THIS ASSET
PURCHASE AGREEMENT (the “ Agreement ”) is
entered into as of December 1, 2006 (the “ Signing
Date ”) by and between Sangamo BioSciences, Inc., a
Delaware corporation (“ Sangamo ”) and
Edwards Lifesciences LLC, a Delaware limited liability company
(“ Edwards ”). Sangamo and Edwards are
referred to individually as a “ Party ”
and collectively as the “ Parties
.”
WHEREAS, Sangamo
and Edwards are parties to the License Agreement (defined below)
and the Research Funding Agreement (defined below);
WHEREAS, the
Parties now desire to terminate the License Agreement and their
respective obligations under the Research Funding Agreement;
and
WHEREAS, Edwards
desires to transfer to Sangamo, in some cases, and revert back to
Sangamo, in other cases, and Sangamo desires to acquire from
Edwards, Edwards’ right, title and interest in and to
Edwards’ assets relating to the Products (defined below), as
more specifically set forth below.
NOW, THEREFORE, in
consideration of the foregoing recitals and the mutual covenants
and agreements contained in this Agreement, the Parties hereby
agree as follows:
The following
terms, when capitalized, shall have the following meanings (such
meanings to be equally applicable to both the singular and plural
forms of the terms defined) as used in this Agreement:
1.1
“ Assets ” has
the meaning set forth in Section 3.1.
1.2
“ Affiliate(s) ”
means, with respect to any person, any person which, directly or
indirectly through the ownership of equity securities or through
other arrangements, either controls, is controlled by or is under
common control with, such person. A person shall be deemed to be in
control of another entity if it owns or controls at least fifty
percent (50%) of the equity securities of the subject entity
entitled to vote in the election of directors (or, in the case of
an entity that is not a corporation, for the election of the
corresponding managing authority); provided , however
, that a person shall not be deemed to be in control of an entity
in which a person owns a majority of the ordinary voting power to
elect a majority of the board of directors or other governing board
but is restricted from electing such majority by contract or
otherwise, until such time as such restrictions are no longer in
effect.
1.3
“ Assigned Copyrights
” has the meaning set forth in
Section 3.1(a)(iii).
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1.4
“ Assigned Data
” has the meaning set forth in
Section 3.1(b).
1.5
“ Assigned Equipment
” has the meaning set forth in
Section 3.1(j).
1.6
“ Assigned Government
Licenses ” has the meaning set forth in
Section 3.1(f).
1.7
“ Assigned Intellectual
Property ” has the meaning set forth in
Section 3.1(a).
1.8
“ Assigned Know-How
” has the meaning set forth in
Section 3.1(a)(ii).
1.9
“ Assigned Materials
” has the meaning set forth in
Section 3.1(c).
1.10
“ Assigned Patent Rights ”
has the meaning set forth in Section 3.1(a)(i).
1.11
“ Assigned Trademarks ” has
the meaning set forth in Section 3.1(a)(iv).
1.12
“ Assumed Contracts ” has
the meaning set forth in Section 3.1(h).
1.13
“ Assumed Liabilities ” has
the meaning set forth in Section 3.3(b).
1.14
“ Assumption Agreement ” has
the meaning set forth in Section 6.6(c).
1.15
“ Breach ” means, with
respect to a representation, warranty, covenant, obligation or
other provision, an inaccuracy in or breach (including any
inadvertent or innocent breach) of, or any failure (including any
inadvertent failure) to comply with or perform, such
representation, warranty, covenant, obligation or other
provision.
1.16
“ Claim Notice ” has the
meaning set forth in Section 11.1(c).
1.17
“ Clinical Trial ” means a
clinical trial conducted by or on behalf of Edwards or its
Affiliates or pursuant to an Edwards Contract, in each case in
which a Product is administered to a human.
1.18
“ Clinical Trial Materials ”
means all Products and placebo for the Products manufactured by or
on behalf of Edwards or its Affiliates that are for use in
preclinical studies or Clinical Trials primarily relating to the
Products, whether in bulk, formulated or finished form and whether
in existence on the Signing Date or manufactured between the
Signing Date and Closing Date.
1.19
“ Clinical Trial Study Reports
” means all reports or summaries of all data, records and
documents resulting from the Clinical Trials.
1.20
“ Closing ” means the
closing of the transactions contemplated by this
Agreement.
1.21
“ Closing Date ” means the
date on which the Closing shall take place at the Palo Alto office
of Cooley Godward Kronish LLP, commencing at 10:00 a.m. local
time, which date shall be the earliest of: (a) one
(1) business day after the date on which the last of the
conditions specified in Article 10 to be satisfied or waived
has been satisfied or waived, (b) the date specified in
Sangamo’s written notice to the Escrow Agent pursuant to
Section 10.3, or (c) such other date as the Parties may agree
upon in writing.
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1.22
“ Common Stock ” means the
common stock, par value $0.01 per share, of Sangamo.
1.23
“ Company ” means Sangamo
for the purposes of Section 5.2.
1.24
“ Confidential Information ”
means all proprietary and confidential information, including
Know-How, disclosed by one Party to the other Party pursuant to, or
in connection with this Agreement, the License Agreement or the
Research Funding Agreement, including any information disclosed in
contemplation of this Agreement prior to the Closing Date,
regardless of the form or manner of disclosure. “Confidential
Information” shall not include information: (a) of which
the Party receiving such information was rightfully in possession
prior to disclosure, as evidenced by appropriate contemporaneous
documentation; (b) that was independently developed by
employees or agents of the Party receiving the information without
the benefit of Confidential Information provided by the Party
disclosing the information, as evidenced by appropriate
contemporaneous documentation; (c) that the Party receiving
the information rightfully receives from a Third Party not owing a
duty of confidentiality to the Party disclosing the information;
(d) that is or becomes publicly available without fault of the
Party receiving the information; (e) that is published
incident to patent application prosecution; or (f) that the
Parties agree in writing will not be treated as Confidential
Information.
