As filed with the Securities and Exchange Commission on September 19, 2024

Registration No. 333-___________

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM S-3

 

REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933

 

60 DEGREES PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware		45-2406880
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)
1025 Connecticut Avenue NW Suite 1000 Washington, D.C. 20036 (202) 327-5422
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Geoffrey Dow Chief Executive Officer and President 60 Degrees Pharmaceuticals, Inc. 1025 Connecticut Avenue NW Suite 1000 Washington, D.C. 20036 (202) 327-5422
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:   Ross D. Carmel, Esq. Jeffrey Hua, Esq. Sichenzia Ross Ference Carmel LLP 1185 Avenue of the Americas, 31st Floor New York, New York 10036 Telephone: (212) 930-9700

 

Approximate date of commencement of proposed sale to the public: From time to time, after the effective date of this registration statement.

 

If the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please check the following box. ☐

 

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box. ☒

 

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐

 

If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐

 

If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐

 

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 definition 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. ☐

 

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 

 

 

The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and we are not soliciting offers to buy these securities in any jurisdiction where the offer or sale is not permitted.

 

Subject To Completion, Dated September 19, 2024

 

PROSPECTUS

 

Up to 8,913,044 Shares of Common Stock

underlying certain Pre-Funded Warrants,

Common Warrants and Placement Agent Warrants

 

 

This prospectus relates to the offer and sale from time to time, on a resale basis, by the selling stockholders identified herein or their permitted transferees, of up to an aggregate of 8,913,044 shares of our common stock, par value $0.0001 per share (“Common Stock”), consisting of: (i) 2,898,551 shares of Common Stock issuable upon exercise of pre-funded warrants held by certain selling stockholders (the “Pre-Funded Warrants”), (ii) 2,898,551 shares of Common Stock issuable upon exercise of Series A warrants (the “Series A Warrants”), (iii) 2,898,551 shares of Common Stock issuable upon exercise of Series B warrants (the “Series B Warrants,” together with Series A Warrants, the “Common Warrants”) (and collectively with the Pre-Funded Warrants and Common Warrants, the “Purchase Warrants”), and (iv) 217,391 share of Common Stock issuable upon the exercise of placement agent warrants (the “Placement Agent Warrants” and together with the Purchase Warrants, the “Warrants”) that were issued to designees of H.C. Wainwright & Co., LLC (“Wainwright” or the “Placement Agent”) as partial compensation for Wainwright acting as placement agent in connection with the Private Placement (as defined below). The Warrants were issued to the selling stockholders in connection with a private placement we completed on September 5, 2024 (the “Private Placement”). We refer to 8,913,044 shares of Common Stock underlying the Warrants being registered herein as the “Registered Securities.”

 

We are not offering any shares of our Common Stock for sale by us under this prospectus. We are registering the shares of Common Stock covered by this prospectus to be sold by the selling stockholders under the terms of a registration rights agreement dated September 4, 2024, entered into with the selling stockholders in connection with the Private Placement. We will not receive any of the proceeds from the sale by the selling stockholders of the Common Stock. Upon any exercise of the Warrants for cash, however, we will receive the exercise price of the respective Warrants.

 

Following the effectiveness of the registration statement of which this prospectus forms a part, the selling stockholders may, from time to time, sell, transfer, or otherwise dispose of any or all of their securities on any stock exchange, market, or trading facility on which the securities are traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of sale, at prices related to the prevailing market price, at varying prices determined at the time of sale, or at negotiated prices. For more information, see “Plan of Distribution.”

 

The selling stockholders may offer, sell or distribute all or a portion of the Registered Securities publicly or through private transactions at prevailing market prices or at negotiated prices. The selling stockholders may retain underwriters, dealers or agents from time to time. See “Plan of Distribution” for more information about how the selling stockholders may sell the Registered Securities.

 

We will not receive any proceeds from the sale of the Registered Securities, but we agreed to bear the expenses relating to the registration of the Registered Securities.

 

Our Common Stock is listed for trading on the Nasdaq Capital Market under the symbol “SXTP.” On September 18, 2024, the last reported sale price of our Common Stock on the Nasdaq Capital Market was $1.41 per share.

 

Please be advised that on August 12, 2024, we effected a reverse stock split of our Common Stock at a ratio of 1-for-12 (the “Reverse Split”). Except as indicated otherwise, all share numbers related to our Common Stock disclosed in this prospectus have been adjusted on a post-Reverse Split basis.

 

Investing in our securities involves a high degree of risk. See the information contained under “Risk Factors” on page 22 of this prospectus and in the documents incorporated herein by reference. You should read this entire prospectus carefully before you make your investment decision.

 

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 this prospectus. Any representation to the contrary is a criminal offense.

 

The date of this prospectus is             , 2024.

