0001104659-19-076460.txt : 20191227 0001104659-19-076460.hdr.sgml : 20191227 20191227155531 ACCESSION NUMBER: 0001104659-19-076460 CONFORMED SUBMISSION TYPE: 1-A PUBLIC DOCUMENT COUNT: 31 FILED AS OF DATE: 20191227 DATE AS OF CHANGE: 20191227 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Virtuoso Surgical, Inc. CENTRAL INDEX KEY: 0001742075 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 812994832 STATE OF INCORPORATION: TN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 1-A SEC ACT: 1933 Act SEC FILE NUMBER: 024-11136 FILM NUMBER: 191313741 BUSINESS ADDRESS: STREET 1: 5701 OLD HARDING PIKE STREET 2: SUITE 200 CITY: NASHVILLE STATE: TN ZIP: 37205 BUSINESS PHONE: (615) 352-9519 MAIL ADDRESS: STREET 1: 5701 OLD HARDING PIKE STREET 2: SUITE 200 CITY: NASHVILLE STATE: TN ZIP: 37205 1-A 1 primary_doc.xml 1-A LIVE 0001742075 XXXXXXXX Virtuoso Surgical, Inc. TN 2016 0001742075 3841 81-2994832 6 1 5701 Old Harding Pike Suite 200 Nashville TN 37205 615-352-9519 David R. Clay Other 602748.00 0.00 21039.00 181940.00 805727.00 114483.00 0.00 114483.00 691244.00 805727.00 0.00 967761.00 10367.00 -338191.00 -0.34 -0.34 Puryear & Noonan, CPAs Common Equity 985000 N/A000000 N/A Preferred Equity 1305000 92837P209 N/A Debt Securities 0 N/A000000 N/A true true Tier2 Audited Equity (common or preferred stock) Y N N Y N N 20000000 1305000 1.0000 20000000.00 0.00 0.00 0.00 20000000.00 Strategic Capital Investments, LLC 1600000.00 Puryear & Noonan, CPAs 15000.00 Waller Lansden Dortch & Davis, LLP 100000.00 38924 18285000.00 true AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY DC PR AL AK AZ AR CA CO CT DE FL GA HI ID IL IN IA KS KY LA ME MD MA MI MN MS MO MT NE NV NH NJ NM NY NC ND OH OK OR PA RI SC SD TN TX UT VT VA WA WV WI WY DC PR Virtuoso Surgical, Inc. Class A Preferred Stock 230000 0 $230,000. Price is $1.00/share. Rule 506(b) of the Securities Act of 1933, as amended PART II AND III 2 tm1927293d1_partiiandiii.htm PART II AND III

 

 

 

PART II - INFORMATION REQUIRED IN OFFERING CIRCULAR

  

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 1-A

 

REGULATION A OFFERING CIRCULAR

UNDER THE SECURITIES ACT OF 1933

 

VIRTUOSO SURGICAL, INC.

(Exact name of issuer as specified in its charter)

 

Tennessee

(State of other jurisdiction of incorporation or organization)

 

5701 Old Harding Pike, Suite 200

Nashville, Tennessee 37205

(615) 352-9519

(Address, including zip code, and telephone number,

including area code of issuer’s principal executive office)

 

C. Mark Pickrell
General Counsel & Chief Administrative Officer
Virtuoso Surgical, Inc.
5701 Old Harding Pike, Suite 200

Nashville, Tennessee 37205
(615) 352-9519
(Name, address, including zip code, and telephone number, including area code, of agent for service)

 

Copy to:

 

David R. Clay, Esq.

Marc J. Adesso, Esq.

Waller Lansden Dortch & Davis, LLP

511 Union Street, Suite 2700

Nashville, Tennessee

(615) 244-6380

 

3841   81-2994832
(Primary Standard Industrial
Classification Code Number)

 

 

(I.R.S. Employer
Identification Number)

 

This Offering Circular shall only be qualified upon order of the United States Securities and Exchange Commission, unless a subsequent amendment is filed indicating the intention to become qualified by operation of the terms of Regulation A.

 

 

 

 

An offering statement pursuant to Regulation A relating to these securities has been filed with the Securities and Exchange Commission. Information contained in this Preliminary Offering Circular is subject to completion or amendment. These securities may not be sold nor may offers to buy be accepted before the offering statement filed with the Commission is qualified. This Preliminary Offering Circular shall not constitute an offer to sell or the solicitation of an offer to buy nor may there be any sales of these securities in any state in which such offer, solicitation or sale would be unlawful before registration or qualification under the laws of any such state. We may elect to satisfy our obligation to deliver a Final Offering Circular by sending you a notice within two business days after the completion of our sale to you that contains the URL where the Final Offering Circular or the offering statement in which such Final Offering Circular was filed may be obtained.

 

PRELIMINARY OFFERING CIRCULAR, SUBJECT TO COMPLETION DATED DECEMBER 27, 2019

 

 

 

VIRTUOSO SURGICAL, INC.

 

$20,000,000 MAXIMUM OFFERING AMOUNT

CLASS A PREFERRED STOCK ($1.00 per Share)

 

This is the initial public offering (this “Offering”) of up to 20,000,000 shares of Class A Preferred Stock, par value $1.00 per share (the “Class A Preferred Stock”), of Virtuoso Surgical, Inc., a Tennessee corporation (the “Company,” “we,” “our,” or “us”). The minimum purchase requirement for an investor to participate in this Offering of Class A Preferred Stock is $1,000. Prior to this Offering, there has been no public market for our Class A Preferred Stock. We may, at our discretion, and, depending upon market conditions, apply to list our Class A Preferred Stock on the OTCQB Venture Market operated by the OTC Markets Group Inc.

 

The Class A Preferred Stock is non-voting, senior preferred stock in the Company, and carries a 7% Paid-In-Kind dividend, or PIK. In the event of a change of control of the Company, the Class A Preferred Stock will be entitled to receive an amount equal to par value, plus any accrued PIK, plus any applicable Success Bonus. If the consideration paid to the Company upon a change of control is not sufficient to pay the full amount due to the holders of the Class A Preferred Stock, then the Class A Preferred Stock will be converted into Shares of our common stock based on the balance of the unpaid amount. The terms of the Class A Preferred Shares are described more fully herein in the sections entitled, “Summary - Class A Preferred Stock” and “Description of Capital Stock - Class A Preferred Stock.”

 

We expect to commence the sale of the Class A Preferred Stock as of the date on which the Offering Statement, of which this Offering Circular is a part, is qualified by the U.S. Securities and Exchange Commission. This Offering will terminate at the earlier of: (1) the date upon which the maximum amount of offered Class A Preferred Stock has been sold, (2) the date which is twelve (12) months after the qualification of this Offering, or (3) the date on which this Offering is earlier terminated by us in our sole discretion. For details about the process of our Offering, please see “Plan of Distribution.”

 

This Offering is being conducted on a “best efforts” basis pursuant to Regulation A of Section 3(6) of the Securities Act of 1933, as amended (the “Securities Act”), for Tier 2 Offerings. C2M Securities, LLC, successor-in-interest to Strategic Capital Investments, LLC, will act as our exclusive placement agent (the “Placement Agent”) for this Offering. The Placement Agent is not purchasing Class A Preferred Stock offered by us and is not required to sell any specific number or dollar amount of Class A Preferred Stock. The Company may undertake one or more closings on a rolling basis. Until we complete a closing, the proceeds for this Offering will be maintained in an escrow account. At the time of a closing, the proceeds will be distributed to the Company and the associated Class A Preferred Stock will be issued to investors. If there are no closings or if funds remain in the escrow account upon termination of this Offering without any corresponding closing, the investments for this Offering will be promptly returned to investors, without interest or deduction. Atlantic Capital Bank, National Association will serve as escrow agent for our Offering.

 

We are an “emerging growth company” as that term is used in the Jumpstart Our Business Startups Act of 2012 and, as such, have elected to comply with certain reduced public company reporting requirements for this Offering Circular and future filings. See “Offering Circular Summary - Implications of Being an Emerging Growth Company.”

 

Investing in our Class A Preferred Stock involves a high degree of risk. See “Risk Factors” for a discussion of certain risks that you should consider in connection with an investment in our Class A Preferred Stock.

 

 

 

 

Title of each class of securities to be registered

    Proposed
offering
price per
share
    Proposed
maximum
aggregate
offering
proceeds
    Placement
Agent
commissions
(1)
    Proceeds to
Company
(2)
 
                           
Class A Preferred Stock     $ 1.00     $ 20,000,000      $ 1,600,000     $ 18,400,000  

 

(1)

We have agreed to pay the Placement Agent a commission equal to one percent (1%) of the total amount invested by investors in the Offering. We also have agreed to pay the Placement Agent and/or third party registered broker-dealers who introduce purchasers of Class A Preferred Stock a commission equal to seven percent (7%) of the total number of shares sold through them in the Offering and issue to the Placement Agent and such third party registered broker-dealers warrants to purchase, at an exercise price of $100 per share, a number of shares of our common stock up to an amount equal to 5% of the gross proceeds of this Offering divided by $100. (If fully subscribed, up to 10,000 shares of common stock of the Company will be reserved for issuance through exercise of the warrants.) Those warrants are not covered by this Offering Statement. See “Plan of Distribution” for details regarding compensation payable to the Placement Agent and such third-party broker-dealers in connection with this Offering.

(2) The amount shown is before deducting organization and offering costs to us, including fees for administrative and escrow services, legal, accounting, printing, due diligence, marketing, consulting, selling commissions, state securities filing compliance, and other costs incurred in the offering of the Class A Preferred Stock.

  

Generally, no sale may be made to you in this Offering if the aggregate purchase price you pay is more than 10% of the greater of your annual income or your net worth. Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(c) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

 

The U.S. Securities and Exchange Commission does not pass upon the merits of or give its approval to any securities offered or the terms of this Offering, nor does it pass upon the accuracy or completeness of any offering circular or other solicitation materials. These securities are offered pursuant to an exemption from registration with the Commission; however, the Commission has not made an independent determination that the securities offered are exempt from registration.

 

This Offering Circular follows the disclosure format of Part I of Form S-1 as applicable to smaller reporting companies pursuant to the general instructions of Part II(a)(1)(ii) of Form 1-A.

 

C2M Securities, LLC

Placement Agent

 

 

The date of this Offering Circular is                         , 2019.

 

 

 

 

TABLE OF CONTENTS

 

    Page
Cautionary Statement Regarding Forward-Looking Statements   1
Summary   3
Risk Factors   11
Use of Proceeds   21
Capitalization   21
Dividend Policy   22
Dilution   22
Management’s Discussion and Analysis of Financial Condition and Results of Operations   23
Business   25
Management   27
Executive Compensation   29
Certain Relationships and Related-Party Transaction   29
Principal Stockholders   31
Description of Capital Stock   32
Shares Eligible for Future Sale   33
Plan of Distribution   34
Legal Matters   37
Experts   37
Where You Can Find More Information   37
Index to Financial Statements   38

 

We are offering to sell our securities only in jurisdictions where such offers and sales are permitted. You should rely only on the information contained in this Offering Circular. We have not authorized anyone to provide you with any information other than the information contained in this Offering Circular. The information contained in this Offering Circular is accurate as of its date, regardless of the time of its delivery or of any sale or delivery of our securities. Neither the delivery of this Offering Circular nor any sale or delivery of our securities shall, under any circumstances, imply that there has been no change in our affairs since the date of this Offering Circular. This Offering Circular will be updated and made available for delivery to the extent required by the federal securities laws.

 

Unless otherwise indicated, data contained in this Offering Circular concerning the business of the Company are based on information from various public sources. Although we believe that these data are generally reliable, such information is inherently imprecise, and our estimates and expectations based on these data involve a number of assumptions and limitations. As a result, you are cautioned not to give undue weight to such data, estimates, or expectations.

 

For investors outside the United States: We and the underwriter have not done anything that would permit this Offering, or possession or distribution of this Offering Circular in any jurisdiction where action for that purpose is required, other than in the United States. Persons outside the United States who come into possession of this Offering Circular must inform themselves about, and observe any restrictions relating to, the offering of common stock and the distribution of this Offering Circular outside of the United States.

 

Use of Industry and Market Data

 

This Offering Circular includes market and industry data that we have obtained from third-party sources, including industry publications, as well as industry data prepared by our management on the basis of its knowledge of and experience in the industries in which we operate (including our management’s estimates and assumptions relating to such industries based on that knowledge). Management has developed its knowledge of such industries through its experience and participation in these industries. While our management believes the third-party sources referred to in this Offering Circular are reliable, neither we nor our management have independently verified any of the data from such sources referred to in this Offering Circular or ascertained the underlying economic assumptions relied upon by such sources. Furthermore, internally prepared and third-party market prospective information, in particular, are estimates only and there will usually be differences between the prospective and actual results, because events and circumstances frequently do not occur as expected, and those differences may be material. Also, references in this Offering Circular to any publications, reports, surveys, or articles prepared by third parties should not be construed as depicting the complete findings of the entire publication, report, survey, or article. The information in any such publication, report, survey, or article is not incorporated by reference in this Offering Circular.

  

Trademarks, Trade Names, and Service Marks

 

The trademarks or service marks of Virtuoso Surgical appearing in this Registration Statement are the property of Virtuoso Surgical.

 

The other trademarks, trade names, and service marks appearing in this Offering Circular are the property of their respective owners. Solely for convenience, the trademarks and trade names in this Offering Circular are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

 

 

 

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

The disclosure and analysis in this Offering Circular contain “forward-looking statements.” Forward-looking statements describe the Company’s current expectations or forecasts of future events as of the date of this Offering Circular and are not statements of historical fact. These forward-looking statements include information about possible or assumed future events, including, among other things, discussion, and analysis of the Company’s assets, business, capital expenditures, cash flows, cost management, condition (financial and otherwise), indebtedness, liquidity, profitability, prospects, results of operations, revenues, and strategic plans. Words such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “intends,” “plans,” “potential,” “predicts,” “projects,” “seeks,” “should,” “will,” “would,” and variations of these words and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and/or could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements.

 

Forward-looking statements involve inherent uncertainty and may ultimately prove to be incorrect or false. You are cautioned not to place undue reliance upon forward-looking statements. Except as otherwise may be required by applicable law, the Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events, or actual operating results. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including, but not limited to:

 

·the Company’s ability to develop new products, improve the Company’s existing products, and increase the demand for and the value of the Company’s products;

 

·supply and demand changes for the Company’s products;

 

·the Company’s ability to achieve its financial projections as presented herein;

 

·the Company’s future financial and operational performance, including trends in sales, operating expenses, and net income;

 

·the sufficiency of the Company’s cash, cash equivalents, and cash generated from operations to meet the Company’s working capital and capital expenditure requirements;

 

·product liability claims;

 

·inadequate insurance coverage;

 

·challenges to the Company’s intellectual property rights or the Company’s inability to defend its products against the intellectual property rights of others;

 

·adverse events affecting third-party manufacturers and the Company’s supply chain;

 

·loss of and/or inability to replace key vendors and/or suppliers;

 

·failures of, interruptions to, or unauthorized tampering with, the Company’s information technology systems;

 

·failures or delays in obtaining FDA approval, CE Marks (defined below), or other regulatory approvals for the Company’s products;

 

·inability to capitalize on business development opportunities;

 

·product quality or patient safety issues;

 

·inability to retain key distributors, sales associates, and other personnel or to attract new talent; and

 

·the Company’s ability to adapt to and comply with healthcare and other applicable laws.

 

1

 

 

The foregoing list of risks and uncertainties, however, is only a summary of some of the most important factors and is not intended to be exhaustive.

 

Although the forward-looking statements in this Offering Circular are based on our beliefs, assumptions, and expectations, taking into account all information currently available to us, we cannot guarantee future transactions, results, performance, achievements, or outcomes. You should carefully review and consider the risks that are described under the section captioned “Risk Factors” of this Offering Circular. New factors that are not currently known to the Company or that the Company is currently unaware of may also emerge from time to time that could materially and adversely affect the Company and its assets, business, cash flows, financial condition, liquidity, prospects, and/or results of operations.  

 

2

 

 

SUMMARY

 

This summary highlights selected information contained elsewhere in this Offering Circular. This summary is not complete and does not contain all the information that you should consider before deciding whether to invest in our Class A Preferred Stock. You should carefully read the entire Offering Circular, including the risks associated with an investment in the Company discussed in the “Risk Factors” section of this Offering Circular, before making an investment decision. Some of the statements in this Offering Circular are forward-looking statements. See the section entitled “Cautionary Statement Regarding Forward-Looking Statements.”

 

In this Offering Circular, references to “Virtuoso Surgical,” “Virtuoso,” the “Company,” “our,” “we,” and “us” refer to the business and operations of Virtuoso Surgical, Inc., unless the context indicates otherwise.

 

 

 

(A rendering of the Company’s second prototype, “Bach.”)

 

Overview

 

Virtuoso Surgical, Inc. was founded to make minimally invasive surgery simpler and more effective by providing surgeons with dexterous, accurate, and cost-effective robotic tools for operation through rigid endoscopes. The Company owns and continues to develop technology that dramatically improves rigid endoscopic surgery. This is the largest, most established segment of minimally invasive surgery, and it is ripe for robotic improvement. The Company’s robotic manipulators are smaller than a toothpick, or nearly ten (10) times smaller than the current state-of-the-art robotic instruments. Our prototype is designed to be small and compact, and to fit smoothly into the surgical workflow. To the Company’s knowledge, no competing technology can deliver surgical tools through rigid endoscopes with the precision, dexterity, and lateral force of the Virtuoso device.

 

Virtuoso Surgical, Inc. operates at the intersection of robotics and minimally invasive surgery. The ongoing revolution in minimally invasive surgery has been likened to the introduction of anesthesia for surgery. (New England Journal of Medicine, 2012.) Rigid endoscopy is the oldest, largest, and most mature segment of minimally invasive surgery, with an annual global market size of approximately $20 billion.

 

Patented Technology

 

The key patented technology that enables the Virtuoso device to perform with such precision, dexterity, and lateral force, through such a small cross-section, is robotic control of 1-millimeter wide manipulators comprised of concentric nitinol tubes. Nitinol is the most well-known member of the family of metal alloys known as Shape Memory Alloys. Nitinol possesses two (2) key physical properties: superelasticity and the shape-memory effect. When correctly processed, and even under high strains, nitinol is able to bend without deformation and return to its original conformation when stress is relieved. This allows concentric tubes of nitinol to translate and rotate relative to one another, which, when controlled through real-time digital processing, allows for dexterous and precise manoeuvering by the surgeon.

 

3

 

 

The Company’s technology uses 1-millimeter wide robotic manipulators to control small surgical tools through rigid endoscopes. The manipulators, usually operating in pairs, can move dexterously in any direction that the surgeon commands. These manipulators are small enough to enable two (2) manipulators to be delivered through a conventional endoscope, allowing two-armed cooperative tasks to be completed. These robotic manipulators do not work automatically; they are under the control of the surgeon, who commands their location through an input device and logic controller. These manipulators can deliver, through 5 to 8-millimeter endoscopes, a multitude of surgical tools, including: lasers, scalpels, scissors, grippers, cautery, suction, and irrigation. We believe that nearly all surgical procedures currently attempted with a rigid endoscope stand to benefit from our platform technology. We anticipate new procedures and surgical techniques to be enabled, and many existing procedures and techniques to be improved, due to this technology.

 

In contrast to other technologies used for robotic devices (including pulley and tendon systems, push-pull systems, and articulated systems), concentric nitinol tubes are able to exert a lateral force that is a multiple stronger than other technologies, generally, by a factor of two (2) and higher. This increased force allows dramatically superior tissue retraction and manipulation by the Virtuoso device. In addition, in comparison to most existing tools for rigid endoscopy, which have one (1) arm capable of moving with two (2) degrees of freedom (translation and rotation), the Virtuoso device has two (2) arms capable of each moving, independently, with four (4) degrees of freedom (translation and rotation, plus X-axis and Y-axis movement). No known technology accomplishes the dexterity, precision, and lateral force of the Virtuoso device for operation through standard rigid endoscopes.

 

Prototype Device

 

The Virtuoso device is composed of a standard endoscope, possessing a standard rod-lens optic and camera, as well as suction and irrigation capabilities (either gaseous or liquid), where the interior endoscope (rigid endoscopes usually have an outer sheath and an inner sheath) has been modified to channel the two (2) concentric-nitinol arms. At the back of the endoscope is a motor unit containing electric motors that connect to and control the rotation and translation of the nitinol tubes and, depending on the configuration, certain operative surgical tools. Some surgical tools are controlled through foot-pedal controls.

 

The Company’s current prototype consists of: 1) a reusable capital piece of equipment to be priced at approximately $250,000 and 2) a disposable instrument projected to be priced at approximately $500 per instrument. We anticipate averaging two (2) instruments per case, and our marginal revenue generation is expected to be primarily from the disposable instrument. It is very common for medical devices to have disposable components for sterility purposes, and the expected cost of this disposable item is comparable to other disposable medical devices currently on the market. We seek to remove many cost barriers for hospitals and surgery centers seeking to acquire the capital piece, and for our disposable-item prices to be less than or equal to existing similar disposable endoscopic surgical tools, depending on market price. Historically, the capital cost of robotic systems has often been too high for many hospitals and surgery centers; we anticipate that a commercially attractive and competitive feature of the Virtuoso device will be its significantly lower capital cost.

 

The surgical tools that are available to the surgeon include: retractors, mono-polar and bi-polar electrocautery, lasers, baskets (for grasping), scalpels, grippers, and scissors. Because the nitinol arms are hollow, suction and irrigation can also be employed through the arms. The suction and irrigation have have the added benefit of enhancing tissue manipulation. At this size of operation, baskets are often superior to grippers for gripping, and electrocautery and lasers are often superior to scissors for cutting tissue.

 

The Virtuoso device is connected to a robotic arm manufactured by KUKA AG (“KUKA”). The KUKA robotic arm possesses two (2) key features: the ability to hold the Virtuoso device and endoscope steadily when desired, while also allowing the surgeon to easily and widely manipulate the Virtuoso device as needed. Additional functionality is permitted by the KUKA robotic arm, including single-axis movement and intentionally limited ranges of motion. The KUKA robotic arm is mounted on a surgical cart, which contains the KUKA CPU and a user interface for surgical-staff setup, monitoring, and breakdown.

 

The surgeon controls the surgical tools through a separate surgeon-input console, which uses reverse-Cartesian controls (mimicking the laparoscopic movements that minimally-invasive surgeons are used to). The surgeon sees the operating field on a separate standard operating room video monitor, which displays the camera feed from the endoscope, as well as other outputs.

 

The Company intends to seek approval from the United States Food and Drug Administration (“FDA”) for the sale of its products in the United States, and it will also seek approval from the European Union for a European Conformation Certificate (“CE Mark”) for the commercialization of its products throughout the European Union and certain other countries where the CE Mark is accepted, such as Columbia, Peru, Argentina, Mexico, Turkey, Israel, New Zealand, and Australia.

 

4

 

 

Intellectual Property

 

The Company has executed licensing agreements with Johns Hopkins University and Vanderbilt University for patents related to the manufacture and sale of the prototype. The Company has also developed particular trade secrets and proprietary software that enable the Virtuoso device to perform as required, making competition with the Company’s device potentially difficult to reverse engineer. The Company has filed an additional patent application itself, currently pending in the United States Patent and Trademark Office (“USPTO”), and it expects to file additional patent applications in the future. For some of those patents, the Company anticipates seeking international coverage under the Patent Cooperation Treaty.

 

No assurances can be given when or if the Company’s other pending patent applications may be granted by the USPTO. The Company may be denied any or all of these pending patent applications, or future patent applications. The Company’s patent rights are subject to challenge in U.S. federal courts; the Company, however, is not aware of any substantive basis for a challenge to the patents’ validity or enforceability. Because the patents are subject to potential legal challenge, or because non-infringing technologies may develop to suit a comparable purpose, the Company’s current or future patent rights may not prevent the Company’s competitors from developing competing products.

 

Johns Hopkins Patents

 

Effective May 11, 2016, the Company entered into a non-exclusive, non-transferable patent license with Johns Hopkins University. Under the terms of the license, the Company has the right to use concentric nitinol tubes for surgical devices in the following countries (or regions), under the following patents: United States (8,152,756 and 8,715,226); Japan (2008-541319, 2012-139088, 2015- 094824, and 2014-000372); European Patent Office (06844376.1); Canada (2,630,061); and China (200680050046.8). Under the terms of the license, Johns Hopkins has received a fee of $2,000 and five percent (5%) of the common stock of the Company, and is entitled to receive a royalty of four percent (4%) of the Net Revenues (as defined in the license) of the Company of sales of products incorporating concentric nitinol tubes and one percent (1%) of the consideration received by the Company upon a sale of the Company or other similar transaction. The royalty is due and owing throughout the life of the patents, for each respective jurisdiction. At this time, the Company does not know the exact dates that the patents, or any possible follow-on patents that utilize this underlying technology, will expire. Generally, under the Patent Cooperation Treaty of 1970 and the Patent Law Treaty of 2000, patents like the Johns Hopkins patents last for twenty (20) years from the initial date of filing. The Johns Hopkins U.S. patents were initially filed on November 15, 2006 and March 9, 2012, and are expected to expire twenty (20) years from those dates. The Johns Hopkins patent license terminates when the final licensed patent lapses, upon 60 days' notice by the Company, or, at the discretion of Johns Hopkins, in the event that, after initial commercial sales begin, a one-year period takes place without any commercial sales.

 

Vanderbilt Patent & Application

 

Effective May 15, 2016, the Company entered into an exclusive, non-transferable patent license with Vanderbilt University. Under the terms of the license, the Company has the right to make, use, offer to sell, sell and import products, for human surgical applications, systems and apparatuses for endoscopic deployment of robotic concentric tube manipulators, and the Company has the exclusive right to manufacture and/or sell such systems or apparatuses in the United States. Under the terms of the license, Vanderbilt University has received a fee of $5,000, reimbursement for Vanderbilt’s patent-prosecution costs and four percent (4%) of the common stock of the Company, and is entitled to receive a royalty of four percent (4%) of the Gross Sales (as defined in the license) of products incorporating the patented technology; annual royalties of at least $3,000, beginning in 2021, and increasing to $50,000 annually beginning in 2025; and $250,000 upon a sale of the Company or other similar transaction. The royalties are due and owing throughout the life of the licensed patents. The Vanderbilt U.S. patents were initially filed on September 13, 2013 and October 2, 2015, and are expected to expire twenty (20) years from those dates. The Company does not have “PCT” coverage on the Vanderbilt patents. The Vanderbilt patent license terminates upon a breach of the agreement by the Company, after an opportunity to cure the breach has lapsed without cure, or by the Company upon 120 days' notice.

 

Trade Secrets, Trademarks, and Copyright

 

In addition to patent rights, the Company possesses other intellectual property, including registered trademarks for its product, copyright protection for its software, and trade secrets related to its materials and their processing.

 

Growth Strategy

 

The Virtuoso device is expected to dramatically enhance scores of surgical applications, which the Company intends to exploit serially. Once regulatory approval is obtained for one surgical area of operation, it is anticipated that follow-on areas of operation will be addressed by the Company serially.

 

The Company is entering a time of accelerated prototype development and regulatory efforts. We received our initial seed capital on September 1, 2017, from the Small Business Innovation Research Program (“SBIR”) of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. With that funding, the Company opened its offices to begin further private development of the Virtuoso device. The Company has received additional SBIR funding, a Tennessee state matching grant, and additional federal funding through the Small Business Technology Transfer Program (“STTR”) to support the Company’s prototype development and regulatory-approval work. The Company will continue to seek governmental funding for its development efforts.

 

The Company is not expected to be able to obtain regulatory approval for its device, or commercialize the device, without raising private capital. Operationally, the Company’s major anticipated milestones include the testing and validation of our system in models, animal studies, cadaver and live-human studies, FDA regulatory testing, United States and European regulatory review, and the commercial rollout of our system. There are five (5) distinct aspects of the Company’s operational plan:

 

·Conducting capital raises, in this Offering and through additional strategic or financial investments.

 

·Further testing and optimization of the Virtuoso device.

 

5

 

 

·Integrating a clinical system and accumulating testing data while submitting applications for FDA and EU regulatory approval.

 

·Model, animal, cadaver and, if necessary, live-human testing of the Virtuoso device.

 

·Commercialization of the Virtuoso device upon regulatory approval, including: physician and surgical-suite training, marketing, and technical support of the Virtuoso device.

 

The capital needs of the Company will likely require a sale of a majority of common stock within the next six (6) years, based on the probable cost of building long-term manufacturing, sales, marketing, physician-training, and customer-support capabilities for a surgical system of this type. Within the medical-device industry, startup-company acquisitions by major medical-device manufacturers often occur upon regulatory approval or initial commercial sales of the start-up companies’ products.

 

Class A Preferred Stock

 

Terms of the Shares

 

Our charter and bylaws allow the Company to issue up to 50,000,000 shares of its Class A Preferred Stock (the “Shares”), which have a right to a paid-in-kind (“PIK”) dividend of seven percent (7%) simple interest per year. As of the date of this Offering Circular, there are 1,305,000 Class A Preferred Stock issued and outstanding. If all of the Shares are sold in this Offering, 21,305,000 Shares will be issued and outstanding. Subsequent to this Offering, the Company may apply to have its Class A Preferred Stock listed on the OTCQB Venture Market operated by the OTC Markets Group Inc.

 

A holder of the Shares is entitled to a “Success Bonus” if a change of control occurs:

 

·more than one (1) year and less than three (3) years after the Shares were purchased or otherwise received by a holder, then 100% of the par value per share plus accrued PIK;

 

·more than three (3) years and less than give five (5) years after the Shares were purchased or otherwise received by a holder, then 200% of the par value per share plus accrued PIK; or

 

·more than five (5) years, then 300% of the par value per share plus accrued PIK.

 

A “change of control” occurs if the stockholders or warrantholders of the Company as of April 25, 2018 (i.e., Robert Webster, S. Duke Herrell, Richard Hendrick, C. Mark Pickrell, Vanderbilt University, Johns Hopkins University, Neal Dillon, Scott Webster, and Evan Blum), or their successors by operation of law, (i) own less than a majority of the shares of common stock, no par value (“Common Stock”), of the Company or (ii) any one of them owns a majority of the Common Stock of the Company. The Board of Directors (the “Board”) of the Company must approve of any stockholder action constituting a change of control.

 

In the event of a change of control, the Shares are due and payable at par value, plus any accrued PIK, plus any applicable Success Bonus. If the consideration paid to the Company upon a change of control is not sufficient to pay off the outstanding Shares, then the consideration received shall, in order of priority, be used to pay pari passu: par value for the Shares, accumulated PIK, and Success Bonus (collectively, the “Waterfall”). After a change of control and payment in accordance with the Waterfall, if the Shares are not paid in full (including any applicable Success Bonuses), the Shares shall be converted into Common Stock, based on the stockholders’ relative unpaid balances. In the event that a change of control occurs and the Shares are not paid in full, the then-outstanding shares of our common stock are extinguished and the holders of the Shares become holders of 100% of the common stock of the Company. The ownership of common stock would be based proportionally upon the dollar amount that is owed to each such holder of the Shares. For that reason, in such an event, there is no conversion rate for the Shares other than their relative amounts outstanding.

 

Pursuant to our bylaws, until the Shares are paid in full, including any applicable Success Bonuses, the Company shall not pay any dividend to the Company’s holders of Common Stock (except as permitted under SEC Regulation A, solely from the proceeds of this Offering), purchase any shares of Common Stock of the Company, or pay any employee bonuses (except for de minimis compensatory cash bonuses to non-management employees).

 

Further, until the Shares are paid in full, the compensation limits established by the National Institutes of Health for grant recipients apply to the Company’s employees and consultants.

 

The Shares are redeemable at any time, at the discretion of the Company’s Board of Directors, provided that a redemption must include 100% of a stockholder’s Shares at par value, plus any accrued PIK. Redeemed shares of Class A Preferred Stock will be retired upon redemption. If a change of control occurs within two (2) years of a redemption, the investor will be entitled to receipt of a Success Bonus equal to the Success Bonus that would have been paid as of the redemption date.

 

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Illustrations of How our Shares Work

 

The following scenarios are illustrations of how our Shares work. These illustrations are solely intended to help prospective investors understand how the structure of our Class A Preferred Stock operates.

 

THESE ILLUSTRATIONS ARE HYPOTHETICAL AND DO NOT CONSTITUTE GUARANTEES OR PROJECTIONS. THESE ILLUSTRATIONS ARE PROVIDED ONLY FOR THE PURPOSE OF HELPING POTENTIAL INVESTORS UNDERSTAND THE TERMS OF THE CLASS A PREFERRED STOCK. BECAUSE YOUR INVESTMENT IS NOT GUARANTEED, YOU MAY LOSE YOUR ENTIRE INVESTMENT, DEPENDING UPON THE SUCCESS OR FAILURE OF THE COMPANY.

 

Illustration 1: Change of Control

 

If an investor purchases 20,000 shares of Class A Preferred Stock for an aggregate investment of $20,000, and the Company causes a change of control eighteen (18) months later, then the investor would be entitled to the sum of: (i) $20,000, (ii) $2,100, the aggregate PIK for the 18-month period (calculated as 10.5% of the $20,000), and (iii) $22,100, the applicable Success Bonus rate of 100% of the par value per share plus accrued PIK (i.e. $20,000 + $2,100).

 

Therefore, the amount owed to the investor would be $44,200. Essentially, the investor receives the original investment, plus $24,200.

 

Illustration 2: Change of Control

 

If an investor purchases 20,000 shares of Class A Preferred Stock for an aggregate investment of $20,000, and the Company causes a change of control four (4) years later, then the investor would be entitled to the sum of: (i) $20,000, (ii) $5,600, the aggregate PIK for the four (4) year period (calculated as 28% of the $20,000), and (iii) $51,200, the applicable Success Bonus rate of 200% of the par value per share plus accrued PIK (i.e. $20,000 + $5,600).

 

Therefore, the amount owed to the investor would be $76,800. The investor receives the original investment, plus $56,800.

 

Illustration 3: Change of Control

 

If an investor purchases 20,000 shares of Class A Preferred Stock for an aggregate investment of $20,000, and the Company causes a change of control six (6) years later, then the investor would be entitled to the sum of: (i) $20,000, (ii) $8,400, the aggregate PIK for the six (6) year period (calculated as 42% of the $20,000), and (iii) $85,200, the applicable Success Bonus rate of 300% of the par value per share plus accrued PIK (i.e. $20,000 + $8,400).

 

Therefore, the amount owed to the investor would be $113,600. The investor receives the original investment, plus $93,600.

 

Illustration 4: Redemption and Later Change of Control

 

If an investor purchases 20,000 shares of Class A Preferred Stock for an aggregate investment of $20,000, and the Company redeems the shares eighteen (18) months later, then at redemption the investor would be entitled to the sum of: (i) $20,000 and (ii) $2,100, the aggregate PIK for the 18-month period (calculated as 10.5% of the $20,000), or a total amount of $22,100.

 

Then eighteen (18) months after the redemption of the Shares if the Company causes a change of control, the investor would also be entitled to $22,100 due to the Success Bonus rate of 100% of the par value per share plus accrued PIK (i.e. $20,000 + $2,100).

 

Therefore, the investor would receive $22,100 at redemption and eighteen (18) months later, $22,100 at the change of control.

 

Illustration 5: Resale and Later Change of Control

 

Investor A purchases 20,000 shares of Class A Preferred Stock for an aggregate investment of $20,000, and one (1) year later Investor A sells all 20,000 shares to Investor B for $25,000. Then, one (1) year after Investor B bought the Shares, the Company causes a change of control. Investor B would be entitled to the sum of: (i) $20,000, (ii) $2,800, the aggregate PIK for the two (2) year period (calculated as 14% of the $20,000), and (iii) $22,800, the applicable Success Bonus rate of 100% of the par value per share plus accrued PIK (i.e. $20,000 + $2,800).

 

Therefore, in the event of a change of control, Investor B would receive $45,600. The fact that the second investor, Investor B, paid $25,000 (or any other amount) to the first investor for the 20,000 Shares does not affect the amount that Investor B is entitled to receive upon a change of control.

 

Illustration 6: Change of Control Without Sufficient Consideration to Pay Off the Outstanding Shares 

 

In the event that a change of control occurs and an investor's principal and accumulated PIK have been paid in full, but the Success Bonus has not been paid in full, then the investor's remaining amount due and payable would be converted to common stock based upon the relative amount owed to the investor, proportional to the amounts outstanding to the other Class A Preferred shareholders. For example, if $100 is owed to the investor, and other investors are owed $900, then the investor would receive 10% of the newly issued common stock and the other preferred shareholders would receive the other 90%. No other common stock, besides that which is conveyed to the preferred shareholders upon the change of control, would exist 

 

You should consult your tax advisor regarding the potential tax treatment of an investment in the Shares. The Company is not providing tax advice to its investors regarding the tax treatment of investments in the Shares, and the Company reserves the right to make decisions regarding the Company without regard to the tax effect to investors of the Company’s business decisions.

 

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Benefits of the Structure of the Shares

 

The structure of the Shares is intended to address two (2) primary drawbacks to early-stage investing: 1) follow-on dilution and 2) uncertain, non-market valuations over time. The Shares provide investors with an opportunity to receive paid-in-kind dividends and, as a result, there is no dilutive effect from later issuances of Shares. (See the section entitled “Dilution” for additional information.) Those same terms also enable investors to mitigate the impact of unforeseeable valuations of our Company. By providing a calculated return, in the event of a successful exit, that is designed to generally outperform returns generated by traditional venture capital-held portfolio companies, the Shares potentially offer an appropriate reward for the risks involved in investments of this type.

 

There are other potential benefits of the structure of the Shares:

 

·The Company anticipates initiating a change of control within the next six (6) years, which would be a shorter tie-up period than the average tie-up period for venture capital investments. We believe that the net proceeds of the Offering, if fully subscribed, will likely provide the Company with the capital necessary to receive regulatory approval and begin initial commercial sales. However, within six (6) years, the Company anticipates needing significant additional capital beyond that which is being raised in the Offering in order for the Company to achieve full-scale manufacturing and sales operations. As a result, the Company will, in all probability, need to pursue selling sufficient amounts of common stock, which could effect a change of control, within the next six (6) years.

 

·An investment in our Shares does not involve fees for management or performance, which are ordinarily charged by venture capital funds. (Historically, two percent (2%) management fee per year and a twenty percent (20%) performance fee.)

 

·

The Shares are intended to provide capital-gains treatment of the returns on a successful exit (through the Success Bonus) and, for individual investors, the Shares are intended to qualify as qualified small business stock under Section 1202 of the Internal Revenue Code of 1986, as amended (“IRC”). Currently, depending on the circumstances, Section 1202 of the IRC may provide an effective tax rate as low as zero percent (0%) for gain recognized from the sale or exchange of qualified small business stock (within the meaning of Section 1202(c) of the IRC) held for more than five (5) years, by permitting a taxpayer to exclude one hundred percent (100%) of such gain from gross income up to the greater of $10 million (reduced by the aggregate amount of any such gain previously excluded by the taxpayer under Section 1202 of the IRC in prior taxable years) or 10 times the aggregate adjusted bases of qualified small business stock (with such basis being determined without regard to any additions to the basis following its original issuance) issued by the Company and disposed of by the taxpayer. The one hundred percent (100%) gain exclusion under Section 1202 of the IRC only applies to qualified small business stock acquired after September 27, 2010.  You should consult your own tax adviser regarding the possible applicability of Section 1202 of the IRC to your current, and any future, situation. The Company is not providing and shall not provide tax advice to its investors, and the Company has reserved the right to make future business decisions without considering the possible tax effect to investors of the Company’s business decisions.

 

 

·In the event that the Company is able to list the Shares on an exchange, the Shares would have increased liquidity.

 

Structure of Potential Returns for an Investment in the Company’s Class A Preferred Stock

 

As with any early-stage investment, and particularly with an early-stage medical-device investment, an investment in the Company’s Class A Preferred Stock carries great risk. You should refer to the risk factors described throughout this Offering Circular to understand those known risks. There are unknown risks as well.

 

The Company believes that, in order to be fair to its investors, the potential returns for an investment in the Company’s Class A Preferred Stock should reflect the risk of the investment. In structuring the potential returns, the Company researched the available academic literature regarding comparable investments of this type (often called “early-stage,” or “development-stage,” or “venture-stage” companies). Based on a peer-reviewed article from 2005 in the Journal of Financial Economics, authored by John Cochrane, the Rose-Marie and Jack Anderson Senior Fellow at the Hoover Institution of Stanford University, entitled, “The risk and return of venture capital,” Prof. Cochrane determined that the historical arithmetic returns on venture-capital firms’ investments in early-stage companies averaged 59% per year. The Company is unaware of any academic literature since 2005 which indicates that the average return for venture-capital investments has materially changed from Prof. Cochrane’s 59% calculation.

 

Prof. Cochrane’s 59% per year calculation is an average return per year for a large set of companies. The values of individual development-stage companies do not go in a straight line, however. As companies reach different milestones in their development, their economic value generally significantly increases at particular points in time. Mathematicians call this type of graph a step-function. Taking the lessons learned from Professor Cochrane, the Company structured the potential returns on an investment in Class A Preferred Stock utilizing the PIK and Success Bonus. The PIK causes a constant 7% rise in the potential return, and the Success Bonus creates a step-function that enables the potential returns that are structured to generally exceed the historical returns for early-stage investments described in Prof. Cochrane’s research, in the event of a successful change of control.

 

It is important for you to understand that the actual return, IF ANY, that may be paid to investors in the Class A Preferred Stock is not known at this time and is dependent on the Company’s actual cash proceeds and/or cash or cash equivalents on hand at the time of any potential payment to the holders of the Class A Preferred Stock is triggered.

 

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Risks and Possible Disadvantages of Owning Class A Preferred Stock

 

As with any equity investment, you may lose your entire investment in the Company. Return of your investment, or payment of any accrued PIK or Success Bonus, is contingent on the amount of the assets of the Company, or the consideration received, at the time of a change of control of the Company. Owners of Class A Preferred Stock have no voting rights and have no management control over the Company. In the event of a successful change of control of the Company, the potential returns, if any, for holders of Class A Preferred Stock will be determined by the PIK and the Success Bonus, rather than the sale price of the Company. Please see the section entitled “Risk Factors” for further discussion about the risks of investing in our Offering.

 

Corporate Information

 

Our principal executive offices are located at 5701 Old Harding Pike, Suite 200, Nashville, Tennessee 37205. Our telephone number is (615) 352-9519. The address of our website is www.virtuososurgical.net. The inclusion of our website address in this Offering Circular does not include or incorporate by reference the information on our website into this Offering Circular.

 

Implications of Being an Emerging Growth Company

 

We are an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”). For as long as we are an emerging growth company, unlike public companies that are not emerging growth companies under the JOBS Act, we will not be required to:

 

·provide an auditor’s attestation report on management’s assessment of the effectiveness of our system of internal control over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002 (the “Sarbanes Oxley Act”);

 

·provide more than two years of audited financial statements and related management’s discussion and analysis of financial condition and results of operations;

 

·comply with any new requirements adopted by the Public Company Accounting Oversight Board (the “PCAOB”) requiring mandatory audit firm rotation or a supplement to the auditor’s report in which the auditor would be required to provide additional information about the audit and the financial statements of the issuer;

 

·provide certain disclosure regarding executive compensation required of larger public companies or hold stockholder advisory votes on the executive compensation required by the Dodd-Frank Wall Street Reform and Consumer Protection Act (the “Dodd-Frank Act”); or

 

·obtain stockholder approval of any golden parachute payments not previously approved.

 

We will cease to be an emerging growth company upon the earliest of the:

 

·last day of the fiscal year in which we have $1.07 billion or more in annual revenues;

 

·date on which we become a “large accelerated filer” (the fiscal year-end on which the total market value of our common equity securities held by non-affiliates is $700 million or more as of June 30);

 

·date on which we issue more than $1.0 billion of non-convertible debt over a three-year period; or

 

·last day of the fiscal year following the fifth anniversary of our initial public offering.

 

In addition, Section 107 of the JOBS Act provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

 

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Offering Summary

 

Issuer   Virtuoso Surgical, Inc.
     
Securities Offered   Class A Preferred Stock
     
Shares of Class A Preferred Stock Offered by the Company   20,000,000 shares, with 21,305,000 shares outstanding assuming the maximum amount of shares are purchased in this Offering
     
Price per Share   $1.00
     
Use of Proceeds   We estimate that net proceeds from the sale of shares of our Class A Preferred Stock will be approximately $18,400,000, based upon the assumed initial public offering price of $1.00 per share, after deducting the Placement Agent commissions and estimated offering expenses payable by us.
     
    We intend to use the net proceeds we receive from this Offering for new product development and general corporate purposes, including working capital, sales and marketing activities, research and development, general and administrative matters, and capital expenditures. We may also use a portion of the net proceeds for the acquisition of, or investment in, technologies, solutions, products, or businesses that complement our business, although we have no present commitments or agreements to enter into any such acquisitions or investments. See the section entitled “Use of Proceeds” for additional information.
     
Market and Trading Symbol   We may, at our discretion, and, depending upon market conditions, apply to list our Class A Preferred Stock on the OTCQB Venture Market operated by the OTC Markets Group Inc.  In such case, we may list with the OTCQB Venture Market under the trading symbol “VSUR.”
     
Risk Factors   Investing in our Class A Preferred Stock involves a high degree of risk. You should read the “Risk Factors” section of this Offering Circular for a discussion of factors to consider carefully before deciding to invest in the Shares.

 

Shares of our Class A Preferred Stock that will be outstanding after this Offering reflected above is based on 1,305,000 shares outstanding as of September 30, 2019. Unless otherwise indicated, this Offering Circular reflects and assumes the following:

 

·no outstanding convertible promissory notes;

 

·no exercise of warrants outstanding or issuable in connection with this Offering; and

 

·no exercise by the Placement Agent of an option to purchase any shares of Class A Preferred Stock.

 

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RISK FACTORS

 

An investment in our Class A Preferred Stock involves a high degree of risk. You should carefully consider the risks described below, together with all of the other information included in this Offering Circular, before making an investment decision. If any of the following risks actually occurs, our business, financial condition, or results of operations could suffer. In that case, the trading price of our shares of Class A Preferred Stock could decline and you may lose all or part of your investment. See “Cautionary Note Regarding Forward Looking Statements” above for a discussion of forward-looking statements and the significance of such statements in the context of this Offering Circular.

