Form 424B3 - Prospectus [Rule 424(b)(3)]
17 Mai 2024 - 10:51PM
Edgar (US Regulatory)
Filed Pursuant to Rule 424(b)(3)
Registration
No. 333-273473
PROSPECTUS SUPPLEMENT NO. 1
(To Prospectus dated April 30, 2024)
Monogram Technologies Inc.
6,207,274 Shares of Common Stock
This prospectus supplement updates and supplements
the prospectus, dated April 30, 2024 (as supplemented to date, the “Prospectus”), which forms a part of our registration statement
on Form S-1 (No. 333-273473). This prospectus supplement is being filed to update and supplement the information in the Prospectus with
the information contained in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the Securities and Exchange
Commission on May 14, 2024 (the “Quarterly Report”). Accordingly, we have attached the Quarterly Report to this prospectus
supplement.
The Prospectus and this prospectus supplement
relate to the offer and resale of up to 6,207,274 shares of our common stock, $0.001 per share (the “common stock”), by B.
Riley Principal Capital II, LLC (“B. Riley” or the “selling stockholder”). The shares included in the Prospectus
consist of shares of common stock that we have issued or that we may, in our discretion, elect to issue and sell to B. Riley, from time
to time after the date of the Prospectus, pursuant to a Common Stock Purchase Agreement we entered into with B. Riley on July 19, 2023
(the “Purchase Agreement”), in which B. Riley has committed to purchase from us, at our direction, up to $19,038,755 of our
common stock, subject to terms and conditions specified in the Purchase Agreement. Concurrently with our execution of the Purchase Agreement
on July 20, 2023, we issued 45,252 shares of common stock to B. Riley as consideration for its irrevocable commitment to purchase shares
of our common stock at our election in our sole discretion, from time to time after the date of the Prospectus, upon the terms and subject
to the satisfaction of the conditions set forth in the Purchase Agreement. See the section of the Prospectus titled “The Committed
Equity Financing” for a description of the Purchase Agreement and the section titled “Selling Stockholder” for additional
information regarding the selling stockholder.
We are not selling any shares of common stock
being offered by the Prospectus and will not receive any of the proceeds from the sale of such shares by B. Riley. However, we may receive
up to $19,038,755 in aggregate gross proceeds from sales of our common stock to B. Riley that we may, in our discretion, elect to make,
from time to time after the date of the Prospectus, pursuant to the Purchase Agreement.
B. Riley may sell or otherwise dispose of the
shares of common stock included in the Prospectus in a number of different ways and at varying prices. See the section of the Prospectus
titled “Plan of Distribution (Conflict of Interest)” for more information about how B. Riley may sell or otherwise dispose
of the common stock being offered in the Prospectus. B. Riley is an “underwriter” within the meaning of Section 2(a)(11) of
the Securities Act of 1933, as amended. We have also engaged Northland Securities, Inc. to act as a “qualified independent underwriter”
in this offering, whose fees and expenses will be borne by the selling stockholder.
This prospectus supplement updates and supplements
the information in the Prospectus and is not complete without, and may not be delivered or utilized except in combination with, the Prospectus,
including any amendments or supplements thereto. This prospectus supplement is qualified by reference to the Prospectus, including any
amendments or supplements thereto, except to the extent that the information in this prospectus supplement updates and supersedes the
information contained therein.
The common stock is listed on The Nasdaq Stock
Market (“Nasdaq”) under the symbol “MGRM.” On May 15, 2024, the last reported sales price of the common stock
as reported on Nasdaq was $2.06 per share.
We are an “emerging growth company”
as defined under U.S. federal securities laws and, as such, have elected to comply with reduced public company reporting requirements.
The Prospectus complies with the requirements that apply to an issuer that is an emerging growth company.
Investing in our securities involves a high
degree of risks. You should review carefully the risks and uncertainties described in the section titled “Risk
Factors” beginning on page 14 of the Prospectus, and under similar headings in any amendments or supplements to the Prospectus.
Neither the Securities and Exchange Commission
nor any state securities commission has approved or disapproved of these securities, or passed upon the accuracy or adequacy of the Prospectus
or this prospectus supplement. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is May 17,
2024.
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 10-Q
☒ QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF
1934
For the quarterly period
ended March 31, 2024
Or
☐ TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT
OF 1934
For the transition period
from ______________ to _____________
Commission file number:
001-41707
Monogram
Orthopaedics Inc.
(Exact name of registrant
as specified in its charter)
3913
Todd Lane,
Austin,
TX |
|
78744 |
(Address of principal executive offices) |
|
(Zip Code) |
(512)
399-2656
(Registrant’s telephone number,
including area code)
N/A |
(Former
name, former address and former fiscal year, if changed since last report) |
Securities registered pursuant to
Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common Stock,
$0.001 par value per share |
|
MGRM |
|
The Nasdaq Capital Market |
Indicate by check mark
whether the registrant (1) has filed reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has
been subject to such filing requirements for the past 90 days. Yes ☒ No
☐
Indicate by check mark
whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of
Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth
company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☐ |
|
Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
|
Smaller reporting company |
☒ |
|
|
|
Emerging growth company |
☒ |
If an emerging growth
company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or
revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark
whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐
No ☒
As of May 13, 2024, there were 31,670,375
shares of Common Stock, par value $0.001 per share, of the registrant issued and outstanding.
MONOGRAM
ORTHOPAEDICS INC.
TABLE
OF CONTENTS
PART I.
FINANCIAL INFORMATION
Item 1. Financial
Statements
MONOGRAM ORTHOPAEDICS INC.
CONDENSED
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
March
31, |
|
December 31, |
|
|
2024 |
|
2023 |
|
|
(unaudited) |
|
|
|
Assets |
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
10,077,573 |
|
$ |
13,589,028 |
Account
receivable |
|
|
— |
|
|
364,999 |
Prepaid
expenses and other current assets |
|
|
629,751 |
|
|
664,262 |
Total
current assets |
|
|
10,707,324 |
|
|
14,618,289 |
Equipment,
net of accumulated depreciation |
|
|
903,011 |
|
|
945,020 |
Intangible
assets, net |
|
|
496,250 |
|
|
548,750 |
Operating
lease right-of-use assets |
|
|
435,116 |
|
|
466,949 |
Total
assets |
|
$ |
12,541,701 |
|
$ |
16,579,008 |
Liabilities
and Stockholders' Equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,321,313 |
|
$ |
2,462,268 |
Accrued
liabilities |
|
|
531,239 |
|
|
227,684 |
Operating
lease liabilities, current |
|
|
131,081 |
|
|
128,266 |
Total
current liabilities |
|
|
1,983,633 |
|
|
2,818,218 |
Operating
lease liabilities, non-current |
|
|
330,561 |
|
|
363,724 |
Total
liabilities |
|
|
2,314,194 |
|
|
3,181,942 |
Commitments
and contingencies |
|
|
— |
|
|
— |
Stockholders'
equity: |
|
|
|
|
|
|
Common
stock, $.001 par value; 90,000,000 shares authorized, 31,633,995 and 31,338,391 shares issued and outstanding at March 31, 2024 and December
31, 2023, respectively |
|
|
31,634 |
|
|
31,338 |
Additional
paid-in capital |
|
|
65,211,241 |
|
|
64,874,392 |
Accumulated
deficit |
|
|
(55,015,368) |
|
|
(51,508,664) |
Total
stockholders' equity |
|
|
10,227,507 |
|
|
13,397,066 |
Total
liabilities and stockholders' equity |
|
$ |
12,541,701 |
|
$ |
16,579,008 |
The accompanying notes
are an integral part of these financial statements.
MONOGRAM ORTHOPAEDICS INC.
CONDENSED
STATEMENTS OF OPERATIONS (UNAUDITED)
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March
31, |
|
|
2024 |
|
2023 |
Product
revenue |
|
$ |
— |
|
$ |
— |
Cost
of goods sold |
|
|
— |
|
|
— |
Gross
profit |
|
|
— |
|
|
— |
Operating
expenses: |
|
|
|
|
|
|
Research
and development |
|
|
2,406,754 |
|
|
1,939,551 |
Marketing
and advertising |
|
|
119,694 |
|
|
1,132,625 |
General
and administrative |
|
|
1,083,711 |
|
|
822,889 |
Total
operating expenses |
|
|
3,610,159 |
|
|
3,895,065 |
Loss
from operations |
|
|
(3,610,159) |
|
|
(3,895,065) |
Other
income: |
|
|
|
|
|
|
Change
in fair value of warrant liability |
|
|
— |
|
|
2,523 |
Interest
income and other, net |
|
|
103,455 |
|
|
34,820 |
Total
other income |
|
|
103,455 |
|
|
37,343 |
Net
loss before taxes |
|
|
(3,506,704) |
|
|
(3,857,722) |
Income
taxes |
|
|
— |
|
|
— |
Net
loss |
|
$ |
(3,506,704) |
|
$ |
(3,857,722) |
Basic
and diluted loss per common share |
|
$ |
(0.11) |
|
$ |
(0.40) |
Weighted-average
number of basic and diluted shares outstanding |
|
|
31,535,795 |
|
|
9,673,870 |
The accompanying notes
are an integral part of these financial statements.
MONOGRAM ORTHOPAEDICS INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Common Stock |
|
Additional |
|
Accumulated |
|
Stockholders' |
|
|
Shares |
|
Amount |
|
Paid-in Capital |
|
Deficit |
|
Equity |
Balance
as of December 31, 2023 |
|
31,338,391 |
|
$ |
31,338 |
|
$ |
64,874,392 |
|
$ |
(51,508,664) |
|
$ |
13,397,066 |
Vesting
of Common Stock from services performed |
|
— |
|
|
— |
|
|
37,500 |
|
|
— |
|
|
37,500 |
Issuance
of Common Stock for cash, net of issuance costs |
|
49,146 |
|
|
49 |
|
|
4,696 |
|
|
— |
|
|
4,746 |
Issuance
of Common Stock upon cashless warrant exercise |
|
246,458 |
|
|
246 |
|
|
(246) |
|
|
— |
|
|
— |
Stock-based
compensation |
|
— |
|
|
— |
|
|
294,899 |
|
|
— |
|
|
294,899 |
Net
loss |
|
— |
|
|
— |
|
|
— |
|
|
(3,506,704) |
|
|
(3,506,704) |
Balance
as of March 31, 2024 |
|
31,633,995 |
|
$ |
31,633 |
|
$ |
65,211,241 |
|
$ |
(55,015,368) |
|
$ |
10,227,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A |
|
|
|
|
Series B |
|
|
|
|
Series C |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
Preferred Stock |
|
|
|
|
Preferred Stock |
|
|
|
|
Preferred Stock |
|
|
|
|
Common Stock |
|
|
|
|
Additional |
|
Accumulated |
|
Stockholders' |
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Paid-in Capital |
|
Deficit |
|
Equity |
Balance
as of December 31, 2022 |
|
4,897,553 |
|
$ |
4,898 |
|
3,195,599 |
|
$ |
3,196 |
|
438,367 |
|
$ |
438 |
|
9,673,870 |
|
$ |
9,674 |
|
$ |
41,894,417 |
|
$ |
(37,763,447) |
|
$ |
4,149,176 |
Issuances
of Class C Preferred Stock, net of issuance costs |
|
— |
|
|
— |
|
— |
|
|
— |
|
21,088 |
|
|
21 |
|
— |
|
|
— |
|
|
147,021 |
|
|
— |
|
|
147,042 |
Stock-based
compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
368,140 |
|
|
— |
|
|
368,140 |
Net
loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(3,857,722) |
|
|
(3,857,722) |
Balance
as of March 31, 2023 |
|
4,897,553 |
|
$ |
4,898 |
|
3,195,599 |
|
$ |
3,196 |
|
459,455 |
|
$ |
459 |
|
9,673,870 |
|
$ |
9,674 |
|
$ |
42,409,578 |
|
$ |
(41,621,169) |
|
$ |
804,636 |
The accompanying notes
are an integral part of these financial statements.
MONOGRAM ORTHOPAEDICS INC.
