Document:

EX-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).

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     (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.

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     (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.

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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.

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     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

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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

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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

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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.

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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.

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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.

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     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

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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

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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.

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     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:
	 

	 	 

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Exhibit A

Specifications

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Exhibit A

[Intentionally Omitted]

 

 

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.

17EX-10.11 Loan Guarantee with Howard J. Leonhardt a

 

EXHIBIT 10.11

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Loan Agreement No:                                         

Guarantor Name:       HOWARD AND BRENDA LEONHARDT

Guarantee Amount:     $1,100,000.00

LOAN GUARANTEE, PAYMENT AND SECURITY AGREEMENT

     This Agreement (the “Agreement”) is made as of June 1, 2007 (the “Effective
Date”), by and between BIOHEART, INC., a Florida corporation (the “Company”), and
Howard and Brenda Leonhardt (the “Guarantor”).

WITNESSETH:

     WHEREAS, the Company expects to obtain a term loan (the “Loan”), in the principal
amount of $5,000,000, from Bank of America, N.A. (the “Bank”);

     WHEREAS, as a condition precedent to the Bank’s making the Loan and as security for the
Company’s obligations relating thereto, the Guarantor will (i) pledge and assign to the Bank (the
“Pledge”) and grant to the Bank a first-priority security interest in, a investment
management account with the Bank having assets of at least $1,100,000 in value deposited in such
account (the “Collateral Account”) and/or (ii) execute and deliver a guaranty agreement
(the “Personal Guaranty”) in favor of the Bank with a maximum liability to the bank of
$1,100,000;

     WHEREAS, subject to the closing of the Loan and in accordance with the terms of this
Agreement, the Guarantor has agreed to make payments to the Company equal to 20% (the
“Guaranteed Percentage”) of the interest and principal payable by the Company to the Bank
in connection with the Loan, which amounts shall be used by the Company solely to pay interest and
principal on the Loan;

     WHEREAS, as consideration for the Guarantor’s agreement to make the payments described above
and to grant, in favor of the Bank, the Pledge and/or the Personal Guaranty, the Company has
agreed, upon the terms and conditions set forth herein, to (i) issue the Guarantor a warrant or
warrants to purchase shares of the Company’s common stock, par value $.001 per share (the
“Common Stock”), and (ii) pay certain fees to the Guarantor;

     NOW, THEREFORE, in consideration of the foregoing premises and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged by the parties hereto,
the Company and the Guarantor agree as follows:

1. CONSIDERATION.

     1.1 GUARANTEE DOCUMENTS AND PAYMENTS FOR THE BENEFIT OF THE COMPANY.

     In consideration of the Company’s issuance of the Warrant (as defined in Section 1.2 below)
and payment of the Guarantee Fee (as defined in Section 1.2 below), the Guarantor hereby agrees
that it shall:

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          (a) At Closing (as defined in Section 2.1 below), execute and deliver, in favor of the Bank,
whatever documentation (such documentation, the “Guarantee Documents”) the Bank reasonably
requires in connection with the Personal Guaranty and/or the Pledge.

          (b) During the period commencing on the Effective Date and terminating on the date that the
Company’s payment obligations under the Loan are satisfied and/or discharged in full, at least ten
(10) business days prior to the due date for any payment of interest (“Interest Payment”)
or payment of principal (“Principal Payment”) or other payment required to be made by the
Company to the Bank under the Loan, pay the Company or the Bank an amount equal to the product
obtained by multiplying (x) the total amount of the payment then due and (y) the Guaranteed
Percentage (each such payment, a “Guarantor Payment”) provided, that the aggregate
amount of Guarantor Payments shall not exceed $1,100,000. The Guarantor may, at its option, elect
to make Guarantor Payments by drawing, or authorizing the Bank to draw, on the Collateral Account,
if approved by the Bank. The Company shall apply the Guarantor Payment towards an Interest
Payment, Principal Payment or other payment due in connection with the Loan, and shall either
notify the Guarantor in writing of the due date for any such payment, or shall promptly forward to
the Guarantor any correspondence received by the Company from the Bank regarding the amount and due
date of such Interest Payment, Principal Payment or other payment (as applicable). All payments
hereunder shall be made to a specified account of the Company maintained at the Bank.

          (c) The Guarantor hereby authorizes the Company to notify the Bank in the event that the
Guarantor fails to make a Guarantor Payment when due.

     1.2 ISSUANCE OF WARRANTS AND PAYMENT OF MONTHLY FEES

     In consideration of the Guarantor’s issuing the Personal Guaranty and/or the Pledge in favor
of the Bank the Company hereby agrees that it shall:

          (a) At Closing (as defined in Section 2.1 below), issue to the Guarantor a warrant to purchase
an aggregate of 57,860 shares (the “Subject Shares”) of the Common Stock, with an exercise price of
$4.75 per share, in the form attached hereto as Exhibit A (the “Warrant”). The
Warrant will provide that the number of Subject Shares will increase to 66,000 shares of the Common
Stock in the event the Company has not satisfied and/or discharged all of its payment obligations
under the Loan by September 30, 2007 (the “Loan Satisfaction”). The Warrant will further
provide that the number of Subject Shares will increase to 82,500, 110,000 and 165,000,
respectively, in the event the Company has not satisfied and/or discharged all of its payment
obligations under this Agreement and the Loan by the first anniversary, second anniversary and
third anniversary of the Effective Date, respectively.