 

Risks Related to Our Company

 

The Company is a development stage company and has a limited operating history, and its selected financial projections are based upon assumptions that inherently contain significant uncertainties. As a result, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations may differ materially from the financial projections.

 

The selected financial projections included in this Offering Circular are based upon a number of assumptions and estimates that inherently are subject to significant business, economic, competitive, regulatory and operational uncertainties, contingencies and risks, many of which are beyond the Company’s control. Such assumptions may be incomplete or inaccurate, and unanticipated events and circumstances may occur that could have a material adverse impact on the Company’s ability to achieve the projections. The selected financial projections also assume the success of the Company’s business strategy. The success of this strategy is subject to various uncertainties and contingencies beyond the Company’s control, and no assurance can be given that the strategy will be successful or that the anticipated benefits from the strategy will be realized in the manner or during the periods reflected in the selected financial projections or at all. Any uncertainties or contingencies could cause the selected financial projections to differ materially from those included in this Offering Circular and could materially and adversely impact the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations.

 

We are in the early stage of product development and there can be no assurance that we will effectively and successfully develop products for commercialization.

 

The medical device we are developing has had only limited research and testing in the fields of use we are presently intending to explore and to commercialize.  We will have to continue to go through extensive research and testing to develop the initial product and any additional products and to determine or demonstrate the safety and effectiveness of their proposed use.  Our products and our proposed testing of those products will require various regulatory approvals and clearances.  Accordingly, the products we intend to pursue are not presently marketable in the fields of use for which we hope to develop them, and it is possible that some or all of them may never become legally and commercially marketable.  The development and testing of medical devices and related treatments and therapies is difficult, time-consuming and expensive, and the successful development of any products based on innovative technologies is subject to inherent uncertainties and risks of failure.  These risks include the possibilities that any or all of the proposed products or procedures may be found to be ineffective, or may otherwise fail to receive necessary regulatory clearances; that the proposed products or procedures may be uneconomical to produce and market or may never achieve broad market acceptance; that third parties may hold proprietary rights that preclude the Company from marketing its intended products or procedures; or that third parties may develop and market superior or equivalent products and procedures.  We are unable to predict whether our research and development or acquisition activities will result in any commercially viable products or procedures.  Furthermore, due to the extended testing and regulatory review process required before marketing clearances can be obtained, the time frames for commercialization of any products or procedures are long and uncertain.

 

We expect to continue to incur losses for the immediate future.

 

We have incurred losses since our inception.  We expect to continue to incur losses for the foreseeable future. The principal causes of our losses are likely to be personnel costs, working capital costs, research and development costs, intellectual property protection costs, brand development costs, marketing and promotion costs, and the lack of any significant revenue stream for the foreseeable future.  We may never achieve profitability.

 

The Company’s future profitability depends upon the success of its principal product lines.

 

Once commercialized, if the Company’s products are not successful or are unable to compete successfully with offerings of competitors, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations will be materially and adversely impacted. Additionally, adverse rulings by regulatory authorities, particularly including, without limitation, decisions of the FDA, will significantly and adversely affect the Company’s sales of its products and, as a result, would materially and adversely impact the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations.

 

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If our products and procedures do not gain market acceptance among physicians, patients, and the medical community, we may be unable to generate significant revenues, if any.

 

Even if we obtain regulatory approval for our products, they may not gain market acceptance among physicians, healthcare payers, patients, and the medical community. In particular, the U.S. government agency Center for Medicare/Medicaid Service or other private reimbursement agencies may decline to reimburse physicians and health care facilities whose patients are on Medicare or Medicaid or private insurance for use of our product, significantly reducing our potential market. Market acceptance will depend on our ability to demonstrate the benefits of our approved products in terms of safety, efficacy, convenience, ease of administration, and cost effectiveness.  In addition, we believe market acceptance depends on the effectiveness of our marketing strategy, the pricing of our approved products, and the reimbursement policies of government and third party payers with respect to our products.  Physicians may not utilize our approved products for a variety of reasons and patients may determine for any reason that our product is not useful to them.  If any of our approved products fail to achieve market acceptance, our ability to generate revenues will be limited.

 

If the Company fails to compete successfully in the future against its existing and potential competitors, its sales and operating results may be negatively affected, and it may not achieve future growth.

 

The market for the Company’s products is potentially highly competitive and is dominated by a number of large companies. The Company’s business will initially be focused on a limited number of segments of the endoscopic surgery market, and, as a result, the Company may not be able to meet the prices offered by its competitors, or offer products similar to or more desirable than those offered by its competitors who compete in many and/or all segments of the surgical products market. Many of the Company’s potential competitors in the medical device market have:

 

·greater financial and other resources;

 

·more robust product portfolios covering a larger portion of the medical device market;

 

·more widely accepted products;

 

·greater technical capabilities;

 

·superior ability to maintain new product flow;

 

·patent portfolios that may present an obstacle to the Company’s conduct of business;

 

·stronger name recognition; and

 

·larger distribution networks.

 

We must effectively manage the growth of our operations, or our Company will suffer.

 

Our ability to successfully implement our business plan requires an effective planning and management process. If we grow our operations, especially in terms of the number of products we offer or the number of surgical fields we sell products to, we will need to hire additional employees and make significant capital investments. If we grow our operations, it will place a significant strain on our existing management and resources. If we grow, we will need to improve our financial and managerial controls and reporting systems and procedures, and we will need to expand, train, and manage our workforce. Any failure to manage any of the foregoing areas efficiently and effectively would cause our business to suffer.

 

If the Company is unable to continue to develop and market new products and technologies, it may experience a decrease in demand for its products or its products could become obsolete, and its business would suffer.

 

The Company intends to be continually and actively engaged in product development and improvement programs. The Company may experience difficulties competing with its competitors unless it can keep pace with existing and/or new technologies. Competitors’ new products and technologies may beat the Company’s products to market, may be more effective or less expensive than the Company’s products or render its products obsolete. If any of the foregoing were to occur, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected.

 

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The Company’s business plan relies upon certain assumptions about the market for its products, which if incorrect, may adversely affect its profitability.

 

The Company believes that the endoscopic market continues to be underserved by its larger robotic competitors and that it can establish a strong, competitive position in those segments. The projected demand for the Company’s products could materially differ from actual demand if its assumptions regarding acceptance by the medical community of its products rather than its competitors’ technologies prove to be incorrect or do not materialize or if other treatments gain more widespread acceptance as a viable alternative to the Company’s offerings. If any of the foregoing were to occur, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected.

 

We are heavily dependent on our senior management, and a loss of a member of our senior management team could cause our financial condition and results of our operations to be harmed.

 

If we lose the services of our key employees, we may not be able to find appropriate replacements on a timely basis, and our business could be adversely affected. Our existing operations and continued future development depend to a significant extent upon the performance and active participation of certain key employees. Although we may enter into employment agreements with key employees in the future, we cannot guarantee that we will be successful in retaining the services of these individuals. Additionally, we may incur additional expenses to recruit and retain new management or executive officers. If, despite our use of non-competition agreements with key employees, any of our management or executive officers joins a competitor or forms a competing company, we may lose some of our potential customers. Finally, we currently do not maintain “key person” life insurance on any of our key employees. If we were to lose any of these individuals, we may not be able to find appropriate replacements on a timely basis and our financial condition and results of operations could be materially adversely affected.

 

The Company may rely upon independent sales distributors and sales associates to market and sell its products.

 

The Company’s success may depend largely upon arrangements with independent sales distributors and sales associates and, in particular, their sales and service expertise and relationships with the customers in the marketplace. Independent sales distributors and sales associates may terminate their relationship with the Company or devote insufficient sales efforts to its products. The Company does not control these independent sales distributors and sales associates who may not be successful in implementing the Company’s sales and marketing plans. The Company’s failure to attract and retain skilled independent sales distributors and sales associates could have a materially adverse effect on the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations.

 

In addition, independent sales distributors and sales associates are frequently subject to restrictive contractual arrangements, such as non-compete agreements, with their prior employers which limit their ability to market and sell products for other medical device companies after having left the employ of their previous employer. When seeking to engage these independent sales distributors and sales associates, the Company must rely, at least in part, upon the distributors and associates to disclose to the Company, and to abide by, such agreements. Further, even if notified of such a restrictive contractual arrangement, the Company must seek to ensure that it does not require the distributor or associate to perform an act which causes a breach of the restrictive contractual arrangement. If the independent sales distributors and sales associates do not so disclose and abide by such agreements or if the Company inadvertently requires the distributor or associate to perform an act in violation of such a restrictive contractual arrangement, then the distributors, associates, and/or the Company could become subject to litigation commenced by the former employer which can be costly and time consuming and which could materially and adversely affect the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations.

 

If the Company loses one of its key vendors and suppliers, it may be unable to meet customer orders for products in a timely manner or within the Company’s budget.

 

The Company relies upon a limited number of vendors and suppliers for the materials and components used in, and the packaging of, its products, and the manufacture and packaging of the Company’s products can be exacting and complex. Vendors and suppliers of materials and components may not be able to supply or may decide, or be required, for reasons beyond the Company’s control to cease supplying materials and components to the Company. In addition, FDA regulations may require additional testing of any materials or components from new suppliers prior to the Company’s use of these materials or components and, in the case of a device with a Pre-Market Approval application (“PMA”), the Company may be required to obtain prior FDA permission, either of which could delay or prevent the Company’s access to or use of such materials or components. The Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely impacted if the Company’s vendor or supply chain is unexpectedly terminated or interrupted, and the Company is unable to obtain an acceptable new source of supply in a timely fashion on economic terms that are beneficial to the Company.

 

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If third-party manufacturing facilities suffer disasters or other similar catastrophic events, the Company may be unable to manufacture its products for a substantial amount of time, and the Company’s sales could be disrupted.

 

The Company will rely upon a limited number of third-party facilities to manufacture its products. These manufacturing facilities and their equipment would be difficult to repair or replace and could require substantial lead-time to repair or replace. The facilities could be adversely affected by, among other catastrophic events, natural or man-made disasters. In the event that one or more of these facilities are affected by a disaster or other catastrophic event, the Company would be forced to rely upon third-party manufacturers.

 

The Company is subject to substantial government regulation that could have a material adverse effect on its business.

 

The production and marketing of the Company’s products and its ongoing research and development, preclinical testing and clinical trial activities are subject to extensive regulation and review by numerous governmental authorities both in the United States and abroad. In the United States, most of the medical devices that the Company develops must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process administered by the FDA. In particular, in order for the Company to market its products for clinical use in the United States, it most likely must obtain clearance from the FDA through a Section 510(k) Premarket Notification, De Novo classification, or a PMA. Products distributed outside of the United States are subject to foreign government regulations, which vary by country. In Europe, in order for a medical device to be commercially distributed, it must bear a CE conformity marking, indicating that it conforms to the essential requirements of the applicable European medical device directive. United States and foreign regulations govern the testing, marketing, and registration of new medical devices, in addition to regulating manufacturing practices, reporting, labeling, and record keeping procedures. The regulatory process requires significant time, effort, and expenditures to bring the Company’s products to market, and no assurances can be made that any of the Company’s products will be approved. The Company’s failure to comply with applicable regulatory requirements could result in these government authorities:

 

·imposing fines, penalties, and taxes on the Company;

 

·preventing the Company from manufacturing or selling its products;

 

·bringing civil or criminal charges against the Company;

 

·delaying the introduction of the Company’s new products into the market;

 

·recalling or seizing the Company’s products; and/or

 

·withdrawing or denying approvals or clearances for the Company’s products.

 

Even if regulatory approval or clearance of a product is granted, such approval could result in limitations on uses for which the product may be labeled and promoted. Further, for a marketed product, its manufacturer and manufacturing facilities are subject to periodic review and inspection. Later discovery or problems with a product, manufacturer, or facility may result in restrictions on the product, manufacturer, or facility, including withdrawal of the product from the market or other enforcement actions. If any of the foregoing were to occur, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected.

 

The Company operates in a heavily regulated sector, and failure to comply with such laws, rules, and regulations could have a materially adverse impact upon the Company’s business, cash flows, financial conditions, and results from operations.

 

The Company’s business is highly regulated, and the penalties for noncompliance are severe. The Company is required to comply with extensive, extremely complicated and overlapping government laws, rules, and regulations at the federal, state, and local levels. These laws, rules, and regulations govern every aspect of how the Company conducts its operations. The failure to comply with these laws, rules, and regulations can result in severe penalties, including, without limitation, criminal penalties and civil sanctions, any of which could have a materially adverse impact upon the Company’s business, cash flows, financial conditions, and results from operations.

 

Not only is the Company’s business heavily regulated, but the laws, rules, and regulations to which the Company is subject often change, with little or no notice, and are often interpreted and applied differently by various regulatory agencies with authority to enforce such requirements. Each change or conflicting interpretation may require the Company to make changes in its facility, equipment, personnel, or services, and may also require that standard operating policies and procedures be re-written and re-implemented. The cost of complying with such laws, rules, and regulations is a significant component of the Company’s overall expenses and negatively impacts the Company’s cash flows and results from operations. Further, this expense has grown in recent periods because of new regulatory requirements and the severity of the penalties associated with non-compliance. Management anticipates that compliance expenses will continue to grow in the foreseeable future as the healthcare industry has seen a number of ongoing investigations and proceedings. If the Company were to become subject to any such investigation or proceeding and if the outcome of such investigation or proceeding were unfavorable to the Company, the Company’s business, cash flows, financial conditions, and results from operations could be materially and adversely impacted.

 

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The Company is unable to predict with certainty the impact of Healthcare Reform Law, which represents significant change to the healthcare industry, may adversely affect the Company, and may have a material adverse effect on the Company’s business, financial condition, results of operations, and cash flows.

 

In both the United States and certain foreign jurisdictions, there have been and will continue to be a number of legislative and regulatory changes to the healthcare system that could impact the Company’s ability to sell its products profitably. In particular, in 2010, the Patient Protection Affordable Care Act, as amended by the Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Law”), was enacted. The Healthcare Reform Law substantially changes the way healthcare is financed by both governmental and private insurers and significantly affects the entire healthcare industry, including medical device companies. Many variables continue to impact the effect of the Healthcare Reform Law, including the law’s complexity, lack of complete implementing regulations and/or interpretive guidance, gradual and partially delayed implementation, court challenges, possible amendment, repeal or further implementation delays, uncertainty regarding the success of national healthcare exchanges enrolling uninsured individuals, possible reductions in funding by the U.S. Congress and future reductions in Medicare and Medicaid reimbursement, and how individuals and businesses will respond to the new choices and obligations under the law. Because of these many variables, the Company is unable to predict with certainty the net effect on its business. In addition, the Company is unable to predict with certainty how providers, payors, employers and other market participants will respond to the various reform provisions because many provisions will not be implemented for several years under the Healthcare Reform Law’s implementation schedule.

 

The Company’s business is subject to inspection by the FDA and international authorities, and the Company could face penalties if the Company is found to be non-compliant with the regulations of the FDA or international authorities.

 

As part of the Company’s pursuit of regulatory approval for the Company’s products, it is possible that the FDA and various other authorities will inspect the Company’s facilities from time to time to determine whether the Company is in compliance with regulations relating to medical device manufacturing, including regulations concerning design, manufacturing, testing, quality control, product labeling, distribution, promotion, and record keeping practices. A determination that the Company is in material violation of such regulations could lead to the imposition of civil penalties, including fines, product recalls, product seizures or, in extreme cases, criminal sanctions or a shutdown of our manufacturing facility. Furthermore, even if regulatory approvals to market a product are obtained from the FDA, such approvals may contain limitations on the indicated uses of the product. The FDA could also limit or prevent the manufacture or distribution of Company’s products and has the power to require the recall of products. FDA regulations depend heavily on administrative interpretation, and future interpretations made by the FDA or other regulatory bodies with possible retroactive effect may adversely affect the Company.

 

If the FDA or international authorities determine that the Company’s promotional materials or activities constitute promotion of its products for an unapproved use or other claim in violation of applicable law relating to the promotion of our products, it could demand that the Company cease the use of or modify its promotional materials and subject it to regulatory enforcement actions, including the issuance of a warning letter, injunction, civil fine, and criminal penalties. Competitors may also assert claims either directly or indirectly with the FDA concerning any alleged illegal or improper marketing promotional activity.

 

The Company must comply with complex statutes prohibiting fraud and abuse, and both the Company and physicians utilizing its products could be subject to significant penalties for noncompliance.

 

There are extensive federal and state laws and regulations prohibiting fraud and abuse in the healthcare industry that can result in significant criminal and civil penalties. These federal laws include: the Anti-Kickback Law which prohibits certain business practices and relationships, including the payment or receipt of remuneration for the referral of patients or the purchase, order, or recommendation of goods or services for which payment will be made by Medicare or other federal healthcare programs; the physician self-referral prohibition, commonly referred to as the Stark Law; the Anti-Inducement Law, which prohibits providers from offering anything to a Medicare or Medicaid beneficiary to induce that beneficiary to use items or services covered by either program; the Civil False Claims Act, which prohibits any person from knowingly presenting or causing to be presented false or fraudulent claims for payment by the federal government, including the Medicare and Medicaid programs; the Health Insurance Portability and Accountability Act of 1996, which creates federal criminal laws that prohibit executing a scheme to defraud any healthcare benefit program and which also imposes certain obligations on entities with respect to the privacy, security, and transmission of individually identifiable health information; the federal False Statements Statute, which prohibits knowingly and willfully falsifying, concealing, or covering up a material fact or making any materially false statement in connection with the delivery of or payment for healthcare benefits, items, or services; and the Civil Monetary Penalties Law, which authorizes the Department of Health and Human Services to impose civil penalties administratively for fraudulent or abusive acts. The Company is also subject to state laws that are analogous to the above federal laws, such as state anti-kickback and false claims laws.

 

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Sanctions for violating these laws include criminal and civil penalties that range from punitive sanctions, damage assessments, money penalties, imprisonment, denial of Medicare and Medicaid payments, or exclusion from the Medicare and Medicaid programs, or both. As federal and state budget pressures continue, federal and state administrative agencies may also continue to escalate investigation and enforcement efforts to root out waste and to control fraud and abuse in governmental healthcare programs. Private enforcement of healthcare fraud has also increased, due in large part to amendments to the Civil False Claims Act in 1986 that were designed to encourage private persons to sue on behalf of the government. The Company’s ongoing efforts to comply with these laws may be costly, and a violation of any of these federal and state fraud and abuse laws and regulations could have a material adverse effect on our liquidity and financial condition. The risk of being found in violation of these laws is increased by the fact that many of them have not been definitively interpreted by the regulatory authorities or the courts, and their provisions are open to a variety of subjective interpretations. In addition, these laws and their interpretations are subject to change. Any action against the Company for violation of these laws, even if the Company successfully defends against it, could cause it to incur significant legal expenses, divert management’s attention from the operation of the business and damage its reputation, and could have a material adverse effect on the Company’s ability to commercialize its products.

 

Clinical trials associated with future applications of the Company’s technology may involve lengthy and expensive processes with uncertain outcomes, and results of earlier studies and trials may not be predictive of future trial results.

 

In the future, as the Company explores additional applications and new technology, clinical trials may be required for regulatory approval. The Company cannot predict whether it will encounter problems with any future clinical trials, which would cause delay or suspensions of those clinical trials, or delay the analysis of data from those clinical trials. Failure can occur at any stage of testing, and the Company may experience numerous unforeseen events during. Thus, the clinical trial process that could delay or prevent commercialization of the current, or a future, more advanced, version of products, including but not limited to: delays in obtaining regulatory approvals to commence a clinical trial; slower than anticipated patient recruitment and enrollment; negative or inconclusive results from clinical trials; unforeseen safety issues; an inability to monitor patients adequately during or after treatment; and problems with investigator or patient compliance with the trial protocols. Despite the successful results reported in early clinical trials regarding its products, the Company does not know whether any clinical trials it may conduct will produce favorable results. The failure of clinical trials to produce favorable results could have a material adverse effect on the Company’s business, financial condition, and results of operations.

 

If adequate levels of reimbursement from third-party payers are not obtained with respect to the Company’s product, specialists may be reluctant to use these products and the Company’s sales may decline.

 

In the United States, healthcare providers that will purchase the Company’s products generally rely upon third-party payers, principally federal Medicare, state Medicaid, and private health insurance plans, to pay for all or a portion of the cost of the products being marketed by the Company and the procedures to complete treatments using these products. The Company may not be able to sell its products on a profitable basis if third-party payers deny coverage for these products and procedures. The Company’s sales will depend largely upon government healthcare programs and private health insurers reimbursing patients’ medical expenses. Health care providers may not purchase these products if they do not receive satisfactory reimbursement from these third-party payers for the cost of the procedures using these products. Payers continue to review their coverage policies carefully for existing and new therapies and can, without notice, deny coverage for treatments that include the use of the Company’s products.

 

In addition, some healthcare providers in the United States have adopted or are considering a managed care system in which the providers contract to provide comprehensive healthcare for a fixed cost per person. Healthcare providers may attempt to control costs by authorizing fewer elective procedures, including those involving the Company’s products, or by requiring the use of the least expensive product or procedure available.

 

If any of the foregoing were to occur, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected.

 

The Company will be subject to the risks inherent in operating in international markets.

 

The Company expects to introduce its products in foreign markets after obtaining regulatory approvals in those markets. The Company also expects to derive a significant portion of its ongoing revenues from sales in foreign markets. Accordingly, risks that the Company encounters in these foreign markets may have a materially adverse impact on its ability to meet its financial projections and achieve profitability. Sales and operations in international markets expose the Company, its representatives, agents, and distributors to risks inherent in operating in these foreign jurisdictions. These risks include:

 

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·the imposition of additional foreign governmental controls or regulations on the Company’s products;

 

·new export license requirements;

 

·political and/or economic instability in the Company’s target markets;

 

·a shortage of high-quality international salespeople and distributors;

 

·changes in third-party reimbursement policies;

 

·changes in tariffs and other trade restrictions;

 

·work stoppages or strikes in the healthcare industry;

 

·difficulties in managing international operations and sales; and

 

·exposure to different legal standards.

 

The Company expects that the majority of its international sales will be generated in Europe. In Europe, healthcare regulation and reimbursement practices vary widely from country to country. This environment could adversely affect the Company’s ability to sell its products in some European markets.

 

If product liability lawsuits are brought against the Company, its business may be harmed.

 

The design, manufacture, and sale of surgical devices exposes the Company to a significant risk of product liability claims. In the future, the Company may be subject to product liability claims with respect to its products, some of which may have a negative impact on the Company’s business. The Company expects to obtain a significant amount of product liability insurance; however, no assurances can be made that the purchased coverage will be adequate to protect the Company from any liabilities it may incur. If a product liability claim or series of claims is brought against the Company for uninsured liabilities or in excess of its insurance coverage, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected. In addition, as a result of a product liability claim, the Company’s senior management may have to expend considerable time in the defense of such a claim, and the Company may have to recall some of its products, which could result in significant costs.

 

Other potential losses may not be covered by insurance.

 

The Company expects to obtain comprehensive insurance coverage for general liability, property, business interruption, and other risks with respect to the business. These policies will offer coverage features and insured limits that the Company, in consultation with its insurance broker, believes are appropriate for the business. However, there are certain risks such as war, certain forms of terrorism such as nuclear, biological or chemical terrorism, acts of God such as floods and earthquakes, and some environmental hazards that may be deemed to fall completely outside the general coverage limits of the Company’s future policies or may be uninsurable or may be too expensive to justify insuring against. If the Company experiences any losses not covered by insurance or in excess of its coverage limits, the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations could be materially and adversely affected.

 

Efforts to acquire other companies or product lines could adversely affect the Company’s operations and financial results.

 

The Company may pursue strategic acquisitions of other companies or product lines. The Company’s ability to grow through acquisitions will depend upon its ability to identify, negotiate, complete, and integrate suitable acquisitions and to obtain any necessary financing. Even if it completes acquisitions, the Company may also experience:

 

·difficulties in integrating any acquired companies, personnel, and products into the Company’s existing business;

 

·delays in realizing the benefits of the acquired company or products;

 

·diversion of the management team’s time and attention from other business concerns;

 

·limited or no direct experience in new markets or countries the Company may enter;

 

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·higher costs of integration than anticipated; and/or

 

·difficulties in retaining key employees of the acquired business who are necessary to manage these acquisitions.

 

In addition, an acquisition could materially impair the Company’s operating results by causing it to incur losses.

 

General economic conditions may negatively impact the Company’s results.

 

Moderate or severe economic downturns or adverse conditions may negatively affect the Company’s operations. These conditions may be widespread or isolated to one or more geographic regions. A tightening of the labor markets in one or more geographic regions may result in fewer and/or less qualified applicants for job openings with the Company or its key suppliers. Higher wages, related labor costs, and increasing cost trends in the insurance markets may also negatively impact the Company’s geographic markets and may have an adverse impact on the Company’s sales and revenues.

 

The Company’s business may suffer from natural disasters, terrorist activity, and war.

 

The Company’s financial and operating performance may be adversely affected by natural disasters, in locations where it owns and/or operates significant assets and properties and in geographic areas from which it draws a large number of customers. Similarly, wars (including the potential for war), terrorist activity (including threats of terrorist activity), political unrest, and other forms of civil strife and geopolitical uncertainty may cause the Company’s business, cash flows, financial condition, liquidity, prospects, and results of operations to differ materially from anticipated results.

 

Risks Related to Our Intellectual Property

 

If the Company’s future patents and other intellectual property rights do not adequately protect its products, the Company may lose market share to its competitors and be unable to operate its business profitability.

 

The Company expects to rely upon patents, trade secrets, copyrights, know-how, trademarks, license agreements, and contractual provisions to establish its intellectual property rights and protect its products. These legal means, however, afford only limited protection and may not adequately protect the Company’s intellectual property rights. In addition, no assurances can be made that patent applications applied for will be approved for issuance. The USPTO may deny or require significant narrowing of any claims in our patent applications, and patents issuing from these applications, if any, may not provide the Company with significant commercial protection of its products. The Company could incur substantial costs in proceedings before the USPTO, the conclusions of which could result in adverse decisions as to the priority of the Company’s inventions and the narrowing or invalidation of claims in issued patents. In addition, the laws of some of the countries in which the Company’s products may be sold may not protect its products and intellectual property to the same extent as U.S. laws, or at all. The Company may be unable to protect its rights in trade secrets and unpatented proprietary technologies in these countries.

 

Additionally, the Company expects to enter into licensing agreements with third parties that will be necessary to utilize certain technologies used in the design and manufacturing of future products. The inability of the Company to obtain these licenses on reasonable terms may prevent the Company from executing its business plan as anticipated and may, therefore, have a materially adverse effect on its ability to meet its financial projections or achieve profitability.

 

The Company also seeks to protect its trade secrets, know-how, and other unpatented proprietary knowledge, in part, with confidentiality agreements with its employees, independent distributors, and consultants. No assurances can be made, however that (i) these agreements will not be breached, (ii) the Company will have adequate remedies for any breach, and/or (iii) trade secrets, know-how, and other unpatented proprietary technologies will not otherwise become known to or independently developed by our competitors.

 

If the Company loses any future intellectual property lawsuits, a court could require it to pay significant damages or prevent it from selling its products.

 

The medical device industry is litigious with respect to patents and other intellectual property rights. Companies in this industry have used intellectual property litigation to gain competitive advantages. In the future, the Company may become a party to lawsuits involving patents or other intellectual property. A legal proceeding, regardless of the outcome, could drain the Company’s financial resources and divert the time and effort of its management. If the Company lost one of these proceedings, a court, or a similar foreign governing body, could require the Company to pay significant damages to third parties, require it to seek licenses from third parties and pay ongoing royalties, require the Company to redesign its products or prevent it from manufacturing, using, or selling its products. In addition to being costly, protracted litigation to defend or prosecute the Company’s intellectual property rights could result in customers or potential customers deferring or limiting their purchase or use of the affected products until resolution of the litigation.

 

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Risks Relating to our Class A Preferred Stock and this Offering

 

There has been no public market for our Class A Preferred Stock prior to this Offering, and an active market in which investors can resell their shares may not develop.

 

There is no established public trading market for the Class A Preferred Stock, and the Company does not expect that an established public trading market for the Class A Preferred Stock will develop in the future. Accordingly, investors who acquire the Class A Preferred Stock will have limited or no liquidity in their investment in the Class A Preferred Stock. Prospective investors therefore (i) may not be able to sell their Class A Preferred Stock as and when desired, or at all, or (ii) may be forced to sell them at a substantial discount from the purchase price. Additionally, there may be significant state law restrictions upon the ability of investors to resell the Class A Preferred Stock.

 

Prospective Investors could lose the entire value of their investment in the Class A Preferred Stock.

 

An investment in the Class A Preferred Stock involves a high degree of risk and should not be acquired by anyone who has an immediate need for liquidity from, and/or who cannot afford the loss of, their entire investment. There can be no assurance of, and the Company does not give any assurance with respect to, the economic viability of, or any benefits which may accrue with respect to, an investment in the Class A Preferred Stock. Moreover, the Company does not in any way represent, warrant and/or guarantee (i) an economic gain or profit with regard to participating in this Offering and/or (ii) the advisability of investing in the Class A Preferred Stock. You could lose the entire value of your investment in the Class A Preferred Stock.

 

The Class A Preferred Stock are subject to substantial restrictions upon transfer.

 

Any transfer of the Class A Preferred Stock is subject to certain legal restrictions, and stockholder should be fully aware of and must appreciate the long-term nature of an investment in the Class A Preferred Stock. Stockholders may not transfer and/or resell their Class A Preferred Stock except (i) as permitted under the Securities Act and any applicable foreign and state securities laws pursuant to registration or exemption therefrom. Given these substantial restrictions upon transfer, the Class A Preferred Stock should not be acquired by stockholders who have an immediate need for liquidity from and/or who cannot afford the loss of their entire investment in the Class A Preferred Stock.

 

The purchase price of each share of Class A Preferred Stock is not connected to the value of the Company.

 

The Company’s issuance of Class A Preferred Stock is based on the Company’s required current expected expenses, which do not correlate to any value for, or of, the Company itself. For that reason, the Company has not sought a third-party valuation of the Class A Preferred Stock or of the book or fair market value of the Company.

 

Investors who acquire Class A Preferred Stock in this Offering will have no voting rights and will have limited control over the affairs, business, and operations of the Company.

 

The Company’s Board of Directors will have oversight and be responsible for the affairs, business, and operations of the Company. Except for certain material matters which require a majority vote of the common stockholders of the Company, the Board will generally make all decisions of behalf of the Company. In respect of the foregoing, stockholders will not be able to control or influence the affairs, business, and operations of the Company, in particular, holders of Class A Preferred Stock, which has no voting rights.

 

The Company may invest or spend the net proceeds of this Offering in ways with which stockholders may not agree or in ways which may not yield a positive return.

 

The Company intends to use the net proceeds to fund new product development, including, without limitation, the payment of design, regulatory, and inventory expenses, and to finance ongoing working capital needs and Company activities. The officers of the Company will have broad discretion in the application of these proceeds, and stockholders (i) will not have the opportunity, as part of their investment decision, to assess whether such net proceeds are being used appropriately or most efficiently, and (ii) may disagree with the manner in which such proceeds are ultimately utilized.

 

The Company will have need for additional funds.

 

The Company’s cash requirements will be significant. The Company anticipates, based on its present operating plan and assumptions, that the proceeds derived from the sale of Class A Preferred Stock will be sufficient to satisfy its cash requirements and maintain its operations for a period of up to 48 months. The Company may seek additional funds by issuing debt or equity to maintain its operations, and there can be no assurance that such needed funds would be available when needed or that they would be available on acceptable terms. The Company’s ability to operate is dependent upon sufficient capital. Accordingly, the Company anticipates that it will, at the appropriate time, increase its capital base, which increase may include the sale of additional securities, including additional Class A Preferred Stock.

 

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Because our charter and bylaws, as each might be amended from time to time, as well as Tennessee law limit the liability of our officers, directors, and others, stockholders may have no recourse for acts performed in good faith.

 

Under our charter and bylaws, as each might be amended from time to time, as well as Tennessee law, each of our officers, managers, members, employees, attorneys, accountants, and agents are not liable to us or the members for any acts they perform in good faith, or for any non-action or failure to act, except for acts of fraud, willful misconduct, or gross negligence. Our charter and bylaws, as each might be amended from time to time, provide that we will indemnify each of our officers, managers, members, employees, attorneys, accountants, and agents from any claim, loss, cost, damage liability, and expense by reason of any act undertaken or omitted to be undertaken by them, unless the act performed or omitted to be performed constitutes fraud, willful misconduct, or gross negligence.

 

Accordingly, our stockholders may have limited resources to pursue an action against any of our officers or managers, as our charter and bylaws, as each might be amended from time to time, contains provisions that eliminate the liability of our managers for monetary damages to our company and members. We may also have contractual indemnification obligations under our agreements with our managers, officers, and employees. The foregoing indemnification obligations could result in our company incurring substantial expenditures to cover the cost of settlement or damage awards against officers, directors, agents, and employees that we may be unable to recoup. These provisions and resultant costs may also discourage the Company from bringing a lawsuit against officers directors, agents, and employees for breaches of their fiduciary duties, and may similarly discourage the filing of derivative litigation against such individuals even though such actions, if successful, might otherwise benefit our Company and stockholders.

 

Investing in Class A Preferred Stock may subject stockholders to foreign, federal, state, and/or local tax consequences.

 

An investment in the Class A Preferred Stock may have foreign, federal, state, and/or local tax consequences for stockholders. You should consult, and rely solely upon the advice of, your tax advisors as to the tax consequences, and the ownership and disposition of, the Class A Preferred Stock, including the applicability and consequences of any foreign, federal, state, and/or local tax laws as well as any pending and/or proposed legislation.

 

Because we do not have an audit, nominating and corporate governance committee, or compensation committee, stockholders will have to rely on our directors, none of whom is independent, to perform these functions.

 

We do not have an audit committee, nominating and corporate governance committee, or compensation committee, and none of our directors are independent. The Board of Directors performs these functions as a whole.  Thus, there is a potential conflict in that board members who are also part of management will participate in discussions concerning management compensation and audit issues that may affect management decisions.

 

The preparation of our financial statements involves the use of estimates, judgments and assumptions, and our financial statements may be materially affected if such estimates, judgments, or assumptions prove to be inaccurate.

 

Financial statements prepared in accordance with generally accepted accounting principles in the United States (“GAAP”) typically require the use of estimates, judgments, and assumptions that affect the reported amounts. Often, different estimates, judgments, and assumptions could reasonably be used that would have a material effect on such financial statements, and changes in these estimates, judgments, and assumptions may occur from period to period over time. These estimates, judgments, and assumptions are inherently uncertain and, if our estimates were to prove to be wrong, we would face the risk that charges to income or other financial statement changes or adjustments would be required. Any such charges or changes could harm our business, including our financial condition, results of operations, and price of our securities.

 

If securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market trading volume of our Common Stock or Class A Preferred Stock could be negatively affected.

 

Any trading market for our Class A Preferred Stock will be influenced in part by any research reports that securities industry analysts publish about us. We do not currently have and may never obtain research coverage by securities industry analysts. If no securities industry analysts commence coverage of us, the market price, and market trading volume of our Class A Preferred Stock could be negatively affected. In the event we are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage or us, the market price and market trading volume of our Class A Preferred Stock could be negatively affected.

 

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USE OF PROCEEDS

  

Assuming the sale of all 20,000,000 shares of Class A Preferred Stock offered by us, the maximum gross proceeds to the Company from the sale of the Shares in this Offering are $20,000,000.

 

The estimated net proceeds from this Offering to the Company is expected to be approximately $18,000,000, after the payment of offering costs including printing, mailing, legal and accounting costs, filing fees, portal hosting fees, escrow fees, and Placement Agent commissions and expense reimbursements that may be incurred. The estimate of the budget for offering costs is an estimate only and the actual offering costs may differ from those expected by management. We intend to use the net proceeds from this Offering for new product development and general corporate purposes, including working capital, sales and marketing activities, research and development, general and administrative matters, and capital expenditures. We may also use a portion of the net proceeds for the acquisition of, or investment in, technologies, solutions, products, or businesses that complement our business, although we have no present commitments or agreements to enter into any such acquisitions or investments.

 

The Company currently anticipates that the net proceeds of the offering will allow the Company to complete the testing and validation of the Virtuoso device and system, as required for Food and Drug Administration approval. The FDA has three (3) primary paths that device manufacturers may pursue in order to begin commercial sales in the United States. Those pathways are generally called the 510(k) pathway, the De Novo pathway, and the Pre-Market Approval pathway. The Company currently anticipates that the FDA will likely evaluate and approve the device and system under either the 510(k) pathway or the De Novo pathway; however, the FDA possesses the statutory responsibility to permit interstate sales of safe and effective medical devices and the statutory authority to bar interstate sales of unsafe or ineffective medical devices. The Company bases its belief about the likely regulatory pathways that are available to the Company on the many robotic surgical devices that have previously received 510(k) clearance or De Novo classification as Class II devices. (A Class II device is a device that represents “moderate” risks.) In the event that the FDA requires Pre-Market Approval, the proceeds of the Offering will not be sufficient to complete the testing and validation necessary for regulatory approval.

 

The following table represents management’s best estimate of the uses of the net proceeds received from the sale of Class A Preferred Stock assuming the sale of, respectively, 100%, 75%, 50% and 25% of the shares offered for sale in this Offering.

 

Offering 
   100%   75%   50%   25% 
Personnel  $500,000   $500,000   $500,000   $500,000 
Engineering Materials, Supplies and Equipment  $4,000,000   $3,000,000   $2,000,000   $1,000,000 
Engineering Consulting, Testing & Validation  $13,000,000   $9,000,000   $5,000,000   $1,000.000 
Working Capital  $500,000   $500,000   $500,000   $500,000 
TOTAL  $18,000,000   $13,000,000   $8,000,000   $3,000,000 

 

As of the date of this Offering Circular, we cannot specify with certainty all of the particular uses for the net proceeds to us from the sale of Class A Preferred Stock. Accordingly, we will retain broad discretion over the use of these proceeds, if any.

 

CAPITALIZATION

 

The following table sets forth our capitalization as of December 31, 2018 on an actual basis and on an as adjusted to reflect the sale by the Company of the full offering amount of 20,000,000 shares of Class A Preferred Stock at a purchase price of $1.00 per share in this Offering.

 

 

   December 31, 2018   Post-Offering 
  

Actual

(Audited)

  

As Adjusted

(Unaudited)

 
Long Term Debt:  $0   $0 
           
Stockholders’ Equity:          
Common Stock, no par value per share 2,000,000 shares authorized 985,000 shares issued and outstanding (1)  $0   $0 
           
Class A Preferred Stock, par value $1.00 per share 50,000,000 shares authorized 1,075,000 shares issued and outstanding as of December 31, 2018 (2) 21,075,000 shares issued or outstanding, as adjusted (2)(3)  $1,075,000   $21,075,000 
           
PIK Dividends  $32,767   $32,767 
           
Retained Earnings (Deficit)  $(416,523)  $(416,523)
           
Total Stockholders’ Equity  $691,244   $20,691,244 
           
Total Debt and Stockholders’ Equity  $691,244   $20,691,244 

 

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(1)Holders of greater than ten percent (10%) of the Common Stock of the Company are: Robert Webster, S. Duke Herrell, and Richard Hendrick.

 

(2)Amounts do not reflect additional 230,000 shares of Class A Preferred Stock issued in a private offering during 2019.

 

(3)The total number of shares of our Class A Preferred Stock outstanding assumes that the maximum number of shares of Class A Preferred Stock is sold by the Company.

 

DIVIDEND POLICY

 

The Company is authorized to issue up to 50,000,000 Class A Preferred Stock, which carry an annual paid-in-kind dividend of seven percent (7%), with no compounding of interest. The Company has no other authorized classes of preferred stock. See “Description of Capital Stock” for further information about the Series A Preferred Stock being sold in this Offering.

 

DILUTION

 

By providing a calculated PIK and Success Bonus, the Shares are intended to provide protection against the risk of follow-on dilution and non-market valuations inherent to most early-stage investments. If you invest in our Class A Preferred Stock, there will be no dilutive effect unless there is a change of control where the Company cannot fully pay amounts owed to holders of Class A Preferred Stock in accordance with the Waterfall (discussed in the section entitled “Summary” at the beginning of this Offering Circular). Only at such point will the shares of Class A Preferred Stock be converted into shares of Common Stock and, therefore, as a holder of Common Stock, holders may experience the dilutive effect on ownership if in the future the Company issues shares of Common Stock or securities convertible into Common Stock.

 

Our Class A Preferred Stock holds no management or operational interest and is not convertible into Common Stock. At the time of this filing, our management owns approximately 80% of our outstanding shares of Common Stock, with the remaining 20% held as minority interests among our employees, certain advisors, and patent licensors. After this Offering, our management will continue to own approximately 80% of the equity interest of our Company. See “Description of Capital Stock” further information about Class A Preferred Stock being sold in this Offering.

 

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MANAGEMENT’S DISCUSSION AND ANALYSIS OF

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis of our financial condition and results of our operations together with our consolidated financial statements and the notes thereto appearing elsewhere in this Offering Circular. This discussion contains forward-looking statements reflecting our current expectations, whose actual outcomes involve risks and uncertainties. Actual results and the timing of events may differ materially from those stated in or implied by these forward-looking statements due to a number of factors, including those discussed in the sections entitled “Risk Factors,” “Cautionary Statement Regarding Forward-Looking Statements,” and elsewhere in this Offering Circular. Please see the notes to our Financial Statements for information about our Significant Accounting Policies and Recent Accounting Pronouncements.

 

Results of Operations

 

The following descriptions summarize key components of our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative of financial results to be achieved in future periods.

 

Comparison of the Years Ended December 31, 2018 and 2017

 

   Year Ended   Year Ended 
   December 31, 2018   December 31, 2017 
Revenues  $0   $0 
           
Gross Profit  $0   $0 
           
Operating Expenses          
           
Research and development  $816,663   $249,366 
           
Sales and marketing  $0   $0 
           
General and administrative  $151,098   $10,214 
           
Amortization of other intangibles  $0   $0 
           
Other Income (Expense), Net  $629,570   $270,848 
           
Income Tax Benefit (Expense)  $0   $0 
           
Net (loss) income  $(338,191)  $11,268 

 

The Company was founded in April 2016 and is an Emerging Growth Company in process of conducting research and development activities and, as a result, we did not generate revenue during the years ended December 31, 2018 and 2017, and we have not generated revenue during the six months ended June 30, 2019. Research and development expenses for the years ended 2018 and 2017 were approximately $800,000 and $250,000, respectively. General and administrative expenses for years ended 2018 and 2017 were approximately $150,000 and $10,000, respectively. The increase was due to increased legal, patent, and capital raising expenses, which are not permitted expenditures under federal and state grants. Additionally, over the two-year period approximately $200,000 was invested in property and equipment.

 

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Comparison of the Six Months Ended June 30, 2019 and 2018

 

During the first half of 2019, the Company accelerated its development operations by increasing research and development expenses to $598,485 for the six months ended June 30, 2019 compared to $335,620 during the same prior year period. In particular, as compared to the first half of 2018, the Company spent a materially larger percentage of the Company’s operating expenditures on outside consulting. The Company hired several outside engineering, software or design firms to assist the Company’s development process in the areas of: project planning; testing and validation needs; software and information-systems improvements; financial-systems improvements; risk analysis (including human-factors analysis); and sterility measures. The acceleration in the Company’s use of outside consultants is expected to continue if the Offering is fully subscribed.

 

Liquidity and Capital Resources

 

Funding for expenditures incurred during the years ended December 31, 2018 and 2017 was received from federal and state grants totaling approximately $1,865,000 and private capital raised from the sale of shares of Series A Preferred Stock in a private offering in 2018 and 2019 totaling $1,305,000. Additionally, during the six months ended June 30, 2019, the Company was awarded an additional $1,400,000 NIH Small Business Innovation Research grant. The grants, private capital, and funds on hand at the beginning of 2019 have enabled the Company to continue development spending, which is expected to approximate $1,200,000 by the end of 2019.

 

Summary of Cash Flows

 

The Company is reimbursed through draws from its federal and state grants for development activities and certain authorized indirect costs incurred. The cash flow timing needs and costs that are not eligible for reimbursement under grant provisions are met by private capital that has been raised through sales of Series A Preferred Stock.

 

While development activities, general and administrative expenses, and expenditures for property and equipment have totaled approximately $450,000, net of reimbursements under grants, the private capital raised during 2018 of $1,075,000 allowed for the accumulation of approximately $600,000 of cash at the end of 2018.

 

Plan of Operations

 

As discussed in more detail in this Offering Circular, the Company has received grants from the SBIR, the State of Tennessee, and the STTR, which are sufficient to fund the operations of the Company for the next twelve (12) months.  In the event this Offering is successful, the Company anticipates that it will utilize the proceeds in the manner described in the section entitled “Use of Proceeds” to accelerate its growth and development.

 

Off-Balance Sheet Arrangements

  

We did not have, during the periods presented, and we do not currently have, any relationships with any organizations or financial partnerships, such as structured finance or special purpose entities, that would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the date of the consolidated financial statements as well as the reported expenses during the reporting periods. The accounting estimates that require our most significant, difficult, and subjective judgments have an impact on revenue recognition, the determination of share-based compensation, and financial instruments. We evaluate our estimates and judgments on an ongoing basis. Actual results may differ materially from these estimates under different assumptions or conditions.

 

Our significant accounting policies are more fully described in Note 2 to our financial statements for the years ended December 31, 2018 and 2017 included elsewhere in this Offering Circular.

 

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

There have been no disagreements with our accountants during 2018 or 2017 or any subsequent interim periods.

 

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BUSINESS

 

Virtuoso Surgical, Inc. was founded in April 2016 to commercialize patented technology that has been developed at Johns Hopkins University and Vanderbilt University. The technology involves the use of concentric tubes of a metal alloy, nitinol, to robotically control small surgical tools through standard 5 to 8-millimeter rigid endoscopes. Nitinol is an alloy of approximately fifty percent (50%) nickel and fifty percent (50%) titanium that has certain unique metallurgical properties. Nitinol is both super-elastic and, when processed through a heat-treatment process, possesses an effect called the Shape Memory Effect. The Company utilizes the super-elastic properties of nitinol for its product.