CONDENSED
STATEMENTS OF CASH FLOWS (UNAUDITED)
|
|
|
|
|
|
|
|
|
Three
months ended |
|
|
March
31, |
|
|
2024 |
|
2023 |
Operating
activities: |
|
|
|
|
|
|
Net
loss |
|
$ |
(3,506,704) |
|
$ |
(3,857,722) |
Adjustments
to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
Stock-based
compensation |
|
|
294,899 |
|
|
368,140 |
Other
expenses settled with stock issuances |
|
|
37,500 |
|
|
— |
Loss
from change in fair value of common stock make-whole obligation |
|
|
45,252 |
|
|
— |
Depreciation
and amortization |
|
|
105,898 |
|
|
102,503 |
Change
in fair value of warrant liability |
|
|
— |
|
|
(2,523) |
Changes
in non-cash working capital balances: |
|
|
|
|
|
|
Account
receivable |
|
|
364,999 |
|
|
— |
Other
current assets |
|
|
(111,445) |
|
|
231,518 |
Accounts
payable |
|
|
(1,140,955) |
|
|
516,762 |
Accrued
liabilities |
|
|
258,303 |
|
|
(243,501) |
Operating
lease assets and liabilities, net |
|
|
1,485 |
|
|
2,446 |
Cash
used in operating activities |
|
|
(3,650,768) |
|
|
(2,882,377) |
Investing
activities: |
|
|
|
|
|
|
Purchases
of equipment |
|
|
(11,389) |
|
|
(14,792) |
Cash
used in investing activities |
|
|
(11,389) |
|
|
(14,792) |
Financing
activities: |
|
|
|
|
|
|
Proceeds
from issuances of Common Stock, net of cash costs |
|
|
150,702 |
|
|
— |
Proceeds
from issuances of Series C Preferred Stock, net |
|
|
— |
|
|
147,042 |
Cash
provided by financing activities |
|
|
150,702 |
|
|
147,042 |
Decrease
in cash and cash equivalents during the period |
|
|
(3,511,455) |
|
|
(2,750,127) |
Cash
and cash equivalents, beginning of the period |
|
|
13,589,028 |
|
|
10,468,645 |
Cash
and cash equivalents, end of the period |
|
$ |
10,077,573 |
|
$ |
7,718,518 |
|
|
|
|
|
|
|
Cash
paid for interest |
|
$ |
— |
|
$ |
— |
Cash
paid for income taxes |
|
$ |
— |
|
$ |
— |
Noncash
investing and financing activities: |
|
|
|
|
|
|
Amortization
of deferred issuance costs of Common Stock Purchase Agreement |
|
$ |
145,956 |
|
$ |
— |
Cashless
exercise of warrant |
|
$ |
246 |
|
$ |
— |
The accompanying notes
are an integral part of these financial statements.
MONOGRAM ORTHOPAEDICS INC.
UNAUDITED
NOTES TO FINANCIAL STATEMENTS
1. |
Description
of Business and Summary of Accounting Principles |
Monogram Orthopaedics Inc.
(“Monogram” or the “Company”), incorporated in the state of Delaware on April 21, 2016, is working to develop
a product solution architecture to eventually enable mass personalized optimization of orthopedic implants by linking 3D printing and
robotics via automated digital image analysis algorithms.
The Company has a
working navigated robot prototype that can optically track a simulated surgical target and execute optimized auto-generated cut paths
for high precision insertion of implants in synthetic bone specimens. These implants and cut-paths are generated with proprietary Monogram
software algorithms.
Basis
of Presentation
The accounting and
reporting policies of the Company conform to accounting principles generally accepted in the United States of America and are consistent
in all material respects with those applied in our Annual Report on Form 10-K for the year ended December 31, 2023. Certain amounts from
previous reporting periods have been reclassified to conform with the current period presentation.
As permitted by SEC
requirements for interim reporting, certain footnotes or other financial information have been condensed or omitted. In the opinion of
management, all normal and recurring adjustments considered necessary for the fair presentation of the financial statements have been
included. Revenues, expenses, assets, and liabilities can vary during each quarter of the year, therefore, the results and trends
in these interim financial statements may not be representative of those for the full year.
The information included
in this Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s
Annual Report on Form 10-K for the year ended December 31, 2023.
Going
Concern
The accompanying unaudited
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company is a business that has not yet generated profits, incurred a net loss
during the three months ended March 31, 2024 of $3,506,704 and has an accumulated deficit of $55,015,368 as of March 31, 2024.
The Company’s
ability to continue as a going concern in the next twelve months following the date the unaudited financial statements were available
to be issued is dependent upon its ability to produce revenues, raise capital, and/or obtain other financing sufficient to meet current
and future obligations. Management has evaluated these conditions and believes its current cash balances, plus the additional capital
available under the Common Stock Purchase Agreement described in Note 3, will be sufficient for the Company to satisfy its near-term capital
needs and to continue as a going concern for a reasonable period.
Use
of Estimates
In preparing financial
statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial
statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s most significant estimates
relate to the fair value of the warrant liability, valuations of stock-based compensation, and the income tax valuation allowance. On
a continual basis, management reviews its estimates, utilizing currently available information, changes in facts and circumstances, historical
experience and reasonable assumptions. After such reviews, and if deemed appropriate, those estimates are adjusted accordingly. Actual
results could differ from those estimates.
Earnings
(Loss) Per Share
Earnings (loss) per
share is computed by dividing net income or loss by the weighted-average number of common stock shares outstanding. To the extent that
stock options, warrants, and convertible preferred stock are anti-dilutive, they are excluded from the calculation of diluted earnings
(loss) per share. For the three months ended March 31, 2024 and 2023, the Company excluded the following shares from the calculation of
diluted loss per share because such amounts were antidilutive:
|
|
|
|
|
|
|
Three
months ended |
|
|
March
31, |
|
|
2024 |
|
2023 |
Shares issuable upon conversion of
Series A Preferred Stock |
|
— |
|
9,795,106 |
Shares issuable upon conversion of
Series B Preferred Stock |
|
— |
|
6,391,334 |
Shares issuable upon conversion of
Series C Preferred Stock |
|
— |
|
918,910 |
Shares issuable upon exercise of warrants |
|
— |
|
2,364,697 |
Shares issuable upon exercise of stock
options |
|
4,885,389 |
|
4,862,166 |
Total |
|
4,885,389 |
|
24,332,213 |
Recent
Accounting Pronouncements
Management does not believe that
any recently issued, but not yet effective, accounting standards could have a material effect on the accompanying financial statements.
As new accounting pronouncements are issued, we will adopt those that are applicable under the circumstances.
Other
current assets consist of the following as of March 31, 2024 and December 31, 2023:
|
|
|
|
|
|
|
|
|
March
31, |
|
December
31, |
|
|
2024 |
|
2023 |
Deferred
issuance costs of Common Stock Purchase Agreement |
|
$ |
— |
|
$ |
145,956 |
Advance paid to vendor for supply development
contract |
|
|
163,380 |
|
|
163,380 |
Other |
|
|
466,371 |
|
|
354,926 |
Prepaid expenses and other current
assets |
|
$ |
629,751 |
|
$ |
664,262 |
3. |
Preferred
and Common Stock |
Common
Stock Purchase Agreement
On July 19, 2023,
the Company entered into a Common Stock Purchase Agreement (the “Common Stock Purchase Agreement”) and a Registration Rights
Agreement with B. Riley Principal Capital, II LLC (the “BRPC II”), pursuant to which the registrant has the right to
sell to BRPC II up to $20.0 million in shares of Common Stock (the “Committed Equity Shares”), subject to certain limitations
and the satisfaction of specified conditions in the Common Stock Purchase Agreement, from time to time over the 24-month period commencing
upon the initial satisfaction of the conditions to the BRPC II’s purchase obligations set forth in the Common Stock Purchase Agreement.
Sales of Common Stock pursuant to the Common Stock Purchase Agreement, and the timing of any sales, are solely at the Company’s
option, and it is under no obligation to sell any securities to BRPC II. As of March 31, 2024, the Company had raised gross proceeds of
$889,042 from the sale of 256,346 shares under the Common Stock Purchase Agreement.
As consideration for
BRPC II’s commitment to purchase shares of Common Stock at the Company’s direction upon the terms and subject to the conditions
set forth in the Purchase Agreement, upon execution of the Purchase Agreement, the Company issued 45,252 shares of Common Stock to BRPC
II (the “Commitment Shares”). Under the terms of the Common Stock Purchase Agreement, if the aggregate proceeds received by
BPRC II from its resale of the Commitment Shares is less than $200,000 then, upon notice by BRPC II, the Company must pay the difference
between $200,000 and the aggregate proceeds received by BPRC II from its resale of the Commitment Shares. At March 31, 2024, the market
value of the Commitment Shares was $110,415. Therefore, the Company’s make-whole obligation was $89,585 and this amount was recorded
as a component of accrued expenses in the accompanying balance sheet. During the three months ended March 31, 2024, the $45,252 increase
in the fair value of the Company’s make-whole obligation was recorded as a component of interest income and other, net, in the accompanying
statement of operations.
Preferred
Stock
On May 17, 2023, the
Company filed a Form 8-A in connection with the listing of its Common Stock on Nasdaq, which was declared effective on the same date.
At that time, each outstanding share of Series A, Series B, and Series C Preferred Stock was converted into two shares of Common Stock
of the Company. At March 31, 2024, the Company had no shares of preferred stock outstanding.
Anti-Dilution
Right of CEO
Benjamin Sexson, the Company’s
Chief Executive Officer (“CEO”), is entitled to pre-emptive rights that permit him to preserve his vested equity position
in the Company in the event of any additional issuances of Common Stock (or securities convertible into Common Stock), at a per-share
price equal to the then current fair value, as reasonably determined by the Board.
In February 2019, the Company
entered into a warrant agreement that provided the holder with the right to acquire $1,000,000 worth of shares of the Company’s
capital stock upon the occurrence of the Company raising $5,000,000 in an equity financing. At December 31, 2023, this warrant was exercisable
into 547,944 shares of Common Stock at a price of $1.83 per share. In two transactions during January and February 2024, this warrant
was exercised by the holder in a cashless exercise under which the Company issued the holder a total of 246,458 shares of Common Stock
and retained the remaining shares as settlement of the $1.83 per share exercise price of the warrant.
The Company has adopted
a stock option plan covering the issuance of up to 5,200,000 shares of Common Stock to qualified individuals. Options granted under this
plan vest over four years and expire ten years from the date of the grant. The following table summarizes stock option activity
for the three months ended March 31, 2024:
|
|
|
|
|
|
|
|
|
|
Option |
|
Weighted-Average |
|
Weighted-Average |
|
|
Number
of |
|
Exercise |
|
Remaining |
|
|
Shares |
|
Price
Per Share |
|
Contractual
Term |
Options outstanding as of January 1,
2024 |
|
4,904,266 |
|
$ |
1.93 |
|
7.50 |
Granted |
|
20,500 |
|
|
3.84 |
|
— |
Exercised |
|
— |
|
|
— |
|
— |
Canceled |
|
(39,377) |
|
|
2.65 |
|
— |
Options outstanding as of March 31,
2024 |
|
4,885,389 |
|
$ |
1.93 |
|
7.20 |
Options exercisable as of March 31,
2024 |
|
2,901,918 |
|
$ |
1.75 |
|
6.50 |
Stock-based compensation
expense resulting from granted stock options was $294,899 and $368,140 for the three months ended March 31, 2024 and 2023, respectively.
Unrecognized stock-based compensation
expense related to stock options of $5,466,998 at March 31, 2024 will be recognized in future periods as the related stock options continue
to vest over a weighted-average period of 3 years.
6. |
Commitments
and Contingencies |
Under the Company’s Exclusive
License Agreement with the Icahn School of Medicine at Mount Sinai (“Mt. Sinai”), the Company has an obligation to make certain
payments to Mt. Sinai as a result of reaching certain milestones in the development and sales of the product, and for significant events
related to the Company. The Company is currently in discussions with Mt. Sinai as to whether the Company becoming publicly traded on Nasdaq
without undertaking a traditional initial public offering constitutes a "Significant Transaction" under the licensing agreement.
Under the licensing agreement, if at the time of completion of a "Significant Transaction" the Company has a valuation greater
than $150,000,000, Mount Sinai will receive 1% of the fair market value of Company at the time of completion of the Significant Transaction.
It is the Company's position that no Significant Transaction has occurred - but there is no guarantee the Company and Mount Sinai
will come to a consensus on this point. If we cannot come to an agreement with Mount Sinai on this point, we may be forced into litigation
- and even if we pursue litigation, it is possible that a court would not rule in our favor. If the Company is required to pay this amount,
it could have a material adverse effect on the Company's operations.
The Company evaluated
subsequent events through May 13, 2024, the date these unaudited financial statements were issued, for events that should be recorded
or disclosed in the financial statements as of March 31, 2024. The Company concluded that no other events have occurred that would require
recognition or disclosure in the unaudited financial statements.
Item 2. Management’s
Discussion And Analysis Of Financial Condition And Results Of Operations
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited
condensed financial statements and the accompanying notes thereto included elsewhere in this Quarterly Report on Form 10-Q and with our
audited consolidated financial statements and the accompanying notes thereto included in our Annual Report on Form 10-K for the year ended
December 31, 2023, as previously filed with the Commission. This discussion contains forward-looking statements based upon current plans,
expectations, and beliefs, involving risks and uncertainties. Our actual results may differ materially from those anticipated in these
forward-looking statements. Our historical results are not necessarily indicative of the results that may be expected for any period in
the future.
Overview
Monogram Orthopaedics
Inc. (the “Company”) was incorporated under the laws of the State of Delaware on April 21, 2016, as “Monogram Arthroplasty
Inc.” On March 27, 2017, the Company changed its name to “Monogram Orthopaedics Inc.” Monogram Orthopaedics is working
to develop a product solution architecture with the long-term goal to enable patient-optimized orthopaedic implants economically at scale
by linking 3D printing and robotics with advanced pre-operative imaging. The Company has a robot prototype that can autonomously execute
optimized paths for high precision insertion of implants in simulated cadaveric surgeries. Monogram intends to produce and market robotic
surgical equipment and related software, orthopaedic implants, tissue ablation tools, navigation consumables, and other miscellaneous
instrumentation necessary for reconstructive joint replacement procedures. The Company has obtained 510(k) clearances for certain implants
but has not yet made 510(k) premarket notification submissions or obtained 510(k) premarket clearances for any of robotic products. FDA
510(k) premarket clearance is required to market our robotic products, and the Company cannot estimate the timing, or assure our ability,
to obtain such clearances.
