dated as of September __,
2008
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PAGE
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1
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1
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ARTICLE 2 Purchase and Sale
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5
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2.1 Agreements to Purchase and Sell
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5
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7
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8
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9
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2.5 Procedures for Purchased Assets not
Transferable
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10
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ARTICLE 3 Purchase Price; Bonus; Consistent
Treatment
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10
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3.1 Purchase Price and Bonus
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10
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3.2 Payment of Purchase Price
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10
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10
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11
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11
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4.2 Transactions at Closing
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11
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ARTICLE 5 Representations and Warranties of
Seller
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12
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12
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13
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5.3 Inventory, Equipment and Raw
Materials
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13
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13
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5.5 Intellectual Property
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14
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14
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14
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14
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5.9 Absence of Undisclosed
Liabilities
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14
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5.10 Governmental Authorizations
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14
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14
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15
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15
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5.14 Environmental Matters
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16
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16
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5.16 Regulatory Compliance
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16
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16
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ARTICLE 6 Representations and Warranties of
Buyer
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17
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17
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17
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17
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17
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6.5 Breach of Representations and
Warranties
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17
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17
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6.7 Independent Investigation
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18
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PAGE
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ARTICLE 7 Pre-Closing Covenants of Seller and
Buyer
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18
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7.1 Corporate and Other Actions
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18
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7.2 Consents and Approvals
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18
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7.3 Access to Information
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18
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7.4 Ordinary Course of Business
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18
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19
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8.1 Conditions to Obligations of
Seller
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19
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8.2 Conditions to Obligations of
Buyer
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20
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21
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ARTICLE 9 Post-Closing Covenants, Other
Agreements
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21
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9.1 Availability of Records
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21
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9.2 Use of Trade or Service Marks
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21
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22
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22
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9.5 Post-Closing Delivery
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22
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22
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9.7 Preparation of 2008 Annual Report
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23
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9.8 No Other Compensation
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23
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ARTICLE 10 Indemnification and
Survival
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23
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10.1 Indemnification by Seller
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23
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10.2 Indemnification by Buyer
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24
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25
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25
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10.5 Net Losses and Subrogation
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26
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26
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27
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11.1 Termination of Agreement
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27
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11.2 Automatic Termination
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27
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11.3 Continuing Effectiveness
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27
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27
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27
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12.2 No Press Release Without Consent
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27
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28
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28
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28
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28
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12.7 No Third Party Beneficiaries
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28
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29
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29
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29
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29
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29
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29
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30
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31
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ii
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Exhibit A
– Assignment and Assumption Agreement
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Exhibit B
– Intellectual Property Transfer Agreement
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Exhibit C
– Testing Procedures
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Exhibit D
– Form of Opinion of Seller’s Counsel
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Exhibit E
– Copy of the Notification of Transfer of Ownership directed
to the FDA
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Exhibit F
– Copy of the Seller Insurance Policies
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Exhibit G
– Inventory Trademark License Agreement
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Schedule 2.1(a) – Sales
Materials
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Schedule 2.1(b) – Transferred
Intellectual Property
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Schedule 2.1(c) – Cell
Banks
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Schedule 2.1(d)(i) – Assumed
Contracts
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Schedule 2.1(d)(ii) – Assumed
Liability Contracts
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Schedule 2.1(e) – Other
Inventory
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Schedule 2.1(g) – Seller Labeled
Inventory
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Schedule 2.1(h) – Seller Unlabeled
Inventory
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Schedule 2.1(i) – Product
Information
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Schedule 2.1(j) – Product
Applications
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Schedule 2.1(l) – Raw
Materials
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Schedule 2.1(m) – Product Stability
Samples
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Schedule 2.1(n) –
Equipment
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Schedule 2.3(b) – Channel
Inventory
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Schedule 3.3 – Prorated
Items
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Schedule 4.2(d) – Notification
Contracts
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Schedule 5.5 – Intellectual
Property
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Schedule 5.6 – Litigation
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Schedule 5.7 – Seller
Consents
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Schedule 5.10 -
Governmental
Authorizations
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Schedule 5.14 – Environmental
Matters
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Schedule 5.16 – Regulatory
Compliance
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Schedule 6.3 – Buyer
Consents
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iii
THIS AGREEMENT, dated as of September
_____, 2008 is entered into by and between IMARX
THERAPEUTICS, INC., a Delaware corporation (“ Seller
”), and MICROBIX BIOSYSTEMS INC., a Canadian corporation
(“ Buyer ”).
WHEREAS, Seller wishes to sell to Buyer the
Purchased Assets and Assumed Liabilities (each as defined below),
and Buyer wishes to purchase such assets from Seller and to assume
such liabilities.
NOW, THEREFORE, in consideration of the premises
and mutual covenants, agreements and provisions herein contained,
the parties hereto agree as follows:
1.1 Definitions . The following terms
have the following meanings when used herein:
“ $ ” means United States
dollars.