 

After its formation, the Company licensed rights to patents held by Johns Hopkins University and Vanderbilt University. The Company’s license with Johns Hopkins University is non-exclusive; it gives the Company freedom to operate the core technology of its product in the United States and certain countries around the world. The Company’s license with Vanderbilt University is exclusive; it gives the Company exclusive rights to manufacture and sell a multiple-armed robotic system in the United States that is able to robotically control surgical instruments through rigid endoscopes using concentric tubes made of nitinol. See “Summary - Intellectual Property” for additional information. We believe that the patents held by Vanderbilt University to which we have an exclusive license will practically limit equivalent competing robotic endoscopic devices in the United States for the life of the patents. On its own behalf, the Company has a patent application pending in the USPTO, and the Company expects to file multiple future patent applications in the United States. Those patent applications may also eventually include applications under the international Patent Cooperation Treaty.

 

The Company’s product operates at the intersection of robotics and minimally invasive surgery. As reported in the New England Journal of Medicine in 2012, “Minimization of the invasiveness of surgical procedures is an advance that is arguably as significant as the discovery of anesthesia.” The principal market for the Company’s products is expected to be hospitals and surgery centers worldwide. The robotic surgery market worldwide was approximately $3.2 billion in 2014, and is expected to be approximately $20 billion by 2021, according to WinterGreen Research. The global market for endoscopy procedures is already approximately $37 billion, according to Transparency Market Research. The Company hopes to combine the benefits of the rapidly growing use of robotics for surgery with the existing large market for minimally invasive endoscopic surgery. That surgical market is ready for the advantages of robotic improvement, particularly for its largest market segment (approximately $20 million annually in global sales), rigid endoscopy. The Company is unaware of any other technology that would allow multiple robotically-controlled surgical tools through rigid endoscopes that possess the dexterity, precision, and power of the Virtuoso device.

 

The Company’s device and system are currently in their development phase. Based on the proof-of-concept models that were developed at Vanderbilt University, the Company’s first prototype began operation in June 2018. That model, internally called “Amadeus,” was intended to test the operation of the nitinol tubes, controlling software, motor controls, and physician-input devices. The Company’s second prototype, internally called “Bach,” began operation in July 2019. The second prototype is intended to test physician controls, test sterilization procedures, allow for human-factors testing, and validate operation and movement of the device, among other purposes. The Company expects to develop at least one, if not more, additional prototypes before entering “design freeze,” which will allow the Company to file its initial, primary application with the FDA.

 

The following is a rendering of the system prototype currently under development. To see a video of the Company’s current prototype in operation, please visit our website, www.virtuososurgical.net. Information contained on or accessible through our website is not a part of this Offering Circular and should not be relied upon in determining whether to make an investment decision.

 

The market segment that the Company expects to serve is “rigid surgical endoscopy.” Currently, that market is served by hand tools only, and there is not any known robotic technology to serve this market. A rendering of our system is below.

 

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The Company was originally capitalized with a $1.4 million Small Business Innovation Research grant from the U.S. National Institutes of Health (“NIH”). That grant was followed by additional NIH funding under a $225,000 Small Business Technology Transfer Research grant, a $150,000 matching grant from the State of Tennessee, and a second $1.4 million SBIR grant. The Company continues to seek funding from state and federal governments. The Company also raised approximately $1.3 million in private capital through the issuance of Class A Preferred Stock in 2018.

 

The Company spent approximately $250,000 on development expenses in 2017 and $800,000 in 2018, and the Company is on pace to spend approximately $1,200,000 in 2019 on development expenses. With capital raised from this Offering, the Company will be able to significantly increase its development spending. The Company began operations in September 2017 with four (4) full-time employees and has added additional full-time employees this year. We also now have one (1) part-time employee, and we have, to date, utilized a number of outside independent contractors to assist in the development process.

 

Before being able to market its device and system in the United States, the Company must receive either clearance or approval from the FDA. The Company is currently communicating with the FDA regarding the appropriate regulatory path for its system. The Company believes that the device is a Class II medical device, which should be approved for sale in the United States through the De Novo pathway. It has not yet been determined whether the system will require human trials, or a human pilot study. The Company intends to establish a rigorous post-market surveillance program, which should lessen or obviate the need for pre-market live-human trials. The post-market surveillance programs should also provide valuable ongoing surgical and business intelligence regarding use of the Company’s device by surgeons.

 

After clearance or approval in the United States, the Company intends to seek “CE Mark” approval in the European Union, as well as regulatory approval in other regions of the world. It is the Company’s expectation that its testing and validation for clearance in the United States will form a basis for its regulatory applications in other parts of the world, although additional testing and validation may be necessary there as well.

 

Upon receiving its initial regulatory approval to sell its device and system, the Company intends to sell its products through internal sales personnel and, potentially, independent sales and marketing organizations. One of the purposes of the capital raised in this Offering is to begin to develop the necessary sales, marketing, and customer-support functions required to sell the Company’s products to hospitals and surgery centers. A key component of that sales and marketing function will be compliance with federal and state regulations affecting the Company’s customers, particularly those that receive Medicare or Medicaid reimbursement.

 

The Company expects its device and system to eventually be used in scores of surgical applications throughout the body. Its first regulatory application will target urologic and gynecologic surgical procedures, due to the know benefits of robotically controlled instruments for those areas of operation. Follow-on areas of application are expected to be: interventional pulmonology, neurologic surgery, ENT, and many other areas of application over time. The Company has not, to date, explored the full range of surgical areas for operation of the Virtuoso device and system. The proceeds of this Offering are expected to be used to explore areas of potential surgical use and, potentially, areas appropriate for improvements in surgical techniques based on this technology.

 

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Facilities

 

We maintain our principal office in Nashville, Tennessee, under a one (1) year oral sublease, effective April 1, 2019, which we may convert to a monthly sublease in April 2020. Our lease rights are secure for up to five (5) years, through 2024, under a written primary lease. (See the section below, “Certain Relationships and Related Party Transactions - Sublease Agreement.”) We believe that our facilities are adequate to meet our needs for the immediate future, and that, should it be needed, we will be able to secure additional space to accommodate any such expansion of our operations.

 

Employees

 

As of June 30, 2019, we had six (6) full time employees and one (1) part-time employee. None of our employees are represented by a union or parties to a collective bargaining agreement. We believe the relationship with our employees to be good.

 

Legal Proceedings

 

We are not subject to any material pending legal proceedings.

 

MANAGEMENT

 

The following table sets forth information regarding our directors and executive officers as of the date of this Offering Circular:

 

Name   Age   Position
Robert Webster   40   President, Chief Technology Officer, and Director
S. Duke Herrell   55   Chief Clinical Strategist and Director
Richard Hendrick   30   Chairman of the Board and Chief Operating Officer
C. Mark Pickrell   53   Chief Administrative Officer, General Counsel, Secretary, and Director

 

Dr. Robert J. Webster, III, Ph.D., the Company’s President and Chief Technology Officer, has spent the past fifteen (15) years at Johns Hopkins University and Vanderbilt University, focused on the creation and validation of novel robotic surgical systems. Dr. Webster is the primary inventor of the core technology underlying the Virtuoso device and system. Dr. Webster received his Bachelor of Science from Clemson University, and he received his Ph.D. from Johns Hopkins University. He is currently the Richard A. Schroeder Professor of Mechanical Engineering at Vanderbilt University. Along with Dr. Herrell, he co-founded the Vanderbilt Institute for Surgery and Engineering. Dr. Webster has been awarded ten (10) patents, published over 200 peer-reviewed articles, and has been cited over 6,000 times for his work related to biomedical robotics and engineering. Dr. Webster is a consultant to the Company.

 

Dr. S. Duke Herrell, M.D., the Company’s Chief Clinical Strategist, is a practicing urologic surgeon at Vanderbilt University Medical Center and is internationally known as a pioneer in robotic surgery and minimally invasive surgical approaches. He is a Professor of Urology and a Professor of Biomedical Engineering at Vanderbilt University. Dr. Herrell received his Bachelor of Science from the University of Richmond, and he received his M.D. from the University of Virginia. He is a co-founder of the Vanderbilt Institute for Surgery and Engineering. Dr. Herrell is a named inventor in six (6) patents or pending applications, has published over 100 peer-reviewed articles, and his research has been recognized by the International World Congress of Endourology and Robotics. He is a former Vice Chair of the American Urologic Association, Clinical Guidelines Panel. Dr. Herrell is a consultant to the Company.

 

Dr. Richard Hendrick, Ph.D., the Company’s Chief Operating Officer, designed, built, and tested the laboratory prototypes underlying the Virtuoso device during his Ph.D. studies at Vanderbilt University. He received his Bachelor of Science from Texas A&M University, and he received his Ph.D. from Vanderbilt University. Prior to his graduate work at Vanderbilt University, Dr. Hendrick worked at DJO Surgical, a medical-device company manufacturing orthopedic implants and instruments. As our Chief Operating Officer, Dr. Hendrick is responsible for overall management of the operations and business of the Company.

 

C. Mark Pickrell, Esq., the Company’s Chief Administrative Officer, General Counsel, and Secretary provides legal, financial, and administrative support to the Company. He received his Bachelor of Arts from Harvard College, and he received his J.D. from the College of Law of the University of Tennessee. He has spent his 25-year legal career advising and representing companies, entrepreneurs, and investors on matters related to corporate formation and governance, contracting, intellectual property, securities, and regulatory compliance. Formerly, he was a partner at Waller, Lansden, Dortch & Davis, LLP in Nashville, Tennessee. As General Counsel and Chief Administrative Officer, Mr. Pickrell provides general legal advice to the management and Board of the Company and manages the administration of the day-to-day business operations of the Company, including its accounting and finance functions.

 

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Board Leadership Structure and Risk Oversight

 

The Board of Directors oversees the Company’s business, evaluating the risks associated with our business strategy and decisions. The Board implements its risk oversight function as a whole. The Board of Directors may determine to create committees, for audit, compensation, or other purposes, as the Company grows, but ultimate responsibility for the strategy and direction of the Company shall remain with the Board for the foreseeable future. Further, as our securities are not listed on a national securities exchange, we are not subject to requirements concerning independent directors or the establishment of any particular committees.

 

Term of Office

 

Under its bylaws, the Company’s four (4) original directors may serve in that capacity unless removed for cause. Up to three (3) additional directors may be elected by the holders of Common Stock of the Company. To date, no additional directors have been added to the Board. The executive officers are appointed by the Board of Directors, subject to removal by the Board of Directors.

 

Family Relationships

 

There are no family relationships among any of our executive officers or directors. 

 

Involvement in Certain Legal Proceedings

 

None of our current directors or executive officers has, during the past ten (10) years:

 

  · been convicted in a criminal proceeding or been subject to a pending criminal proceeding (excluding traffic violations and other minor offenses);

 

  · had any bankruptcy petition filed by or against the business or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive officer, either at the time of the bankruptcy filing or within two years prior to that time;

 

  · been subject to any order, judgment, or decree, not subsequently reversed, suspended, or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining, barring, suspending, or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking, savings and loan, or insurance activities, or to be associated with persons engaged in any such activity;

 

  · been found by a court of competent jurisdiction in a civil action or by the SEC or the U.S. Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and the judgment has not been reversed, suspended, or vacated;

 

  · been the subject of, or a party to, any federal or state judicial or administrative order, judgment, decree, or finding, not subsequently reversed, suspended, or vacated (not including any settlement of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order, or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity; or

 

  · been the subject of, or a party to, any sanction or order, not subsequently reversed, suspended, or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association, entity, or organization that has disciplinary authority over its members or persons associated with a member.

 

Except as set forth in our discussion below in “Certain Relationships and Related Transactions,” none of our directors or executive officers has been involved in any transactions with us or any of our directors, executive officers, affiliates, or associates, which are required to be disclosed pursuant to the rules and regulations of the SEC.

 

We are not currently a party to any legal proceedings, the adverse outcome of which, individually or in the aggregate, we believe will have a material adverse effect on our business, financial condition, or operating results.

 

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EXECUTIVE COMPENSATION

 

The following table presents summary information regarding the total compensation awarded to, earned by and paid to our executive officers for the year ended December 31, 2018.

 

Name  Capacities in which
compensation was received
  Cash compensation
($)
   Other compensation
($)
   Total compensation
($)
 
Richard Hendrick  Chief Operating Officer  $86,667   $5,267   $91,934 
C. Mark Pickrell  General Counsel and Chief Administrative Officer  $72,734   $4,709   $77,443 
Robert Webster  President and Chief Technology Officer  $33,937   $0   $33.937 
S. Duke Herrell  Chief Clinical Strategist  $23,375   $0   $23,375 

 

Drs. Webster and Herrell, as employees of Vanderbilt University and Vanderbilt University Medical Center, respectively, are limited in the amount of consulting time that they can expend on outside endeavors. Dr. Hendrick is a full-time employee, and Mr. Pickrell is a part-time employee. Their compensation and benefits are established in their letters of employment. The Company’s bylaws also limit the payment of dividends, repurchase of stock, or payment of bonuses, while Class A Preferred Shares remain outstanding. 

 

General. We compensate our named executive officers through a base salary, with a health-insurance subsidy and Simplified Employee Pension (“SEP”) retirement plan equal to four percent (4%) of each employee’s annual salary. Each of our named executive officers has substantial responsibilities in connection with our day-to-day operations.

 

Base Salary. Under our bylaws, while any Class A Preferred Shares are outstanding, the Company’s employees and consultants are limited to the National Institutes of Health limitations on income for grant recipients, which is approximately $176,000 annually.

 

Equity Awards. We do not have an equity incentive program. The equity granted to employees in relation to their employment is made pursuant to employment agreements with individual employees. Dr. Hendrick and Mr. Pickrell received equity established at the time of the Company’s founding as founders, unrelated to their future employment with the Company.

 

Simplified Employee Pension Plan. The Company provides each employee employed at the end of the calendar a SEP contribution of four percent (4%) of the employee’s annual salary.

 

Health and Welfare Benefits. Our named executive officers are eligible to participate in the same benefit plans designed for all of our full-time employees, consisting of a subsidy for health-related insurance. The Company expects to provide health insurance to employees in the future, in order to retain existing employees and attract future employees.

 

Agreements with Named Executive Officers

 

We have entered into employment agreements with Richard Hendrick and C. Mark Pickrell. Generally, their employment agreements (in the form of mutually-executed employment letters) provide a base salary, which was increased by the Board of Directors in 2018 to reflect market rates, along with a health-insurance subsidy and four percent (4%) Simplified Employee Pension (“SEP”) contribution that mirror those benefits provided to all other employees.

 

Under the terms of his employment agreement, as orally amended, Richard Hendrick is a full-time employee of the Company and paid a salary of $110,000 per year. In addition, he receives a health-insurance subsidy of $150 per month and an annual SEP contribution of four percent (4%) of his annual salary. In addition, Mr. Hendrick’s employment agreement contains a “Work for Hire” provision, which provides Company ownership of any intellectual property generated by Mr. Hendrick during the course of his employment, and it contains a one (1) year non-compete provision.

 

Under the terms of his employment agreement, as orally amended, Mark Pickrell is a part-time employee (.6 FTE) of the Company and paid a salary of $103,000 per year. In addition, he receives a health-insurance subsidy of $150 per month and an annual SEP contribution of four percent (4%) of his annual salary.

 

Director Compensation

 

Our Company currently does not offer members of our Board of Directors compensation for their services.

 

CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

 

Other than compensation arrangements for our directors and named executive officers, which are described in the sections entitled “Management” and “Executive Compensation,” below we describe transactions since April 27, 2016 to which we were a party or will be a party, in which:

 

·the amounts involved exceeded or will exceed the lesser of $120,000 and one percent (1%) of the average of our total assets at year-end; and

 

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·any of our directors, director nominees, executive officers or holders of more than ten percent (10%) of our capital stock, or any member of the immediate family of, or person sharing the household with, the foregoing persons, had or will have a direct or indirect material interest.

 

Sublease Agreement

 

On February 6, 2019, C. Mark Pickrell executed a five (5) year lease agreement for the Company’s office. On May 1, 2019, the Company and Mr. Pickrell entered into a one-year oral sublease agreement whereby the Company pays the lease at cost, $6,000 per month.

 

2017 Loan Agreements

 

In 2016 and 2017, S. Duke Herrell, C. Mark Pickrell and the Company executed loan agreements whereby Messrs. Herrell and Pickrell loaned $40,000 and $30,000, respectively, to the Company at 4.5% annual interest. On or about June 13, 2018, the Company repaid the accrued interest on both loans as well as a partial repayment of $15,000 on the principal owed to Mr. Herrell, and all remaining outstanding principal owed to Messrs. Herrell and Pickrell were converted into 25,000 shares of Class A Preferred Stock, each.

 

Each of the members of the Board of Directors, or their family members, is an owner of Class A Preferred Stock, in addition to the Common Stock in the Company.

 

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PRINCIPAL STOCKHOLDERS

 

The following table sets forth the beneficial ownership of our Common Stock immediately prior to and immediately after the completion of this Offering by:

 

·each stockholder known by us to beneficially own more than five percent (5%) of our outstanding Common Stock;
   
·each of our directors;
   
·each of our named executive officers; and
   
·all of our directors and executive officers as a group.

 

​We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally provide that a person is the beneficial owner of securities if such person has or shares the power to vote or direct the voting of securities, or to dispose or direct the disposition of securities. A security holder is also deemed to be, as of any date, the beneficial owner of all securities that such security holder has the right to acquire within 60 days after such date through (i) the exercise of any option or warrant, (ii) the conversion of a security, (iii) the power to revoke a trust, discretionary account or similar arrangement, or (iv) the automatic termination of a trust, discretionary account, or similar arrangement. Except as disclosed in the footnotes to this table and subject to applicable community property laws, we believe that each person identified in the table has sole voting and investment power over all of the shares shown opposite such person’s name.

 

The percentage of beneficial ownership is based on 985,000 shares of our Common Stock outstanding as of June 30, 2019 before and after the completion of this Offering. 

 

  

Common Stock

 
   Before this Offering   After this Offering 
Name  Number of
Shares
Beneficially
Owned
   Percentage
Shares
Beneficially
Owned
   Number of
Shares
Beneficially
Owned
   Percentage
Shares
Beneficially
Owned
 
Robert Webster   240,000    24%   240,000    24%
S. Duke Herrell   240,000    24%   240,000    24%
Richard Hendrick   240,000    24%   240,000    24%
C. Mark Pickrell   80,000    8%   80,000    8%

 

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DESCRIPTION OF CAPITAL STOCK

 

The following is a summary of the rights of our capital stock as provided in our charter and bylaws. For more detailed information, please see our charter and bylaws, which have been filed as exhibits to the Offering Statement of which this Offering Circular is a part.

 

General

 

As of the date of this Offering Circular, our authorized capital stock consists of 2,000,000 shares of common stock, no par value, of which 985,000 shares are issued and outstanding, and 50,000,000 shares of Class A Preferred Stock, par value $1.00 per share, 1,305,000 of which are issued and outstanding. 

 

Common Stock

 

The holders of the Common Stock are entitled to one vote for each share held at all meetings of stockholders (and written actions in lieu of meeting) and do not have cumulative voting rights. The holders of shares of Common Stock are not entitled to dividends while any Class A Preferred Stock remain outstanding. In the event of our liquidation or dissolution, the holders of Common Stock are entitled to receive proportionately all assets available for distribution to stockholders after the payment of all debts and other liabilities and subject to the prior rights of any outstanding preferred stock. Holders of Common Stock have no preemptive, subscription, redemption, or conversion rights. The rights, preferences, and privileges of holders of Common Stock are subject to and may be adversely affected by the rights of the holders of shares of any series of preferred stock, including those that we may designate and issue in the future.

 

The number of authorized shares of Common Stock may be increased or decreased subject to the Company’s legal commitments at any time and from time to time to issue them, by the affirmative vote of the holders of a majority of the stock of the Company entitled to vote.

 

Class A Preferred Stock

 

Under the terms of our charter, the Board of Directors is authorized to issue shares of preferred stock in one or more series without stockholder approval. The Board of Directors may not establish any class of preferred shares that is senior to the Class A Preferred Stock.

 

Holders of Class A Preferred Stock have no voting, management, or beneficial rights, and are entitled to a paid-in-kind dividend of seven percent (7%) per year, uncompounded.

 

Upon a change of control, an owner of Class A Preferred Stock will be entitled to a “Success Bonus” equal to: 100% of par value plus the PIK per share if the change of control occurs more than one (1) year and less than three (3) years after the shares were purchased or otherwise received by the investor; 200% of par value plus the PIK per share if the change of control occurs more than three (3) years and less than five (5) years after the shares were purchased or otherwise received by the investor; or 300% of par value plus the PIK per share if the change of control occurs more than five (5) years after the shares were purchased or otherwise received by the investor.

 

A “change of control” occurs if the holders of the Common Stock of the Company as of April 25, 2018 (i.e., Robert Webster, S. Duke Herrell, Richard Hendrick, C. Mark Pickrell, Vanderbilt University, Johns Hopkins University, Neal Dillon, Scott Webster, and Evan Blum), or their successors by operation of law, own less than a majority of the shares of Common Stock the Company, or any one of them shall own a majority of the shares of Common Stock of the Company. The Company’s Board of Directors must approve of any stockholder action constituting a change of control.

 

In the event of a change of control, shares of Class A Preferred Stock are due and payable in the amount of par value, any accrued PIK, and any applicable Success Bonus. In the event that the consideration paid to the Company upon a change of control is not sufficient to pay in full amounts due to the outstanding Class A Preferred Stock, the consideration received shall be used to pay in order of priority, pari passu, the par value for the shares of Class A Preferred Stock, accrued PIK, and any applicable Success Bonus.

 

After a change of control, and payment in accordance with the foregoing distribution, if the shares of Class A Preferred Stock are not paid in full (including any applicable Success Bonuses), the preferred shares shall be converted into Common Stock based on the relative unpaid balances owing to a holder of Class A Preferred Stock.

 

Until the Shares are paid in full, including any applicable Success Bonuses, the Company may not pay any dividend to holders of Common Stock (except for permissible dividends in the event of a successful offering conducted pursuant to Regulation A), purchase any Common Stock, or pay any employee bonuses (except for de minimis cash bonuses for non-management employees).

 

32

 

 

Until the Shares are paid in full, the salary and wage limits established by the National Institutes of Health for grant recipients shall apply to the Company’s employees and consultants.

 

Shares are redeemable at any time, at the discretion of the Company’s Board of Directors, provided that a redemption must include all of a stockholder’s shares of Class A Preferred Stock at par value, plus any accrued PIK. If a change of control occurs within two (2) years of a redemption, the former stockholder will be entitled to receipt of a Success Bonus equal to the Success Bonus that would have been paid as of the redemption date.

 

Transfer Agent and Registrar

 

The transfer agent and registrar for our Class A Preferred Stock is ComputerShare Trust Co., N.A.

 

Listing and Trading

 

We may, at our discretion, and, depending upon market conditions, apply to list our Class A Preferred Stock on the OTCQB Venture Market operated by the OTC Markets Group Inc. In such event, we may list our Class A Preferred Stock on the OTCQB Venture Market under the symbol “VSUR.”

 

SHARES ELIGIBLE FOR FUTURE SALE

 

Prior to this offering, there has been no established public market for our Class A Preferred Stock. Although we may apply to list our Class A Preferred Stock on the OTCQB Venture Market, we cannot assure you that this listing will occur or that a significant public market for our Shares will develop or be sustained. Actual or anticipated issuances or sales of substantial amounts of our Class A Preferred Stock following this Offering could cause the market price of our Class A Preferred Stock to decline significantly and make it more difficult for us to sell equity or equity-related securities in the future at a time and on terms that we deem appropriate.

 

If we successfully sell the maximum amount of Class A Preferred Stock offered in this Offering, we will have 21,305,000 shares of Class A Preferred Stock issued and outstanding. Of the outstanding Class A Preferred Stock, all of the Shares sold in this Offering will be freely tradable, except for limitations under state securities laws (as discussed below) and that any Shares held by our affiliates, as that term is defined in Rule 144 under the Securities Act, may only be sold in compliance with the limitations described below. Shares of Class A Preferred Stock acquired other than through this Offering will be “restricted securities” as such term is defined in Rule 144. These restricted securities were issued and sold by us, or will be issued and sold by us, in private transactions and are eligible for public sale only if registered under the Securities Act or if they qualify for an exemption from registration under the Securities Act, including the exemptions provided by Rule 144 or Rule 701.

 

Lock-up Agreements

 

We have not entered into lock-up agreements with any of our executive officers, directors or significant stockholders.

 

Rule 144

 

All shares of our Class A Preferred Stock held by our “affiliates,” as that term is defined in Rule 144 under the Securities Act, generally may be sold in the public market only in compliance with Rule 144. Rule 144 defines an affiliate as any person who directly or indirectly controls, or is controlled by, or is under common control with, the issuer, which generally includes our directors, executive officers and certain other related persons.

 

Rule 701

 

Rule 701 generally allows a stockholder who purchased shares of our Class A Preferred Stock pursuant to a written compensatory plan or contract and who is not deemed to have been an affiliate of ours during the immediately preceding 90 days to sell these shares in reliance upon Rule 144, but without being required to comply with the public information, holding period, volume limitation, or notice provisions of Rule 144. Rule 701 also permits affiliates of ours to sell their Rule 701 shares under Rule 144 without complying with the holding period requirements of Rule 144.

 

Blue Sky Law Considerations

 

The holders of our shares of Class A Preferred Stock and persons who desire to purchase them in any trading market that might develop in the future should be aware that there may be significant state law restrictions upon the ability of investors to resell our shares.

 

33

 

 

Accordingly, even if we list our Class A Preferred Stock on the OTCQB Venture Market, investors should consider any secondary market for our securities to be a limited one. We currently do not intend, and may be unable, to qualify our shares for resale by you in states that require securities or the transactions in which they are resold to meet certain criteria or filing requirements before they can be resold by our stockholders.

 

PLAN OF DISTRIBUTION

 

Placement Agent Agreement

 

We have entered into a placement agent agreement with C2M Securities, LLC, successor in interest to Strategic Capital Investments, LLC (the “Placement Agent”), a broker registered with the Financial Industry Regulatory Authority ("FINRA"), to obtain its services as the exclusive placement agent for our Offering.

 

Offering Expenses

 

We are responsible for all fees and expenses incurred in relation to our Offering, including: (i) fees for legal counsel, accountants, and other professionals we engage; (ii) fees and expenses incurred in the production of our Offering documents; (iii) all filing fees, including those charged by the SEC and FINRA; and (iv) costs of making our Offering available online.

 

Placement Agent Compensation

 

We have agreed to pay the Placement Agent a commission equal to one percent (1%) of the total amount invested by investors in the Offering. We also have agreed to pay the Placement Agent and/or other broker-dealers who introduce purchasers of Class A Preferred Stock a commission equal to seven percent (7%) of the total number of shares sold through them in the Offering (priced at $1.00/share).

 

In addition to the cash-based fee, we have agreed to issue to the Placement Agent and other registered broker-dealers who introduce purchasers of Class a Preferred Stock warrants to purchase a number of shares of our common stock up to an amount equal to 5% of the gross proceeds of this Offering divided by $100, with 1% going to the Placement Agent, and up to 4% going to the registered broker-dealers. (If fully subscribed, 10,000 shares of common stock would be reserved for exercise of the warrants.) The warrants will be exercisable, in whole or in part, commencing on a date which is six months after the commencement of sales in this Offering and ending on the fifth year anniversary of the commencement of sales of shares in the Offering. The warrants will have an exercise price of $100 per share, subject to adjustment for stock splits. In the event of a change of control (as defined in Section 11 of the Company’s By-Laws), the warrants may be exercised, and the shares redeemed, in a “cashless transaction” in which the net proceeds are paid directly to the warrantholder.

 

The Placement Agent Warrants are deemed compensation by FINRA, and, therefore, they are subject to a 180-day lock-up period pursuant to Rule 5110(g)(1) of FINRA. The Placement Agent, or permitted assignees under such rule, may not (i) exercise, sell, transfer, assign, pledge, or hypothecate the Placement Agent Warrants or (ii) engage in any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of the Placement Agent Warrants for a period 180-days immediately following the date of qualification or commencement of sales of this Offering, except as provided in FINRA Rule 5110 (g)(2).

 

Indemnification

 

We have agreed to indemnify the Placement Agent and its affiliates against liabilities relating to this Offering that arise under federal and state securities laws, including the Securities Act.

 

Our Relationship with the Placement Agent

 

In the ordinary course of its various business activities, the Placement Agent and its affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers, and such investment and securities activities may involve securities and/or instruments of the issuer. The Placement Agent and its affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or instruments, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

 

34

 

 

Procedures for Subscribing

 

We will use our website, www.virtuososurgical.net, to provide notification of this Offering. Prospective investors who would like information about purchasing will be further directed to a webpage describing this Offering, which will be hosted by Capital2Market LLC (“Capital2Market”).

 

This Offering Circular will be furnished to prospective investors via download 24 hours per day, 7 days per week on our website and Capital2Market’s webpage relating to this Offering.

 

In order to subscribe to purchase shares of our Class A Preferred Stock, a prospective investor must complete a subscription agreement and send payment by check, wire transfer, or ACH. The subscription agreement requires investors to answer certain questions to determine compliance with the investment limitation set forth in the securities laws, reaffirms that the securities will not be listed on a registered national securities exchange upon qualification, and that the aggregate purchase price to be paid by the investor for the securities cannot exceed ten percent (10%) of the greater of the investor’s annual income or net worth. In the case of an investor who is not a natural person, revenues, or net assets for the investor’s most recently completed fiscal year are used instead. The investment limitation does not apply to accredited investors, as that term is defined in Rule 501 under the Securities Act of 1933, as amended. See “-Limitations on Your Investment Amount” below for additional information.

 

Escrow of Funds

 

We have entered into an escrow agreement with Atlantic Capital Bank, National Association (“Atlantic Bank”) pursuant to which Atlantic Bank will act as the escrow agent (the “Escrow Agent”) in connection with this Offering.

 

All monies collected from prospective purchasers of our Shares will be held in a separate non-interest bearing escrow account at the Escrow Agent (the “Escrow Account”) for the benefit of the investors in accordance with Rules 10b-9 and 15c2-4 promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Capital2Market will instruct purchasers to transfer funds either directly to the Escrow Agent by wire transfer or by check payable to “Virtuoso Surgical, Atlantic Bank, as Escrow Agent.”

 

Substantially simultaneously with each deposit to the Escrow Account, the Placement Agent will provide the Escrow Agent with the subscription information for applicable prospective purchasers. The Escrow Agent will not be required to accept for credit into the Escrow Account or for deposit into the Escrow Account subscription funds that are not accompanied by the appropriate subscription information. Wire transfers representing payments by prospective purchasers will not be deemed deposited in the Escrow Account until the Escrow Agent has received in writing the subscription information required with respect to such payments.

 

We have agreed to pay fees to the Escrow Agent pursuant to an escrow agreement and fees to Capital2Market pursuant to a licensing agreement. In addition to a one-time licensing fee of $10,000 and initial customer service fee of $2,500, we will pay a monthly fee for the escrow services and use of Capital2Market’s online platform.

 

Pricing of this Offering

 

Prior to this Offering, shares of our Class A Preferred Stock have not been traded on an established public trading market, and, therefore, quotations for them are not available. The offering price was determined by negotiation between us and the Placement Agent. The principal factors considered in determining the offering price include:

 

·the information set forth in this Offering Circular and otherwise available to the Placement Agent;

 

·our history and prospects and the history of and prospects for the industry in which we compete;

 

·our past and present financial performance;

 

·our prospects for future earnings and the present state of our development;

 

·the general condition of the securities markets at the time of this Offering;

 

·the recent market prices of, and demand for, publicly traded common stock of generally comparable companies; and

 

·other factors deemed relevant by the Placement Agent and us.

 

35

 

 

Although we may attempt to list our Class A Preferred Stock on the OTCQB Venture Market, we cannot assure you that a liquid trading market for our Class A Preferred Stock will develop or be sustained after this Offering. You may not be able to sell your shares quickly or at all, or at the market price if trading in our Class A Preferred Stock does not commence or is not active.

 

Limitations on Your Investment Amount

 

With regard to individuals who are not accredited investors, we are permitted to sell you any Shares in this Offering if the aggregate purchase price you pay is not more than ten percent (10%) of the greater of your annual income or net worth.

 

Different rules apply to accredited investors and non-natural persons. Before making any representation that your investment does not exceed applicable thresholds, we encourage you to review Rule 251(d)(2)(i)(C) of Regulation A. For general information on investing, we encourage you to refer to www.investor.gov.

 

Because this is a Tier 2, Regulation A offering, most investors must comply with the ten percent (10%) limitation on investment in this Offering. The only type of investor in this Offering exempt from this limitation is an “accredited investor” as defined under Rule 501 of Regulation D under the Securities Act (an “Accredited Investor”).

 

If you meet one of the following tests, you should qualify as an Accredited Investor:

 

(i)You are a natural person who has had individual income in excess of $200,000 in each of the two (2) most recent years, or joint income with your spouse in excess of $300,000 in each of these years, and have a reasonable expectation of reaching the same income level in the current year;

 

(ii)You are a natural person and your individual net worth, or joint net worth with your spouse, exceeds $1,000,000 at the time you purchase Shares;

 

(iii)You are an executive officer or general partner of the issuer or a manager or executive officer of the general partner of the issuer;

 

(iv)You are an organization described in Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, or the Code, a corporation, a Massachusetts or similar business trust or a partnership, not formed for the specific purpose of acquiring the shares in this Offering, with total assets in excess of $5,000,000;

 

(v)You are a bank or a savings and loan association or other institution as defined in the Securities Act, a broker or dealer registered pursuant to Section 15 of the Exchange Act, an insurance company as defined by the Securities Act, an investment company registered under the Investment Company Act of 1940 (the “Investment Company Act”), or a business development company as defined in that act, any Small Business Investment Company licensed by the Small Business Investment Act of 1958 or a private business development company as defined in the Investment Advisers Act of 1940;

 

(vi)You are an entity (including an Individual Retirement Account trust) in which each equity owner is an Accredited Investor;

 

(vii)You are a trust with total assets in excess of $5,000,000, your purchase of Shares is directed by a person who either alone or with his or her purchaser representative(s) (as defined in Regulation D promulgated under the Securities Act) has such knowledge and experience in financial and business matters that he or she is capable of evaluating the merits and risks of the prospective investment, and you were not formed for the specific purpose of investing in the shares in this Offering; or

 

(viii)You are a plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has assets in excess of $5,000,000.

 

Offering Period and Termination Date

 

This Offering will start on or after the date that the Offering Statement is qualified by the SEC and will terminate at the earlier of: earlier of: (1) the date upon which the maximum amount of offered Class A Preferred Stock has been sold, (2) the date which is twelve (12) months after the qualification of this Offering, or (3) the date on which this Offering is earlier terminated by us in our sole discretion. We refer to the duration of this Offering as described above as the offering period.

 

36

 

 

LEGAL MATTERS

 

Certain legal matters with respect to the shares of Class A Preferred Stock offered hereby will be passed upon by Waller Lansden Dortch & Davis, LLP, Nashville, Tennessee.

 

EXPERTS

 

The financial statements of the Company appearing elsewhere in this Offering Circular have been included herein in reliance upon the report of Puryear & Noonan, CPAs, an independent registered public accounting firm, appearing elsewhere herein, and upon the authority of that firm as experts in accounting and auditing.  

 

WHERE YOU CAN FIND MORE INFORMATION

 

We have filed with the SEC a Regulation A Offering Statement on Form 1-A under the Securities Act of 1993, as amended, with respect to the shares of Class A Preferred Stock offered hereby. This Offering Circular, which constitutes a part of the Offering Statement, does not contain all of the information set forth in the Offering Statement or the exhibits and schedules filed therewith. For further information about us and our offering of Class A Preferred Stock, we refer you to the Offering Statement and the exhibits and schedules filed therewith. Statements contained in this Offering Circular regarding the contents of any contract or other document that is filed as an exhibit to the Offering Statement are not necessarily complete, and each such statement is qualified in all respects by reference to the full text of such contract or other document filed as an exhibit to the Offering Statement. Upon the completion of this Offering, we will be required to file periodic reports, proxy statements, and other information with the SEC pursuant to the Securities Exchange Act of 1934, as amended. You may read and copy this information at the SEC’s Public Reference Room, 100 F Street, N.E., Room 1580, Washington, D.C. 20549. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet website that contains reports, proxy statements and other information about issuers, including us, that file electronically with the SEC. The address of this site is www.sec.gov.

 

37

 

 

PART F/S

 

INDEX TO FINANCIAL STATEMENTS

  

Audited Financial Statements for Fiscal Year End December 30, 2018 and 2017    
     
Report of Independent Registered Public Accounting Firm   F-1
   
Balance Sheets   F-3
   
Statements of Operations   F-4
   
Statement of Stockholders’ Equity (Deficit)   F-5
     
Statements of Cash Flows   F-6
     
Notes To Financial Statements   F-7
     
Unaudited Interim Financial Statements    
     
Balance Sheet for the period ending June 30, 2019   F-14
     
Statement of Operations for six (6) months ended June 30, 2019   F-15
     
Statement of Stockholders’ Equity for six (6) months ended June 30, 2019   F-16
     
Statement of Cash Flows for six (6) months ended June 30, 2019   F-17
     
Notes to Unaudited Financial Statements
  F-18

 

38

 

 

 

 

 

 Independent Auditor’s Report

 

To the Board of Directors of

Virtuoso Surgical, Inc.

Nashville, Tennessee

  

Report on Financial Statements

 

We have audited the accompanying financial statements of Virtuoso Surgical, Inc. (the Company), which comprise the balance sheets as of December 31, 2018 and 2017, and the related statements of operations, stockholders’ equity (deficit), and cash flows for the years then ended, and the related notes to the financial statements.

 

Management’s Responsibility for the Financial Statements

 

Management is responsible for the preparation and fair presentation of these financial statements in accordance with accounting principles generally accepted in the United States of America; this includes the design, implementation, and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free from material misstatement, whether due to fraud or error.

 

Auditor’s Responsibility

 

Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards generally accepted in the United States of America. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the financial statements are free from material misstatement.

 

An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend on the auditor’s judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the Company’s preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the overall presentation of the financial statements.

 

40 Burton Hills Blvd. | Suite 170 | Nashville, TN 37215   p: (615) 296-0500 | f: (615) 296-0493
830 Crescent Centre Drive | Suite 320 | Franklin, TN 37067   pn-cpas.com

 

 F-1 

 

 

We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our audit opinion.

 

Opinion

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Virtuoso Surgical, Inc. as of December 31, 2018 and 2017, and the results of operations and cash flows for the years then ended in accordance with accounting principles generally accepted in the United States of America.

 

Emphasis of Matter

 

We draw attention to Note 5 to the financial statements. The Company approved an increase in authorized common shares and ten thousand for one common share stock split. Our opinion is not modified with respect to this matter.

 

 

Puryear & Noonan, CPAs

Nashville, Tennessee

October 16, 2019 except for

Note 5 as to which the date is

November 30, 2019

  

 F-2 

 

  

VIRTUOSO SURGICAL, INC.

 

Balance Sheets

 

December 31, 2018 and 2017

 

  2018   2017 
Assets        
         
Assets:        
Current Assets        
Cash and cash equivalents  $602,748   $45,820 
Grants receivable   21,039    27,459 
Total Current Assets   623,787    73,279 
Property and equipment, net   181,940    36,113 
Total Assets  $805,727   $109,392 

 

Liabilities and Stockholders’ Equity (Deficit)        
         
Liabilities:        
Current Liabilities          
Accounts payable  $88,818   $3,274 
Accrued liabilities   25,665    85,598 
Demand notes payable   -    60,000 
Total Liabilities   114,483    148,872 
           
Stockholders’ Equity (Deficit):          
Common stock, no par   -    - 
Class A preferred stock   1,107,767    - 
Accumulated deficit   (416,523)   (39,480)
Total Stockholders’ Equity (Deficit)   691,244    (39,480)
           
Total Liabilities and Stockholders’ Equity (Deficit)  $805,727   $109,392 

 

See independent auditor’s report and the accompanying notes to financial statements.

 

 F-3 

 

 

VIRTUOSO SURGICAL, INC.

 

Statements of Operations

 

For the Years Ended December 31, 2018 and 2017

  

   2018   2017 
Operating Expenses:          
Research and development  $816,663   $249,366 
General and administrative   151,098    10,214 
Total Operating Expenses   967,761    259,580 
           
Other Income (Expense):          
SBIR I grant   455,087    241,574 
SBIR – 7% fee   24,628    11,095 
STTR I grant   33,346    - 
Launch Tennessee grant   117,211    18,550 
Interest income   3,681    - 
Interest expense   (4,383)   (371)
           
Total Other Income (Expense)   629,570    270,848 
Net Income (Loss)  $(338,191)  $11,268 

 

See independent auditor’s report and the accompanying notes to financial statements.

 

 F-4 

 

  

VIRTUOSO SURGICAL, INC.

 

Statements of Stockholders’ Equity (Deficit)

 

For the Years Ended December 31, 2018 and 2017

 

   Series A Convertible  

(See Note 5)

         
   Preferred stock   Common stock   Accumulated     
   Shares   Par Value   Shares   Value   Deficit   Total 
Balance at January 1, 2017   -   $-    985,000   $-   $(50,748)  $(50,748)
Net income   -    -    -    -    11,268    11,268 
                               
Balance at December 31, 2017   -    -    985,000    -    (39,480)   (39,480)
                               
Sale/conversion of Class A preferred stock   1,075,000    1,075,000    -    -    -    1,075,000 
Accrued paid-in-kind (PIK) dividends   -    32,767    -    -    (32,767)   - 
Class A issuance costs   -    -    -    -    (6,085)   (6,085)
Net loss   -    -    -    -    (338,191)   (338,191)
                               
Balance at December 31, 2018   1,075,000   $1,107,767    985,000   $-   $(416,523)  $691,244 

 

See independent auditor’s report and the accompanying notes to financial statements.

 

 F-5 

 

  

VIRTUOSO SURGICAL, INC.

 

Statements of Cash Flows

 

For the Years Ended December 31, 2018 and 2017

 

  2018   2017 
Cash flows from operating activities:          
Net income (loss)  $(338,191)  $11,268 
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:          
Depreciation   10,367    2,043 
Decrease (increase) in grants receivable   6,420    (27,459)
Increase (decrease) in accounts payable   85,544    (22,026)
Increase (decrease)in accrued liabilities   (59,933)   85,597 
Net cash provided by (used in) operating activities   (295,793)   49,423 
           
Cash flows from investing activities:          
Purchases of property and equipment   (156,194)   (38,156)
Net cash used in investing activities   (156,194)   (38,156)
           
Cash flows from financing activities:          
Increase (decrease) of notes payable   (10,000)   18,500 
Class A issuance costs   (6,085)   - 
Proceeds from sale of convertible preferred stock   1,025,000    - 
Net cash provided by financing activities   1,008,915    18,500 
Net increase in cash and cash equivalents   556,928    29,767 
Cash and cash equivalents at beginning of year   45,820    16,053 
Cash and cash equivalents at end of year  $602,748   $45,820 
           
Supplemental information:          
Conversion of notes payable into Class A Preferred stock  $50,000   $- 
Class A Preferred dividends paid in kind  $32,767   $- 
Cash paid for interest  $4,383   $371 

 

See independent auditor’s report and the accompanying notes to financial statements.

 

 F-6 

 

 

 

VIRTUOSO SURGICAL, INC.

 

Notes to Financial Statements

 

December 31, 2018 and 2017

 

(1)Nature of Business

 

Virtuoso Surgical, Inc. (the “Company”) was incorporated in April 2016, as a Tennessee corporation, with operations based in Nashville, Tennessee. The Company was formed to design, develop, and market medical devices to transform minimally invasive surgery by providing dexterous, accurate and cost-effective robotic tools. Since incorporation, the Company has devoted substantially all efforts to research and development, business planning, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company has not commenced its planned principal operations.

 

The Company is subject to a number of risks similar to other medical device companies, including, but not limited to, raising additional capital, development by its competitors of new technological innovations, safety and efficacy of the product in clinical trials, the regulatory approval process governing medical devices, market acceptance of the Company's products, and protection of proprietary technology. The Company has funded its operations to date primarily through federal grants, a state of Tennessee SBIR matching grant and the sale of preferred stock. The Company's management believes that the current cash resources will suffice to fund operations into 2020.

 

(2)Summary of Significant Accounting Policies

 

Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and cash equivalents - Cash equivalents include all highly liquid investments with original maturities within 90 days from the date of purchase.

 

Concentrations of Credit Risk - Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. For all periods presented, substantially all the Company's cash and cash equivalents were deposited in accounts at a single financial institution which the Company believes to be of high quality.

 

Property and Equipment - Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment.

 

 F-7 

 

 

(2)Summary of Significant Accounting Policies (continued)

 

The Company accounts for external use capitalized software costs under the provisions of Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) 985, Software. The costs that have been capitalized as shown by Note 3 represent costs incurred after technological feasibility was established. It is anticipated further costs will be capitalized until development is complete and a working model is ready for customer testing. Costs thereafter will be expensed as incurred.

 

Depreciation is provided using the straight-line method over the following estimated useful lives when the corresponding asset is placed in service:

 

Asset Classification Useful Life
Laboratory equipment
Computer equipment
Office furniture and equipment
Software (capital)
Software (developed)
Leasehold improvements
Five years
Five years
Five years
Three years
Three years
Lesser of useful life or remaining lease term

 

Research and Development Costs - Costs incurred in the research and development of the Company's products are expensed as incurred.

 

Patent Costs - The Company entered into license agreements with two research institutions for patented technology owned by these institutions. The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of December 31, 2018, no costs had been capitalized since inception of the Company. The Company has expensed $3,000 and $5,495 of patent costs within Research and Development expenses in the Statements of Operations for the years ended December 31, 2018 and 2017, respectively.

 

The patents under these license agreements require certain initial fees, paid in cash and Common Stock. Royalties, as defined in the agreements, are payable to each institution upon sales of licensed products.

 

Income Taxes - The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company's financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is used to reduce the net deferred tax assets to the amount that will more likely than not be realized.

 

 F-8 

 

 

(3)Property and Equipment

 

Property and equipment at December 31, 2018 and 2017, consist of the following:

 

   2018   2017 
Laboratory equipment  $88,397   $- 
Computer equipment   7,741    7,741 
Software – capital   19,826    13,741 
Software – developed   78,386    16,674 
    194,350    38,156 
Less accumulated depreciation and amortization   (12,410)   (2,043)
   $181,940   $36,113 

 

The Company incurred depreciation and amortization expense of $10,367 and $2,043 for the years ended December 31, 2018 and 2017, respectively.