Recent
Developments
FDA
Update
On April 19, 2024,
Monogram received written feedback from the FDA regarding the Company's Q1 2023 pre-submission request. Subsequently, Monogram conducted
a teleconference meeting with the FDA on April 24, 2024 to discuss the written feedback further and obtain feedback on the Monogram mBôs™
TKA System verification test plan, including a proposed clinical trial protocol on an outside the U.S. (OUS) target population. Management
believes the feedback was comprehensive and will be advantageous for preparing a successful 510(k) submission to obtain clearance.
The Company shared
with the FDA various test protocols essential for establishing the safety and effectiveness of the Monogram mBôs™ TKA System.
The Company also shared a synopsis of its proposed OUS clinical investigation plan with the FDA.
Based on the feedback,
management assesses that: 1) the proposed testing plan generally appears acceptable to address the technical differences identified with
the proposed predicate device; and 2) a clinical testing plan that includes approximately 100 knee surgeries conducted on an OUS population
at three sites with three months of follow-up should generally be sufficient for evaluating the safety and effectiveness of the Monogram
mBôs™ TKA System.
The FDA indicated
they support a least burdensome approach to acquiring clinical data. Management anticipates running an OUS clinical trial could
save the Company significant cost and time. Currently, management estimates the cost to run an OUS clinical trial as proposed to be approximately
$1.5M. Notably, on March 21, 2024, the Company announced that it had modified the Monogram mBôs™ TKA System to reduce the likelihood
of an FDA clinical data request with its submission. The OUS clinical trial protocol is expected to take six weeks to three months.
Given the favorable
FDA feedback for using OUS clinical data, Monogram management anticipates establishing an ongoing OUS clinical strategy to support its
innovation strategy. The Company believes its verification and validation testing will be largely complete in Q2 of 2024 and anticipates
a 510(k) submission to follow in H2 2024. The Company's plan to aggressively accelerate 510(k) submission for its mBôs surgical
system with design modifications (Semi-Active) that management believes reduce the risk of a clinical trial is on track. The protocol
testing process, which requires cadaveric procedure testing performed by 15 separate, independent, orthopedic surgeons, is a major part
of the Verification and Validation process required for the 510(k) submission. To date, the Company has successfully completed 6 of 15
surgeries.
General
Market Update
The Company continues
to see a significant and growing market opportunity for an active cutting robotic system that does not utilize haptic controls. Haptic
controls may describe haptic control schemes such as admittance control, impedance control, or hybrid control, i.e., configurations where
the device is not intended to move autonomously on its own. The Company believes the patent landscape for haptic control and the widespread
adoption of products like Mako could be favorable for next-generation active cutting robots like Monogram’s mBôs™ TKA
System, which is being designed to efficiently resect bone without utilizing haptic controls. Monogram has filed several patents around
its active control scheme. Monogram is not aware of any widely accepted products where the robot efficiently resects bone with a saw on
the market today other than Mako.
Amendment
to Company’s Certificate of Incorporation
On March 14, 2024,
the Company received confirmation from the Delaware Secretary of State that its Sixth Amended and Restated Certificate of Incorporation
had been accepted and was deemed filed and effective as of same date.
The Sixth Amended
and Restated Certificate of Incorporation was previously described in the Company’s DEF 14A filed with the SEC on October 6, 2023,
and has the effect of (i) eliminating all Series A, Series B, and Series C classes of Preferred Stock of the Company, leaving only a single
authorized class of Preferred Stock, with 60,000,000 shares of Preferred Stock authorized; and (ii) establishing a classified board of
directors with three classes and staggered terms.
Investor
Relations Services
On May 13, 2023, Monogram
entered into an investor relations consulting agreement with MZHCI, LLC, a company that provides investor relations and corporate communications
services.
Results of Operations
for the three months ended March 31, 2024 and 2023
Revenues
The
Company is currently focused on commercialization of its robotic products, including seeking 510(k) clearances from the FDA for those
products. While the Company made an initial sale of a single unit of robotic surgical equipment to global robotics distributor in November
2023 as part of an effort to explore the possibility of conducting clinical trials in OUS markets, the Company did not make any sales
during the three months ended March 31, 2024 or 2023. The Company does not anticipate additional sales before initiating a clinical study
and obtaining the appropriate regulatory approvals.
Operating
Expenses
The following table sets forth
our operating expenses for the three months ended March 31, 2024 and 2023:
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2024 |
|
2023 |
Research
and development |
|
$ |
2,406,754 |
|
$ |
1,939,551 |
Marketing
and advertising |
|
|
119,694 |
|
|
1,132,625 |
General
and administrative |
|
|
1,083,711 |
|
|
822,889 |
Total operating
expenses |
|
$ |
3,610,159 |
|
$ |
3,895,065 |
Research and
development expenses increased 24.1% during the three months ended March 31, 2024 compared to the three months ended March 31, 2023, primarily
as a result of the Company moving into the verification and validation phase of its robot prototype, which the Company plans to be finalized
in the first half of 2024. The Company also introduced a novel registration and tracking system prototype named mVision in February, 2024.
The Company incurred additional costs related to its research and development efforts to refine this product offering during the three
months ended March 31, 2024 that it did not incur during the three months ended March 31, 2023. R&D expenses in both periods
were primarily comprised of payroll and related costs, contractor and prototype material expenses for the development of its novel robotic
system and associated implants.
Marketing
and advertising expenses decreased significantly (89.4%) during the three months ended March 31, 2024 compared to the three months ended
March 31, 2023. Marketing and advertising expenses incurred during the three months ended March 31, 2023 were primarily related Company’s
marketing campaign for its Regulation A – Tier 2 offering of its Common Stock (the “Reg A Common Stock Offering”) that
began during the three months ended March 31, 2023 and successfully culminated with a round closing in May of 2023. The Company made minimal
marketing or advertising expenditures of $119,694 related to the Company’s capital raising efforts during the three months ended
March 31, 2024.
General
and administrative expenses increased 31.7% during the three months ended March 31, 2024 compared to the three months ended March 31,
2023 primarily due to increases in consulting fees, insurance and regulatory compliance and consulting and professional fees.
|
● |
Insurance
and regulatory compliance expenses were higher during the three months ended March 31, 2024 compared to the three months ended March 31,
2023 due to additional insurance and regulatory compliance activities required to list as a publicly traded company on NASDAQ, which occurred
mid-2023 (and therefore led to an increase in expenses incurred during the three months ended March 31, 2024 compared to those incurred
during the three months ended March 31, 2023 before the Company had its shares of Common Stock listed on NASDAQ). |
|
● |
Consulting
and professional services expenses were higher during the three months ended March 31, 2024 compared to the three months ended March 31,
2023 as a result of the Company’s use of such services related to its offering of Common Stock pursuant to its registration statement
on Form S-1 that was declared effective on September 7, 2023 (which is still ongoing as of the date of this Quarterly Report on Form 10-Q),
increased legal and accounting expenses due to our increased regulatory reporting requirements as an Exchange Act reporting company (which
we had not yet become as of March 31, 2023), and continued protection for the Company’s intellectual property. |
As a result of the
foregoing, with the significant reduction in marketing and advertising expenses being the primary driver, the Company’s total operating
expenses were 7.3% lower during the three months ended March 31, 2024 compared to the three months ended March 31, 2023.
Other
Income (Expense)
The following table sets forth our other income (expense)
for the three months ended March 31, 2024 and 2023:
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
March 31, |
|
|
2024 |
|
2023 |
Change in fair value of warrant liability |
|
$ |
— |
|
$ |
2,523 |
Interest income and other, net |
|
|
103,455 |
|
|
34,820 |
Total other income |
|
$ |
103,455 |
|
$ |
37,343 |
The increase in interest
income during the three months ended March 31, 2024 compared to the three months ended March 31, 2023 is primarily the result of proceeds
from the Reg A Common Stock Offering which were invested in a JP Morgan US Government Money Market Fund beginning in Q2 2023.
Net
Loss
As a result of the
foregoing, the Company had a net loss of $3,506,704 for the three months ended March 31, 2024 – a 9.1% improvement in net loss compared
to $3,857,722 in net loss for the three months ended March 31, 2023.
Liquidity
and Capital Resources
As of March 31, 2024
the Company had approximately $10.1 million in cash on hand, largely resulting from proceeds received from the Company’s Reg A Common
Stock Offering that ended in May 2023. The Company has recorded losses since inception and, as of March 31, 2024, had working capital
of approximately $8.7 million and total stockholders’ equity of $10,227,507. Since inception, the Company has been primarily capitalized
through securities offerings. The Company plans to continue to try to raise additional capital through available financing options to
the Company, including, but not limited to, registered or exempt equity and/or debt offerings, as well as straight or convertible debt
financings, although there can be no assurance that we will be successful in these fundraising efforts. Absent additional capital, the
Company may be forced to reduce expenses significantly and could become insolvent.
To provide additional
flexibility to the Company ahead of generating sufficient revenues to support operations, the Company entered into a Common Stock Purchase
Agreement (the “Purchase Agreement”) and a Registration Rights Agreement with B. Riley Principal Capital, II LLC (the
“BRPC II”) on July 19, 2023. Under the Purchase Agreement and Registration Rights Agreement, the Company has the right to
sell to BRPC II up to $20.0 million in shares of Common Stock (the “Committed Equity Shares”), subject to certain limitations
and the satisfaction of specified conditions in the Purchase Agreement, from time to time over the 24-month period commencing upon the
initial satisfaction of the conditions to the BRPC II’s purchase obligations set forth in the Purchase Agreement, including that
the registration statement declared effective by the SEC on September 7, 2023. Sales of Common Stock pursuant to the Purchase Agreement,
and the timing of any sales, are solely at the Company’s option, and it is under no obligation to sell any securities to BRPC II
under the Purchase Agreement. As of the March 31,2024 we have sold 256,346 shares of Common Stock to BRPC II for gross proceeds of $889,042
pursuant to this purchase obligation – and therefore have approximately $19.1 million worth of our Common Stock that we may
sell to BRPC II.
The Company’s
unaudited condensed financial statements included in this Quarterly Report on Form 10-Q have been prepared on a going concern basis, which
contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company is a business
that has not yet generated profits, incurred a net loss during the three months ended March 31, 2024 of $3,506,704 and has an accumulated
deficit of $55,015,368 as of March 31, 2024.
The Company’s
ability to continue as a going concern in the next twelve months following the date the unaudited condensed financial statements were
available to be issued is dependent upon its ability to produce revenues, raise capital, and/or obtain other financing sufficient to meet
current and future obligations. Management has evaluated these conditions and believes its current cash balances, plus the additional
capital available under the Purchase Agreement, will be sufficient for the Company to satisfy its near-term capital needs and to continue
as a going concern for a reasonable period.
Issuances of Equity
In two transactions during January and
February 2024, ZB Capital Partners LLC, holder of a warrant exercisable for 547,944 shares of Common Stock, executed a cashless exercise
of its warrant under which the Company issued the holder a total of 246,458 shares of Common Stock and retained the remaining shares as
settlement of the $1.83 per share exercise price of the warrant.
During the three months ended March
31, 2024, the Company sold 49,146 shares of its Common Stock to BRPC II for total proceeds of $162,548.
Pro-Dex
Coverage Warrants
On October 2, 2023, as consideration
for Pro-Dex, Inc., a Colorado corporation (“Pro-Dex”) agreeing to exercise certain warrants exercisable for shares of
the Company’s Common Stock held by Pro-Dex in full, Monogram agreed to the following:
If, (a) between October 2,
2023 and March 31, 2024; or (b) during the six month period between (i) April 1 and September 30 or (ii) October 1
and March 31 of each year thereafter, Monogram engages in or otherwise consummates an issuance of securities that results in Monogram
receiving, or having the right to receive, gross proceeds of $5,000,000 or more during such period, then Monogram will issue Pro-Dex a
warrant to be exercised in cash to purchase 5% (calculated after giving effect to such issuance to Pro-Dex) of the types, series and classes
of securities issued during such period at a price equal to the total gross proceeds received over the such period divided by the number
of securities issued during that same period on terms at least as favorable to Pro-Dex as the most favorable terms pursuant to which any
such securities are acquired by any investor during such period (each, a “Coverage Warrant”). Each Coverage Warrant will be
issued to Pro-Dex within ten (10) business day after the last day of the applicable period, will have a term of six (6) months
from the date of issuance and, unless otherwise agreed to in writing by Pro-Dex in its sole and absolute discretion, will have other provisions
consistent with the provisions of the Pro-Dex Warrants. Pro-Dex’s rights in this regard will expire on December 31, 2025 and
will apply to all warrant coverage issuances conducted from time to time, and at any time, by Monogram prior to that date.
During the three months
ended March 31, 2024, the Company did not issue Pro-Dex any such Coverage Warrants.
Indebtedness
As of March 31, 2024,
the Company had $2,314,194 in total liabilities, primarily comprised of vendor accounts payable of $1,321,313, accrued liabilities of
$531,239, and lease liabilities of $461,642.