 

 

TABLE OF CONTENTS

 

	Page
IMPORTANT INFORMATION ABOUT THIS PROSPECTUS	ii
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS	iii
SUMMARY	1
THE OFFERING	21
RISK FACTORS	22
USE OF PROCEEDS	22
SELLING STOCKHOLDERS	23
PLAN OF DISTRIBUTION	25
DESCRIPTION OF SECURITIES	26
DIVIDEND POLICY	30
LEGAL MATTERS	30
EXPERTS	30
WHERE YOU CAN FIND MORE INFORMATION	30
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE	31
PART II INFORMATION NOT REQUIRED IN PROSPECTUS	II-1
SIGNATURES	II-4
EXHIBIT INDEX	II-5

 

 

IMPORTANT INFORMATION ABOUT THIS PROSPECTUS

 

This prospectus is part of a registration statement that we have filed with the SEC pursuant to which the selling stockholders named herein may, from time to time, offer and sell or otherwise dispose of the shares of our Common Stock, $0.0001 par value covered by this prospectus. You should not assume that the information contained in this prospectus is accurate on any date subsequent to the date set forth on the front cover of this prospectus or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or shares of Common Stock are sold or otherwise disposed of on a later date. It is important for you to read and consider all information contained in this prospectus, including the documents incorporated by reference therein, in making your investment decision. You should also read and consider the information in the documents to which we have referred you under “Where You Can Find More Information” and “Incorporation of Certain Documents by Reference” in this prospectus.

 

We have not authorized anyone to give any information or to make any representation to you other than those contained or incorporated by reference in this prospectus. You must not rely upon any information or representation not contained or incorporated by reference in this prospectus. This prospectus does not constitute an offer to sell or the solicitation of an offer to buy any of our shares of Common Stock other than the shares of our Common Stock covered hereby, nor does this prospectus constitute an offer to sell or the solicitation of an offer to buy any securities in any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction. Persons who come into possession of this prospectus in jurisdictions outside the United States are required to inform themselves about, and to observe, any restrictions as to the offering and the distribution of this prospectus applicable to those jurisdictions.

 

Unless we have indicated otherwise, or the context otherwise requires, references in this prospectus to “SXTP,” the “Company,” “we,” “us” and “our” refer to 60 Degrees Pharmaceuticals, Inc.

 

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This prospectus contains “forward-looking statements.” Forward-looking statements reflect the current view about future events. When used in this prospectus, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this prospectus relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:

 

	●	Our ability to effectively operate our business segments;
	●	Our ability to manage our research, development, expansion, growth and operating expenses;
	●	Our ability to evaluate and measure our business, prospects and performance metrics;
	●	Our ability to compete, directly and indirectly, and succeed in a highly competitive and evolving industry;
	●	Our ability to respond and adapt to changes in technology and customer behavior;
	●	Our ability to protect our intellectual property and to develop, maintain and enhance a strong brand; and
	●	other factors (including the risks contained in the section of this prospectus entitled “Risk Factors”) relating to our industry, our operations and results of operations.

 

Should one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended or planned.

 

Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to actual results.

 

 

RISK FACTORS

 

 Investing in our securities involves a high degree of risk. Before deciding whether to invest in our securities, you should consider carefully the risks and uncertainties described under this section and the section titled “Risk Factors” contained in the applicable prospectus supplement, and discussed under the section titled “Risk Factors” contained in our most recent Annual Report on Form 10-K and in our most recent Quarterly Report on Form 10-Q, as well as any amendments thereto reflected in subsequent filings with the SEC, which are incorporated by reference into this prospectus in their entirety, together with other information in this prospectus, and the documents incorporated by reference that we may authorize for use in connection with a specific offering. The risks described in this section and in these documents are not the only ones we face, but those that we consider being material. There may be other unknown or unpredictable economic, business, competitive, regulatory or other factors that could have material adverse effects on our future results. Past financial performance may not be a reliable indicator of future performance, and historical trends should not be used to anticipate results or trends in future periods. If any of these risks actually occur, our business, financial condition, results of operations or cash flow could be harmed. This could cause the trading price of our securities to decline, resulting in a loss of all or part of your investment. Please also read carefully the section above titled “Cautionary Note Regarding Forward-Looking Statements.”

 

USE OF PROCEEDS

 

We will not receive any proceeds from the sale of the Registered Securities by the selling stockholders. We will bear all other costs, fees and expenses incurred by us, or by the selling stockholders, in effecting the registration of the Registered Securities. The selling stockholders, however, will pay any other expenses incurred in selling their Registered Securities, including any brokerage commissions or costs of sale.

 

 

SELLING STOCKHOLDERS

 

This prospectus relates to the offer and sale from time to time, on a resale basis, by the selling stockholders or their permitted transferees, of up to an aggregate of 8,913,044 shares of our Common Stock consisting of: (i) 2,898,551 shares of Common Stock issuable upon exercise of Pre-Funded Warrants held by certain selling stockholders, (ii) 2,898,551 shares of Common Stock issuable upon exercise of Series A Warrants (iii) 2,898,551 shares of Common Stock issuable upon exercise of Series B Warrants, and (iv) 217,391 share of Common Stock issuable upon the excise of the Placement Agent Warrants owned by certain holders. The shares of Common Stock being registered for resale hereby consist of the shares that have been issued or are issuable upon exercise of outstanding Warrants that were issued in connection with the Private Placement.