1.25
“ Contract ” means any
written, oral, implied or other agreement, contract, understanding,
arrangement, instrument, note, guaranty, indemnity, representation,
warranty, deed, assignment, power of attorney, certificate,
purchase order, work order, insurance policy, benefit plan,
commitment, covenant, assurance or undertaking of any
nature.
1.26
“ Damages ” means any loss,
damage, injury, decline in value, Liability, claim, demand,
settlement, judgment, award, fine, penalty, Tax, fee (including any
reasonable legal fee, expert fee, accounting fee or advisory fee),
charge, cost (including any reasonable cost of investigation) or
expense of any nature.
1.27
“ Dispute ” means any claim,
dispute or controversy of whatever nature arising out of or
relating to this Agreement, including the performance or alleged
non-performance of a Party of its obligations under this
Agreement.
1.28
“ Edwards Confidential Information
” means (a) all Confidential Information disclosed by
Edwards to Sangamo, except for the Assigned Patent Rights, Assigned
Know-How, Assigned Data, Assigned Materials, Clinical Trial
Materials, Technical Documents, Government Files and Financial
Materials, and (b) the terms of this Agreement, the License
Agreement and the Research Funding Agreement.
1.29
“ Edwards Contracts ” means
the Contracts listed on Schedule [1.29] .
1.30
“ Edwards Indemnitees ”
means the following Persons: (a) Edwards;
(b) Edwards’ current and future Affiliates; (c) the
respective Representatives of the Persons referred to in clauses
“(a)” and “(b)” above; and (d) the
respective successors and assigns of the Persons referred to in
clauses “(a)”, “(b)” and “(c)”
above.
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1.31
“ Encumbrance ” means any
lien, pledge, hypothecation, charge, mortgage, security interest,
encumbrance, equitable interest, claim, lease, license, covenant,
infringement, interference, order, right of first refusal,
reservation, limitation, impairment, imperfection of title, and
condition or restriction of any nature that has an adverse effect
on the title, ownership, possession, use, exercise or transfer of
any asset, including any restriction on the receipt of any income
derived from any asset; except Permitted Encumbrances and any of
the foregoing or other matters, individually or in the aggregate,
that are not materially adverse to, or materially interfere with,
the use of the asset as they are currently or contemplated to be
used or their adequacy for such use.
1.32
“ Entity ” means any
corporation (including any non-profit corporation), general
partnership, limited partnership, limited liability partnership,
joint venture, estate, trust, cooperative, foundation, society,
political party, union, company (including any limited liability
company or joint stock company), firm or other enterprise,
association, organization or entity.
1.33
“ Escrow Account ” has the
meaning set forth in Section 2.1.
1.34
“ Escrow Agent ” has the
meaning set forth in Section 2.1.
1.35
“ Escrow Agreement ” has the
meaning set forth in Section 2.1.
1.36
“ Escrowed Agreements ” has
the meaning set forth in Section 2.1.
1.37
“ Excluded Assets ” has the
meaning set forth in Section 3.2.
1.38
“ Exchange Act ” means the
Securities Exchange Act of 1934, as amended.
1.39
“ FDA ” means the United
States Food and Drug Administration, or any successor agency
thereto.
1.40
“ FDA Transfer Letter ” has
the meaning set forth in Section 6.8(b).
1.41
“ Financial Materials ” has
the meaning set forth in Section 3.1(i).
1.42
“ GAAP ” means United States
generally accepted accounting principles.
1.43
“ Government Files ” means
any filings made by or on behalf of Edwards or its Affiliates with
any Governmental Authority with respect to the IND or primarily
related to any Product.
1.44
“ Government License ” means
a regulatory approval or license, or investigational applications,
issued, granted, allowed or given by or under the authority of any
Governmental Authority or pursuant to any law, rule or regulation
throughout the Territory and required for, and used primarily in
connection with, the clinical testing in humans of the Product
anywhere in the Territory. For clarity, the IND shall constitute a
Government License.
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1.45
“Governmental Authority ”
means any United States, state, local or foreign governmental
entity or municipality or subdivision thereof or any authority,
department, commission, board, bureau, agency, court or
instrumentality.
1.46
“ IND ” has the meaning set
forth in Section 6.8(b).
1.47
“ Indemnitee ” means either
Sangamo Indemnitee or Edwards Indemnitee, as applicable.
1.48
“ IRB ” means an
institutional review board.
1.49
“ Key Employees ” has the
meaning set forth in Section 6.5.
1.50
“ Know-How ” means all
non-publicly available knowledge, data (including pharmacological,
toxicological, preclinical and clinical test data, and analytical
and quality control data), information, assay protocols, methods,
results or ideas that (a) is necessary to research, develop or
manufacture a Product, (b) was made, conceived or reduced to
practice pursuant to the License Agreement, in the course of
manufacturing a Product or pursuant to a Clinical Trial, or
(c) was used by or on behalf of Edwards or its Affiliates
prior to the Closing Date in the course of researching, developing,
or manufacturing a Product.
1.51
“ Know-How Transfer ” has
the meaning set forth in Section 6.4.
1.52
“ Knowledge of Edwards ”
means the actual knowledge of the individuals listed on Schedule
[1.52] .