“ Affiliate ” shall mean a
Person that directly, or indirectly through one or more
intermediaries, controls or is controlled by, or is under common
control with, the Person specified. For purposes of this
definition, the terms “control,” “controlled
by” and “under common control with” shall mean
the possession, directly or indirectly, of the power to direct or
cause the direction of the management or policies of such Person
and, in the case of an entity, shall require (i) in the case
of a corporate entity, direct or indirect ownership of at least a
majority of the securities having the right to vote for the
election of directors, and (ii) in the case of a non-corporate
entity, direct or indirect ownership of at least a majority of the
equity interests with the power to direct the management and
policies of such non-corporate entity.
“ Agreement ” means this
Asset Purchase Agreement, including all Schedules and Exhibits
hereto, as it may be amended from time to time in accordance with
its terms.
“ Assignment and Assumption
Agreement ” means the Assignment and Assumption Agreement
and Bill of Sale in substantially the form attached hereto as
Exhibit A .
“ Assumed Contracts ” has the
meaning set forth in Section 2.1(d)(i) .
“ Assumed Liabilities ” has
the meaning set forth in Section 2.3 .
“ Assumed Liability Contracts
” has the meaning set forth in Section 2.1(d)(ii)
.
“ Bonus ” has the meaning set
forth in Section 3.1 .
“ Buyer ” has the meaning set
forth in the preamble hereto.
“ Cell Banks ” has the
meaning set forth in Section 2.1(c) .
“ cGMP ” means the current
Good Manufacturing Practice requirements promulgated under section
520 of the FDCA.
“ Channel Inventory ” has the
meaning set forth in Section 2.2(e) .
“ Chargeback ” means all
credits, chargebacks, rebates, reimbursements, refund payments or
replacement for returns, administrative fees, and other amounts
owed to wholesalers, insurers, distributors, group purchasing
organizations, insurers, and other institutions pursuant to any
Assumed Liability Contract.
“ Closing ” means the closing
of the purchase and sale of the Purchased Assets and assumption of
the Assumed Liabilities contemplated by this Agreement.
“ Closing Date ” means the
date set forth in Section 4.1 .
“ Confidential Information ”
has the meaning set forth in Section 12.3 .
“ Contracts ” means the
Assumed Contracts and the Assumed Liability Contracts,
collectively.
“ Disclosure Schedules ”
shall mean the schedules attached hereto.
“ Encumbrance ” shall mean
any interest, consensual or otherwise, in property, whether real,
personal or mixed property or assets, tangible or intangible,
securing an obligation owed to, or a claim by a third Person, or
otherwise evidencing an interest of a Person other than the owner
of the property, whether such interest is based on common law,
statute or contract, and including, but not limited to, any
security interest, security title or lien arising from a mortgage,
recordation of abstract of judgment, deed of trust, deed to secure
debt, encumbrance, restriction, charge, covenant, restriction,
claim, exception, encroachment, easement, right of way, license,
permit, pledge, conditional sale, option trust (constructive or
otherwise) or trust receipt or a lease, consignment or bailment for
security purposes and other title exceptions and encumbrances
affecting the property.
“ Environmental Laws ” shall
mean any legal requirement relating to: (i) the protection or
restoration of the environment, health, or natural resources,
(ii) the handling, use, presence, disposal, release or
threatened release of any Hazardous Substance or
(iii) wetlands, indoor air, pollution, contamination or any
injury or threat of injury to persons or property in connection
with any Hazardous Substance.
“ Equipment ” has the meaning
set out in Section 2.1(n) .
“ Excluded Assets ” has the
meaning set out in Section 2.2 .
“ Excluded Liabilities ” has
the meaning set forth in Section 2.4 .
“ FDA ” means the U.S. Food
and Drug Administration.
“ FDCA ” means the Federal
Food, Drug and Cosmetic Act of 1938, as amended.
2
“ Governmental Authorizations
” has the meaning set forth in Section 2.1(f)
.
“ Hazardous Substance ” shall
mean any substance that is (i) listed, classified or regulated
pursuant to any Environmental Law, or (ii) any petroleum
product or by-product, asbestos-containing material,
polychlorinated biphenyls, radioactive materials or
radon.
“ IND 1444 ” means the
investigational new drug application, numbered 1,444, filed with
the FDA.
“ Indemnified Person ” has
the meaning set forth in Section 10.5(a) .
“ Indemnifying Person ” has
the meaning set forth in Section 10.5(a) .
“ Intellectual Property Rights
” means all intellectual property, industrial and other
proprietary rights, protected or protectable, under the laws of the
United States or any other country, or any political subdivision
thereof, including, without limitation, (i) all trade names,
trade dress, trademarks, service marks, logos, brand names and
other identifiers; (ii) copyrights, moral rights (including
rights of attribution and rights of integrity); (iii) all
trade secrets, inventions, discoveries, devices, processes,
designs, techniques, ideas, know-how and other confidential or
proprietary information, whether or not reduced to practice;
(iv) all domestic and foreign patents and the registrations,
applications, renewals, extensions, divisional applications and
continuations (in whole or in part) thereof; and (v) all
goodwill associated therewith and all rights and causes of action
for infringement, misappropriation, misuse, dilution or unfair
trade practices associated with (i) through
(iv) above.
“ Intellectual Property Transfer
Agreement ” means the Intellectual Property Transfer
Agreement in substantially the form attached hereto as
Exhibit B .
“ Inventory ” means the
Labeled Inventory, Other Inventory and Unlabeled Inventory,
collectively.