Commitments and Contingencies
Under the Company’s
Exclusive License Agreement with the Icahn School of Medicine at Mount Sinai (“Mount Sinai”), the Company has an obligation
to make certain payments to Mount Sinai as a result of reaching certain milestones in the development and sales of the product, and for
significant events related to the Company. The Company is currently in discussions with Mount Sinai in regard to the payment obligation
associated with a “Significant Transaction” following the Company becoming publicly traded on Nasdaq without undertaking a
traditional initial public offering contemplated by that term. Under the licensing agreement, if at the time of completion of a “Significant
Transaction” the Company has a valuation greater than $150,000,000, Mount Sinai will receive 1% of the fair market value of Company
at the time of completion of the Significant Transaction. It is the Company’s position that no Significant Transaction has occurred
- but there is no guarantee the Company and Mount Sinai will come to a consensus on this point. If we cannot come to an agreement with
Mount Sinai on this point, we may be forced into litigation - and even if we pursue litigation, it is possible that a court would not
rule in our favor. If the Company is required to pay this amount, it could have a material adverse effect on the Company’s operations.
Cash Flows
|
|
|
|
|
|
|
|
|
For
the three months ended |
|
|
March
31, |
|
|
2024 |
|
2023 |
Cash used in operating activities |
|
$ |
(3,650,768) |
|
$ |
(2,882,377) |
Cash used in investing activities |
|
$ |
(11,389) |
|
$ |
(14,792) |
Cash provided by financing activities |
|
$ |
150,702 |
|
$ |
147,042 |
Cash
Used In Operating Activities
For the three months
ended March 31, 2024, of the approximately $3.5 million net loss, there were various cash and non-cash adjustments that were added or
subtracted from the net loss to arrive at $3,650,768 in cash used in operating activities, such as $294,899 for non-cash stock-based compensation,
$105,898 for non-cash depreciation and amortization, $364,999 for accounts receivable, $(1,140,955) in accounts payable, and $258,303
in accrued liabilities. The increase in cash used in operating activities during the three months ended March 31, 2024, compared to the
same period in 2023, was primarily driven by our payment of R&D invoices related to activities in 2023 that were paid during the three
months ended March 31, 2024 (which reduced accounts payable as of March 31, 2024), partially offset by receivables related to Q4 2023
revenues that were collected during the three months ended March 31, 2024 (which reduced accounts receivable as of March 31, 2024).
Cash
Used in Investing Activities
For the three months
ended March 31, 2024 and 2023, cash used in investing activities were comprised entirely of equipment purchases and remained relatively
stable between the two periods.
Cash
provided by Financing Activities
Cash provided by financing
activities during the three months ended March 31, 2024 was provided entirely by sales of Common Stock to B. Riley Principal Capital II,
LLC pursuant to the Purchase Agreement. Cash provided by financing activities during the three months ended March 31, 2023 was provided
by the Reg A Common Stock Offering that concluded in May 2023.
Impact
of inflation
While inflation may
impact our capital and operating expenditures, we believe the effects of inflation, if any, on our results of operations and financial
condition have not been significant. However, there can be no assurance that our results of operations and financial condition will not
be materially impacted by inflation in the future, including by heightened levels of inflation experienced globally as a consequence of
the COVID-19 pandemic and recent geopolitical conflict.
Funding
Requirements
We believe our existing
cash and cash equivalents, including potential cash available to us under the Purchase Agreement, will be sufficient to meet anticipated
cash requirements for at least 12 months from the date of this Quarterly Report on Form 10-Q. However, our forecast of the period of time
through which our financial resources will be adequate to support operations is a forward-looking statement that involves risks and uncertainties,
and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could expend capital
resources sooner than we expect.
Future capital requirements
will depend on many factors, including:
|
● |
Establishing
and maintaining supply relationships with third parties that can provide adequate, in both amount and quality, products and services to
support our development; |
|
● |
Technological
or manufacturing difficulties, design issues or other unforeseen matters; |
|
● |
Addressing
any competing technological and market developments; |
|
● |
Seeking
and obtaining regulatory approvals; and |
|
● |
Attracting,
hiring, and retaining qualified personnel. |
Until such time, if
ever, as we can generate substantial revenues to support our cost structure, we expect to finance cash needs through a combination of
equity offerings, debt financings, commercial and other similar arrangements. To the extent that we raise additional capital through the
sale of equity or convertible debt securities, the ownership interest of stockholders will be, or could be diluted, and the terms of these
securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing and equity
financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such
as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through commercial agreements, or
other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies and/or future revenue streams,
or grant licenses on terms that may not be favorable to us and/or may reduce the value of our Common Stock. Also, our ability to raise
necessary financing could be impacted by the COVID-19 pandemic, recent geopolitical events, and inflationary economic conditions and their
effects on the market conditions. If we are unable to raise additional funds through equity or debt financings when needed, we may be
required to delay, limit, reduce or terminate our commercialization efforts or grant rights to develop and market other products even
if we would otherwise prefer to develop and market these products ourselves or potentially discontinue operations.
Summary of Accounting
Principles
Basis
of Presentation
The accounting and
reporting policies of the Company conform to accounting principles generally accepted in the United States of America and are consistent
in all material respects with those applied in our December 31, 2023 Form 10-K.
As permitted by SEC
requirements for interim reporting, certain footnotes or other financial information have been condensed or omitted. In the opinion of
management, all normal and recurring adjustments considered necessary for the fair presentation of the financial statements have been
included. Revenues, expenses, assets, and liabilities can vary during each quarter of the year, therefore, the results and trends in these
interim financial statements may not be representative of those for the full year.
The information included
in this Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2023.
Going
Concern
The accompanying unaudited
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company is a business that has not yet generated profits, incurred a net loss during
the three months ended March 31, 2024 of $3,506,704 and has an accumulated deficit of $55,015,368 as of March 31, 2024.
The Company’s
ability to continue as a going concern in the next twelve months following the date the unaudited financial statements were available
to be issued is dependent upon its ability to produce revenues, raise capital, and/or obtain other financing sufficient to meet current
and future obligations. Management has evaluated these conditions and believes its current cash balances, plus the additional capital
available under the Common Stock Purchase Agreement described in Note 3, will be sufficient for the Company to satisfy its near-term capital
needs and to continue as a going concern for a reasonable period.
Use
of Estimates
In preparing financial
statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial
statements, and the reported amounts of revenues and expenses during the reporting period. The Company’s most significant estimates
relate to the fair value of the warrant liability, valuations of stock-based compensation, and the income tax valuation allowance. On
a continual basis, management reviews its estimates, utilizing currently available information, changes in facts and circumstances, historical
experience and reasonable assumptions. After such reviews, and if deemed appropriate, those estimates are adjusted accordingly. Actual
results could differ from those estimates.
Emerging
Growth Company
As a Nasdaq listed
public reporting company, we are required to publicly report on an ongoing basis as an “emerging growth company” (as defined
in the Jumpstart Our Business Startups Act of 2012, which we refer to as the JOBS Act) under the reporting rules set forth under the Exchange
Act. For so long as we remain an “emerging growth company”, we may take advantage of certain exemptions from various reporting
requirements that are applicable to other Exchange Act reporting companies that are not “emerging growth companies”, including
but not limited to:
|
● |
not
being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act; |
|
● |
taking
advantage of extensions of time to comply with certain new or revised financial accounting standards; |
|
● |
being
permitted to comply with reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements;
and |
|
● |
being
exempt from the requirement to hold a non-binding advisory vote on executive compensation and shareholder approval of any golden parachute
payments not previously approved. |
We expect to take
advantage of these reporting exemptions until we are no longer an emerging growth company. We may remain an “emerging growth company”
for up to five years, beginning January 26, 2022, although if the market value of our Common Stock that is held by non-affiliates exceeds
$700 million as of June 30th, before that time, we would cease to be an “emerging growth company” as of the following December
31st.
In summary, we are subject to ongoing
public reporting requirements that are less rigorous than Exchange Act rules for companies that are not “emerging growth companies”
and therefore, our shareholders could receive less information than they might expect to receive from more mature public companies.
Item 3. Quantitative
And Qualitative Disclosures About Market Risk
We are a smaller reporting company,
as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, and are not required to provide the information required
under this item.
Item 4. Controls
And Procedures
As
required by Rule 13a-15 under the Exchange Act, our management has carried out an evaluation, with the participation and under the supervision
of our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls
and procedures as of March 31, 2024. Disclosure controls and procedures refer to controls and other procedures designed to ensure that
information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the rules and forms of the SEC and that such information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.
In designing and evaluating our disclosure controls and procedures, management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required
to apply its judgment in evaluating and implementing possible controls and procedures.
Based
upon their evaluation of these disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were effective as of March 31, 2024.
Change in Internal Control
over Financial Reporting
There was no change in our internal
control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the three months
ended March 31, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Limitations
on Effectiveness of Controls and Procedures
In designing and evaluating the
disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures,
no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition,
the design of disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are resource
constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative
to their costs.
PART II -
OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, the Company
may be involved in a variety of legal matters that arise in the normal course of business. The Company is not currently involved in any
litigation, and its management is not aware of any pending or threatened legal actions relating to its intellectual property, conduct
of its business activities, or otherwise.
Item 1A. Risk Factors.
As a smaller reporting company,
the Company is not required to provide the information required by this item.
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds.
|
1. |
On
March 1, 2023, the Company commenced an offering of Tier 2 of Regulation A under the Securities Act (the “Reg A Common Stock Offering).
This offering closed on May 16, 2023, and a total of 2,374,641 shares of Common Stock were sold in this offering for gross proceeds of
$17,216,147. The Company engaged Digital Offering, LLC (“Digital Offering”) to act as lead selling agent for this offering
to offer prospective investors in this offering shares of the Company’s Common stock on a “best efforts” basis. |
|
2. |
In
two transactions during January and February 2024, ZB Capital Partners LLC, holder of a warrant exercisable for 547,944 shares of Common
Stock, executed a cashless exercise of its warrant under which the Company issued the holder a total of 246,458 shares of Common Stock
and retained the remaining shares as settlement of the $1.83 per share exercise price of the warrant. |
Except as set forth
above, no underwriters were involved in the foregoing sales, conversions, and/or exchanges of securities.
All purchasers of the securities
described above issued in reliance upon the exemption from the registration requirements of the Securities Act the as set forth under
Regulation A and/or in Section 4(a)(2) of the Securities Act (and Regulation D promulgated thereunder) as transactions by an issuer not
involving any public offering represented to the registrant in connection with their respective purchases and/or exchanges that they were
accredited investors and were acquiring the shares for their own account for investment purposes only and not with a view to, or for sale
in connection with, any distribution thereof and that they could bear the risks of the investment and could hold the securities for an
indefinite period of time. Such purchasers and/or recipients received written disclosures that the securities had not been registered
under the Securities Act and that any resale must be made pursuant to a registration statement or an available exemption from such registration.
Item 3. Defaults
Upon Senior Securities.
None.
Item 4. Mine Safety
Disclosures.
Not applicable.
Item 5. Other Information.
Item
1.01 Entry into a Material Definitive Agreement
Engagement
Agreement with Contract Research Organization to Oversee mBôs Robot Clinical Trial Activities Outside the U.S.
On May 8, 2024, the
Company entered into an agreement with a Contract Research Organization based in India (the “CRO”), for the purpose of overseeing
the Company’s clinical trial activities for its mBôs Total Knee Arthroplasty (TKA) System and to represent its submission to
the local regulators outside the United States.
The agreement will
be valid for a period of five (5) years thereafter unless earlier terminated. The Company may terminate the agreement at any time, and
for any reason, upon thirty (30) days’ notice to the CRO, and the either party may terminate the agreement upon material breach
by the other party or if a force majeure event affecting either party’s ability to perform lasts for more than ninety (90) days,
among other events.
The agreement states
that any work product created under the agreement by the CRO will be considered a “work for hire”, and the Company will retain
all right, title, and interest to any work product created under the agreement – and that any technology, tools, or processes developed
by the Company related to the work to be performed under the agreement will remain the property of the Company. The results of any studies
and clinical trials performed by the CRO under this agreement will be the sole property of the Company.
Per the terms of the
agreement, the Company will indemnify the CRO against or arising from any third-party claims, actions, proceedings, or litigation relating
to or arising from the Company’s negligent acts or omissions under this agreement, as well as any losses arising from or in connection
with any study, test, device, product or potential product to which this agreement relates, including losses due to death or injury from
the Company’s devices that the CRO is testing, except to the extent that such losses arise from: (ix) any gross negligent act or
omission, or willful misconduct by the CRO or any breach of the agreement by the CRO. the CRO has agreed to indemnify the Company against
all losses, damages, and other expenses arising from its gross negligence in its performance under the agreement, its breach of the agreement,
or any failure to comply with applicable laws related to the work contemplated under the agreement.
The foregoing description of this
agreement does not purport to be complete and is qualified by reference to the complete text of this agreement filed as exhibit 10.23
to this Quarterly Report on Form 10-Q.
