ADVANCED CARDIOVASCULAR SYSTEMS,
INC.
Dated as of June 24,
2003
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PAGE
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ARTICLE 1 PURCHASE AND SALE
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1
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1.1 Items Included in the Assets
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1
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2
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1.3 Assumed and Retained Liabilities
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2
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2
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2
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2
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2
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ARTICLE 3 LICENSE AGREEMENT
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3
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3
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3.2 License from Buyer to Seller
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3
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3.3 Assignment; Successors and
Assigns
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3
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3.4 Termination of License
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3
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4
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4
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4
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ARTICLE 4 SUPPLY AGREEMENT
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4
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4
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4
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5
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4.4 Shipping Costs; Risk of Loss
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5
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5
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4.6 Exclusivity; Termination
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5
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ARTICLE 5 REPRESENTATIONS AND WARRANTIES OF
SELLER
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5
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5.1 Organization and Good Standing
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5
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6
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6
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6
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5.5 Operations In Accordance with Law
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6
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6
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5.7 Defaults; Liens; Required
Consents
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7
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5.8 Intellectual Property.
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5.9 No Other Representations
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8
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ARTICLE 6 REPRESENTATIONS AND WARRANTIES OF
BUYER
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8
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6.1 Organization and Good Standing
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8
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8
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6.4 No Other Representations
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PAGE
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ARTICLE 7 ITEMS TO BE DELIVERED AT
CLOSING
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9
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9
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9
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ARTICLE 8 SURVIVAL AND
INDEMNIFICATION
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9
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9
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9
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ARTICLE 9 OTHER PROVISIONS
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11
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11
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9.2 Expenses; Certain Taxes.
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12
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12
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12
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12
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12
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9.7 Headings and Table of Contents; Certain
References
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13
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14
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14
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14
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14
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14
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9.14 No Third-Party Rights
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14
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Schedule 1.1(a)
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Product
Intellectual Property Assumed Contracts
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Schedule 1.1(b)
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Schedule 1.1(d)
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Manuals, Forms,
and Diagrams
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Schedule 1.2
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Exhibit A
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Exhibit B
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Form of Bill of
Sale, Assignment and Assumption
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Exhibit C
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Form of Patent
Assignment
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This Asset
Purchase Agreement (this “ Agreement ”) is
entered into this 24th day of June, 2003, between Advanced
Cardiovascular Systems, Inc., a California corporation (“
Buyer ”), and Bioheart, Inc., a Florida corporation
(“ Seller ”).
WHEREAS, Seller is
focused on the discovery, development, and commercialization of
cell-based therapy products for the treatment of cardiovascular
diseases, including myocardial infarction, congestive heart
failure, and cardiovascular electrical abnormalities;
WHEREAS, part of
Seller’s business consists of the production of a
catheter-based micro-implant system, including the system named
MyoCath™ (the “ Product ”); and
WHEREAS, Seller
wishes to sell to Buyer certain assets of Seller specifically
related to the Product as more particularly set forth herein, and
Buyer wishes to purchase such assets, each under the terms and
conditions herein.
NOW, THEREFORE,
the parties hereby agree as follows:
PURCHASE AND SALE
1.1 Items
Included in the Assets . At Closing (as defined in
Section 1.4 ), Seller shall sell, transfer, and assign
to Buyer, and Buyer shall purchase and acquire from Seller, all of
Seller’s right, title, and interest in and to the following
assets (the “ Assets ”) free and clear of all
liens, charges, claims, pledge, security interests, and other
encumbrances (collectively, “ Liens ”), except
as specifically assumed by Purchaser pursuant to the terms of this
Agreement.
(a)
Product Intellectual Property . All of Seller’s right,
title and interest (whether owned, licensed, or otherwise) in all
United States and foreign patents and patent applications listed on
Schedule 1.1(a) , and all know-how, manufacturing
processes, trade secrets, inventions, discoveries, and technical
information including information embodied in drawings, designs,
material specifications, processing instructions, formulas,
equipment specifications, product specifications, confidential
data, computer software, electronic files, research notebooks,
invention disclosures, research and development reports, and the
like specifically related thereto and all amendments,
modifications, and improvements to any of the foregoing, in each
case as they specifically relate to the Product (collectively, the
“ Product Intellectual Property ”).
