Document:

EX-10.8 Asset Purchase Agreement

 

Exhibit 10.8

*****

ASSET PURCHASE AGREEMENT

BETWEEN

ADVANCED CARDIOVASCULAR SYSTEMS, INC.

AND

BIOHEART, INC.

Dated as of June 24, 2003

*****

 

 

TABLE OF CONTENTS

	 	 	 	 	 
	 	 	PAGE
	ARTICLE 1 PURCHASE AND SALE
	 	 	1	 
	1.1 Items Included in the Assets
	 	 	1	 
	1.2 Excluded Assets
	 	 	2	 
	1.3 Assumed and Retained Liabilities
	 	 	2	 
	1.4 Closing
	 	 	2	 
	1.5 Title
	 	 	2	 
	 
	 	 	 	 
	ARTICLE 2 CONSIDERATION
	 	 	2	 
	2.1 Purchase Price
	 	 	2	 
	 
	 	 	 	 
	ARTICLE 3 LICENSE AGREEMENT
	 	 	3	 
	3.1 Definitions
	 	 	3	 
	3.2 License from Buyer to Seller
	 	 	3	 
	3.3 Assignment; Successors and Assigns
	 	 	3	 
	3.4 Termination of License
	 	 	3	 
	3.5 Government Approvals
	 	 	4	 
	3.6 Patent Filings
	 	 	4	 
	3.7 Enforcement
	 	 	4	 
	 
	 	 	 	 
	ARTICLE 4 SUPPLY AGREEMENT
	 	 	4	 
	4.1 Supply
	 	 	4	 
	4.2 Labels.
	 	 	4	 
	4.3 Permits
	 	 	5	 
	4.4 Shipping Costs; Risk of Loss
	 	 	5	 
	4.5 Defective Products
	 	 	5	 
	4.6 Exclusivity; Termination
	 	 	5	 
	 
	 	 	 	 
	ARTICLE 5 REPRESENTATIONS AND WARRANTIES OF SELLER
	 	 	5	 
	5.1 Organization and Good Standing
	 	 	5	 
	5.2 Binding Agreement
	 	 	6	 
	5.3 Assumed Contracts
	 	 	6	 
	5.4 Litigation; Claims
	 	 	6	 
	5.5 Operations In Accordance with Law
	 	 	6	 
	5.6 Title to Assets.
	 	 	6	 
	5.7 Defaults; Liens; Required Consents
	 	 	7	 
	5.8 Intellectual Property.
	 	 	7	 
	5.9 No Other Representations
	 	 	8	 
	 
	 	 	 	 
	ARTICLE 6 REPRESENTATIONS AND WARRANTIES OF BUYER
	 	 	8	 
	6.1 Organization and Good Standing
	 	 	8	 
	6.2 Binding Agreement
	 	 	8	 
	6.3 Litigation; Claims
	 	 	8	 
	6.4 No Other Representations
	 	 	8	 

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	 	 	PAGE
	ARTICLE 7 ITEMS TO BE DELIVERED AT CLOSING
	 	 	9	 
	7.1 Deliveries by Seller
	 	 	9	 
	7.2 Deliveries by Buyer
	 	 	9	 
	 
	 	 	 	 
	ARTICLE 8 SURVIVAL AND INDEMNIFICATION
	 	 	9	 
	8.1 Survival
	 	 	9	 
	8.2 Indemnification.
	 	 	9	 
	 
	 	 	 	 
	ARTICLE 9 OTHER PROVISIONS
	 	 	11	 
	9.1 Confidentiality.
	 	 	11	 
	9.2 Expenses; Certain Taxes.
	 	 	12	 
	9.3 Successors
	 	 	12	 
	9.4 Assignment
	 	 	12	 
	9.5 Further Assurances
	 	 	12	 
	9.6 Notices
	 	 	12	 
	9.7 Headings and Table of Contents; Certain References
	 	 	13	 
	9.8 Governing Law
	 	 	14	 
	9.9 Waiver of Provisions
	 	 	14	 
	9.10 Counterparts
	 	 	14	 
	9.11 Entire Agreement
	 	 	14	 
	9.12 Severability
	 	 	14	 
	9.13 No Joint Venture
	 	 	14	 
	9.14 No Third-Party Rights
	 	 	14	 

SCHEDULES

	 	 	 
	Schedule 1.1(a)
	 	Product Intellectual Property Assumed Contracts

	Schedule 1.1(b)
	 	Assumed Contracts

	Schedule 1.1(d)
	 	Manuals, Forms, and Diagrams

	Schedule 1.2
	 	Excluded Assets

EXHIBITS

	 	 	 
	Exhibit A
	 	Specifications

	Exhibit B
	 	Form of Bill of Sale, Assignment and Assumption

	Exhibit C
	 	Form of Patent Assignment

 

 

ASSET PURCHASE AGREEMENT

     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 MyoCathTM (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:

ARTICLE 1

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
Schedule 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.

ARTICLE 2

CONSIDERATION

     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”).

     4.2 Labels.

          (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.

     5.6 Title to 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.

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     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.

          (b) Seller and Comedicus Incorporated entered into a License Agreement, dated January 31,
2000, as amended (the “License Agreement”). Except as set forth on Schedule 5.8,
the License Agreement is in full force and effect and is valid and binding upon the parties thereto
in accordance with its terms. Except as set forth on Schedule 5.8, neither Seller nor
Comedicus Incorporated has breached any representation, warranty or covenant contained in the
License Agreement and is not in default with respect thereto.

          (c) Seller has not entered into any agreement or commitment or obligation with any
un-Affiliated third Person that conflicts in any way with its obligations under this Agreement.

          (d) Each individual and entity, including each employee, agent, consultant, and contractor,
who has materially contributed to or participated in any material way in the conception, creation,
reduction to practice and/or development of the Product Intellectual Property was at the time of
such contribution or participation a party to and bound by a valid, enforceable, duly executed
agreement with Seller, a copy of which has been previously provided to Buyer (the “Invention
Agreement”).

          (e) To the best of Seller’s knowledge, the Product Intellectual Property is valid and
enforceable.

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          (f) To the best of Seller’s knowledge, no product or process incorporating any Product
Intellectual Property infringes, misappropriates, or otherwise violates any IP Rights of any
un-Affiliated third Person.

          (g) Each of Seller’s consultants, agents, advisors, attorneys, outside contractors and
clinical investigators having access to any confidential information will be subject to a valid,
binding and enforceable agreement or obligation with respect to nondisclosure and non-use of
confidential information.

     5.9 No Other Representations. Seller is not making any representations or warranties,
express or implied, of any nature whatsoever with respect to the Assets, except for the
representations and warranties in this Article 5.

ARTICLE 6

REPRESENTATIONS AND WARRANTIES OF BUYER

Buyer represents and warrants to Seller as follows;

     6.1 Organization and Good Standing. Buyer is a duly incorporated, duly organized, and
validly existing corporation in good standing under the laws of the State of California, 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.

     6.2 Binding Agreement. This Agreement has been duly executed and delivered by Buyer
and is a valid and binding obligation and agreement of Buyer, enforceable in accordance with its
terms (subject to Enforcement Limitations). The execution, delivery, and performance of this
Agreement have received all necessary corporate approval 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 Buyer or (b) any judgment, law, rule, regulation or decree applicable to Buyer.

     6.3 Litigation; Claims. There is no action, suit, litigation, proceeding, claim, or
investigation pending, or to Buyer’s knowledge threatened, against or with respect to Buyer that,
if adversely determined, would be reasonably likely to have a material adverse effect on Buyer’s
ability to consummate the transactions contemplated herein. Buyer 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 that would be reasonably likely
to have a material adverse effect on Buyer’s ability to consummate the transactions contemplated
herein.

     6.4 No Other Representations. Buyer is not making any representations or warranties,
express or implied, of any nature whatsoever, except for the representations and warranties in this
Article 6.

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ARTICLE 7

ITEMS TO BE DELIVERED AT CLOSING

     7.1 Deliveries by Seller. At Closing, Seller shall deliver to Buyer:

          (a) a Bill of Sale, Assignment and Assumption (the “Bill of Sale”), executed by
Seller, in the form attached hereto as Exhibit B;

          (b) an assignment, executed by Seller, in the form attached hereto as Exhibit C for
any patents or patent applications comprising part of the Assets;

          (c) such other items expressly contemplated herein, including the Assets not necessary for
Seller to fulfill its commitments in Article 4.

     7.2 Deliveries by Buyer. At Closing, Buyer shall deliver to Seller:

          (a) the Purchase Price;

          (b) the Bill of Sale, executed by Buyer; and

          (c) such other items expressly contemplated herein.