“ Inventory Trademark License
Agreement ” means the Inventory Trademark License
Agreement in substantially the form attached hereto as
Exhibit G .
“ Knowledge ” means, with
respect to Seller, the actual knowledge after reasonable inquiry of
the persons listed on Schedule 1.1 .
“ Labeled Inventory ” has the
meaning set forth in Section 2.1(g) .
“ Losses ” has the meaning
set forth in Section 10.1(a) .
“ Master Cell Bank ” means
cell suspension of Urokinase Kidney Cells, as described on
Schedule 2.1(c) .
“ NDA 21-846 ” means new drug
application 21-846 filed with the FDA, previously assigned the NDA
number 76-1021.
3
“ Other Agreements ” means,
collectively, the Assignment and Assumption Agreement, the
Intellectual Property Transfer Agreement and Inventory Trademark
License Agreement.
“ Other Inventory ” has the
meaning set forth in Section 2.1(e) .
“ Person ” means any
individual, corporation, partnership, limited partnership, joint
venture, limited liability company, trust or unincorporated
organization, governmental entity, government or any agency or
political subdivision thereof.
“ Product ” or “
Products ” means Seller’s urokinase product
formerly marketed under the brand name Abbokinase
® and as of the date of this Agreement being
rebranded under the brand name Kinlytic™.
“ Product Impact ” has the
meaning set forth in Section 5.14 .
“ Purchase Price ” has the
meaning set forth in Section 3.1 .
“ Purchased Assets ” has the
meaning set forth in Section 2.1 .
“ Raw Materials ” means those
raw materials set forth on Schedule 2.1(l) .
“ Seller ” has the meaning
set forth in the preamble hereto.
“ Seller Insurance Policies ”
has the meaning set forth in Section 10.6
hereof.
“ SNDAs ” means supplemental
new drug applications S-076 through S-101 filed with the FDA, where
S-101 is pending and addresses the change to expiration
date.
“ Taxes ” shall mean all
taxes, charges, fees, duties, levies or other assessments,
including, without limitation, income, gross receipts, net
proceeds, ad valorem, turnover, real and personal property
(tangible and intangible), sales, use, franchise, excise, value
added, goods and services, license, payroll, unemployment,
environmental, customs duties, capital stock, disability, stamp,
leasing, lease, user, transfer, fuel, excess profits, occupational
and interest equalization, windfall profits, severance and
employees’ income withholding, social security and similar
employment taxes or any other taxes imposed by the United States or
any other foreign country or by any state, municipality,
subdivision or instrumentality of the Unites States or of any other
foreign country or by any other tax authority, including all
applicable penalties and interest, and such term shall include any
interest, penalties or additions to tax attributable to such
taxes.
“ Testing Procedures ” means
the procedures set forth on Exhibit C
hereto.
“ Transferred Intellectual Property
” has the meaning set forth in Section 2.1(b)
.
“ United States ” or “
U.S. ” means the United States of America.
“ Unlabeled Inventory ” has
the meaning set forth in Section 2.1(h) .
“ Working Cell Banks ” means
cell suspension subcultured from Urokinase Kidney Cells, Frozen
Sub-2, as set forth on Schedule 2.1(c) .
4
2.1 Agreements to Purchase and Sell .
Subject to the terms and conditions contained herein, at the
Closing, Seller shall sell, transfer, convey, assign and deliver to
Buyer, and Buyer shall purchase and accept from Seller, free and
clear from all Encumbrances, all right, title, and interest of
Seller in and to all assets related to the Products, including the
following (collectively, the “ Purchased Assets
”):
(a) all sales and marketing information,
including all customer records and sales history with respect to
customers (including invoices), sales and marketing records, price
lists, documents, correspondence, studies, reports, and all other
books, ledgers, files, and records of every kind, tangible data,
customer lists (including appropriate contact information), vendor
and supplier lists, service provider lists, promotional literature
and advertising materials, catalogs, data and laboratory books,
media records, research material, technical information,
blueprints, technology, technical designs, drawings, specifications
and other product development records (including those relating to
development costs) of the Seller, relating to the Products and
including but not limited to those related to the Kinlytic™
relaunch ( Schedule 2.1(a) lists some but not all of
the materials described in this Section 2.1(a) )
;
(b) (i) all Intellectual Property Rights
related to the Products, including the domain names, domain name
registration applications, contents of websites hosted at the
aforementioned domain names, copyrights, copyright applications,
trademarks, trademark applications, patents and patent applications
set forth on Schedule 2.1(b) , (ii) the package
designs, labels, logos (whether or not registered) and associated
artwork and typeface, trade names, brand names, logos (whether or
not registered), certification marks and service marks that are
licensed to or owned, used or held for use by the Seller as of the
Closing and are related to the Products and (iii) all
technical information, references and standards, methodologies,
processes, protocols, specifications, techniques, trade secrets and
know how, databases and formulas related to the Products and any
supporting documentation that are related to the Products