1.53
“ Knowledge of Sangamo ”
means the actual knowledge of the individuals listed on Schedule
[1.53] .
1.54
“ Legal Requirement ” means
any federal, state, local, municipal, foreign or other law,
statute, legislation, constitution, ordinance, code, edict, decree,
proclamation, treaty, convention, rule, regulation, ruling,
directive, pronouncement, determination, decision, opinion or
interpretation issued, enacted, adopted, passed, approved,
promulgated, made, implemented or otherwise put into effect by or
under the authority of any Governmental Authority.
1.55
“ Liability ” means any
debt, obligation, duty or liability of any nature (including any
unknown, undisclosed, unmatured, unaccrued, unasserted, contingent,
indirect, conditional, implied, vicarious, derivative, joint,
several or secondary liability), regardless of whether such debt,
obligation, duty or liability would be required to be disclosed on
a balance sheet prepared in accordance with GAAP and regardless of
whether such debt, obligation, duty or liability is immediately due
and payable.
1.56
“ License Agreement ” means
that certain License Agreement by and between Sangamo and Baxter
Healthcare Corporation (Edwards’ predecessor in interest),
dated as of January 11, 2000, including all amendments
thereto.
1.57
“ Mutual Release Agreement ”
has the meaning set forth in Section 2.1.
5
1.58
“ Net Sales ” means the
gross sales price of a Royalty Product sold by Sangamo, its
Affiliates, sublicensees or assignees of the Sangamo IP (or
Affiliates of such sublicensees or assignees) to a Third Party,
less the following to the extent borne by the seller and not taken
into account in determining gross sales price: (a) deduction
of cash, trade and quantity discounts actually given;
(b) discounts, refunds, rebates, chargebacks, retroactive
price adjustments, and any other allowances actually given which
effectively reduce the net selling price, including institutional
rebates or discounts such as those actually provided to Medicare,
Medicaid, the Department of Defense or any similar organization in
the United States or otherwise; and (c) credits and allowances for
product returns actually made; (d) any other adjustments
required by generally accepted accounting principles in the United
States. Net Sales shall exclude samples distributed in the usual
course of business. In the event a Royalty Product is sold as a
part of a combined product that contains other active
ingredient(s), Net Sales shall be calculated by multiplying the Net
Sales of the combined product by the fraction A over B, in which A
is the sales price of the Royalty Product portion of the combined
product when such Royalty Product is sold separately, and B is the
sales price of the combined product. In the event that there is no
separate sales price of the Royalty Product, Net Sales allocable to
the Royalty Product shall be reasonably and mutually determined by
Sangamo and Edwards.
1.59
“ Patent ” means all United
States patents, applications for patents, including any
divisionals, continuations, continuations-in-part (to the extent
claiming subject matter disclosed in the parent application),
continued prosecution applications, provisional applications for
patent, and any patents issuing therefrom, and any reexaminations,
reissues, extensions, and patent term restorations and any foreign
equivalents thereof filed anywhere in the Territory.
1.60
“ Permitted Encumbrances ”
means (a) Encumbrances for Taxes not yet due and payable or
that are being contested in good faith by appropriate proceedings,
(b) any mechanics’, carriers’, workmen’s,
repairmen’s or other similar liens arising or incurred in the
ordinary course of business, and (c) any liens arising under
original purchase price, conditional sales contracts and equipment
leases with Third Parties entered into in the ordinary course of
business.
1.61
“ Person ” means any
individual, Entity or Governmental Authority.
1.62
“ Product ” means a pharmaceutical
product that comprises zinc finger DNA binding proteins or nucleic
acids that encode zinc finger DNA binding proteins for the
activation of VEGF genes or VEGF receptors. For the avoidance of
doubt, a pharmaceutical product shall not be Product if the zinc
finger DNA binding protein contained in or encoded by such product
primarily targets and activates a gene other than VEGF or a VEGF
receptor.
1.63
“ RAC ” means the
Recombinant DNA Advisory Committee of the National Institutes of
Health, or any successor thereto.
1.64
“ Register ”, “
registration ”, and “
registered ” refers to a registration effected
by preparing and filing a registration statement in compliance with
the Securities Act, and the declaration or ordering of
effectiveness of such registration statement.
1.65
“ Registrable Securities ”
means any and all of the Shares issued to Edwards hereunder;
provided , however , that such term shall not include
any shares of Common Stock which have been previously registered or
which have been sold to the public either pursuant to a
registration statement or Rule 144.
6
1.66
“ Regulatory Approval ”
means all approvals (including pricing and reimbursement
approvals), product and/or establishment licenses, registrations or
authorizations of any regional, federal, state or local regulatory
agency, department, bureau or other governmental entity, necessary
for the sale of Products in a regulatory jurisdiction.
1.67
“ Related Party ” means each
of the following: (a) each individual who is, or who has at
any time been, an officer of Edwards; (b) each member of the
family of each of the individuals referred to in clause
“(a)” above; and (c) any Entity (other than
Edwards) in which any one of the individuals referred to in clauses
“(a)” and “(b)” above holds or held (or in
which more than one of such individuals collectively hold or held),
beneficially or otherwise, a controlling interest or a material
voting, proprietary or equity interest.
1.68
“ Representatives ” means
officers, directors, employees, agents, attorneys, accountants,
advisors and representatives.
1.69
“ Required Third Party Consent
” has the meaning set forth in
Section 6.6(a).
1.70
“ Research Funding Agreement
” means that certain Research Funding Agreement by and
between Sangamo and Baxter Healthcare Corporation (Edwards’
predecessor in interest), dated as of January 11, 2000, including
all amendments thereto.