 

(4)Federal and State Grants

 

The Company received certain awards from Federal and local sources to support its research and development activities as follows:

 

National Institute of Health – Small Business Innovation Research Program (SBIR) including amendment  $1,489,524 
National Institute of Health – Small Business Technology Transfer Program (SBTT)   224,598 
    1,714,122 
Authorized spending through December 31, 2018   765,730 
Remaining authorized funds  $948,392 

 

Through December 31, 2018, the Company has billed $765,730 under the terms of these Federal awards. The Company has received $744,691 with $21,039 and $27,459 recorded as grants receivable as of December 31, 2018 and 2017, respectively.

 

The Company was awarded and has received a $150,000 SBIR matching funding for its Federal grants from Launch Tennessee, of which $135,761 has been spent by the Company during fiscal years 2018 and 2017 with $14,239 grant payable recorded in accrued liabilities as of December 31, 2018.

 

(5)Stockholders’ Equity (Deficit)

 

The authorized capital stock of the Company consists of 50,000,100 shares, of which 50,000,000 shares are designated as Class A Preferred Stock, and 100 shares are designated as Common Stock.

 

Class A Preferred Stock

 

In 2018, the Company offered 3,000,000 shares of Class A Preferred Stock (Preferred Stock) at $1.00 per share. As of December 31, 2018, 1,075,000 shares had been sold yielding gross proceeds of $1,075,000.

 

 F-9 

 

 

(5)Stockholders’ Equity (Deficit) (Continued)

 

The Class A Preferred Stock has the following characteristics:

 

Voting - The holders of the Preferred Stock shall have no voting or other management rights, or other beneficial rights other than those disclosed in the Articles of Incorporation, as Amended.

 

Dividends - Issued Preferred Stock shares will carry a Paid-In-Kind (PIK) dividend of 7% per year, uncompounded. Dividends for the period from issuance through December 31, 2018 are shown as an addition to Series A Preferred Stock outstanding in the statements of stockholders’ equity (deficit).

 

Other Provisions - Other provisions related to the Preferred Stock are set forth in the Articles of Incorporation and include certain rights upon a change of control, as defined, including success bonus terms, and rights and priorities with respect to consideration received or conversion rights in redemption.

 

Preferred shares are redeemable upon a change of control of the Company or at any time, at the discretion of the Board of Directors, provided that the redemption must include 100% of a shareholders’ preferred shares at par, plus any accrued PIK and the applicable Success Bonus amount. Until all Preferred Stock shares are redeemed certain restrictions exist as to compensation levels and dividend distributions.

 

Common Stock

 

The Company issued 82 shares of common stock to certain founding parties who have been responsible for incubating and forming the Company and 9 shares to research institutions, in exchange for certain technology and contractual rights. The Company has issued 7.5 shares to employees.

 

Effective August 7, 2019, the Board of Directors approved an increase in the number of Common shares from 100 shares to 2,000,000 shares. The Board also approved a 10,000 for one Common share stock split that increased the number of Common shares issued and outstanding from 98.5 to 985,000. In accordance with ASC 260-10-55-12 and Staff Accounting Bulletin Topic 4C, the financial statements have been adjusted retroactively for all periods presented to reflect the Common share stock split.

 

Stock Issuance Costs

 

The Company recorded stock issuance costs in the amount of $6,085 as contra-equity in 2018, as set forth in the statements of stockholders’ equity (deficit).

 

 F-10 

 

 

(6)Related Party Transactions

 

The Company had the following transactions with stockholders during 2018 and 2017:

 

   2018   2017 
Consulting fees  $84,325   $23,202 
Rent   34,508    11,503 
Interest on stockholder loans   4,383    371 

 

Additionally, during 2017 certain stockholders loaned $60,000 to the Company. During 2018, $10,000 was repaid, and the balance of $50,000 was converted to the same amount of Class A Preferred Stock.

 

(7)Income Taxes

 

Since inception, the Company has experienced net operating losses (NOL) which is consistent with a company conducting extensive research and development (R&D) activities. Prior to 2018, the Company, as a Subchapter S Corporation, passed these losses and credits to the stockholders. Beginning January 1, 2018, the Company converted to C Corporation status, and as such, these NOLs and R&D tax credits create net deferred tax assets (DTA); however, because of the current operating status of the Company these DTAs have been reduced to zero for reporting purposes through a 100% valuation allowance at December 31, 2018.

 

As of December 31, 2018, the NOLs and R&D tax credits available to reduce taxable income in future periods were $441,644 and $37,655, respectively. There is also a state NOL totaling $389,183 at December 31, 2018.

 

Income Tax Policy for Interest and Penalties

 

The Company follows FASB ASC 740-10, Accounting for Uncertainty in Income Taxes, as it relates to uncertain tax positions. Any interest and penalties recognized associated with a tax position are classified in expense in the Company’s financial statements.

 

Uncertain Tax Positions

 

The Company recognizes the tax benefits of uncertain tax positions only where the position is “more likely than not” to be sustained assuming examination by tax authorities. Management has analyzed the Company’s tax positions and has concluded that no liability for unrecognized tax benefits should be recorded related to uncertain tax positions taken on returns filed for the open tax years (2016 - 2017), or is expected to be taken in the Company’s 2018 tax returns. The Company identifies its major tax jurisdictions as the U.S. Federal and the State of Tennessee. However, the Company is not currently under audit nor has the Company been contacted by any of these jurisdictions. The Company is not aware of any tax positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will change in the next twelve months.

 

During the years ended December 31, 2018 and 2017, the Company did not recognize any interest and penalties relating to taxes, nor were any accrued at December 31, 2018 and 2017.

 

 F-11 

 

 

(8)Fair Value Measurements

 

The Company follows ASC 820-10, Fair Value Measurements, with respect to its financial assets and liabilities. Fair value is defined as the price that would be received to sell an asset in the principal or most advantageous market for the asset in an orderly transaction between market participants on the measurement date. Fair value should be based on the assumptions market participants would use when pricing an asset. U.S. Generally Accepted Accounting Principles establishes a fair value hierarchy that prioritizes investments based on those assumptions. The fair value hierarchy gives the highest priority to quoted prices in active markets (observable inputs) and the lowest priority to an entity’s assumptions (unobservable inputs). The Company groups assets at fair value in three Fair Value Measurements levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value. These levels are as follows:

 

Level 1 - Unadjusted quoted market prices for identical assets or liabilities in active markets as of the measurement date.

 

Level 2 - Other observable inputs, either directly or indirectly, including:

 

·Quoted prices for similar assets/liabilities in active markets;
·Quoted prices for identical or similar assets in non-active markets;
·Inputs other than quoted prices that are observable for the asset/liability; and,
·Inputs that are derived principally from or corroborated by other observable market data.

 

Level 3 - Unobservable inputs that cannot be corroborated by observable market data.

 

Generally accepted accounting principles requires disclosure of an estimate of fair value of certain financial instruments. The Company’s significant financial instruments are cash and cash equivalents and other short-term assets and liabilities. For these financial instruments, carrying values approximate fair value.

 

(9)Recent Accounting Pronouncements

 

In May 2014, the FASB issued Accounting Standards Update (ASU) 2014-09, “Revenue from Contracts with Customers,” which establishes a comprehensive revenue recognition standard for virtually all industries in U.S. Generally Accepted Accounting Principles (GAAP), including those that previously followed industry-specific guidance. For non-public entities, the new standard was originally effective for annual periods beginning after December 15, 2017. In August 2015, the FASB issued ASU 2015-4, “Revenue from Contracts with Customers (Topic 606) – Deferral of Effective Date,” which deferred the effective date for one year. Accordingly, this ASU will be effective for the Company for the year ending December 31, 2019. The Company is currently evaluating the effect the provisions of ASU 2014-09 will have on the financial statements.

 

In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842), which requires lessees to recognize assets and liabilities for most leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee is not expected to significantly change under such guidance. The standard will be effective for annual reporting periods beginning after December 15, 2019. Accordingly, this ASU will be effective for the Company for the year ending December 31, 2020. The Company is currently evaluating the impact that adoption of this ASU will have on the Balance Sheet and Statement of Operations.

 

 F-12 

 

 

(10)Subsequent Events

 

The Company has evaluated subsequent events through October 16, 2019, the date which the financial statements were available to be issued. The following events have occurred during the period which are of significance:

 

-The Company received another approximately $1,400,000 Small Business Innovation Research grant award.
   
-The Company sold an additional 230,000 Series A Preferred Stock shares at par of $1 for total proceeds of $230,000.

 

 F-13 

 

 

 

VIRTUOSO SURGICAL, INC.

 

Balance Sheets

 

(Unaudited)

 

June 30, 2019 and 2018

 

   June 30, 2019   June 30, 2018 
Assets          
Assets:          
Current Assets          
Cash and cash equivalents  $282,831   $398,753 
Grants receivable   64,004    - 
Total Current Assets   346,835    398,753 
           
Property and equipment, net   235,958    63,905 
           
Total Assets  $582,793   $462,658 
           
Liabilities and Net Assets          
           
Liabilities:          
           
Current Liabilities          
           
Accounts payable  $11,029   $- 
Accrued liabilities   14,650    8,433 
Grants payable   -    139,141 
           
Total Liabilities   25,679    147,574 
           
Stockholders’ Equity:          
Common stock, no par   -    - 
Class A preferred stock   1,175,647    391,459 
Accumulated deficit   (618,533)   (76,375)
           
Total Stockholders’ Equity   557,114    315,084 
           
Total Liabilities and Stockholders’ Equity  $582,793   $462,658 

 

See the accompanying notes to financial statements.

 

 F-14 

 

 

VIRTUOSO SURGICAL, INC.

 

Statements of Operations

 

(Unaudited)

 

For the Six Months Ended June 30, 2019 and 2018

 

   June 30, 2019   June 30, 2018 
Operating Expenses:          
           
Research and development  $598,485   $335,620 
General and administrative   181,216    32,733 
           
Total operating expenses   779,701    368,353 
           
Other income (expense):          
           
SBIR I grant   544,871    255,907 
SBIR – 7% fee   -    21,308 
STTR I grant   55,531    8,140 
Launch Tennessee grant   14,239    50,383 
Interest income   930    163 
Interest expense   -    (2,984)
           
Total other income (expense)   615,571    332,917 
           
Net loss  $(164,130)  $(35,436)

 

See the accompanying notes to financial statements.

 

 F-15 

 

 

VIRTUOSO SURGICAL, INC.

 

Statements of Stockholders’ Equity

 

(Unaudited)

 

For the Six Months Ended June 30, 2019 and 2018

 

   Series A Convertible
Preferred stock
   Common stock   Accumulated     
   Shares   Par Value   Shares   Value   Deficit   Total 
Balance at December 31, 2017   -    -    985,000    -    (39,480)   (39,480)
                               
Sale/conversion of Class A preferred stock   390,000    390,000    -    -         390,000 
Accrued paid-in-kind (PIK) dividends   -    1,459              (1,459)   - 
Net loss   -                   (35,436)   (35,436)
                               
Balance at June 30, 2018   390,000   $391,459    985,000   $-   $(76,375)  $315,084 
                               
Balance at December 31, 2018   1,075,000    1,107,767    985,000    -    (416,323)   691,244 
                               
Sale/conversion of Class A preferred stock   30,000    30,000    -    -         30,000 
Accrued paid-in-kind (PIK) dividends   -    37,880              (37,880)   - 
Net loss   -                   (164,130)   (164,130)
                               
Balance at June 30, 2019   1,105,000   $1,175,647    985,000   $-   $(618,533)  $557,114 

 

See the accompanying notes to financial statements.

 

 F-16 

 

 

VIRTUOSO SURGICAL, INC.

 

Statements of Cash Flows

 

(Unaudited)

 

For the Years Ended December 31, 2018 and 2017

 

   June 30, 2019   June 30, 2018 
Cash flows from operating activities:          
Net income (loss)  $(164,130)  $(35,436)
Adjustments to reconcile net income (loss) to net          
cash provided by (used in) operating activities:          
Depreciation   14,547    3,064 
Decrease (increase) in grants receivable   (42,965)   27,459 
Decrease in accounts payable   (77,789)   (3,274)
Decrease in accrued liabilities   (11,015)   (77,165)
Increase in grants payable   -    139,141 
           
Net cash provided by (used in) operating activities   (281,352)   53,789 
           
Cash flows from investing activities:          
           
Purchases of property and equipment   (68,565)   (30,856)
           
Net cash used in investing activities   (68,565)   (30,856)
           
Cash flows from financing activities:          
           
Payments on notes payable   -    (60,000)
Proceeds from sale of convertible preferred stock   30,000    390,000 
           
Net cash provided by financing activities   30,000    330,000 
           
Net increase (decrease) in cash and cash equivalents   (319,917)   352,933 
           
Cash and cash equivalents at beginning of year   602,748    45,820 
           
Cash and cash equivalents at end of year  $282,831   $398,753 
           
Supplemental information:          
           
Class A Preferred dividends paid in kind  $37,880   $1,459 
Cash paid for interest  $-   $2,983 

 

See the accompanying notes to financial statements.

 

 F-17 

 

 

VIRTUOSO SURGICAL, INC.

 

Notes to Unaudited Financial Statements

 

June 30, 2019 and 2018

 

In the opinion of management, all adjustments necessary in order to make the interim financial statements not misleading have been included.

 

(1)Nature of Business

 

Virtuoso Surgical, Inc. (the “Company”) was incorporated in April 2016, as a Tennessee corporation, with operations based in Nashville, Tennessee. The Company was formed to design, develop, and market medical devices to transform minimally invasive surgery by providing dexterous, accurate and cost-effective robotic tools. Since incorporation, the Company has devoted substantially all efforts to research and development, business planning, recruiting management and technical staff, acquiring operating assets, and raising capital. The Company has not commenced its planned principal operations.

 

The Company is subject to a number of risks similar to other medical device companies in the development stage, including, but not limited to, raising additional capital, development by its competitors of new technological innovations, safety and efficacy of the product in clinical trials, the regulatory approval process governing medical devices, market acceptance of the Company’s products, and protection of proprietary technology. The Company has funded its operations to date primarily through federal grants, a state of Tennessee SBIR matching grant, and the sale of preferred stock. The Company’s management believes that the current cash resources will suffice to fund operations into 2020.

 

(2)Summary of Significant Accounting Policies

 

Use of Estimates - The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates.

 

Cash and cash equivalents - Cash equivalents include all highly liquid investments with original maturities within 90 days from the date of purchase.

 

Concentrations of Credit Risk - Cash and cash equivalents are financial instruments that potentially subject the Company to concentrations of credit risk. For all periods presented, substantially all the Company’s cash and cash equivalents were deposited in accounts at a single financial institution which the Company believes to be of high quality.

 

 F-18 

 

 

(2)Summary of Significant Accounting Policies (continued)

 

Property and Equipment - Property and equipment are recorded at cost and depreciated over their estimated useful lives using the straight-line method. Repairs and maintenance costs are expensed as incurred, whereas major improvements are capitalized as additions to property and equipment.

 

The Company accounts for external use capitalized software costs under the provisions of Accounting Standards Codification (ASC) 985, Software. The costs that have been capitalized as shown by Note 3 represent costs incurred after technological feasibility was established. It is anticipated further costs will be capitalized until development is complete and a working model is ready for customer testing. Costs thereafter will be expensed as incurred.

 

Depreciation is provided using the straight-line method over the following estimated useful lives when the corresponding asset is placed in service:

 

Asset Classification Useful Life
Laboratory equipment
Computer equipment
Office furniture and equipment
Software (capital)
Software (developed)
Leasehold improvements
Five years
Five years
Five years
Three years
Three years
Lesser of useful life or remaining lease term

 

Research and Development Costs - Costs incurred in the research and development of the Company’s products are expensed as incurred.

 

Patent Costs - The Company entered into license agreements with two research institutions for patented technology owned by these institutions. The Company expenses as incurred all costs, including legal expenses, associated with obtaining patents until the patented technology becomes feasible. All costs incurred after the patented technology is feasible will be capitalized as an intangible asset. As of December 31, 2018, no costs had been capitalized since inception of the Company. The Company has expensed $3,000 and $3,000 of patent costs within Research and Development expenses in the Statements of Operations for the six months ended June 30, 2019 and 2018, respectively.

 

The patents under these license agreements require certain initial fees, paid in cash and Common Stock. Royalties, as defined in the agreements, are payable to each institution upon sales of licensed products.

 

 F-19 

 

 

(2)Summary of Significant Accounting Policies (continued)

 

 

Income Taxes - The Company records deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the Company’s financial statement carrying amounts and the tax basis of assets and liabilities using enacted tax rates expected to be in effect in the years in which the differences are expected to reverse. A valuation allowance is used to reduce the net deferred tax assets to the amount that will more likely than not be realized.

 

(3)Property and Equipment

 

Property and equipment at June 30, 2019 and 2018, consist of the following:

 

   June 30, 2019   June 30, 2018 
Laboratory equipment  $88,397   $- 
Computer equipment   40,321    7,741 
Software – capital   19,826    13,741 
Software – developed   114,370    47,530 
    262,914    69,012 
Less accumulated depreciation and amortization   (26,956)   (5,107)
   $235,958   $63,905 

 

The Company incurred depreciation and amortization expense of $14,547 and $3,064 for the six months ended June 30, 2019 and 2018, respectively.

 

(4)Federal and State Grants

 

The Company received certain awards from Federal and local sources to support its research and development activities as follows:

 

    June 30, 2019     June 30, 2018  
National Institute of Health – Small Business Innovation Research Program (SBIR)  including amendment   $ 1,489,524     $ 1,489,524  
National Institute of Health – Small Business Technology  Transfer Program (SBTT)     224,598       224,598  
      1,714,122       1,714,122  
Authorized spending     1,366,193       538,022  
Remaining authorized funds   $ 347,929     $ 1,176,100  

 

Through June 30, 2019 and June 30, 2018, the Company has billed $1,302,129 and $596,099, respectively, under the terms of these Federal awards with $64,004 recorded as grants receivable as of June 30, 2019 and $58,074 as a grant payable as of June 30, 2018.

 

The Company was awarded and has received a $150,000 SBIR matching funding for its Federal grants from Launch Tennessee. The Company had spent $68,933 through June 30, 2018 resulting in a grant payable of $81,067 as of June 30, 2018. All Launch Tennessee funds were received and spent by June 30, 2019.

 

(5)Stockholders’ Equity

 

The authorized capital stock of the Company consists of 50,000,100 shares, of which 50,000,000 shares are designated as Class A Preferred Stock, and 2,000,000 shares are designated as Common Stock.

 

 F-20 

 

 

Class A Preferred Stock

 

In 2018, the Company offered 3,000,000 shares of Class A Preferred Stock (Preferred Stock) at $1.00 per share. As of June 30, 2019, 1,105,000 shares had been sold yielding gross proceeds of $1,105,000.

 

The Class A Preferred Stock has the following characteristics:

 

Voting - The holders of the Preferred Stock shall have no voting or other management rights, or other beneficial rights other than those disclosed in the Articles of Incorporation, as Amended.

 

Dividends - Issued shares of Preferred Stock will carry a Paid-In-Kind (PIK) dividend of 7% per year, uncompounded. Dividends for the period from issuance through June 30, 2019 and June 30, 2018 are shown as an addition to Series A Preferred Stock in the statements of stockholders’ equity.

 

Other Provisions - Other provisions related to the Preferred Stock are set forth in the Articles of Incorporation and include certain rights upon a change of control, as defined, including success bonus terms, and rights and priorities with respect to consideration received or conversion rights in redemption.

 

Shares of Preferred Stock are redeemable upon a change of control of the Company or at any time, at the discretion of the board of directors, provided that the redemption must include 100% of a shareholder’s shares of Preferred Stock at par value, plus any accrued PIK and the applicable Success Bonus amount. Until all shares of Preferred Stock are redeemed, certain restrictions exist as to compensation levels and dividend distributions.

 

Common Stock

 

The Company issued 820,000 shares of common stock to certain founding parties who have been responsible for incubating and forming the Company and 90,000 shares to research institutions, in exchange for certain technology and contractual rights. The Company has issued 75,000 shares to employees.

 

(6)Related Party Transactions

 

The Company had the following transactions with stockholders through June 30, 2019 and 2018:

 

   June 30, 2019   June 30, 2018 
Consulting fees  $62,457   $29,002 
Rent   14,378    17,251 
Interest on stockholder loans   -    2,984 

 

Additionally, during 2017 certain stockholders loaned $60,000 to the Company. During 2018, $10,000 was repaid, and the balance of $50,000 was converted to the same amount in shares of Class A Preferred Stock.

 

(7)Income Taxes

 

Since inception, the Company has experienced net operating losses (NOL), which is consistent with the Company conducting extensive research and development (R&D) activities. Prior to 2018, the Company, as a Subchapter S Corporation, passed these losses and credits to the stockholders. Beginning January 1, 2018, the Company converted to C Corporation status, and as such, these NOLs and R&D tax credits create net deferred tax assets (DTA); however, because of the current operating status of the Company, these DTAs have been reduced to zero for reporting purposes through a 100% valuation allowance at December 31, 2018.

 

 F-21 

 

 

As of December 31, 2018, the NOLs and R&D tax credits available to reduce taxable income in future periods were $441,644 and $37,655, respectively.

 

Income Tax Policy for Interest and Penalties

 

The Company follows FASB ASC 740-10, Accounting for Uncertainty in Income Taxes, as it relates to uncertain tax positions. Any interest and penalties recognized associated with a tax position are classified in expense in the Company’s financial statements.

 

Uncertain Tax Positions

 

The Company recognizes the tax benefits of uncertain tax positions only where the position is “more likely than not” to be sustained assuming examination by tax authorities. Management has analyzed the Company’s tax positions and has concluded that no liability for unrecognized tax benefits should be recorded related to uncertain tax positions taken on returns filed for the open tax years (2016 - 2017), or is expected to be taken in the Company’s 2018 tax returns. The Company identifies its major tax jurisdictions as the U.S. Federal and the State of Tennessee. However, the Company is not currently under audit nor has the Company been contacted by any of these jurisdictions. The Company is not aware of any tax positions for which it is reasonably possible that the total amounts of unrecognized tax benefits will change in the next twelve months.

 

During the years ended December 31, 2018 and 2017, the Company did not recognize any interest and penalties relating to taxes, nor were any accrued at December 31, 2018 and 2017.

 

(8)Fair Value Measurements

 

The Company follows ASC 820-10, Fair Value Measurements, with respect to its financial assets and liabilities. Fair value is defined as the price that would be received to sell an asset in the principal or most advantageous market for the asset in an orderly transaction between market participants on the measurement date. Fair value should be based on the assumptions market participants would use when pricing an asset. U.S. GAAP establishes a fair value hierarchy that prioritizes investments based on those assumptions. The fair value hierarchy gives the highest priority to quoted prices in active markets (observable inputs) and the lowest priority to an entity’s assumptions (unobservable inputs). The Company groups assets at fair value in three levels, based on the markets in which the assets and liabilities are traded, and the reliability of the assumptions used to determine fair value. These levels are as follows:

 

Level 1 - Unadjusted quoted market prices for identical assets or liabilities in active markets as of the measurement date.

 

Level 2 - Other observable inputs, either directly or indirectly, including:

 

  · Quoted prices for similar assets/liabilities in active markets;
  · Quoted prices for identical or similar assets in non-active markets;
  · Inputs other than quoted prices that are observable for the asset/liability; and,
  · Inputs that are derived principally from or corroborated by other observable market data.

 

Level 3 - Unobservable inputs that cannot be corroborated by observable market data.

 

 F-22 

 

 

Generally accepted accounting principles require disclosure of an estimate of fair value of certain financial instruments. The Company’s significant financial instruments are cash and cash equivalents and other short-term assets and liabilities. For these financial instruments, carrying values approximate fair value.

 

(9)Recent Accounting Pronouncements

 

In May 2014, the FASB issued ASU 2014-09, “Revenue from Contracts with Customers,” which establishes a comprehensive revenue recognition standard for virtually all industries in U.S. Generally Accepted Accounting Principles (GAAP), including those that previously followed industry-specific guidance. For non-public entities, the new standard was originally effective for annual periods beginning after December 15, 2017. In August 2015, the FASB issued ASU 2015-4, “Revenue from Contracts with Customers (Topic 606) – Deferral of Effective Date,” which deferred the effective date for one year. It is anticipated that the effective date will be further deferred by FASB. The Company is currently evaluating the effect the provisions of ASU 2014-09 will have on the financial statements.

 

In February 2016, the FASB issued ASU 2016-02, Leases (ASC 842), which requires lessees to recognize assets and liabilities for most leases. The recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee is not expected to significantly change under such guidance. The effective date of the standard is expected to be deferred by FASB until 2023 for private companies. The Company is currently evaluating the impact that adoption of this ASU will have on the Balance Sheet and Statement of Operations.

 

 F-23 

 

 

PART III

 

EXHIBITS

 

Index to Exhibits

 

Exhibit No.   Description of Exhibit
1.1   Exclusive Placement Agent Agreement between the Company and Strategic Capital Investments, LLC, dated October 17, 2019*
2.1   Charter of Virtuoso Surgical, Inc.*
2.2   Amended Corporate Bylaws of Virtuoso Surgical, Inc.*
4.1   Form of Subscription Agreement for Regulation A, Tier 2, Offering**
6.1   Technology Licensing - Platform Agreement between the Company and Capital2Market, LLC, dated October 17, 2019*
6.2   Non-Exclusive License Agreement with Johns Hopkins University, effective May 11, 2016*
6.3   License Agreement with Vanderbilt University, effective May 15, 2016*
6.4   Employment Agreement with Richard Hendrick, dated September 7, 2017*
6.5   Employment Agreement with C. Mark Pickrell, dated September 7, 2017*
8.1   Escrow Agreement among Atlantic Capital Bank, National Association, the Company, and Capital2Market, LLC, dated October 17, 2019**
11.1   Consent of Puryear & Noonan, CPAs*
11.2   Consent of Waller Lansden Dortch & Davis, LLP (included in Exhibit 12.1)*
12.1   Opinion of Waller Lansden Dortch & Davis, LLP*
15(a).1   Correspondence submitted by Virtuoso Surgical, Inc. on December 6, 2019 pursuant to Rule 252(d)*

 

* Filed herewith

** To be filed by amendment

 

 

 

SIGNATURES

 

Pursuant to the requirements of Regulation A, the issuer certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form 1-A and has duly caused this offering statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Nashville, Tennessee on December 27, 2019.

 

VIRTUOSO SURGICAL, INC.  
   
By: /s/ Robert Webster, III  
  Robert Webster, III  
  Principal Executive Officer  
     
By: /s/ C. Mark Pickrell  
  C. Mark Pickrell  
  Principal Financial Officer and Principal Accounting Officer  

 

Pursuant to the requirements of the Securities Act of 1933, as amended, this Form 1-A has been signed by the following persons in the capacities and on the dates indicated

 

Signature   Title   Date
         
/s/ Richard Hendrick       December 27, 2019
Richard Hendrick   Chief Operating Officer and Chairman    
         
/s/ Robert Webster, III       December 27, 2019
Robert Webster, III   President, Chief Technology Officer and Director    
         
/s/ C. Mark Pickrell       December 27, 2019
C. Mark Pickrell   General Counsel, Chief Administrative Officer and Director    
         
/s/ S. Duke Herrell       December 27, 2019
S. Duke Herrell   Chief Clinical Strategist and Director    

 

 

EX1A-1 UNDR AGMT 3 tm1927293d1_ex1-1.htm EXHIBIT 1.1

 

Exhibit 1.1

 

EXCLUSIVE PLACEMENT AGENCY AGREEMENT

 

This Placement Agency Agreement (this “Agreement”) is made as of October 1st, 2019, between Virtuoso Surgical, Inc., a Tennessee corporation (the “Company”), and Strategic Capital Investments, LLC, a Michigan limited liability company (the “Placement Agent”). The Placement Agent and the Company agree:

 

1. Engagement of Placement Agent. The Company hereby engages Placement Agent, and Placement Agent hereby accepts such engagement, to act as the Company’s exclusive Placement Agent with respect to sales by the Company in an offering pursuant to Regulation A (the “Offering”) under the Securities Act of 1933, as amended (the “Securities Act”) for up to $20,000,000 of the Company’s Class A Preferred securities (the “Securities”). One or more closings for the purchase and sale of the Securities (each, a “Closing”) shall be conducted from time to time at the request of the Company, subject to certain conditions to closing established by the Placement Agent and the Company and annexed hereto as an appendix to this Agreement.

 

2. Offering Procedures. Placement Agent will introduce the Company to investors who Placement Agent reasonably believes satisfy the eligibility requirements under the applicable rules and regulations of Regulation A, state securities laws and such suitability criteria as may be established by the Company (if any) to participate in the Offering (the “Offerees”).

 

3. Placement Agent’s Compensation. In consideration for the services rendered by Placement Agent hereunder, the Company shall pay the Placement Agent, upon the distribution of funds from the escrow account established for the Offering in connection with each Closing for the issuance and sale of the Securities, in accordance with written wire transfer payment instructions from the Placement Agent:

 

(i) Cash compensation equal to one percent (1%) of the gross proceeds of the Offering for Executing Broker Services. Additionally, seven (7%) of the aggregate subscription proceeds originated by an Introducing Broker other than the Placement Agent shall be payable in cash to such Introducing Broker provided that the Introducing Broker introduces an Introduced Investor as defined directly below.

 

Introduced Investor” means an investor introduced to the Offering by an Introducing Broker-Dealer, who purchases shares of Class A Preferred Stock pursuant to the Offering. An Introduced Investor’s stock must be acquired from the Company by either (a) an Introducing Broker-Dealer (on behalf of the Introduced Investor) or (b) C2M, at the request of the Introducing Broker-Dealer. For the avoidance of doubt, any investor who invests directly on the virtuososurgical.net website “Invest Now” button is not an Introduced Investor.

 

In addition, subject to such Introducing Broker providing Company with an Introduced Investor, and subject to the terms of the Warrant Issuance Agreement, the Company shall issue five percent (5%) in warrants of the gross proceeds of the Offering, allocated and with a strike price of $100/share, allocated between Placement Agent (1%) and the introducing brokers (4%). (By way of example, if an Introducing Broker places a $10,000 investment in the Company’s Class A Preferred Shares, the Placement Agent would receive a warrant to purchase one share of the Company’s common stock at a strike price of $100 for that share; the Introducing Broker would receive a warrant to purchase four shares of the Company’s common stock at a strike price of $100/share.)

 

The Company also will pay a $10,000 refundable due diligence fee to the Placement Agent at the signing of this Agreement.

 

1

 

 

4. Certain Matters Relating to Placement Agent’s Duties.

 

(a) Placement Agent’s responsibilities shall be limited to introducing potential investors to the Company. Placement Agent shall act as the Company’s placement agent for soliciting offers to purchase the Securities. In performing is responsibilities hereunder, the Placement Agent shall not use any offering materials other than the Offering Circular, Subscription Agreement and any Offering Questionnaire and/or similar documents provided to Placement Agent by the Company and other documents authorized by the Company permitted under applicable federal and state securities laws (collectively, the “Offering Materials”). Placement Agent shall have no responsibility for fulfilling any SEC reporting or filing requirements, or fulfilling the filing obligations or other requirements applicable to the offer and sale of the Company’s securities under state securities or blue-sky laws as relates to the Company, but Placement Agent agrees to provide the Company with reasonable assistance related to any registration, qualification or other requirements of applicable securities laws and other regulatory matters, upon request of the Company. 

 

(b) Placement Agent agrees to introduce the Company to Offerees only in states in which Placement Agent has been advised by the Company that offers and sales of the Securities can he legally made by the Company.

 

(c) Placement Agent shall perform its duties hereunder in a manner consistent with the instructions of the Company. Such performance shall include the delivery to each Offeree the Offering Materials. Placement Agent shall maintain a copy of any written information it obtains regarding the suitability of each Offeree. Placement Agent shall use only the Offering Materials in introducing Offerees to the Company. The Company shall, promptly following execution of this Agreement, provide Placement Agent with a written list of any prospective Offerees the Company does not want Placement Agent to contact. Placement Agent agrees to not contact the persons on such list, and Placement Agent shall not be entitled to the compensation set forth in Section 3 with respect to any investment made by such persons in the Securities. The Placement Agent shall not have any liability with respect to the information set forth in the Offering Circular, except to the extent specifically furnished to the Company for inclusion in the Offering Circular.

 

(d) Placement Agent is and will hereafter act as an independent contractor and not as an employee of the Company and nothing herein shall be interpreted or construed to create any employment, partnership, joint venture, or other relationship between Placement Agent and the Company. Placement Agent will not hold itself out as having, and will not state to any person that Placement Agent has, any relationship with the Company other than as an independent contractor. Placement Agent shall have no right or power to find or create any liability or obligation for or in the name of the Company or to sign any documents on behalf of the Company.

 

2

 

 

5. Termination of Agreement. Either party may terminate this Agreement by notifying the other in writing upon a material breach by that other party, unless such breach is curable and is in fact cured within 15 days after such notice. This Agreement will otherwise terminate upon completion or termination of the Offering. The Company may terminate this Agreement, for any or no reason, following 15 days after the date hereof upon written notice to Placement Agent, but all provisions hereof other than Sections 1, 2, 4, 5, the last sentence of this Section 5 and Section 6 shall survive the termination with respect to Offerees that Placement Agent introduces to the Company before any termination with respect to the Offering.

 

Placement Agent shall be entitled to compensation under Section 3 based on investments made by such Offerees prior to the termination of this Agreement or at any time within one year thereafter; provided that if Company sells any of its securities to an Offeree introduced by Placement Agent within one year of termination of this Agreement, Placement Agent shall be entitled to fees based upon the sale of the securities purchased and the exercise, exchange or conversion of any derivative securities purchased by that Offeree or any permitted assignee of such Offeree within such one-year period, regardless of when exercised, exchanged or converted.

  

6. Indemnification. The Company and Placement Agent each shall indemnify and defend the other and the other’s affiliates, directors, officers, employees, agents, consultants, attorneys, accountants and other representatives (each an “Indemnified Person”) and shall hold each Indemnified Person harmless, to the fullest extent permitted by law, from and against any and all claims, liabilities, losses, damages and expenses (including reasonable attorney’s fees and costs), as they are incurred, in connection with the Offering, resulting from the indemnifying party’s negligence, bad faith or willful misconduct in connection with the Offering, any violation by the indemnifying party (not caused by an Indemnified Person) of Federal or state securities laws in connection with the Offering, or any breach by the indemnifying party of this Agreement.

 

In case any litigation or proceeding shall be brought against any Indemnified Person under this section, the indemnifying party shall be entitled to assume the defense of such litigation or proceeding with counsel of the indemnifying party’s choice at its expense (in which case the indemnifying party shall not be responsible for the fees and expenses of any separate counsel retained by such Indemnified Person, except in the limited circumstances described below in this section); provided, however, that such counsel shall be reasonably satisfactory to the Indemnified Person. Notwithstanding the indemnifying party’s election to assume the defense of such litigation or proceeding (a) such Indemnified Person shall have the right to employ separate counsel and to participate in the defense of such litigation or proceeding, and (b) the indemnifying party shall bear the reasonable fees, costs and expenses of separate counsel if (but only if) the use of counsel selected by the indemnifying party to represent such Indemnified Person would present such counsel with a conflict of interest under applicable laws or rules of professional conduct.

 

7. Notices. Any notice, consent, authorization or other communication to be given hereunder shall be in writing and shall be deemed duly given and received when delivered personally, when transmitted by fax or electronic mail, three days after being mailed by first class mail, or one day after being sent by a nationally recognized overnight delivery service, charges and postage prepaid, properly addressed to the party to receive such notice, at the following address or fax number for such party (or at such other address or fax number as shall hereafter be specified by such party by like notice):

 

3

 

 

  (a)

If to the Company, to: Virtuoso Surgical, Inc.

Address: 5701 Old Harding Pike, Suite 200; Nashville, Tennessee 37205

Attn: Mark Pickrell

     
  (b)

If to the Placement Agent, to: Strategic Capital Investments, LLC,

701 Riversedge Dr.

Saline, MI 48176

Attention: Victor MacLaughlin

 

8. Company to Control Transactions. The prices, terms and conditions under which the Company shall offer or sell any Securities shall be determined by the Company in its sole discretion. The Company shall have the authority to control all discussions and negotiations regarding any proposed or actual offering or sale of Securities. Nothing herein shall obligate the Company to actually offer or sell any Securities or consummate any transaction. The Company may terminate any negotiations or discussions at any time and may cease any offering or sale of Securities. Compensation pursuant hereto shall he paid to Placement Agent only in the event of an actual Closing of the Offering to an Offeree introduced by Placement Agent.

 

9. Confidentiality of Company Information. Placement Agent, and its officers, directors, employees and agents shall maintain in strict confidence and not copy, disclose or transfer to any other party (a) all confidential business and financial information regarding the Company and its affiliates, including without limitation, projections, business plans, marketing plans, product development plans, pricing, costs, customer, vendor and supplier lists and identification, channels of distribution, and terms of identification of proposed or actual contracts and (b) all confidential technology of the Company. In furtherance of the foregoing, Placement Agent agrees that it shall not transfer, transmit, distribute, download or communicate, in any electronic, digitized or other form or media, any of the confidential technology of the Company. The foregoing is not intended to preclude the Placement Agent from utilizing, subject to the terms and conditions of this Agreement, the Offering Materials or other documents prepared or approved by the Company for use in the Offering.

 

All communications regarding any possible transactions, requests for due diligence or other information, requests for facility tours, product demonstrations or management meetings, will be submitted or directed to the Company, and Placement Agent shall not contact any employees, customers, suppliers or contractors of the Company or its affiliates without express permission. Nothing herein shall constitute a grant of authority to Placement Agent or any representatives thereof to remove, examine or copy any particular document or types of information regarding the Company, and the Company shall retain control over the particular documents or items to be provided, examined or copied. If the Offering is not consummated, or if at any time the Company so requests, Placement Agent and its representatives will return to the Company all copies of information regarding the Company in their possession.

 

The provisions of this Section shall survive any termination hereof.

 

4

 

 

10. Press Releases, Etc. The Company shall control all press releases or announcements to the public, the media or the industry regarding any offering, placement, transaction or business relationship involving the Company or its affiliates; provided that the Company shall furnish the Placement Agent with drafts of any such press releases or announcements a reasonable period of time prior to release or distribution and give due consideration to any comments thereon submitted to the Company prior to the release or distribution thereof, except that the Company shall not use the name of the Placement Agent in a manner in which the Placement Agent objects in writing. . Except for communication to Offerees in furtherance of this Agreement and the provision of the Offering Materials, Placement Agent will not disclose the fact that discussions or negotiations are taking place concerning a possible transaction involving the Company, or the status or terms and conditions thereof. Notwithstanding the foregoing, the Company agrees to issue a press release prior to the opening of the market on the business day following the Company’s receipt of executed agreements binding Offerees to purchase Securities in at least the amount of the minimum Offering (if there is any such minimum) setting forth the material terms of the Offering.

 

11. Expenses, Etc. The compensation described in Section 3 shall be Placement Agent’s sole compensation for all of its services and efforts to the Company and its affiliates, in connection with any offering or placement of Securities. The Company further agrees to pay for all legal expenses relating to closing the transaction contemplated. Placement Agent shall be exclusively responsible for any compensation, fees, commissions or payments of its employees, agents, representatives, co-Placement Agents or other persons or entities utilized by it in connection with its activities on behalf of the Company, and Placement Agent will indemnify and hold harmless the Company and its affiliates from the claims of any such persons or entities.

 

12. Covenants of the Company. The Company will provide Placement Agent for delivery to all offerees and purchasers and their representatives any additional information, documents and instruments which Placement Agent shall deem necessary to comply with the rules, regulations and judicial and administrative interpretations in those states and jurisdictions where the Securities are to be offered for sale or sold. The Company will file all post-Offering forms, documents or materials and take all other actions required by states in which the Securities have been offered or sold. Placement Agent will not make offers or sales of the Securities in any jurisdiction in which the Securities have not been qualified or registered or are not exempt from such qualification or registration.

 

(a) Reg. A Compliance. The Company will comply in all respects with the terms and conditions of Reg. A applicable state securities laws with respect to the Offering and the sale of the Securities.

 

(b) Due Diligence Materials. The Company shall provide Placement Agent copies of all information provided to all prospective offerees and copies of all documents pertaining to the closing and sale of Securities. Additionally, the Company shall provide Placement Agent copies of any documentation reasonably requested by the Placement Agent.

 

(c) Background Investigation. The Company shall deliver authorization (s) to have background investigations conducted by an outside third party on officers, directors, principal shareholders, promoters and other individuals or entities participating in the Offering, as determined by Placement Agent.

 

5

 

 

(d) Public Information. The Company acknowledges that all information regarding their officers, directors and principal shareholders have been filed with all appropriate regulatory agencies and are of public record. The Company agrees to provide Placement Agent with any material differences that have not been filed.

 

13. Compliance with Laws. Placement Agent represents and warrants that it is a duly registered broker/dealer and in good standing with the SEC, FINRA and the State of MI and has and shall maintain such registrations as well as all other necessary licenses and permits to conduct its activities under this Agreement, which it shall conduct in compliance with applicable federal and state laws relating to a private placement under Regulation D of the 1933 Act. Placement Agent represents that it is not a party to any other agreement which would conflict with or interfere with the terms and conditions of this Agreement.

 

14. Assignment Prohibited. No assignment of this Agreement shall be made without the prior written consent of the other party.

 

15. Amendments. Neither party may amend this Agreement or rescind any of its existing provisions without the prior written consent of the other party.

 

16. Governing Law. This Agreement shall be deemed to have been made in the State of New York and shall be construed, and the rights and liabilities determined, in accordance with the law of the State of New York, without regard to the conflicts of laws rules of such jurisdiction.

 

17. Waiver. Neither Placement Agent’s nor the Company’s failure to insist at any time upon strict compliance with this Agreement or any of its terms nor any continued course of such conduct on their part shall constitute or be considered a waiver by Placement Agent or the Company of any of their respective rights or privileges under this Agreement.

 

18. Severability. If any provision herein is or should become inconsistent with any present or future law, rule or regulation of any sovereign government or regulatory body having jurisdiction over the subject matter hereof, such provision shall be deemed to be rescinded or modified in accordance with such law, rule or regulation. In all other respects, this Agreement shall continue to remain in full force and effect.

 

19. Counterparts. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, and will become effective and binding upon the parties at such time as all of the signatories hereto have signed a counterpart of this Agreement. All counterparts so executed shall constitute one agreement binding on all of the parties hereto, notwithstanding that all of the parties are not signatory to the same counterpart. Each of the parties hereto shall sign a sufficient number of counterparts so that each party will receive a fully executed original of this Agreement.

 

20. Entire Agreement. This Agreement and all other agreements and documents referred herein constitute the entire agreement between the Company and Placement Agent. No other agreements, covenants, representations or warranties, express or implied, oral or written, have been made by any party hereto to any other party concerning the subject matter hereof. All prior and contemporaneous conversations, negotiations, possible and alleged agreements, representations, covenants and warranties concerning the subject matter hereof are merged herein. This is an integrated Agreement.

 

6

 

 

21. Arbitration. The parties agree that this Agreement and all controversies which may arise between Placement Agent and the Company, whether occurring prior, on or subsequent to the date of this Agreement, will be determined by JAMS, expedited, single-arbitrator arbitration, in New York, New York. The parties understand that:

 

(a) Arbitration is final and binding on the parties. Judgment on the award may be entered in any court having jurisdiction.

 

(b) The parties are waiving their right to seek remedies in court, including the right to a jury trial.

 

(c) Pre-arbitration discovery is generally more limited than and different from court proceedings.

 

(d) The arbitrator’s award is not required to include factual findings or legal reasoning and any party’s right to appeal or to seek modification or rulings by the arbitrators is strictly limited.

 

Any forbearance to enforce an agreement to arbitrate will not constitute a waiver of any rights under this Agreement except to the extent stated herein.

 

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

 

Strategic Capital Investments, LLC

 

/s/ Victor MacLaughlin  
Victor MacLaughlin, CEO  

 

/s/ Udi Laska  
Udi Laska, Supervisor  

 

Virtuoso Surgical, Inc.

 

By: /s/ C. Mark Pickrell  
  C. Mark Pickrell  
   
Its: Chief Administrative Officer  

 

7

 

EX1A-2A CHARTER 4 tm1927293d1_ex2-1.htm EXHIBIT 2.1

 

Exhibit 2.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

EX1A-2B BYLAWS 5 tm1927293d1_ex2-2.htm EXHIBIT 2.2

 

Exhibit 2.2

 

Amended Corporate Bylaws

 

of

 

Virtuoso Surgical, Inc.

 

ARTICLE I

CORPORATE OFFICES

 

The registered office and principal office of Virtuoso Surgical, Inc. (the “Corporation”) within the State of Tennessee shall be 5701 Old Harding Pike; Suite 200 Nashville, TN 37205. The Corporation shall also have such other offices, including its principal office, at such places, within or without the State of Tennessee, as the board of directors may from time to time designate or the business of the Corporation may require.

 

ARTICLE II

SHAREHOLDERS

 

Section 1. Annual Meetings. The annual meeting of common shareholders shall be held at such place and such time as the director or directors shall designate each year for the purpose of electing directors and transacting such other business as may be properly brought before the meeting.

 

Section 2. Special Meetings. Special meetings of common shareholders may be called for any purpose or purposes by the board of directors or by holders of at least ten percent (10%) of all the votes entitled to be cast on any issue to be considered at the proposed special meeting who sign, date and deliver to the Corporation’s secretary one or more written demands for the meeting. Such demand or demands must describe the purpose or purposes for which the meeting is to be held.

 

Section 3. Notice of Meetings. A written notice of each meeting of common shareholders stating the place, date and time of the meeting, and, in the case of a special meeting, describing the purpose or purposes for which the meeting is called, shall be given to each common shareholder entitled to notice of such meeting not less than ten days nor more than two months before the date of the meeting.

 

Section 4. Place of Meetings. Meetings of common shareholders shall be held at such places, within or without the State of Tennessee, as may be designated by the board of directors and stated in the notice of meeting.

 

Section 5. Quorum. The holders of common shares entitled to vote as a separate voting group may take action on a matter at a meeting only if a quorum exists with respect to that matter. Unless the charter or the Act provides otherwise, the holders of two-thirds (66 2/3%) of the votes entitled to be cast on a matter by a voting group constitute a quorum of that voting group for action on that matter. Once a common share is represented for any purpose at a meeting, the holder is deemed present for quorum purposes for the remainder of the meeting and for any adjournment of that meeting, unless a new record date is or must be set for that adjourned meeting.