 

We will pay the expenses relating to such registration other than brokerage commissions in connection with the sale of the Common Stock under this prospectus by the respective selling stockholders.

 

All information with respect to share ownership has been furnished by the selling stockholders. The Common Stock being offered is being registered to permit secondary trading of the shares and the selling stockholders may offer all or part of the Common Stock owned for resale from time to time. Other than as described in the footnotes below, the selling stockholders do not have any family relationships with our officers, directors or controlling shareholders.

 

The term “selling stockholder” also includes any transferees, pledges, donees, or other successors in interest to the selling stockholders named in the table below. To our knowledge, each person named in the table has sole voting and investment power with respect to the Common Stock set forth opposite such person’s name. We will file a supplement to this prospectus (or a post-effective amendment hereto, if necessary) to name successors to any named selling stockholder who is able to use this prospectus to resell the securities registered hereby. 

 

The shares of Common Stock being offered by the selling stockholders are those issuable to the selling stockholders, upon exercise of the Warrants. For additional information regarding the issuances of those shares of Purchase Warrants and Placement Agent Warrants, see “Business - Recent Developments” above. We are registering the shares of Purchase Warrants and Placement Agent Warrants in order to permit the selling stockholders to offer the shares for resale from time to time. Except for the ownership of the shares of the Purchase Warrants and Placement Agent Warrants, the selling stockholders have not had any material relationship with us within the past three years.

 

The table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of Common Stock by each of the selling stockholders. The second column lists the number of shares of Common Stock beneficially owned by each selling stockholder, based on its ownership of the shares of Private Placement Common Stock and Warrants, as of September 19, 2024, assuming exercise of the Warrants held by the selling stockholders on that date, without regard to any limitations on exercises.

 

The third column lists the shares of Common Stock being offered by this prospectus by the selling stockholders.

 

In accordance with the terms of a registration rights agreement with the selling stockholders, this prospectus generally covers the resale of the sum of (i) the number of shares of Private Placement Common Stock issued to the selling stockholders in the “Business - Recent Developments” described above and (ii) the maximum number of shares of Common Stock issuable upon exercise of the related Warrants, determined as if the outstanding Warrants were exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the SEC, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided in the registration right agreement, without regard to any limitations on the exercise of the warrants. The fourth column assumes the sale of all of the shares offered by the selling stockholders pursuant to this prospectus.

 

Under the terms of the Warrants, a selling stockholder may not exercise the Warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of Common Stock which would exceed 4.99% or 9.99%, as applicable, of our then outstanding Common Stock following such exercise, excluding for purposes of such determination shares of Common Stock issuable upon exercise of such Warrants which have not been exercised. The number of shares in the second and fourth columns do not reflect this limitation, if any. The selling stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”

 

 

The following table sets forth certain information concerning the selling stockholders and the shares of Common Stock beneficially owned by them and offered by them in this prospectus. The percentage of ownership of the selling stockholders in the following table is based upon 1,861,914 shares of Common Stock outstanding as of September 18, 2024.

 

Name of Selling Stockholder		Number of Shares Owned Prior to Offering(1)				Maximum Number of Shares to be Sold Pursuant to this Prospectus(1)				Number of Shares Owned After Offering(2)				Percentage of Shares Owned After Offering(2)
Armistice Capital LLC.(3)			8,695,653				8,695,653				0				0
Craig Schwabe (4)			7,337				7,337				0				0
Charles Worthman (4)			2,174				2,174				0				0
Michael Vasinkevich(4)			139,402				139,402				0				0
Noam Rubinstein(4)			68,478				68,478				0				0

 

(1)

For each selling stockholder, includes shares of Common Stock known by us to be held by such selling stockholder as of the date of the prospectus plus any shares of Common Stock that are issuable upon exercise of warrants that are being registered hereunder without giving effect to any beneficial ownership limitations that may exist on such warrants. This column does not include any other securities that a selling stockholder may hold, including any other warrants that such selling stockholder may hold, that are not applicable to this prospectus.

 

(2)

Assumes the sale of all shares of Common Stock offered pursuant to this prospectus.

 

(3)	The securities to be sold pursuant to this prospectus consist of up to 8,694,653 (subject to adjustments) shares of Common Stock, consisting of 2,898,551 shares of Common Stock issued or issuable upon exercise of Pre-Funded Warrants, 2,898,551 shares of Common Stock issuable upon exercise of Series A Warrants and 2,898,551 shares of Common Stock issuable upon exercise of Series B Warrants, all of which are directly held by Armistice Capital Master Fund Ltd. (the “Master Fund”), a Cayman Islands exempted company, and may be deemed to be indirectly beneficially owned by Armistice Capital, LLC (“Armistice Capital”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the managing member of Armistice Capital. The Pre-Funded Warrants are subject to a 9.99% beneficial ownership limitation and the Common Warrants are subject to a 4.99% beneficial ownership limitations, which limitations prohibit the Selling Stockholder and its affiliates owning, after exercise, a number of shares of Common Stock in excess of  the beneficial ownership limitation. The address of the Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.
(4)	The selling stockholder is affiliated with H.C. Wainwright & Co., LLC, a registered broker dealer with a registered address of H.C. Wainwright & Co., LLC, 430 Park Ave, 3rd Floor, New York, NY 10022, and has sole voting and dispositive power over the securities held. The number of shares beneficially owned consists of shares of Common Stock issuable upon exercise of Placement Agent Warrants, which were received as compensation in connection with our Private Placement. The selling stockholder acquired the Placement Agent Warrants in the ordinary course of business and, at the time the Placement Agent Warrants were acquired, the selling stockholder had no agreement or understanding, directly or indirectly, with any person to distribute such securities.