1.71
“ Royalty Indication ” means
diabetic neuropathy, intermittent claudication, critical limb
ischemia, ischemic cerebral vascular disease (excluding hemorrhagic
stroke), peripheral artery disease and ischemic heart
disease.
1.72
“ Royalty Product ” means a
Product that is sold in any Territory for treatment of one or more
Royalty Indications.
1.73
“ Rule 144 ” means
Rule 144 as promulgated by the SEC under the Securities Act,
as such Rule may be amended from time to time, or any similar
successor rule that may be promulgated by the SEC.
1.74
“ Sangamo Confidential Information
” means (a) all Confidential Information disclosed by
Sangamo to Edwards pursuant to the License Agreement, Research
Funding Agreement or this Agreement, including Sangamo Materials
and sequence information relating thereto, (b) the terms of
this Agreement, the License Agreement and Research Funding
Agreement, and (c) after the Closing Date, the Assigned Patent
Rights (but only to the extent such Assigned Patent Rights relate
to unpublished patent applications or are otherwise not publicly
available), and that portion of the Assigned Know-How, Assigned
Data, Assigned Materials, Clinical Trial Materials, Technical
Documents, Government Files and Financial Materials that are not
publicly available as of the Signing Date.
1.75
“ Sangamo Indemnitees ”
means the following Persons: (a) Sangamo;
(b) Sangamo’s current and future Affiliates;
(c) the respective Representatives of the Persons referred to
in clauses “(a)” and “(b)” above; and
(d) the respective successors and assigns of the Persons
referred to in clauses “(a)”, “(b)” and
“(c)” above.
7
1.76
“ Sangamo IP ” means any and
all intellectual property rights licensed to Edwards pursuant to
the terms of the License Agreement.
1.77
“ Sangamo Materials ” means
the materials and information transferred to Edwards by Sangamo
under the License Agreement, and all copies, progeny and
derivatives thereof.
1.78
“ Sangamo Party ” has the
meaning set forth in Section 4.2.
1.79
“ Sangamo SEC Documents ”
has the meaning set forth in Section 9.5.
1.80
“ Sausalito Facilities ”
means the leased facility of Edwards located at One Harbor Drive,
Suite 209, Sausalito, California 94965.
1.81
“ SEC ” means the U.S.
Securities and Exchange Commission.
1.82
“ Securities Act ” means the
Securities Act of 1933, as amended.
1.83
“ Shares ” has the meaning
set forth in Section 5.1(a).
1.84
“ Tax ” means any tax
(including any income tax, franchise tax, capital gains tax,
estimated tax, gross receipts tax, value-added tax, surtax, excise
tax, ad valorem tax, transfer tax, stamp tax, sales tax, use tax,
property tax, business tax, occupation tax, inventory tax,
occupancy tax, withholding tax or payroll tax), levy, assessment,
tariff, impost, imposition, toll, duty (including any customs
duty), deficiency or fee, and any related charge or amount
(including any fine, penalty or interest), that is, has been or may
in the future be (a) imposed, assessed or collected by or
under the authority of any Governmental Authority, or
(b) payable pursuant to any tax-sharing agreement or similar
Contract.
1.85
“ Technical Documents ”
means all scientific and technical information and documentation
that is primarily related to the research, development or
manufacture of any Product and that is in embodied in documents or
computer files owned or controlled by Edwards or its Affiliates as
of the Closing Date or during the Transition Period, including:
laboratory notebooks, technical documentation, manufacturing
documentation, quality records, specifications, data, vector maps,
protocols, manuals, reference materials, and application notes;
detailed restriction maps and complete sequence information for
each plasmid and nucleic acid included in the Assigned Materials;
full descriptions of all cell lines included in the Assigned
Materials; detailed cell transfection protocols; protocols for
administering Product to humans, animals or cells; protocols
detailing methods, assays, processes, and procedures (including
standard operating procedures) for manufacturing or testing any
Product.
1.86
“ Termination Agreement ”
has the meaning set forth in Section 2.1.
1.87
“ Territory ” means all
countries of the world.
8
1.88
“ Third Party ” means any
person or entity other than Sangamo or Edwards and their respective
Affiliates.
1.89
“ Transactional Agreements ”
means the Assumption Agreement, the Mutual Release Agreement, the
Termination Agreement and the Escrow Agreement.
1.90
“ Transition Period ” means
the period from the Signing Date through the Closing
Date.
1.91
“ VEGF ” means vascular
endothelial growth factors.
2.1
Signing Date . On the Signing Date,
each Party shall duly execute the Termination Agreement, Mutual
Release Agreement, Assumption Agreement and FDA Transfer Letter, in
the forms attached hereto as Exhibits A , B ,
C and D , respectively (the “ Escrowed
Agreements ”), and shall deposit the executed
Escrowed Agreements into an escrow account (the “
Escrow Account ”) to be held and distributed by
the escrow agent (the “ Escrow Agent ”)
on the Closing Date in accordance with the terms of the Escrow
Agreement dated as of the Signing Date by and among the Parties and
the Escrow Agent, in the form attached hereto as
Exhibit E (the “ Escrow Agreement
”). In addition, on the Signing Date, Sangamo shall deposit
the Shares into the Escrow Account pursuant to Section 5.1 of
this Agreement.
PURCHASE AND SALE OF
ASSETS
3.1
Purchase and Sale of Assets .
