause to be
designed, assembled or characterized) one or more zinc finger DNA binding
proteins for the activation of VEGF or VEGF receptors for the treatment or
prevention of ischemic cardiovascular and vascular disease in humans, in
addition to those developed under the Sponsored Research, and any zinc
finger DNA binding protein and/or the nucleic acid that encodes therefor;
provided, however, that the
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subsequent making, using, offering for sale, selling or importing of
such zinc finger DNA binding proteins shall be limited to the scope of
the licenses granted hereunder. If this Agreement is rejected by
SANGAMO in bankruptcy then, upon the written request of XXXXXX, and as
required by the Insolvency Statute, SANGAMO shall promptly deliver to
XXXXXX any intellectual property and/or know-how or any other
information which is in the control of SANGAMO and which XXXXXX
reasonably needs or requires to allow XXXXXX itself to design,
assemble and characterize (or cause to be designed, assembled or
characterized) zinc finger DNA binding proteins and/or the nucleic
acid that encodes therefor; provided, however, that the subsequent
making, using, offering for sale, selling or importing of such zinc
finger DNA binding proteins shall be limited to the scope of the
licenses granted hereunder. XXXXXX shall be relieved from any payment
obligation to SANGAMO under Paragraph 3.3 above for zinc finger DNA
binding proteins which XXXXXX designs, assembles or characterizes (or
causes to be designed, assembled or characterized) after the rejection
of this Agreement by SANGAMO.
23. FORCE MAJEURE
In the event of any delay in performance by either party of any of its
obligations or liabilities pursuant to this Agreement to the extent due to
any cause arising from or attributable to acts, events, non-happenings,
omissions, accidents or acts of God beyond the reasonable control of the
party to perform (including but not limited to strikes, lock-outs, shortage
of labor, civil commotion, riot, war, threat of or preparation for war,
breaking off of diplomatic relations, fire, explosion, sabotage, storm,
flood, earthquake, fog, subsidence, pestilence, epidemics, computer system
or machinery breakdown, failure of plant, collapse of structures, voluntary
or mandatory compliance with any direction, request or order of any person
having or appearing to have authority whether for defense or other
governmental or national purposes, or any requisition for materials or
services apparently or stated to be used for the purposes of defense,
inability to obtain suitable raw material, equipment, fuel, power,
components or transportation), the party so delayed or prevented will be
under no liability for loss or injury suffered by the other party and any
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such delay or failure to perform will not constitute a breach of this
agreement to the extent due to such cause, provided that the party so delayed
uses commercially reasonable efforts to remedy the effect of such cause.
EXECUTED as an agreement.
SIGNED by /s/ XXXXXX XXXXXXXX )
)
a duly authorized officer of SANGAMO )
BIOSCIENCES, INC. in the presence of: )
Witness /s/ XXXXX XXXXXXX PRESIDENT & CEO
--------------------------- --------------------------------------
Duly Authorized Officer
Print Name Xxxxx Xxxxxxx Xxxxxx Xxxxxxxx
--------------------------- --------------------------------------
VP, Corporate Development Print Name
SIGNED by )
)
a duly authorized officer of XXXXXX )
HEALTHCARE CORPORATION in the presence )
of:
Witness /s/ XXX X. SMALL /s/ X. X. XXXX, XX.
--------------------------- --------------------------------------
Duly Authorized Officer
Print Name Xxx X. Small X. X. Xxxx, Xx.
--------------------------- --------------------------------------
Print Name
VP, Business Development
CardioVascular Group
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