ARTICLE 8

SURVIVAL AND INDEMNIFICATION

     8.1 Survival. In addition to the representations and warranties set forth in
Article 5, the statements contained in the Schedules, read in conjunction with the
applicable representation set forth in Article 5, shall be deemed to be representations and
warranties of Seller hereunder. The representations and warranties hereunder shall survive the
Closing and shall expire and terminate one year thereafter, except for claims based on fraud or
intentional misrepresentation (“Fraud Claims”), which shall survive until the expiration of
the applicable statute of limitations. The expiration of the survival period of the
representations and warranties provided herein shall not affect the rights of any party in respect
of any claim made by the party in a writing received by the other party before expiration of the
survival period.

     8.2 Indemnification.

          (a) Seller shall indemnify and hold Buyer and its Affiliates and each of their respective
officers, directors, shareholders and assignees harmless from and against any and all liabilities,
damages, losses, costs and expenses (including reasonable attorneys’ fees and expenses) (each, a
“Loss” and collectively, “Losses”) arising out of or resulting from (i) any
inaccuracy in, or breach of, any representation, warranty, covenant or agreement made herein by
Seller or in any agreement delivered pursuant hereto, (ii) the nonperformance or breach of any
covenant or obligation to be performed by Seller hereunder or in any agreement delivered pursuant
hereto, (iii) any liability of Seller that is not an Assumed Liability (including any liability of
Seller that becomes a liability of Buyer under any common-law doctrine of de-facto merger or any
doctrine of successor liability under any legal requirement), or (iv) the actual or

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threatened commencement of any actions, suits, proceedings, demands, judgments, costs, legal
fees and other expenses caused by the foregoing.

          (b) Buyer shall indemnify and hold harmless Seller and its Affiliates and each of their
respective officers, directors, shareholders and assignees from and against any and all Losses
arising out of or resulting from (i) any inaccuracy in, or breach of, any representation, warranty,
covenant or agreement made herein by Buyer or in any agreement or document delivered pursuant
hereto, (ii) the nonperformance or breach of any covenant or obligation to be performed by Buyer
hereunder or in any agreement or document delivered pursuant hereto, (iii) any Assumed Liability or
any liabilities or obligations arising from ownership or operation of the Assets after the Closing
Date, or (iv) the actual or threatened commencement of any actions, suits, proceedings, demands,
judgments, costs, legal fees and other expenses caused by any of the foregoing.

          (c) An indemnified party hereunder (the “Claiming Party”) shall give the indemnifying
party (the “Indemnifying Party”) prompt written notice of any claim of a third party (a
“Third-Party Claim”) as to which the Claiming Party proposes to demand indemnification
hereunder. The Indemnifying Party shall forthwith assume the Good Faith Defense (as hereinafter
defined) of the Third-Party Claim at its own expense and may settle the Third-Party Claim, but may
not, without the consent of the Claiming Party, agree to (i) any injunctive relief affecting the
Claiming Party or (ii) any settlement that would adversely affect the business or operations of the
Claiming Party. The Indemnifying Party shall keep the Claiming Party updated on a reasonable basis
regarding the status of the defense or settlement of any Third-Party Claim. “Good Faith
Defense” means legal defense conducted by reputable counsel of good standing. If a Good Faith
Defense is not commenced within 20 days following receipt of notice of the Third-Party Claim from
the Claiming Party (or such shorter period, if any, during which a defense must be commenced in
order for the defendant to preserve its right), the Claiming Party may, at its option, settle or
defend the claim at the expense of the Indemnifying Party. The Claiming Party shall keep the
Indemnifying Party updated on a reasonable basis regarding the status of the claim and its defense
or settlement. Subject to the other provisions of this Section 8.2, in the event that (A)
a final judgment or order in favor of the third party is rendered against the Claiming Party, that
is not subject to appeal or with respect to which the time to appeal has expired without an appeal
having been made, or (B) the Third-Party Claim is settled in accordance with this Section
8.2(c), resulting in liability on the part of the Claiming Party, then the amount of the
liability together with costs and expenses (including reasonable attorneys’ fees) incurred by the
Claiming Party shall be paid by the Indemnifying Party.

          (d) In addition to and not in limitation of Section 8.2(c), a Claiming Party shall
give prompt written notice to an Indemnifying Party of each claim for indemnification hereunder as
to which the Claiming Party proposes to demand indemnification specifying the amount and nature of
the claim. The failure to give notice to the Indemnifying Party shall not relieve the Indemnifying
Party of any liability hereunder, unless the Indemnifying Party was prejudiced thereby.

-10-

 

          (e) Except for Fraud Claims, the following shall apply:

               (i) (A) The right of Buyer to indemnification hereunder shall be limited, in the
aggregate, to an amount equal to the Purchase Price (the “Cap”); and

                     (B) Seller shall have no obligation to indemnify Buyer hereunder unless and until the
aggregate amount of indemnification to which Buyer is entitled (including for Third-Party
Claims), exceeds $10,000 (the “Basket”), and then only for any amounts in excess of
the Basket.

               (ii) (A) The right of seller to indemnification hereunder shall be limited, in the
aggregate, to an amount equal to the Cap; and

                     (B) Buyer shall have no obligation to indemnify Seller hereunder unless and until the
aggregate amount of indemnification to which Seller is entitled (including for Third-Party
Claims) exceeds the Basket, and then only for any amounts in excess of the Basket.

               (iii) The right to indemnity under this Section 8.2 shall terminate on the
first anniversary of the Closing Date or, in the event of a fraud or intentional
misrepresentation, such right to indemnity shall terminate on the end of the applicable
statute of limitations.

ARTICLE 9

OTHER PROVISIONS

     9.1 Confidentiality.

          (a) Each party, when it is the receiving party, agrees to hold the disclosing party’s
Confidential Information (as defined below) in strict confidence and not to disclose such
Confidential Information to any other Person without the prior written consent of the disclosing
party; and not to use, at any time following the execution of this Agreement, any Confidential
Information of the disclosing party for any purposes other than as permitted by this Agreement and
to further the intents and purposes of this Agreement; provided, however, that each
taxpayer participating in this transaction (and each employee, representative, or other agent of
the taxpayer) may disclose to any and all persons, without limitation of any kind, the tax
treatment and tax structure of the transaction and all materials of any kind (including opinions or
other tax analyses) that are provided to the taxpayer relating to such tax treatment and tax
structure. “Confidential Information” means confidential and proprietary information of a
party, whether in written, printed, verbal or electronic form, and whether disclosed before or
after the effective date of this Agreement, including the terms of this Agreement, research and
development activities, product design details and specifications, technology and know-how, sales
and marketing plans, finances and business forecasts, procurement requirements and vendor
information, customer lists, personnel information, and other proprietary information (including
any Product intellectual Property, Files and Clinical Records, and Manuals, Forms and Diagrams, all
of which shall be deemed to have been disclosed by Buyer to Seller).

-11-

 

          (b) If a receiving party is required to disclose Confidential Information of the disclosing
party by any applicable law, regulation, legal process, judicial order or by any applicable order
or requirement of any governmental or regulatory authority, it may do so only to the extent
required thereby; provided, however, that the receiving party will (i) to the
extent practical, provide advance notice to the disclosing party of the required disclosure to
allow the disclosing party an opportunity to take steps to object to, prevent or limit its
disclosure or obtain a protective or other similar order with respect to the required disclosure
(collectively, “Protective Measures”), (ii) if requested by the disclosing party, cooperate
with the disclosing party in seeking Protective Measures, and (iii) restrict disclosure to only
that portion of the Confidential Information that is required to be disclosed.

     9.2 Expenses; Certain Taxes.

          (a) Each party hereto shall pay all expenses incurred by the party (or at the party’s
direction) in connection with the transactions contemplated by this Agreement, including all fees
and costs of attorneys, accountants, and other professional advisors and brokers.

          (b) Buyer shall pay all sales, use, transfer, documentary, and similar taxes (if any) imposed
on the transactions contemplated by this Agreement.

     9.3 Successors. The rights created by this Agreement shall inure to the benefit of,
and the obligations created hereby shall be binding upon, the successors and assigns of the
respective parties hereto.

     9.4 Assignment. Subject to Section 3.2, no party may assign this Agreement or
any of its rights or obligations hereunder without the other party’s prior written consent, except
that either party may sell, assign or otherwise transfer this Agreement, in whole or in part, to
any Person that purchases all or substantially all of such party’s assets by way of merger,
consolidation, sale of stock or assets without the other party’s consent; provided,
however, that Buyer may assign this Agreement or any of its rights or obligations hereunder
to any of its Affiliates without Seller’s consent. Any attempted assignment in contravention of
the foregoing shall be void.

     9.5 Further Assurances. From time to time after Closing, each party and its
Affiliates shall execute and deliver such documents and take such actions as the other parry
reasonably requests in connection with carrying out and effectuating the intent and purpose hereof
and all transactions and undertakings contemplated hereby.