Subject to the terms and conditions set forth herein, on the
Closing Date, Edwards shall sell, assign, transfer, convey, grant
and deliver to Sangamo, and Sangamo shall purchase, acquire and
receive from Edwards, good and valid title and all other rights and
interests in and to the Assets, free and clear of any Encumbrances.
For purposes of this Agreement, “ Assets
” means the following assets:
(a) Intellectual Property .
(i) Patent Rights . All Patents
listed on Schedule 3.1(a)(i) (collectively, the “
Assigned Patent Rights ”).
(ii) Know-How . All Know-How owned by
Edwards or its Affiliates as of the Closing Date that is primarily
related to a Product (collectively, the “ Assigned
Know-How ”).
(iii) Assigned Copyrights and Other Related
Proprietary Rights . All copyrights, copyright registrations or
copyright applications listed on Schedule 3.1(a)(iii)
(collectively, the “ Assigned Copyrights
”).
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(iv) Trademarks . All trademarks, design marks,
service marks, trade names and trade dress (including registrations
and applications for the foregoing) listed on
Schedule 3.1(a)(iv) (collectively, the “
Assigned Trademarks ”).
The Assigned
Patent Rights, Assigned Know-How, Assigned Copyrights and Assigned
Trademarks shall be referred to collectively as the “
Assigned Intellectual Property .”
(b) Data . All data (including raw data, data
files and summaries, including the Clinical Trial Study Reports)
owned by Edwards or its Affiliates as of the Closing Date that were
generated in the course of a Clinical Trial or other research on or
testing of any Product by or on behalf of Edwards or its Affiliates
(collectively, the “ Assigned Data
”).
(c) Materials . All biological or chemical
materials (including DNA, RNA, plasmids, vectors, cell lines,
proteins, antibodies, assays, poloxymers) owned by Edwards or its
Affiliates as of the Closing Date which (i) have been used by
Edwards or its Affiliates during the term of the License Agreement
primarily in the research, development or manufacture of the
Products, but excluding all non-proprietary materials, such as
reagents and other consumables that are generally available; or
(ii) have been derived from any Sangamo Materials and any and
all progeny, derivatives, replications, variants, and recombinants
thereof, including those generated by recombinant genetic
engineering methods (collectively, “ Assigned
Materials ”).
(d) Clinical Trial Materials . All Clinical
Trial Materials owned by Edwards or its Affiliates as of the
Closing Date.
(e) Technical Documents . All Technical
Documents owned by Edwards or its Affiliates as of the Closing
Date.
(f) Government Licenses . All Government
Licenses owned by Edwards or its Affiliates on the Closing Date and
all applications therefor and related correspondence (collectively,
the “ Assigned Government Licenses
”).
(g) Government Files . All Government Files
owned by Edwards or its Affiliates on the Closing Date.
(h) Contracts . All rights of Edwards or its
Affiliates under the Edwards Contracts listed on
Schedule 3.1(h) (the “ Assumed
Contracts ”).
(i) Financial Materials . Any and all copies
owned by Edwards or its Affiliates as of the Closing Date of final
market research analyses prepared on behalf of Edwards or its
Affiliates, relating primarily to the Products (collectively, the
“Financial Materials” ).
(j) Personal Property . All personal property
physically located at the Sausalito Facilities, including
equipment, owned by Edwards on the Closing Date and used by or on
behalf of Edwards solely with respect to the Product (the “
Assigned Equipment ”).
3.2
Excluded Assets . Anything in
Section 3.1 to the contrary notwithstanding, the Assets do not
include any assets, rights or interests of Edwards (collectively,
the “ Excluded Assets ”) not specifically
set forth in Section 3.1, including:
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(a) Contracts or agreements with any Third
Party that are not Assumed Contracts;
(b) Edwards facilities that are not Sausalito
Facilities;
(c) Employment agreements;
(d) Intellectual property and rights thereto
that were developed, conceived, reduced to practice or otherwise
acquired prior to the date of the License Agreement or, except as
described in Section 7.5, that are developed, conceived,
reduced to practice or otherwise acquired after the Closing
Date;
(e) Corporate records (formation documents,
stock records, board resolutions and minutes, and the like);
and
(f) laboratory and refrigerated storage
equipment at Edwards’ facilities located in Irvine,
California.
3.3
Assumed Liabilities .
(a) Other than as specifically set forth in
this Section 3.3, Sangamo shall not assume any Liabilities of
Edwards whatsoever, whether relating to the Assets or
otherwise.
(b) Notwithstanding Section 3.3(a), at and
following the Closing Date, Sangamo shall assume and agree to
honor, pay and discharge when due the following Liabilities of
Edwards (the “ Assumed Liabilities
”):
(i) all Liabilities of Edwards
under the Assumed Contracts to be performed on or after, and in
respect of periods following, the Closing Date;
(ii) all Liabilities of Edwards under the
Assigned Government Licenses to be performed on or after, and in
respect of periods following, the Closing Date; and
(iii) all other Liabilities arising out of or
related to the Assets, in respect of periods following the Closing
Date;
provided , however , that notwithstanding the
foregoing, and notwithstanding anything to the contrary contained
in this Agreement, the Assumed Liabilities shall be limited to
Liabilities that:
(1) arise on or after the Closing
Date;
(2) do not arise from or relate to
any Breach by Edwards of any provision of any of the Assumed
Contracts; or
(3) do not arise from or relate to
any event, circumstance or condition occurring or existing on or
prior to the Closing Date that, with notice or lapse of time, would
constitute or result in a Breach of any of the Assumed
Contracts.
