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Exhibit 10.1

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible)

Tax ID Number: 33-0827593

DUNS Number: 111029179

Proof of Concept for Use of the Celution System as a Medical Countermeasure for Thermal Burn

A. The purpose of this modification is to revise the SOW to design, execute, and complete robust testing, verification, and validation of the System and Process used for intravenous ADRC delivery.

B. This is a bilateral, supplemental agreement modification. The total contract amount is increased by $2,499,162.00 and all other terms and conditions remain unchanged.

Continued ...

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

SUMMARY OF CHANGES

Beginning with the effective date of this modification, the below portions of contract HHS0100201200008C between the Government and Contractor are modified as follows:

Statement of Work Addendum 1

Preface

Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to Broad Agency Announcement (BAA) BARDA CBRN BAA 11-100-SOL-00009.

Specific Objectives and Scope

As proposed herein, the Contractor intends to design, execute, and complete robust testing, verification, and validation of the System and Process used for intravenous ADRC delivery as needed for the IDE Submission. In particular, because of the different risk profile of intravenous delivery the process by which the cell therapy product is prepared for intravenous delivery is different than that used for topical delivery. Cytori has previously developed a general system for intravenous delivery and has applied this process in clinical trials in the USA and Europe. The majority of the work proposed for this supplement is directed at completing final testing and documentation for porting that approach from the older Celution 800 System to the new system of the device intended for use in the clinical trial to be executed under the proposed IDE. The objective is to complete the activities and documentation thereof needed in preparation for this clinical trial

WBS 2.1Project Management

Objective: Execution of activities throughout this project will require that meetings, site visits, In­Process Reviews, subcontractor management plan, risk management plan, EVMS, and related activities are properly coordinated and that the outcome of said activities be communicated to BARDA and other stakeholders in an efficient, timely manner. The purpose of these project-wide activities is to facilitate this coordination and communication.

Description: Examples of activities performed to facilitate meetings, site visits, In-Process Review and similar activities include: scheduling meetings, timely distribution of an agenda in advance of the meeting, and timely distribution of meeting minutes, action items, and other deliverables after the meeting, maintain subcontractor and risk management activities and documentation, and EVMS reporting requirements

WBS 2.2Non-Clinical Toxicology

Not Applicable

WBS 2.4Clinical

2.4.1.1Pilot Clinical Trial Preparation

Objective: The current option funded work required for initiation of a Pilot Clinical Trial involving delivery of ADRCs using topical spray. While the majority of the work performed for topical delivery is applicable to intravenous delivery there are, inevitably, some non-overlapping tasks pertaining to study design modifications, preparing clinical trial sites, and so forth associated uniquely with the intravenous route of delivery.

Description: Activities to be conducted include: finalization of the clinical trial protocol in accordance with comments received from the FDA; assessment and selection of Clinical Contract Research Organization (CRO); and assessment, selection, and pre-qualification of clinical trial sites including a preliminary assessment of contractual matters to ensure that the budget for the modified clinical trial is accurate. These activities will be executed with input from Cytori's Thermal Burn Scientific Advisory Board.

WBS 2.5Regulatory

Objective: The FDA must grant approval before clinical use of an Investigational Device can be initiated. In the case of the Celution System in Thermal Burn Injury this will require approval under the Investigational Device Exemption mechanism. Since the intravenous route of administration involves systemic delivery (as contrasted with the topical route of delivery which is local only) the package to be prepared in response to FDA questions and comments will be different from that anticipated under the current contract.

Description: Cytori’s regulatory team will prepare and submit a package of documents that is specifically for intravenous delivery of ADRCs. Contents will be based upon the clinical trial protocol, data obtained in studies described above, and feedback received from the Agency in response to the IDE package.

WBS 2.6CMC

2.6.2Celution System Verification and Validation

Objective: To obtain data and reports that will complete the documentation for all development activities needed for the proposed clinical trial.

Rationale: Robust testing, verification, and validation of the system and process used for ADRC preparation for intravenous delivery is a necessary component for clinical trial readiness. While much of this work will be completed within the current contract due to overlap in testing required for intravenous system and the topical delivery system, use of an intravenous route of delivery necessitates supplemental activities associated with, for example, the software and reagents that are specific to processing ADRCs for intravenous delivery. For example, the lntravase^® reagent is used only for intravenous processing, not for topical spray. There are also differences in the timing of an approach wherein the cells are delivered to the patient after the completion of their burn surgery (as now planned) rather than within the context of the surgery (as previously proposed for the topical spray approach).

Description: Continuation of Verification and Validation Testing required in support of clinical execution, but not required for IDE submission. Examples of this type of activity include: equipment reliability testing, fully integrated ship testing, additional testing of time points associated with accelerated and real-time aging for consumables set, and packaging. lntravase stability testing in support of enzyme shelf life. Testing of the intravenous processing device to meet the full complement of safety testing in support of 60601compliance. In addition, for certain prolonged burn surgeries it may be necessary to delay the start of tissue processing so that the cell therapy product is prepared ‘just-in-time’ rather than have it sit for an extended period while the surgery is completed and back in the care unit where the cells will be delivered. This is different from the previously planned approach in which tissue was to be processed as soon as possible. For this reason, it will be necessary to execute additional process validations such as that needed for use of tissue that has been set aside prior to processing to derive ADRCs.