     9.6 Notices. All notices and other communications hereunder shall be in writing and
shall be effective only if delivered by hand or by nationally recognized overnight courier service
to the addresses below:

-12-

 

     If to Buyer:

			
	          	 	Advanced Cardiovascular Systems, Inc.

3200 Lakeside Drive

Santa Clara, California 95054-2807

Attention: Thomas R. Peterson

Facsimile: (408) 845-3987

     with a copy to:

			
	          	 	Faegre & Benson LLP

2200 Wells Fargo Center

90 South Seventh Street

Minneapolis, Minnesota 55402-3901

Attention: Michael A Stanchfield

Facsimile: (612) 766-1600

     If to Seller:

			
	          	 	Bioheart, Inc.

2400 North Commerce Parkway

Suite 408

Weston, Florida 33133

Attention: John L. Babitt

Facsimile: (954) 385-5340

     with a copy to:

			
	          	 	Tobin & Reyes, P.A.

7251 West Palmetto Park Road

Suite 205

Boca Raton, Florida 33433

Attention: David S. Tobin, Esq.

Facsimile: (561) 620-0657

or to such other address as a party may from time to time designate in writing in accordance with
the foregoing. All notices and other communications shall be deemed to have been given upon
receipt thereof.

     9.7 Headings and Table of Contents; Certain References. The headings contained in
this Agreement and the table of contents hereof are for convenience of reference only and neither
such headings nor such table of contents shall affect the construction or interpretation of this
Agreement. Each reference herein to “include” or “includes” or “including”
shall be deemed to be followed by the words “without limitation.” Each reference herein to
Schedules, Sections, Articles, or Exhibits shall be deemed to be followed by “hereto” or
“herein” unless otherwise noted.

-13-

 

     9.8 Governing Law. This Agreement shall be governed by and construed in accordance
with the material laws of the State of California, without giving effect to principles of conflicts
of law.

     9.9 Waiver of Provisions. Compliance with any term, covenant, representation,
warranty or condition of this Agreement may be waived only by a written instrument executed by the
party waiving compliance. No waiver of any provision hereof or any breach of any provision hereof,
whether by conduct or otherwise, in any one or more instances shall be deemed to be, or construed
as, a further or continuing waiver of any such provision or breach.

     9.10 Counterparts. This Agreement may be executed in any number of counterparts, each
of which shall be deemed an original, and all of which taken together shall constitute one single
agreement

     9.11 Entire Agreement. This Agreement, together with all Schedules and Exhibits
hereto (which are incorporated herein as part of this Agreement), constitutes the entire agreement
between the parties relating to the subject matter hereof and supersedes and cancels any and all
prior agreements and understandings, written or oral, relating to the subject matter hereof, and
may not be amended or modified except by a writing signed by all parties hereto.

     9.12 Severability. The provisions of this Agreement shall be deemed severable, and if
any provision or application of any provision of this Agreement is held unlawful, invalid, void or
unenforceable in any respect, such provision shall be revised or applied in a manner that renders
it lawful and enforceable to the fullest extent possible to effectuate the intent of the parties
hereto.

     9.13 No Joint Venture. Nothing in this Agreement shall be deemed to create an agency,
joint venture or partnership relationship between the parties.

     9.14 No Third-Party Rights. This Agreement is not intended, and shall not be
construed, to create any rights in any Person other than Seller and Buyer, and no Person may assert
any rights as third-party beneficiary hereunder.

     9.15 Press Releases. Neither party (which shall include their respective employees,
agents and representatives) shall issue or disseminate any press release or statement, nor initiate
any communication of information regarding the terms of this Agreement (written or oral) to the
communications media or third parties without the prior written consent of the other party.

-14-

 

     IN WITNESS WHEREOF, the parties have caused this Asset Purchase Agreement to be duly executed
as of the date and year first above written.

ADVANCED CARDIOVASCULAR 

SYSTEMS, INC.

 

			
	By:	 	

 

Mark A. Murray

Vice President, Finance and Business

Development

			
		 	 

BIOHEART. INC.

			
	By:	 	

 

			
	Its:	 	

 

-15-

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCatho PEMI Device

	 	Cover Page

 

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	APPROVAL	 	 	EFFECTIVITY	 
	 	REV	 	 	ECN#	 	 	DESCRIPTION	 	 	(sign & date)	 	 	DATE	 
	 	 	1	 	 	 	 	N/A	 	 	 	First draft of specification

	 	 	Mike Lee
	 	 	02-JUN-00	 
	 	 	2	 	 	 	 	N/A	 	 	 	Update of specification

	 	 	Mike Lee
	 	 	05-OCT-00	 
	 	 	3	 	 	 	 	N/A	 	 	 	Update of specification

	 	 	Mike Lee
	 	 	16-JAN-01	 
	 	 	4	 	 	 	 	N/A	 	 	 	Update of specification

	 	 	Mike Lee
	 	 	28-MAR-01	 
	 	 	5	 	 	 	 	N/A	 	 	 	Title device as SR200 MyoCathTM

	 	 	Mike Lee
	 	 	05-DEC-01	 
	 	 	6	 	 	 	 	N/A	 	 	 	Update device classification, clarify 

packaging/sterilization requirements

	 	 	Mike Lee
	 	 	21-FEB-02	 
	 	 	8	 	 	 	 	N/A	 	 	 	Insertion depth reduced from 3 to 8mm to 3 to 6mm

	 	 	K. Kristoffersen
	 	 	25-Jun-02	 
	 	 	7	 	 	 	 	N/A	 	 	 	Update functional specification of lumen leak
test to remove requirement of air (other
solutions may be more relevant).

	 	 	Mike Lee
	 	 	21-FEB-02	 
	 	 	9	 	 	 	 	0400	 	 	 	Moving 6.1.2 and 6.1.3 to functional
specifications; Changing burst requirements from
5 psi to 60 psi for the flush lumen, and 75 psi
for the inject lumen; Decreasing maximum plunger
force from 10 lb. Max to 1.75 lb. Max;
Increasing several minimum tensile
specifications; Documenting additional
functional criteria.

	 	 	D. Fifer
	 	 	01-Nov-02	 
	 	 	10	 	 	 	 	0436	 	 	 	Move 6.2.10.c to 6.6.1.

	 	 	M. Lee
	 	 	08-Nov-02	 
	 

DISTRIBUTION

	 	 	 	 	 	 	 	 	 
	 
	 	LOCATION	 	 	No.	 	 	RETRIEVAL (initial & date)	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 	 
	 	 	 	 	 	 	 
	 

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCathTM PEMI Device

	 	Cover Page

 

	1.0	 	TITLE: SR200 MyoCathTM (PEMI) Percutaneous MicroImplant Device
	 
	 	 	Review Stage: Design Verification Phase
	 
	2.0	 	SCOPE:
	 
	 	 	This Product Specification applies to the SR200 MyoCathTM device in the family of PEMI
devices, hereafter known as the SR200 MyoCathTM. To this date PEMI, SR200, and MyoCathTM have
been used synonymously. In the future, it is the intent that the SR200 is a model in the
MyoCathTM catheter family, in the larger PEMI family of percutaneous devices.
	 
	3.0	 	REFERENCES:
	 
	 	 	D10-00026-01M-Curve MyoCathTM

D10-00026-02L-Curve MyoCathTM
	 
	4.0	 	CLINICAL APPLICATION:
	 
	 	 	The SR200 MyoCathTM is a system to allow injection of myogenic, angiogenic and/or other
aqueous solutions into the left ventricle myocardium. The SR200 MyoCathTM is for single use
only.
	 
	 	 	Additional clinical justifications are in the SR200 MyoCathTM Test Plan documents SR200
MyoCathTM Bench Test Plan, SR200 MyoCathTM Animal Test Plan, and SR200 MyoCathTM
Biocompatibility Test Plan.
	 
	5.0	 	DEVICE DESCRIPTION:

	 	5.1.	 	The device is a catheter comprised of an injection lumen and a sheath lumen.
The injection lumen should allow for the solution to be delivered with a reasonably low
number of adverse events, within a reasonable rate in accordance with user feedback and
with an acceptable level of retention and functionality. The sheath lumen allows
flushing of the space between the core needle and the deflectable sheath to enhance
needle movement.
	 
	 	5.2.	 	The distal end of the device system should be atraumatic and facilitate ease of
entry/tracking to the appropriate location in the heart. The distal needle tip should
not buckle under standard insertion techniques.
	 
	 	5.3.	 	The proximal end of the catheter should include sufficient standard connectors
to allow the physician to connect to, monitor, flush and inject through. Standard
syringe compatibility allows for manual incremental injections and flexibility for
various solution delivery volumes.

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCathTM PEMI Device

	 	Cover Page

 

	 	5.4.	 	The device is anatomically curved, or allowed to curve, to allow for proper
placement(s) into the left ventricle. Positioning of the device will be predictable
and stable once in place.
	 
	 	5.5.	 	The environment in which the SR200 MyoCathTM is to be used will be a cardiology
suite. The product will interface with cardiology equipment, instruments and devices.
	 