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3.4
Taxes . Edwards and Sangamo shall each bear and
pay one-half of any sales taxes, use taxes, transfer taxes,
documentary charges, filing fees, recording fees or similar taxes,
charges, fees or expenses that may become payable in connection
with the sale of the Assets to Sangamo. The Parties shall
reasonably cooperate to file all requests for certifications of
sales and use tax due, including pursuant to Section 6812 of
the California Revenue and Taxation Code.
3.5
Allocation . As soon as reasonably
practicable after the Signing Date, but in any event prior to the
Closing Date, the Parties shall prepare and mutually agree to a
statement setting forth the Parties’ determination of the
manner in which the consideration paid by Sangamo with respect to
the Assets is to be allocated among the Assets, which statement
shall be attached hereto as Schedule 3.5 . The
allocation prescribed by such statement shall be conclusive and
binding upon the Parties for all purposes. The Parties shall not
file any Tax Return or other document with, or make any statement
or declaration to, any Governmental Authority that is inconsistent
with such allocation.
INTELLECTUAL PROPERTY
RIGHTS
4.1
Trademarks . Edwards shall not
adopt, use or register any trademark or service mark confusingly
similar to any Assigned Trademark, in any context on the Internet
or elsewhere in any country.
4.2
Edwards Covenant Not to Assert .
Edwards agrees, effective as of the Closing Date, that neither it
nor any of its Affiliates (and in each case such entity’s
successor or assign) shall assert or enforce against Sangamo, its
Affiliates, or any licensee, sublicensee, manufacturer or
distributor (and in each case such entity’s successor or
assign) (each a “ Sangamo Party ”), any
intellectual property owned by or exclusively licensed to Edwards
or its Affiliates as of the Closing Date that would be infringed,
misappropriated or otherwise violated by any Sangamo Party’s
manufacture, use, development, import, offer for sale, or sale of
the Products within the Territory. The Parties acknowledge and
agree that the covenant set forth in this Section 4.2 shall be
limited to the Products and shall not, under any circumstances,
extend to any medical devices including, catheters or delivery
systems, whether or not sold in combination with the
Products.
(a) As partial consideration for the sale,
assignment, transfer, conveyance, grant and delivery by Edwards of
the Assets, the other rights and licenses granted by Edwards
hereunder, and the covenants, agreements and releases made by
Edwards, all to or in favor of Sangamo, and in addition to assuming
the Assumed Liabilities, Sangamo shall issue and deliver to Edwards
1,000,000 shares of Common Stock (the “ Shares
”) as follows: On the Signing Date, Sangamo shall deposit the
Shares into the Escrow Account, to be held and distributed by the
Escrow Agent to Edwards on the Closing Date in accordance with the
terms of the Escrow Agreement.
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(b) Edwards understands that the Shares issued
pursuant to Section 5.1(a) will not have been registered under
the Securities Act nor qualified under the blue sky laws of any
state, and that the Shares are being offered and sold to Edwards
pursuant to an exemption from such registration and qualification
based in part upon the representations of Edwards contained herein.
Edwards acknowledges the certificate representing the shares shall
contain an appropriate legend regarding the foregoing. Edwards
acknowledges and agrees with Sangamo that it is acquiring the
Shares for investment for its own account and not with a view to,
or for resale in connection with, the distribution or other
disposition thereof in violation of applicable securities
laws.
(c) Edwards represents and warrants to Sangamo
that it is an “accredited investor,” as defined in
Rule 501 under the Securities Act, and has such knowledge and
experience in financial and business matters that it is capable of
evaluating the merits and risks of an investment such as the
Shares.
(d) Edwards acknowledges to Sangamo that it is
fully aware of the applicable transfer restrictions of the Shares.
Edwards understands that there are substantial risks pertaining to
the making of an investment in the Shares hereunder.
5.2
Registration Rights .
(a) Form S-3 Registrations . In case the
Company shall receive from Edwards a written request that the
Company effect a registration statement on Form S-3 with respect to
all or a part of the Registrable Securities, the Company shall use
commercially reasonable efforts to file, as soon as practicable but
not later than twenty (20) business days from the date of
receipt by the Company of the Notice of Registration (as defined
below), with the SEC a registration statement on Form S-3 covering
the resale of such Registrable Securities in a manner consistent
with the method or plan of distribution requested and shall use
commercially reasonable effort to cause such Registration Statement
to be declared effective by the SEC as soon as practicable. Any
request for such registration by Edwards (a “ Notice of
Registration ”) shall specify (i) the amount of
Registrable Shares proposed to be registered; and (ii) the
intended method or methods and plan of distribution thereof. In
addition, Edwards shall provide to the Company all information and
materials reasonably requested by the Company in order to permit
the Company to comply with all applicable SEC requirements. The
Company shall not be obligated to file or effect any such
registration pursuant to this Section 5.2(a):
(i) if Form S-3 is not available
for such offering;
(ii) if Edwards proposes to sell less
than 200,000 shares of Registrable Securities and such other
securities (if any);
(iii) if the request is made by Edwards prior
to six (6) months after the Closing Date;
(iv) if the Company has, within the
twelve (12) month period preceding the date of such request,
already effected one (1) registration on Form S-3 for Edwards
pursuant to this Section 5.2(a);
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(v) for any Registrable Securities
that have been sold to the public;
(vi) if all the Registrable Securities
are eligible for resale during a three (3) month period
pursuant to Rule 144 under the Securities Act;
(vii) if the sale of Registrable Securities
pursuant to the method and plan of distribution requested in the
Notice of Registration is not permissible under applicable law and
the requirements of the Form S-3; or
(viii) in any particular jurisdiction in which
the Company would be required to qualify to do business or to
execute a general consent to service of process in effecting such
registration, qualification or compliance.