 

Section 6. Voting. Directors shall be elected by a plurality of the votes cast by common shareholders entitled to vote in the election at a meeting at which a quorum is present. Common Shareholder action on any other matter is approved by a voting group if the votes cast by common shareholders within the voting group in favor of the action exceed the votes cast by common shareholders within the voting group in opposition to such action, unless the charter or the Act provides otherwise. If two or more groups are entitled to vote separately on a matter, action on the matter is approved only when approved by each voting group.

 

 

 

 

Section 7. Adjournment. If a meeting of common shareholders is adjourned to another date, time or place, notice need not be given of the adjourned meeting if the new date, time and place are announced at the meeting before the adjournment. At the adjourned meeting, the Corporation may transact any business which might have been transacted at the time originally designated for the meeting if a quorum existed at the time originally designated for the meeting; provided, however, if a new record date is or must be fixed under the Act or these bylaws, a notice of the adjourned meeting must be given to shareholders as of the new record date.

 

Section 8. Proxies. A common shareholder may appoint a proxy to vote at a meeting of shareholders or otherwise act for him by signing an appointment form, either personally or by his attorney-in-fact. An appointment of a proxy is effective when received by the secretary or other officer or agent authorized to tabulate votes. An appointment is valid for eleven months, unless another period is expressly provided for in the appointment form. An appointment of a proxy is revocable by the common shareholder, unless the appointment form conspicuously states that it is irrevocable and the appointment is coupled with an interest.

 

Section 9. Action by Written Consent. Any action required or permitted to be taken at a meeting of the common shareholders may be taken without a meeting if all shareholders entitled to vote on the action consent to the taking of such action without a meeting by signing one or more written consents describing the action taken and indicating each shareholder’s vote or abstention on the action. The affirmative vote of the number of shares which would be necessary to authorize or take action at a meeting of common shareholders is the act of the shareholders without a meeting. The written consent or consents shall be included in the minutes or filed with the corporate records reflecting the action taken. Action taken by written consent is effective when the last common shareholder signs the consent, unless the consent specifies a different effective date.

 

Section 10. Original Shareholders and Issuance of New Shares. The original common shareholders of the Corporation shall be Robert J. Webster III, Duke Herrell, Richard Hendrick, and C. Mark Pickrell. The original common shares owned be each shall be: Robert J. Webster III, 18; Duke Herrell, 18; Richard Hendrick, 18; C. Mark Pickrell, 6. Additional common shares or preferred shares may be issued by approval of a two-thirds (66 2/3%) vote of the board of directors. No preferred shares or other types of stock may be issued with rights senior to the Class A Preferred Stock established in Section 11.

 

 

 

 

Section 11. Class A Preferred Stock.

 

i.Class A preferred shares may be issued at $1.00 par value, to a maximum of 50,000,000 shares, pursuant to Section 10.

 

ii.Issued Class A preferred shares will carry a Paid-in-Kind dividend (“PIK”) of 7% per year, uncompounded.

 

iii.Upon a change of control, an owner of Class A preferred shares will be entitled to a Success Bonus equal to: 100% of (par plus the PIK) if the change of control occurs more than year and less than three years after the shares were purchased or otherwise received by the investor; 200% of (par plus the PIK) if the change of control occurs more than three years and less than five years after the shares were purchased or otherwise received by the investor; or 300% of (par plus the PIK) if the change of control occurs more than five years after the shares were purchased or otherwise received by the investor.

 

iv.A change of control occurs if the common shareholders and warrantholders of the Company as of April 25, 2018 (i.e., Robert Webster, Duke Herrell, Richard Hendrick, Mark Pickrell, Vanderbilt University, Johns Hopkins University, Neal Dillon, Scott Webster, and Evan Blum), or their successors by operation of law, shall own less than a majority of the common shares of the Company, or any one of them shall own a majority of the common shares of the Company. Board approval shall be required for any shareholder action constituting a change of control.

 

v.In the event of a change of control, the Class A preferred shares are due and payable at par, plus any accrued PIK, plus any applicable Success Bonus. In the event that the consideration paid to the Company upon a change of control is not sufficient to pay off the outstanding Class A preferred shares, the consideration received shall, in order of priority, be used to pay, pari passu: par value for the preferred shares, accumulated PIK, Success Bonus. After a change of control, and payment along the waterfall, if the Class A preferred shares are not paid in full (including any applicable Success Bonuses), the preferred shares shall be converted to common stock based on the Class A preferred shareholders’ relative unpaid balances.

 

vi.In the event of a change of control, all existing common shares shall be extinguished unless all Class A preferred shares (including accrued PIK, and all outstanding Success Bonuses) are paid in full.

 

vii.Until the Class A preferred shares are paid in full, including any applicable Success Bonuses, the Company shall not pay any dividend (except for a dividend permissible under SEC Regulation A, for a successful offering under that regulation) to the common stockholders, or purchase any common shares, or pay any employee bonuses (except for de minimis cash bonuses to non-management employees).

 

 

 

 

viii.Until the Class A preferred shares are paid in full, the compensation limits established by the National Institutes of Health for grant recipients shall apply to the Company’s employees and consultants.

 

ix.Class A preferred shares are redeemable at any time, at the discretion of the board of directors, provided that a redemption must include 100% of a shareholder’s preferred shares at par, plus any accrued PIK. If a change of control occurs within two years of a redemption, the investor will be entitled to receipt of a Success Bonus equal to the Success Bonus that would have been paid as of the redemption date.

 

x.Class A preferred shareholders shall, as preferred shareholders, have no voting or other management rights, or any beneficial rights as preferred shareholders, except as specifically provided for in this Section 11.

 

ARTICLE III

RECORD DATE

 

In order that the Corporation may determine the common shareholders entitled to notice of or to vote at any meeting of common shareholders or any adjournment thereof, or entitled to receive payment of any dividend or other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of common stock or for the purpose of any other action, the board of directors may fix, in advance, a record date, which shall not be more than seventy nor less than ten days before the date of such meeting, nor more than seventy days prior to any other action. If no record date is fixed, the record date for determining common shareholders entitled to notice of or to vote at a meeting of common shareholders shall be at the close of business on the day before the day on which the first notice is given to such common shareholders and the record date for determining common shareholders for any other purpose shall be at the close of business on the day that the board of directors authorizes the action. A determination of common shareholders of record entitled to notice of or to vote at a meeting of common shareholders shall apply to any adjournment of the meeting, unless the board of directors fixes a new record date. The board of directors must fix a new record date, if the meeting is adjourned to a date more than four months after the date fixed for the original meeting.

 

ARTICLE IV

DIRECTORS

 

Section 1. Powers. The business and affairs of the Corporation shall be managed by or under the direction of a board of directors, which may exercise all such powers of the Corporation and do all such lawful acts and things as are not by law or by the Charter of the Corporation or these bylaws directed or required to be exercised or done by the common shareholders.

 

Section 2. Number and Term. The number of directors which shall constitute the whole board shall not be less than one (1) nor more than seven (7). The original four directors shall be Robert J. Webster III, Duke Herrell, Richard Hendrick, and C. Mark Pickrell, none of whom may be removed as a director without cause. Within the limits above specified, the number of additional directors shall be determined by resolution of board of directors or the common shareholders. The additional directors shall be elected at the annual meeting of the common shareholders, except as provided in Section 5 hereof, and each additional director elected shall hold office until his successor is elected and qualified or until his earlier resignation, death or removal.

 

 

 

 

 

Section 3. Compensation. Directors may receive such compensation as fixed by the board of directors. Directors shall be entitled to reimbursement for any reasonable expenses incurred in attending meetings and otherwise carrying out their duties as determined by the board of directors. Directors may also serve the Corporation in any other capacity and receive compensation therefor.

 

Section 4. Resignation. A director may resign at any time by delivering written notice to the Corporation, the board of directors, the chief executive officer or the president. A resignation is effective when the notice is delivered, unless the notice specifies a later effective date.

 

Section 5. Vacancies. The board of directors may fill any vacancy occurring on the board of directors, including any vacancy resulting from an increase in the number of directors or from the resignation or removal of a director. If the directors remaining in office constitute fewer than a quorum, the board of directors may fill the vacancy by the affirmative vote of a majority of all the directors remaining in office.

 

Section 6. Quorum and Voting. A quorum of the board of directors consists of two-thirds (66 2/3%) of the number of directors fixed by the board of directors or common shareholders pursuant to Section 2 of this Article IV. If a quorum is present when a vote is taken, the affirmative vote of a majority of directors present is the act of the board of directors, unless the charter or these bylaws requires the vote of a greater number of directors.

 

Section 7. Regular Meetings. Regular meetings of the board of directors may be held without notice at such places, within or without the State of Tennessee, on such dates and at such times as the board of directors may determine from time to time.

 

Section 8. Special Meetings. Special meetings of the board of directors may be called by the president, chairman of the board, or a majority of directors and shall be held at such places, within or without the State of Tennessee, on such dates and at such times as may be stated in the notice of meeting.

 

Section 9. Notices. Special meetings of the board of directors must be preceded by at least one days’ notice of the date, time and place of the meeting. The notice need not describe the purpose of the meeting, unless the purpose, or one of the purposes, of the meeting is to remove a director or directors. Notice of an adjourned meeting need not be given, if the time and place to which the meeting is adjourned are fixed at the meeting at which the adjournment is taken and if the period of any one adjournment does not exceed one month.

 

Section 10. Action by Written Consent. Any action required or permitted to be taken at a meeting of the board of directors may be taken without a meeting, if all directors consent to the taking of such action without a meeting by signing one or more written consents describing the action taken and indicating each director’s vote or abstention on the action. The affirmative vote of the number of directors that would be necessary to authorize or take action at a meeting is the act of the board of directors without a meeting. The written consent or consents shall be included in the minutes or filed with the corporate records reflecting the action taken. Action taken by written consent is effective when the last director signs the consent, unless the consent specifies a different effective date.

 

Any action required or permitted to be taken at a meeting of the common shareholders may be taken without a meeting, if 80% of the common shareholders consent to the taking of such action without a meeting by signing one or more written consents describing the action taken and indicating each common shareholder’s vote or abstention on the action. The affirmative vote of the number of common shareholders that would be necessary to authorize or take action at a meeting is the act of the common shareholders without a meeting. The written consent or consents shall be included in the minutes or filed with the corporate records reflecting the action taken. Action taken by written consent is effective when the last necessary common shareholder signs the consent, unless the consent specifies a different effective date.

 

 

 

 

ARTICLE V

WAIVER OF NOTICE

 

A common shareholder or director may waive any notice required to be given by the Act, the charter of the Corporation or these bylaws before or after the date and time stated in the notice. The waiver must be in writing, signed by the common shareholder or director entitled to the notice and delivered to the Corporation and filed in the Corporation’s minutes or corporate records, except that a common shareholder’s or director’s attendance at or participation in a meeting may constitute a waiver of notice under the Act. Neither the business to be transacted at, nor the purpose of, any meeting of the common shareholders or directors need be specified in any waiver of notice.

 

ARTICLE VI

OFFICERS

 

Section 1. Election and Term. At the first meeting of the board of directors following the annual meeting of shareholders, or as soon thereafter as is conveniently possible, the board of directors shall elect a president and a secretary and such other officers as the board of directors may determine. The board of directors may elect officers at such additional times as it deems advisable. Each officer of the Corporation shall serve until his successor is elected and qualified or until his earlier resignation or removal. Any number of offices may be held by the same person, except that the president may not serve as the secretary.

 

Section 2. Compensation. The salaries and other compensation of the officers of the Corporation shall be determined by the board of directors.

 

Section 3. Removal. The board of directors may remove any officer at any time, with or without cause, but no such removal shall affect the contract rights, if any, of the person so removed.

 

Section 4. Resignation. An officer of the Corporation may resign at any time by delivering notice to the Corporation. A resignation is effective when the notice is delivered, unless the notice specifies a later effective date. If a resignation is made effective at a later date and the Corporation accepts the future effective date, the board of directors may fill the pending vacancy before the effective date if it provides that the successor does not take office until the effective date. An officer’s resignation does not affect the Corporation’s contract rights, if any, with the officer.

 

 

 

 

ARTICLE VII

EMERGENCY BYLAW

 

In the event that a quorum of directors cannot be readily assembled because of a catastrophic event, the board of directors may take action by the affirmative vote of a majority of those directors present at a meeting and may exercise any emergency power granted to a board of directors under the Act not inconsistent with this bylaw. If no regularly elected director is present, the officer present having the greatest seniority as an officer shall serve as a substitute director. Special meetings of the board of directors may be called in an emergency by any director or, if no director is present at the Corporation’s principal offices, by the officer present having the greatest seniority as an officer.

 

ARTICLE VIII

FISCAL YEAR

 

The fiscal year of the Corporation shall begin the 1st day of January and end on 31st day of December of each calendar year.

 

ARTICLE IX

AMENDMENT

 

These Bylaws may be amended, altered and repealed, and new Bylaws may be adopted, by the common stockholders or the board of directors of the Corporation at any regular or special meeting upon a four-fifths (80%) affirmative vote. Any increase in the number of authorized common shares of the Corporation shall require a four-fifths (80%) affirmative vote of the common shares issued and outstanding.

 

ARTICLE X

DEFINITION

 

The term “Act” as used in these bylaws refers to the Tennessee Business Corporation Act, as amended from time to time. Terms defined in the Act shall have the same meanings when used in these bylaws.

 

The foregoing bylaws were duly adopted by the Board of Directors as of May 15, 2018.

 

 

 

EX1A-6 MAT CTRCT 6 tm1927293d1_ex6-1.htm EXHIBIT 6.1

 

Exhibit 6.1

 

 

TECHNOLOGY LICENSING - PLATFORM AGREEMENT

 

Customer Legal Name: Virtuoso Surgical, Inc.

Contact: Mark Pickrell

Website: www.virtuososurgical.net

Phone: (615) 352-9519

Address: 5701 Old Harding Pike, Suite 200; Nashville, Tennessee 37205

 

Email: mark.pickrell@virtuososurgical.net

 

Licensing Fee: - one-time payment of $ 10,000 to be paid at the execution of this Agreement. Regulation A+ offering

 

Monthly Fees –

 

·$2,500 initial customer service fee for the first 3 months when the offering is live.
·$ 1,000 per month after three months from the Launch Date for hosting fees. “Launch Date” is defined as the date the offering is taken live online.
·After 3 months, if the offering is still live, there will be a $250 per hour fee or a flat fee of $1,000 per month for all customer service services which are defined as responding to investor calls, responding to investor emails, resolving customer investment processing issues. These services will be documented and recorded for accuracy of hourly rate. This fee is not included for standard processing of investments, only for customer service issues. This fee is in addition to the standard $1,000 hosting fee which begins 3 months after offering is launched.

 

Services: White label API, website dashboard and other API driven applications (e.g. widgets or i-frames) to create and manage subscription based investments through the exemptions of Regulations D 506 b and c, Regulation A+ of Titles II and IV of the JOBS Act of 2012 and Rule 147. User identity and compliance checks, transactions and accounts as further detailed in Section 3 of the Platform Agreement (collectively, the “Services” or “API”).

 

PLATFORM AGREEMENT

 

This Platform Agreement (“Platform Agreement” or “Agreement”) is entered into as of the date noted below (the “Effective Date”) between Capital2Market, LLC, a Virginia Limited Liability Company (“Company” or “us”), and the customer listed above (“Customer” or “you”). This Platform Agreement includes and incorporates this, the attached Software as a Service Terms and Conditions (“SaaS Terms and Conditions”), and amendments hereto, and supersedes all previous understandings and agreements between the parties, whether oral or written. There shall be no force or effect to any different terms of any related order form or similar form even if signed by the parties after the date hereof. By signing this Platform Agreement as indicated below, you agree to the terms and conditions of this Platform Agreement and the SaaS Terms and Conditions. In addition, you attest to the Company that you are authorized to agree to this Platform Agreement and any other agreements necessary in order to process subscription based investments through this platform.

 

Date: October 16, 2019     VIRTUOSO SURGICAL, INC.
     
By: /s/ Victor MacLaughlin   By: /s/ C. Mark Pickrell
Victor MacLaughlin     C. Mark Pickrell
Managing Partner     Its: Chief Administrative Officer
275 S. 12th St.  
Richmond VA 23219    

 

 

 

 

SaaS Terms and Conditions

 

1. General Introduction to Users, User Activity, Bank and the API

 

This Platform Agreement is between the Company and Customer. This Platform Agreement governs how Customer may manage User Accounts and User Activity, and the manner in which Company will provide the Services. A ("User") means a natural person, corporation, or other entity that has established an account (“User Account”) via the API. Customer may use the Company APIs within its website (“Customer Platform”) on behalf of itself to manage “User Activity” meaning all electronic interactions between a User and the Customer Platform, including use of the Company’s Services and API. The API shall provide for direct payment of a User’s investment transaction payments via ACH, wire or check to an escrow account maintained by the Company’s bank partner, which shall be Atlantic Capital Bank for the purposes of the Customer Platform (the “Bank”). The Bank shall operate as an escrow agent pursuant to the negotiated terms of a separate Subscription Escrow Agreement between you the Bank and potentially and broker of record or placement agent. Subject to the terms and conditions of the Agreement, Company grants to Customer a non-exclusive, non-transferable license to use the software identified in Exhibit A for the purpose of. Customer may use the platform for its own use only and may not, however, transfer or sublicense the platform to any third party, in whole or in part, in any form, whether modified or unmodified.

 

2. Services

 

Commencing as of the Effective Date and continuing throughout the term of this Platform Agreement, the Company will provide Customer with the following products and services through Company’s API in accordance with the terms herein, including the service levels set forth below:

 

a) White Label API Services

 

The Company will provide access to our API’s and other Services under the “white label” to enable Customer to create, edit and manage Users, User Accounts, transactions and other User Activity on the API as further set forth in the Company’s API documentation, website located at www.capital2market.com and below. The Company, either directly or through an affiliate, will monitor User Activity for compliance with the terms of this Agreement and including the terms described under the Broker of Record Agreement or Placement Agreement with the customers’ broker/dealer.

 

b) Transaction Timing and Limits

 

i. Timing

 

Depending on the sending and receiving node protocol (ACH, domestic wire, international wire or intra-Bank transfers), and risk or compliance factors, transaction speed may vary. Absent a risk or compliance flag, transaction may be processed in time frame according to industry standards. In certain circumstances, ACH batch times, wire settlement times and intra-bank transfer timing may vary due to unforeseen circumstances relating to Bank, NACHA or the Company. The Company will promptly notify you prior to such major timing variances.

 

ii. Limits

 

Transaction limits are a function of the agreement between the company and the bank, some transactions may need to be processed over multiple days due to ACH limitations. You and your Users may be asked to provide additional information in order to process certain transactions. Transaction limit approvals are subject to the Company’s sole discretion and may be reassessed and/or revoked at any time without prior notice as may become necessary to protect Company.

 

c) KYC / AML Program

 

The Company through an affiliate will provide you with “know your customer” (“KYC”) and “anti-money laundering” (“AML”) services for the User Accounts created on your Customer Platform to help you with your regulatory and compliance burdens (the “KYC Platform”) if necessary.

 

 

 

 

i. KYC Platform Use

 

In the event that the Company provides you the KYC Platform, and subject to your obligations under Section 8 (Underwriting and Verified Information), use of the KYC Platform in the normal course of your offering to (i) help verify the accuracy of information submitted by Users or User Accounts and (ii) help identify potential money laundering activity. No license or right to use, reproduce, translate, rearrange, modify, enhance, display, resell, lease, sublicense or otherwise distribute, transfer or dispose of the KYC Platform, in whole or in part, is granted except as expressly provided by this Section (b). The KYC Platform is not intended to replace a credit report or “consumer report.” Company represents and warrants that the KYC Platform, and its use in accordance with the terms and conditions herein, does not violate any applicable laws, rules, regulations or ordinances. Subject to the foregoing sentence, you promise and warrant that you will not use the KYC Platform in a way that violates: (a) the Fair Credit Reporting Act, 15 U.S.C. § 1681, et seq. (“FCRA”); (b) the Gramm-Leach-Bliley Act, 15 U.S.C. § 6801, et seq. (“GLBA”), (c) the Driver's Privacy Protection Act, 18 U.S.C. § 2721, et. seq. (“DPPA”) and other applicable laws and regulations governing the use and disclosure of User Data (as defined below); or (d) any other applicable laws, regulations, rules or other governmental mandates (collectively, the “KYC Applicable Laws”). You understand that the Company is not a consumer reporting agency as defined by the FCRA (“Consumer Reporting Agency”). Further, you agree that you will not use the KYC Platform for any purposes enumerated in the FCRA in lieu of obtaining a “Consumer Report” (as that term is defined in the FCRA) or for any other purpose that violates this Platform Agreement. You promise and warrant your use of the KYC Platform does not violate any agreement or obligation between User and any third party, and that neither your or any User’s use of the KYC Platform will infringe or violate the rights of any third party. THE KYC PLATFORM IS INTENDED TO HELP CUSTOMER WITH COMPLIANCE AND RISK MITIGATION; HOWEVER, KYC PLATFORM SERVICES ARE PROVIDED “AS IS” AND ARE NOT GUARANTEED. ADDITIONALLY, TRANSACTIONS ARE NOT GUARANTEED AGAINST RETURNS OR REVERSALS AND CUSTOMER IS SUBJECT TO REVERSALS AND REVERSAL LIABILITY AS FURTHER DETAILED HEREIN.

 

ii. Your Responsibility

 

You understand and agree that: (i) you are responsible for the accuracy and validity of all information provided by Customer to the Company; (ii) the failure by any User or third party acting on our behalf to provide accurate and valid information may result in incorrect identification or analysis by the KYC Platform; (iii) you are responsible for meeting your regulatory obligations; (iv) you shall only provide access to the KYC Platform to those employees or providers who have a need to know and only to the extent necessary to meet your regulatory obligations, and (v) you understand that the Company cannot disclose if a suspicious activity report was filed with FinCEN or similar report to regulators.

 

d) Technical Support

 

Company represents and warrants that it will use best efforts to ensure that the APIs will be available and respond to API calls (the “Service Standard”). Downtime due to (1) any acts, events or occurrences beyond Company’s reasonable control, or (2) planned system maintenance performed by Company during the hours of 1 am and 4 am Eastern Standard time or as otherwise communicated in writing to you within a reasonable time prior to such maintenance, shall not be counted against the Service Standard. Subject to the terms hereof, Company will provide you with commercially reasonable technical support services including any implementation services and priority support, if applicable on weekdays during the hours of 9:00 am through 5:00 pm Eastern time, with the exclusion of Federal Holidays or other bank holidays (“Support Hours”). You may initiate a helpdesk ticket at any time by emailing support@capital2market.com. Company will use best efforts to respond to all issues within one (1) business day for critical issues (e.g., Users creation, virtual document or physical document verification, and transaction creation API endpoints are not working or are significantly impaired). Non-critical issues and feature requests will be responded to within a commercially reasonable amount of time depending on the nature of the request, at the Company’s discretion.

 

 

 

 

e) Privacy Policy

 

Company will prominently display and comply with a privacy on policy on each webpage that a User is directed to from the Customer Platform via the API. Company represents, warrants and covenants that its privacy policy, and its collection, use, processing, storage and transfer of User Activity data and any other information collected by Company from Users is and shall remain in compliance with all applicable laws, rules, regulations and ordinances. In addition, Customer represents and warrants that its collection, use, processing, storage and transfer of any information regarding any User to which it has access, or whether provided to Customer by the Company, any User or any other third party, shall comply with all applicable laws (including without limitation privacy laws), rules, regulations and ordinances.

 

3. Fees

 

a) General

 

In addition to those fees relating to transactions, you shall pay the Company the then applicable fees described in this agreement for the Services in accordance with the terms therein. The Company reserves the right to increase the Monthly Fees or applicable charges (provided that any such increase shall not exceed 3%) at the end of the Initial Service Term or then current renewal term, upon thirty (30) days prior written notice to you. If you believe that the Company has billed you incorrectly, you must contact Company no later than sixty (60) days after the closing date on the first billing statement in which the error or problem appeared, in order to receive an adjustment or credit. Inquiries should be directed to support@capital2market.com.

 

b) Monthly Fees and Billing

 

You will be billed for your fees monthly and have the option to pay direct or from your third party escrow account. Services that provide for Monthly Fees are billed in advance on or before the fifth (5th) day of each month or next business day or as notified otherwise by the Company. Amounts which remain unpaid for thirty (30) days are subject to a finance charge of 1.5% per month on any outstanding balance, or the maximum permitted by law, whichever is lower. You shall be responsible for all taxes associated with Services provided.

 

c) Funds Processing Fees

 

Company’s funds processing fees are billed monthly (e.g. ACH-US or WIRE-US).

 

d) AML and Accreditation Platform Fees

 

AML Platform fees and accreditation reports are charged per User per initial transaction and billed monthly.

 

4. Representations, Warranties and Expectations

 

4.1 Customer represents and warrants to the Company that:

 

a) When executed and delivered by Customer, this Platform Agreement will constitute the legal, valid, and binding obligation of Customer, enforceable in accordance with its terms;

 

b) Your use of the Services complies with all applicable laws, rules and regulations (provided that Customer does not represent or warrant that the Services complies with all applicable laws, rules and regulations).

 

c) Your use of the Services and, to the best of your knowledge, User Activity, do not include: (i) operating or engaging in any business regulated by FinCEN, including the money service business, e-money business, and payday lending, sales of money orders or traveler’s checks, escrow services and virtual / crypto- currency marketplaces and exchanges; (ii) being in association with or payment of illegal or fraudulent goods or services, including, but not limited to, illegal substances, counterfeit goods, stolen goods, illegal or controlled substances, and substances that pose a risk to consumer safety (including synthetics, “potpourri not for human consumption”, and other similar items), illegal online gambling / wagering, escort services, white label ATM services, pyramid schemes, counterfeit goods, unlicensed sale of firearms and certain weapons or any type of money laundering; (iii) providing false or inaccurate information to the Company, including attempt to falsify your identity, such as by providing false account information or false documents; (iv) defrauding the Company, Bank or other Users in any way; (v) engaging in transactions involving debt collection services; (vi) attempting to receive or actually receiving duplicate compensation for a disputed payment from the recipient (such as a seller), the Company and/or your bank or other financial institution; or (vii) violating any agreement or obligation between Customer and any third party.

 

 

 

 

d) You must not take any action to sell, distribute or lend information or data provided by Users via the API (“User Data”) to third party advertisers or advertising networks of any kind utilizing contact information not independently developed by you or exposed in the APIs or otherwise. This obligation will no longer apply to any User that invests in your company after such investment

 

e) You shall comply with all privacy and comparable laws of any jurisdiction with respect to all User Data (including without limitation copies of such information) in your possession and control. This obligation will no longer apply to any User that invests in your company after such investment

 

 

f) You will not give your API’s key or API code to any third party for any reason and you shall use commercially reasonable measures consistent with industry standards to prohibit unauthorized access to the API keys and Customer Platform.

 

g) The Customer Platform must publish a privacy policy that includes an accurate disclosure regarding the Company’s collection, use and sharing of data in accordance with the Company’s privacy policy available at (https://www.NAME TO BE DECIDED/terms-of-use). [to be completed with the eventual investment site]

 

h) You must not publish any fraudulent or misleading information.

 

i) Company or its affiliates will provide customer support to all Users to resolve any questions or disputes relating to a User Account and User Activity. Your contact page and terms of service will include a publicly available email address and phone number to contact the Company during normal business hours. The Company agrees to respond to all User questions and attempt to resolve such issues within a commercially reasonable amount of time. In the event a dispute arises between a User and your Platform relating to User Activity or a User wishes to make a complaint against the Company or Bank for the banking Services provided, then you will immediately direct such instances to support@capital2market.com to be resolved in accordance with Section 8(b) and applicable law. Company also agrees to communicate any such instances to the Customer within 2 business days. Customer agrees to pay for customer support for at least 3 months while offering is live “Launch Date”, based on pricing in Appendix A. Fixed rate service option will be offered after 3 months of Launch Date as per Appendix A.

 

4.2 Company represents, warrants and covenants to Customer:

 

(1) When executed and delivered by Company, this Platform Agreement will constitute the legal, valid, and binding obligation of Company, enforceable in accordance with its terms;

 

(2) Company has all necessary licenses, rights and consents (including all relevant regulatory approvals) and has provided all notices required to provide and perform the Services;

 

(3) The Services do not violate any applicable laws, rules, regulations or ordinances, and Customer’s use of such Services in conformance with the terms herein, will not violate such laws, rules, regulations or ordinances; The Services do not infringe, violate or otherwise misappropriate any intellectual property rights of any third parties;

 

(4) Company has implemented, and will maintain industry standard administrative, physical and technical security measures designed to protect User Data against unauthorized access, disclosure and use. Furthermore, Company represents, warrants and covenants that it will promptly notify Customer upon becoming aware of any known or attempted unauthorized access, disclosure and/or use of User Data, and will (i) reasonably cooperate with Customer in any investigation of such incident, including, without limitation, providing Customer with reasonable information related to the Users affected, types of User Data accessed, and method of access; and (ii) take all commercially reasonable steps to prevent any further unauthorized access, disclosure and use of User Data.

 

(5) Company’s collection, use, storage, processing and disclosure of User Data and User Activity data does not violate any applicable laws, rules, regulations or ordinances;

 

 

 

 

(6) Company will continuously back-up the User Data and User Activity data throughout the term of this Platform Agreement. Customer may access, download and export User Data and User Activity data from the Service at any time during the term of this Platform Agreement and the Disengagement Period (as defined below); and

 

(7) Company has implemented and will maintain throughout the term of this Platform Agreement, a business continuity and disaster recovery plan designed to minimize the risks associated with a disaster affecting Company’s ability to provide the Services, and shall provide a copy of such plan to Customer upon request. Company further represents, warrants and covenants that it (i) will test its disaster recovery plan at least annually, and will share such disaster recovery plan results with Customer upon request, and (ii) implement such disaster recovery plan upon the occurrence of a disaster.

 

(8) Prior to the Launch Date, Company undertakes to review the Customer Platform, in all of its aspects (including, without limitation, compliance with (i) all applicable laws and regulations as specified in this Platform Agreement, and (ii) all other requirements specified under this Platform Agreement, specifically with respect to the privacy policy of the Customer Platform), and confirm that the Customer Platform is ready to launch. Company shall provide Customer with its written confirmation of the Customer Platform prior to the Launch Date (“Confirmation”), and in the event of any deficiencies, Company shall notify Customer immediately in writing and shall cooperate with Customer and provide any necessary assistance to rectify such deficiencies until the Customer receives the Confirmation. For avoidance of doubt, confirmation of the above may be made via electronic mail.

 

5. Account Creation

 

You may not create User Accounts on behalf of your customers.

 

6. Underwriting and Verified Information

 

a) The Company may require that you establish certain criteria for accepting User Accounts consistent with the Company’s programs for underwriting User Accounts (“Underwriting Policies”). The Company has the ultimate discretion regarding underwriting and risk decisions including, without limitation, any decision of whether or not to provide Services and the API to any User Account including your Customer Platform’s User Account. Company reserves the right to (i) change the identification required for sender or receivers at any time; and (ii) to suspend or terminate provision of API to any User Account at any time if (a) the Company determines, in its sole discretion, that the User Account’s activities violate the Company’s underwriting policies, this Platform Agreement, the - User agreement, or applicable law; or (b) a User Account is engaged in activities listed on the prohibited activities list in Section 5.1(c) of this Agreement.

 

b) Company will take steps to reasonably verify the legal name and identity of any sender or receiver. Company may use the KYC Platform to help verify User information.

 

c) To the extent that you become aware of a User Account being engaged in any suspicious, illegal, deceptive or fraudulent activity, you agree to promptly notify the Company. Likewise, the Company will use commercially reasonable efforts to promptly terminate or suspend any such User Accounts once notified by you.

 

d) CUSTOMER UNDERSTANDS AND AGREES THAT CUSTOMER OR USERS MAY NOT BE ABLE TO TRANSFER FUNDS IF CUSTOMER’S USER ACCOUNT OR A USER ACCOUNT IS CLOSED, SUSPENDED, HAS A HOLD PLACED ON IT, OR IS OTHERWISE LIMITED, AS DETAILED IN THIS SECTION.

 

e) You understand and agree that Company is not responsible for any losses or liability resulting from actions taken by Customer against a User Account, as permitted under this Platform Agreement, or as a result of any User’s disclosure of their access credentials.

 

 

 

 

f) You understand and agree that the decision by the Company to take certain actions, including placing holds on or limiting access to a User Account as detailed below, may be based on confidential criteria that are essential to risk management or security concerns. You understand and agree that Company is not under any obligation to disclose the details of our risk management or security procedures to Customer or a User; provided that, Company will not take any arbitrary action or other action in accordance with this subpart (f) that is not reasonably designed to protect the safety and/or security of the Company, Users, the Bank and any personal or sensitive data related thereto.

 

g) You understand and agree that the Company is authorized to take the following actions due to Customer’s or a User’s misconduct, security concerns or otherwise breach of this Platform Agreement:

 

i) Place a hold on access to funds in a User Account for up to 90 days;

 

ii) Temporarily or permanently suspend or otherwise limit access to a User Account;

 

iii) Contact Users who have purchased goods or services through Platform Services, contact the User’s bank, and/or warn other Users, law enforcement, or impacted third parties of a User’s actions;

 

iv) Take action against use as detailed in the Agreement to recover funds for fees owed or other amounts due to the Company or its Users;

 

v) Close a User Account;

 

vi) Refuse or deny your ability for current or future direct or indirect use (via a Third Party Platform) of the Services, API or Capital2Market System; or

 

vii) Take legal action against Customer or User.

 

7. Returns, Reversals, Disputes and Reserves

 

a) Returns and Reversals

 

User transactions debited from bank accounts via ACH (including White Label Accounts) are subject to returns (e.g., non-sufficient funds) and reversals from chargebacks (e.g., unauthorized activity) per the Electronic Fund Transfer Act (15 U.S.C. 1693 et seq. as may be amended), Regulation E, and NACHA guidelines (See achrulesonline.org for more information) (collectively, such returns and reversals are “Reversals”). The Company will work to protect Customer and the receiving Users from unwarranted Reversals; however, Customer acknowledges and agrees that:

 

i) Customer is liable for all Reversals associated with User Activity, and, as between Company and Customer, Customer is liable for all User Activity;

 

ii) If Bank receives a Reversal, the Company may in its sole discretion charge Customer the full amount of the Reversal (“Reversed Payment”) plus an additional $15 reversal fee (“Reversal Fee” and collectively the “Reversal Liability”); ]

 

iii) The Company has sole discretion to determine who is at fault and liable for the Reversed Payment and Reversal Fee;

 

iv) The Reversal Liability in some cases, may be debited from your White Label Account or if insufficient balance is in such account, will be billed and paid immediately to cover the shortfall in the Customers account;

 

 

 

 

v) If Customer does not have a balance in such accounts, the Company shall notify Customer, and Customer will pay all undisputed amounts. Alternatively, Customer may authorize the Company to take any of the following actions (in any particular order): (i) collect the unpaid portion of the Reversal Liability from funds sent to your third party escrow account; (ii) suspend your User Account and Customer’s use of the Services and require you to take immediate actions to repay the unpaid portion of the Reversal Liability; (iii) engage in collection efforts to recover the unpaid portion of the Reversal Liability and/or (iv) take legal action or any other action under this Platform Agreement.

 

vi) If Customer accepts payments via ACH, Ten Percent (10%), of ACH transaction value will be held for 60 days after transaction date subject to Electronic Transfer Act.

 

b) Disputes and Refunds

 

Company and Customer shall negotiate in good faith and make all reasonable efforts in order to resolve and settle amicably any disputes regarding the Customer Platform. The Company or its affiliates will be responsible for resolving any disputes you or your Users may have with the Customer Platform. You may file a claim with the Company by contacting the Company at support@capital2market.com. The Company will have the final decision-making authority with respect to claims, including without limitation claims for refunds for purchased items or services that are filed with the Company by you or the Customer’s Users.

 

8. Liability and Indemnification

 

Without limiting the liability detailed in Section 7 (Returns and Reversals), you agree to defend, indemnify and hold harmless the Company and its respective members, owners, officers, directors and employees (collectively “Company Indemnified Parties”) from and against any liabilities, damages, settlements, penalties, losses, fines, costs or expenses (including reasonable attorneys' fees and other litigation expenses) (collectively, “Losses”) actually incurred by a Company Indemnified Party as a result of any third party claim, suit, demand, action, proceeding or suits (collectively, “Claims”) arising out of or relating to your violation of any applicable laws and regulations including, but not limited to those relating to (A) money transmission, storage or currency exchange and FinCen or state money transmission regulators and (B) marketing, selling or exchanging securities or commodities and the Securities and Exchange Commission, Commodity Future Trading Commission, state regulators or (C) any of international regulators.

 

Company will indemnify, defend and hold harmless Customer, its affiliates, and their respective members, owners, officers, directors and employees (collectively, the “Customer Indemnified Parties”) from and against any Losses actually incurred a Customer Indemnified Party as a result of any Claims arising out of or relating to: (i) any claim that the Services infringe upon, or misappropriate any third party’s intellectual property rights; (ii) any claim that the Services violate any applicable laws, rules, regulations or ordinances; or (iii) Company’s violation or breach of Section 4.2.

 

You are responsible and liable for selecting and implementing security controls that are appropriate for your business in relation to this offering

 

EXCEPT FOR EITHER PARTY’S GROSS NEGLIGENCE, WILLFUL MISCONDUCT, INDEMNIFICATION OBLIGATIONS AND BREACHES OF CONFIDENTIALITY, INCLUDING CLAIMS OF DATA LOSS AND/OR DATA BREACH, NEITHER PARTY NOR ITS SUPPLIERS (INCLUDING BUT NOT LIMITED TO ALL EQUIPMENT AND TECHNOLOGY SUPPLIERS), OFFICERS, AFFILIATES, REPRESENTATIVES, CONTRACTORS AND EMPLOYEES OF SUCH PARTIES SHALL BE RESPONSIBLE OR LIABLE WITH RESPECT TO ANY SUBJECT MATTER OF THIS PLATFORM AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT LIABILITY OR OTHER THEORY FOR: (A) LOSS OR INACCURACY OR CORRUPTION OF DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS, SERVICES OR TECHNOLOGY OR LOSS OF BUSINESS; (B) FOR ANY INDIRECT, EXEMPLARY, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES; (C) FOR ANY MATTER BEYOND SUCH PARTY’S REASONABLE CONTROL;

 

 

 

 

9. API Use

 

a) The Company grants Customer a limited, non-exclusive, revocable, non-transferable license without the right to sublicense, to electronically access and use the Company's publicly documented APIs and other Services to initiate User Activity in a manner consistent with this Platform Agreement and documentation provided to you. The Services includes the Company’s APIs and any software, programs, documentation, tools, Internet-based services, components, images and any updates (including software maintenance, service information, help content, bug fixes or maintenance releases) thereto provided to you by the Company. You will be entitled to updates to the API, subject to any additional terms made known to you at that time, when the Company makes these updates available.

 

b) The license granted by this Agreement is solely for your website or website you choose to offer securities. Customer Platform, and/or application and you may not use it for any personal, family, household purposes. Such license is limited to be used solely for your website, Customer Platform or application and not repackaged or resold by Customer as Customer’s own white label API or software. Customer is not granted a license or right to use, reproduce, translate, rearrange, modify, enhance, display, resell, lease, sublicense or otherwise distribute, transfer of dispose of the API or Services, in whole or in part, to be separately provided by Customer on a white label basis to Customer’s Users. Further, the Services are licensed and not sold and the Company reserves all rights not expressly granted to Customer in this Platform Agreement. Copyright, trade secret and other intellectual property laws protect the APIs. Company owns all right, interest, title and other worldwide intellectual property and proprietary rights in and to the APIs and the Services. Customer owns all right, title and interest in and to the branding and content of the Customer Platform, other than the APIs and Services.

 

c) You will not, and you will not permit your Users to directly or indirectly: reverse engineer, decompile, disassemble or otherwise attempt to discover the source code, object code or underlying structure, ideas, know-how or algorithms relevant to the APIs or Services or any software, documentation or data related to the Services or API; modify, translate, or create derivative works based on the Services or the API (except to the extent expressly permitted by the Company); use the Services or API for timesharing or service bureau purposes or otherwise for the benefit of a third; or, except as otherwise approved in writing by the Company, remove any proprietary notices or labels.

 

d) Further, you may not remove or export from the United States or allow the export or re-export of the Services, APIs or anything related thereto, or any direct product thereof in violation of any restrictions, laws or regulations of the United States Department of Commerce, the United States Department of Treasury Office of Foreign Assets Control, or any other United States or foreign agency or authority. As defined in FAR section 2.101, the API and documentation are “commercial items” and according to DFAR section 252.2277014(a)(1) and (5) are deemed to be “commercial computer software” and “commercial computer software documentation.” Consistent with DFAR section 227.7202 and FAR section 12.212, any use modification, reproduction, release, performance, display, or disclosure of such commercial software or commercial software documentation by the U.S. Government will be governed solely by the terms of this Platform Agreement and will be prohibited except to the extent expressly permitted by the terms of this Platform Agreement.

 

e) As the Company and Customer Platform innovates, occasional changes to our APIs and Customer Platform, including backwards-incompatible changes will be required. In addition, Company may make some changes to the Platform necessary for updates, improvements and security measures. The Company will use commercially reasonable efforts to give advanced notice of these changes, and will not materially degrade the performance, features or functions of the APIs.

 

f) The Company may, from time to time, perform maintenance on the API and/or update the API and other Services. Such maintenance and updates may result in temporary unavailability of the Services or API. The Company will use its best efforts to conduct such updates during planned system outages between the hours of 1am – 4am EST, and will provide Customer with prior written notice.

 

 

 

 

g) In the event Company will integrate and/or configure the API/Services on the Customer Platform, such integration and/or configuration services will be subject to Customer’s testing and acceptance in accordance with the terms herein. Upon completion of any integration or configuration services, Customer will have a ten business days (the “Testing Period”) period to test and inspect such services to validate whether such services conform in all material respects with the written specifications and acceptance conditions mutually agreed upon by the parties (the “Specifications”). At the end of the Testing Period, Customer shall notify Company whether it has accepted such services (“Accept”), or whether it has identified discrepancies with the Specifications (“Reject”). If Customer Rejects a service, it will provide Company with a written list of items that must be corrected. On receipt of Customer’s notice, Company will, at no additional charge to Customer, promptly commence all commercially reasonable efforts to complete, as quickly as possible, such necessary corrections, repairs and modifications of the APIs and services, as will permit them to be ready for retesting. The testing and inspection process shall resume as set forth above with Customer have an additional Testing Period. If Customer determines that the services, as revised, still do not comply with all material respects with the Specifications, then Customer may either (1) afford Company the opportunity to repeat the correction and modification process as set forth above at no additional cost to Customer, or (2) terminate the relevant Platform Agreement, in which case, Customer will return the API(s) to Company and Company will refund to Customer, within ten business days, all amounts prepaid by Customer with respect to such APIs and/or Services that are the subject of the Rejection. Such process will be repeated until Customer either Accepts the services or terminates the relevant SaaS Order Form.

 

10. Powered by Capital2Market

 

Upon request, Customer shall insert “Powered by Capital2Market”, the Company’s logo, mark and/or similar verbiage as provided by the Company into its payment flow for Users in a manner and in locations as reasonably agreed between the parties. The Company will provide Customer with usage guidelines on the Company’s Marks from time to time.

 

11. Taxes and Reporting

 

As between you and the Company, unless the Company otherwise agree with you in writing or are otherwise required to do so by law, you are solely responsible for the filing of any tax disclosure forms associated with your payment of funds to the receiver (e.g., 1099 forms).

 

12. Term and Survival

 

a) Subject to earlier termination as provided below, this Platform Agreement is for the Initial Service Term as specified in the Order Form, and shall be automatically renewed for additional periods of 1 month each (collectively, the “Term”), unless Customer requests termination at least thirty (30) days prior to the end of the then-current term.

 

b) Additionally, either party may terminate this Platform Agreement in the event:

 

i) The other party’s material breach that remains not cured and continues for a period of (A) in the case of a failure involving the payment of any undisputed amount due hereunder, fifteen (15) days and (B) in the case of any other failure, thirty (30) days after the nonperforming party receives notice from the terminating party specifying such failure;

 

ii) Any statement, representation or warranty of the other party is untrue or misleading in any material respect or omits material information;

 

iii) The other party (A) voluntarily or involuntarily is subject to bankruptcy proceedings, (B) applies for or consents to appointment of a receiver, trustee, custodian, sequestrator, or similar official, (C)makes a general assignment to creditors, (D) commences winding down or liquidation of its business affairs or (E) otherwise takes corporate action for the purpose of effecting any of the foregoing;

 

iv) If any change to, enactment of, or change in interpretation or enforcement of any law occurs that would have a material adverse effect upon a party’s ability to perform its obligations under this Platform Agreement or a party’s costs/revenues with respect to the services under this Platform Agreement;

 

v) Upon direction to a party from any regulatory authority or National Automated Clearing House Association to cease or materially limit the exercise or performance of such party’s rights or obligations under this Platform Agreement;

 

 

 

 

vi) If there shall have occurred a material adverse change in the financial condition of the other party; or

 

vii) Upon a force majeure event that materially prevents or impedes a party from performing its obligations hereunder for a period of more than ten (10) business days. Notwithstanding this Section (b), in the event the Bank terminates the TOS (“Terms of Service”), this Platform Agreement will terminate immediately subject to the notice provisions found in the TOS.

 

c) Customer may terminate this Platform Agreement upon thirty (30) days’ notice to Company in the event the TOS or Privacy Policy to which you or your end Users are a party (the “Company Agreements”) are modified, if such modifications have a material adverse effect on Customer’s Services, Customer or Customer’s end users. Upon such termination, no termination fee, early termination fee or similar charge shall be imposed, and you shall be released from any recurring Monthly Fees due for services on or after the earliest effective date of the Modifications, other than transition or other services requested by you and actually provided by us. You will pay in full for the Services up to and including the last day on which the Services are provided prior to termination of this Platform Agreement.