	 	5.6.	 	This device is for single use only.

	6.0	 	REGULATORY CLASSIFICATION

	 	5.1.	 	FDA Classification:

Class II
	 
	 	5.2.	 	Outside U.S. Classifications:

Classifications for other countries (e.g. Europe, Canada, etc.) will be assessed as
applicable.

	6.0	 	DEVICE SPECIFICATION:

	 	6.1.	 	Dimensional Specification:

	 	6.1.1.	 	The system must pass through (enter and exit) a ring gauge of diameter
< 0.105” (note 8.0F = 0.105”).
	 
	 	6.1.2.	 	The insertable length of the device (distal catheter tip to the proximal
strain relief) should be 105-125 cm.
	 
	 	6.1.3.	 	The length of the needle should be ±1.5mm of the length indicated on the
depth gauge for a range between 3-6mm while the catheter is in a mock arch
curve.

	 	6.2.	 	Functional Specification

	 	6.2.1.	 	Flush and Inject:

			
	                                             a.)	 	The time to prepare the Injection Lumen and
Sheath Lumen must be compatible with the time restraints of a
cardiology procedure- less than 30 seconds for each lumen when using
water at room temperature.

			
	                                             b.)	 	The flow rate of room temperature water through
the injection lumen must be at least 0.05cc/sec of water with a force
less than

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCathTM PEMI Device

	 	Cover Page

 

			
	                                                  	 	1.75 on the 1cc syringe plunger. This plunger force correlates to
the thumb pressure necessary to activate syringe injection through
the catheter.

			
	                                             c.)	 	The injection lumen must maintain an internal
pressure of 75 psi. minimum.

			
	                                             d.)	 	The sheath lumen must maintain an internal
pressure of 60 psi. minimum.

	 	6.2.2.	 	Tensile Specifications:

			
	                                              a.)	 	Injection (Needle) Core

	 	 	 	 	 
	•
	 	Needle to distal core (polyimide) tubing

	 	1.0 lb. min.
	•
	 	Proximal core (hypotube) to distal core (polyimide)

	 	1.5 lb. min.
	•
	 	Proximal core (hypotube) to handle component (proximal slide)

	 	2.5 lb. min.

			
	                                              b.)	 	Fluid Path Connectors

	 	 	 	 	 
	•
	 	Luer connector to tubing

	 	3.0 lb. min.
	 	 	(Sheath/flush Luer to flextube)
	 	 
	 	 	(Inject Luer to flextube)
	 	 
	•
	 	Tubing to handle component

	 	3.0 lb. min.
	 	 	(Inject flextube to proximal slide)
	 	 
	 	 	(Sheath inner flextube to seal housing)
	 	 

			
	                                              c.)	 	Catheter Shaft

	 	 	 	 	 
	•
	 	Tip to pull-wire

	 	3.0 lb. min.
	•
	 	Tip to ribbon

	 	3.0 lb. min.
	•
	 	Deflectable tip to shaft (distal outer bond)

	 	2.0 lb. min.
	•
	 	Shaft to handle (proximal braid to deflection rod)

	 	4.0 lb. min.

			
	                                              d.)	 	Internal Handle

	 	 	 	 	 
	•
	 	Pull-wire to anchor pin

	 	4.0 lb. min.
	•
	 	Seal housing to multilumen

	 	2.0 lb. min.

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCathTM PEMI Device

	 	Cover Page

 

	 	6.2.3.	 	Needle Lateral Fatigue:
	 
	 	 	 	Needle Bond must be able to withstand 300 cycles at .200” range test with
catheter fixed 2cm proximal of the catheter tip (simulating the needle
insertion into a beating heart).
	 
	 	6.2.4.	 	Flexibility:
	 
	 	 	 	The device flexibility must meet the performance and safety requirements of
the user.
	 
	 	6.2.5.	 	Torque:
	 
	 	 	 	The device torque characteristics must meet the performance and safety
requirements of the user.
	 
	 	 	 	Catheter Shaft:

	 	 	 	 	 
	•	 	Entire shaft (tip to handle) must withstand 2 handle rotations while
maintaining needle insertion and auto-retraction.
	•
	 	Shaft to deflection rod

	 	2.5 oz-in.
	•
	 	Distal outer bond

	 	2.5 oz-in.

	 	6.2.6.	 	Kink Resistance:
	 
	 	 	 	The distal section must be able to withstand a 90° bend (in preferential
plane only) around a 0.5” radius without kinking.
	 
	 	 	 	The proximal section must be able to withstand a 90° bend around a 2.5”
radius without kinking.
	 
	 	6.2.7.	 	Deflection:

			
	a.)	 	Curvature Compliance— The deflection curvature
must be compatible with the expectations of the user and the product
labeling.

			
	b.)	 	Repeated Deflection— The distal section
reliably and repeatedly deflects during a standard procedure. Device
should deflect at least 100 times at body temperature.

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

	 	6.2.8.	 	Needle Insertion and Retraction:
	 
	 	 	 	The manual needle core advancement feature must be compatible with the
expectations of the user and the product labeling. The maximum advancement
force must be less than 4.0 lb. The needle retraction mechanism must
reliably and fully retract the extended needle when the manual force is
removed.
	 
	 	6.2.9.	 	Radiopacity:
	 
	 	 	 	The catheter must be adequately radiopaque, allowing fluoroscopic
visualization of the catheter during use.
	 
	 	6.2.10.	 	Finished Device:

			
	a.)	 	Must pass biocompatibility testing per ISO
10993 for an external communicating device in circulating blood with
limited contact duration.

			
	b.)	 	Must be non-pyrogenic

	 	6.3.	 	Physical Specification

	 	6.3.1.	 	The injection and sheath connector(s) will be labeled
	 
	 	6.3.2.	 	The device should have the BIOHEART logo embossed or printed on it.
	 
	 	6.3.3.	 	The device should have adequate markings/features to allow for accurate
insertion depths.

	 	6.4.	 	Packaging and Labeling

	 	6.4.1.	 	The device will be packaged in a PETG tray and tray lid that is within a
Tyvek/Nylon-Polyethylene pouch boxed in a chipboard carton.
	 
	 	6.4.2.	 	Packaging for sterilization shall be in accordance with AAMI/FDS-1 TIR27, ISO
11137, EN 552/556, or equivalent.
	 
	 	6.4.3.	 	Shipping configuration shall be designed to withstand simulated transit per
ASTM 4169, Distribution Cycle 13, or equivalent.
	 
	 	6.4.4.	 	Product labels will be on the pouch and the box.

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

EXHIBIT A

	 	 	 
	BIOHEART INC.

	 	Doc. D96-00026-01
	Product Specification

	 	Rev.:10
	TITLE: SR200 MyoCathTM PEMI Device

	 	Cover Page

 

	 	6.4.5.	 	Label information should meet the applicable regulatory clearance/approvals.

	 	6.5.	 	Sterilization

	 	6.5.1.	 	The product will be sterilized via E-beam sterilization method to a SAL of
10-6.

	 	6.6.	 	Shelf Life

	 	6.6.1.	 	Must be sterile in unopened package, through labeled “Use by Date.”
	 
	 	6.6.2.	 	The product and sterile packaging will have a shelf life of at least 3
months, with 2 years preferable.

 

CONFIDENTIAL

May not be reproduced, transmitted or disseminated in any form or by any means

without the written permission of an authorized representative of Bioheart, Inc.

 

 

Exhibit B

Bill of Sale, Assignment and Assumption

     Reference is hereby made to the Asset Purchase Agreement, dated as of June 24, 2003 (the
“Purchase Agreement”), between Advanced Cardiovascular Systems, Inc., a California corporation
(“Buyer”), and Bioheart, Inc., a Florida corporation (“Seller”). Each term used in this Bill of
Sale, Assignment and Assumption, if not otherwise defined herein, has the meaning ascribed therefor
in the Purchase Agreement.

     In exchange for good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, (a) Seller hereby sells, assigns, transfers and conveys to Buyer all right,
title and interest in and to all of the Assets, and (b) Buyer hereby assumes and agrees to perform
when due the Assumed Liabilities.

     This Bill of Sale, Assignment and Assumption may be executed in one or more counterparts, any
one of which need not contain the signature of more than one party, but all such counterparts taken
together will constitute one and the same instrument.

	 	 	 	 	 
	Dated: June 24, 2003 	ADVANCED CARDIOVASCULAR SYSTEMS, INC.

 	 
	 	By:  	/s/
 	 
	 	 	Mark A. Murray 	 
	 	 	Vice President, Finance and Business
Development 	 
	 
	 	BIOHEART, INC.