(b)
Contracts . Each agreement, instrument, contract, and other
commitment listed in S chedule 1.1(b) (each, an “
Assumed Contract ”)
(c)
Files and Clinical Records . All records and documentation
relating to the Product, including all (i) regulatory filings,
together with any supporting documents; (ii) clinical studies and
tests, including any such filings; (iii) permits, documents,
studies, and tests; (iv) all reporting documents required by
any regulatory authority; (vi) other correspondence with
regulatory agencies, adverse event files, investigation safety
reports, complaint files; (vi) manufacturing records; and
(vii) foreign equivalents of the foregoing (collectively, the
“ Files and Clinical Records ”). Seller may
retain one copy of all such Files and Clinical Records
for
evaluating the
Product and to make, have made, sell, offer to sell and use the
Product; provided , however , Seller shall not
disclose to any other person such records and documentation or use
such records and documentation for any other use.
(d)
Manuals, Forms, and Diagrams . All of the manuals, forms,
and diagrams relating to the Product listed on Schedule
l.1(d) (the “ Manuals, Forms and Diagrams
”). Seller may retain one copy of all such Files and Clinical
Records for evaluating the Product and to make, have made, sell,
offer to sell and use the Product; provided , however
, Seller shall not disclose to any other person such records and
documentation or use such records and documentation for any other
use.
1.2 Excluded
Assets . There shall be excluded from the Assets to be
transferred and conveyed hereunder, and Seller shall retain all of
its right, title and interest in and to, (a) all assets
relating to the Product listed on Schedule 1.2 and
(b) all other assets of Seller not specifically included in
Section 1.1 . Without limiting the generality of the
foregoing, Buyer acknowledges and agrees that no assets of Seller
relating to the discovery, development, and commercialization of
cell-based therapy products for the treatment of cardiovascular
diseases, including myocardial infarction, congestive heart
failure, and cardiovascular electrical abnormalities, are being
conveyed under this Agreement. It is the intent of the parties that
only those Assets specifically included in Section 1.1
related to the Product are to be conveyed to Buyer
hereunder.
1.3 Assumed and
Retained Liabilities . Except for obligations arising on or
after the Closing Date (as defined in Section 1.4 )
under the Assumed Contracts which Buyer hereby assumes as of the
Closing Date (the “ Assumed Liabilities ”),
Buyer shall not assume any liabilities or obligations of Seller,
and Seller shall be liable for all liabilities and obligations
arising from or in connection with ownership of the Assets or
operation of Seller’s business before the Closing Date,
whether such liability or obligation be absolute, accrued, fixed,
contingent or otherwise and whether known or unknown.
1.4 Closing
. The simultaneous execution of this Agreement and closing of the
transactions contemplated by this Agreement (the “
Closing ”) shall occur on June 24, 2003 (the
“ Closing Date ”), at 10:00 a.m., local
time, at the offices of Faegre & Benson LLP, 2200 Wells Fargo
Center, 90 South Seventh Street, Minneapolis, Minnesota (or at such
other time or place as Buyer and Seller may agree).
1.5 Title .
Title to the Assets shall pass to Buyer as of the Closing
Date.
2.1 Purchase
Price . As consideration for the Assets, Buyer shall pay to
Seller the amount of $900,000 (the “ Purchase Price
”), on the Closing Date, by wire transfer of immediately
available United States funds to an account specified by
Seller.
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ARTICLE 3
LICENSE AGREEMENT
3.1
Definitions . The following terms have the meanings set
forth below (which are equally applicable to both the singular and
plural forms of the terms defined):
(a) “
ACS Background IP Rights ” means all IP Rights
relating to intellectual property owned, developed or controlled
(via license or otherwise) by Buyer (i) existing on the date
hereof, or (ii) after the Closing Date.
(b) “
Bioheart Foreground IP Rights ” means all IP Rights
specifically relating to the Product that are conceived or first
reduced to practice by Seller during the term of the License
granted in this Article 3 . The terms “
conceived ” and “ first reduced to
practice ” will be interpreted according to U.S. patent
law.