 

 

PLAN OF DISTRIBUTION

 

We are registering the Registered Securities on behalf of the selling stockholders. The selling stockholders and any of their pledgees, assignees, distributees, and successors-in-interest in the Registered Securities received after the date of this prospectus from the selling stockholders as a partnership distribution, gift, pledge, or other transfer, may, from time to time, sell, transfer, or otherwise dispose of any or all of the shares of our Common Stock covered hereby on the Nasdaq Capital Market or any other stock exchange, market or trading facility on which the Common Stock is traded or in private transactions. These dispositions may be at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. The selling stockholders may use any one or more of the following methods when selling Common Stock:

 

●

ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

 

●

block trades in which the broker-dealer will attempt to sell the Common Stock as agent but may position and resell a portion of the block as principal to facilitate the transaction;

 

●

purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

 

●

exchange distributions in accordance with the rules of the applicable exchange;

 

●

privately negotiated transactions;

 

●

settlement of short sales;

 

●

transactions through broker-dealers that agree with the selling stockholders to sell a specified number of such Common Stock at a stipulated price per security;

 

●

through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

 

●

a combination of any such methods of sale; or

 

●

any other method permitted pursuant to applicable law.

 

The selling stockholders may, from time to time, pledge or grant a security interest in some or all of the Registered Securities owned by them and, if they default in the performance of their secured obligations, the pledgees or secured parties may offer and sell the Registered Securities, from time to time, under this prospectus, or under an amendment to this prospectus under Rule 424(b)(3) or other applicable provision of the Securities Act amending the list of selling stockholders to include the pledgee, transferee or other successors in interest as selling stockholders under this prospectus. The selling stockholders also may transfer the Registered Securities in other circumstances, in which case the transferees, pledgees or other successors in interest will be the selling beneficial owners for purposes of this prospectus.

 

In connection with the sale of the Registered Securities, the selling stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in turn engage in short sales of the Registered Securities in the course of hedging the positions they assume. To the extent permitted by applicable securities laws, the selling stockholders may also sell the Registered Securities short and deliver these securities to close out their short positions, or loan or pledge the Registered Securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer or other financial institution of the Registered Securities offered by this prospectus, which Registered Securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

 

 

The aggregate proceeds to the selling stockholders from the sale of the Registered Securities offered by them will be the purchase price of the Registered Securities less discounts or commissions, if any. Each of the selling stockholders reserves the right to accept and, together with their agents from time to time, to reject, in whole or in part, any proposed purchase of the Registered Securities to be made directly or through agents. We will not receive any of the proceeds from this offering.

 

The selling stockholders also may resell all or a portion of the Registered Securities in open market transactions in reliance upon Rule 144 under the Securities Act, provided that they meet the criteria and conform to the requirements of that rule.

 

The selling stockholders and any underwriters, broker-dealers or agents that participate in the sale of the Registered Securities or interests therein may be “underwriters” within the meaning of Section 2(11) of the Securities Act. Any discounts, commissions, concessions or profit they earn on any resale of the Registered Securities covered by this prospectus may be underwriting discounts and commissions under the Securities Act. Selling stockholders who are “underwriters” within the meaning of Section 2(11) of the Securities Act will be subject to the prospectus delivery requirements of the Securities Act.

 

To the extent required, the Registered Securities to be sold, the names of the selling stockholders, the respective purchase prices and public offering prices, the names of any agents, dealer or underwriter, any applicable commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if appropriate, a post-effective amendment to the registration statement that includes this prospectus.

 

In order to comply with the securities laws of some states, if applicable, the Registered Securities may be sold in these jurisdictions only through registered or licensed brokers or dealers. In addition, in some states the Registered Securities may not be sold unless it has been registered or qualified for sale or an exemption from registration or qualification requirements is available and is complied with.

 

Description of Securities

 

Description of Capital Stock

 

General

 

The following description summarizes some of the terms of our capital stock. Because it is only a summary, it does not contain all the information that may be important to you and is subject to and qualified in its entirety by reference to our certificate of incorporation, as corrected (“Certificate of Incorporation”) and amended and restated bylaws (“Bylaws”), which are filed as exhibits to our most recent Annual Report on Form 10-K and are incorporated by reference herein. We encourage you to read our Certificate of Incorporation and Bylaws for additional information.