Item 6. Exhibits
|
|
|
Exhibit No. |
|
Description |
3.1 |
|
Sixth
Amended and Restated Certificate of Incorporation of the Company (incorporated by reference Exhibit
3.1 to the Company’s Current
Report on Form 8-K filed with the SEC on March 15,
2024) |
3.2 |
|
Amended
and Restated Bylaws, effective as of March 12, 2024 (incorporated by reference to Exhibit 3.2 to the Company’s Annual Report on
Form 10-K for the fiscal year ended December 31, 2023 filed with the SEC on March 15, 2024) |
4.1 |
|
Warrant
Agreement dated December 20, 2018 between Monogram Orthopaedics Inc. and Pro-Dex, Inc. (incorporated by reference to Exhibit 4.1 to the
Company’s Form S-1 filed with the SEC on July 27, 2023) |
4.2 |
|
Warrant
to Purchase Capital Stock dated February 7, 2019 between Monogram Orthopaedics, Inc. and ZB Capital Partners, LLC as Holder (incorporated
by reference to Exhibit 4.2 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
4.3 |
|
Form
of Warrant to be issued to StartEngine Primary, LLC (incorporated by reference to Exhibit 4.3 to the Company’s Form S-1 filed with
the SEC on July 27, 2023) |
4.4 |
|
Description
of Securities (incorporated by reference to exhibit 4.4 to the Company's Annual Report on Form 10 - K for the fiscal year ended December
31, 2023 filed with the SEC on March 14, 2024) |
10.1 |
|
Consulting
agreement dated April 5, 2021 between Monogram Orthopaedics, Inc. and Doug Unis (incorporated by reference to Exhibit 10.1 to
the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.2 |
|
Amended
Employment Agreement dated April 29, 2018 between Monogram Orthopaedics, Inc. and Benjamin Sexson (incorporated by reference
to Exhibit 10.2 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.3 |
|
April 30,
2019 Amendment to Employment Agreement dated April 29, 2018 between Monogram Orthopaedics, Inc. and Benjamin Sexson (incorporated
by reference to Exhibit 10.3 to the Company’s Form S-1 filed with the SEC on July 27, 2023). |
10.4 |
|
May 31,
2020 Amendment to Employment Agreement dated April 29, 2018 between Monogram Orthopaedics, Inc. and Benjamin Sexson (incorporated
by reference to Exhibit 10.4 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.5 |
|
Exclusive
Licensing Agreement dated October 3, 2017 between Monogram Orthopaedics, Inc. as Licensee and Icahn School of Medicine at Mount
Sinai as Licensor (incorporated by reference to Exhibit 10.5 to the Company’s Form S-1 filed with the SEC on July 27,
2023) |
10.6 |
|
Option
Agreement dated March 18, 2019 between Monogram Orthopaedics, Inc. and Icahn School of Medicine at Mount Sinai (incorporated
by reference to Exhibit 10.6 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.7 |
|
Amendment
No. 2 to the Exclusive Licensing Agreement dated June 28, 2019 between Monogram Orthopaedics, Inc. as Licensee and Icahn School
of Medicine at Mount Sinai (incorporated by reference to Exhibit 10.7 to the Company’s Form S-1 filed with the SEC
on July 27, 2023) |
10.8 |
|
Amendment
No. 3 to the Exclusive Licensing Agreement dated September 17, 2020 between Monogram Orthopaedics, Inc. as Licensee and Icahn School of
Medicine at Mount Sinai (incorporated by reference to Exhibit 10.8 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.9 |
|
Amendment
No. 4 to the Exclusive Licensing Agreement dated May 17, 2023 between Monogram Orthopaedics, Inc. as Licensee and Icahn School of Medicine
at Mount Sinai (incorporated by reference to Exhibit 10.9 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.10 |
|
Stock
Issuance Agreement between Monogram Orthopaedics, Inc. and Icahn School of Medicine at Mount Sinai (incorporated by reference to
Exhibit 10.10
to the Company’s Form S-1 filed with the SEC on July 27,
2023) |
10.11 |
|
Development
and Supply Agreement dated December 20, 2018 between Monogram Orthopaedics Inc. and Pro-Dex, Inc. (incorporated by
reference to Exhibit 10.11 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.12 |
|
Amended
and Restated 2019 Stock Option and Grant Plan (incorporated by reference to Exhibit 10.12 to the Company’s Form S-1 filed with
the SEC on July 27, 2023) |
10.13 |
|
Noel
Knape Offer Letter (incorporated by reference to Exhibit 10.13 to the Company’s Form S-1 filed with the SEC on July 27,
2023) |
10.14 |
|
Form of
Indemnification Agreement with Executive Officers and Directors of the Company (incorporated by reference to Exhibit 10.14 to the
Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.15 |
|
Common
Stock Purchase Agreement, dated July 19, 2023 by and between Monogram Orthopaedics, Inc. and B. Riley Principal Capital II, LLC (incorporated
by reference to Exhibit 10.15 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.16 |
|
Registration
Rights Agreement, dated July 19, 2023 by and between Monogram Orthopaedics, Inc. and B. Riley Principal Capital II, LLC (incorporated
by reference to Exhibit 10.16 to the Company’s Form S-1 filed with the SEC on July 27, 2023) |
10.17 † |
|
Supply
Agreement dated October 3, 2023 between Monogram Orthopaedics, Inc. and Pro-Dex, Inc. (incorporated by reference to Exhibit 10.1 to the
Company’s Current Report on Form 8-K filed with the SEC on October 6, 2023) |
10.18 |
|
Warrant
Exercise Side Letter dated October 2, 2023 between Monogram Orthopaedics, Inc. and Pro-Dex, Inc. (incorporated by reference to Exhibit
10.2 to the Company’s Current Report on Form 8-K filed with the SEC on October 6, 2023) |
10.19 |
|
November
3, 2023 Amendment to Warrant Exercise Side Letter dated October 2, 2023 between Monogram Orthopaedics, Inc. and Pro-Dex, Inc. (incorporated
by reference to exhibit 10.19 to the Company’s Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2023
filed with the SEC on November 8, 2023) |
10.20 |
|
Kamran
Shamaei Offer Letter dated February 11, 2021 (incorporated by reference to exhibit 10.20 to the Company's Annual Report on Form 10
- K for the fiscal year ended December 31, 2023 filed with the SEC on March 14, 2024) |
10.21 |
|
Consulting
agreement dated July 28, 2023 between Monogram Orthopaedics Inc. and Colleen Gray (incorporated by reference to Exhibit 10.21 to the Company's
Form POS - AM filed with the SEC on April 18, 2024) |
10.22 |
|
Consulting
agreement dated September 19, 2022 between Monogram Orthopaedics Inc. and Paul Riss (incorporated by reference to Exhibit 10.22 to the
Company's Form POS - AM filed with the SEC on April 18, 2024) |
10.23*† |
|
Clinical
Research Services Master Agreement between the Company and the CRO dated May 8, 2024. |
31.1* |
|
Certification
of the principal executive officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
31.2* |
|
Certification
of the principal financial officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
32.1* |
|
Certification
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
101.INS* |
|
XBRL Instance Document - the
instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. |
101.SCH* |
|
Inline XBRL Taxonomy Extension
Schema |
101.PRE* |
|
Inline XBRL Taxonomy Extension
Presentation Linkbase |
101.CAL* |
|
Inline XBRL Taxonomy Extension
Calculation Linkbase |
101.LAB* |
|
Inline XBRL Taxonomy Extension
Label Linkbase |
101.DEF* |
|
Inline XBRL Taxonomy Extension
Definition Linkbase |
104 |
|
Cover Page Interactive Data
File—the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within
the Inline XBRL document. |
*
Filed herewith.
† Portions of this exhibit
have been omitted pursuant to Rule 601(b)(10) of Regulation S-K. The omitted information is not material and would likely cause competitive
harm to the registrant if publicly disclosed.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
MONOGRAM ORTHOPAEDICS, INC.
|
|
|
By |
/s/ Benjamin Sexson |
|
Benjamin Sexson, Chief Executive Officer |
|
Monogram Orthopaedics, Inc. |
|
|
|
The following persons in the capacities and on the
dates indicated have signed this offering statement. |
|
|
/s/ Benjamin Sexson |
|
Benjamin Sexson, Chief Executive Officer, Director |
|
Date: May 13, 2024 |
|
|
|
/s/ Noel
Knape |
|
Noel Knape, Chief Financial Officer, Principal Financial
Officer, Principal Accounting Officer |
|
Date: May 13, 2024 |
|
Exhibit
10.23
CERTAIN
IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT
IF PUBLICLY DISCLOSED. “[OMITTED]” INDICATES THAT INFORMATION HAS BEEN REDACTED. ADDITIONALLY, THE NAME OF THE PARTY HAS BEEN
REPLACED WITH “[CRO]” IN CERTAIN INSTANCES.
CLINICAL
RESEARCH SERVICES MASTER AGREEMENT
This
Master Services Agreement (this "Master Agreement") is effective as of 08 May 2024 (the "Effective Date"), by and
between
Monogram
Orthopaedics Inc. with office located at 3913 Todd Lane Suite 307, Austin,
TX 78744, USA (hereinafter referred to as “Monogram / Sponsor”);
and
[Omitted],
through its Clinical Research Services business, an Indian Company, having its office at [Omitted] (hereinafter referred to as “[Omitted]
/ CRO”).
WHEREAS
[Omitted]
is engaged in providing clinical trial-related services in connection with the research and development of pharmaceutical and biopharmaceutical
products;
Sponsor
is engaged in the business of commercializing orthopaedic products, including but not limited to orthopaedic implants, navigation systems
and surgical robotics.
Sponsor
has approached [Omitted] to perform the clinical studies on the Test Medical Device (as mentioned in the Work orders) for its products
and [Omitted] has the ability and is willing to perform the clinical studies for and on behalf of the Sponsor in accordance with the terms
and conditions contained herein.
The
parties are collectively called as Parties and solely as Party.
Both
parties have mutually agreed and drafted this agreement in presence of each other for being equal business partners, signed based on mutual
benefit and understanding for each together:
NOW
THEREFORE, in consideration of the premises and the mutual promises and undertakings herein contained, the parties hereto agree as follows:
|
A. |
“Adverse
Events or AE” shall be defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including
an abnormal laboratory finding) in subjects, users or other persons, whether or not related to the Investigational Medical Device. |
|
B. |
“Affiliate”
means, with respect to a particular Party, a person, corporation, firm or other entity that controls, is controlled by or is under common
control with such Party. For the purposes of this definition, “control” means the actual power, either directly or indirectly
to direct or cause the direction of the management and policies of such entity, whether by the ownership |
of
more than fifty percent (50%) of the voting stock of such entity, or by contractual arrangement or otherwise.
|
C. |
“Investigational
Medical Device” or “Test Medical Device” means medical device being assessed for safety or performance in a clinical
investigation. |
|
D. |
“Clinical
Investigation” means the systematic study of an Investigational Medical Device in or on human participants to assess its safety,
performance or effectiveness |
|
E. |
"Clinical
Trial Site" means any hospital or institute or any other clinical establishment having the required facilities to conduct a clinical
trial |
|
F. |
“Clinical
Investigation Plan/ Protocol” means a document which contains the information about the rationale, aims and objective, design and
the proposed analysis, conduct, methodology including performance, management, adverse event, withdrawal and statistical consideration
and record keeping pertaining to clinical investigation. |
|
G. |
“Services”
shall mean the Clinical Trial related services provided to Sponsor by [Omitted] under the terms of this Agreement and shall include services
in the area of conducting clinical trials, and any other agreed upon services associated with Sponsor’s Test Medical Device and
other services as may be required by Sponsor under the Work Order. |
|
H. |
“Work
Order (WO)” shall mean the details of the Service to be performed by [Omitted] including timelines, Deliverables, acceptance criteria
and any other details as may be required by Sponsor pursuant to this Agreement and that is mutually agreed by the Parties in the format
provided in Exhibit A |
|
I. |
“Serious
Adverse Event or SAE” means an untoward medical occurrence that leads to |
|
b. |
a
serious deterioration in the health of the subject that either- |
i. |
|
resulted
in a life-threatening illness or injury; or |
ii. |
|
resulted
in a permanent impairment of a body structure or a body function; or |
iii. |
|
required
in-patient hospitalisation or prolongation of existing hospitalization; or |
iv. |
|
resulted
in medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or a body
function; or |
v. |
|
foetal
distress, foetal death or a congenital abnormality or birth defect |
|
J. |
“Third
Party CRO/ Provider” shall mean any person approved by Sponsor and which are qualified by the [Omitted] as their CRO in accordance
with its SOP/s (whether in writing or in a Work Order) that performs ancillary services for a Study or the Services pursuant to a contract
entered into by either Sponsor or [Omitted], or any agent or representative of either. Third Party CROs/ Providers include, but are not
limited to, central laboratories, drug depots, meeting planners, transportation companies, translation CROs, scale providers, equipment
providers, electronic data capture (EDC) providers or any other CRO performing services not within those offered by CRO. For purposes
of clarification, Third Party CROs/ Providers shall not include [Omitted] Personnel, Investigators or Clinical Trial Sites or Subcontractors. |
|
K. |
“Deliverables”
shall have the meaning as described in the applicable Work Order. |
|
L. |
“Data”
shall mean health-related information that is associated with patient care or as part of the clinical trial program or any information
related to Monogram products and their performance. Data shall include electronic copies of raw data along with all other documents, including
source documents. |
|
M. |
“Regulatory
Agency” shall mean an independent governmental body established by legislative act in order to set standards in a specific field
of activity, or operations, in the private sector of the economy and then to enforce those standards. |
|
N. |
“Laws”
shall mean a system of rules that regulate the conduct of a community, and is often enforced by a controlling authority through penalties. |
|
O. |
“Subjects”
shall mean an individual who participates in a clinical trial either as a recipient of the investigational product(s) or as a control.