(b) Suspension of Registration Rights .
Notwithstanding anything to the contrary contained herein, the
Company shall not be obligated to file or effect the Registration
Statements, or to file any amendment or supplement thereto, and may
suspend the right of Edwards to make sales pursuant to an effective
Registration Statement, at any time when the filing thereof at the
time requested, or the offering of securities pursuant thereto,
(i) would, in the good faith judgment of the Company and its
counsel, materially and adversely affect a pending or proposed
acquisition, merger, recapitalization, consolidation,
reorganization, joint venture, divestiture, tender offer, financing
or similar transaction of the Company or one of its Affiliates, or
negotiations, discussions or pending proposals related thereto or
(ii) would materially and adversely impact the Company and its
Affiliate, including by requiring, in the good faith judgment of
the Company and its counsel, the disclosure of an event or state of
facts relating to the Company or its Affiliates which is material
to the Company and the disclosure of which could be adverse to the
Company, provided that the Company may not suspend the
rights to make sales pursuant to this Section 5.2(b) for more than
an aggregate of ninety (90) days, and provided
further that Sangamo shall not defer its obligation in this
manner more than twice in any twelve (12) month
period.
(c) Expenses . All expenses incurred in
connection with a registration pursuant to Section 5.2(a),
including all registration, filing and qualification fees,
printers’ and accounting fees, fees and disbursements of
counsel for the Company, and the reasonable fees and disbursements
of one counsel for Edwards (but excluding underwriters’
discounts and commissions), shall be borne by the Company. Edwards
shall bear all discounts, commissions or other amounts payable to
underwriters or brokers in connection with such
offering.
(d) Obligations of the Company . Whenever
required to effect the registration of any Registrable Securities
under this Agreement, the Company shall use commercially reasonable
efforts to do the following as expeditiously as reasonably
possible:
(i) Prepare and file with the SEC a
registration statement with respect to such Registrable Securities
and cause such registration statement to become effective, and,
upon the request of Edwards, keep such registration statement
effective for up to ninety (90) days.
(ii) Prepare and file with the SEC such
amendments and supplements to such registration statement and the
prospectus used in connection with such registration statement as
may be necessary to comply with the provisions of the Securities
Act with respect to the disposition of all securities covered by
such registration statement.
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(iii) Furnish to Edwards such number of copies
of prospectus, including a preliminary prospectus, in conformity
with the requirements of the Securities Act, and such other
documents as Edwards may reasonably request in order to facilitate
the disposition of Registrable Securities owned by it that are
included in such registration.
(iv) Use reasonable efforts to register
and qualify the securities covered by such registration statement
under such other securities or Blue Sky laws of such jurisdictions
as shall be reasonably requested by the Edwards, provided
that the Company shall not be required in connection therewith or
as a condition thereto to qualify to do business or to file, a
general consent to service of process in any such states or
jurisdictions.
(v) Notify Edwards at any time when
a prospectus relating thereto is required to be, delivered under
the Securities Act of the happening of any event as a result of
which the prospectus included in such registration statement, as
then in effect, includes an untrue statement of a material fact or
omits to state a material fact required to be stated therein or
necessary to make the statements therein not misleading in the
light of the circumstances then existing.
(vi) If the registration of Registrable
Securities covers an underwritten offering, furnish, at the request
of Edwards, on the date that such Registrable Securities are
delivered to the underwriters for sale (1) an opinion, dated
as of such date, of the counsel representing the Company for the
purposes of such registration, in form and substance as is
customarily given to underwriters in an underwritten public
offering and reasonably satisfactory to the lead underwriter,
addressed to the underwriters and (2) a “comfort”
letter dated as of such date, from the independent certified public
accountants of the Company, in form and substance as is customarily
given by independent certified public accountants to underwriters
in an underwritten public offering and reasonably satisfactory to
the lead underwriter, addressed to the underwriters.
(e) Rule 144 Reporting . With a view to
making available the benefits of certain rules and regulations of
the SEC which may at any time permit the sale of Registrable
Securities to the public without registration, after such time as a
public market exists for the Common Stock of the Company, the
Company agrees to:
(i) Make and keep public
information available, as those terms are understood and defined in
Rule 144 under the Securities Act;
(ii) Use reasonable, diligent efforts to
file with the SEC in a timely manner all reports and other
documents required of the Company under the Securities Act and the
Exchange Act; and
(iii) So long as Edwards owns any Registrable
Securities, to furnish to Edwards forthwith upon request a written
statement by the Company as to its compliance with the reporting
requirements of said Rule 144, and of the Securities Act and
the Exchange Act, a copy of the most recent annual or quarterly
report of the Company, and such other reports and documents of the
Company as Edwards may reasonably request in availing itself of any
rule or regulation of the SEC allowing Edwards to sell any such
securities without registration.
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(a) As additional partial consideration for the
sale, assignment, transfer, conveyance, grant and delivery by
Edwards of the Assets, the other rights and licenses granted by
Edwards hereunder, and the covenants, agreements and releases made
by Edwards, all to or in favor of Sangamo, and in addition to
assuming the Assumed Liabilities, subject to the terms and
conditions of this Agreement, Sangamo shall pay Edwards a royalty
equal to:
(i) Five percent (5%) of the Net
Sales of each Royalty Product sold by Sangamo or its Affiliate for
use in a Royalty Indication; and
(ii) The greater of (i) five percent
(5%) of the Net Sales of each Royalty Product sold by a sublicensee
for use in a Royalty Indication or (ii) twenty-five percent
(25%) of the royalty payment received by Sangamo from its
sublicensee on account of a Royalty Product sold by such
sublicensee for use in a Royalty Indication.