 

As of September 19, 2024, our authorized capital stock presently consists of 150,000,000 shares of Common Stock, par value $0.00001 per share, and 1,000,000 shares of “blank check” preferred stock, par value $0.00001 per share, of which 80,965 shares of preferred stock have been designated as “Series A Non-Voting Convertible Preferred Stock” (“Series A Preferred Stock”).

 

Common Stock

 

The holders of our Common Stock are entitled to the following rights:

 

Voting Rights. Each share of our Common Stock entitles its holder to one vote per share on all matters to be voted or consented upon by the stockholders.

 

Dividend Rights. Subject to limitations under Delaware law, holders of our Common Stock are entitled to receive ratably such dividends or other distributions, if any, as may be declared by our Board out of funds legally available therefor.

 

 

Liquidation Rights. In the event of liquidation, dissolution or winding up of our business, the holders of our Common Stock are entitled to share ratably in the assets available for distribution after the payment of all of our debts and other liabilities.

 

Other Matters. The holders of our Common Stock have no subscription, redemption or conversion privileges; in addition, such Common Stock does not entitle its holders to pre-emptive rights. All of the outstanding shares of our Common Stock are fully paid and non-assessable. 

 

Preferred Stock

 

Our Certificate of Incorporation authorizes 1,000,000 shares of “blank check” preferred stock, par value $0.0001 per share. We have currently authorized 80,965 shares of Series A Preferred Stock with the following terms and rights: (i) 6% dividend, (ii) non-voting; (iii) not redeemable; and (iv) convertible into shares of Common Stock, solely at the Company’s discretion, determined by (A) multiplying the number of shares of Series A Preferred Stock to be converted by $100, (B) adding to the result all accrued and accumulated and unpaid dividends on such shares to be converted, if any, and then (C) dividing the result by a price equal to the lower of (1) $100, (2) the price paid for the shares of Common Stock in the IPO and (3) the 10-day volume weighted average share price immediately preceding our election to convert the shares of Series A Preferred Stock; provided that the conversion of the shares of Series A Preferred Stock does not result in the holder’s ownership of Common Stock exceeding 19.9%. As of September 19, 2024, there are 80,965 shares of Series A Preferred Stock issued and outstanding.

 

The Board may provide for the issue of any or all of the unissued and undesignated shares of the preferred stock in one or more series, and to fix the number of shares and to determine or alter for each such series, such voting powers, full or limited, or no voting powers, and such designation, preferences, and relative, participating, optional, or other rights and such qualifications, limitations, or restrictions thereof, as shall be stated and expressed in the resolution or resolutions adopted by the Board providing for the issuance of such shares and as may be permitted by law, without stockholder approval. Our Board is able to determine, with respect to any series of preferred stock, the terms and rights of that series, including:

 

●

the designation of the series;

 

●

the number of shares of the series;

 

●

whether dividends, if any, will be cumulative or non-cumulative and the dividend rate, if any, of the series;

 

●

the dates at which dividends, if any, will be payable;

 

●

the redemption rights and price or prices, if any, for shares of the series;

 

●

the terms and amounts of any sinking fund provided for the purchase or redemption of shares of the series;

 

●

the amounts payable on shares of the series in the event of any voluntary or involuntary liquidation, dissolution or winding-up of the affairs of our Company;

 

●

whether the shares of the series will be convertible into shares of any other class or series, or any other security, of our Company or any other entity, and, if so, the specification of the other class or series or other security, the conversion price or prices or rate or rates and provisions for any adjustments to such prices or rates, the date or dates as of which the shares will be convertible, and all other terms and conditions upon which the conversion may be made;

 

●

the ranking of such series with respect to dividends and amounts payable on our liquidation, dissolution or winding-up, which may include provisions that such series will rank senior to our Common Stock with respect to dividends and those distributions;

 

●

restrictions on the issuance of shares of the same series or any other class or series; or

 

●

voting rights, if any, of the holders of the series.

 

The issuance of preferred stock could adversely affect, among other things, the voting power of holders of Common Stock and the likelihood that stockholders will receive dividend payments and payments upon our liquidation, dissolution or winding up. The issuance of preferred stock could also have the effect of delaying, deferring or preventing a change in control of us.

 

 

Section 203 of the Delaware General Corporation Law

 

We are subject to the provisions of Section 203 of the DGCL regulating corporate takeovers. This statute prevents certain Delaware corporations, under certain circumstances, from engaging in a “business combination” with:

 

●

a stockholder who owns 15% or more of our outstanding voting stock (otherwise known as an “interested stockholder”);

 

●

an affiliate of an interested stockholder; or

 

●

an associate of an interested stockholder, for three years following the date that the stockholder became an interested stockholder.

 

A “business combination” includes a merger or sale of more than 10% of our assets. However, the above provisions of Section 203 do not apply if:

 

●

our Board approves the transaction that made the stockholder an “interested stockholder,” prior to the date of the transaction; or

 

●

after the completion of the transaction that resulted in the stockholder becoming an interested stockholder, that stockholder owned at least 85% of our voting stock outstanding at the time the transaction commenced, other than statutorily excluded shares of Common Stock.