(c) “
IP Rights ” means all intangible property rights
arising under equity or operation of law including all rights under
or to intellectual property.
3.2 License
from Buyer to Seller . As of the Closing Date, Buyer hereby
grants to Seller, and Seller accepts from Buyer, a co-exclusive
(Buyer has the right to practice the Product Intellectual Property
as well as Seller), worldwide, fully paid up, irrevocable license
(the “ License ”), without the right to assign,
transfer or sublicense to any third party the Product Intellectual
Property except as set forth in Section 3.2 of this
Agreement, to make, have made, sell, offer to sell and use the
Product. Except for the License granted hereunder, Buyer retains
all rights under the Product Intellectual Property for itself and
Affiliates (as hereinafter defined).
3.3 Assignment;
Successors and Assigns . The License granted to Seller under
Section 3.2 shall be a personal right of the Seller and
may not be assigned to another Person (as defined herein) without
the prior consent of Buyer; provided , however , that
Seller shall have the right to assign this License without the
consent of Buyer in connection with (a) a change of control of
the Seller, or (b) the sale of all or substantially all of the
Seller’s assets. Any assignment or transfer of this License
to any third party, other than in connection with a change of
control of the Seller, or the sale of all or substantially all of
the Seller’s assets, shall be considered a material breach of
this license and this license shall automatically terminate upon
such breach. Any assignment of this license shall not relieve the
assignee from the requirement of obtaining the prior consent of
Buyer to any further assignment. This Agreement shall be binding
upon and shall inure to the benefit of the parties and their
successors and permitted assigns. “ Person ”
means any individual, corporation, partnership, limited liability
company, association, joint venture, trust, government or
governmental instrumentality, agency, division or office or any
other entity, organization or group.
3.4 Termination
of License . Unless the license under this Agreement is
terminated according to the provisions in this Agreement, this
license shall terminate with the last to expire of any issued or
granted patents, or the final rejection, including any appeals, of
any patent applications, directly related to Product Intellectual
Property. Seller will not acquire any rights in and is not entitled
to move, sell, copy, license, or otherwise exploit ACS Background
IP Rights in any manner (except the License granted under
Section 3.2 ), and Buyer will not acquire
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any rights in
and is not entitled to use, sell, copy, license, or otherwise
exploit Bioheart Foreground IP Rights in any manner.
3.5 Government
Approvals . Seller shall reasonably cooperate with Buyer in
connection with the preparation, filing and prosecution of
regulatory applications for the conduct of clinical trials and for
the marketing of the Products in order to obtain the approval of
government or regulatory authorities for the same. In addition,
Seller agrees that it will grant to Buyer any necessary or
appropriate authorizations to (a) allow access to, and refer
to, applicable data, files, or information on file with any
governmental or regulatory authorities specifically relating to the
Product Intellectual Property, including without limitation safety
data and drug master files and (b) reference any such data,
files, or information in Buyer’s and its Affiliates’
filings with any governmental or regulatory authorities.
3.6 Patent
Filings . Buyer will have the exclusive right, at Buyer’s
expense, to file, prosecute, issue, maintain, license, enforce or
defend all patent applications and patents, throughout the world,
containing Product Intellectual Property. Seller will provide
reasonable cooperation and assistance to Buyer under this
Section 3.6 related to such activities.
3.7
Enforcement . A party learning of an infringement of the
Product Intellectual Property rights by an un-Affiliated third
Person will notify the other party. Buyer will have the primary
right to enforce Product Intellectual Property rights under this
Agreement. Any recovery as a result of enforcement under this
Section 3.7 will inure solely to the benefit of Buyer.
If Buyer enforces any Product Intellectual Property rights under
this Agreement, (a) Seller will reasonably cooperate with
Buyer in making available its employees and records for purposes of
providing evidence and background information in support of the
enforcement, and (b) Seller agrees to be named as a party to
any claim, lawsuit or other action necessary for Buyer to initiate,
maintain or pursue such claim, lawsuit or action. If Buyer shall
fail, within a period of 90 days after learning of such
infringement, to take such action, Seller shall have the right to
take such action at Seller’s expense and for Seller’s
benefit. Neither party may settle a claim or action related to the
infringement of the Product Intellectual Property without the
consent of the other party, if such settlement would impose any
monetary obligation on the other party or require the other party
to submit to an injunction or otherwise limit the other
party’s rights under this Agreement.