 

d) In addition to the termination provisions found in this Platform Agreement and TOS, Company may terminate this Agreement at any time upon providing notice to Customer in the event Customer or its Users are in violation of the TOS or Company believes in its sole discretion Customer or its Users are a threat to the Services.

 

e) Subject to the restrictions and other provisions of Section 6 (Platform Expectations), upon any termination, Company will make all User Data available to Customer for electronic retrieval for a period of ninety (90) days, but thereafter Company may, but is not obligated to, delete or provide Customer access to stored User Data.

 

f) In addition to any provision that is reasonably necessary to accomplish or enforce the purpose of this Platform Agreement, those terms surviving in the TOS and those terms relating to fees and liability, the following sections shall survive the termination of this Platform Agreement: Section 7 (Returns, Reversals, Disputes), Section 9 (Liability and Indemnification), Section 13 (Term and Survival), Section 14 (NO WARRANTY, NO ENDORSEMENT AND NO GUARANTEE), and Section 15 (General) shall survive the termination of this Platform Agreement and TOS.

 

14. NO WARRANTY, NO ENDORSEMENT AND NO GUARANTEE

 

EXCEPT AS OTHERWISE SET FORTH HEREIN, SERVICES ARE PROVIDED "AS IS" AND “AS AVAILABLE”, WITHOUT ANY REPRESENTATION OF WARRANTY, WHETHER EXPRESS, IMPLIED OR STATUTORY. USE OF COMPANY SERVICES IS AT CUSTOMER’S OWN RISK. EXCEPT AS OTHERWISE SET FORTH HEREIN, COMPANY, AND THEIR RESPECTIVE OFFICERS, DIRECTORS, AGENTS, EMPLOYEES AND SUPPLIERS, SPECIFICALLY DISCLAIM ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. EXCEPT AS OTHERWISE SET FORTH HEREIN, NEITHER COMPANY NOR THE BANK HAS CONTROL OF, OR LIABILITY FOR, ANY PRODUCTS OR SERVICES THAT ARE PAID FOR USING THE COMPANY SERVICES AND CANNOT ENSURE THAT ANY THIRD PARTY YOU TRANSACT WITH WILL COMPLETE THE TRANSACTION. EXCEPT AS OTHERWISE SET FORTH HEREIN, NEITHER COMPANY NOR THE BANK REPRESENTS OR WARRANTS THAT THE COMPANY SERVICES WILL MEET YOUR REQUIREMENTS, BE CONTINUOUS, UNINTERRUPTED, SECURE, TIMELY, OR ERROR FREE, OR THAT DEFECTS WILL BE CORRECTED. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY PLATFORM FROM COMPANY OR THROUGH THE COMPANY SERVICES WILL CREATE ANY WARRANTY NOT EXPRESSLY STATED HEREIN. EXCEPT AS OTHERWISE SET FORTH HEREIN, NEITHER COMPANY NOR THE BANK SHALL BE RESPONSIBLE FOR ANY SERVICE INTERRUPTIONS OR SERVICE FAILURES THAT MAY AFFECT THE PROCESSING, COMPLETION OR SETTLEMENT OF COMPANY SERVICES TRANSACTIONS. THIS DISCLAIMER OF WARRANTY SECTION SHALL APPLY TO THE FULLEST EXTENT PERMITTED BY LAW IN THE APPLICABLE JURISDICTION. FUNDS ASSOCIATED WITH CUSTOMER'S USER ACCOUNTS OR CUSTOMER USER’S USER ACCOUNT ARE HELD IN A POOLED ACCOUNT MAINTAINED BY OUR BANK. FUNDS HELD IN USER ACCOUNTS ON THE API MAY BE ELIGIBLE INSURANCE BY THE FEDERAL DEPOSIT INSURANCE CORPORATION (FDIC) SUBJECT TO THE RULES AND LIMITATIONS SET FORTH BY THE FDIC. FOR PURPOSES OF APPLICABLE FDIC DEPOSIT INSURANCE LIMITATIONS, DEPOSITS IN ACCOUNTS AT THE BANK OPENED THROUGH THE BANK WITH COMPANY MAY NOT BE SEPARATELY INSURED FROM ANY OTHER ACCOUNTS YOU MAY HAVE OPENED WITH THE BANK, DEPENDING ON THE NAMED ACCOUNT OWNERS. NO OTHER WARRANTIES ARE EXPRESS OR IMPLIED. CUSTOMER UNDERSTANDS AND AGREES THAT COMPANY IS A SOFTWARE PLATFORM THAT MANAGES INFORMATION ASSOCIATED WITH USERS AND USER ACCOUNTS. EXCEPT AS OTHERWISE SET FORTH HEREIN, KYC PLATFORM SERVICES ARE PROVIDED “AS IS” AND ARE NOT GUARANTEED AGAINST FRAUD. TRANSACTIONS ARE NOT GUARANTEED AGAINST RETURNS OR REVERSALS. CUSTOMER IS SUBJECT TO REVERSALS AND REVERSAL LIABILITY AS FURTHER DETAILED HEREIN.

 

 

 

 

d) Subject to the restrictions and other provisions of this Platform Agreement, upon any termination, the Company will make all User Data available to Customer for electronic retrieval for a period of ninety (90) days (the “Disengagement Period”), but thereafter the Company may, but is not obligated to, delete or provide Customer access to stored User Data. Prior to disengagement, Company will notify Customer with notice of expiration.

 

f) Neither party shall be deemed in breach of this Platform Agreement to the extent that performance of its obligations or attempts to cure any breach are delayed, restricted or prevented by reason of any act of God, fire, natural disaster, act of government, strikes or labor disputes, any act of terrorism, inability to obtain power or supplies, failure of Internet or telecommunications providers or carriers, or any other act or condition beyond the reasonable control of the Party seeking to be relieved of its obligations (“Force Majeure Event”).

 

15. General

 

If any provision of this Platform Agreement is found to be unenforceable or invalid, that provision will be limited or eliminated to the minimum extent necessary so that this Platform Agreement will otherwise remain in full force and effect and enforceable. Neither party may transfer or assign any of its rights or obligations hereunder without the prior written of the other party, such consent not to be unreasonably withheld, conditioned or delayed; provided, however, either party may assign or transfer its rights in whole to an acquirer in connection with a merger, consolidation or sale of all of substantially all of the assigning party’s business or assets. No agency, partnership, joint venture, or employment is created as a result of this Platform Agreement and Customer does not have any authority of any kind to bind the Company in any respect whatsoever. Customer acknowledged and consents to receiving electronic notices under this Platform Agreement including termination notices via email listed in the Platform Agreement or the emails associated with Customer’s User Account. Additionally, notices of updates the Services and API may be provided via email or on the Company’s website and API documentation page. All notices to the Company shall be emailed to info@capital2market.com unless notified otherwise by the Company. This Agreement shall be governed by the laws of the State of New York without reference to its choice of law rules. The parties hereby expressly consent to the nonexclusive personal jurisdiction and venue of the state and federal courts located in the U.S. District Court for the state of New York for any lawsuit filed there by either party arising from or relating to this Platform Agreement. The payment terms and fees of the Platform Agreement shall be confidential information of the Company which Customer shall not disclose or reveal to employees, agents or other third parties unless reasonably necessary to perform Customer’s obligations under this Platform Agreement. Due to the unique nature of the confidential information, monetary damages may be inadequate to compensate either party for the other party’s violations and any such violations or threatened violations may cause irreparable injury to such party and, in addition to any other remedies that may be available, in law, in equity or otherwise, either party shall be entitled to seek injunctive relief against the threatened breach of confidentiality or the continuation of any such breach by the other party. This Platform Agreement is the complete and exclusive statement of the mutual understanding of the parties and supersedes and cancels all previous written and oral agreements, communications and other understandings relating to the subject matter of this Platform Agreement, and that all waivers and modifications must be in a writing signed by both parties, except as otherwise provided herein. Customer shall receive written approval from the Company prior to making any public announcement or marketing Customer’s use of the API with the Company’s name, logo or other marks

 

 

 

 

Schedule A:

 

Transactional Technology Licensing Fee $10,000 per offering
   

Escrow Setup

Requires 10% of ACH transactions to be held 60 days, post- closing

$500 per account
   

Funds Processing

-          ACH

-          Wire

-          Check

per investor transaction

$1

$15 domestic | $50 international

$20 domestic | $50 international

   
Cap Table Mgt Fee $1500 per tranche
   

OBO (On Behalf Of) Processing

Outside of standard processing

$10 per investor
   

AML/OFAC/FinCen Compliance

-          Individual Suitability Reports

-          Entity Suitability Reports

-          Resolution/Decline

per investor transaction

$2 domestic | $50 international

$35 domestic | $65 international

$10 per documentation

   

Hosting Fee

 

$1,000 per month after 3 months or $10,000 per year one time fee

Customer Support

While offering is live

$2,500 per month for first 3 months then either $250 per hour or $1,000 per month

 

Broker of Record Services (optional)

Diligence Fee -Securities offered through Strategic Capital -

Member FINRA/SIPC

Diligence Fee

 

$20,000 per company

$30,000 per fund

In addition: 1% of capital placed

$10,000

Rule 5110

(Reg A+ requirement)

$15,000

 

 

 

 

EX1A-6 MAT CTRCT 7 tm1927293d1_ex6-2.htm EXHIBIT 6.2

 

Exhibit 6.2

 

NON-EXCLUSIVE LICENSE AGREEMENT

 

BETWEEN

 

THE JOHNS HOPKINS UNIVERSITY

 

&

 

VIRTUOSO SURGICAL, INC.

 

 

 

JHU Agreement: A29889

 

 

1

 

May 3, 2016

 

NON-EXCLUSIVE LICENSE AGREEMENT- FOR SALES

 

This Non-Exclusive License Agreement (hereinafter “Agreement”) is entered into by and between The Johns Hopkins University (hereinafter “JHU”), a corporation of the State of Maryland, having a principal place of business 3400 N. Charles Street, Baltimore, Maryland 21218-2695 and, Virtuoso Surgical, Inc. (hereinafter “Company”), a Tennessee corporation having an address at 5701 Old Harding Pike; Suite 200; Nashville, TN 37205. The parties hereto agree as follows:

 

1.                  BACKGROUND

 

1.1In the course of a fundamental research program at JHU, a valuable invention entitled Active Cannulas for Bio-Sensing and Surgical Intervention (JHU Ref. C04873) was developed by Drs. Robert Webster, III, Noah Cowan, Allison Okamura, and Russell Taylor (hereinafter “Inventors”).

 

1.2JHU has acquired all right, title and interest, with the exception of certain retained rights by the United States government, in said invention but is without the capacity to commercially develop, manufacture and distribute products and methods which embody the invention.

 

1.3Company is interested in providing such commercial products and methods to third parties on a non-exclusive basis and agrees to comply with the terms and conditions in this Agreement.

 

1.4All references to particular Exhibits or Paragraphs shall mean the Exhibits to, and Paragraphs of, this Agreement, unless otherwise specified.

 

2.                  DEFINITIONS

 

2.1“EFFECTIVE DATE” of this Agreement shall mean the date the last party hereto has executed this Agreement.

 

2.2“LICENSED FIELD” shall mean Cannulated Surgical Intervention.

 

2.3“LICENSED PRODUCT(S)” as used herein in either singular or plural shall mean any material, compositions, or other product, the manufacture, use or sale of which would constitute, but for the license granted to Company pursuant to this Agreement, an infringement of a claim of PATENT RIGHT(S) (infringement shall include, but is not limited to, direct, contributory, or inducement to infringe).

 

2.4“LICENSED SERVICE(S)” as used herein in either singular or plural shall mean the performance on behalf of a third party of any method including cannulated surgical intervention or the manufacture of any product or the use of any product which would constitute, but for the license granted to Company pursuant to this Agreement, an infringement of a claim of the PATENT RIGHT(S), (infringement shall include, but not be limited to, direct, contributory or inducement to infringe).

 

 

2

 

May 3, 2016

 

2.5“NET SALES” shall mean gross sales revenues and fees billed by Company from the sale of LICENSED PRODUCT(S) less trade discounts allowed, refunds, returns and recalls, and sales taxes. In the event that Company sells a LICENSED PRODUCT(S) in combination with other ingredients or substances or as part of a kit, the NET SALES for purposes of royalty payments shall be based on the sales revenues and fees received from the entire combination or kit.

 

2.6“NET SERVICE REVENUES” shall mean gross service revenues and fees billed by Company for the performance of LICENSED SERVICE(S) less sales and/or use taxes imposed upon and with specific reference to the LICENSED SERVICE(S). In the event that Company sells a LICENSED SERVICE(S) in combination with other services or substances or as part of a kit, the NET SERVICE REVENUES for purposes of royalty payments shall be based on the sales revenues and fees received from the entire combination.

 

2.7“PATENT RIGHT(S)” shall mean, collectively, JHU’s interest in those set forth in EXHIBIT C of this Agreement and the inventions disclosed and claimed therein, and all continuations, divisions, and reissues based thereof, and any corresponding foreign patent applications, and any patents, or other equivalent foreign PATENT RIGHT(S) issuing, granted or registered thereon.

 

3.                  GRANT

 

3.1License Granted: Subject to the terms and conditions of this Agreement and to non-exclusive license agreements executed prior to the EFFECTIVE DATE, JHU hereby grants to the Company a non-exclusive, non-transferable license to make, have made, import, offer for sale and sell the LICENSED PRODUCT(S) and the LICENSED SERVICE(S) in the United States and worldwide under the PATENT RIGHT(S) in the LICENSED FIELD.

 

3.2No Sublicensing: Company shall not sublicense to others under this Agreement, nor extend the rights granted hereunder to any affiliated company.

 

4.                  PAYMENTS, ROYALTY AND REPORTING

 

4.1License Fee: As consideration for JHU’s grant of a License to Company under this Agreement, Company shall pay to JHU a license fee, cash and equity, as set forth in Exhibit A within thirty (30) days of the EFFECTIVE DATE. The license fee is nonrefundable and shall not be credited against royalties or other fees.

 

4.2Minimum Annual Royalties: Company shall pay to JHU minimum annual royalties as set forth in Exhibit A. These minimum annual royalties shall be due within thirty (30) days of each anniversary of the EFFECTIVE DATE beginning with the first anniversary. Running royalties accrued under Paragraph 4.3 and paid to JHU during the one year period preceding an anniversary of the EFFECTIVE DATE shall be credited against the minimum annual royalties due on that anniversary date.

 

 

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May 3, 2016

 

4.3Running Royalties: Company shall pay to JHU, a running royalty as set forth in Exhibit A, for each LICENSED PRODUCT(S) sold and each LICENSED SERVICE(S) provided, based upon NET SALES and NET SERVICE REVENUES respectively, for the term of this Agreement. Such payments shall be made within thirty (30) days of the end of each calendar quarter following first commercial sale of LICENSED PRODUCT or providing LICENSED SERVICES. All non-US taxes related to LICENSED PRODUCT(S) and LICENSED SERVICE(S) sold under this Agreement shall be paid by Company and shall not be deducted from royalty or other payments due to JHU.

 

4.4Reporting and Payments: Upon achieving first commercial sale of LICENSED PRODUCTS and LICENSED SERVICES, Company shall provide a quarterly royalty report, substantially in the format of Exhibit B, accompanying each royalty payment as required in Paragraph 4.3. Royalty reports shall disclose the amount of LICENSED PRODUCT(S) and LICENSED SERVICE(S) sold, the total NET SALES and NET SERVICE REVENUES of such LICENSED PRODUCT(S) and LICENSED SERVICE(S), and the running royalties due to JHU as a result of NET SALES and NET SERVICE REVENUES by Company. In lieu of sending quarterly royalty reports to JHU via mail or courier, Company may provide all required reports in electronic format to the email address specified by JHU.

 

4.5Late Payments: In the event that any payment due hereunder is not made when due, the payment shall accrue interest beginning on the tenth day following the due date thereof, calculated at the annual rate of six percent (6%), the interest being compounded on the last day of each calendar year. Each such royalty payment when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not negate or waive the right of JHU to seek any other remedy, legal or equitable, to which it may be entitled because of the delinquency of any payment.

 

4.6Records: The Company shall make and retain, for a period of three (3) years following the period of each report required by Paragraph 4.4, true and accurate records, files and books of account containing all the data reasonably required for the full computation and verification of sales and other information required in Paragraph 4.4. Such books and records shall be in accordance with generally accepted accounting principles consistently applied. The Company shall permit the inspection and copying of such records, files and books of account by JHU or its agents during regular business hours upon ten (10) business days’ written notice to the Company. Such inspection shall not be made more than once each calendar year. All costs of such inspection and copying shall be paid by JHU, provided that if any such inspection shall reveal that an error has been made in the amount equal to five percent (5%) or more of such payment, such costs shall be borne by the Company.

 

 

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4.7Non-Arms Length Transactions: In order to insure JHU the full royalty payments contemplated hereunder, the Company agrees that in the event any LICENSED PRODUCT(S) shall be sold to an affiliated company or to a corporation, firm or association with which Company shall have any agreement, understanding or arrangement with respect to consideration (such as, among other things, an option to purchase stock or actual stock ownership, or an arrangement involving division of profits or special rebates or allowances) the royalties to be paid hereunder for such LICENSED PRODUCT(S) shall be based upon the greater of: 1) the net selling price at which the purchaser of LICENSED PRODUCT(S) resells such product to the end user, 2) the NET SERVICE REVENUE received from using the LICENSED PRODUCT(S) in providing a service, 3) the fair market value of the LICENSED PRODUCT(S) or 4) the net selling price of LICENSED PRODUCT(S) paid by the purchaser.

 

4.8Method of Payment: All payments under this Agreement shall be made in U.S. Dollars by either check or wire transfer.

 

4.9Payment Information. All check payments from Company to JHU shall be sent to:

 

Director

Johns Hopkins Technology Ventures

The Johns Hopkins University

100 N. Charles Street, 5th Floor

Baltimore, MD 21201

 

Reference: JHU Agreement A29889

 

or such other addresses which JHU may designate in writing from time to time. Checks are to be made payable to “The Johns Hopkins University”.

 

Wire transfers may be made through:

 

ACH for U.S. Payments

Johns Hopkins University Central Lockbox

Bank of America

1400 Best Plaza Drive

Richmond, VA 23227

Transit/routing/ABA number: 052001633

Account number:

Type of account: depository

CTX format is preferred; CCD+ is also accepted

Reference: JHU Tech Transfer (JHU Agreement A29889)

 

FED WIRE for International Payments

Johns Hopkins University Central Lockbox

Bank of America

100 West 33rd Street New York, NY 10001

SWIFT code: BOFAUS3N

Account number:

Type of account: depository

 

 

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Reference: JHU Tech Transfer (JHU Agreement A29889)

 

Company shall be responsible for any and all costs associated with wire transfers. Company shall provide JHU with the date of wire transfer payment and ACH confirmation number upon completion of such payment.

 

4.10Invoices. Any invoice for payment sent by JHU to Company may be electronically provided by e-mail service. JHU will send invoices to an e-mail address provided by Company. Company will provide JHU with any updates to this e-mail address.

 

5.                  PATENT MATTERS

 

5.1Prosecution & Maintenance: JHU, at its sole option and discretion, shall file, prosecute and maintain all patents and patent applications specified under PATENT RIGHT(S). Title to all such patents and patent applications shall reside in JHU. JHU shall have full and complete control over all patent matters in connection therewith under the PATENT RIGHT(S).

 

5.2Right to Enforce: JHU shall have the first right to enforce the PATENT RIGHTS against any infringement or alleged infringement thereof in the LICENSED FIELD OF USE.

 

6.                  TERM AND TERMINATION

 

6.1Expiration: This term of this Agreement shall commence on the EFFECTIVE DATE and shall continue, in each country, until the date of expiration of the last to expire patent within PATENT RIGHT(S) in that country.

 

6.2Termination by Company: Company may terminate this Agreement and the license granted herein, for any reason, upon giving JHU sixty (60) days written notice under Paragraph 8.1.

 

6.3Termination by JHU: JHU, at its option, may terminate this Agreement and the license granted herein if Company has not made any sales of LICENSED PRODUCT(S) or LICENSED SERVICE(S) in any period of four consecutive quarters, after the initial commercial sale of the PRODUCT(S) or LICENSED SERVICE(S).

 

6.4Unpaid Royalty/Reversion of Rights: Termination or expiration of this Agreement shall not affect JHU’s right to recover unpaid royalties accrued prior to termination or expiration. Upon termination or expiration of this Agreement, all rights in and to the licensed technology shall revert to JHU at no cost to JHU.

 

6.5Survival: All applicable provisions, including but not limited to Paragraphs 4.1 (License Fee), 9.3 (Severability), 9.4 (Use of Name), 9.6 (Disclaimer of Warranties), 9.7 (Indemnification), 9.8 (Product Liability), 9.13 (Binding Effect) and 9.14 (Governing Law) shall survive termination or expiration of this Agreement.

 

 

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7.                  DEFAULT

 

7.1Default & Termination: Upon breach or default of any term or condition of this Agreement by either party, the defaulting party shall be given written notice of such default in writing by the party not in default. The defaulting party shall have a period of sixty (60) days after receipt of such notice to correct the default or breach. If the default or breach is not corrected within said sixty (60) day period, the party not in default shall have the right to terminate this Agreement.

 

8.                  NOTICES

 

8.1Notice Information: All notices and/or other communications pertaining to this Agreement shall be in writing and sent by registered mail or certified mail, return receipt requested, or sent by overnight courier, such as Federal Express, to the parties at the following addresses or such other address as such party shall have furnished in writing to the other party in accordance with this Paragraph 8.1:

 

FOR JHU:
Director
Johns Hopkins Technology Ventures
The Johns Hopkins University
100 N. Charles Street, 5th Floor
Baltimore, MD 21201

 

Reference: JHU Agreement A29889

 

FOR Company:
VIRTUOSO SURGICAL, INC.
5701 Old Harding Pike; Suite 200
Nashville, TN 37205

 

9.                  MISCELLANEOUS

 

9.1Audit: JHU shall have the right to audit any and all Company records related to this Agreement.

 

9.2Assignment: This Agreement is binding upon and shall inure to the benefit of JHU, its successors and assignees and shall not be assignable to another party, except that the Company shall have the right to assign this Agreement to another party in the case of the sale or transfer by the Company of all, or substantially all, of its assets relating to the LICENSED PRODUCT(S), LICENSED SERVICE(S) or PATENT RIGHT(S), to that party.

 

 

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9.3Severability: In the event that any one or more of the provisions of this Agreement should for any reason be held by any court or authority having jurisdiction over this Agreement, or over any of the parties hereto to be invalid, illegal or unenforceable, such provision or provisions shall be reformed to approximate as nearly as possible the intent of the parties, and if unreformable, shall be divisible and deleted in such jurisdictions; elsewhere, this Agreement shall not be affected.

 

9.4Use of Name: The Company shall not use the name of The Johns Hopkins University or The Johns Hopkins Health System or any of its constituent parts, such as the Johns Hopkins Hospital or any contraction thereof or the name of Inventors in any advertising, promotional, sales literature or fundraising documents without prior written consent from an authorized representative of JHU. Company shall allow at least seven (7) business days notice of any proposed public disclosure for JHU’s review and comment or to provide written consent.

 

9.5Duties of the Parties: JHU is not a commercial organization. It is an institute of research and education. Therefore, JHU has no ability to evaluate the commercial potential of any PATENT RIGHT(S), LICENSED PRODUCT(S), LICENSED SERVICE(S) or other license or rights granted in this Agreement. It is therefore incumbent upon Company to evaluate the rights and products in question, to examine the materials and information provided by JHU, and to determine for itself the validity of any PATENT RIGHT(S), its freedom to operate, and the value of any LICENSED PRODUCT(S) or LICENSED SERVICE(S) or other rights granted.

 

9.6Disclaimer of Warranties: JHU does not warrant the validity of any patents or that the practice under such patents, or the manufacture, use, sale or import of LICENSED PRODUCT(S) or LICENSED SERVICE(S), shall be free from patent infringement. EXCEPT AS EXPRESSLY SET FORTH IN THIS PARAGRAPH 9.6, COMPANY AGREES THAT THE PATENT RIGHT(S) ARE PROVIDED “AS IS”, AND THAT JHU MAKES NO REPRESENTATION OR WARRANTY WITH RESPECT TO THE PERFORMANCE OF LICENSED PRODUCTS OR LICENSED SERVICES INCLUDING THEIR SAFETY, EFFECTIVENESS, OR COMMERCIAL VIABILITY. JHU DISCLAIMS ALL WARRANTIES WITH REGARD TO LICENSED PRODUCTS AND LICENSED SERVICES UNDER THIS AGREEMENT, INCLUDING, BUT NOT LIMITED TO, ALL WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY AND FITNESS FOR ANY PARTICULAR PURPOSE. NOTWITHSTANDING ANY OTHER PROVISION OF THIS AGREEMENT, JHU ADDITIONALLY DISCLAIMS ALL OBLIGATIONS AND LIABILITIES ON THE PART OF JHU AND INVENTORS, FOR DAMAGES, INCLUDING, BUT NOT LIMITED TO, DIRECT, INDIRECT, SPECIAL, AND CONSEQUENTIAL DAMAGES, ATTORNEYS’ AND EXPERTS’ FEES, AND COURT COSTS (EVEN IF JHU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, FEES OR COSTS), ARISING OUT OF OR IN CONNECTION WITH THE MANUFACTURE, USE, OR SALE OF THE LICENSED PRODUCTS AND LICENSED SERVICES UNDER THIS AGREEMENT. COMPANY ASSUMES ALL RESPONSIBILITY AND LIABILITY FOR LOSS OR DAMAGE CAUSED BY ANY PRODUCT OR SERVICE MANUFACTURED, USED, OR SOLD BY COMPANY WHICH IS A LICENSED PRODUCT OR LICENSED SERVICE AS DEFINED IN THIS AGREEMENT.

 

 

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9.7Indemnification: JHU and the Inventors will have no legal liability exposure to third parties if JHU does not license the LICENSED PRODUCT(S) and LICENSED SERVICE(S), and any royalties JHU and the Inventors may receive is not adequate compensation for such legal liability exposure. Therefore, JHU requires Company to protect JHU and Inventors from such exposure to the same manner and extent to which insurance, if available, would protect JHU and Inventors. JHU and the Inventors will not, under the provisions of this Agreement or otherwise, have control over the manner in which Company or those operating for its account or third parties who purchase LICENSED PRODUCT(S) or LICENSED SERVICE(S) from any of the foregoing entities, practice the inventions of LICENSED PRODUCT(S) and LICENSED SERVICE(S). The Company shall indemnify, defend with counsel reasonably acceptable to JHU, and hold JHU, The Johns Hopkins Health Systems, their representatives including but not limited to present and former, trustees, officers, Inventors, agents, faculty, employees and students harmless as against any judgments, fees, expenses, or other costs arising from or incidental to any product liability or other lawsuit, claim, demand or other action brought as a consequence of the practice of said inventions by any of the foregoing entities, whether or not JHU or said Inventors, either jointly or severally, is/are named as a party defendant in any such lawsuit. Practice of the inventions covered by LICENSED PRODUCT(S) or LICENSED SERVICE(S) by an agent or a third party on behalf of or for the account of the Company, or by a third party who purchases LICENSED PRODUCT(S) or LICENSED SERVICE(S) from the Company, shall be considered the Company’s practice of said inventions for purposes of this Paragraph 9.7. The obligation of the Company to defend and indemnify as set out in this Paragraph 9.7 shall survive the termination of this Agreement and shall not be limited by any other limitation of liability elsewhere in the Agreement.

 

9.8Product Liability: Prior to first commercial sale of any LICENSED PRODUCT(S) or LICENSED SERVICE(S) as the case may be in any particular country, Company shall establish and maintain, in each country in which Company shall sell LICENSED PRODUCT(S) or LICENSED SERVICE(S), product liability or other appropriate insurance coverage appropriate to the risks involved in marketing LICENSED PRODUCT(S) and/or LICENSED SERVICE(S) and will annually present evidence to JHU that such coverage is being maintained. Upon JHU’s request, Company will furnish JHU with a Certificate of Insurance of each product liability insurance policy obtained. JHU shall be listed as an additional insured in Company’s said insurance policies. If such Product Liability insurance is underwritten on a ‘claims made’ basis, Company agrees that any change in underwriters during the term of this Agreement will require the purchase of ‘prior acts’ coverage to ensure that coverage will be continuous throughout the term of this Agreement.

 

9.9Entire Agreement: This Agreement constitutes the entire understanding between the parties with respect to the obligations of the parties with respect to the subject matter hereof, and supersedes and replaces all prior agreements, understandings, writings, and discussions between the parties relating to said subject matter.

 

 

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9.10Amendment & Waiver: This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by the authorized officials of the parties or, in the case of a waiver, by the party waiving compliance. The failure of either party at any time or times to require performance of any provision hereof shall in no manner affect its right at a later time to enforce the same. No waiver by either party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of any other condition or term.

 

9.11Binding Effect: This Agreement shall be binding upon and inure to the benefit of and be enforceable by the parties hereto and their respective successors and permitted assigns.

 

9.12Governing Law: This Agreement shall be construed, and legal relations between the parties hereto shall be determined, in accordance with the laws of the State of Maryland applicable to contracts solely executed and wholly to be performed within the State of Maryland without giving effect to the principles of conflicts of laws. Any disputes between the parties to the Agreement shall be brought in the state or federal courts of Maryland. Both parties agree to waive their right to a jury trial.

 

9.13Headings: Article headings are for convenient reference and are not a part of this Agreement. All Exhibits are incorporated herein by this reference.

 

9.14Use of Name: Nothing contained in this Agreement confers any right to either party hereto to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of the other party hereto (including any contraction, abbreviation or simulation of any of the foregoing).

 

Unless otherwise required by law, LICENSEE is prohibited from using the name “The Johns Hopkins University” or the name of any affiliate of the Johns Hopkins University, including but not limited to The Johns Hopkins Health System Corporation, or any of its hospitals or affiliates, or the names of any of their respective faculty, employees, students or INVENTORS, in advertising, publicity, or other promotional activities, without JHU’s prior written approval of such use.

 

JHU may disclose to all INVENTORS the terms and conditions of this Agreement upon their request.

 

JHU may acknowledge to third parties the existence of this Agreement and the extent of the licenses granted to LICENSEE and AFFILIATES under Section 3 hereof, but JHU shall not disclose the financial terms of this Agreement to third parties, except where JHU is required by law to do so. LICENSEE hereby grants JHU permission to include LICENSEE’s name and a link to LICENSEE’s website in JHU’s annual reports and on JHU’s website to showcase technology transfer-related stories.

 

JHU shall have the right to list LICENSEE and display the logotype or symbol of LICENSEE on JHU’s website and on JHU publications as a licensee startup company based upon JHU technology.

 

 

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IN WITNESS WHEREOF the respective parties hereto have executed this Agreement by their duly authorized officers on the date appearing below their signatures.

 

THE JOHNS HOPKINS UNIVERSITY   VIRTUOSO SURGICAL, INC.
                  
By: /s/ Neil Veloso   By: /s/ C. Mark Pickrell
  Neil Veloso   Name: C. Mark Pickrell
  Executive Director   Title: Attorney-in-Fact
  Johns Hopkins Technology Ventures    
     
Date: 5/11/2016   Date:: 5/4/2016

 

 

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EXHIBIT A

 

LICENSE FEES and ROYALTY

 

1.                  LICENSE FEE

 

1.1The license fee due under Paragraph 4.1 is two-thousand dollars ($2000).

 

1.2In addition, COMPANY shall issue to JHU that number of shares of common stock representing five percent (5%) of the outstanding common and preferred shares on a fully diluted basis of COMPANY pursuant to an agreed upon stock purchase agreement between COMPANY and JHU. The stock purchase agreement shall contain provisions protecting JHU against dilution of its equity interest in the event the post-money valuation of any equity investment is less than two million dollars ($2,000,000), and it will also contain a provision for the piggy-back registration of common shares with any other class of stock in an initial public offering. If COMPANY proposes to sell any equity securities or securities that are convertible into equity securities of COMPANY (collectively, “Equity Securities”) in any new round of financing, then COMPANY shall offer JHU and/or its Assignee (as defined below) an opportunity to purchase either:

 

(i)up to that portion of the Equity Securities that equals JHU’s then current, fully-diluted percentage ownership interest in COMPANY, or

 

(ii)if the percentage offered for sale by COMPANY is less, then up to five percent (5%) of the Equity Securities offered for sale. Such offer to purchase shall be on the same terms and conditions as are offered with respect to such Equity Securities sold in such financing. For purposes of this section 7 of Exhibit A, the term “Assignee” means: (a) any entity to which JHU’s preemptive rights have been assigned either by JHU or by another entity, or (b) any entity that is controlled by JHU.

 

2.                  EARNED ROYALTY

 

2.1Annual Earned Royalty. COMPANY shall pay an annual EARNED ROYALTY as follows:

 

2.1.1       Four percent (4%) of the sum of NET REVENUES.

 

2.2Royalty Stacking. If COMPANY is required to pay running royalties on any patent rights not licensed hereunder (“Other Royalties”) in order to make, use or sell a particular LICENSED PRODUCT or LICENSED SERVICE, COMPANY shall be entitled to credit half (50%) of such Other Royalties against the Earned Royalty due, but the Earned Royalties shall not be reduced below fifty percent (50%) of those that would otherwise be due JHU for that LICENSED PRODUCT or LICENSED SERVICE.

 

 

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2.3Least Developed Countries. EARNED ROYALTY shall not be due and payable to JHU on NET REVENUES generated from: (i) LICENSED PRODUCTS sold in Least Developed Countries as defined by the United Nations Country Classification in the most recent United Nations’ publication “Statistical Annex” (“LEAST DEVELOPED COUNTRIES”); or (ii) LICENSED PRODUCTS sold to the Public Sector providing LICENSED PRODUCTS at a Cost-Based Price in such Least Developed Countries, but only if COMPANY sells such LICENSED PRODUCTS at COMPANY’s cost of production thereof.

 

3.                  MINIMUM ANNUAL ROYALTIES

 

3.1The minimum annual royalties pursuant to the Agreement are:

 

1st anniversary of the EFFECTIVE DATE and each subsequent anniversary of the EFFECTIVE DATE during the term:

 

Three-thousand dollars ($3000)

 

3.2Earned Royalties payable for each calendar year are creditable on a non-cumulative basis against MINIMUM ANNUAL ROYALTIES for that year only.

 

4.                  LIQUIDITY EVENT

 

4.1COMPANY will pay JHU a fee equal one percent (1%) of the Aggregate Consideration received by the COMPANY, or the total amount received by stockholders of COMPANY, upon the occurrence of a Liquidity Event. Such fee shall be paid after only the first to occur of either a Liquidation Event or an Initial Public Offering. The respective fees, when and if payable, shall be paid upon closing; except that if there are additional contingent amounts (“Trailing Consideration”) payable upon the occurrence of subsequent events, then the Trailing Consideration shall be due and payable to JHU within thirty (30) days after receipt thereof by COMPANY.

 

4.2For a Liquidity Event, the fee required under Section 4.1 of this Exhibit A above shall be payable to JHU by COMPANY in the same form as the proceeds paid or payable to either COMPANY or its security holders, whether in cash, securities or other property, and in the same proportion as such form of consideration is paid or payable to COMPANY or its security holders. Notwithstanding the foregoing, in the event the form of consideration paid or payable includes securities for which there is not an active public market, in lieu of paying that portion of the fee with such securities COMPANY will make a cash payment to JHU equal to the fair market value of such securities. The valuation of such securities shall be determined in accordance with the definition of “Aggregate Consideration” set forth below.

 

4.3For an Initial Public Offering, the fee shall be payable in the form of cash, and shall be based upon the Pre Money Valuation.

 

 

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4.4“Aggregate Consideration” means the amount equal to:

 

4.4.1In the case of an Asset Sale, the sum of: (a) all cash, and the fair market value of all securities or other property transferred to COMPANY at the time of the transaction, less all current and long-term liabilities (but not contingent liabilities) of COMPANY that are not discharged or assumed by the buyer (or its affiliates) in connection with the Asset Sale; and (b) all cash, and the fair market value of all securities and other property for Trailing Consideration payable to COMPANY, when and if actually paid; or

 

4.4.2In the case of a Merger or Stock Sale, the sum of: (a) all cash, and the fair market value of all securities and other property transferred to the stockholders of COMPANY (and any option holders or warrant holders) in return for their stock (or options or warrants) in COMPANY at the time of the transaction, and (b) all cash, and the fair market value of all securities and other property transferred to the stockholders of COMPANY (and any option holders or warrant holders) for Trailing Consideration payable to the holders of COMPANY’s securities, when and if actually paid.

 

4.4.3The valuation of any securities or other property shall be determined by reference to the operative transaction agreement for a respective Merger, Stock Sale or Asset Sale, provided that, if no such valuation is readily determinable from such operative transaction agreement, then for securities for which there is an active public market:

 

(a)If traded on a securities exchange or the NASDAQ Stock Market, the value shall be deemed to be the average of the closing prices of the securities on such exchange or market over the thirty day (30) period ending three (3) days prior to the closing of such transaction; or

 

(b)If actively traded over-the-counter, the value shall be deemed to be the average of the closing bid prices over the thirty day (30) period ending three (3) days prior to the closing of such transaction.

 

(c)The method of valuation of securities subject to investment letters or other similar restrictions on free marketability shall take into account an appropriate discount from the market value as determined pursuant to clause (a) or (b) above so as to reflect the approximate fair market value thereof.

 

(d)For securities for which there is no active public market, the value shall be the fair market value thereof as either: (i) determined in good faith by the Board of Directors of COMPANY; (ii) approved by JHU, such approval not to be unreasonably withheld; or (iii) determined by a third party appraiser appointed and paid for by COMPANY.

 

 

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4.5“Pre-Money Valuation” means the amount equal to the product of: (i) the price per share of common stock sold in the Initial Public Offering, and (ii) the total number of outstanding shares of common stock of COMPANY immediately prior to the closing of the Initial Public Offering, determined on a fully diluted, as converted into common stock basis, giving effect to any stock split, stock dividend, stock combination, recapitalization or similar action impacting COMPANY’s capitalization that occurs, or is deemed to occur, upon consummation of the Initial Public Offering.

 

 

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EXHIBIT B

 

QUARTERLY SALES & ROYALTY REPORT

 

FOR NON-EXCLUSIVE LICENSE AGREEMENT A29889

 

BETWEEN

 

VIRTUOSO SURGICAL, INC. AND THE JOHNS HOPKINS UNIVERSITY

 

EFFECTIVE DATE OF AGREEMENT _________________

 

FOR PERIOD OF _________ TO _________

 

TOTAL ROYALTIES DUE FOR THIS PERIOD$_________

 

Product
ID No.

PRODUCT

NAME

*JHU
REF
No.
pt
COMMERCIAL
SALE DATE
TOTAL NE
SALES/SERVICES
Royalty
Rate
Amount
Due
             
             
             
             
             

 

* Please provide the JHU Ref. C04873

 

This report format is to be used to report quarterly royalty statements to JHU. It should be placed on Company letterhead and accompany any royalty payments due for the reporting period. This report shall be submitted even if no sales are reported.

 

 

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EXHIBIT C

 

JHU Ref
Number
Technology Title Inventors Country/#
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
Japan
2008-541319
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
European Patent Office
06844376.1
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
Canada
2,630,061
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
Japan
2012-139088
5550682
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
Japan
2015-094824
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
Japan
2014-000372
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
China
200680050046.8
ZL 200680050046.8
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
United States
8,152,756
C04873 Active Cannulas for Bio-sensing and Surgical Intervention Allison M. Okamura
Noah J. Cowan
Robert James Webster, III
Russell H. Taylor
United States
8,715,226

 

 

 

 

 

EX1A-6 MAT CTRCT 8 tm1927293d1_ex6-3.htm EXHIBIT 6.3

 

Exhibit 6.3

 

LICENSE AGREEMENT
BETWEEN
VANDERBILT UNIVERSITY
AND
Virtuoso Surgical, Inc.

 

Table of Contents

 

 

Article 1 DEFINITION OF TERMS 1
Article 2 GRANT 4
Article 3 FINANCIAL CONSIDERATIONS 4
Article 4 DILIGENCE 6
Article 5 RECORDS, REPORTS AND PAYMENTS 7
Article 6 PATENT PROSECUTION AND ENFORCEMENT 9
Article 7 DURATION AND TERMINATION 13
Article 8 CONFIDENTIALITY 14
Article 9 DISPUTE RESOLUTION 14
Article 10 INDEMNIFICATION AND INSURANCE 15
Article 11 DISCLAIMERS 17
Article 12 COMPLIANCE 18
Article 13 NON-USE OF NAMES AND PUBLICITY 19
Article 14 ASSIGNMENT 20
Article 15 MISCELLANEOUS 20
Appendix A LICENSED PATENTS 24
Appendix B QUARTERLY REPORTS 25

 

 

 

 

LICENSE AGREEMENT
BETWEEN

VANDERBILT UNIVERSITY
AND

Virtuoso Surgical, Inc.

 

This Agreement, by and between Vanderbilt University, a not-for-profit corporation, organized and existing under the laws of the state of Tennessee (“Vanderbilt”), and Virtuoso Surgical, Inc., a corporation organized and existing under the laws of the State of Tennessee, with a principal place of business at 5701 Old Harding Pike, Suite 200, Nashville, TN 37205 (collectively, with its Affiliates, “Virtuoso”) (each a “Party” and collectively the “Parties”), is effective as of the 15th day of May, 2016 (the “Effective Date”).

 

RECITALS

 

WHEREAS, “System and Apparatus for Endoscopic Deployment of Robotic Concentric Tube Manipulators for Performing Surgery” (VU 13034) was developed by Messers S. Duke Herrell, Robert J. Webster, Trevor Bruns, Philip J. Swaney and Richard Hendrick and “Hand-held Concentric Tube Manipulator Actuation Unit and Mechanism for Surgery” (VU 16035) was developed by Messers S. Duke Herrell, Richard Hendrick and Robert J. Webster; and

 

WHEREAS Messers Herrell, Webster, Hendrick, Bruns and Swaney are collectively hereinafter known as the Inventors; and

 

WHEREAS, Virtuoso wishes to obtain a license under the Licensed Patents to develop and commercialize products, and Virtuoso is capable of and committed to developing and commercializing products utilizing such rights; and

 

WHEREAS, Vanderbilt is willing to grant such a license to Virtuoso, in consideration of Virtuoso’s satisfaction of its obligations hereunder, and for other good and valuable consideration as set forth below.

 

NOW, THEREFORE, the Patties agree as follows:

 

Article 1
DEFINITION OF TERMS

 

1.1              “Affiliate” shall mean, with respect to an entity, any other entity that directly or indirectly owns or controls, is owned or controlled by, or is under common ownership or control with such entity. With respect to an entity, the terms “own” and “control” shall mean (a) possession, the right to possession or beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities; (b) the power to direct management and policies; (c) the power to appoint or remove a majority of the board of directors or trustees; and/or (d) the right to receive 50% or more of the profits or earnings or the right to 50% or more of the net assets. The term “entity” includes without limitation any individual, corporation, or other organization.

 

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1.2              Confidential Information” shall mean any information exchanged between Vanderbilt and Virtuoso, regarding the Licensed Patents or this Agreement and/or the performance of either Party hereunder, either orally or in writing or other tangible medium, provided that (except for information provided under Section 6.1) if the information is provided in writing or other tangible medium it is marked “Confidential,” and if the information is provided verbally or visually it is identified as confidential at the time of disclosure and thereafter promptly reduced to a writing marked “Confidential.” The obligations under Article 8 (Confidentiality) shall not apply to that part of the Confidential Information that (i) is or becomes known to the public without fault of the Party receiving the information; (ii) the receiving Party can establish that it knew prior to the receipt of the same from the disclosing Party; (iii) is obtained from a third party having the right to disclose same without breach of any obligation of confidentiality to the disclosing Party; or (iv) is developed by the receiving Party independently of and without reference to the information.

 

1.3              Fair Market Value” shall mean the cash consideration that Virtuoso or its Sublicensee(s) would realize from a non-Affiliate, independent buyer in an arm’s length sale of an identical item or right sold in the same quantity and at the same time and place of the transaction.

 

1.4              Field” shall mean human surgical applications.

 

1.5              Issue Fee” shall have the meaning given in Section 3.1.

 

1.6              Licensed Patents” shall mean the patent applications and issued patents listed in Appendix A, attached hereto and made a part hereof; any divisions, continuations (but excluding continuations-in-part) or patents issuing thereon or reissues thereof; and any and all United States and foreign patents and patent applications corresponding thereto, all to the extent controlled by Vanderbilt.

 

1.7              Licensed Product” shall mean (i) any product, process, or service in the Field (a) the making, use, sale, offer to sell, or import of which is covered by (in whole or in part), or absent the license granted herein would infringe, one or more Valid Claims, or (b) that is made, uses, or is used by or in a process that is covered by (in whole or in part), or absent the license granted herein would infringe, one or more Valid Claims, or (ii) a service performed using a product or process described in subsection (i)(a) or (b) above.

 

1.8              Minimum Annual Royalty” shall have the meaning given in Section 3.3.

 

1.9              Gross Sales” shall mean:

 

1.9.1        the gross amount billed by Virtuoso for Licensed Products. No deductions will be made for commissions paid to individuals whether they are with independent sales agencies or regularly employed by Virtuoso, and on its payroll, or for cost of collections.

 

1.9.2        In the case of a sale of a Licensed Product within Virtuoso or between or among Virtuoso for further sale by such transferee, Gross Sales shall be based on the gross amount billed for the first sale of such Licensed Product to (i) an entity other than Virtuoso, or (ii) a transferee that is the final purchaser or transferee.

 

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1.9.3        In the case of a sale of a Licensed Product for which Virtuoso does not bill, Gross Sales shall mean the amount received by Virtuoso for the sale of such Licensed Product.

 

1.9.4        If Licensed Product is billed or otherwise sold at a discounted price that is substantially lower than the customary prices charged by Virtuoso, or billed or otherwise sold for non-monetary consideration (whether or not at a discount), Gross Sales will be calculated based on the average non-discounted amount charged for such Licensed Product in an arms-length transaction to a non-Affiliate, independent third party during the same calendar quarter in the same country or, in the absence of such sales, on the Fair Market Value of such Licensed Product.

 

1.10           Patent Challenge” shall mean any direct or indirect dispute, challenge, or assistance in the challenge of the validity, patentability, scope, construction, enforceability, non-infringement or Vanderbilt’s ownership of any issued patent comprising the Licensed Patents or any claims thereof, or opposition or assistance in the opposition of the grant of any letters patent comprising the Licensed Patents, in any legal or, administrative proceedings, including in a court of law, before the United States Patent and Trademark Office or other agency or tribunal in any jurisdiction, or in arbitration.