(collectively, the “ Transferred Intellectual Property
”);
(c) the Master Cell Bank and Working Cell
Banks described on Schedule 2.1(c) (the “ Cell
Banks ”);
(i) all rights and interest of Seller under
and to the contracts set forth on Schedule 2.1(d)(i)
(the “ Assumed Contracts ”), including any
amounts, payments and receipt due under the Assumed Contracts;
however, such rights and interest will not include any rights and
interest that relate to Products not included in the
Inventory;
(ii) any amounts, payments and receipt due
under the contracts set forth on Schedule 2.1(d)(ii)
(the “ Assumed Liability Contracts ”) that
relate to the Channel Inventory;
5
(e) the drug substances, clinical lots,
reference standards, reserve samples, patient samples and other
materials stored for the Seller by Fisher BioServices, Inc. in
Rockville, MD, Catalent Pharma Solutions in Philadelphia, PA and
BioReliance Corporation in Rockville, MD (the “ Other
Inventory ”), including the ones identified on
Schedule 2.1(e) hereto;
(f) all licenses, approvals, filings,
certificates, permits, registrations, rights, franchises, or other
evidence of authority issued to Seller or Seller’s Affiliates
by a federal, state, local or foreign governmental agency or
authority, regardless of jurisdiction, relating to the Products, in
each case to the extent assignable, including NDA 21-846, the SNDAs
and IND 1444 (the “ Governmental Authorizations
”);
(g) 29,798 vials of labeled Product,
further described in Schedule 2.1(g) hereto, comprising the
three lots labeled with National Drug Code (NDC) number
24430-1003-1 (Lots 10800Z7, 10761Z7, 10758Z7) that are the subject
of the new NDA 21-846 previously submitted to the FDA seeking,
among other things, authorization for release of the Product that
is the subject matter of such application so that it can be used
commercially by the Seller and distributed by the Seller, but
which, as of the date of this Agreement, have not been approved for
release by the FDA (“ Labeled Inventory
”);
(h) 78,865 vials of unlabelled Product,
further described in Schedule 2.1(h) hereto, that have been
approved by Seller for distribution, but have not been submitted by
Seller for approval by the FDA (“ Unlabeled Inventory
”);
(i) all records, reports and Product
information files (including Product development and regulatory
history files), in each case relating primarily to the Products,
including without limitation the categories of documents identified
on Schedule 2.1(i) ;
(j) all current and pending new drug
applications, supplemental new drug applications and
investigational new drug applications for the Products as set forth
on Schedule 2.1(j) ;
(k) all goodwill relating to the
Products;
(l) the Raw Materials specified on
Schedule 2.1(l) ;
(m) all vials of Products stability samples
set forth on Schedule 2.1(m) ;
(n) the equipment set forth on
Schedule 2.1(n) (the “ Equipment ”);
and
(o) a total of 64 vials of Abbokinase,
comprising of (i) 24 vials are in the keeping of Commonwealth
Biotechnologies, Inc. on the date hereof and (ii) 40 vials,
bearing National Drug Code (NDC) number 0074-6109-05 and
belonging to lot numbered 30821Z7, which shall be repurchased by
Seller from the three wholesalers AmerisourceBergen Drug
Corporation, McKesson Corporation and Cardinal Health on or after
the date hereof but prior to the Closing. The Seller shall
repurchase at least 10 vials from each aforementioned
wholesaler.
6
2.2 Excluded Assets . Notwithstanding
anything to the contrary in this Agreement, Seller shall not sell,
transfer or assign, and Buyer shall not purchase or otherwise
acquire, the following assets of Seller (such assets being
collectively referred to hereinafter as the “ Excluded
Assets ”):
(a) all rights of Seller arising under this
Agreement, the Other Agreements or from the consummation of the
transactions contemplated hereby or thereby;
(b) all rights of Seller arising under any
contract other than: (i) the Assumed Contracts, to the extent
such rights do not relate to any Products other than those included
in the Inventory, and (ii) the right to amounts, payments and
receipts due under Assumed Liability Contracts relating to Channel
Inventory;
(c) all corporate minute books, stock
records and Tax returns (including all work papers relating to such
Tax returns) of Seller and such other similar corporate books and
records of Seller and Seller’s Affiliates as may exist on the
Closing Date;
(d) all Intellectual Property Rights of
Seller or Seller’s Affiliates of any kind not listed on
Schedule 2.1(b) or referred to in Section 2.1(b)
;
(e) approximately 3,700 vials of labeled
Product bearing National Drug Code (NDC) number 0074-6109-05,
further specified on Schedule 2.3(b) hereto, which, as
of the date of this Agreement, have been sold to drug wholesale
distributors and are in the distribution channel (“
Channel Inventory ”);
(f) all rights to refunds of Taxes paid by
or on behalf of Seller;
(g) all insurance policies of the Seller
and claims thereunder existing at the Closing Date;
(h) the services of any employee of Seller
other than as expressly specified herein;
(i) all assets of any employee benefit
plan, arrangement, or program maintained or contributed to by
Seller;
7
(j) all assets, tangible or intangible,
wherever situated, not expressly included in the Purchased
Assets;
(k) all raw materials not listed on
Schedule 2.1(l); and
(l) all equipment of Seller other than the
Equipment (as set forth on Schedule 2.1(n)
).