ARTICLE 4
SUPPLY AGREEMENT
4.1 Supply
. Seller agrees to manufacture and deliver to Buyer, at no cost to
Buyer, a total of 160 units of the Product, less any units of the
Product delivered by Seller to Buyer prior to the Closing Date (the
“ Supply Units ”).
(a) Each
Product shall be labeled as either having a shelf life of
6 months, 12 months, or 24 months. From the date of this
Agreement until the second anniversary of such date, Seller shall
replace (at no cost to Buyer) any Supply Unit delivered to Buyer
and labeled as having a shelf life of 6 months that expires
before the Supply Unit is used.
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(b) If
any testing conducted by Seller extends the shelf life noted on any
of the Supply Units delivered by Seller to Buyer, then Buyer has
the option to return those Supply Units to Seller to be re-labeled
with the extended expiration date (at no cost to Buyer).
4.3 Permits
. Seller shall be responsible for obtaining and maintaining any
permits or approvals from any United States or foreign regulatory
authorities and any other government authorities that are required
in connection with its manufacture and delivery of the Supply Units
to Buyer under this Article 4 . Seller shall be
responsible for all process, analytical method and equipment
validation and shall take all necessary steps for its facilities
used for the manufacture of Supply Units to pass government
inspection.
4.4 Shipping
Costs; Risk of Loss . Buyer shall pay all shipping and
transportation costs associated with the shipping and
transportation of the Supply Units to Buyer from Seller or by Buyer
to Seller. Deliveries of Supply Units shall be F.O.B.
Seller’s distribution facility or such other sites as Seller
may, from time to time, designate (the “ Distribution
Facility ”). Title to Supply Units sold and risk of
casualty, with respect to the Supply Units, will pass to Buyer upon
Seller’s tender of the Supply Units to Buyer or a common
carrier at the Distribution Facility.
4.5 Defective
Products . All Supply Units delivered hereunder shall be
subject to final inspection and approval by Buyer within
20 days after delivery of the Supply Units to Buyer. If such
inspection discloses that a Supply Unit fails to conform to the
specifications as described in Exhibit A , or is
defective or damaged in any manner (a “ Defective
Product ”), Buyer shall return the Defective Product to
Seller within the 20-day inspection period specifying the failure,
defect or damage in reasonable detail. Seller shall replace the
Defective Product within 30 days of receiving the Defective
Product.
4.6
Exclusivity; Termination . Seller shall not manufacture for,
or transfer any units of the Product to, any other party (except
for Seller) until Seller has delivered to Buyer 160 units of the
Product that Buyer has accepted and approved. Seller shall complete
its obligations under this Article 4 no later than
December 31, 2003. Upon the delivery of the 160th Supply Unit
accepted and approved by Buyer,
(a) Seller
may continue to manufacture the Product or have the Product
manufactured only for Seller and make, have made, sell, offer to
sell and use the Product consistent with the License granted in
Section 3.2 ; and
(b) Seller’s
obligations under this Article 4 shall be
terminated.
ARTICLE 5
REPRESENTATIONS AND WARRANTIES OF SELLER
Seller represents
and warrants to Buyer as follows:
5.1
Organization and Good Standing . Seller is a duly
incorporated, duly organized, and validly existing corporation in
good standing under the laws of the State of Florida, with full
corporate power and authority to own or lease its properties and
assets, conduct its business as now conducted and enter into and
complete all transactions contemplated by this
Agreement.
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5.2 Binding
Agreement . This Agreement has been duly excluded and delivered
by Seller and is a valid and binding obligation and agreement of
Seller, enforceable in accordance with its terms (except as
enforceability may be limited by applicable bankruptcy,
reorganization, insolvency, moratorium or other similar laws from
time to time in effect affecting creditors’ rights generally
or by principles governing the availability of equitable remedies
(the “ Enforcement Liabilities ”)). The
execution, delivery, and performance of this Agreement have been
approved by the board of directors of Seller and will not violate,
contravene, result in a breach of, create any right of acceleration
or prepayment under, or constitute a default under (with or without
due notice or lapse of time or both) (a) the articles of
incorporation or by-laws of Seller, (b) any judgment, law,
rule, regulation or decree applicable to Seller, or (c) any
contract or agreement relating to the Product.