 

Potential Effects of Authorized but Unissued Stock

 

Our shares of common and preferred stock are available for future issuance without stockholder approval. We may utilize these additional shares for a variety of corporate purposes, including future public offerings to raise additional capital, to facilitate corporate acquisitions, payment as a dividend on the capital stock or as equity compensation to our service providers under our equity compensation plans.

 

The existence of unissued and unreserved Common Stock and preferred stock may enable our Board to issue shares to persons friendly to current management or to issue preferred stock with terms that could render more difficult or discourage a third-party attempt to obtain control by means of a merger, tender offer, proxy contest or otherwise, thereby protecting the continuity of our management. In addition, our Board has the discretion to determine designations, rights, preferences, privileges and restrictions, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences of each series of preferred stock, all to the fullest extent permissible under the Delaware General Corporation Law and subject to any limitations set forth in our Certificate of Incorporation. The purpose of authorizing the Board to issue preferred stock and to determine the rights and preferences applicable to such preferred stock is to eliminate delays associated with a stockholder vote on specific issuances. The issuance of preferred stock, while providing desirable flexibility in connection with possible financings, acquisitions and other corporate purposes, could have the effect of making it more difficult for a third-party to acquire, or could discourage a third-party from acquiring, a majority of our outstanding voting stock.

 

Also, if we issue additional shares of our authorized, but unissued, Common Stock, these issuances will dilute the voting power and distribution rights of our existing Common Stockholders.

 

 

Transfer Agent and Registrar

 

The transfer agent and registrar for our Common Stock will be Equity Stock Transfer, LLC (“Equity Stock Transfer”), located at 237 West 37th Street, Suite 602, New York, NY 10018. The phone number and facsimile number for Equity Stock Transfer are (212) 575-5757 and (347) 584-3644, respectively. Additional information about Equity Stock Transfer can be found on its website at www.equitystock.com.

 

Listing

 

Our Common Stock and Tradeable Warrants have been approved for listing on The Nasdaq Capital Market under the symbols “SXTP” and “SXTPW,” respectively.

 

Description of Warrants

 

September 2024 Warrants

 

On September 5, 2024, in connection with the Private Placement, we issued (i) Pre-Funded Warrants to purchase up to an aggregate of 2,898.551 shares at an exercise price of $0.001 per share; (ii) Series A Common Stock Warrants to purchase up to an aggregate of 2,898.551 shares of Common Stock at an exercise price of $1.38 per share; and (iii) Series B Common Stock Warrants to purchase up to an aggregate of 2,898.551 shares of Common Stock at an exercise price of $1.38 per share.

 

The Pre-Funded Warrants are exercisable immediately upon issuance and expire when exercised in full at an exercise price of $0.001 per share. The Series A Warrants and Series B Warrants will be exercisable beginning on the effective date of Stockholder Approval of the issuance of the shares of Common Stock upon exercise of the Common Warrants. The Series A Warrants will expire five years from Stockholder Approval and the Series B Warrants will expire eighteen (18) months from Stockholder Approval.

 

The Pre-Funded Warrants and the Series A Common Stock Warrants and Series B Common Stock Warrants provide that a holder of Pre-Funded Warrants and the Series A Common Stock Warrants and Series B Common Stock Warrants, as applicable, will not have the right to exercise any portion of its Pre-Funded Warrants and the Series A Common Stock Warrants and Series B Common Stock Warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99% or 9.99% of the number of shares of the Company’s Common Stock outstanding immediately after giving effect to such exercise (the “Beneficial Ownership Limitation”); provided, however, that each holder may increase or decrease the Beneficial Ownership Limitation by giving 61 days’ notice to the Company, but not to any percentage in excess of 9.99%. If there is no effective registration statement at the time of exercise, the Pre-Funded Warrants and the Series A Common Stock Warrants and Series B Common Stock Warrants may be exercised on a cashless basis.

 

The Company also issued to H.C. Wainwright or its designees warrants the Placement Agent Warrants to purchase up to an aggregate of 217,391 shares of Common Stock at an exercise price equal to $1.725 per share. The Placement Agent Warrants are exercisable beginning on the effective date of the Stockholder Approval for five years from Stockholder Approval.

 

January 2024 Warrants

 

On January 29, 2024, we entered into an Underwriting Agreement with WallachBeth Capital LLC, as representative of the underwriters listed on Schedule I thereto (the “Underwriting Agreement”), relating to the Company’s public offering (the “Offering”) of 5,260,901 units (the “Units”) at an offering price of $0.385 per Unit and 999,076 pre-funded units (the “Pre-Funded Units”) at an offering price of $0.375 per Pre-Funded Unit. Each Unit consists of one share of Common Stock and one warrant exercisable for one share of Common Stock (the “Warrant”). Each Warrant has an exercise price of $0.4235 per share, is exercisable immediately upon issuance and expires five years from the date of issuance. Each Pre-Funded Unit consists of one pre-funded warrant exercisable for one share of Common Stock (the “January 2024 Pre-Funded Warrant”) and one warrant identical to the Warrants included in the Units. The purchase price of each January 2024 Pre-Funded Unit is equal to the price per Unit sold to the public in the offering, minus $0.01, and the exercise price of each January 2024 Pre-Funded Warrant is $0.01 per share. The January 2024 Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the January 2024 Pre-Funded Warrants are exercised in full. 