2.3 Assumed Liabilities . On the Closing
Date, subject to the provisions of Section 2.4 , Buyer
shall assume, or shall cause Buyer’s Affiliates to
assume:
(a) the following liabilities of Seller
relating exclusively to the Purchased Assets:
(i) Subject to the provisions of
Section 2.4(f) , all liabilities and all obligations
arising after the Closing Date under the Assumed Contracts (to the
extent that such liabilities and obligations do not relate
to any Products other than those included in the Inventory), the
Transferred Intellectual Property and the Governmental
Authorizations being transferred from Seller to Buyer
hereunder;
(ii) Taxes related to Purchased Assets
attributable to any period or partial period beginning after the
Closing are the responsibility of Buyer. Anything herein to the
contrary notwithstanding, Taxes specified in
Section 3.3 and Section 9.3 hereof shall be
paid in accordance with the respective provisions of such
sections;
(iii) Except as provided in
Section 2.4(f) , all liabilities or other claims
related to the research, development, marketing, manufacture,
distribution, testing, sale or trials of the Products included in
the Inventory, that arise from acts performed after the Closing
Date; and
(b) the liability of Seller for payment of
up to $500,000 for all monthly Chargebacks related to the Channel
Inventory bearing National Drug Code (NDC) number 0074-6109-05 as
more particularly set forth on Schedule 2.3(b) provided
that when there is no longer any Channel Inventory in the sales
channel, if Buyer has expended less than $500,000 for the costs
described herein then the difference between the total actual costs
expended and $500,000 shall be paid to Seller upon the later of
(i) the time at which the Bonus shall have become due and
payable by Buyer, or (ii) two months after the receipt by
Buyer of confirmation in writing from the pertinent wholesale or
distributor of the sale or expiration of the last unsold vial
comprising the Channel Inventory. The Buyer shall have no
obligation to pay the aforementioned costs in excess of $500,000
and any such costs in excess of $500,000 shall be Seller’s
liability. Buyer shall provide a detailed report on a monthly basis
containing a description of the payments made under this section
for the preceding month.
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The liabilities assumed pursuant to this
Section 2.3 shall collectively be referred to as the
“ Assumed Liabilities ”.
2.4 Excluded Liabilities . Neither Buyer
nor Buyer’s Affiliates assume nor will they become
responsible for any of the liabilities and obligations of Seller
(collectively, the “ Excluded Liabilities ”)
except for those set out in Section 2.3 . The Excluded
Liabilities shall include, without limitation:
(a) all liabilities and obligations of
Seller arising under this Agreement, the Other Agreements or from
the consummation of the transactions contemplated hereby or
thereby;
(b) any liability or obligation of Seller
arising under any contract or agreement that is not an Assumed
Liability;
(c) all obligations related to employees of
Seller;
(d) any and all claims, causes of action,
administrative actions, investigations, criminal or civil actions
or other litigation relating to the sale, manufacture or use of
Products prior to the Closing, including but not limited to the
matters set forth on Schedule 5.6 ;
(e) subject to the express provisions of
Section 2.3(b) hereof, any and all claims, causes of
action, administrative actions, investigations, criminal or civil
actions or other litigation relating to the sale, manufacture or
use of Channel Inventory, regardless of whether such actions,
claims, causes of actions, investigations or other litigation arose
before the Closing or arise after the Closing;
(f) any and all claims, causes of action,
administrative actions, investigations, criminal or civil actions
or other litigation relating to Products sold after Closing to the
extent related to Seller’s failure to manufacture the
Inventory in compliance with the standards set forth in the
specifications in NDA 21-846, the SNDAs and IND 1444;
and
(g) all other liabilities of Seller
existing at the Closing Date.
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2.5 Procedures for Purchased Assets not
Transferable . If any property or other rights included in the
Purchased Assets are not assignable or transferable either by
virtue of the provisions thereof or under applicable law without
the consent of some third party or parties, Seller shall use its
commercially reasonable efforts to obtain such consents after the
execution of this Agreement, but prior to the Closing, and Buyer
shall use its commercially reasonable efforts to assist in that
endeavor. If any such consent cannot be obtained prior to the
Closing and the Closing occurs, this Agreement, the Other
Agreements and the related instruments of transfer shall not
constitute an assignment or transfer of the Purchased Asset
regarding which such consent was not obtained and Buyer shall not
assume Seller’s obligations with respect to such Purchased
Asset, but Seller shall use its commercially reasonable efforts to
obtain such consent as soon as reasonably possible after the
Closing or otherwise obtain for Buyer the practical benefit of such
property or rights and Buyer shall use its commercially reasonable
efforts to assist in that endeavor. For purposes of this
Section 2.5 only and not for the purposes of the rest
of this Agreement, commercially reasonable efforts for the Buyer
shall not include any requirement of either party to expend money,
commence any litigation or offer or grant any accommodation
(financial or otherwise) to any third party.
Purchase Price; Bonus; Consistent
Treatment
3.1 Purchase Price and Bonus . The
purchase price (“ Purchase Price ”) for the
Purchased Assets shall consist of a payment at Closing in the
amount of Two Million U.S. dollars ($2.0 million), subject to
the provisions of Section 4.1 , plus the assumption of
the Assumed Liabilities. Upon receipt by Buyer from the FDA of
written authorization to release the Labeled Inventory, the Buyer
shall make a bonus payment of Two Million Five-Hundred Thousand
U.S. dollars ($2.5 million) (the “ Bonus ”)
within 30 business days of receipt of such
authorization.