 

1.11            Past Patenting Costs” shall have the meaning given in Paragraph 6.2.1.

 

1.12            Patenting Costs” shall mean any past or ongoing costs incurred or to be incurred, including government fees and attorneys’ fees, in the course of Prosecuting the Licensed Patents.

 

1.13           Prosecution” or “Prosecuting” shall mean preparation, filing, prosecution, issuance and maintenance of the Licensed Patents, including continuations, divisionals, extensions, re-examinations, reissues, supplemental examination, appeals, interferences, derivation proceedings, oppositions, all other proceedings before the United States Patent and Trademark Office (including the Patent Trial and Appeal Board) and foreign patent offices, and any judicial or other appeals of the foregoing.

 

1.14            Representatives” shall mean Vanderbilt’s trustees, directors, officers, employees, faculty, Inventors, personnel, affiliated investigators, agents and representatives, medical and professional staff, students and Affiliates, and their respective successors, heirs and assigns.

 

1.15            The terms “sale”, “sold” and “sell” as used in this Agreement include without limitation, sales, leases, licenses, rentals, performance and other modes of distribution or transfer of a product, process or service or its beneficial use.

 

1.16            ”Term” has the meaning given in Section 7.1.

 

1.17            Valid Claim” shall mean any pending claim of any Licensed Patent, or issued and unexpired claim of any Licensed Patent, that has not been permanently revoked, nor held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal, and which has not been cancelled, withdrawn or abandoned or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

 

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Article 2

GRANT

 

2.1              Grant to Virtuoso. Subject to the terms of this Agreement, Vanderbilt hereby grants to Virtuoso an exclusive license in the Field under its interest in and to the Licensed Patents, to make, use, offer to sell, sell and import Licensed Products during the Term. No right to sublicense the Licensed Patents are granted under this Agreement.

 

2.2              Government Rights and Requirements. Notwithstanding anything herein to the contrary, any and all licenses and other rights granted hereunder are limited by and subject to the rights and requirements of the United States Government which may attach as a result of United States Government sponsorship of research in connection with which an invention covered by the Licensed Patents was conceived or first actually reduced to practice, as set forth in 35 U.S.C. §§200-212, and 37 C.F.R. Part 401, each as amended or any successor statutes or regulations, and in the relevant United States Government research contracts with Vanderbilt, as such rights and requirements may be amended or modified by law, rule or regulation. To the extent applicable, such rights and requirements include without limitation (i) the grant of a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States Government any of the Licensed Patents throughout the world (as set forth in 35 U.S.C. §202(c)(4)), and (ii) the requirement that Licensed Products used or sold in the United States will be manufactured substantially in the United States (as set forth in 35 U.S.C. §204).

 

2.3              Reservation by Vanderbilt. Notwithstanding anything herein to the contrary, and without limitation, (i) Vanderbilt reserves the right to: (a) make, use, practice and further develop the Licensed Patents for educational, research, patient care, and treatment purposes and other internal purposes; (b) grant to others non-exclusive licenses to make and use the Licensed Patents and the subject matter described therein for academic research or not-for-profit educational purposes; and (c) grant licenses to Licensed Patents to third parties outside the Field or to products other than Licensed Products; and (ii) Vanderbilt excludes from the rights granted to Virtuoso herein the right to bring an infringement action against, seek monetary damages from, or seek an injunction against, any Inventor or their present or future not-for-profit employers even after such employment has ended, for infringement of any of the Licensed Patents in carrying out not-for- profit research or education; and nothing herein shall be construed to require Vanderbilt to bring any such action against any such party.

 

2.4              No Additional Rights. Nothing in this Agreement shall be construed to confer any rights upon Virtuoso by implication, estoppel, or otherwise as to any technology or patent rights of Vanderbilt or any other entity other than the Licensed Patents in the Field during the Term for the Licensed Products regardless of whether such technology or patent rights shall be dominant or subordinate to any Licensed Patents.

 

Article 3

FINANCIAL CONSIDERATIONS

 

3.1              Issue Fee. Virtuoso shall pay to Vanderbilt a non-refundable, non-creditable license issue fee in cash and in equity (“Issue Fee”) comprising:

 

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3.1.1        Five Thousand U.S. Dollars (U.S. $5,000), payable to Vanderbilt, within Ten (10) days of execution of this Agreement; and

 

3.1.2        A warrant in the form attached hereto as Exhibit C (the “Vanderbilt Warrant”), which shall be exercisable as described therein. Upon exercise, Virtuoso shall issue to Vanderbilt shares of its fully paid, non-assessable Common Membership Units/Common Stock (the “Warrant Shares”). Virtuoso’s obligation to issue Warrant Shares upon Vanderbilt’s exercise of the Vanderbilt Warrant is unconditional, and the Warrant Shares issued thereunder shall not be offset, assessed or otherwise applied to or against any other payments due under this Agreement or otherwise any liabilities of Vanderbilt in connection with this Agreement or otherwise, including those arising from any breach or alleged breach of the Agreement by Vanderbilt.

 

For avoidance of doubt, it is the Parties’ intent that the interest in Virtuoso acquired by Vanderbilt under this Section 3.1.2 not be diluted below Four percent (4%) of the aggregate number of outstanding shares of Common Membership Units/Common Stock of Virtuoso, calculated on a fully diluted basis assuming the exercise and/or conversion of all outstanding securities exercisable for or convertible into Common Membership Units/Common Stock outstanding at the time of a Warrant Share Freeze Event (as defined in the Vanderbilt Warrant). Following the Warrant Share Freeze Event, except as set forth in the Vanderbilt Warrant, Vanderbilt will be subject to dilution in the same manner as any other holder of Common Membership Units/Common Stock.

 

3.2               Running Royalties. Virtuoso shall pay to Vanderbilt a running royalty of Four percent (4%) of Gross Sales on all Licensed Products (including those made during the Term but sold after the Term) in accordance with the table below. No multiple running royalties shall be payable because the Licensed Product, or the manufacture or use thereof, is or shall be covered by more than one Licensed Patent.

 

3.3              Minimum Annual Royalties. Virtuoso shall pay to Vanderbilt a minimum annual royalty payment for each calendar year in the amounts set forth below (the “Minimum Annual Royalty”) at the time set forth in Paragraph 5.5.1. Each Minimum Annual Royalty payment shall be fully creditable against running royalties paid to Vanderbilt under Section 3.2 for the same calendar year, but shall not be creditable against any other payment due under this Agreement, including past or future running royalties that may be or may become due.

 

For Calendar Year Payable on Minimum Annual
Royalty
2021 February 1 of 2022 $3,000
2022 February 1 of 2023 $5,000
2023 February 1 of 2024 $10,000
2024 February 1 of 2025 $20,000
2025 and each Calendar Year thereafter February 1 of 2026 and each February 1 thereafter $50,000

 

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3.4              Payment Due Upon an Exit Event. Upon the (i) legal or beneficial sale or transfer of more than 50% of Virtuoso’s equity to a third party who is not a shareholder as of the date hereof in one or in a series of transactions; or (ii) sale or transfer of all or substantially all of the assets of Virtuoso to a third party, Virtuoso shall pay to Vanderbilt a one-time payment of $250,000 on or before thirty (30) days of such transfer or sale.

 

Article 4

DILIGENCE

 

4.1              Diligent Efforts. Virtuoso, shall use commercially reasonable efforts to develop Licensed Products and to bring Licensed Products to market through a thorough, vigorous and diligent program for exploitation of the Licensed Patents and to continue active, diligent marketing efforts for Licensed Products throughout the Term. Virtuoso shall endeavor to keep Licensed Products reasonably available to the public.

 

4.2              Diligence Milestones. In addition to Virtuoso’s diligence obligations in Section 4.1, Virtuoso, shall achieve the following diligence milestones (the “Diligence Milestones”) by the dates set forth below (the “Diligence Milestone Dates”):

 

A.Milestone 1: Within six (6) months after the Effective Date, Virtuoso shall furnish Vanderbilt with a written research and development plan describing the major tasks to be achieved in order to develop and bring to market Licensed Products, a timeline for achievement of such tasks, and an estimate of the number of staff and financial and other resources to be devoted to such development and commercialization effort (“Commercialization Plan”);

 

B.Milestone 2: Obtaining SBIR/STTR or equivalent funding for prototype development and FDA submission planning: on or before Eighteen (18) months after the Effective Date;

 

C.Milestone 3: Complete design refinements towards FDA submission: on or before thirty six (36) months after the Effective Date;

 

D.Milestone 4: Complete verification and validation studies and submit either FDA 510(k) or other FDA product approval submission: on or before sixty (60) months after the Effective Date.

 

E.Milestone 5: Pilot rollout of product and start of marketing of the product: on or before seventy two (72) months after the Effective Date

 

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Virtuoso shall provide to Vanderbilt commercially reasonable evidence of Virtuoso having achieved each of the above-defined Diligence Milestones within thirty (30) days after the corresponding Diligence Milestone Date set forth above.

 

4.3              Diligence Reporting. Throughout the course of development and commercialization of Licensed Products by Virtuoso, Virtuoso shall provide Vanderbilt with reasonably detailed confidential periodic summary reports evidencing its efforts in, progress made, and future plans for, its development and commercialization of Licensed Products, on a Licensed Product-by- Licensed Product basis, including progress made toward the objectives set forth in the Commercialization Plan (as defined in Section 4.2) during the preceding year and any updates or revisions to the Commercialization Plan. The report shall also contain a discussion of intended efforts, development progress, and sales projections for the next twelve-month period. Such reports shall be provided no less frequently than every calendar year, the first report to be due one year after the Effective Date.

 

4.4              Diligence Failure. In the event Vanderbilt determines that Virtuoso has failed to fulfill any of its obligations under Section 4.1 or Section 4.2, Vanderbilt may terminate this Agreement in accordance with Section 7.3.

 

Article 5
RECORDS, REPORTS AND PAYMENTS

 

5.1              Record Accounting.

 

Virtuoso shall keep complete and accurate books of account containing all particulars that may be necessary for the purpose of showing the amounts payable to Vanderbilt by Virtuoso hereunder, and for otherwise verifying Virtuoso’s performance hereunder. Such books of account shall be kept at Virtuoso’s principal place of business, and shall be maintained for at least five (5) years following the end of the reporting period to which they pertain. For the purpose of verifying Virtuoso’s royalty statement or compliance in other respects with this Agreement, Vanderbilt or its agents or representatives shall have the right to conduct an audit of Virtuoso’s business activities relating to this Agreement. Such examinations shall be made during reasonable business hours, and not more than once during each calendar year. Should any of the foregoing examinations reveal an underpayment, then Virtuoso shall immediately pay to Vanderbilt the underpaid amount, plus interest (as provided for below). Furthermore, if such underpayment exceeds five percent (5%) of the amount paid by Virtuoso to Vanderbilt for any calendar year examined, then Virtuoso shall also bear the cost of such audit, including accountant’s fees and expenses, and shall immediately reimburse Vanderbilt for all such costs.

 

5.2              Quarterly Reports. Within thirty (30) days of the end of each calendar quarter, Virtuoso shall deliver to Vanderbilt a complete and accurate report for that quarter in the form specified in Appendix B. Such report shall be certified by an officer or director of Virtuoso for completeness and accuracy. For purposes of calculating royalties, and reporting under this Section 5.2, Gross Sales shall be deemed to occur on the date of billing for a Licensed Product. For a Licensed Product for which Virtuoso does not bill, Gross Sales shall be deemed to have occurred on the earliest of the date of the sale, use, performance or importing of the Licensed Product, but royalty on such Gross Sales shall be due with the report for the quarter in which payment is received.

 

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5.3              Diligence Reports/financial Statements. Virtuoso shall deliver annually a report containing (i) an update on Virtuoso’s progress towards achieving the Diligence Milestones, including a summary of amounts invested in development of commercial products and other steps necessary under the Commercialization Plan, and (ii) Virtuoso’s financial statements for the preceding twelve (12) months including, at a minimum, a balance sheet and an operating statement certified by Virtuoso’s treasurer or chief financial officer or by an independent auditor. Such reports shall be considered Confidential Information, and shall be subject to the confidentiality provisions contained herein.

 

5.4              Notification of Transaction. Virtuoso shall notify Vanderbilt within thirty (30) days of the occurrence of any of the following events: (a) a merger or consolidation of Virtuoso, (b) a transaction or series of related transactions in which a third party, together with its Affiliates, becomes the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of Virtuoso, or (c) the sale or other transfer to a third party of all or substantially all of Virtuoso’s assets.

 

5.5              Payments

 

5.5.1        Virtuoso shall pay to Vanderbilt the Running Royalties (Section 3.2), accruing during each calendar quarter with the corresponding report for that quarter. Minimum Annual Royalties shall accrue on the last day of each calendar year set forth in Section 3.3.

 

5.5.2        Time is of the essence with respect to all payments due under this Agreement, and the Patties agree that the value of the payments due under this Agreement is acceptable as appropriate consideration only if such payments are received in full as provided for herein. Payments shall be paid in United States Dollars in such place as Vanderbilt may reasonably designate consistent with the laws and regulations controlling in any foreign country. If any currency conversion is required in connection with the payment of royalties hereunder, such conversion shall be made by using the average rate of exchange during the calendar quarter during which such payments accrued, as determined by reference to the currency exchange rates quoted by Bloomberg Professional, a service of Bloomberg L.P., or in the event Bloomberg Professional is not available, then International Financial Statistics (publisher, International Monetary Fund). Vittuoso shall bear all transfer fees in connection with payment.

 

5.5.3        The Issue Fee shall be due within ten (10) days after the Effective Date, and if such payments are not timely received, this Agreement shall automatically be null, void and without effect. Except as otherwise provided herein, all other payments shall be made within thirty (30) days after the end of the calendar quarter in which they became due and payable to Vanderbilt.

 

5.5.4        Any amounts payable to Vanderbilt and overdue hereunder shall bear simple interest at the rate of one percent (1%) per month.

 

5.5.5        All payments under this Agreement will be made without any deduction or withholding for or on account of any tax, except as expressly permitted in this Agreement. If any income or other taxes, withholdings or other deductions required by applicable law to be withheld or deducted from any of the payments made by or on behalf of Virtuoso hereunder (“Withholding Taxes”) are imposed on a payment by any applicable law, Virtuoso will pay such Withholding Taxes to the proper taxing authority and, if available, evidence of such payment will be secured and sent to Vanderbilt within one (1) month of such payment. In the case of any Withholding Taxes imposed with respect to any payment hereunder, Virtuoso will pay to Vanderbilt an additional amount as is necessary to ensure that the amount actually received by Vanderbilt with respect to such payment, free and clear of the Withholding Taxes (including any such Withholding Taxes imposed on such additional amount), will equal the amount of the payment that would have been made if no such Withholding Taxes had applied.

 

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5.6              Small Entity Status. At any time during the Term, in the event Virtuoso no longer qualifies as a “small entity” (as defined in 37 C.F.R. 1.27), Virtuoso shall then immediately notify Vanderbilt of same.

 

Article 6

PATENT PROSECUTION AND ENFORCEMENT

 

6.1              Patent Prosecution

 

6.1.1        Vanderbilt shall have exclusive responsibility for the Prosecution of the Licensed Patents, including choice of patent counsel. Provided that Virtuoso covers all of Vanderbilt’s Patenting Costs in accordance with Section 6.2, Vanderbilt shall keep Virtuoso informed of patent prosecution, and will consider Virtuoso’s comments and suggestions prior to taking material actions for the same; Vanderbilt will, at the request of Virtuoso, take all prosecution actions reasonably recommended by Virtuoso which would expand the scope of rights sought or add dependent claims to cover specific Licensed Products; and Vanderbilt shall notify Virtuoso prior to any deadline if it intends to abandon, or otherwise elect to forego its rights in, any Licensed Patents and Virtuoso shall have the opportunity to continue prosecuting and maintaining such Licensed Patents in the name of Vanderbilt at Virtuoso’s expense. Virtuoso shall cooperate with Vanderbilt to insure that each Licensed Patent reflects and will reflect, to the extent practicable and to the best of Virtuoso’s knowledge, all items of commercial interest to Virtuoso.

 

6.1.2        Virtuoso will be reasonably permitted to discuss Prosecution of the Licensed Patents with Vanderbilt’s outside patent counsel, provided that, Virtuoso will pay all resulting outside counsel fees in accordance with Section 6.2. All non-public information exchanged between the Parties or between Vanderbilt’s outside patent counsel and Virtuoso regarding Prosecution of the Licensed Patents, and all shared information regarding analyses or opinions of third party intellectual property, will be deemed Confidential Information of the disclosing Party, whether or not identified or marked as “Confidential.” In addition, the Parties acknowledge and agree that, with regard to such activities, the interests of the Parties as licensor and licensee are to obtain the strongest and broadest patent protection possible, and as such, are aligned and are legal in nature. The Parties agree and acknowledge that they have not waived, and nothing in this Agreement constitutes a waiver of, any legal privilege concerning the Licensed Patents or the Confidential Information, including without limitation, privilege under the common interest doctrine.

 

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6.2              Patent Reimbursements

 

6.2.1        Past Patenting Costs. Virtuoso shall reimburse Vanderbilt for Patenting Costs incurred by Vanderbilt prior to the Effective Date in an amount equal to $22,495 (“Past Patenting Costs”) in accordance with the following schedule of payments:

 

(A)       On or before July 1, 2016: $5,000

 

(B)       On or before September 1, 2016: $5,000

 

(C)       On or before November 1, 2016: $5,000

 

(D)       On or before January 1, 2017: $5,000

 

(E)       On or before March I, 2017: $2,495.

 

6.2.2        Ongoing Patenting Costs. With respect to any Patenting Costs incurred by or on behalf of Vanderbilt after the Effective Date of this Agreement, Virtuoso shall remit payment of such Patenting Costs within thirty (30) days after Virtuoso receives invoices for same. Notwithstanding the foregoing, at least sixty (60) days before a particular action is required for the protection of certain rights comprising the Licensed Patents (the “Bar Date”), Vanderbilt shall have the right to request advance payment of reasonable estimated Patenting Costs for such action if such estimated Patenting Costs are at least $20,000, and Virtuoso shall be obligated to pay the amount of such estimated Patenting Costs no less than thirty (30) days before the Bar Date. So long as Vanderbilt’s request is timely made, Vanderbilt shall have no obligation to take or have taken such action, and no liability for failing to take such action, to protect the Licensed Patents at issue, unless the estimated Patenting Costs are timely paid by Virtuoso, even if the result is the in-evocable loss of rights.

 

6.2.3        Exclusion of Certain Rights. With respect to any action necessary to protect a particular Licensed Patent in a particular country, if Virtuoso instructs Vanderbilt in writing not to take such action, which instruction must be given at least sixty (60) days prior to any Bar Dates (as defined in Paragraph 6.2.2) for such Licensed Patent, Virtuoso shall be relieved from its obligation to pay for future Patent Costs relating to such Licensed Patent in such country but Virtuoso shall not be relieved from responsibility to pay Patent Costs for such Licensed Patent incurred prior to the expiration of the sixty (60) day notice period. Such Licensed Patent shall thereupon cease to be a Licensed Patent hereunder and Virtuoso shall have no further rights therein. Thereafter, Vanderbilt shall have the right to (i) abandon some or all of such rights at Vanderbilt’s sole discretion, or (ii) incur those costs at its own expense; in either case, Vanderbilt shall be free to license such rights to third parties without any further obligation to Virtuoso.

 

6.2.4        Unpaid Patenting Costs. Any amounts due hereunder that remain unpaid thirty (30) days after Virtuoso receives an invoice from Vanderbilt or its counsel for same shall bear interest as provided in Paragraph 5.5.4. In addition, after said thirty (30) days, Vanderbilt shall thereafter have the right to take action, at its sole discretion, to terminate this Agreement in accordance with Section 7.3 and/or cease further Prosecution of the Licensed Patents even if the result is irrevocable loss of rights. However, nothing herein shall be construed to release Virtuoso from any obligations to reimburse or pay Patenting Costs that matured prior to the effective date of any such termination.

 

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6.3           Notice of Alleged Infringement

 

6.3.1        If either Party believes that a Licensed Patent is being, or has been, infringed by a third party, such Party shall promptly, and before communicating with such third party about the alleged infringement, notify the other party of such belief, and as part of such notice shall provide copies of all documentary evidence of the alleged infringement.

 

6.3.2        Each Party shall promptly notify the other if it becomes aware that any legal proceedings are commenced or threatened, or any claims or allegations are made, against either Party or any purchaser of a Licensed Product sold by Virtuoso on the ground that the manufacture, use, sale, possession or import of the Licensed Product is an infringement of a third party’s patent or other intellectual property rights (an “Infringement Dispute”).

 

6.4              Infringement of Licensed Patents. Virtuoso shall have the first right to bring an action against an infringer of the Licensed Patents in the Field, at Virtuoso’s sole expense, so long as Virtuoso remains the exclusive licensee of the Licensed Patents in the Field. Virtuoso shall notify Vanderbilt of its intent to exercise that right within ninety (90) days after Virtuoso becomes aware of the alleged infringement. Prior to commencing any such action, Virtuoso shall consult with Vanderbilt and shall consider the views of Vanderbilt regarding the advisability of the proposed action and its effect on the public interest. If Virtuoso exercises its right to bring an infringement action against the alleged infringer, Virtuoso shall be obligated to defend any cross claim or counterclaim or action for declaratory judgment related to the Licensed Patents or Licensed Product. Vanderbilt will cooperate in such action as reasonably requested by Virtuoso, at Virtuoso’s sole expense. If Vanderbilt is legally required to be named as a party to such action for standing or other purposes, Virtuoso may join Vanderbilt to such action in name only, provided that Vanderbilt shall not be the first named party in such action and that Virtuoso shall hold Vanderbilt harmless from, and indemnify Vanderbilt against, any costs (including out-of-pocket and internal costs), expenses, or liability that Vanderbilt incurs in connection with such action. Virtuoso shall reimburse Vanderbilt for any costs, expenses or liability it incurs in connection with any action under this Section 6.4 within thirty (30) days after receiving an invoice from Vanderbilt for same. In the event that Virtuoso does not timely notify Vanderbilt of its intent to bring or pursue an infringement action against an alleged infringer, or in the event Virtuoso gives such notice but does not bring suit or stop the infringement within a reasonable time, but no longer than one hundred eighty (180) days, after Virtuoso first becomes aware of the basis for such action, Vanderbilt shall have the right (but not the obligation) to do so at its sole expense, and to retain all recovered damages. In such instances, Virtuoso will cooperate as requested by Vanderbilt, and will be compensated by Vanderbilt for its reasonable out-of-pocket expenses, provided Vanderbilt has approved same for reimbursement in advance.

 

6.5              Progress and Disposition of Infringement Actions. Virtuoso shall keep Vanderbilt reasonably informed of the status and progress of any action brought under Section 6.4 or any Infringement Dispute (as defined in Paragraph 6.3.2), and shall not take any position or action that would have an adverse effect on the Licensed Patents or scope, claims, validity or enforceability thereof. Virtuoso agrees that it will not settle, compromise, voluntarily dispose of or fail to defend any action brought under Section 6.4 or any Infringement Dispute without the prior written consent of Vanderbilt, which consent shall not be unreasonably withheld, so long as such disposition is not an admission of fault on the part of, does not create an obligation for or have an adverse effect on, and provides an unconditional release from all liability for, Vanderbilt and its Representatives. Any damages, award, settlement or other recovery received by Virtuoso (including without limitation statutory damages, compensatory damages, lost profits damages, exemplary damages, increased damages, and awards of costs and attorney’s fees) shall first be applied to the reimbursement of Virtuoso’s reasonable costs, expenses and legal fees, including amounts Virtuoso has reimbursed to Vanderbilt. The remaining balance of such damages shall be treated as the basis of lost profits and Vanderbilt shall recover the royalty Vanderbilt would have received under this Agreement if the infringing sales had been made by Virtuoso.

 

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6.6              Licensed Patent Challenges. In the event that Virtuoso directly or indirectly brings, or assists in bringing, a Patent Challenge, then (a) Virtuoso shall provide Vanderbilt with at least sixty (60) days’ notice prior to taking any such action, (b) the Parties consent that Section 9.2 shall apply; (c) Virtuoso shall pay all costs, fees and expenses associated with such Patent Challenge that are incurred by Vanderbilt and its Representatives, including attorneys’ fees and all costs associated with administrative, judicial or other proceedings, within thirty (30) days after receiving an invoice from Vanderbilt for same; (d) the exclusive licenses granted herein above shall, as of the date of initiation of said challenge or opposition, automatically convert to a non-exclusive license for the remainder of the Term, and Vanderbilt shall have the right to grant licenses under the Licensed Patents to third parties, subject to the then-existing non-exclusive license provided herein; (e) any fees, royalties, milestones or revenues payable to Vanderbilt under Sections 3.2-3.7 shall double in amount if and when any Licensed Patent survives the Patent Challenge such that it remains valid in whole or in part; and (f) at any time after the Patent Challenge is brought, Vanderbilt may, at its option, terminate this Agreement according to Section 7.3; provided that if any of subsections (a)-(f) is held invalid or unenforceable for any reason, such invalidity or unenforceability shall not affect any of the other said subsections. Notwithstanding any other provision of this Agreement, Virtuoso shall not have the right to assume or participate in the defense, settlement or other disposition of such Patent Challenge, but shall pay associated costs, fees and expenses as provided in Section 0(c). The Parties agree any challenge or opposition to a Licensed Patent by Virtuoso may be detrimental to Vanderbilt, and that the above provisions shall constitute reasonable liquidated damages to reasonably compensate Vanderbilt for any loss it may incur as a result of Virtuoso taking such action.

 

6.7              Patent Extensions. Virtuoso and Vanderbilt agree that the Licensed Patents shall be extended by all means provided by law or regulation, including without limitation extensions provided under United States law at 35 U.S.C. §§154(b), 155A, and 156. Virtuoso hereby agrees to provide Vanderbilt with all necessary assistance in securing such extensions, including without limitation, providing all information regarding applications for regulatory approval, approvals granted, and the timing of same. Virtuoso acknowledges that extensions under 35 U.S.C. §156 must be applied for within sixty (60) days of the date that a Licensed Product receives permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use, and that Virtuoso’s failure to promptly provide the necessary information or assistance to Vanderbilt during such sixty (60) day period will cause serious injury to Vanderbilt, for which Virtuoso will be liable.

 

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Article 7
DURATION AND TERMINATION

 

7.1              Term. The term of this Agreement shall commence on the Effective Date and shall continue until the expiration of the last to expire of the Licensed Patents, unless sooner terminated in accordance with the provisions herein (the “Term”).

 

7.2              Bankruptcy. If Virtuoso becomes bankrupt or insolvent, files a petition in bankruptcy, or is placed in the hands of a receiver, assignee, or trustee for the benefit of creditors, whether by the voluntary act of Virtuoso or otherwise, this Agreement shall automatically terminate, inasmuch as permitted under applicable and prevailing law.

 

7.3              Vanderbilt Termination. If Virtuoso (i) fails to make a payment to Vanderbilt of royalties, Patenting Costs or any other payment in accordance with the terms of this Agreement, (ii) breaches or defaults on its obligations under Article 4 (Diligence), or (iii) breaches or defaults on any other material term of this Agreement, Vanderbilt shall have the right to serve notice upon Virtuoso of Vanderbilt’s intention to terminate the entirety of the rights, privileges and licenses granted hereunder within thirty (30) days from the mailing of such notice. If Virtuoso does not timely pay all such overdue amounts to Vanderbilt, or, as applicable, if Virtuoso fails to reasonably cure such breach or default and to timely provide Vanderbilt with reasonably acceptable written evidence of such cure, then this Agreement may be immediately terminated upon notice by Vanderbilt at any time after said thirty (30) day period by notice to Virtuoso. Such termination shall be effective as of the date of mailing of said termination notice. If Virtuoso disputes the grounds for such termination, Virtuoso must provide written notice of the dispute to Vanderbilt prior to the effective date of said termination. If Virtuoso fails to provide such notice, Virtuoso agrees it forfeits its right to dispute such termination. Notwithstanding the foregoing, the non-timely payment of the Issue Fee or Past Patenting Costs automatically renders this Agreement null, void, and without effect, and any breach of the Indemnification and Insurance article automatically terminates this Agreement (subject to the Lapse of Coverage section). If Virtuoso brings a Patent Challenge against Vanderbilt, assists others in bringing a Patent Challenge against Vanderbilt or otherwise breaches its obligations under Section 0 then Vanderbilt may, at its option, terminate this Agreement without notice.

 

7.4              Virtuoso Termination. Virtuoso shall have the right to terminate this Agreement at any time by providing Vanderbilt with one hundred twenty (120) days advance notice, stating the reason for such termination. Upon such termination, Vanderbilt shall be free to license such rights to third parties, without any further obligation to Virtuoso whatsoever.

 

7.5              Continued Obligations. Upon termination of this Agreement for any reason, (i) all rights and licenses granted to Virtuoso under the terms of this Agreement will terminate and nothing herein shall be construed to release either Party from any obligation that matured prior to the effective date of such termination; (ii) all Confidential Information of the other Party shall be promptly returned or destroyed, at the disclosing Party’s election; (iii) Virtuoso shall cease all production and sale of Licensed Product; (iv) final reports in accordance with Section 4.3 and Article 5 (Records, Reports and Payments) shall be submitted to Vanderbilt; and (v) all royalties and other payments, including without limitation any unreimbursed Patent Costs, accrued or due to Vanderbilt as of the termination date shall become immediately payable. Notwithstanding the foregoing sentence, after the effective date of termination of this Agreement, unless for breach by Virtuoso (including breach due to a lapse of coverage as described in Section 10.4), Virtuoso may, for a period of six (6) months, sell all Licensed Products existing at the time of such termination, and complete Licensed Products in the process of manufacture at the time of such termination and sell the same, provided that Virtuoso shall comply with, all of the terms of this Agreement, including, (i) Virtuoso shall pay to Vanderbilt the running royalties and other payments as required hereinabove including Article 3 (Financial Considerations), (ii) insurance required hereunder shall be in effect, as described in Sections 10.2 through 10.3, and (iii) Virtuoso shall submit the reports required by Section 5.2 hereof.

 

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7.6              Survival. The following provisions of this Agreement, and the defined terms and provisions used or referenced therein, shall survive termination of this Agreement: Section 3.2 (Running Royalties), Section 5.1 (Record Accounting), Article 7 (Duration and Termination), Article 8 (Confidentiality), Article 9 (Dispute Resolution), Article 10 (Indemnification and Insurance), Article 11 (Disclaimers), Section 12.3 (Export Control), Article 13 (Non-Use of Names and Publicity), and Article 15 (Miscellaneous).

 

Article 8
CONFIDENTIALITY

 

8.1              Confidential Information. During the Term and for a period of five (5) years thereafter, the Parties agree that all Confidential Information shall be maintained in confidence by the receiving Party and shall not be disclosed by the receiving Party to any third parties unless agreed to in writing by the Party providing the information; nor shall any such Confidential Information be used by the receiving Party for any purpose other than those contemplated by this Agreement; except, however, the Parties agree that nothing herein will be construed to prevent (i) the Parties from providing information about this Agreement and amounts paid as part of other routinely prepared summary documents, (ii) Vanderbilt from reporting consideration received hereunder to the Inventors and to the Government, as required, or de-identified raw terms as part of a larger database, or (iii) the Parties from providing information that is required to be disclosed by law, regulation or judicial order.

 

8.2              Security. Virtuoso and Vanderbilt agree that the confidentiality obligations hereunder shall require that each Party use those security and confidentiality procedures and practices as each would use for its own confidential records.

 

8.3              Publication. Virtuoso agrees that nothing herein shall prevent Vanderbilt from disclosing or publishing any information other than Virtuoso Confidential Information, or create any legal liability for doing so, irrespective of whether such information comprises Vanderbilt Confidential Information.

 

Article 9
DISPUTE RESOLUTION

 

9.1              Law to Govern. This Agreement, and all disputes arising out of or related to this Agreement, shall be subject to and construed and enforced in accordance with the laws of the State of Tennessee without regard to its conflict of laws principles, except that questions affecting the construction and effect of any patent or patent application shall be determined by the law of the jurisdiction in which the patent has issued or would issue.

 

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9.2              Venue. Each Party (a) irrevocably submits to the exclusive jurisdiction of the United States District Court for the Middle District of Tennessee or a local court sitting in Davidson County, Tennessee (collectively, the “Courts”) for purposes of any action, suit or other proceeding relating to or arising out of this Agreement and (b) agrees not to raise any objection at any time to the laying or maintaining of the venue of any such action, suit or proceeding in any of the Courts, irrevocably waives any claim that such action, suit or other proceeding has been brought in an inconvenient forum and further irrevocably waives the right to object, with respect to such action, suit or other proceeding, that such Court does not have any jurisdiction over such Party. In the event of any controversy, claim or counterclaim arising out of or relating to this Agreement, either Party may effect service of process by providing a complaint and/or summons or other court filing to the other Party pursuant to Section 15.1. Any defenses based on adequacy of service of process, other than breach of Section 15.1, are waived.

 

9.3              Performance to Continue. Each Party shall continue to perform its undisputed obligations under this Agreement pending final resolution of any dispute arising out of or relating to this Agreement.

 

9.4              Statute of Limitations. The Parties agree that all applicable statutes of limitation and time- based defenses (such as estoppel and laches) shall be tolled pending final resolution of any dispute arising out of or relating to this Agreement. The Parties shall cooperate in taking any actions necessary to achieve this result.

 

Article 10
INDEMNIFICATION AND INSURANCE

 

10.1       Indemnification. The Parties acknowledge that Virtuoso, shall be fully responsible for the quality, safety and operability of all Licensed Products, and shall have sole control over, and responsibility for, the development, design, testing, promotion, marketing, sales, and other activities directed to the commercialization of Licensed Products. Virtuoso acknowledges that the technology embodied in the rights licensed hereunder is experimental and agrees to take all reasonable precautions to prevent death, personal injury, illness and property damage. Virtuoso shall obtain and maintain product liability and general liability insurance which is sufficient to meaningfully protect Vanderbilt as required by this Article.

 

10.1.1    Virtuoso shall indemnify, defend and hold harmless Vanderbilt and its Representatives (the “Indemnitees”) against any liability, obligation, damage, loss, adverse impact or expense (including reasonable attorney’s fees and expense of litigation) (“Losses”) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, allegations, assertions, investigations, demands or judgments (“Claims”) arising out of or related to: the exercise of any rights granted under this Agreement; any breach of this Agreement; any product, process or service made, used or sold pursuant to any right or license granted under this Agreement, under any theory of law (including, but not limited to, actions in the form of tort, warranty or strict liability); infringement of a third party’s rights by a Licensed Product; or any declaratory judgment action or other Claim related to Licensed Patents in the Field, including their validity, enforceability, non-infringement or scope.

 

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10.1.2    Vanderbilt shall give prompt notice to Virtuoso of the commencement of any action, suit or proceeding for which indemnification may be sought, provided that failure to do so shall not affect the rights of the Indemnitees unless, and then only to the extent that, such delay or failure is prejudicial to or otherwise adversely affects Virtuoso. Virtuoso agrees, at its own expense, to provide attorneys reasonably acceptable to Vanderbilt to defend against any Claims brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such Claims are rightfully brought; provided, however, that Vanderbilt shall be entitled to participate in any such action, suit or proceeding with counsel of its own choice, but at its own expense. If Virtuoso fails to assume the defense within a reasonable time, Vanderbilt may assume such defense and the reasonable fees and expenses of its attorneys and any Losses will be covered by the indemnity provided for in this Section IO. I. Any Indemnitee shall have the right to retain its own counsel, at the expense of Virtuoso, if representation of such Indemnitee by the counsel retained by Virtuoso would be inappropriate because of actual or potential differences in the interests of such Indemnitee and any other party represented by such counsel. The Indemnitees shall cooperate in such defense as reasonably requested by Virtuoso, at Virtuoso’s sole expense. Virtuoso agrees to keep Vanderbilt informed of the progress in the defense and disposition of such claim and to consult with Vanderbilt with regard to any proposed settlement. Virtuoso agrees that it will not settle, compromise, voluntarily dispose of or fail to defend any such action (including any cross claim, counterclaim or declaratory judgment action) without the prior written consent of Vanderbilt.

 

10.2          Insurance. Virtuoso shall not make, use, import, offer to sell or sell any Licensed Product, or engage in any other act involving any Licensed Product or the Licensed Rights, if such act could possibly create risk of a claim against the Indemnitees for personal injury or property damage, unless Virtuoso shall have first provided Vanderbilt with certificates of insurance, to be updated yearly, proving that Virtuoso has in force, during the term of this Agreement, policies of: (i) commercial general liability insurance, containing contractual liability coverage, with sufficient occurrence and annual aggregate limits and (ii) product liability insurance with sufficient claims- made and tail coverage limits to indemnify the Indemnitees against liability claims for accidental death, injury, illness or other damages arising from such act, as required by the previous paragraph. Such product liability insurance shall cover each Licensed Product with total limits of not less than:

 

(1)From the Effective Date throughout the Term of this Agreement: general liability insurance in the amount of one million dollars ($1,000,000) per occurrence; two million dollars ($2,000,000) general aggregate.

 

(2)From the date immediately prior to first sale of Licensed Product: product liability insurance in the amount of ten million dollars ($10,000,000) per occurrence; ten million dollars ($10,000,000) aggregate.

 

Such commercial general liability and product liability policies shall: (i) be obtained within thirty (30) days of the Effective Date, (ii) be deemed primary; the insurance of Vanderbilt will be excess and non-contributory and (iii) name Indemnitees as an additional insured party with respect to the sale or other dispensation of Licensed Products. Virtuoso’s insurance carrier for such policies will waive all subrogation rights against Indemnitees.

 

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10.3          Term of Insurance. Virtuoso agrees that the above-described liability insurance policies shall be continuously maintained in force for so long as this Agreement remains in effect, and such policy will provide coverage for all liabilities that may arise due to the actions of Virtuoso or the manufacture, use or sale of Licensed Products, irrespective of whether such liability may occur or be claimed for a period of up to three (3) years after termination hereof. Neither Virtuoso nor any third party shall terminate, reduce the face value of, or otherwise materially modify such insurance coverage while such policy is in effect, unless equal or greater coverage is first provided under another policy in compliance with the foregoing provisions and without any gap in coverage.

 

10.4          Lapse of Coverage. This Agreement and the licenses granted herein to Virtuoso shall immediately and automatically terminate without notice in the event Virtuoso or other party acting under authority of Virtuoso, fails to obtain the insurance required hereunder, or if the insurance lapses or is cancelled. A termination occurring under this paragraph shall occur and become effective at the time such insurance coverage ends or becomes required and is not obtained, and Virtuoso shall then have no right to complete production and sale of Licensed Products under the Continued Obligations paragraph hereinabove. Nothing herein shall be construed to release either Patty from any obligation that matured prior to the effective date of such termination. Notwithstanding the foregoing, in the three (3) month period subsequent to the date of such an automatic termination of this Agreement by operation of this paragraph, to the extent that such rights are still available for licensing, Virtuoso shall have the right to reinstate the effectiveness of this Agreement by obtaining the required insurance, whereupon this Agreement shall automatically become effective as of the date of reinstatement of said insurance, including coverage for the period of lapse or cancellation, and shall remain in full force and effect without any further action of the Patties. For the avoidance of doubt, in the event of such reinstatement, royalties shall be owed on any Licensed Products sold during the period of lapse or cancellation.

 

Article 11
DISCLAIMERS

 

Virtuoso acknowledges and agrees that all rights licensed by Vanderbilt hereunder are licensed “as is” and without any representation, indemnification or warranty with respect to possible infringement of third party rights. Nothing in this Agreement shall be construed as (i) a warranty or representation by Vanderbilt as to the validity or scope of any Licensed Patents, (ii) a warranty or representation that anything made, used, imported, developed, promoted, offered for sale, sold, or otherwise disposed of under any license granted in this Agreement does not or will not infringe patents, trade secrets or other proprietary rights; (iii) a representation or warranty of operability or that development of a commercial product is possible; (iv) an obligation to bring or prosecute actions or suits against third parties for infringement; (v) conferring the right to use in advertising, publicity or otherwise any trademark, trade name, or names, or any contraction, abbreviation, simulation or adaptation thereof of Virtuoso or Vanderbilt; (vi) conferring by implication, estoppel or otherwise any license or rights under any patents of Vanderbilt other than the Licensed Patents regardless of whether such patents are dominant or subordinate to any Licensed Patents; and (vii) any other representations or warranties, either express or implied, unless specified in this Agreement. Except as expressly provided herein, the furnishing of Confidential Information by Vanderbilt shall not be interpreted to convey any grant of rights, titles, interests, options or licenses to Virtuoso under any of the Licensed Patents or other patents. VANDERBILT DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY STATED IN THIS ARTICLE, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE, WITH RESPECT TO THE LICENSED PATENTS OR ANY LICENSED PRODUCTS, AND INCLUDING WARRANTIES WITH RESPECT TO THE SCOPE, VALIDITY OR ENFORCEABILITY OF ANY OF THE LICENSED PATENTS, THAT ANY PATENT WILL ISSUE BASED UPON ANY OF THE PENDING APPLICATIONS COMPRISING SAME, OR THAT THE USE OF ANY OF THE LICENSED PATENTS WILL NOT INFRINGE OTHER INTELLECTUAL PROPERTY RIGHTS. IN NO EVENT WILL VANDERBILT, OR THE VANDERBILT INDEMNITEES, BE LIABLE FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES OF ANY KIND, LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT OR PUNITIVE DAMAGES, WHETHER GROUNDED IN TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, CONTRACT OR OTHERWISE, REGARDLESS OF WHETHER VANDERBILT IS ADVISED, HAS REASON TO KNOW, OR IN FACT KNOWS OF THE POSSIBILITY OF SUCH DAMAGES. VANDERBILT WILL HAVE NO RESPONSIBILITIES OR LIABILITIES WHATSOEVER WITH RESPECT TO LICENSED PRODUCTS. Virtuoso shall make no statements, representations or warranties whatsoever to any third parties which are inconsistent with the foregoing. In no event shall Vanderbilt, or the Vanderbilt Indemnitees be liable for damages in excess of amounts Vanderbilt has received from Virtuoso under this Agreement.

 

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Article 12
COMPLIANCE

 

12.1          Compliance with Law. Virtuoso shall have the sole obligation for compliance with, and shall ensure that any of its Affiliates comply with, all government statutes and regulations that relate to Licensed Products and its activities pursuant to this Agreement.

 

12.2          Marking. Virtuoso shall mark all Licensed Products made or sold in the United States in accordance with 35 U.S.C. §287(a), and will mark all Licensed Products made or sold in other countries in accordance with the laws and regulations then applicable in each such country; and Virtuoso agrees that it will be liable to Vanderbilt for infringement damages lost due to improper or defective patent marking.

 

12.3          Export Controls. Virtuoso shall comply with all United States laws and regulations controlling the export of licensed commodities and technical data. (For the purpose of this Section 12.3, “licensed commodities” means any article, material or supply but does not include information; and “technical data” means tangible or intangible technical information that is subject to United States export regulations, including blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions.) These laws and regulations may include, but are not limited to, the Export Administration Regulations (15 C.F.R. 730-774), the International Traffic in Arms Regulations (22 C.F.R. 120-130) and the various economic sanctions regulations administered by the United States Department of the Treasury (31 C.F.R. 500-600). Among other things, these laws and regulations prohibit or require a license for the export or retransfer of certain licensed commodities and technical data to specified countries, entities and persons. Virtuoso hereby gives written assurance that it will comply with, and will cause its Affiliates to comply with, all United States export control laws and regulations, that it beam sole responsibility for any violation of laws and regulations by itself or its Affiliates, and that it will indemnify, defend and hold Vanderbilt and the Indemnitees (as defined in Paragraph 10.1.1) harmless for the consequences of any such violation.

 

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12.4          Anti-Kickback and Stark Law. It is the intention of the Parties to comply with all applicable laws, rules, and regulations, including (i) the federal anti-kickback statute (42 U.S.C.§1320a-7b) and related safe harbor regulations, and (ii) the Limitation Certain Physician Referrals (42 U.S.C. §1395nn, the “Stark Law”) and related regulations. Accordingly, the Parties agree and acknowledge that no consideration received under this Agreement is, or is intended to be, a prohibited payment for the recommending or arranging for the referral of business or ordering of items or services, nor is any such consideration intended to induce illegal referrals of business.

 

12.5          Debarment. Virtuoso hereby represents and warrants that it has not been debarred, suspended, excluded or otherwise determined to be ineligible to participate in federal healthcare programs or federal procurement and non-procurement programs (collectively, “Debarred”) and Virtuoso agrees not to engage or assign any employee, agent or contractor (“Agent”) to perform services under this Agreement who has been Debarred. Virtuoso acknowledges that Vanderbilt shall have the right to terminate this Agreement immediately without further obligation in the event that Virtuoso or an Agent is Debarred. Accordingly, Virtuoso shall provide Vanderbilt with immediate notice if during the Term Virtuoso (a) receives notice of action or threat of action with respect to its Debarment or (b) becomes Debarred.

 

12.6          Conflict of Interest. Virtuoso acknowledges that Vanderbilt’s employees and medical and professional staff members and the employees and staff members of Vanderbilt’s Affiliates are subject to the applicable policies of Vanderbilt and such Affiliates, including, without limitation, policies regarding conflicts of interest, intellectual property and other matters. Virtuoso shall not enter into any oral or written agreement with such employee or staff member which conflicts with any such policy.

 

12.7          Tax Exempt Status. The Parties recognize that Vanderbilt is a non-profit, tax-exempt organization and agree that this Agreement will take into account and be consistent with Vanderbilt’s tax-exempt status.

 

Article 13
NON-USE OF NAMES AND PUBLICITY

 

13.1          Non-Use of Names. Neither Party shall use the name, trademark, service mark, trade name, or symbol or any adaptation thereof of the other Party or of any of its trustees, directors, officers, employees, faculty, Inventors, affiliated investigators, agents and representatives, medical and professional staff, students or Affiliates for advertising, marketing, endorsement, promotional or sales literature, publicity, public announcement or disclosure or in any document employed to obtain funds or financing without the specific prior written consent of an authorized representative of the other Party or individual whose name is to be used as to each such use.