 

 

DIVIDEND POLICY

 

We have never declared or paid any dividends. We currently intend to retain earnings, if any, for use in our business. We do not anticipate paying dividends in the foreseeable future. Any future determination to declare dividends will be made at the discretion of our board of directors and will depend on our financial condition, operating results, capital requirements, general business conditions, and other factors that our board of directors may deem relevant.

 

LEGAL MATTERS

 

The validity of the securities offered hereby will be passed upon for us by Sichenzia Ross Ference Carmel LLP, located in New York, New York.

 

EXPERTS

 

The financial statements of 60 Degrees Pharmaceuticals, Inc. as of December 31, 2023 and 2022 and for the years then ended incorporated in this registration statement and prospectus by reference to our Annual Report on Form 10-K, for the year ended December 31, 2023, have been audited by RBSM LLP, an independent registered public accounting firm, as stated in their report thereon, incorporated herein by reference, and have been incorporated in this registration statement and prospectus in reliance upon such report and upon the authority of such firm as experts in accounting and auditing.

 

WHERE YOU CAN FIND MORE INFORMATION

 

This prospectus is part of the registration statement on Form S-3 that we filed with the Commission under the Securities Act and does not contain all of the information set forth in the registration statement. Whenever a reference is made in this prospectus to any of our contracts, agreements or other documents, the reference may not be complete and you should refer to the exhibits that are part of the registration statement or the exhibits to the reports or other document incorporated into this prospectus for a copy of such contract agreement or other document. Because we are subject to the information and reporting requirements under the Exchange Act, we file annual, quarterly and current reports, proxy statements and other information with the Commission. Our filings with the Commission are available to the public over the Commission’s website at www.sec.gov. Our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, including any amendments to those reports, and other information that we file with or furnish to the Commission pursuant to Section 13(a) or 15(d) of the Exchange Act can also be accessed free of charge on our website. You may also read and copy any document we file with the SEC at its public reference facility at 100 F Street, N.E., Washington, D.C., 20549, on official business days during the hours of 10 a.m. to 3 p.m. You may also obtain copies of the documents at prescribed rates by writing to the Public Reference Section of the SEC at 100 F Street, N.E., Washington, D.C., 20549. Please call the SEC at 1-800-SEC-0330 for further information on the operation of the public reference facility. In addition, you can find more information about us on our website at https://60degreespharma.com. Information contained on or accessible through our website is not a part of this prospectus and is not incorporated by reference herein, and the inclusion of our website address in this prospectus is an inactive textual reference only.

 

 

INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE

 

The SEC allows us to “incorporate by reference” information that we file with it into this prospectus, which means that we can disclose important information to you by referring you to those documents. The information incorporated by reference is an important part of this prospectus. The information incorporated by reference into this prospectus is deemed to be part of this prospectus, and any information filed with the SEC after the date of this prospectus will automatically be deemed to update and supersede information contained in this prospectus and any accompanying prospectus supplement.

 

The following documents previously filed with the SEC are incorporated by reference in this prospectus:

 

●

The Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on April 1, 2024;

 

	●	The Registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024, filed with the SEC on May 15, 2024;
	●	The Registrant’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024, filed with the SEC on August 14, 2024;

 

●

The Registrant’s Preliminary Schedule 14A, filed with the SEC on May 3, 2024, and the Registrant’s Definitive Schedule 14A, filed with the SEC on May 30, 2024;

 

●

The Registrant’s Current Reports on Form 8-K filed with the SEC on January 16, 2024, February 2, 2024, February 20, 2024, February 28, 2024, July 16, 2024, July 26, 2024, August 12, 2024, August 14, 2024, August 28, 2024 and September 06, 2024 to the extent the information in such report is filed and not furnished; and

 

●

The description of the Registrant’s Common Stock, which is contained in a registration statement on Form 8-A12B filed with the SEC on June 27, 2023, under the Exchange Act, including any amendment or report filed for the purpose of updating such description.

 

All filings filed by us pursuant to the Exchange Act after the date of the initial filing of the registration statement of which this prospectus is a part and prior to effectiveness of the registration statement shall be deemed to be incorporated by reference into this prospectus.

 

We also incorporate by reference all additional documents that we file with the Securities and Exchange Commission under the terms of Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act that are made after the date of the initial registration statement but prior to effectiveness of the registration statement and after the date of this prospectus but prior to the termination of the offering of the securities covered by this prospectus. We are not, however, incorporating, in each case, any documents or information that we are deemed to furnish and not file in accordance with Securities and Exchange Commission rules.

 

You should rely only on the information contained or incorporated by reference in this prospectus. We have not authorized any other person to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. You should assume that the information appearing in this prospectus is accurate only as of the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since that date.