 	 
	 	By:  	 	 
	 	 	Its:       	 
	 	 	 	 

B-1

 

	 	 	 	 	 

Exhibit C

Patent Assignment

     This Patent Assignment (this “Assignment”) is made effective as of this 24th day of June,
2003, by BIOHEART, INC., a Florida corporation (“Assignor”), having its principal offices at 2400
North Commerce Parkway, Suite 408, Weston, FL, and ADVANCED CARDIOVASCULAR SYSTEMS, INC., a
California corporation (“Assignee”), having its principal offices at 3200 Lakeside Drive, Santa
Clara, CA.

RECITALS

	 	A.	 	Assignor is the sole and exclusive owner of the entire right, title and
interest in and to the United States Letters Patents and pending patent applications
(collectively the “Patents”) listed on Schedule A attached hereto, and in and
to all inventions claimed or disclosed therein (“Inventions”).
	 
	 	B.	 	Assignee is desirous of acquiring the entire right, title and interest in, to
and under said Patents and the Inventions claimed therein.

AGREEMENT

     NOW, THEREFORE, in consideration of and exchange for good and valuable consideration, the
receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound thereby,
the parties agree as follows:

	1.	 	Assignor does hereby sell, assign, transfer and set over to Assignor all right, title,
interest, and benefit of the Patents and Inventions, and any patents which may be granted or
any patent applications related to the Patents and Inventions, including without limitation
all reexaminations, reissues, continuations, continuations-in-part, divisions, other
extensions, U. S. patents and applications having claims that are deemed patentable over any
of the above Patents or Inventions based on 35 USC 103(c), and any international or non-U. S.
patents and applications claiming priority from any of the above Patents or Inventions, the
same to be held and enjoyed by Assignee for its own use and enjoyment, and for the use and
enjoyment of its successors, assigns, or other legal representatives, to the end of the term
or terms of the Patents or any patents that may issue from the Patents, as fully and entirely
as the same would have been held and enjoyed by Assignor if this assignment and sale had not
been made; together with all claims for damages by reason of past infringement of the Patents,
with the right to sue for and collect the same for its own use and enjoyment, and for the use
and enjoyment of its successors, assigns or other legal representatives.
	 
	2.	 	Assignor hereby requests the Commissioner of Patents and Trademarks of the United States of
America, or any official or any jurisdiction whose duty it is to issue patents, to issue any
and all patents resulting from applications pertaining to any of the Patents or Inventions to
Assignee or its designee in accordance with the terms of this instrument.

C-1

 

	3.	 	Assignor agrees to execute all such documents, instruments or agreements necessary to more
fully vest in Assignee the Patents and Inventions being assigned hereunder.

     IN WITNESS WHEREOF, Assignor has caused this Assignment to be executed as of the date first
above written.

	 	 	 	 	 
	 	ASSIGNOR

 	 
	 	By:  	/s/
 	 
	 	 	Name:  	 	 
	 	 	Title:  	 	 
	 

	 	 	 	 	 	 	 
	STATE OF __________________

	 	 	)	 	 	 
	 

	 	 	)	 	 	§.
	COUNTY OF __________________

	 	 	)	 	 	 

     On this ___, before me personally appeared __________________, who produced
__________________ as identification, who executed the foregoing instrument, and acknowledged
that s/he executed the same as his/her free act and deed.

	 	 	 	 	 
	 	 	 
	 	                                         /s/
 	 
	 	Notary Public      	 
	 	 	 
	 

C-2EX-10.10 Manufacturing and Service Agreement

 

Exhibit 10.10

MANUFACTURING AND SERVICE AGREEMENT

     This Manufacturing and Service Agreement (this “Agreement”) is effective as of September 30,
2005 (the “Effective Date”), by and between Bioheart, Inc., a Florida corporation (“Bioheart”), and
Bolton Medical, Inc., a New Jersey corporation (“Bolton”).

RECITALS

     WHEREAS, Bioheart is a developer of a novel cellular based therapies to regenerate damaged
heart muscle tissue, among these therapies is the use of autologous myogenic cells
(“MyoCellä”) that can be delivered to the patient via (i) a catheter-based microimplant
system (“MyoCathä”) or (ii) a surgical procedure; and

     WHEREAS, Bioheart has developed specifications for the MyoCathä cardiac catheter to be
utilized in connection with the delivery of its MyoCellä product to a patient’s damaged heart
muscle tissue, but currently does not have the capabilities of manufacturing the Product (as
hereinafter defined); and

     WHEREAS, Bolton is experienced in and has the capability to provide manufacturing support for
the Product; and

     WHEREAS, the parties desire to enter into an arrangement whereby Bolton will manufacture the
Product for Bioheart to be used in clinical trials, and Bioheart will buy Products pursuant to the
terms of this Agreement;

     NOW, THEREFORE, in consideration of the mutual promises of the parties hereto and of good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties
hereto agree as follows:

ARTICLE I

DEFINITIONS

     When used in this Agreement, each of the following terms shall have the meaning specified in
this Article I:

     Section 1.1 Product. “Product” or “Products” shall mean the item to be
manufactured listed on Exhibit A as amended from time to time pursuant to Article III.

     Section 1.2 Affiliate. “Affiliate” means any entity which controls, is
controlled by, or is under common control with Bioheart or Bolton, as the case may be.

     Section 1.3 Confidential Information. “Confidential Information” shall have
the meaning specified in Article X.

     Section 1.4 FDA. “FDA” means the Food and Drug Administration.

 

 

     Section 1.5 Forecast. “Forecast” means a three-month “moving window”
prediction on Product needs in the form of a written or electronic communication from Bioheart to
Bolton and is intended to be used as a tool by which Bolton orders components.

     Section 1.6 Forecast Period. “Forecast Period” means the three-months
following the end of the one-month period for each Order.

     Section 1.7 Bolton Technology. “Bolton Technology” means all Intellectual
Property, including process sequences, validations and all other processes and procedures developed
by Bolton.

     Section 1.8 Bioheart Technology. “Bioheart Technology” means all Intellectual
Property developed by Bioheart.

     Section 1.9 Improvements. “Improvements” means any information, whether or
not patentable, which is developed or acquired by Bioheart during the term of the Agreement
relating to the Bioheart Technology.

     Section 1.10 Intellectual Property. “Intellectual Property” means all
patents, patent applications, inventors’ certificates and applications therefore, printed and
unprinted technical data, know-how, trade secrets, copyrights and other intellectual property
rights, inventions, discoveries, techniques, works, processes, methods, plans, software, designs,
specifications, communications, protocols, source and object codes and modifications, test
procedures, program cards, tapes, disks and all other scientific or technical information, in
whatever form.

     Section 1.11 Order. “Order” means a written or electronic communication from
Bioheart to Bolton for Products for a one-month period.

     Section 1.12 Specification. “Specification” means a design document or
document package that describes components, packaging, labeling, and functional test requirements
for the Product.

ARTICLE II

ORDERS; ALTERNATIVE SUPPLIERS; FORECAST

     Section 2.1 Orders.

     (a) Orders. Each Order shall be in the form of a written or electronic
communication and shall contain the following information: (i) a description of the Product
by model number and revision number, (ii) the quantity of the Product, and (iii) the
delivery date or shipping schedule. Each Order shall provide an order number for billing
purposes and may include other instructions and terms as may be appropriate under the
circumstances.

     (b) Confirmation of Orders. Bolton shall confirm all Orders within five
business days of receipt. If Bolton is unable to meet the delivery schedule set forth in a
proposed Order, or finds the schedule to be unacceptable for some other reason, the parties
shall negotiate in good faith to resolve the disputed matter(s).

2

 

     (c) Delivery of Orders. Bolton will deliver each Product within the time
specified in the confirmation of the Order. Expedited Orders are subject to Bolton’s
capacity and ability to obtain supplies.

     (d) Changed Orders. Bioheart may change an Order at any time and shall be
responsible for all costs associated with an Order change including stop orders, components,
works-in-process, and finished goods costs.

     Section 2.2 Material Management. Bolton will procure components from Bioheart
approved manufacturers or suppliers in accordance with Bioheart’s component Specifications. Bolton
will be responsible for all procurement, quality acceptance, inventory management, and supplier
certification/qualification of components required for the manufacture of each Product. Bolton
will be responsible for developing and maintaining agreements (addressing component price, support
and end-of-life material management) with suppliers. Notwithstanding anything to the contrary
herein contained, Bolton does not independently warrant any components it obtains from any
supplier. Bolton’s sole warranty under this Agreement is set forth in Section 8.1.

     Section 2.3 Inability to Supply.

     (a) Acknowledgments. Bolton may not subcontract with third parties to
manufacture or supply any or all of the Products hereunder without the prior written
approval of Bioheart. Bioheart shall have the right to manufacture the Product for itself
or to have the Product manufactured by Guidant Corporation (“Guidant”) or an Affiliate of
Guidant in such quantities as Bioheart may determine from time to time in its sole
discretion; provided, however, Bioheart agrees that so long as (i) Bolton’s manufactured
Products are of a quality at least consistent with the quality of the Products manufactured
by Guidant and (ii) the Per-Unit Cost is not greater than the cost of the Product charged to
Bioheart by Guidant, Bolton shall have the right to manufacture not less than 200 of the
Products each twelve months during the Term of this Agreement. Except as set forth in the
immediately preceding sentence, Bioheart shall exclusively utilize Bolton to manufacture the
Product.