5.3 Assumed
Contracts . Seller has made available to Buyer a true, correct,
and complete copy of the Assumed Contract (or, in the case of any
oral Assumed Contract, a description thereof that is included in
Schedule 1.1(b) ), while together with the agreement
described in Schedule 5.3(a) constitute all agreements,
instruments, contracts, and other commitments, oral or written, to
which Seller is a party or by which Seller is bound that relate to
the Product. Seller has not breached any representation, warranty
or covenant contained in any Assumed Contract and, to the best of
its knowledge, is not in default with respect thereto. Except as
set forth in Schedule 5.3(b) , Seller has no knowledge
that any other party to any Assumed Contract is in breach or
default or is claimed to be in breach or default in complying with
any provision thereof. Except as set forth in
Schedule 5.3(b) , each Assumed Contract is in full
force and effect and is valid and binding upon the parties thereto
in accordance with its terms (subject to Enforcement
Limitations).
5.4 Litigation;
Claims . Except as set forth in Schedule 5.4 ,
there is no action, suit, litigation, proceeding, claim or
investigation pending, or to Seller’s knowledge threatened,
against or with respect to Seller, the Product or any Assets, and
(b) Seller is not operating under, subject to or in default
with respect to, any order, injunction, or decree of any court or
any federal, state, municipal, or other governmental agency or
instrumentality.
5.5 Operations
in Accordance with Law . To the best of its knowledge, Seller
is in compliance with all laws, rules, regulations, ordinances, and
administrative orders applicable to the Product. To Seller’s
knowledge, its business has been conducted, and the Assets have
been maintained and used, in compliance with all applicable
federal, state, and local laws, regulations, ordinances, and other
requirements of all governmental authorities having jurisdiction
over Seller or the Assets.
(a) Seller
has good title to the Assets (or, in the case of licensed software
and other Assets not owned by Seller, such rights as are necessary
to permit such use), free and clear of all Liens.
(b) Except
as set forth in Schedule 5.6 , the Assets include all
assets of Seller that Seller uses or holds for use in the
manufacture, use, or sale of the Product on the date
hereof.
-6-
5.7 Defaults;
Liens; Required Consents . The execution, delivery and
performance of this Agreement and any of the transactions
contemplated hereby will not (a) violate, conflict with or
constitute a breach or default under, or require any consent,
approval, filing or notice under any provisions of, or result in
the acceleration of any obligation under, or result in the
termination of, any material contract, agreement, lease, security
agreement, promissory note, mortgage, Lien or license relating to
any of the Assets, Seller, or Seller’s Affiliates;
(b) result in the creation or imposition of any Lien in favor
of any Person upon any of the Assets; or (c) constitute an event
that, after notice or lapse of time or both, would result in any
such breach, default, violation, conflict, termination,
acceleration or the creation or imposition of any Lien on any of
the Assets. “ Affiliate ” means, with respect to
any Person, another Person that directly, or indirectly through one
or more intermediaries, controls, is controlled by or is under
common control with, that Person. For purposes of the foregoing
definition, control means (i) the direct or indirect ownership
of at least 50% of the outstanding voting securities or other
equity interests of such Person, (ii) the present right or
ability to elect or appoint 50% or more of the members of the board
of directors or similar governing body of such Person, or
(iii) the present right or ability to control the decision
making authority of such Person.
5.8
Intellectual Property .
(a) Seller
is the sole and exclusive owner of, or otherwise has a valid
license or right to use and freely transfer, the Product
Intellectual Property, free and clear of any Liens. The Product
Intellectual Property constitutes all IP Rights owned by or
licensed to Seller relating to the Product. All Product
Intellectual Property remains in full force and effect including,
without limitation, rights transferred in the Purchase Agreement
between Seller and John Geis and Michael Braun.
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