          (b) Pay the Guarantor a cash fee (the “Guarantee Fee”) in the amount determined by
multiplying $1,100,000 by 5.0% and multiplying the resulting amount by a fraction, the numerator of
which is the number of days elapsed between the date hereof and the earlier of (i) the date of the
Loan Satisfaction and (ii) the date that is eight months following the Effective Date (or such
later date to which the maturity date of the Note may be extended), and the denominator of which is
365 in accordance with the terms of this Section 1.2(b). The Company shall pay the Guarantee Fee
within five (5) business days of the Trigger Date (as defined below). For purposes of this
Agreement, the “Trigger Date” shall mean the earliest to occur of: (i) the closing date of
an initial public offering of the Company’s Common Stock generating at least $30 million of net
proceeds to the Company occurring on or before January 31, 2008 (a “Qualified Offering”),
and (ii) the date the Company satisfies and/or discharges all of its payment obligations (a
“BlueCrest Loan Satisfaction”) under that certain Loan and Security Agreement, dated as of
May 31, 2007 by and between the Company and BlueCrest Capital Finance, L.P. (the “BlueCrest
Loan”).

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          (c) If on or before the first business day of the 36th full calendar month after
the date of the BlueCrest Loan (the “Outside Payment Date”), the Company has not
effectuated a BlueCrest Loan Satisfaction or a Qualified Offering:

               (A) the Company shall use its best efforts to effectuate a BlueCrest Loan Satisfaction as soon
as possible following the Outside Payment Date; and

               (B) the Company shall pay the Guarantee Fee no later than five (5) business days following a
BlueCrest Loan Satisfaction.

2. THE CLOSING.

     2.1. CLOSING DATE. The parties agree to effect the transactions contemplated hereby (the
“Closing”) contemporaneously with the execution of this Agreement, which Closing shall be
contemporaneous with the closing of the Loan.

     2.2 CLOSING DELIVERABLES.

          (a) At the Closing, the Company shall deliver or cause to be delivered to the Guarantor:

               (i) an executed copy of this Agreement; and

               (ii) an executed copy of the Warrant.

          (b) At the Closing, the Guarantor shall deliver or cause to be delivered to the Company an
executed copy of this Agreement.

          (c) At the Closing, the Guarantor shall deliver to the Bank duly executed copies of the
Guarantee Documents.

3. RESTRICTIONS ON TRANSFER OF THE WARRANT

     No transfer of all or any portion of the Warrant shall be made except in accordance with the
applicable provisions of this Agreement and/or the Warrant.

4. REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE COMPANY.

     The Company hereby represents, warrants and covenants to the Guarantor and agrees as set forth
below; provided, however, that the Guarantor shall not be able to rely on any representation and/or
warranty made by the Company if Mr. Leonhardt, who is the Executive Chairman and Chief Technology
Officer of the Company, has actual knowledge as of the Effective Date that such representation is
inaccurate:

     4.1. CORPORATE POWER. The Company is a corporation duly organized, validly existing, and in
good standing under the laws of the State of Florida and is duly qualified to do business as a
foreign corporation and is in good standing in each jurisdiction in which the failure to so qualify
would have a material adverse effect on the Company’s business, properties, or financial condition
(a “Material Adverse Effect”). The Company has all requisite corporate power and authority
to execute and deliver this Agreement, the Warrant and the agreements related to the Loan and to
carry out and perform

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its obligations hereunder and thereunder. The Company has all requisite corporate power and
authority to issue and deliver the shares of Common Stock issuable upon valid exercise of the
Warrant.

     4.2 AUTHORIZATION. This Agreement has been duly authorized, executed and delivered by the
Company. All corporate action on the part of the Company and its shareholders, directors and
officers necessary for the authorization, execution and delivery of this Agreement, the execution
of the agreements related to the Loan, the issuance of the Warrant and the shares of Common Stock
issuable upon conversion of the Warrant, the consummation of the other transactions contemplated
hereby and the performance of all the Company’s obligations hereunder has been taken. This
Agreement constitutes the legal, valid and binding obligation of the Company, enforceable against
the Company in accordance with its terms, subject to (i) laws of general application relating to
bankruptcy, insolvency and the relief of debtors, (ii) rules of law governing specific performance,
injunctive relief and other equitable remedies, and (iii) the limitations imposed by applicable
federal or state securities laws on the indemnification provisions contained in this Agreement. The
shares of Common Stock issuable upon exercise of the Warrant have been duly authorized (the
“Warrant Shares”). When the Warrant Shares have been delivered against payment in
accordance with the terms of the Warrant, such Conversion Shares will have been, validly issued,
fully paid and nonassessable.