     (b) Inability to Supply; Alternative Manufacturer. Bolton shall give Bioheart
prompt written notice if Bolton determines that it is unable to timely supply Bioheart with
Products in accordance with this Agreement.

     Section 2.4 Forecasts.

     (a) Bioheart shall send a Forecast to Bolton on the first business day of every month.
Each Forecast shall be in a written or electronic communication and shall contain the
following information: (i) a description of the Product by model number and revision
number, (ii) the quantity of the Product, and (iii) the delivery date or shipping schedule
for each of the following three months. For example, Bioheart will send Bolton a Forecast
on November 3, 2005 covering production expectations for the months of December 2005 and
January and February 2006.

3

 

     (b) Bioheart may modify each forecast by the 15th day of each month for the
upcoming Forecast Period. If a Forecast change occurs either by Bioheart’s modifying a
Forecast or by a monthly Forecast’s changing the requirements of a previous Forecast,
Bioheart shall be responsible for all costs of all components ordered and paid by Bolton to
meet a Forecast before it was changed.

ARTICLE III

BIOHEART SPECIFICATION CHANGES

     Section 3.1 Change Request. Bioheart may request, from time to time, changes
to a Specification by written notice at least 90 days before the change is expected to occur.
Bioheart shall provide Bolton with the changes to the Specification, including any unique
processes, fixtures, or equipment necessary to produce the Product.

     Section 3.2 Acceptance. Bolton shall provide Bioheart with an “impact
statement” advising Bioheart of the cost of the Product with the Specification change, support
resources needed, costs associated with completing the design transfer and other implications the
change may evoke. Cost will be based on necessary personnel hours at Bolton’s then-current rates.
Upon agreement by both parties to the impact statement, Bolton shall supply Bioheart with an
effective date of when the change will be implemented and design transfer will begin.

     Section 3.3 Transfer Activities.

     (a) Bioheart will supply drafts of impacted manufacturing procedures, on-line test
procedures, fixture drawings, equipment specifications or other necessary documentation to
convey the change to Bolton.

     (b) Bioheart will provide training and certification to the Bolton transfer support
team for new designs. This training includes understanding of the Specification and unique
process activities and testing.

     (c) Bolton will be responsible for implementing processes, which include validations,
on-line verification testing, inspections, qualifications, and any other assembly, test, and
equipment documentation necessary. Bioheart technical support will be available throughout
the transfer process and any necessary validation process.

     (d) Bioheart will provide technical support to Bolton as needed after the design
transfer activities are completed.

     Section 3.4 Change Cost. Bioheart shall be responsible for all costs
associated with a Specification change including (a) excess and obsolete Products inventory, and
rework costs, up to the amount required to satisfy the most recent Order before the change and (b)
excess and obsolete component inventory cost up to the amount required to satisfy the most recent
Forecast before the change.

4

 

ARTICLE IV

RETURN GOODS AND FAILURE ANALYSIS

     Section 4.1 Product Handling. Bolton shall be responsible for handling and
decontaminating biohazard Products per Bolton’s procedures, which handling and decontamination
shall be at a cost of $75, which cost shall not be included in the standard Per-Cost. Upon
documented decontamination, Bolton shall release the returned Product to Bioheart personnel for
failure analysis. Bolton shall promptly notify Bioheart when Product arrives in the returned-goods
lab.

     Section 4.2 Failure Analysis. Bioheart shall be responsible for tracking
returned Products, conducting failure analysis, and reporting to regulatory agencies for all
Products. If the failure mode cause or corrective action involves manufacturing, Bioheart shall
provide Bolton with a copy of the failure analysis report.

     Section 4.3 Corrective Action. In the event the failure analysis report
identifies manufacturing as part of the corrective action, Bolton shall make the necessary changes
to the affected manufacturing process(es) as reasonably requested by Bioheart. Bioheart shall
incur the cost of these changes as long as the device in question originally met Bioheart
Specifications.

ARTICLE V

INVOICES; COSTS

     Section 5.1 Order Invoices. Bolton shall provide Bioheart with an invoice
upon the earlier of (a) shipment of Products to or at the direction of Bioheart, or (b) the date on
which the Products are available for shipment (the “Ready to Ship Date”). Invoices shall specify
Order number, part number, lot number(s), quantity, and price of Products as described in Section
5.3, less any credit. Payment of Bolton invoices shall be under 30 days after shipment or the
Ready to Ship Date, as applicable.

     Section 5.2 Other Invoices. Bolton shall provide Bioheart with an invoice for
services rendered outside the standard costs in Exhibit B, including unique product
testing, process validations, Specification changes. Invoices shall itemize the charges and be
within the limits set forth in the approved “impact statement.” Payment of Bolton invoices outside
the standard Per-Unit Costs shall be net 30 days.

     Section 5.3 Costs. The standard cost is a per-unit cost for each Product as
listed in Exhibit B (the “Per-Unit Cost”) and covers all activities within this Agreement
at no additional cost unless otherwise specified herein.

ARTICLE VI

DELIVERY

     Section 6.1 Shipping Documentation. Bolton shall ship finished product
directly to Bioheart’s customers and will include with every shipment a packing slip that includes
model number, lot number, revision level, number of Products and a certification of conformance to
the Specifications. Bolton will provide duplicate copies if all such documentation to Bioheart
simultaneous with each shipment.

5

 

     Section 6.2 Risk of Loss. Possession, title, responsibility and risk of loss
of the Products shall pass to Bioheart at the time of delivery to and acceptance by Bioheart or, if
the Products are shipped by common carrier, delivery to and acceptance by the carrier selected by
Bioheart. Bioheart shall bear all costs of shipping the Products. The parties acknowledge and
agree that it may become necessary for Bolton to store finished Products in its facility at the
request of Bioheart. In the event Bioheart requests Bolton to store finished Products at its
facility, Bolton agrees to do so at no charge; provided, however, title, responsibility and risk of
loss of such stored Products shall pass to Bioheart at the Ready to Ship Date.

ARTICLE VII

REGULATORY

     Section 7.1 Manufacturing. Bolton will manufacture the Products according to
the Specifications for each model number. Additionally, Bolton will manufacture the Products
according to current Good Manufacturing Practices (“cGMP”) as developed by the FDA, as such cGMP
are amended from time to time. Bolton will test all sub-assemblies and final assemblies per
Bioheart’s Specifications. Bolton is responsible for manufacturing product traceability until
delivered to Bioheart or its customer as directed by Bioheart, shall retain all such records in
accordance with the Quality Agreement described in Section 7.4 below and shall use its current
procedures, process sequences, process validations and other documentation to manufacture Products
according to the Specifications. Bolton shall also use its current procedures to receive, test and
trace incoming components.

     Section 7.2 Changes. Bolton shall communicate to Bioheart changes made to
components, processes, or test procedures used to manufacture any Product and documented. Bioheart
must approve all changes to components, processes, and test procedures prior to implementation.

     Section 7.3 Regulations. Bolton will manufacture the Products in accordance
with FDA’s Quality System Regulations manufacturing requirements.

     Section 7.4 Device History Record and Quality Standards. Bolton shall be
responsible for maintaining Product traceability in accordance with Bioheart Specifications and the
Bolton Quality Agreement then in effect between the parties.

     Section 7.6 Failure Reporting. Bolton will maintain and relay to Bioheart
quality data, inspection and test data, failure trends, and scrap data for each lot of Products
manufactured. Each party shall promptly report to the other party in writing on failure trends of
the Product that it identifies that might reveal problems in the Product. Bioheart shall be
responsible for trend analysis and will inform Bolton of any investigation and/or corrective action
necessary as a result of such analysis.

     Section 7.7 Quality Control; Inspections of Facilities; Tours of Facilities.
Bioheart shall have the right to inspect Bolton’s facilities and to conduct reasonable audits of
Bolton’s quality control inspection processes and standards, including a review of documentation at
reasonable times during normal business hours upon reasonable notice. Additionally, Bioheart shall
have the right to conduct tours ofthe Bolton’s facilities for its invited guests during normal

6

 

business hours, provided that Bioheart provides Bolton with at least 72 hours prior notice and
a list of the individuals and their employer who will be attending such tour. Bolton shall have
the right to reasonably reject any Bioheart invited guest based upon a legitimate business reason.
Inspections, audits and tours shall be limited to areas affected by Products and this Agreement.

     All information disclosed in connection with such audits or inspections shall be deemed to be
confidential information pursuant to the terms of this Agreement.