(b) The parties acknowledge and agree that,
with respect to any unit of Royalty Product sold for use in a
Royalty Indication, Sangamo shall only owe royalties pursuant to
Section 5.3(a)(i) or Section 5.3(a)(ii), but not
both.
(c) Subject to this Section 5.3 and
Section 5.4, the royalty obligations of Sangamo and its
Affiliates, sublicensees and successors in interest set forth in
Section 5.3(a) shall be perpetual and apply to the
Territory.
(d) Each Product sold by Sangamo or its
Affiliate or sublicensee in a particular country shall be presumed
to be sold for the indication(s) for which it has received
Regulatory Approval in such country. Such presumption may be
overcome if a Party, at its sole expense, procures and provides the
other Party with commercially reasonable evidence of off-label
sales of such Product in such country during the relevant period.
Written notice and evidence shall be promptly provided to the other
Party upon learning of any such off-label sales of the Product.
Such evidence shall be based upon prescription data products or
services or other relevant pharmaceutical sales tracking research
services (including, for example, use of random sampling, use of
data regarding distribution channels as a proxy for
indication-specific sales and development of mathematical models
for approximating indication-specific sales) generally recognized
in the pharmaceutical industry as being reliable in the tracking of
sales of pharmaceutical products of similar nature and prescribed
by similar physicians. For example, if Edwards timely provides
Sangamo with such commercially reasonable evidence that twenty
percent (20%) of Sangamo’s sales in the United States in a
particular calendar quarter, of a Product that has only been
approved for indications that are not Royalty Indications, are sold
for use in a Royalty Indication, then Sangamo shall pay royalties
pursuant to Section 5.3(a)(i) with respect to such twenty
percent (20%) of such sales by Sangamo with respect to that
particular Product in the United States during such calendar
quarter.
5.4
Maximum Royalties . The total
royalties paid by Sangamo pursuant to Section 5.3 shall not
exceed:
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(a) $20,000,000 in any calendar year;
or
(b) $100,000,000 in the aggregate.
Sangamo’s
obligation to make royalty payments to Edwards shall terminate with
respect to a particular calendar year once Sangamo has paid Edwards
$20,000,000 in royalties pursuant to Section 5.3 with respect to
such calendar year. Sangamo shall not have any further obligation
to make royalty payments to Edwards once Sangamo has paid Edwards a
total of $100,000,000 in royalties pursuant to Section 5.3
during the term of this Agreement.
5.5
Royalty Reports and Payments .
Within sixty (60) days after the end of each calendar quarter
prior to the termination of Sangamo’s royalty obligations
pursuant to Section 5.4(b), Sangamo shall deliver to Edwards a
true and accurate report of Net Sales of Product sold by Sangamo
and its Affiliates and sublicensees (to the extent that Sangamo has
such sublicensee information, provided that Sangamo shall
use commercially reasonable efforts to obtain such information, and
while Sangamo may delay payment due to unavailability of
information, it shall nevertheless promptly make payments once such
information is available) during such calendar quarter and the
royalty payments received by Sangamo with respect to
sublicensee’s sales of Royalty Products during such calendar
quarter, accompanied by all royalties due under Section 5.3
for such calendar quarter. In addition, within such sixty
(60) day period after the end of each calendar quarter for
which royalty payments are due pursuant to this Agreement, Sangamo
shall deliver to Edwards a true and accurate true-up report of all
royalty payments not timely made pursuant to
Section 5.3.
5.6
Payment Method . All payments due
to Edwards under this Agreement shall be made by Sangamo in the
United States in U.S. Dollars by wire transfer to a bank account
designated by Edwards.
5.7
Exchange Rate . With respect to
sales of Royalty Products made in a currency other than U.S.
dollars, for the purposes of calculating royalties due under
Section 5.3, Net Sales will be determined in the original
currency and then converted into U.S. dollars based on the rate of
exchange published in the Wall Street Journal for the last business
day in the relevant calendar quarter.
5.8
Withholdings . All taxes,
assessments and fees of any nature levied or incurred on account of
any royalty payments accruing under this Agreement, by national,
state or local governments, will be assumed and paid by Sangamo,
except taxes levied thereon as income taxes to Edwards, and if such
taxes are required to be withheld by Sangamo by the applicable
national, state or local Governmental Authority, then Sangamo shall
deduct such taxes from such payments due to Edwards and shall pay
such taxes on the account of Edwards, and shall secure and provide
to Edwards a receipt of such payment, together with copies of all
pertinent communications from or with such Governmental Authority
with respect thereto. Sangamo agrees to reasonably cooperate with
Edwards in any effort by Edwards in claiming any exemption from
such deductions or withholdings under any double taxation or
similar agreement or treaty from time to time in force and in
minimizing the amount required to be so withheld or
deducted.
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5.9
Records; Audit . Sangamo will
maintain, and cause its Affiliates and sublicensees to maintain,
complete and accurate records of all sales and other dispositions
of Royalty Products prior to the termination of Sangamo’s
royalty obligations pursuant to Section 5.4(b), including the
amounts which are relevant to the calculation of Net Sales under
this Agreement, and such records shall be retained and open during
reasonable business hours for a period of three (3) years from
the creation of individual records for examination or for a longer
period of time, if required by applicable law, and not more often
than once each calendar year, by an independent certified public
accountant that is selected by Edwards and reasonably acceptable to
Sangamo for the sole purpose of verifying the correctnes
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