     4.3. GOVERNMENTAL CONSENTS. All consents, approvals, orders, or authorizations of, or
registrations, qualifications, designations, declarations, or filings with, any governmental
authority, required on the part of the Company in connection with the valid execution and delivery
of this Agreement, the offer, sale and issuance of the Warrant have been obtained and will be
effective at the Closing, except for notices required or permitted to be filed thereafter with
certain state and federal securities commissions, which notices shall be filed on a timely basis.

     4.4. OFFERING. Assuming the accuracy of the representations and warranties of the Guarantor
contained in Section 5 below, the offer, sale and issuance of the Warrant is exempt from the
registration and prospectus delivery requirements of the Securities Act and has been registered or
qualified (or is exempt from registration and qualification) under the registration, permit, or
qualification requirements of all applicable state securities laws.

     4.5. CAPITALIZATION. The authorized capital of the Company consists of 40,000,000 shares of
Common Stock and 5,000,000 shares of Preferred Stock. As of March 31, 2007, 20,948,994 shares of
Common Stock and no shares of Preferred Stock were issued and outstanding.

     4.5 USE OF PROCEEDS FROM GUARANTOR CASH PAYMENTS. The Company shall use the proceeds of any
Guarantor Payment solely to pay amounts due or payable under the Loan.

     4.6 LITIGATION. Except as referenced on Exhibit 3(d) to the Loan Agreement, there is no
proceeding involving the Company pending or, to the knowledge of the Company, threatened before
any court or governmental authority, agency or arbitration authority.

     4.7 NO CONFLICTING AGREEMENTS. There is no charter, bylaw, stock provision, partnership
agreement or other document pertaining to the organization, power or authority of the Company and
no provision of any existing agreement (including, without limitation, the Loan Agreement with
Bank of America (the “Loan Agreement”) or the Senior Loan Agreement [as defined in the
Loan Agreement]), mortgage, indenture or contract binding on the Company or affecting its
property, which would conflict with or in any way prevent the execution, delivery or carrying out
of the terms of this Agreement.

     4.8 OWNERSHIP OF ASSETS. The Company has good title to its assets, and its assets

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are free and clear of liens, except for the security interest of BlueCrest (as defined in the
Loan Agreement). For purposes of this Section 4.8, a sublicense of any of the Company’s
intellectual property is not deemed to be a “lien”.

     4.9 TAXES. All taxes and assessments due and payable by the Company have been paid or are
being contested in good faith by appropriate proceedings and the Company has filed all tax returns
which it is required to file.

     4.10 FINANCIAL STATEMENTS. The financial statements of Company heretofore delivered to the
Guarantor have been prepared in accordance with GAAP applied on a consistent basis throughout the
period involved and fairly present the Company’s financial condition as of the date or dates
thereof, and there has been no material adverse change in Company’s financial condition or
operations since the date of the financial statements. All factual information furnished by the
Company to the Guarantor in connection with this Agreement is and will be accurate on the date as
of which such information is delivered to the Guarantor.

     4.11 ENVIRONMENTAL. The conduct of the Company’s business operations and the condition of the
Company’s property does not and will not violate any federal laws, rules or ordinances for
environmental protection, regulations of the Environmental Protection Agency, any applicable local
or state law, rule, regulation or rule of common law or any judicial interpretation thereof
relating primarily to the environment or Hazardous Materials (as defined in the Loan Agreement).

     4.12 AFFIRMATIVE COVENANTS. Until full payment and performance of all obligations of the
Company to the Guarantor hereunder, the Company will, unless Guarantor consents otherwise in
writing:

          (a) Existence and Compliance. Maintain its existence, good standing and qualification to do
business, where required, and comply with all laws, regulations and governmental requirements
including, without limitation, environmental laws applicable to it or to any of its property,
business operations and transactions.

          (b) Adverse Conditions or Events. Promptly advise the Guarantor orally or in writing of (i)
any condition, event or act which comes to its attention that would or might materially adversely
affect the Guarantor’s rights under this Agreement or the Warrant, and (ii) any litigation in
excess of $500,000 is filed by or against Company, or (iii) any event that has occurred that would
constitute an event of default under the Loan Agreement.

          (c) Taxes and Other Obligations. Pay all of its taxes, assessments and other obligations,
including, but not limited to, taxes, costs or other expenses arising out of this transaction, as
the same become due and payable, except to the extent the same are being contested in good faith by
appropriate proceedings in a diligent manner.

     4.13 NEGATIVE COVENANTS. Until full payment and performance of all obligations of the Company
to the Guarantor hereunder, the Company will not, unless the Guarantor consents otherwise in
writing:

               (a) Character of Business. Change the general character of business as conducted at the date
hereof, or engage in any type of business not reasonably related to its business as presently
conducted.