3.2 Payment of Purchase Price . The
Purchase Price shall be paid in accordance with
Section 4.2(b) .
3.3 Prorations . Seller and Buyer agree
that anything herein to the contrary notwithstanding no items
relating to the Purchase Assets shall be prorated, other than those
specified on Schedule 3.3 which describes in sufficient
detail such prorations.
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4.1 Closing Date . The Closing shall take
place on or before September 23, 2008 (such date, the “
Closing Date ”) at a place and location to be agreed
upon between Buyer and Seller, subject to the satisfaction or
waiver of each of the conditions set forth in Article 8
. The Seller acknowledges previous receipt of payment in the amount
of $50,000.00 (the “ Extension Fee”) from Buyer,
which amount shall be creditable against the Purchase Price at
Closing. In the event the transaction does not close on or before
September 23, 2008, Seller shall be entitled to retain the
Extension Fee without any obligation to close the transaction after
the aforementioned date.
4.2 Transactions at Closing . At the
Closing, subject to the terms and conditions hereof:
(a) Transfer of Purchased Assets . Seller
shall transfer and convey or cause to be transferred and conveyed
to Buyer all of the Purchased Assets and Seller and Buyer shall
execute and Seller shall deliver to Buyer each of the Other
Agreements and such other good and sufficient instruments of
transfer and conveyance as shall be necessary to vest in Buyer
title to all of the Purchased Assets or as shall be reasonably
requested by the Buyer. The Seller shall also deliver to Buyer the
certificate required by Section 8.2(b) and all other
documents required to be delivered by Seller at Closing pursuant
hereto. Furthermore, the Seller shall deliver or cause to be
delivered to the Buyer’s address specified in
Section 12.13 all records, reports and Product
information files (including Product development and regulatory
history files), in each case relating primarily to the Products,
including without limitation the ones falling in the categories
identified on Schedule 2.1(i) .
(b) Payment of Purchase Price, Assumption of
Assumed Liabilities and Buyer’s Closing Deliveries . In
consideration for the transfer of the Purchased Assets and other
transactions contemplated hereby Buyer shall: (i) pay to Seller on
the Closing Date One Million Nine Hundred and Fifty Thousand U.S.
dollars ($1,950,000) of the Purchase Price by electronic bank
transfer in immediately available funds directly to Seller’s
Account for which wiring instructions shall be provided to Buyer by
Seller in writing before the Closing; and (ii) execute and
deliver to Seller the Assignment and Assumption Agreement, whereby
Buyer assumes the Assumed Liabilities, and each of the Other
Agreements, as well as the certificate required by
Section 8.2(b) and all other documents required to be
delivered by Buyer at Closing pursuant hereto.
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(c) Regulatory Transfer . At Closing,
Seller will provide to Buyer copies of all portions of NDA 21-846,
the SNDAs and IND 1444 necessary to allow Buyer to comply with its
obligations as the application holder. Seller further agrees to
notify the FDA of the transfer of ownership of NDA 21-846, the
SNDAs and IND 14444 in accordance with Section 505(j) of the FDCA
and 21 CFR 314.72, effective immediately upon the Closing, using
the respective forms of notice attached hereto as
Exhibit E . Buyer agrees to notify the FDA of the
transfers of NDA 21-846, the SNDAs and IND 1444 effective
immediately upon the Closing and to submit as the new owner a
Form FDA 356h and letter in accordance with 21 CFR
314.72.
(d) Notification of transfer of Purchased
Assets . At or before the Closing, Seller will notify all
parties to the contracts specified on Schedule 4.2(d)
hereto of the transfer of the Purchased Assets to Buyer and provide
copies of such notices to Buyer.
Representations and Warranties of
Seller
Except as set forth in the Disclosure Schedules,
Seller represents and warrants to Buyer as follows:
5.1 Organization . Seller is a
corporation duly incorporated and validly existing in good standing
under the laws of the State of Delaware, duly qualified to transact
business as a foreign corporation in such jurisdictions where the
nature of its business makes such qualification necessary, except
as to jurisdictions where the failure to qualify would not
reasonably be expected to have a material adverse effect on the
business of the Seller or the Purchased Assets, and has all
requisite corporate power and authority to own, lease and operate
the Purchased Assets and to carry on its business, including its
business related to the Purchased Assets, as now being
conducted.