The term “subject” is part of the federal regulation and may be used interchangeably with participants. |
|
P. |
“Results”
shall mean health-related information that is associated with patient outcomes as part of the clinical trial program or any information
related to Monogram products and their performance in the clinical trial program. |
|
Q. |
“Acceptance
Criteria” shall mean patient eligibility criteria for inclusion in the study. |
|
R. |
“Ethics
Committee” shall mean an independent body that ensures that the trial is conducted in accordance with GCP guidelines and to safeguard
the safety and well-being of subjects participating in a clinical trial. |
Scope
1. |
Services:
[Omitted] will provide the Sponsor with various Services in connection with Studies for its products. |
2. |
Scope
of the Agreement: Sponsor shall outsource exclusively to [Omitted] all
Services concerning its clinical Studies of its Investigational Medical Device product in India. The data generated from the Studies
are to be used as data for submission to Regulatory Agencies and Sponsor is free to use such data as needed. |
3. |
Work
Orders: The specific details of each clinical trial study (hereinafter
referred to as ‘Study’
or plural “Studies”), including but not limited to timelines and the agreed price shall be negotiated in good faith and agreed
upon in the Work Orders entered into between the Parties from time-to-time and on a product-to-product basis before commencement of a
Study with respect to that particular product. Upon the execution of a Work Order, [Omitted] will provide Services as described on a Study-specific
basis in individual Work Order. Each Work Order shall include the Study-related details including, but not limited to, the nature and
scope of Services, timelines, budget, payment schedules, and Deliverables that [Omitted] shall be obligated to deliver to Sponsor under
such Work Order, and must be signed by both parties before forming part of this Service Master Agreement. A Work Order may also
include terms and requirements that are specific to that Study. Each Work Order is incorporated by reference into this Master Agreement
upon its execution. |
4. |
Change
Order: Any change in the details of a Work Order or the assumptions
upon which the Work Order is based including, but not limited to, changes to the design, the agreed number of subjects participating in
the study and/or suspension of the Study by the Sponsor may require changes in the budget and shall require a written amendment to the
Work Order (a “Change Order”). Each Change Order shall detail the requested changes to the applicable task, responsibility,
duty, budget, timeline or other matter. The Change Order will become effective upon the execution of such Change Order by both Parties,
and [Omitted] will be given a reasonable period of time within which to implement the changes, unless implementation is otherwise explicitly
addressed in the Change Order, and if so, the Change Order timelines will prevail. Both Parties agree to act in good faith and promptly
when considering a Change Order requested by the other Party |
5. |
The
parties acknowledge and agree that their respective Affiliates may execute Work Orders under this Master Agreement. In that event, such
Affiliate(s) shall be bound by all terms and conditions of this Master Agreement and the applicable Work Order, and entitled to all rights
and protections afforded under this Master Agreement. While this Master Agreement creates certain obligations between the parties, it
does not create an obligation on the part of Sponsor or any Sponsor Affiliate to engage [Omitted] to provide services, or an obligation
on the part of [Omitted] or any [Omitted] Affiliate to provide services; such obligations shall arise only upon the execution of a Work
Order, or a Change Order. |
6. |
Each
Party understands and agrees that the other Party or its Affiliates may be in a business similar to or offer products or services the
same as the other Party (or one or more of its Affiliates) and may already have developed, be in the process of developing, or plan to
develop products, services and information similar to those owned or developed by the other. Nothing |
contained
herein shall be construed to prohibit a Party from so doing as long as it does so independently and without using Confidential Information
disclosed by the other.
Any
external vendors or subcontractors that [Omitted] solicits on behalf of this study (e. g, imaging, etc.) shall be compliant with the confidentiality
terms of this agreement. [Omitted] should notify the Sponsor of the execution of the same and provide a copy of the agreement.
I.
[Omitted]’s Obligations:
1. |
[Omitted]
shall conduct the Study for the Sponsor in accordance with this Master Agreement, Protocol (as amended from time to time), Good Clinical
Practices (GCP)during the Term, and approval of the Ethics Committee and all applicable Laws. |
2. |
[Omitted]
agrees to provide such personnel, facilities and resources to the Sponsor as [Omitted] deems necessary to perform the Study under this
Master Agreement. |
3. |
In
order to provide these Services, [Omitted] will use investigators, investigative sites or related subcontractors as per recommendation
and approval of the Sponsor. In performing the Services, all such personnel, investigators and subcontractors shall be bound by confidentiality
obligations and compliance to local regulatory requirements including FDA requirements. The separate agreement between Sponsor and investigators
will be executed to conduct the Study at different Clinical Trial Sites. |
4. |
With
regard to any Work Order related to the development and consultation of any Protocols designed for the Study, [Omitted] shall consult
on design, objectives, inclusion and exclusion criteria, procedures for reporting Adverse Events, statistical analysis or any other relevant
issues, in line with all applicable Laws of both Indian and US jurisdictions, and industry standards. |
5. |
For
any Study described in a Work Order, [Omitted] shall prepare informed consent forms (“Informed Consent Forms”) and Case Record
Forms (“CRFs”) for the Study. If described in a Work Order, [Omitted] shall submit Informed Consent Forms and CRFs in the
agreed form to the applicable Regulatory Authorities and/or applicable Ethics Committee as required by Indian regulatory requirements. |
6. |
[Omitted]
shall deliver the Study within stipulated timelines as agreed in the Work Order with Sponsor. Any delay in Deliverables should be communicated
as soon as practically possible but not to exceed one week. |
7. |
[Omitted]
shall support Sponsor with all reasonable efforts to provide Sponsor with the information requested by the Sponsor without undue delay. |
8. |
[Omitted]
shall complete the Study in accordance with the Protocol and all identified methodologies. In case of any deviation, [Omitted] shall promptly
notify the Sponsor. The Protocol may be amended from time to time provided that any such amendments are mutually agreed in writing
and signed by the Parties and as per the prevalent local regulations and GCP. |
9. |
[Omitted]
and site shall immediately notify the Sponsor and EC of any occurrences of an investigator’s deviations from Protocol due to a Subject’s
safety or the terminations of the |
participation
of a Subject respectively. The reason for the deviation shall be documented in the Study records.
10. |
[Omitted]
shall ensure that Clinical Trial Sites shall enroll a requisite number of Subjects in the Study, who meet the Subject selection criteria
described in the Protocol and only after the approval of the Ethics Committee and the Regulatory Authority. |
11. |
[Omitted]
shall prepare and deliver a final report based on the findings of the Results of the Study (“Report”) (together with copies
of the CRFs) to the Sponsor, compliant with GCP and applicable regulatory requirements and submit one copy (soft) to the Sponsor. [Omitted]
agrees to make any reasonable corrections to the Report requested by the Sponsor and deliver the revised Report to the Sponsor. |
12. |
[Omitted]
will ensure through its Quality Assurance Unit (QA), that services under this Master Agreement are performed in compliance with applicable
Laws and [Omitted]’s Standard Operating Procedures (SOPs). |
13. |
[Omitted]
shall comply and cooperate with Sponsor’s auditing team, which will have the right to audit / inspect at reasonable times and in
a reasonable manner, the SOPs and facilities of [Omitted] and also verify any records as may reasonably be required to determine whether
the Services are being performed in compliance with the provisions of this Master Agreement and /or the relevant Work Order. |
14. |
[Omitted]
shall ensure that the Clinical Trial Site retains electronic copies of raw data along with all other documents, including source documents,
for a period of at least fifteen years or the minimum required by Indian or US based regulations after the submission of the final Report,
which will be open to inspection and copying by Sponsor and thereafter transfer the same to Sponsor. |
15. |
During
the course of the Study, [Omitted] shall keep the Sponsor informed of routine progress in the conduct of every phase of the Study. |
16. |
For
each Study conducted, [Omitted] shall report any occurrence of SAEs to local Central Licencing Authority, the Sponsor or its representative,
as required by current local regulation and as specified in the study-specific Protocol. Sponsor shall be responsible for reporting SAEs
to the relevant Regulatory Authorities outside India, as applicable. |
17. |
Unless
specifically mentioned in the applicable Work Order, upon satisfactory completion of the Study, [Omitted] shall prepare a final Report
with respect to the Study in the ICH-E3/eCTD format. If in an event Sponsor requires a hard copy of the Report, [Omitted] shall provide
the same to the Sponsor and courier it to Sponsor at Sponsor’s cost. |
18. |
[Omitted]
shall not disclose its working relationship with Monogram with any third party unless required for the execution of its obligations under
this Master Agreement. |
19. |
[Omitted]
will be responsible for monitoring of the study on the behalf of the Sponsor conducted at Clinical Trial Site under this Agreement. |
20. |
The
timelines described in this Master Agreement are contingent on [Omitted] receiving inputs as relevant in a timely manner. |
II.Sponsor’s
obligations:
1.Sponsor
expressly acknowledges that [Omitted] will require documents, Test product/Test Medical Device, data, records and necessary cooperation
in order to properly perform the Services as required by this Master Agreement. [Omitted] shall not be responsible for errors, delays
or other consequences arising from the failure of Sponsor and/or the participating Clinical Trial Sites to comply with the requirements
as stated in the Master Agreement, in any Work Order, or as reasonably required.
2. |
The
Sponsor shall provide the Test Product/ Test Medical Device described in the Work Order to Clinical Trial Site. Sponsor shall define the
reliability, performance and other relevant characteristics of the Test Medical Device. |
3. |
Sponsor
shall certify to the effect that the Test Medical Devices are manufactured and tested as per relevant regulations. |
III.Payment
1. |
For
performance of the Services, Sponsor shall pay [Omitted] the amounts specified in Work Order(s) in accordance with the Payment Schedule
described therein. Unless agreed otherwise, the amount stated in the Work Order shall be net of all taxes which will be levied in addition
to the amount stated in the Work Order as per prevalent provisions of law. All quotes shall include estimates of applicable taxes. [Omitted]
shall be reimbursed for its documented expenses, if any such expenses shall be incurred by [Omitted], after receipt of Sponsor’s
approval. |
2. |
All
payments shall be made by Sponsor to [Omitted] in US Dollars or INR to the bank information provided on the applicable invoice. [Omitted]
shall submit the invoices to Sponsor by email. Sponsor shall make the payment within 30 days from the date of the invoice. Payments shall
be made in INR or in USD at the prevailing INR: USD exchange rate on the date of invoice. In case of any delay in payment more than thirty
(30) days past the due date, interest at 18% per annum shall be paid by Sponsor. All quotes shall be inclusive of all estimated taxes
(GST). |
IV.Confidentiality:
1. |
The
Parties agree to hold in confidence all the information and data disclosed by one Party (the “Discloser”) to the other (the
“Recipient”) in confidence, including any and all data and/or other information connected to the Services and or the Parties’
business, and not to use the same except for the purpose of carrying out their obligations pursuant to this Master Agreement. Nothing
contained herein shall be construed or interpreted as limiting the Sponsor's right to make any and all use (including but not limited
to publication) of all Results and/or data from any Study, as it sees fit. For the purposes of this Master Agreement, “Confidential
Information” shall mean any information, including but not limited to data, techniques, Protocols or Results, or business, financial,
commercial or technical information (including but not limited to information concerning Sponsor Materials, clinical trial protocols,
clinical data and analysis, formulae, data, software programs and source documents; the Report and the Research Information, disclosed
by Discloser to Recipient or generated by Recipient and owned by Discloser. For clarity, [Omitted] Technology and [Omitted] IP (as defined
herein) are Confidential |
Information
of [Omitted], and Sponsor Material, Sponsor IP, Results and Reports (as defined herein) are Confidential Information of Sponsor.
2. |
The
obligations of confidence shall not apply to any of the following: |
|
2.1 |
information
which can be proved by evidence in writing that it was known to the other Party before its disclosure; or |
2.2information
which was available to the public before that date of disclosures; or
2.3information
which was received from a third party not bound by any obligation of secrecy to any Party; or
3. |
Recipient
may disclose Discloser’s Confidential Information, including materials containing or embodying such Confidential Information, to
the extent required by applicable law or regulation; provided, however, that before such legally required disclosure Recipient shall give
prompt written notice of such required disclosure to Discloser. In the event of a limited disclosure of Discloser’s Confidential
Information that is required by law or regulation, Recipient shall continue to treat such disclosed information as Discloser’s Confidential
Information for all other purposes and subject to the other terms and conditions of this Master Agreement. |
4. |
Both
Parties agree that they will at any time upon the request by the other return or otherwise dispose of all written or other documentary
Confidential Information or copies thereof given to it or resulting from the Master Agreement. |
5. |
The
confidentiality obligations of this Master Agreement shall continue for a period of seven (7) years after termination of this Agreement.