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               (b) Incur Obligations. Incur any obligations or take any action that could reasonably be
expected to, or have the effect of, causing the Company not to satisfy its obligations under
Section 8 of this Agreement.

5. REPRESENTATIONS, WARRANTIES AND COVENANTS OF THE GUARANTOR.

     The Guarantor hereby represents and warrants to the Company and agrees as follows:

     5.1 RELIANCE. The Guarantor understands that the Company has relied on the information and
representations with respect to the Guarantor set forth in this Section 5 in determining, among
other things, whether an investment in the Warrant is suitable for the Guarantor, and the Guarantor
represents and warrants that all such information is true and correct as of the date hereof.

     5.2 POWER AND AUTHORITY. The Guarantor has all requisite power and authority to execute and
deliver this Agreement and the Guarantee Documents and to carry out and perform its obligations
hereunder and thereunder.

     5.3 EXPERIENCE. The Guarantor is an “accredited investor” within the meaning of Regulation D
under the Securities Act and such Guarantor has no ability to acquire the Warrant Shares until at
least one year after the date the Warrants are issued.

     5.4. INFORMATION AND SOPHISTICATION. The Guarantor has received all the information it has
requested from the Company that it considers necessary or appropriate for deciding whether to
acquire the Warrant. The Guarantor has had an opportunity to ask questions and receive answers from
the Company regarding the terms and conditions of the Warrant and to obtain any additional
information necessary to verify the accuracy of the information given to the Guarantor. The
Guarantor further represents that it has such knowledge and experience in financial and business
matters that it is capable of evaluating the merits and risk of the investment in the Warrant and
the Warrant Shares (collectively, the “Securities”).

     5.5 DUE DILIGENCE. The Guarantor has consulted with its own legal, regulatory, tax, business,
investment, financial and accounting advisers in connection with its determination to enter into
this Agreement. The Guarantor has made its own decisions based upon its own judgment, due
diligence and advice from such advisers as it has deemed necessary and, except for the
representations and warranties expressly set forth herein, is not relying upon any information,
representation or warranty by the Company or any agent of the Company in determining to enter into
this Agreement.

     5.6. ABILITY TO BEAR ECONOMIC RISK. The Guarantor acknowledges that investment in the
Securities involves a high degree of risk. The Guarantor is able, without materially impairing its
financial condition, to hold the Securities for an indefinite period of time and to suffer a
complete loss of its investment. Neither the Securities and Exchange Commission nor any state
securities commission has approved any of the Securities or passed upon or endorsed the merits of
the offering of the Securities by the Company.

     5.7 LOCK-UP AGREEMENT. The Guarantor hereby agrees that, during the period of duration (not
to exceed one hundred eighty (180) days) specified by the Company and an underwriter of Common
Stock or other securities of the Company in an agreement in connection with any initial public
offering of the Company’s securities, following the effective date of the registration statement
for a public offering of the Company’s securities filed under the Securities Act, it shall not, to
the extent requested by the Company and such underwriter, directly or indirectly sell, offer to
sell, contract to sell (including, without limitation, any short sale), grant any option to
purchase or otherwise transfer or dispose of (other

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than to donees who agree to be similarly bound) any securities of the Company held by it at any
time during such period, except Common Stock, if any, included in such registration.

     5.8 The Guarantor hereby acknowledges that:

IN THE EVENT THAT SALES OF THE SECURITIES OFFERED HEREBY ARE MADE TO FIVE (5) OR
MORE PERSONS IN FLORIDA, ALL PURCHASERS IN FLORIDA HAVE THE RIGHT TO VOID THE SALE
OF THE SECURITIES OFFERED HEREBY WITHIN THREE (3) DAYS AFTER THE PAYMENT OF THE
PURCHASE PRICE IS MADE TO THE COMPANY, AN AGENT OF THE COMPANY, OR AN ESCROW
AGENT, OR WITHIN THREE (3) DAYS AFTER THE AVAILABILITY OF THAT PRIVILEGE IS
COMMUNICATED TO SUCH PURCHASER, WHICHEVER OCCURS LATER. PAYMENTS FOR TERMINATED
SUBSCRIPTIONS VOIDED BY PURCHASERS AS PROVIDED FOR IN THIS PARAGRAPH WILL BE
PROMPTLY REFUNDED WITHOUT INTEREST.

     5.9 The Guarantor shall, at all times from the date hereof until the date the Company
effectuates a Loan Satisfaction, maintain, as security for the Loan, Eligible Collateral (as
defined in that certain Pledge Agreement dated of even date herewith between the Guarantor and the
Bank (the “Pledge Agreement”)) with an Adjusted Collateral Value (as defined in the Pledge
Agreement) in excess of the Guaranty Minimum (as defined in the Pledge Agreement).