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5.2 Due Authorization . Seller has full
corporate power and authority to execute, deliver and perform its
obligations under this Agreement and the Other Agreements, and the
execution and delivery of this Agreement and the Other Agreements
and the performance of all of its obligations hereunder and
thereunder has been duly and validly authorized and approved by all
necessary corporate action of the Seller, including approval of
this Agreement and the Other Agreements by the board of directors
of the Seller. The signing, delivery and performance of this
Agreement and the Other Agreements by Seller is not prohibited or
limited by, and will not result in the breach of or a default
under, or conflict with any obligation of Seller with respect to
the Purchased Assets under (i) any provision of the
Certificate of Incorporation or By-Laws of Seller, (ii) any
material agreement or instrument to which Seller is a party or by
which it or its properties are bound, (iii) any judgment,
order, award, writ, injunction or decree of any court, governmental
body or instrumentality, or arbitrator, (iv) any Governmental
Authorizations, or (v) any applicable law, statute, ordinance,
regulation or rule, and, to Seller’s Knowledge, will not
result in the creation or imposition of any Encumbrance on any of
the Purchased Assets, except to the extent that any such
prohibition, limitation, breach, default or conflict would not
reasonably be expected to have a material adverse effect on the
Purchased Assets. This Agreement has been, and on the Closing Date
the Other Agreements will have been, duly executed and delivered by
Seller and constitutes, or, in the case of the Other Agreements,
will constitute, the legal, valid and binding obligation of Seller,
enforceable against Seller in accordance with their respective
terms, except as enforceability may be limited or affected by
applicable bankruptcy, insolvency, moratorium, reorganization or
other laws of general application relating to or affecting
creditors’ rights generally.
5.3 Inventory, Equipment and Raw
Materials . The Raw Materials, references and standards and
Equipment transferred pursuant to Section 2.1 are in
good condition, except as would not reasonably be expected to have
a material adverse effect on such Raw Materials, references and
standards or Equipment, respectively. The Inventory is, in all
material respects, in good and merchantable condition (it being
understood that for purposes of the foregoing representation, the
Inventory shall be deemed to be in good and merchantable condition
in all material respects unless the aggregate amount arising out of
all Losses attributable to all the deficiencies in the Inventory,
whether qualitative or quantitative, is greater than $10,000, has
been manufactured and stored in compliance with all applicable laws
and regulations, including cGMP, and the best practices prevalent
in the industry, and conforms to all material Governmental
Authorizations; provided, however, that the foregoing
representation shall be subject to the Buyer’s compliance
with any and all applicable material laws and regulations relating
to labeling and packaging of the Inventory.
5.4 Title . The Purchased Assets are
owned legally and beneficially by Seller with good and marketable
title thereto, free and clear of all Encumbrances. At the Closing,
Buyer will receive legal and beneficial title to all of the
Purchased Assets, free and clear of all Encumbrances, except for
liens for Taxes not yet due and payable and the Assumed
Liabilities, and except as set forth on Schedule 5.4
and subject to obtaining any consents of Persons listed on
Schedule 5.7 .
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5.5 Intellectual Property . Except as set
forth on Schedule 5.5 , the Transferred Intellectual
Property is owned free and clear of all Encumbrances or has been
duly licensed for use by Seller and all pertinent licenses and
their respective material terms are set forth on
Schedule 5.5 . Except as set forth on
Schedule 5.5 , to Seller’s Knowledge, the
Transferred Intellectual Property has not been nor is likely to be
the subject of any pending adverse claim or any threatened
litigation or claim of infringement or misappropriation. Except as
set forth on Schedule 5.5 , the Seller has not violated
the terms of any license pursuant to which any part of the
Transferred Intellectual Property has been licensed by the Seller.
To Seller’s Knowledge, except as set forth on
Schedule 5.5 , the Transferred Intellectual Property
does not materially infringe on any Intellectual Property Rights of
any third party.
5.6 Litigation . Except as set forth on
Schedule 5.6 , there is no litigation, proceeding,
claim or governmental investigation pending or, to Seller’s
Knowledge, threatened with respect to Seller or the
Products.
5.7 Consents . Except as set forth on
Schedule 5.7 , no notice to, filing with, authorization
of, exemption by, or consent of any Person is required for Seller
to consummate the transactions contemplated hereby.
5.8 Brokers, Etc . No broker or
investment banker acting on behalf of Seller or under the authority
of Seller is or will be entitled to any broker’s or
finder’s fee or any other commission or similar fee directly
or indirectly from Seller or Buyer in connection with any of the
transactions contemplated herein, other than any fee that is the
sole responsibility of Seller.
5.9 Absence of Undisclosed Liabilities .
To Seller’s Knowledge, Seller has not incurred any
liabilities or obligations with respect to the Purchased Assets
(whether accrued, absolute, contingent or otherwise), which
continue to be outstanding, except as otherwise expressly disclosed
in this Agreement.
5.10 Governmental Authorizations .
Schedule 5.10 sets forth a complete list of the
Governmental Authorizations. The Governmental Authorizations listed
in Schedule 5.10 are all the authorizations required to
be in material compliance with all laws applicable to the Purchased
Assets and their sale, distribution and marketing in the United
States. The Governmental Authorizations are in full force and
effect in accordance with their terms, and there have been no
material violations of such Governmental Authorizations, no
proceedings are pending or, to the Knowledge of the Seller,
threatened, which could result in their revocation or limitation
and all steps have been taken and filings made on a timely basis
with respect to each Governmental Authorization and its renewal; in
each case, except as would not reasonably be expected to have a
material adverse effect on the Purchased Assets.
5.11 Contracts . All current and complete
copies of all Contracts have been delivered to or made available to
the Buyer. The Contracts are all in full force and effect and, to
Seller’s Knowledge, there are no outstanding defaults or
violations under such Contracts on the part of the Seller or, to
the Knowledge of the Seller, on the part of any other party to such
Contracts and there are no current or pending negotiations with
respect to the renewal, repudiation or amendment of any Contract.