The provisions of this section will survive the termination or expiry of this Master Agreement for any reason. |
V.Representations
and Warranties
1. |
Each
Party represents that it is authorized to enter into this Master Agreement, and any Work Order issued hereunder, and that the terms of
this Master Agreement are not inconsistent with or a violation of any contracted or other legal obligation to which it is subject. |
2. |
Each
Party represents that in performing under this Master Agreement it shall (a) conduct business in conformance with sound ethical standards
of integrity and honesty and in compliance with all applicable Laws; (b) comply with Article XXI. |
3. |
[Omitted]
represents and warrants that it shall perform the Services in a good and professional manner, in line with highest level industry standards. |
VI.Term:
The
term of this Master Agreement shall commence from the Effective Date and shall be valid for a period of five (5) years thereafter unless
terminated in accordance with, Article XV. This Master Agreement may be extended or amended by express mutual consent of the Parties conveyed
in writing. Notwithstanding the above, should the Services to be provided in accordance with any Work Order extend beyond the above term,
said Work Order shall be construed as a mutually agreed extension to this Master Service Agreement, with regard to the relevant Services.
VII.Investigational
Product/ Test Medical Device:
1. |
The
Sponsor shall provide, without charge, Test Medical Device and related component to be used by Clinical Trial Site investigators and monitored
by [Omitted] in performing Services as further described in the applicable Work Order. The Test Medical Device shall be made available
at the Clinical Trial Sites in appropriate condition and in accordance with the Protocol. |
2. |
Clinical
Trial Site nor [Omitted] shall use Test Medical Device for any purposes other than to perform the Services contemplated in this Agreement. |
VIII.Regulatory:
1. |
[Omitted]
agrees to comply with any audit and inspection requests by Regulatory Agencies, and shall cooperate with such inspection. Upon request
by Sponsor and at Sponsor’s cost, [Omitted] shall cooperate with the request, inquiry, investigation, audit or proceeding with applicable
governmental regulatory authority, at Sponsor’s expense. [Omitted] shall respond promptly to the queries raised by regulatory authorities
on the conduct of the Study by [Omitted]. Sponsor shall notify [Omitted] in writing promptly after becoming aware of any audits of the
Study to be conducted by regulatory authorities. [Omitted] shall have the right to recover from Sponsor the expenses involved in preparing
the reports in accordance with the regulatory guidelines of the country of any audit submission under this Section. The expenses incurred
for audits under this Section would be charged to Sponsor at the prevailing rate. The cost of which shall be mutually agreed on later
date. |
2. |
[Omitted]
shall notify Sponsor within five (5) business days, of receipt of communication letter, in writing of any Regulatory Authority wishing
to conduct inspections or inquiring about any Study conducted for Sponsor by [Omitted]. |
3.[Omitted]
shall inform Sponsor about any regulatory inspection of a Study conducted at the Clinical Trial Sites for the Sponsor as soon as it is
announced by the Regulatory Agency. Following
such inspection, [Omitted] shall update Sponsor about the outcome of the regulatory inspection.
IX.Retention:
As
the Studies to be conducted by Clinical Trial Sites and monitored by [Omitted] for the Sponsor, Parties agree that Study related Documents
(“Materials”) shall be archived beyond the term of the Studies by Clinical Trial Sites and [Omitted] as follows:
Clinical
Trial Site will retain electronic copies of raw data along with all other documents, including source documents, for a minimum period
of fifteen years, after the submission of the final Report, unless required for additional time by the regulatory authorities.
If
any Materials need to be retained by Clinical Trial Sites and [Omitted] beyond the periods specified herein, the Sponsor will specify
the same in the corresponding Work Order and [Omitted] shall archive them at additional cost to the Sponsor at the then prevailing rate.
X.Indemnification:
1. |
[Omitted]
shall indemnify, defend and hold the Sponsor, its Affiliates, officers, directors, employees, agents, ,(“Sponsor Indemnitees”)
harmless from any and all direct losses, direct damages, liabilities, reasonable attorney fees, court costs and expenses (collectively
“Losses”) arising out of (i) [Omitted] Indemnitee’s deviation or omission or gross negligence in the performance of
its obligations under this Master Services Agreement and/or under a Task/Work Orders; and (ii) [Omitted] Indemnitee’s failure to
comply with applicable Laws except to the extent that such Losses arise from: (i) any negligent act or omission, or wilful misconduct,
of any Sponsor Indemnified Party, or (ii) any breach of this MSA by Sponsor. |
2. |
The
Sponsor shall indemnify and hold harmless [Omitted] and its Affiliates, and its directors, officers, employees and agents, (each,
a “[Omitted] Indemnitees”), from and against any and all Losses resulting or arising from any third-party claims, actions,
proceedings, or litigation relating to or arising from (i) Sponsor Indemnitee’s negligent acts or omissions under this Agreement,
any Work Order or the Services contemplated herein including, any Losses arising from or in connection with any study, test, device, product
or potential product to which this Agreement or any Task/Work Order relates; or (ii), death or injury to ( a.) a participant/subject in
a Study performed by [Omitted] on behalf of Sponsor, as specified in the applicable Work Order (“Clinical Investigation”)
or (b) any employee or contractor of [Omitted] involved in the performance of a Study or Services hereunder, in which death or personal
injury arises from or is attributable to the Test Medical Device; or (c ) the procedures set forth in the Study protocol/clinical investigation
plan; or (d) arise directly or indirectly from Sponsor’s use, or a third party’s use pursuant to Sponsor’s authority,
of Study Report provided by [Omitted] under this MSA, except to the extent that such Losses (i)-(ii) arise from: (ix) any gross negligent
act or omission, or wilful misconduct, of any [Omitted] Indemnitees , or (y) any breach of this MSA by [Omitted].
Each Party’s obligation under the above Article X is conditioned
upon timely written notice of any such claim, proceeding or investigation (including a copy thereof). Notwithstanding the foregoing, a
Party’s failure to give timely written notice of any such claim, proceeding or investigation shall not limit the other Parties’
right to indemnification except to the extent such failure affects the ability of such Party to defend against such claim, proceeding
or investigation. The indemnifying Party must consent to the settlement of a claim, and such consent shall not be unreasonably withheld. |
XI.Limitation
of Liability:
1. |
The
Sponsor shall reimburse [Omitted] or the investigator/Institutions for the actual cost of diagnostic procedures and medical treatment
necessary to treat a Research Related Injury and also provide financial compensation to the research Subject as per the order of the licensing
authority under rule 122 DAB of Drugs and Cosmetics Rules 1945. For purposes of this MSA, the term” Research Related Injury”
means physical injury or ill effect, disability whether temporary or permanent and serious or otherwise caused by the Products or procedures
prescribed in the Protocols. |
2. |
Neither
party shall have any claim or right against the other, whether in contract, warranty, tort (including negligence), strict liability or
otherwise, for any special, indirect, incidental, or consequential damages of any kind or nature whatsoever, such as but not limited to
loss of |
revenue,
loss of profits on revenue, loss of customers or contracts, loss of use of equipment or loss of data, work interruption, increased cost
of work or cost of any financing, howsoever caused, even if same were reasonably foreseeable;.
Disclaimer:
[Omitted]
does not give any representation or warranty that Investigational Medical Devices covered by this Master Service Agreement can either
during the terms of the Master Service Agreement or thereafter, be successfully developed or if so developed, will receive the required
approval by respective Regulatory Authority or any regulatory body of the jurisdiction in connection with which the Services are to be
provided.
XII.Publicity
and publication:
Neither
Party shall use the name of the other Party or its employees in any advertisement, press release or publicity with reference to this Master
Agreement without prior written approval of the other Party. However, it is understood that all Data is the property of Sponsor and that
Sponsor can use the Data in publications or regulatory reporting without any prior consent of [Omitted].
XIII.Intellectual
Property and License:
1.Sponsor
and [Omitted] acknowledge that during the course of, and as a result of, the performance of the Services, [Omitted] or its permitted subcontractors
will create written materials, computer files, reports, studies or other tangible manifestations of [Omitted]’s efforts under this
Agreement (hereinafter individually or collectively referred to as “Work Product”). Work Product prepared by [Omitted] or
its permitted subcontractors pursuant to this Agreement shall be “works for hire,” and all rights, title and interest to the
Work Product, including, but not limited to, any and all copyrights in the Work Product, shall be, owned by Sponsor irrespective of any
copyright notices or confidentiality legends to the contrary which may have been placed in or on such Work Product by [Omitted] or others.
[Omitted] and its permitted subcontractors waive in whole all the moral rights which may be associated with such Work Product. If
for any reason any part of or all of the Work Product is not considered work for hire for Sponsor or if ownership of all right, title
and interest in the Work Product shall not otherwise vest in Sponsor, then [Omitted] agrees that such ownership and copyrights in the
Work Product, whether or not such Work Product are fully or partially complete, shall be automatically assigned from [Omitted] to Sponsor,
without further consideration, and Sponsor shall thereafter own all right, title and interest in the Work Product, including all copyright
interests.
2.It
is agreed between the Parties that as between [Omitted] and Sponsor, tools, processes and technology developed, licensed or used by [Omitted]
for the purpose of a Study, other than the Sponsor Material shall remain the sole property of [Omitted], and tools, processes and technology
developed, licensed or used by Monogram for the purpose of a Study, other than the [Omitted] Material shall remain the sole property of
Sponsor. Any invention based on or related to [Omitted] Technology, whether developed by [Omitted], Sponsor or both (“[Omitted]
Technology Invention”), shall be solely owned by [Omitted]. Any invention based on or related to Monogram Technology, whether developed
by Monogram, [Omitted] or both (“Monogram Technology Invention”), shall be solely owned by Monogram. [Omitted] Technology
and [Omitted] Technology Invention shall be referred to as “[Omitted] IP”. All IP shall be the Confidential Information of
[Omitted]. Monogram Technology and Monogram Technology
Invention
shall be referred to as “Monogram IP”. All Monogram IP shall be the Confidential Information of Monogram.
3. |
The
results of the Study together with the Data of the Study (together, “Results”) and the final Report containing the Results
provided by [Omitted] as part of the Work Order, shall remain the property of Sponsor as the case may be. |
4. |
All
data, ideas, methods, inventions, discoveries, information, reports and other proprietary or protectable materials which relate to the
Sponsor, Sponsor’s products and their applications, Sponsor’s business and/or relating to the Investigational Medical Devices
and arising out of the Study performed under this Master Agreement which are developed by [Omitted] or submitted by Sponsor to [Omitted]
(“Sponsor Material”) are owned by Sponsor. |
5. |
Sponsor
hereby grants [Omitted] and its affiliates, a non-exclusive, fully paid-up, sub-licensable and non-transferable limited license for the
term of the Master Agreement, in and to the Sponsor Material and Sponsor IP for the sole purpose of conducting the Study in accordance
with the Work Order. |
XIV.Termination:
1.This
Master Agreement or any Work Order may be terminated, in whole or in part, only as follows:
i. |
|
by
Sponsor, without cause at any time during the term of the Master Agreement upon thirty (30) days' prior written notice to the other
Party; or |
ii. |
|
by
either Party upon written notice if a Force Majeure affecting a Party’s ability to perform lasts for more than ninety (90) days
as provided in Article XVII; or |
iii. |
|
by
either Party for material breach of the other Party upon thirty (30) days' written notice specifying the nature of the breach, if
such breach has not been substantially cured within the thirty (30) day period; or |
iv. |
|
by
either Party if that Party reasonably believes, that its continued performance under the Agreement or a Work Order would violate any applicable
law or regulations; provided that the Party shall provide prior written notification of the same to the other Party and, at the
discretion of and in accordance with written instructions of the Sponsor, either [Omitted] shall continue to provide Services under the
related Work Order, other than and excluding the violative services, and the parties shall amend the scope of Services in the related
Work Order to exclude the violative services, or the related Work Order shall be terminated. |
|
2. |
Either
Party shall have the right to terminate this Agreement at any time upon written notice to the other Party, if the other Party has reasonable
basis for believing the other Party is about to become insolvent or bankrupt, the other Party shall be adjudicated insolvent or have filed
petition for or consent to any relief under any insolvency, re-organization, receivership, liquidation, compromise, or any moratorium
statute, whether now or hereafter in effect, or shall make an assignment for the benefit of its creditors, or shall petition for the appointment
of a receiver, liquidator, trustee, or custodian for all or a substantial part of its assets, or if a receiver, liquidator, trustee or
custodian is appointed for all or a substantial part of its assets and is not discharged within thirty (30) days after the date of such
appointment. In the event that any of the events contemplated in this Article occur, that Party must immediately notify the other,
in writing, of its occurrence. |
3. |
Any
written termination notice shall identify the specific Work Order that is being terminated. Unless specifically terminated the outstanding
work Order will continue to be valid and subsisting until the obligations thereof are performed under this Master Agreement. |
4. |
In
the event this Master Agreement or any Work Order is terminated, the Parties shall promptly meet to prepare a close-out schedule and the
Sponsor shall pay [Omitted] for all Services performed under this Master Agreement and reimburse [Omitted] for all costs and expenses
including non-cancellable costs incurred in performing those Services up to the effective date of termination. Sponsor shall also reimburse
any outstanding investigator fees/expenses, including any investigator or clinical trial site, non-cancellable third-party obligations
which cannot be mitigated through reasonable efforts of [Omitted] or the institution, and any other obligations agreed to by Sponsor and
[Omitted] for the purpose of winding down the Study. Upon termination of a Work Order, [Omitted] shall forward all Sponsor Materials pertinent
to such Work Order and all Sponsor Materials related to all outstanding Work Orders to Sponsor. In the event that an individual
Work Order is terminated, the remainder of this Master Agreement shall otherwise remain in full force and effect, unless otherwise agreed
to by the Parties. |
5. |
In
the event, the Study is terminated due to Adverse Events, then Sponsor agrees to pay [Omitted] for all documented and approved costs,
expenses and obligations actually incurred/ committed till the date of such termination. |
6. |
In
the event of Study termination, [Omitted] shall inform promptly to all sites and Local Regulatory Authority. Site shall promptly inform
the concerned Subjects and the Ethics Committee of such termination and the reason for the same. Study termination notices should go to
Subjects (future enrolled and patients that have already undergone a procedure),. |
7. |
The
pending payment from Sponsor, if any, should be settled by Sponsor in accordance with the Payment Terms, Article IV. |
8. |
In
case the Work Order is terminated during the continuance of any phase, the proportionate amount appropriate to the work completed or irrevocably
committed to be completed shall be payable by Sponsor. If payments under a Work Order are milestone-based, and the Master Agreement or
applicable Work Order is terminated after costs have been incurred by [Omitted] toward achieving a milestone, but that milestone has not
yet been completed, then [Omitted] shall be entitled to receive the proportionate amount appropriate to the milestone completed and reimburse/refund
the balance amount proportionate to work not completed to the Sponsor. |
XV.Insurance:
The
Parties shall maintain sufficient insurance, at its own costs, to cover liabilities arising under this Agreement.