6. REIMBURSEMENT OF PAYMENTS IN CONNECTION WITH GUARANTEE DOCUMENTS.

     (a) The Company hereby agrees to pay to the Guarantor (i) all reasonable and documented costs
and expenses (including court costs and reasonable legal expenses) incurred or expended by the
Guarantor in connection with (x) the Guarantor’s negotiation, drafting and execution of this
Agreement, the Guarantee Documents and any agreements with Magellan Group Investments, LLC, the
Guarantor’s review of all documents in connection with the Loan and the Guarantor’s establishment
of the Collateral Account (the “Initial Expenses”) and (y) the Bank’s taking any action
against the Guarantor to enforce the Bank’s rights under the Guarantee Documents (together with the
Initial Expenses, the “Expenses”) and (ii) to repay to Guarantor the Guarantor Payments.
Notwithstanding the foregoing or anything else to the contrary in this Agreement, the Company shall
not be required to reimburse the Guarantor for Expenses that the Guarantor would not have incurred
but for the Guarantor’s failure to satisfy the terms and conditions of this Agreement or the
Guarantee Documents.

     (b) Each payment to be made by the Company hereunder shall be due within thirty (30) days of
the receipt by the Company of a request for reimbursement from Guarantor; provided,
however, that if the date of any reimbursement request occurs prior to the Trigger Date, such
payment shall be made within thirty (30) days after the Trigger Date or on the same date the
Company is required to pay the Guarantee Fee in accordance with Section 1.2(c) hereof, whichever
occurs first. Notwithstanding the foregoing, the Company shall reimburse the Guarantor for the
Initial Expenses within ten (10) business days of the Closing.

     (c) All payments payable by the Company hereunder shall be made in immediately available funds
to an account that the Guarantor shall designate from time to time in writing to the Company.
Except for any Collection Expenses (which shall not bear any interest), payments due shall be made
with interest thereon from the due date (or, in the case of the Guarantor Payments, from the date
that the Guarantor made such payment) until payment thereof by the Company, at the Prime Rate
offered by the

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Bank, plus 5%, and in effect as such due date. For the avoidance of doubt, the due date for
any reimbursement request shall be thirty (30) days after the date of a written reimbursement
request made by the Guarantor.

     (d) The Company shall make the payments specified above even if there is a dispute about
whether the Bank is or was entitled to take any action to enforce its rights under the Guarantee
Documents. In no event shall the Company be liable to Guarantor for any special, indirect or
consequential damages incurred by Guarantor.

7. DEFAULT; REMEDIES UPON DEFAULT.

     7.1 GUARANTOR DEFAULT.

          (a) The failure by the Guarantor to: (x) pay any Guarantor Payment (whether in cash or by the
Bank drawing on, taking control of or foreclosing the assets deposited into the Collateral Account)
which failure is not cured within two (2) business days of the Guarantor’s receipt of written
notice from the Company of such failure or (y) comply with the covenant set forth in Section 5.9
hereto shall constitute a “Key Default” hereunder.

          (b) Upon any Key Default by the Guarantor, the following shall occur immediately and
automatically, provided that the Company shall provide Guarantor with written notice promptly upon
learning of any such default: (a) the Warrant shall be cancelled; (b) the Company’s obligations to
make payments to the Guarantor under Section 1.2(b) of this Agreement shall be terminated; and (c)
the Company’s obligations under Section 6 to reimburse the Guarantor for Expenses shall be
terminated.

          (c) Notwithstanding anything to the contrary in this Agreement, the Guarantor shall indemnify,
defend and hold the Company harmless from and against all losses (including, without limitation,
reasonable attorneys fees and court costs) incurred by the Company as a result of the Guarantor’s
breach of any of its material obligations under this Agreement, including, but not limited to, a
breach that results in a Key Default; provided, however, (z) in no event shall the
Guarantor be liable to the Company for (A) any special, indirect or consequential damages; or (B)
an amount in excess of $1.3 million (the “Damages Cap”); provided, however,that if the Bank
liquidates all or any portion of the Collateral Account, the amount liquidated by the Bank shall
reduce the Damages Cap on a dollar for dollar basis.

     7.2 COMPANY DEFAULT. The failure by the Company to pay or perform any material obligation
hereunder (including, without limitation, a breach of its obligations under Section 8 below) which
failure is not cured within two (2) business days of the Company’s receipt of written notice from
the Guarantor of such failure shall constitute a default hereunder. Upon any such default by the
Company, the Guarantor’s obligations to pay the Guarantor Payments shall be terminated.
Notwithstanding anything to the contrary in this Agreement, the Company shall indemnify, defend and
hold the Guarantor harmless from and against all losses (including, without limitation, reasonable
attorneys fees and court costs) incurred by the Guarantor as a result of the Company’s failure to
comply with its obligations hereunder; provided that Company’s maximum liability to the Guarantor
under this Agreement shall not exceed $1.3 million.