The Seller Insurance Policies completely satisfy any and all
insurance obligations of Buyer under all Contracts. All provisions
relating to Chargebacks related to Channel Inventory and product
returns, applicable to the Assumed Liability Contracts, whether
such provisions relate to direct parties to the Assumed Liability
Contracts or to final customers of the Products, have been made
available in writing to the Buyer.
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5.12 Tax Matters . In each case except as
would not reasonably be expected to have a material adverse effect
on the Purchased Assets:
(a) No failure, if any, of the Seller to
duly and timely pay all Taxes, including all installments on
account of Taxes for the current year, that are due and payable by
it will result in an Encumbrance on the Purchased
Assets;
(b) There are no proceedings,
investigations, audits or claims now pending or threatened against
the Seller in respect of any Taxes, and there are no matters under
discussion, audit or appeal with any governmental authority
relating to Taxes, which will result in an Encumbrance on the
Purchased Assets;
(c) The Seller has duly and timely withheld
all Taxes and other amounts required by law to be withheld by it
relating to the Purchased Assets (including Taxes and other amounts
relating to the Purchased Assets required to be withheld by it in
respect of any amount paid or credited or deemed to be paid or
credited by it to or for the account or benefit of any Person,
including any employees, officers or directors and any non-resident
Person), and has duly and timely remitted to the appropriate
Governmental Authority such Taxes and other amounts required by law
to be remitted by it; and
(d) The Seller has duly and timely
collected all amounts on account of any sales or transfer taxes,
including goods and services, harmonized sales and provincial or
territorial sales taxes with respect to the Purchased Assets,
required by law to be collected by it and has duly and timely
remitted to the appropriate Governmental Authority any such amounts
required by law to be remitted by it.
5.13 Cell Banks . The Cell Banks are in
viable condition as of the Closing and have been stored in
accordance with any and all applicable laws, rules, regulations,
Governmental Authorizations and the quality procedures in
accordance with cGMP.
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5.14 Environmental Matters . Except as
set forth on Schedule 5.14 , the Seller is in
compliance in all respects with all applicable Environmental Laws
to the extent such compliance or lack thereof would have any impact
on the Seller’s business related to the production, sale and
distribution of the Products or the Seller’s ability to
consummate the transactions contemplated herein in accordance with
the terms hereof (such impact, a “ Product Impact
”). The Seller has not received any written communication
that alleges that the Seller is not in compliance in all respects
with all applicable Environmental Laws. All permits and other
governmental authorizations currently held by Seller pursuant or in
connection with any Environmental Law are in full force and effect,
Seller is in compliance in all respects with all of the terms of
such permits and authorizations to the extent such compliance or
lack thereof would have any Product Impact, and no other permits or
authorizations material to the conduct of the Seller’s
business related to the production, sale and distribution of the
Products are required by the Seller. Except as set forth on
Schedule 5.14 , the management, handling, storage,
transportation, treatment and disposal by Seller of all Hazardous
Substances have been in compliance in all respects with all
applicable Environmental Laws to the extent such compliance or lack
thereof would have any Product Impact.
5.15 Chargebacks . The sum of all
Chargebacks related to the Channel Inventory bearing National Drug
Code (NDC) number 0074-6109-05 as more particularly set forth
on Schedule 2.3(b) can be no greater than $500,000.
5.16 Regulatory Compliance . The Seller
has been, and is in compliance, in all material respects with
applicable provisions of the FDCA and the regulations of the FDA
promulgated thereunder with respect to the Product, except where
the failure to have the same would not have a material adverse
effect and the Seller has not received any notice (oral or written)
of Proceedings relating to the revocation, withdrawal, recall, or
modification of any Governmental Authorization. Seller has been and
is in compliance in all materials respects with the FDCA and FDA
regulations with respect to manufacturing, clinical research and
development, submission of applications for review by governmental
authorities, marketing, promotion, and sale of the Product. Except
as set forth on Schedule 5.16 , there are no pending
or, to the knowledge of the Seller, threatened actions or
proceedings by the FDA or U.S. Department of Justice, which would
prohibit or impede the sale or marketing of the Product.
5.17 Disclaimer . EXCEPT AS OTHERWISE
EXPRESSLY PROVIDED IN THIS ARTICLE 5, SELLER IS MAKING NO
REPRESENTATION OR WARRANTY AS TO THE PURCHASED ASSETS. For greater
certainty, nothing in this Section 5.17 shall in any
way limit Seller’s indemnification obligations as set forth
in Article 10 .
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Representations and Warranties of
Buyer
Buyer represents and warrants to Seller as
follows:
6.1 Organization . Buyer is a corporation
duly incorporated and validly existing in good standing under the
laws of the Province of Ontario, Canada, duly qualified to transact
business as a foreign corporation in all jurisdictions except where
the failure to be so qualified would not reasonably be expected to
have a material adverse effect on Buyer, and with all requisite
corporate power and authority to own, lease and operate its
properties and to carry on its business as now being
conducted.
6.2 Due Authorization . Buyer has full
corporate power and authority to execute, deliver and perform its
obligatio
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