ARTICLE VIII

WARRANTY

     Section 8.1 General. Bolton’s warranty period is two years from the date of
manufacture for each Product and is limited to correction of defects in Bolton’s workmanship. For
the purpose of this Section, “workmanship” shall mean Bolton’s work in manufacturing and testing
each Product in accordance with Bioheart’s Specifications. During the warranty period, Bolton
shall, at its option and at its expense, (a) repair any defects in workmanship or replace the
Product at no charge and return the Product to Bioheart’s inventory within 30 calendar days of
Bolton’s receipt of any defective Product or (b) credit the full amount of the cost of the Product
to Bioheart. In addition, Bolton will pass on to Bioheart all manufacturer’s component warranties
to the extent they are transferable but will not independently warrant any components.

     Section 8.2 Sole Remedy. THE SOLE REMEDY UNDER THIS WARRANTY SHALL BE THE
REPAIR, REPLACEMENT OR CREDIT FOR DEFECTIVE PARTS AS STATED ABOVE. THIS WARRANTY IS IN LIEU OF ANY
OTHER WARRANTIES EITHER EXPRESS OR IMPLIED, INCLUDING MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.

ARTICLE IX

INTELLECTUAL PROPERTY RIGHTS

     Section 9.1 Bioheart Technology. Bioheart shall own the entire right, title
and interest in and to all Bioheart Technology and any Improvements thereto.

     Section 9.2 Bolton Technology. Bolton shall own the entire right, title and
interest in and to all Bolton Technology.

ARTICLE X

CONFIDENTIALITY

     Section 10.1 Definitions. For the purpose of this Agreement,

     (a) “Confidential Information” means information (in any form or media) regarding a
party’s customers, prospective customers (including lists of customers and prospective
customers), methods of operation, engineering methods and processes (including any
information which may be obtained by a party by reverse engineering, decompiling or
examining any software or hardware provided by the other party under this Agreement),
programs and databases, patents and designs, billing rates, billing procedures, vendors and
suppliers, business methods, finances, management, or any other

7

 

business information relating to such party (whether constituting a trade secret or
proprietary or otherwise) which has value to such party and is treated by such party as
being confidential; provided, however, that Confidential Information does
not include information that (i) is known to the other party prior to receipt from the
disclosing party hereunder, which knowledge shall be evidenced by written records, (ii) is
or becomes in the public domain through no breach of this Agreement, (iii) is received from
a third party without breach of any obligation of confidentiality or (iv) information
independently developed by the other party.

     (b) “Person” shall mean and include any individual, partnership, association,
corporation, trust, unincorporated organization, limited liability company or any other
business entity or enterprise.

     (c) “Representative” shall mean a party’s employees, agents, or representatives,
including, without limitation, financial advisors, lawyers, accountants, experts, and
consultants.

     Section 10.2 Nondisclosure Covenants.

     (a) In connection with this Agreement, each party (the “Disclosing Party”) may furnish
to the other party (the “Receiving Party”) or its Representatives certain Confidential
Information. For a period of three years from the date of termination or expiration of this
Agreement, the Receiving Party (i) shall maintain as confidential all Confidential
Information disclosed to it by the Disclosing Party during the term of this Agreement, (ii)
shall not, directly or indirectly, disclose any such Confidential Information to any Person
other than those Representatives of the Receiving Party whose duties justify the need to
know such Confidential Information and then only after each Representative has agreed to be
bound by the provisions of this Confidentiality Agreement and clearly understands his or her
obligation to protect the confidentiality of such Confidential Information and to restrict
the use of such Confidential Information and (iii) shall treat such Confidential Information
with the same degree of care as it treats its own Confidential Information (but in no case
with less than a reasonable degree of care).

     (b) The disclosure of any Confidential Information is solely for the purpose of
enabling each party to perform under this Agreement, and the Receiving Party shall not use
any Confidential Information disclosed by the Disclosing Party for any other purpose.

     (c) Except as otherwise set forth in this Agreement, all Confidential Information
supplied by the Disclosing Party shall remain the property of the Disclosing Party and will
be promptly returned by the Receiving Party upon receipt of written request therefore or as
provided in Section 12.5 hereof.

     (d) If the Receiving Party or its Representative is requested or becomes legally
compelled to disclose any of the Confidential Information, it will provide the Disclosing
Party with prompt written notice. If a protective order or other remedy is not obtained,
then only that part of the Confidential Information that is legally required to be

8

 

furnished will be furnished, and reasonable efforts will be made to obtain reliable
assurances of confidentiality.

     Section 10.3 Injunctive Relief Authorized. Any material breach of this
Section by a party or its Representatives will cause irreparable injury, and the non-breaching
party shall be entitled to equitable relief, including injunctive relief and specific performance,
in the event of a breach. The above will not be construed to limit the remedies available to a
party. In addition, the prevailing party will be entitled to be reimbursed for all of its
attorneys’ fees and expenses at all levels of proceedings and for investigations from the
non-prevailing party.

     Section 10.4 Effect of Termination. This Article X shall survive termination
of this Agreement.

ARTICLE XI

INDEMNIFICATION

     Section 11.1 By Bioheart. The Parties acknowledge that Bioheart will have
control of and responsibility for the design, development, and marketing of the Product. Bioheart
therefore agrees to indemnify, defend and hold Bolton harmless from and against any and all
demands, claims, actions, causes of action, proceedings, suits, assessments, losses, damages,
liabilities, settlements, judgments, fines, penalties, interest, costs and expenses (including fees
and disbursements of counsel) of every kind (each a “Claim,” and collectively the “Claims”) arising
out of or in connection with the use and sale of the Products to the extent such Claim does not
arise from the negligence or willful misconduct of Bolton.

     Section 11.2 By Bolton. Bolton shall indemnify, defend and hold Bioheart
harmless from and against any and all Claims arising out of or in connection with Bioheart’s
manufacture, use and sale of the Product to the extent such Claim arises from the negligence or
willful misconduct of Bolton.

     Section 11.3 Intellectual Property. Bioheart shall indemnify, defend, and
hold Bolton harmless from and against all Claims arising from or relating to any actual or alleged
infringement or misappropriation of any Intellectual Property rights of third patties arising from
or in connection with the Product, except to the extent that such Claim is based on actual or
alleged infringement or misappropriation of Bolton Technology.

     Section 11.4 Notice and Cooperation. The indemnitee under the indemnities
provided under this Article shall give the indemnitor reasonably prompt written notice of any Claim
subject to the indemnity and shall cooperate with the indemnitor and authorize the indemnitor to
defend and settle the Claim in the indemnitor’s full discretion; provided, however that neither
party may settle a Claim related to a liability 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 to conduct its business
thereafter. Any payment made by a party to settle any such Claim shall be at its own cost and
expense.

     Section 11.6 Effect of Termination. This Article XI shall survive termination
of this Agreement.

9

 

ARTICLE XII

TERM AND TERMINATION

     Section 12.1 Term. The term (the “Term”) of this Agreement shall begin on the
Effective Date and shall continue through September 30, 2007, unless terminated earlier pursuant to
the terms hereof.

     Section 12.2 [Intentionally left blank.]

     Section 12.3 Termination for Breach. Either party may terminate this
Agreement on 60 days’ written notice to the other party if the other party is in material default
or breach of any provision of this Agreement; provided, however, that if the party receiving such
notice cures the breach or default within such 60-day period (or, if such default is one which
cannot reasonably be cured within such 60-day period, takes reasonable steps to begin cure of the
default and thereafter diligently proceeds towards curing said default), this Agreement shall
continue in full force and effect.

     Section 12.4 Termination for Insolvency. This Agreement may be immediately
terminated without prejudice to any other rights which the terminating party may have, whether
under this Agreement, in law, equity or otherwise, as follows:

     (a) By either party if the other party ceases doing business as a going concern, makes
an assignment for the benefit of creditors, files a voluntary petition in bankruptcy, is
adjudicated bankrupt or insolvent, files a petition seeking for itself any reorganization,
composition, readjustment, liquidation, dissolution, or similar arrangement under any
present or future statute, law, or regulation, or files an answer admitting the material
allegations of a petition against it in any proceeding, consents to or acquiesces in the
appointment of a trustee, receiver, or liquidator of it, or of all or any substantial part
of its assets or properties, or if it or its shareholders shall take any action looking to
its dissolution or liquidation.

     (b) By either party, if within 60 days after the commencement of any proceedings
against the other party seeking reorganization, arrangement, readjustment, liquidation,
dissolution, or similar relief under any present or future statute, law, or regulation, such
proceedings shall not have been dismissed, or if within 60 days after the appointment
without such party’s consent or acquiescence of any trustee, receiver, or liquidator of it
or of all or any substantial part of its assets and properties, such appointment shall not
be vacated.

     Section 12.5 Effect of Termination.