8. REPAYMENT ELECTION.

     (a) Subject to this Section 8, in the event the Company does not close an initial public
offering of the Company’s Common Stock generating at least $30 million of net proceeds to the
Company by August 13, 2007, the Guarantor, by providing written notice to the Company (the

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“Repayment Election Notice”) at any time between August 13, 2007 and October 15, 2007,
may compel the Company to effectuate (i) a BlueCrest Loan Satisfaction or (ii) a BlueCrest Loan
Satisfaction and a Loan Satisfaction. Within two (2) days of the Company’s receipt of the
Repayment Election Notice, the Company shall (x) provide notice (the “Other Guarantor
Notice”) to Mr. Bruce Carson, the R&A Spencer Family Limited Partnership, Dr. William Murphy
and Magellan Group Investments, LLC (collectively, the “Other Guarantors”) of the Company’s
receipt of the Repayment Election Notice and (y) (A) enter into the Requisite Substitution
Agreements (as defined below) or (B) effectuate a BlueCrest Loan Satisfaction or a BlueCrest Loan
Satisfaction and Loan Satisfaction (as specified in the Repayment Election Notice).

     (b) In anticipation of its receipt of a Repayment Election Notice, the Company may seek to,
but is not required to, locate Eligible Substitute Guarantors (as defined below) desiring to
provide collateral to secure the Loan in substitution of the Pledge and the Personal Guaranty. For
purposes of this Agreement, an “Eligible Substitute Guarantor” is a natural person or
entity that:

          (i) is an “Accredited Investor”;

          (ii) is acceptable to the Bank, in the Bank’s sole discretion;

          (iii) agrees to provide collateral to secure the Loan, which collateral is acceptable to the
Bank in the Bank’s sole discretion (“Substitute Collateral”);

          (iv) agrees to enter into a subordination agreement with BlueCrest Capital Finance, L.P.,
which subordination agreement is acceptable to BlueCrest Capital Finance, L.P. in its sole
discretion;

          (v) agrees to enter into a loan guarantee, payment and security agreement with the Company on
terms and conditions acceptable to the Company (“Substitute Loan Guarantee Agreements”);
and

          (vi) agrees to be bound by that certain Indemnification Agreement, dated as of the date
hereof, by and among the Guarantor and the Other Guarantors.

     (c) In the event that, within two (2) days of the date of the Company’s receipt of the
Repayment Election Notice (the “Substitution Period”), (i) the Company enters into fully
executed Substitute Loan Guarantee Agreements with one or more Eligible Substitute Guarantors
agreeing to provide Substitute Collateral in an amount equal to or greater than $1,100,000 (the
“Requisite Substitution Agreements”) and (ii) the Bank cancels the Pledge and the Personal
Guaranty, then the Company shall have no obligation to effectuate a BlueCrest Loan Satisfaction or
a BlueCrest Loan Satisfaction and Loan Satisfaction, as applicable, in accordance with Section
8(a).

     (d) In the event that the Company does not, within the Substitution Period, enter into the
Requisite Substitution Agreements and the Bank has not cancelled the Pledge and the Personal
Guaranty, the Company shall effectuate a BlueCrest Loan Satisfaction or a BlueCrest Loan
Satisfaction and Loan Satisfaction (as specified in the Repayment Election Notice) by the end of
the Substitution Period.

     (e) In the event that, in accordance with the Repayment Election Notice, (i) the Company
effectuates a BlueCrest Loan Satisfaction but not a Loan Satisfaction, (ii) the Company enters into
the Requisite Substitution Agreements and (iii) the Bank cancels the Pledge and the Personal
Guaranty:

          (i) the amount of the Guarantee Fee payable by the Company under this Agreement

9

 

EXECUTION COPY

shall be determined by multiplying the Collateral Amount by 5.0% and multiplying the resulting
amount by a fraction, the numerator of which is the number of days elapsed between the date hereof
and the date the Pledge and Personal Guaranty is cancelled by the Bank, and the denominator of
which is 365; and

          (ii) the Guarantor shall have no obligation to make any Guarantor Payments due after the end
of the Substitution Period.

     (f) Notwithstanding anything contained in this Agreement to the contrary, the
Company acknowledges and agrees that (i) the Company’s obligations under this Section 8 are a
material inducement for Guarantor to enter into this Agreement and provide the Bank with the Pledge
and the Personal Guaranty and but for the Company’s agreements under this Section 8, Guarantor
would not have entered into this Agreement or provided the Bank with the Pledge and the Personal
Guaranty; and (ii) that irreparable damage would occur to Guarantors in the event the provisions of
this Section 8 are not performed in accordance with their specific terms by the Company or are
otherwise breached by the Company. Accordingly, it is agreed that Guarantor shall be entitled to
an injunction or injunctions to prevent breaches of the provisions of this Section 8 and to enforce
specifically the terms and provisions hereof in any court of competent jurisdiction in the United
States or any state thereof, in addition to any other remedy to which they may be entitled at law
or equity.