XVI.Force
Majeure
A
Party shall not be in breach of this Master Agreement if there is any total or partial failure by it of its duties and obligations occasioned
by any act of god, act of nature, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or a
hindrance in obtaining
raw
material, energy or other supplies, labour disputes of whatever nature or any reason beyond the control of the Party which affect the
ability to perform its obligations under this Agreement (each such event, a “Force Majeure Event”). If the Party is unable
to perform its duties and obligations under this Master Agreement as a direct result of any such reasons, that Party shall give written
notice to the other Party of such inability stating the reason in question. The performance shall be suspended during the period in which
the reason continues. The suspension of performance shall be of no greater scope and no longer duration than is reasonably required and
the non-performing Party shall use commercially reasonable efforts to remedy its inability to perform; provided, however, that in the
event the suspension of performance continues for longer than ninety (90) days after the date of the occurrence, and such failure to perform
would constitute a material breach of this Master Agreement in the absence of such Force Majeure Event, the non-affected Party may terminate
this Master Agreement immediately by written notice to the affected Party.
XVII.Assignment
This
Master Agreement and/or any Work Orders shall not be assigned by either Party without the prior written consent of the other. In case
of any such assignment, the Party taking up the assignment shall succeed to the rights, benefits, titles, duties, interest and obligations
and liabilities of the Party making such an assignment under the Agreement.
XVIII.Miscellaneous:
1. |
For
the purposes of this Master Agreement, the Parties hereto are independent contractors and nothing contained in this Master Agreement shall
be construed to place them in the relationship of partners, principle and agent, employer/employee or joint ventures. [Omitted] agrees
that it shall have no power or right to bind or obligate the Sponsor, nor shall [Omitted] hold itself out as having such authority. |
2. |
Any
notices between [Omitted] and the Sponsor shall be in writing and sent by delivery service or registered mail, and shall be deemed given
on the date received to the following addresses. |
|
|
Address
of [Omitted] |
Address
of Sponsor: |
[Omitted] |
Mr.
Benjamin Sexson, CEO
Monogram
Orthopaedics Inc.
3913
Todd Lane Suite 307
Austin,
TX 78744, USA
|
3. |
This
Master Agreement constitutes the entire Master Agreement between [Omitted] and the Sponsor with regard to its subject matter, and supersedes
all previous written or oral representations, Master Agreements and understandings between the Parties. This Master Agreement may be amended
only by written document signed by both [Omitted] and the Sponsor. |
4. |
In
the event that any one or more of the provisions contained in this Master Agreement shall, for any reason, be held to be invalid, illegal
or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Master
Agreement, and all other |
provisions
shall remain in full force and effect. If any provision of this Master Agreement is held to be excessively broad, it shall be reformed
and construed by limiting and reducing it so as to be enforceable to the maximum extent permitted by law.
5. |
In
the event there is a conflict between the terms of this Master Agreement and a Work Order, then the terms of this Master Agreement unless
otherwise explicitly stated in a Work Order is executed. |
XIX.Arbitration
and Governing Law:
The
Master Agreement shall be constructed, governed, interpreted and applied in accordance with the laws of England and Wales.
The
Parties shall attempt in good faith to resolve promptly any dispute arising out of or relating to this Master Agreement by negotiation.
If the matter cannot be resolved in the normal course of business, within ten (10) days after the dispute arises, any interested Party
shall give the other Party written notice of any such dispute not resolved, after which the dispute shall be referred to one or more senior
executives of both Parties, who shall likewise attempt to resolve the dispute. In case an amicable settlement of any disputes arising
out of or relating to this Master Agreement is not achieved within twenty (20) days after written notice is received, such dispute shall
be referred to Arbitration under the Rules of International Chamber of Commerce (ICC) by one (1) arbitrator appointed in accordance with
said Rules. The seat of the arbitration shall be London, UK. The arbitration shall be conducted in the English language and the award
shall be final and binding upon the Parties. Each Party shall bear its own costs of the arbitration unless the arbitrator otherwise directs.
The courts of London, UK alone shall have jurisdiction in respect of all matters pertaining to Arbitration
XX.Anti-Corruption
The
parties agree (and shall require all personnel, agents, involved in the provision of the Services to agree) that they will not provide
any money or item of value to any governmental official or representative to improperly influence governmental actions, or to private
individuals to reward the improper performance of a function or activity; and further agree (and shall require that all personnel, agents,
servants and subcontractors involved in the provision of the Services agree) that they will comply at all times with any applicable laws
and regulations relating to anti-bribery and corruption including, the US. Foreign Corrupt Practices Act, U.K. Bribery Act of 2010 and
any other applicable laws and regulations of the country in which Services are performed.
XXI.Subcontracting
A. |
Subcontractor
is a person or entity who has a direct contract with [Omitted] to perform Service as determined by CRO. The term “Subcontractor”
is referred to throughout this Agreement as if singular in number and means a Subcontractor or an authorized representative of the Subcontractor.
In the event that a Subcontractor, in the ordinary course of its business, retains the services of any other corporation, professional
associate or subcontractor, a Subcontractor and [Omitted] shall ensure that such other corporation, professional associate or subcontractor
is subject to the same terms and conditions set forth in this Agreement and [Omitted] shall be liable for any actions of such other corporation,
professional associate or subcontractor with regards to this Agreement |
B. |
[Omitted]
shall have the right to sub-contract all or part of the Services to a Subcontractor provided that the prior written consent of the Sponsor,
which shall not be unreasonably withheld, is obtained. In the event of such a sub-contract, [Omitted] shall remain fully liable for and
shall ensure that the Services, whether provided by a Subcontractor or [Omitted], are performed in strict accordance with the terms of
this Agreement and any Work Order issued pursuant to this Agreement |
XXII.Survival
Articles:
Confidentiality, Regulatory, Retention, Indemnification, Limitation of Liability, Intellectual Property, shall survive termination or
expiration of this Agreement, in addition to any provisions which by their nature should, or by their express terms do, survive or extend
beyond termination or expiration of this Agreement.
IN
WITNESS whereof Parties have executed this deed on the day and place herein above mentioned through their authorized representatives.
For
and on behalf of |
|
For
and on behalf of |
[Omitted]. |
|
Monogram
Orthopaedics Inc. |
|
|
|
/s/
[omitted] |
|
/s/
Benjamin Sexson |
Name:
[Omitted] |
|
Name:
Mr. Benjamin Sexson |
Title:
CEO |
|
Title:
CEO |
Date:
5/10/2024 |
|
Date:
5/9/2024 |
Exhibits:
Exhibit
A: Work Order
EXHIBIT
A
WORK
ORDER # 01
This
Work Order is made effective as of 08 May 2024 (the “Effective Date”) by and between
Monogram
Orthopaedics Inc.; with office located at 3913 Todd Lane Suite 307,
Austin, TX 78744, USA (hereinafter referred to as “Monogram / Sponsor”);
and
[CRO],
through its Clinical Research Services business, an Indian Company, having its office at [Omitted] (hereinafter referred to as “[Omitted]
/ CRO”) pursuant to the Master Services Agreement between [CRO] and Sponsor dated as of 08 May 2024 as the same may be amended from
time to time, (the “Master Agreement”), which is incorporated by reference herein.
The
parties hereby agree as follows:
1.Work
Order.
This
document constitutes a “Work Order” under the Master Agreement and this Work Order and the Services contemplated herein are
subject to the terms and provisions of the Master Agreement.
2.Services.
[CRO]
shall carry out the clinical Study with due diligence, care and skill in accordance with all applicable laws and in accordance with the
Study Protocol and in accordance with written Work Order, such as this one, entered into from time to time describing such Services. The
specific Services and Scope of Work contemplated by this Work Order (the “Services”) are set forth in the Attachment 1, which
is incorporated herein by reference.
3.Study
Report
On
completion of the Study, [CRO] will submit the Final Report as per [CRO]’s SOP to Sponsor consisting of the following details.
● |
Clinical
Report as per ICH E3 Guideline (without any online submission requirement) |
● |
Raw
Data of the Study, 100% CRFs (soft copy). |
● |
Hard
copy of the Report shall be provided at additional cost, if required |
● |
Any
other data format required as per USFDA submission requirement is not included in this scope of work. |
4.Payment
of Fees and Expenses
In
consideration of [CRO]’s performance under this Work Order, Sponsor shall pay to [CRO] the Fees and Pass-through amount for the
services/ Deliverables for the Study as specified and detailed in Attachment 2 to this Work Order, which is incorporated herein by reference.
5.Term.
The
term of this Work Order shall commence on the Effective Date and shall continue until the Services described in Attachment 1 are completed,
unless this Work Order is terminated in accordance with the Master Agreement. If the Master Agreement is terminated or expires,
but this Work Order is not terminated or completed, then the terms of the Master Agreement shall continue to apply to this Work Order
until the Work Order is either terminated or completed.
6.Notices.
In
addition to the recipients of Notice listed in the Master Agreement, notices applicable to this Work Order shall be sent to:
|
|
Address
of [CRO] |
Address
of Sponsor: |
[Omitted] |
Monogram
Orthopaedics Inc.
Attention:
Mr. Benjamin Sexson |
|
3913
Todd Lane Suite 307, Austin, TX |
|
78744,
USA |
|
|
7.Amendments.
No
modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed and delivered by each Party
to the other.
ACKNOWLEDGED,
ACCEPTED AND AGREED TO:
[Omitted] |
Sponsor |
[CRO] |
Monogram
Orthopaedics Inc. |
/s/
[Omitted]
|
/s/
Benjamin Sexson |
Name:
[Omitted] |
Name:
Mr. Benjamin Sexson |
Title:
CEO |
Title:
CEO |
Date:
5/10/2024 |
Date:
5/9/2024 |
ATTACHMENTS:
|
|
ATTACHMENT 1 |
SERVICES AND SCOPE OF WORK [OMITTED] |
ATTACHMENT 2 |
TIMELINES [OMITTED] |
ATTACHMENT 3 |
STUDY BUDGET & PAYMENT SCHEDULE [OMITTED] |
Exhibit
31.1
CERTIFICATIONS
I, Benjamin Sexson,
certify that:
1. I have reviewed
this Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 of Monogram Orthopaedics Inc.;
2. Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
(a) Designed such
disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) Designed such
internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the
effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this
report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant
deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Date: May 13, 2024 |
|
|
|
/s/ Benjamin Sexson |
|
Benjamin Sexson |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
|
Exhibit
31.2
CERTIFICATIONS
I, Noel Knape, certify
that:
1. I have reviewed
this Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 of Monogram Orthopaedics Inc.;
2. Based on my knowledge,
this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements
made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge,
the financial statements, and other financial information included in this report, fairly present in all material respects the financial
condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s
other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange
Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f))
for the registrant and have:
(a) Designed such
disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure
that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) Designed such
internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision,
to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles;
(c) Evaluated the
effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness
of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this
report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most
recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or
is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s
other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to
the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent
functions):
(a) All significant
deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely
to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material,
that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Date: May 13, 2024 |
|
|
|
/s/ Noel Knape |
|
Noel Knape |
|
Chief Financial Officer |
|
(Principal Financial Officer) |
|
Exhibit
32.1
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report of Monogram Orthopaedics Inc. (the “Company”) on Form 10-Q for the quarter ended March
31, 2024 as filed with the Securities and Exchange Commission (the “Report”), I, Benjamin Sexson, Chief Executive Officer
of the Company, and I, Noel Knape, Chief Financial Officer of the Company, certify that:
1.
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2. The information
contained in the Report fairly presents, in all material respects, the financial condition and result of operations of the Company.
Date: May 13, 2024 |
|
|
|
/s/ Benjamin Sexson |
|
Chief Executive Officer |
|
(Principal Executive Officer) |
|
|
|
/s/ Noel Knape |
|
Chief Financial Officer |
|
(Principal Financial Officer) |
|
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