     (a) Return of Information. Upon termination of this Agreement, each party
shall, at the request of the other party, promptly return to the other party, or otherwise
dispose of as the other party may reasonably direct, all Confidential Information, samples,
patterns, instruction books, technical pamphlets, advertising materials, plans, software,
designs, specifications, communications protocols, source and object codes, program cards,
tapes, disks and other materials, documents and papers and copies thereof whatsoever
delivered by the other party and still in its possession or under its control.

10

 

Upon termination of this Agreement for any reason, Bolton shall provide Bioheart with
all Device History Records and Device Master Records per Sections 7.4 and 7.5.

     (b) Financial Consequences. In the event of termination for any reason other
than a breach of this Agreement by Bolton, Bioheart shall pay Bolton, within 30 days of
Bolton’s invoice setting forth the termination charges under this Section:

     (i) the Per-Unit Price for all finished Products existing at the time of
termination that are delivered to Bioheart, through and including the final Order;

     (ii) Bolton’s cost (including labor, materials and a reasonable mark-up based
on the percentage of work put into the Product) for all work in process through and
including the final Order;

     (iii) Bolton’s cost of components actually ordered by Bolton which orders can
not be cancelled, to produce a number of Products equal to the greater of (i) the
number of Products contained in Bioheart’s most recent Forecast and (ii) the average
number of Products included in the Bioheart’s Forecasts for the previous [6] months
or in any previous Bioheart’s Forecasts if Termination happens in the first 6 months
of the duration of the Agreement (Bolton shall then send to Bioheart such
components); and

     (iv) if Bolton terminates this Agreement without cause, Bolton shall be
responsible for all component costs, work-in-process costs, and finished goods costs
remaining after filling all the Orders, and taking into account any costs associated
with Forecasts and Specification changes.

Upon payment in full of the charges set forth in this Section, neither party shall incur any
additional liability by reason of the termination of this Agreement.

ARTICLE XIII

MISCELLANEOUS

     Section 13.1 Governing Law and Jurisdiction. This Agreement shall be governed
by and construed in accordance with the laws of the State of Florida. Both parties consent to the
exclusive jurisdiction of the federal or state courts located in Broward County, Florida.

     Section 13.2 No Agency. It is understood and agreed between Bolton and
Bioheart that the full and exclusive relationship between them is that of an independent contractor
and nothing in this Agreement shall be construed to create any relationship between the parties
other than that of independent contractor. Neither party shall have any express or implied right
or authority to assume or create any obligations on behalf of or in the name of the other party or
to bind the other party with regard to any other contract, agreement, or undertaking with a third
party.

     Section 13.3 Titles and Headings. Titles and headings in this Agreement are
for the convenience of the parties only and are not intended to be a part of or affect the meaning
or interpretation of this Agreement.

11

 

     Section 13.4 Interpretation. Each reference herein to “include” or
“including” or “includes” shall be deemed to be followed by the words “without limitation”.

     Section 13.5 Severability of Provisions. If any term or provision of this
Agreement or the application thereof to any person or circumstance shall to any extent be invalid
or unenforceable, the remainder of this Agreement or the application of such term or provision to
persons or circumstances other than those as to which it is held invalid or unenforceable shall not
be affected, and each term and provision of this Agreement shall be valid and be enforced to the
fullest extent permitted by law.

     Section 13.6 Complete Contract; Conflicting Commercial Forms. This Agreement
constitutes the entire agreement of the parties relating to the subject matter hereof. There are
no promises, terms, conditions, obligations, or warranties other than those contained in this
Agreement. This agreement is a continuation of the Manufacturing and Services agreement signed on
December 10, 2003. Bioheart and Bolton the technology transfer has been completed and all services
provided by Bolton on and after the Effective Date shall be in accordance with the terms set forth
in this Agreement.

     Section 13.7 Amendment. This Agreement may not be amended, supplemented or
otherwise modified except by an instrument in writing signed by both parties.

     Section 13.8 Assignment. This Agreement may not be assigned by either party
except to an Affiliate without the prior written consent of the other party; provided, however,
Bioheart shall have the right to assign this Agreement without Bolton’s prior written consent in
connection with the sale of all, or substantially all, or its assets or business.

     Section 13.9 No Use of Name. Neither party shall employ or use the name or
logo of the other party in any publication or promotional materials or in any form of public
distribution nor make any public disclosure of this Agreement without the prior express written
consent of the other party, except as may be required for compliance with governmental obligations.

     Section 13.10 Notices. Any Orders, Forecasts, notices, waivers, and other
communications required or permitted hereunder shall be in writing and shall be deemed to be fully
given when delivered by hand or facsimile transmission or by an internationally recognized
overnight courier service, addressed to the party to whom the notice is intended to be given at the
addresses specified below.

			
	          (a)	 	If to Bioheart:

13794 N.W.
4th Street

Suite 212

Sunrise, Florida 33325

Attention: Howard J. Leonhardt, Chief Executive Officer

12

 

			
	             	 	
With a copy to:

Tobin & Reyes, P.A.

7251 West Palmetto Park Road

Suite 205

Boca Raton, Florida 33433

Attention: David S. Tobin, Esq.

			
	          (b)	 	If to Bolton:

799 International Parkway

Sunrise, Florida 33325

Attention: Oscar Rospigliosi, Chief Exeeutive Officer

or such other addresses or addresses as either party may from time to time designate for itself by
like notice.

     Section 13.11 Waiver. No provision of this Agreement shall be deemed to have
been waived unless such waiver is in writing, signed by the waiving party. No failure by any party
to insist upon the strict performance of any provision of this Agreement, or to exercise any right
or remedy consequent upon a breach thereof, shall constitute a waiver of any such breach of such
provision, or of any other provision. No waiver of any provision of this Agreement shall be deemed
a waiver of any other provision of this Agreement or a waiver of such provision with respect to any
subsequent breach, unless expressly provided in writing.

     Section 13.12 No Third-Party Beneficiary Rights. No person not a party to
this Agreement is an intended beneficiary of this Agreement, and no person not a party to this
Agreement shall have any right to enforce any term of this Agreement.

     Section 13.13 Force Majeure. Neither party shall be responsible for failure
or delay in performing any or its obligations due to component or material market allocations or
shortage conditions beyond such party’s influence or control, any act of God or public enemy, act
of terrorism, war, riot, rebellion, insurrection, explosion, flood, storm, fire, earthquake,
strike, injunction, governmental act, rule regulation, order, or directive or the order of any
court of competent jurisdiction, freight embargoes, any other similar causes beyond the control and
without the fault or negligence of such party. In the event of a delay or failure to perform due
to any such cause, the time for performance shall be extended for a period of time equal to the
time lost by reason of such cause, except that if any delay continues for a period of three months
or more, the party not claiming a force majeure may terminate any affected Orders. The party
invoking Force Majeure shall give prompt written notice thereof to the other party.

     Section 13.14 Counterparts. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which together shall constitute
one and the same instrument.

     Section 13.15 Consultation With Counsel and Reliance. Bioheart and Bolton
each acknowledge that it has consulted with, or has had the opportunity to consult with, counsel of
its

13

 

choice, and that in executing this Agreement it has not relied upon any statements,
representations or agreements of any other person other than those contained herein.

     Section 13.16 Non-Solicitation. During the term of this Agreement and for a
period of one (1) year after termination or expiration of this Agreement, neither party nor its
Affiliates shall solicit for employment any person who is directly involved in the performance of
this Agreement and who is an employee of the other party or its Affiliates.

14

 

     IN WITNESS WHEREOF, each party has caused this Agreement to be signed and delivered by its duly
authorized representative, effective as of the date first above written.

	 	 	 
	BIOHEART, INC.

	 	BOLTON MEDICAL, INC.
	 
	 	 
	By:

	 	By:
	 

	 	 
	Its:

	 	Its:
	 

	 	 
	Date:

	 	Date:
	 

	 	 

15

 

Exhibit A

Specifications

16

 

Exhibit B

The price to Bioheart for each Product manufactured by Bolton for Bioheart under this Agreement
shall be equal to the lesser of (i) Bolton’s actual cost of manufacturing such Product, plus
thirty percent (30%) (the “Cost Plus Methodology”); and (ii) an amount to be mutually agreed
between Bolton and Bioheart based on actual volume purchases and based on the actual historic
manufacturing costs incurred by Bolton until that date. Notwithstanding the foregoing, in the
event the Cost Plus Methodology is less than $1,500 per Product, all cost savings below that
amount shall be shared equally by Bioheart and Bolton; provided, however, in the event either
party incurs expenses in connection with the cost reduction, the party incurring such costs shall
be entitled to reimbursement of those costs from the costs savings prior to the implementation of
the cost sharing. For example, if Bolton’s actual cost of manufacturing a Product plus 30% is
equal to $1,000, then the price of such Product to Bioheart shall equal $1,250, calculated as
follows: (1,500-1,000)/2)+1,000 = $1,250.

17

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