     (g) In the event that, during the period commencing on the Effective Date and ending on August
13, 2007, the Company closes an initial public offering of the Company’s Common Stock generating at
least $30 million of net proceeds to the Company, the Company shall effectuate a Loan Satisfaction
within five (5) business days of the closing of such offering.

9. MISCELLANEOUS.

     9.1. BINDING AGREEMENT; NON-ASSIGNMENT. This Agreement shall inure to the benefit of and be
binding upon the parties hereto and their respective successors. This Agreement is not assignable
without the express written consent of both parties, which consent may be withheld for any reason.
Nothing in this Agreement, express or implied, is intended to confer upon any third party any
rights, remedies, obligations, or liabilities under or by reason of this Agreement except as
expressly otherwise provided in this Agreement. If the Guarantor secures the consent of a third
party to indemnify it for certain costs and expenses it may incur hereunder or in connection with
the Guaranty Documents, the Guarantor agrees that is shall provide the Company notice of such
agreement, including the contact information of the subject third party.

     9.2. GOVERNING LAW. This Agreement shall be governed by and construed under the laws of the
State of Florida, irrespective of any contrary result otherwise required under the conflict or
choice of law rules of Florida.

     9.3. COUNTERPARTS. This Agreement may be executed in counterparts, each of which shall be
deemed an original, but both of which together shall constitute one and the same instrument.

     9.4. TITLES AND SUBTITLES. The titles and subtitles used in this Agreement are used for
convenience only and are not to be considered in construing or interpreting this Agreement.

     9.5. NOTICES. Any notice required or permitted under this Agreement must be given in writing
and shall be deemed effectively given upon personal delivery or upon overnight mail, postage
prepaid, if to the Company, addressed to William H. Kline, Chief Financial Officer, Bioheart, Inc.
13794 NW 4th Street, Suite 212, Sunrise, Florida 33325, with a copy to David E. Wells,
Esq., Hunton & Williams, LLP, 1111 Brickell Avenue, Suite 2500, Miami, Florida 33131, or to the
Guarantor at

10

 

EXECUTION COPY

Mr. Howard J. Leonhardt, [insert address], with a copy to Tobin & Reyes, P. A., Attn: David S. Tobin,
The Plaza, 5355 Town Center Road, Suite 204, Boca Raton, FL 33486 and Mrs. Brenda Leonhardt,
[insert address] with a copy to Sherman Law Offices, Attn: Craig B. Sherman, 1000 Corporate Drive,
Suite 310, Fort Lauderdale, Florida 33334 or at such other address as a party may designate by ten
days’ advance written notice to the other party.

     9.6. MODIFICATION; WAIVER. No modification or waiver of any provision of this Agreement or
consent to departure therefrom shall be effective unless in writing and approved by the Company and
the Guarantor.

     9.7. FURTHER ASSURANCES. The parties shall take such further actions, and execute, deliver and
file such documents, as may be necessary or appropriate to effectuate the intent of this Agreement.

     9.8. CONSTRUCTION. The language used in this Agreement shall be deemed to be the language
chosen by the parties to express their mutual intent, and no rule of strict construction shall be
applied against any party. Any references to any federal, state, local or foreign statute or law
shall also refer to all rules and regulations promulgated thereunder, unless the context otherwise
requires. Unless the context otherwise requires: (a) a term has the meaning assigned to it by this
Agreement; (b) forms of the word “include” mean that the inclusion is not limited to the items
listed; (c) “or” is disjunctive but not exclusive; (d) words in the singular include the plural,
and in the plural include the singular; (e) provisions apply to successive events and transactions;
(f) “hereof”, “hereunder”, “herein” and “hereto” refer to the entire Agreement and not any section
or subsection; and (g) “$” means the currency of the United States.

     9.9. ENTIRE AGREEMENT. This Agreement and the Exhibits hereto constitute the full and entire
understanding and agreement between the parties with regard to the subjects hereof and no party
will be liable or bound to the other in any manner by any representations, warranties, covenants
and agreements other than those specifically set forth herein.

     9.10 VENUE. The parties irrevocably submit to the exclusive jurisdiction of the courts of
State of Florida located in Broward County and federal courts of the United States for the Southern
District of Florida in respect of the interpretation and of the provisions of this Agreement and in
respect of the transactions contemplated hereby.

     9.11 SPECIFIC PERFORMANCE. The parties hereto acknowledge and agree that irreparable damage
would occur in the event that any of the provisions of this Agreement were not performed in
accordance with their specific terms or were otherwise breached. Accordingly, it is agreed that
they shall be entitled to an injunction or injunctions to prevent breaches of the provisions of
this Agreement and to enforce specifically the terms and provisions hereof in any court of
competent jurisdiction in the United States or any state thereof, in addition to any other remedy
to which they may be entitled at law or equity.