 

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13.2          Publicity. The Parties will maintain the terms of this Agreement confidential, and neither Party shall issue any press release or other public statements related to this Agreement without the specific prior written consent of an authorized representative of the other Party as to each such use; provided that the Parties may make factual statements that Virtuoso has a license from Vanderbilt under one or more of the patents or patent applications comprising the Licensed Patents and regarding the type and extent of the license.

 

Article 14
ASSIGNMENT

 

14.1          This Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective permitted assigns and successors in interest. Except as expressly permitted in this Agreement, Virtuoso shall not assign, delegate or subcontract any of its rights or obligations under this Agreement without the prior written consent of Vanderbilt.

 

14.1.1    No such consent will be required to assign this Agreement to a successor in connection with a merger or consolidation of Virtuoso, or to the purchaser of all or substantially all the assets of Virtuoso, provided that: (i) Virtuoso is not in breach of this Agreement; (ii) such successor or purchaser shall agree in writing to be bound by the terms and conditions hereof prior to such assignment; (iii) Virtuoso shall provide Vanderbilt with evidence to demonstrate that such successor or purchaser has or is likely to acquire, in a reasonable period of time, capital and personnel resources sufficient to fulfill the obligations it is assuming hereunder; (iv) Virtuoso shall notify Vanderbilt in writing of any assignment and provide a copy of all assignment documents (pursuant to which such transferee shall have agreed in writing to be bound by the terms and conditions of this Agreement) to Vanderbilt within thirty (30) days of assignment; and (v) Virtuoso shall pay to Vanderbilt a fee of one hundred thousand dollars (U.S. $100,000). Following such assignment, the term “Virtuoso” as used herein shall include the assignee.

 

14.1.2    Failure of an assignee to agree to be bound by the terms hereof or failure of Virtuoso to notify Vanderbilt and provide copies of assignment documentation shall be grounds for termination of this Agreement for default. Any attempted assignment in contravention of this Section 14.1 shall be null and void.

 

Article 15
MISCELLANEOUS

 

15.1          Payments and Notices. Any notice or other communication given under this Agreement (not including correspondence or communications pursuant to Section 6.1 or reports and payments under Sections 5.2 and 5.5) shall be in writing and shall be deemed delivered when sent by certified first class mail, or by overnight courier with confirmed receipt, addressed to the Parties as follows (or at such other addresses as the Parties may notify each other in writing):

 

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Virtuoso Surgical, Inc.

5701 Old Harding Pike, Suite 200

Nashville, TN 37205

(615) 352-9588

 

Attention: Mark Pickrell

Vanderbilt

Center for Technology Transfer and

Commercialization

Vanderbilt University

1207 17th Avenue S., Suite 105

Nashville, TN 37212

Attention: Assistant Vice Chancellor

 

15.2          Severability. In the event that any provision of this Agreement shall be held invalid or unenforceable for any reason, such invalidity or unenforceability shall not affect any other provision of this Agreement, and the Parties shall negotiate in good faith to modify the Agreement to preserve (to the extent possible) their original intent.

 

15.3          Interpretation. The article and paragraph headings contained in this Agreement are for reference purposes only, and shall not in any way affect the meaning or interpretation of this Agreement. The words “include” or “including” shall be construed as incorporating, also, “but not limited to” or “without limitation.” The Parties acknowledge that each Party has read and negotiated the language used in this Agreement. Because all Patties participated in negotiating and drafting this Agreement, no rule of construction will apply to this Agreement which construes ambiguous language in favor of or against any Party by reason of that Party’s role in drafting this Agreement.

 

15.4          Amendment and Waiver. No waiver, modification, release or amendment of any obligation under this Agreement shall be valid or effective unless in writing and signed by an authorized representative of the Patty to be bound and explicitly references this Agreement and specifies that it is the Parties’ intent to modify the terms and/or conditions set forth herein. The Parties acknowledge that invoices, purchase orders or other mechanisms for administering any payment or other obligation set forth herein shall not contain terms and conditions separate from, in addition to, and/or in conflict with this Agreement, and that any such terms, if present, shall be void and without effect, and shall not be enforceable by any Party hereto. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Patty of any condition or term shall be deemed as a further or continuing waiver of such condition or term or of any other condition or term.

 

15.5          Entire Agreement. The Parties hereto agree that this Agreement (including any attachments, appendices, exhibits or the like) sets forth the entire agreement and understanding of the Parties hereto as to the subject matter hereof, and supersedes any and all prior written and oral agreements, understandings, promises or offers, including any term sheet which preceded its drafting, but does not supersede any confidentiality or non-disclosure agreement between the Parties.

 

15.6          Independent Contractors. For the purpose of this Agreement and any services to be provided hereunder, each Party shall be, and shall be deemed to be, an independent contractor and not an agent, partner, joint venturer or employee of the other Party. Neither Party shall have authority to make any statements, representations or commitments of any kind, or to take any action which shall be binding on the other Party, except as may be explicitly authorized in writing.

 

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15.7          Counterparts. This Agreement and any amendment hereto may be executed in counterparts, including by facsimile or by electronic scan copies delivered by email, each of which counterparts, when so executed and delivered, shall be deemed to be an original, and all of which counterparts, taken together, shall constitute one and the same instrument.

 

* * * * * * *

 

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

 

VIRTUOSO SURGICAL, INC.

 

By:    
     
Date:    
     
Title:    

 

VANDERBILT UNIVERSITY

 

By: /s/ Padma Raghavan  
     
Title: Vice Provost for Research  
     
Date: 5/24/2016  
     
By: /s/ Susan L. Hart  
     
Title: Associate Vice Chancellor, Academic Affairs  
     
Date: 6/7/2016  

 

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Appendix A
LICENSED PATENTS

 

VU Ref.
No.
Country Application
No.
Title Patent
No.
VU 13034 us 14/256,540 System and Apparatus for Endoscopic Deployment of Robotic Concentric Tube Manipulators for Performing Surgery n/a
VU 16035 us 62/236,187 Hand-held Concentric Tube Manipulator Actuation Unit and Mechanism for Surgery

n/a

 

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Appendix B

QUARTERLY REPORTS

 

These reports shall include at least the following, on a Licensed Product-by-Licensed Product and country-by-country basis:

 

(A)       The numbers or quantity of each Licensed Product sold by Virtuoso during the calendar quarter;

 

(B)       The gross amount billed by Virtuoso for Licensed Products, and an accounting of any non-monetary consideration for each Licensed Product sold by Virtuoso during the calendar quarter;

 

(C)       Average sale price during the calendar quarter;

 

(D)       Exchange rates used for currency conversion for the calendar quarter and the basis and methodology used;

 

(E)       Total payments due to Vanderbilt under Running Royalties (Section 3.2) for the calendar quarter, as well as a detailed accounting of how such payments were calculated;

 

(F)       Description and product codes, or other Virtuoso identifier, of each Licensed Product sold during the calendar quarter; and

 

(G)       A list of countries in which a first commercial sale occurred in the calendar quarter.

 

Page 25

 

 

Exhibit C
Warrant

 

 

NEITHER THIS WARRANT NOR THE SECURITIES ISSUABLE UPON EXERCISE HEREOF HAVE BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR ANY STATE SECURITIES ACT (COLLECTIVELY, THE “SECURITIES LAWS”). THIS WARRANT HAS BEEN ACQUIRED FOR INVESTMENT PURPOSES ONLY AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. THIS WARRANT MAY NOT BE SOLD, OFFERED FOR SALE OR OTHERWISE TRANSFERRED EXCEPT IN COMPLIANCE WITH SECTION 11 OF THIS WARRANT AND UNLESS THE SECURITIES (I) ARE REGISTERED UNDER THE SECURITIES LAWS OR (II) ARE EXEMPT FROM REGISTRATION UNDER THE SECURITIES LAWS AND THE COMPANY IS PROVIDED AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED.

 

WARRANT TO PURCHASE COMMON STOCK OF

 

Virtuoso Surgical, Inc.

 

This WARRANT (“Warrant”) is issued this 15th day of May 2016, by Virtuoso Surgical, Inc., a Tennessee corporation (the “Company”), to Vanderbilt University, a Tennessee not-for-profit corporation (the “Holder”).

 

1.       Grant.

 

(a)       For and in consideration of Holder entering into that certain license agreement with Company of even date herewith (the “License Agreement”), and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Company hereby grants to Holder the right to purchase, from time to time at Holder’s option, that number of shares of Company’s Common Stock (the “Warrant Shares”) as is equal to, on the date of exercise, X percent (X%) of the aggregate number of outstanding shares of Company’s Common Stock, calculated on a fully-diluted basis assuming the exercise and/or conversion of all outstanding securities exercisable for or convertible into Company’s Common Stock (including this Warrant), whether or not such securities are currently exercisable or convertible, assuming that such conversions and/or exercises are effected for the maximum number of shares exercisable under all such outstanding securities.

 

(b)       At such time as the Company shall have sold and issued at least FIVE HUNDRED THOUSAND DOLLARS ($500,000) of equity securities that are not subject to redemption for any reason other than the passage of a period of time not less than seven (7) years (a “Warrant Share Freeze Event”), then the number of shares for which this Warrant shall thereafter by exercisable shall equal the maximum number of shares for which this Warrant was exercisable immediately after such Warrant Share Freeze Event, except as provided in Section l(c) hereof

 

Page 26

 

 

(c)       If the Company at any time makes a redemption of, or special dividend in respect of, any equity securities the purchase price for which is included among the $500,000 described in Section l(b), then it shall be treated for purposes of this Warrant as though such securities had never been issued and, unless a Warrant Share Freeze Event would nonetheless be deemed to have occurred based on the aggregate sales of other equity securities, the number of shares for which this Warrant is exercisable shall be increased accordingly, subject to the later sale and issuance of equity securities sufficient to have triggered a Warrant Share Freeze Event when aggregated with the prior sales that previously triggered the Warrant Share Freeze Event.

 

2.       Exercise Price. The aggregate exercise price (not per Warrant Share, but for any or all of the Warrant Shares that may be purchased pursuant to this Warrant at any time or from time to time) shall be Ten Dollars ($10.00) (the “Exercise Price”).

 

3.       Warrant Exercise. This Warrant may be exercised by Holder at any time and from time to time following the “Effective Date” as described in the License Agreement, by delivering to Company: (i) the attached form of Election to Purchase, duly completed and executed by Holder; and (ii) payment of the Exercise Price in cash or by check. Notwithstanding the occurrence of a Warrant Share Freeze Event, this Warrant shall continue in full force and effect until the Termination Date (as hereinafter defined).

 

4.       Delivery of Stock Certificates. Within five (5) days after any exercise of this Warrant, Company, at its expense, shall issue in the name of and deliver to Holder a certificate or certificates for the number of Warrant Shares to which Holder shall be entitled upon such exercise. Holder shall for all purposes be deemed to have become the holder of record of such Warrant Shares on the date on which payment of the Exercise Price is made, irrespective of the date of delivery of the certificate or certificates representing the Warrant Shares; provided that, if the date of such payment is a date when the stock transfer books of Company are closed, Holder shall be deemed to have become the holder of record of such Warrant Shares at the close of business on the next succeeding date on which the stock transfer books are open.

 

5.       Certain Items. Company represents, warrants and agrees that all Warrant Shares issued pursuant to the terms of this Warrant will, upon their issuance, be validly issued and outstanding, fully paid and nonassessable. Company further represents, warrants and agrees that Company will at all times have authorized and reserved a sufficient number of shares of Common Stock to provide for Holder’s exercise of the rights represented by this Warrant.

 

6.       Investment Representations of Holder. Holder represents, warrants and agrees on the date hereof, as follows:

 

(a)       Holder understands that neither this Warrant nor any of the Warrant Shares acquired pursuant to this Warrant have been, nor will they be, registered under the securities laws of the United States and any applicable state laws (“Securities Laws”), and Company is under no obligation to register either the Warrant or such Warrant Shares under the Securities Laws.

 

(b)       To the extent applicable, Holder is acquiring this Warrant and will be acquiring the Warrant Shares pursuant to this Warrant for investment and for its own account, and not with a view to, or for resale in connection with, any distribution.

 

Page 27

 

 

(c)       Holder understands that the Warrant and the Warrant Shares must be held indefinitely and Holder must continue to bear the economic risk of the investment for an indefinite time unless the Warrant or the Warrant Shares, as applicable, is subsequently registered under the Securities Laws or an exemption from such registration is available.

 

(d)       Holder is an “accredited investor” as defined in Rule 501 of Regulation D promulgated under the United States Securities Act of 1933, as amended.

 

7.       Termination. This Warrant shall be cancelled and the rights granted hereunder shall terminate at the close of business on the tenth (10th) anniversary of the issuance of the Warrant (the “Termination Date”).

 

8.       Significant Business Transactions. If at any time while this Warrant, or any portion thereof, is outstanding and unexpired there shall be: (i) a reorganization; (ii) a merger or consolidation of Company with or into another corporation in which Company is not the surviving entity, or a reverse triangular· merger in which Company is the surviving entity but the shares of Company’s capital stock outstanding immediately prior to the merger are converted by virtue of the merger into other property, whether in the form of securities, cash, or otherwise; or (iii) a sale or transfer of Company’s properties and assets as, or substantially as, an entirety to any other party, then, unless prior to or contemporaneous with the closing of such reorganization, merger, consolidation, sale or transfer, Holder has exercised this Warrant, as a part of such reorganization, merger, consolidation, sale or transfer, lawful provision shall be made so that Holder shall thereafter be entitled to receive upon exercise of this Warrant (or partially exercised, then only for that portion of the Warrant outstanding), during the period specified herein and upon payment of the Exercise Price then in effect, that number of shares of stock or other securities or property of the successor corporation resulting from such reorganization, merger, consolidation, sale or transfer that a holder of the shares deliverable upon exercise of this Warrant would have been entitled to receive in such reorganization, consolidation, merger, sale or transfer if this Warrant had been exercised immediately before such reorganization, merger, consolidation, sale or transfer, all subject to further adjustment as provided in this Section 8. The foregoing provisions of this Section 8 shall similarly apply to successive reorganizations, consolidations, mergers, sales and transfers and to the stock or securities of any other corporation that are at the time receivable upon the exercise of this Warrant. In all events, appropriate adjustment (as determined in good faith by Company’s Board of Directors) shall be made in the application of the provisions of this Warrant with respect to the rights and interests of Holder after the transaction, to the end that the provisions of this Warrant shall be applicable after that event, as near as reasonably may be, in relation to any shares or other property deliverable after that event upon exercise of this Warrant.

 

9.       Fractional Shares. No fractional shares shall be issued upon the exercise of this Warrant.

 

10.       Restrictions on Transfer. This Warrant may not be transferred unless: (i) the Warrant is registered under the Securities Laws; (ii) Company has received a legal opinion reasonably satisfactory to Company to the effect that the transfer is exempt from the prospectus delivery and registration requirements of the Securities Laws; or (iii) Company otherwise satisfies itself that such transfer is exempt from registration. A legend setting forth the foregoing restrictions shall be placed on any certificate representing a security issued pursuant to the exercise hereof and a stop transfer restriction or order may be placed on the books of Company and with any transfer agent until such securities may be legally sold or otherwise transferred.

 

Page 28

 

 

11.       Holder as Owner. Company may deem and treat Holder as the absolute owner of this Warrant for all purposes regardless of any notice to the contrary.

 

12.       No Rights as Shareholder. This Warrant shall not by itself entitle Holder to any voting rights or any other rights as a shareholder of Company or to any other rights whatsoever except the rights stated herein; and no cash or stock dividend or interest shall be payable or shall accrue in respect of this Warrant or the Warrant Shares purchasable hereunder unless, until and to the extent that this Warrant shall be exercised.

 

13.       Construction. The descriptive headings of the several sections of this Warrant are inserted for convenience only and shall not control or affect the meaning or construction of any of the provisions thereof

 

14.       Expiration. This Warrant shall be void and all rights represented thereby shall cease unless exercised on or before the Termination Date. All restrictions set forth herein on the Warrant Shares issued upon exercise of any rights hereunder shall survive such exercise and expiration of the rights granted hereunder.

 

15.       Lost Warrant Certificate. If this Warrant is lost, stolen, mutilated or destroyed, Company shall issue a new warrant of like denomination, tenor and date as this Warrant, subject to Company’s right to require Holder to give Company a bond or other satisfactory security sufficient to indemnify Company against any claim that may be made against it (including any expense or liability) on account of the alleged loss, theft, mutilation or destruction of this Warrant or the issuance of such new warrant.

 

16.       Waivers and Amendments. This Warrant or any provision hereof may be changed, waived, discharged or terminated only by a statement in writing signed by Company and Holder.

 

17.       Notices. All notices or other communications required or permitted hereunder shall be in writing and shall be delivered in person, mailed by United States mail, first-class postage prepaid, or by registered or certified mail with return receipt requested, or delivered by nationally recognized overnight courier service, addressed as follows:

 

If to Holder:

 

Center for Technology Transfer and Commercialization

Vanderbilt University

1207 17th Avenue South

Suite 105

Nashville, TN 37212

Attention: Assistant Vice Chancellor

Fax: 615-343-4419

 

Page 29

 

 

With a copy to:

 

Vanderbilt University

305 Kirkland Hall

Nashville, Tennessee 37240

Attention: General Counsel

Facsimile: (615) 343-3930

If to Company:

 

Virtuoso Surgical, Inc.

5701 Old Harding Pike, Suite 200

Nashville, TN 37205

 

Each of the parties shall be entitled to specify a different address by giving five (5) days’ advance written notice to the other patty.

 

19.       Applicable Law. The validity and construction of this Warrant shall be determined according to the laws of Tennessee applicable to contracts executed and performed within that state, without reference to its conflict of law principles. Each patty hereby irrevocably and unconditionally consents to exclusive venue in any state or federal court located in the Davidson County, Tennessee (the “Davidson County Courts”) for any litigation arising out of or relating to this Warrant, and each party hereby waives any objection to the laying of venue of any such litigation in the Davidson County Courts and agrees not to plead or claim in any Davidson County Court that such litigation brought therein has been brought in an inconvenient forum.

 

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

 

VANDERBILT UNIVERSITY  Virtuoso Surgical, Inc.

         
By:     By:  
         
Name:     Name:  
         
Title:     Title:  
         
Date:     Date:    

 

Page 30

 

 

NOTICE OF EXERCISE

 

TO: Virtuoso Surgical, Inc.

 

Vanderbilt University, pursuant to the provisions set forth in the attached Warrant, hereby elects to exercise the Warrant and subscribe for the purchase of _______________ Shares covered by the Warrant and hereby makes payment in full for the Shares at the price per share of Common Stock set forth in the Warrant as follows:

 

¨       By check in the amount of $10.00.

 

The undersigned requests that the certificates for the Shares be issued in the name of “Vanderbilt University” and delivered to the address set forth below the signature.

 

Vanderbilt University   
    
    
Name  Date
    
    
Title   
    
    
    
    
Address   

 

Page 31

EX1A-6 MAT CTRCT 9 tm1927293d1_ex6-4.htm EXHIBIT 6.4

 

Exhibit 6.4

 

 

 

September 7, 2017

 

Dr. Richard Hendrick

2036 Graybar Lane

Nashville, Tennessee 37215

 

Re: Employment by Virtuoso Surgical, Inc.

 

Dear Rich:

 

It is my pleasure to formally offer you employment with Virtuoso Surgical, Inc. (the “Company”), effective September 1, 2017. This letter serves as a memorandum regarding the terms and conditions of your employment. Your job title will be Chief Operating Officer. Your job duties shall include overall management responsibility for the operations and business of the Company.

 

Terms

 

This is a full-time, salaried position. You are expected to devote your full working efforts to work on behalf of the Company. In the event that you perform material work for another organization or person, your salary will be reduced on a pro-rata basis. Your salary shall be $6,250 per month, payable (less tax withholdings) in two equal installments, semi-monthly, on the first business day after the 15th of each month, and the last business day of each month. Expense reimbursements are payable on the last business day of each month.

 

You are entitled to one day of paid time off (whether for vacation, personal days, or sickness) for each month of service, which you can accumulate throughout each calendar year. At the end of each calendar year, any accumulated days of paid time off that are not used shall lapse, and they are not reimbursable in cash or any other consideration. Any additional days taken off, except for sickness, may result in a pro-rata reduction in pay. Additional days taken off for sickness shall be accounted for under the Family and Medical Leave Act of 1993.

 

You are not expected to work on federal holidays or weekends. In the event that you do work on a federal holiday or part of a weekend, you may accrue up to six additional days of comp paid time off in any given calendar year. As with regular paid time off, any accumulated days of comp paid time off that are not used are lost at the end of each calendar year, and they are not reimbursable in cash or any other consideration.

 

 

 

 

In light of the Company’s funding by the NIH, you will be required to keep a log of your work hours and effort. You will remain a salaried employee, even though you are keeping track of your time for report to the NIH.

 

Your employment is “at will,” meaning that you can cease working for the company at any time that you choose, and the Company may terminate your employment at any time.

 

Intellectual Property

 

During the course of your employment by the Company, it is anticipated that you will create original works of authorship or invention that may constitute protectable intellectual property. Any works of authorship or invention, or any other protectable form of intellectual property, that you develop as part of your work for the Company shall be and remain the property of the Company to the fullest extent permissible by law.

 

Non-Disclosure of Confidential Information

 

During the course of your employment, it is anticipated that you will personally learn, and have personal access to, proprietary & confidential information related to the Company. It is anticipated that much of the information that you will have access to as part of your work for the Company includes confidential trade secrets. You agree to keep all confidential information learned or obtained through your work on behalf of the Company confidential, except as reasonably necessary for the fulfillment of your duties on behalf of the Company. Upon the cessation of your employment with the Company, you agree to return all Company-related information maintained in a tangible medium of expression, which was obtained or developed through your work on behalf of the Company, to the Company.

 

Non-Competition Agreement

 

In light of the confidential information that you will have access to as part of your work for the Company, you agree that you will not compete with the Company’s core business or businesses (including specifically, without limitation, the development and sale of endoscopic surgical tools) in any capacity for a duration of one year after the cessation of your employment with the Company. Due to the global nature of surgical-device sales, the geographic area for this non-competition agreement shall be worldwide; to the extent that a court of competent jurisdiction determines that a one-year, world-wide limitation is not enforceable, you and the Company agree that the largest enforceable geographical or temporal limitation shall be enforced to the greatest extent permissible by law.

 

 

 

 

Medical Subsidy Payments

 

The Company will not provide health insurance plans for its employees. Should you be eligible to join a health insurance plan (of a spouse, parent, etc.), the company will provide a $150 monthly subsidy payment, payable to you for deposit into a Health Savings Account on the last business day of each calendar month during the period of your employment. In the event that you are not eligible to join a health insurance plan through other means, the Company will increase its monthly subsidy payment to $250 per person, for up to a four person family plan (with a maximum payment of $1000/month) that you may select at your discretion. You must notify the Company in writing to request a change in medical subsidy payment.

 

¨I will join an eligible health insurance plan (of a spouse, parent, etc.) and will receive the $150/month medical subsidy payment.
¨I am not eligible to join another health insurance plan and will pursue my own health insurance with family members on the plan. I would like to receive the $250 monthly subsidy per person on the plan and understand that the maximum monthly payment is $1000 per month.
¨I do not wish to receive a medical subsidy payment.

 

Retirement Plan

 

The Company will pay 4% of your annual salary (prorated for partial years of employment) expressly for retirement saving. This is not a match program, and it must be used for retirement savings through a traditional IRA. The company will not manage or select the retirement plan for you, and the payment will be made to you in one lump sum at the end of each calendar year.

 

If you have any questions or concerns regarding these terms, please let me know. I look forward to working with you.

 

VIRTUOSO SURGICAL, INC.
   
  By:  /s/ Robert J. Webster III
    Robert J. Webster III
    President

 

Agreed to and Accepted By:  
   
/s/ Richard Hendrick  
Dr. Richard Hendrick  

 

 

 

 

EX1A-6 MAT CTRCT 10 tm1927293d1_ex6-5.htm EXHIBIT 6.5

 

Exhibit 6.5

 

 

September 7, 2017

 

C. Mark Pickrell, Esq.

111 Brookfield Avenue

Nashville, Tennessee 37205

 

Re: Employment by Virtuoso Surgical, Inc.

 

Dear Mark:

 

It is my pleasure to formally offer you employment with Virtuoso Surgical, Inc. (the “Company), effective September 1, 2017. This letter serves as a memorandum regarding the terms and conditions of your employment. Your job title will be General Counsel & Chief Administrative Officer. Your job duties shall include the provision of general legal advice to the management and Board of the Company and the administration of the day-to-day business operations of the Company.

 

Terms

 

This is a part-time, salaried position. You are expected to devote 1/2 of your working efforts to work on behalf of the Company. Your salary shall be $4,167.00 per month, payable (less tax withholdings) in two equal installments, semi-monthly, on the first business day after the 15th of each month, and the last business day of each month. Expense reimbursements are payable on the last business day of each month.

 

You are entitled to one day of paid time off (whether for vacation, personal days, or sickness) for each month of service, which you can accumulate throughout each calendar year. At the end of each calendar year, any accumulated days of paid time off that are not used shall lapse, and they are not reimbursable in cash or any other consideration. Any additional days taken off, except for sickness, may result in a pro-rata reduction in pay. Additional days taken off for sickness shall be accounted for under the Family and Medical Leave Act of 1993.

 

You are not expected to work on federal holidays or weekends. In the event that you do work on a federal holiday or part of a weekend, you may accrue up to six additional days of comp paid time off in any given calendar year. As with regular paid time off, any accumulated days of comp paid time off that are not used are lost at the end of each calendar year, and they are not reimbursable in cash or any other consideration.

 

 

 

 

In light of the Company’s funding by the NIH, you will be required to keep a log of your work hours and effort. You will remain a salaried employee, even though you are keeping track of your time for report to the NIH.

 

Your employment is “at will,” meaning that you can cease working for the company at any time that you choose, and the Company may terminate your employment at any time.

 

Intellectual Property

 

During the course of your employment by the Company, it is anticipated that you will create original works of authorship or invention that may constitute protectable intellectual property. Any works of authorship or invention, or any other protectable form of intellectual property, that you develop as part of your work for the Company shall be and remain the property of the Company to the fullest extent permissible by law.

 

Medical Subsidy Payments

 

The Company will not provide health insurance plans for its employees. Should you be eligible to join a health insurance plan (of a spouse, parent, etc.), the company will provide a $150 monthly subsidy payment, payable to you for deposit into a Health Savings Account on the last business day of each calendar month during the period of your employment. In the event that you are not eligible to join a health insurance plan through other means, the Company will increase its monthly subsidy payment to $250 per person, for up to a four person family plan (with a maximum payment of $1000/month) that you may select at your discretion. You must notify the Company in writing to request a change in medical subsidy payment.

 

I will join an eligible health insurance plan (of a spouse, parent, etc.) and will receive the $150/month medical subsidy payment.
I am not eligible to join another health insurance plan and will pursue my own health insurance with family members on the plan. I would like to receive the $250 monthly subsidy per person on the plan and understand that the maximum monthly payment is $1000 per month.
I do not wish to receive a medical subsidy payment.

 

Professional Licensure

 

The Company will pay professional licensure fees and taxes, including Continuing Legal Education fees and expenses, up to $1,000 per year.

 

Retirement Plan

 

The Company will pay 4% of your annual salary (prorated for partial years of employment) expressly for retirement saving. This is not a match program, and it must be used for retirement savings through a traditional IRA. The company will not manage or select the retirement plan for you, and the payment will be made to the agent designated by you in one lump sum at the end of each calendar year.

 

 

 

 

If you have any questions or concerns regarding these terms, please let me know. I look forward to working with you.

 

  VIRTUOSO SURGICAL, INC.
     
  By:  /s/ Richard Hendrick
     Richard Hendrick
    Chief Operating Officer

 

Agreed to and Accepted By:

 

/s/ C. Mark Pickrell  
C. Mark Pickrell  

 

 

 

 

EX1A-11 CONSENT 11 tm1927293d1_ex11-1.htm EXHIBIT 11.1

 

Exhibit 11.1

 

 

 

CONSENT OF INDEPENDENT PUBLIC ACCOUNTING FIRM

 

We consent to the inclusion of our Independent Auditor’s Report dated October 16, 2019, except for Note 5 as to which the date is November 30, 2019, on the financial statements of Virtuoso Surgical, Inc. as of and for the years ended December 31, 2018 and 2017 and to the reference of our firm as experts in accounting and auditing in the Company’s Regulation A Offering Circular Under the Securities Act of 1933 on Form 1-A.

 

/s/ Puryear & Noonan, CPAs

 

Puryear & Noonan, CPAs

Nashville, Tennessee

December 27, 2019

 

40 Burton Hills Blvd. I Suite 170 I Nashville, TN 37215 p: (615) 296-0500 I f:(615) 296-0493
830 Crescent Ce ntre Dr ive I Suite 320 I Franklin, TN 37067 pn-cpas.com

 

 

 

EX1A-12 OPN CNSL 12 tm1927293d1_ex12-1.htm EXHIBIT 12.1

 

Exhibit 12.1

 

 

 

December 27, 2019

 

Virtuoso Surgical, Inc.

5701 Old Harding Pike, Suite 200

Nashville, TN 37205

 

Re:Virtuoso Surgical, Inc.

 

Ladies and Gentlemen:

 

In our capacity as special securities counsel to Virtuoso Surgical, Inc., a Tennessee corporation (the “Company”), we have examined the Offering Statement on Form 1-A (the “Offering Statement”) filed by the Company pursuant to Regulation A promulgated under the Securities Act of 1933, as amended (the “Securities Act”), relating to the offering of 20,000,000 shares of Class A Preferred Stock, par value $1.00 per share (the “Preferred Stock”). In this regard, we have examined and relied upon such records, documents and other instruments as in our judgment are necessary or appropriate in order to express the opinions hereinafter set forth and have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals, and the conformity to original documents of all documents submitted to us as certified or photostatic copies.

 

Based upon the foregoing, we are of the opinion that the shares of Preferred Stock referred to in the Offering Statement, to the extent actually issued and sold in the manner and on the terms described in the Offering Statement, will be duly authorized and validly issued, fully paid and nonassessable shares of the Preferred Stock of the Company.

 

The foregoing opinion is limited to matters arising under the Tennessee Business Corporation Act as in effect on the date hereof. We hereby consent to the filing of this opinion as an exhibit to the Offering Statement. This consent is not to be construed as an admission that we are a party whose consent is required to be filed with the Offering Statement under the provisions of the Securities Act, or the rules and regulations of the United States Securities and Exchange Commission promulgated thereunder.

 

  Very truly yours,
 
  /s/ Waller Lansden Dortch & Davis, LLP

 

 

EX1A-15 ADD EXHB 13 tm1927293d1_ex15-1.htm EXHIBIT 15.3

 

Exhibit 15(a).1

 

December 6, 2019

 

Paul Fischer

U.S. Securities and Exchange Commission

Division of Corporation Finance

Office of Life Sciences

100 F Street, NE

Washington, D.C. 20549

 

Re:         Virtuoso Surgical, Inc.

Draft Offering Statement on Form 1-A

Submitted on October 23, 2019

CIK No. 0001742075

 

Dear Mr. Fischer:

 

Virtuoso Surgical, Inc. (the “Company”) is in receipt of your letter dated November 20, 2019 (the “Comment Letter”) regarding the Company’s confidential draft Offering Statement on Form 1-A. On behalf of the Company, I am responding to comments provided by the Division of Corporation Finance (the “Staff”). The Company is concurrently submitting for confidential review an amended Offering Statement on Form 1-A (the “Offering Statement”), which includes changes to reflect responses to the Staff’s comments.

 

Cautionary Statement Regarding Forward-Looking Statements, page 1

 

1.Note that the safe harbor protections for forward-looking statements under the Private Securities Litigation Reform Act do not apply to statements made by companies that are not reporting companies under section 13(a) or 15(d) of the Securities Exchange Act. See Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Please delete the reference to the safe harbor provided by the Private Securities Litigation Reform Act.

 

Response: The reference to the safe harbor provision has been deleted.

 

Summary

Intellectual Property, page 5

 

2. Please describe the material terms of the license agreements with Johns Hopkins University and Vanderbilt University, including the rights and obligations of each party, any payment terms including upfront, milestone and royalty payments, the royalty term, and term and termination provisions.

 

Response: The following disclosure has been added to page 5 of the Offering Statement.

 

“Effective May 11, 2016, the Company entered into a non-exclusive, non-transferable patent license with Johns Hopkins University. Under the terms of the license, the Company has the right to use concentric nitinol tubes for surgical devices in the following countries (or regions), under the following patents: United States (8,152,756 and 8,715,226); Japan (2008-541319, 2012-139088, 2015- 094824, and 2014-000372); European Patent Office (06844376.1); Canada (2,630,061); and China (200680050046.8). Under the terms of the license, Johns Hopkins has received a fee of $2,000 and five percent (5%) of the common stock of the Company, and is entitled to receive a royalty of four percent (4%) of the Net Revenues (as defined in the license) of the Company of sales of products incorporating concentric nitinol tubes and one percent (1%) of the consideration received by the Company upon a sale of the Company or other similar transaction. The royalty is due and owing throughout the life of the patents, for each respective jurisdiction. At this time, the Company does not know the exact dates that the patents, or any possible follow-on patents that utilize this underlying technology, will expire. Generally, under the Patent Cooperation Treaty of 1970 and the Patent Law Treaty of 2000, patents like the Johns Hopkins patents last for twenty (20) years from the initial date of filing. The Johns Hopkins U.S. patents were initially filed on November 15, 2006 and March 9, 2012, and are expected to expire twenty (20) years from those dates.”

 

 

 

 

“Effective May 15, 2016, the Company entered into an exclusive, non-transferable patent license with Vanderbilt University. Under the terms of the license, the Company has the right to make, use, offer to sell, sell and import products, for human surgical applications, systems and apparatuses for endoscopic deployment of robotic concentric tube manipulators, and the Company has the exclusive right to manufacture and/or sell such systems or apparatuses in the United States. Under the terms of the license, Vanderbilt University has received a fee of $5,000, reimbursement for Vanderbilt’s patent-prosecution costs and four percent (4%) of the common stock of the Company, and is entitled to receive a royalty of four percent (4%) of the Gross Sales (as defined in the license) of products incorporating the patented technology; annual royalties of at least $3,000, beginning in 2021, and increasing to $50,000 annually beginning in 2025; and $250,000 upon a sale of the Company or other similar transaction. The royalties are due and owing throughout the life of the licensed patents. The Vanderbilt U.S. patents were initially filed on September 13, 2013 and October 2, 2015, and are expected to expire twenty (20) years from those dates. The Company does not have “PCT” coverage on the Vanderbilt patents.”

 

3. Please provide a description of the U.S. Patents that you have licensed from Johns Hopkins University and Vanderbilt University, as well as the expiration dates and the foreign jurisdictions in which you also have issued patents.

 

Response: Please see our additional disclosure response to Comment 2 above, which also is responsive to Comment 3.

 

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Class A Preferred Stock, page 6

 

4. We note your disclosure that you anticipate initiating a change of control within the next six years, which would be a shorter tie-up period than the average tie-up period for venture capital investments. Please tell us why you express in such certain terms that you will be initiating a change of control within the next six years.

 

Response: In our draft Offering Statement, we stated, “The Company anticipates initiating a change of control within the next six (6) years […].” We appreciate the Staff’s comment, and note that when we elected to use the term “anticipates” rather than “will,” it was not our intention to indicate that any future event would occur.

 

Based on the Staff’s comment, page 8 of the Offering Statement includes amended disclosure as follows:

 

“We believe that the net proceeds of the Offering, if fully subscribed, will likely provide the Company with the capital necessary to receive regulatory approval and begin initial commercial sales. However, within six (6) years, the Company anticipates needing significant additional capital beyond that which is being raised in the Offering in order for the Company to achieve full-scale manufacturing and sales operations. As a result, the Company will, in all probability, need to pursue selling sufficient amounts of common stock, which could effect a change of control, within the next six (6) years.”

 

We also added the following language to page 6 of the Offering Statement:

 

“The capital needs of the Company will likely require a sale of a majority of common stock within at least six (6) years, based on the probable cost of building long-term manufacturing, sales, marketing, physician-training, and customer-support capabilities for a surgical system of this type. Within the medical-device industry, startup-company acquisitions by major medical-device manufacturers often occur upon regulatory approval or initial commercial sales of the start-up companies’ products.”

 

5. Please revise to provide more fulsome disclosures concerning the application of Section 1202 of the Internal Revenue Code.

 

Response: The Offering Statement includes the following additional disclosure on page 9:

 

“Under Section 1202 of the IRC, also called the Small Business Stock Gains Exclusion, taxpayers are allowed to exclude from federal tax capital gains from select small business stock sales, up to $10 million. Section 1202 of the IRC only applies to qualified small business stock acquired after September 27, 2010, which is held for more than five (5) years. You should consult your own tax adviser regarding the possible applicability of Section 1202 of the IRC to your current, and any future, situation. The Company is not providing and shall not provide tax advice to its investors, and the Company has reserved the right to make future business decisions without considering the possible tax effect to investors of the Company’s business decisions.”

 

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6. Please remove the “Potential Investment Returns” chart following bullet point four of this discussion, as it appears to assume the issuance of Success Bonuses and your ability to make these payments.

 

Response: The chart has been removed and replaced with the following disclosure on page 8 of the Offering Statement:

 

Structure of Potential Returns for an Investment in the Company’s Class A Preferred Stock

 

As with any early-stage investment, and particularly with an early-stage medical-device investment, an investment in the Company’s Class A Preferred Stock carries great risk. You should refer to the risk factors described throughout this Offering Circular to understand those known risks. There are unknown risks as well.

 

The Company believes that, in order to be fair to its investors, the potential returns for an investment in the Company’s Class A Preferred Stock should reflect the risk of the investment. In structuring the potential returns, the Company researched the available academic literature regarding comparable investments of this type (often called “early-stage,” or “development-stage,” or “venture-stage” companies). Based on a peer-reviewed article from 2005 in the Journal of Financial Economics, authored by John Cochrane, the Rose-Marie and Jack Anderson Senior Fellow at the Hoover Institution of Stanford University, entitled, “The risk and return of venture capital,” Prof. Cochrane determined that the historical arithmetic returns on venture-capital firms’ investments in early-stage companies averaged 59% per year. The Company is unaware of any academic literature since 2005 which indicates that the average return for venture-capital investments has materially changed from Prof. Cochrane’s 59% calculation.

 

Prof. Cochrane’s 59% per year calculation is an average return per year for a large set of companies. The values of individual development-stage companies do not go in a straight line, however. As companies reach different milestones in their development, their economic value generally significantly increases at particular points in time. Mathematicians call this type of graph a step-function. Taking the lessons learned from Prof. Cochrane, the Company structured the potential returns on an investment in Class A Preferred Stock utilizing the PIK and Success Bonus. The PIK causes a constant 7% rise in the potential return, and the Success Bonus creates a step-function that enables potential returns that are structured to generally exceed the historical returns for early-stage investments described in Prof. Cochrane’s research, in the event of a successful change of control.

 

It is important for you to understand that the actual return, IF ANY, that may be paid to investors in the Class A Preferred Stock is not known at this time and is dependent on the Company’s actual cash proceeds and/or cash or cash equivalents on hand at the time of any potential payment to the holders of the Class A Preferred Stock is triggered.”

 

7. Please balance your disclosure regarding the benefits of the structure of the Class A Preferred Stock with the risks and disadvantages of owning Class A Preferred Stock.

 

Response: After the new section entitled, “Structure of Potential Returns for an Investment in the Company’s Class A Preferred Stock,” the following new section has been added:

 

4

 

 

Risks and Possible Disadvantages of Owning Class A Preferred Stock

 

As with any equity investment, you may lose your entire investment in the Company. Return of your investment, or payment of any accrued PIK or Success Bonus, is contingent on the amount of the assets of the Company, or the consideration received, at the time of a change of control of the Company. Owners of Class A Preferred Stock have no voting rights and have no management control over the Company. In the event of a successful change of control of the Company, the potential returns, if any, for holders of Class A Preferred Stock will be determined by the PIK and the Success Bonus, rather than the sale price of the Company. Please see the section entitled “Risk Factors” for further discussion about the risks of investing in our Offering.”

 

Illustrations of How our Shares Work, page 7

 

8. Please revise the introduction of this section to highlight, by the use of bold typeface or some other means, that the illustrations are hypothetical and do not constitute guarantees or projections, and that an investor could lose all or a part of their investment, as you state in your introduction to Risk Factors at page 11, and at “Prospective Investors could lose the entire value of their investment in the Class A Preferred Stock” at page 19 of your offering circular.

 

Response: The following disclosure has been added to the Offering Statement:

 

THESE ILLUSTRATIONS ARE HYPOTHETICAL AND DO NOT CONSTITUTE GUARANTEES OR PROJECTIONS. THESE ILLUSTRATIONS ARE PROVIDED ONLY FOR THE PURPOSE OF HELPING POTENTIAL INVESTORS UNDERSTAND THE TERMS OF THE CLASS A PREFERRED STOCK. BECAUSE YOUR INVESTMENT IS NOT GUARANTEED, YOU MAY LOSE YOUR ENTIRE INVESTMENT, DEPENDING UPON THE SUCCESS OR FAILURE OF THE COMPANY.

 

Risk Factors

Investors who acquire Class A Preferred Stock in this Offering will have limited control..., page 19

 

9. Please revise to clarify that holders of Class A Preferred Stock have no voting rights.

 

Response: The suggested clarification has been was added to page 19 of the Offering Statement.

 

Use of Proceeds, page 21

 

10. Please revise your disclosure in this section to state whether the net proceeds of the offering will allow you to complete testing and validation of your Virtuoso device. If not, please specify, for each assumed percentage of shares sold, how far along in your testing and validation you will be able to complete with your proceeds, and if any material amounts of other funds are necessary for clearance or approval, please state the amounts of such other funds needed and the sources thereof. Refer to Item 504 of Regulation S-K.

 

Response: The following disclosure has been added to page 21 of the Offering Statement:

 

5

 

 

“The Company currently anticipates that the net proceeds of the offering will allow the Company to complete the testing and validation of the Virtuoso device and system, as required for Food and Drug Administration approval. The FDA has three (3) primary paths that device manufacturers may pursue in order to begin commercial sales in the United States. Those pathways are generally called the 510(k) pathway, the De Novo pathway, and the Pre-Market Approval pathway. The Company currently anticipates that the FDA will likely evaluate the device and system under either the 510(k) pathway or the De Novo pathway and that the FDA will likely approve the system on either pathway. The Company bases its belief about the likely regulatory pathways that are available to the Company on the many robotic surgical devices that have previously received 510(k) clearance or De Novo classification as Class II devices. (A Class II device is a device that represents “moderate” risks.) In the event that the FDA requires Pre-Market Approval, the proceeds of the Offering will not be sufficient to complete the testing and validation necessary for regulatory approval.”

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations, page 23

 

11. Please expand your discussion of results of operations and liquidity in MD&A to include the interim periods ended June 30, 2019 and 2018 in accordance with Item 9 of Form 1-A.

 

Response: The following disclosure has been added to the MD&A:

 

Comparison of the Six Months Ended June 30, 2019 and 2018

 

During the first half of 2019, the Company accelerated its development operations by increasing research and development expenses to $598,485 for the six months ended June 30, 2019 compared to $335,620 during the same prior year period. In particular, as compared to the first half of 2018, the Company spent a materially larger percentage of the Company’s operating expenditures on outside consulting. The Company hired several outside engineering, software or design firms to assist the Company’s development process in the areas of: project planning; testing and validation needs; software and information-systems improvements; financial-systems improvements; risk analysis (including human-factors analysis); and sterility measures. The acceleration in the Company’s use of outside consultants is expected to continue if the Offering is fully subscribed.”

 

Management, page 27

 

12. Please file as exhibits the employment agreements with Richard Hendrick and C. Mark Pickrell. See Item 17.6.(c) of Form 1-A. Please also ensure that all material terms of the agreements are disclosed. Refer to Item 402(o)(1) of Regulation S-K.

 

Response: The employment agreements have been added as exhibits to the Offering Statement. The following disclosure also has been added to the section entitled “Executive Compensation” on page 29:

 

“Under the terms of his employment agreement, as orally amended, Richard Hendrick is a full-time employee of the Company and paid a salary of $110,000 per year. In addition, he receives a health-insurance subsidy of $150 per month and an annual SEP contribution of four percent (4%) of his annual salary. In addition, Mr. Hendrick’s employment agreement contains a “Work for Hire” provision, which provides Company ownership of any intellectual property generated by Mr. Hendrick during the course of his employment, and it contains a one (1) year non-compete provision.

 

6

 

 

Under the terms of his employment agreement, as orally amended, Mark Pickrell is a part-time employee (.6 FTE) of the Company and paid a salary of $103,000 per year. In addition, he receives a health-insurance subsidy of $150 per month and an annual SEP contribution of four percent (4%) of his annual salary.”

 

Financial Statements

Notes to Financial Statements

Note 10. Subsequent Events, page F-10

 

13. We note subsequent to year end you authorized a 10,000 for one share stock split. Please revise all financial statements presented to reflect the stock split in accordance with ASC 260-10-55-12 and SAB Topic 4C. In this regard, also have your independent auditor revise its report on page F-1 to reference the stock split and dual-date its opinion in accordance with AICPA AU-C Section 560.A11.

 

Response: The financial statements and auditor report have been amended to reflect the 10,000:1 forward stock split.

 

Unaudited Interim Financial Statements, page F-11

 

14. Please revise your interim financial statements, for the six months ended June 30, 2019, to include the corresponding period of the preceding fiscal year, in accordance with Part F/S(b)(5) of Form 1-A and include the statement required by Part F/S(b)(5)(iii). In addition, please include footnotes to your interim financial statements, in accordance with Part F/S(c)(1)(i) of Form 1-A and Rule 8-03(b)(1) of Regulation S-X, or tell us why you believe they are not necessary.

 

Response: The financial statements have been amended to include unaudited financial statements for H1 2018 and H1 2019. Those unaudited financial statements also include footnotes.

 

7

 

  

We appreciate the opportunity to respond to your comments. If you have any questions during your review, or we can assist in any way, please do not hesitate to contact David Clay or me.

 

  Sincerely,
   
  /s/ C. Mark Pickrell
  General Counsel & Chief Administrative Officer
  Virtuoso Surgical, Inc.
   
cc: David R. Clay  
  Sharon A. Carroll  

 

 

8

 

 

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