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 (" MyoCelle4" ) that can be delivered to the patient via (i) a catheter-based microimplant system (" MyoCathe4" ) or (ii) a surgical procedure; and WHEREAS, Bioheart has developed specifications for the MyoCathe4 cardiac catheter to be utilized in connection with the delivery of its MyoCelle4 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 15 th 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 includ ...