     9.12 ATTORNEYS’ FEES. In the event of any litigation, including appeals, with regard to this
Agreement, the prevailing party shall be entitled to recover from the non-prevailing party all
reasonable fees, costs, and expenses of counsel (at pre-trial, trial and appellate levels).

11

 

EXECUTION COPY

     IN WITNESS WHEREOF, the parties have executed this Agreement as of the date first written
above.

	 	 	 	 	 	 	 
	 	 	BIOHEART, INC.
	 
	 	 	 	 	 	 
	 

	 	BY:	 	 	 	 
	 

	 	 	 	 	 	 
	 

	 	Name:	 	 	 	 
	 

	 	Title:	 	 	 	 
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	Howard Leonhardt
	 
	 	 	 	 	 	 
	 	 	 	 	 
	 	 	Brenda Leonhardt

12

 

Exhibit 3(d)

Litigation / Threatened Proceeding

Law Litigation

     On March 9, 2007, Peter K. Law, Ph.D. and Cell Transplants Asia, Limited, or the Plaintiffs,
filed a complaint against Bioheart, Inc. (referred to herein as “us” or “we”) and Howard J.
Leonhardt, individually, in the United States District Court, Western District of Tennessee. On
February 7, 2000, we entered a license agreement, or the Original Law License Agreement, with Dr.
Law and Cell Transplants International pursuant to which Dr. Law and Cell Transplants International
granted us a license to certain patents, including the Primary MyoCell Patent, or the Law IP. The
parties executed an addendum to the Original Law License Agreement, or the License Addendum, in
July 2000, the provisions of which amended a number of terms of the Original License Agreement.

     More specifically, the Original License Agreement provided, among other things:

	 	•	 	The parties agreed that we would issue, and we did issue, to Cell Transplants
International a five-year warrant exercisable for 1.2 million shares of our common stock at
an exercise price of $8.00 per share instead of, as originally contemplated under the
Original Law License Agreement, issuing to Cell Transplants International or Dr. Law
600,000 shares of our common stock and options to purchase 600,000 shares of our common
stock at an exercise price of $1.80.
	 
	 	•	 	The parties agreed that our obligation to pay Cell Transplants International a $3
million milestone payment would be triggered upon our commencement of a bona fide U.S.
Phase II human clinical trial that utilizes technology claimed under the Law IP instead of,
as originally contemplated under the Original Law License Agreement, upon initiation of a
FDA approved human clinical trial study of such technology in the United States.

     The Plaintiffs are not challenging the validity of our license of the Law IP, but rather are
alleging and seeking, among other things, a declaratory judgment that the License Addendum fails
for lack of consideration. Based upon this argument, the Plaintiffs allege that we are in breach
of the terms of the Original Law License Agreement for failure to, among other things, (i) issue to
Cell Transplants International or Peter Law the 600,000 shares of our common stock and options to
purchase 600,000 shares of our common stock contemplated by the Original Law License Agreement and
(ii) pay Cell Transplants International the $3 million milestone payment upon our commencement of a
FDA approved human clinical study of MyoCell in the United States.

     The Plaintiffs have alleged, among other things, certain other breaches of the Original Law
License Agreement not modified by the License Addendum including a purported breach of our
obligation to pay Plaintiffs royalties on gross sales of products that directly read upon the
claims of the Primary MyoCell Patent and a purported breach of the contractual restriction on
sublicensing the Primary MyoCell Patent to third parties. The Plaintiffs are also alleging that we
and Mr. Leonhardt engaged in a civil conspiracy against the Plaintiffs and that the court should
toll any periods of limitation running against the Plaintiffs to bring any causes of action arising
from or which could arise from the alleged breaches.

 

 

     In addition to seeking a declaratory judgment that the License Addendum is not enforceable,
the Plaintiffs are also seeking an accounting of all revenues, remunerations or benefits derived by
us or Mr. Leonhardt from sales, provision and/or distribution of products and services that read
directly on the Law IP, compensatory and punitive monetary damages and preliminary and permanent
injunctive relief to prohibit us from sublicensing our rights to third parties.

     We believe this lawsuit is without merit and intend to defend the action vigorously. While
the complaint does not appear to challenge our rights to license this patent and we believe this
lawsuit is without merit, this litigation, if not resolved to the satisfaction of both parties, may
adversely impact our relationship with Dr. Law and could, if resolved unfavorably to us, adversely
affect our MyoCell commercialization efforts.

Threatened Proceeding

     We received notice of a potential claim by an existing shareholder, Steve May. Mr. May claims
that he filed a complaint with the Securities and Exchange Commission on May 15, 2007 apparently in
connection with a request that the Company transfer to his name certain shares that were previously
issued in the name of another shareholder. Our counsel is currently attempting to contact Mr. May
to discuss the details of the transfers Mr. May is seeking to make. As best as we can tell, the
issue involves no more than 12,500 shares, but we are still seeking to understand Mr. May’s
position/rights.

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