 

Any statement contained in a document incorporated or deemed to be incorporated by reference into this prospectus will be deemed to be modified or superseded for the purposes of this prospectus to the extent that a statement contained herein, or in any other subsequently filed document which also is or is deemed to be incorporated by reference herein, modifies or supersedes that statement. The modifying or superseding statement need not state it has modified or superseded a prior statement or include any other information set forth in the document that it modifies or supersedes. The making of a modifying or superseding statement is not an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation, an untrue statement of a material fact or an omission to state a material fact that is required to be stated or that is necessary to make a statement not misleading in light of the circumstances in which it was made. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.

 

You may request, and we will provide you with, a copy of these filings, at no cost, by calling us at (202) 327-5422 or by writing to us at the following address:

 

60 Degrees Pharmaceuticals, Inc.

1025 Connecticut Avenue NW Suite 1000
Washington, D.C. 20036

Attn: Geoffrey Dow, Chief Executive Officer and President

 

 

 

60 Degrees Pharmaceuticals, Inc. 

8,913,044 Shares of Common Stock underlying certain Pre-Funded Warrants, Common Warrants and

Placement Agent Warrants

 

 

PROSPECTUS

 

 

, 2024

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PART II
INFORMATION NOT REQUIRED IN PROSPECTUS

 

Item 14. Other Expenses of Issuance and Distribution

 

		Amount to Be Paid
U.S. Securities and Exchange Commission registration fee		$	1,858.24
Legal fees and expenses			65,000	*
Accounting fees and expenses			5,000	*
Miscellaneous			5,000	*
Total			76,858.24	*

 

*	These fee and expense amounts are estimated.

 

Item 15. Indemnification of Directors and Officers

 

Under the General Corporation Law of the State of Delaware (“DGCL”), a corporation may include provisions in its certificate of incorporation that will relieve its directors of monetary liability for breaches of their fiduciary duty to the corporation, except under certain circumstances, including a breach of the director’s duty of loyalty, acts or omissions of the director not in good faith or which involve intentional misconduct or a knowing violation of law, the approval of an improper payment of a dividend or an improper purchase by the corporation of stock or any transaction from which the director derived an improper personal benefit. The Company’s Amended and Restated Certificate of Incorporation eliminates the personal liability of directors to the Company or its stockholders for monetary damages for breach of fiduciary duty as a director with certain limited exceptions set forth in the DGCL.

 

Section 145 of the DGCL grants to corporations the power to indemnify each officer and director against liabilities and expenses incurred by reason of the fact that he or she is or was an officer or director of the corporation if he or she acted in good faith and in a manner he or she reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe his or her conduct was unlawful. The Company’s Amended and Restated Certificate of Incorporation and Bylaws provide for indemnification of each officer and director of the Company to the fullest extent permitted by the DGCL. Section 145 of the DGCL also empowers corporations to purchase and maintain insurance on behalf of any person who is or was an officer or director of the corporation against liability asserted against or incurred by him in any such capacity, whether or not the corporation would have the power to indemnify such officer or director against such liability under the provisions of Section 145 of the DGCL.

 

Item 16. Exhibits and Financial Statement Schedules

 

The exhibits to the Registration Statement are listed in the Exhibit Index attached hereto and incorporated by reference herein.

 

 

Item 17. Undertakings

 

(a)	The undersigned registrant hereby undertakes:

 

1.

To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

 

(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;

 

(ii) To reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which individually or in the aggregate, represent a fundamental change in the information set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;

 

(iii)  To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;

 

provided, however, that paragraphs (1)(i), (1)(ii) and (1)(iii) of this section do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the registration statement.

 

2.

That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

3.

To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.

 

4.

That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:

 

(i) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and

 

(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date.

 

 

5.

That, for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

 

(i) Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

 

(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

 

(iii) The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

 

(iv) Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser.

 

(b)

The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefits plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

 

(c)

The undersigned registrant hereby undertakes to supplement the prospectus, after the expiration of the subscription period, to set forth the results of the subscription offer, the transactions by the underwriters during the subscription period, the amount of unsubscribed securities to be purchased by the underwriters, and the terms of any subsequent reoffering thereof. If any public offering by the underwriters is to be made on terms differing from those set forth on the cover page of the prospectus, a post-effective amendment will be filed to set forth the terms of such offering.

 

(d)

Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933, as amended, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Securities Act of 1933, as amended, and will be governed by the final adjudication of such issue.

  

 

SIGNATURES

 

Pursuant to the requirements of the Securities Act of 1933, the registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized in the City of Washington, District of Columbia, on September 19, 2024.

 

60 DEGREES PHARMACEUTICALS, INC.
By:	/s/ Geoffrey Dow
	Geoffrey Dow
	President and Chief Executive Officer (Principal Executive Officer)

 

POWER OF ATTORNEY

 

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Geoffrey Dow and Tyrone Miller, and each of them (with full power to each of them to act alone), his or her true and lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any or all amendments (including post-effective amendments) to this registration statement, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or any of them, or their substitutes, may lawfully do or cause to be done by virtue hereof.

 

Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

 

Name		Position		Date
/s/ Geoffrey Dow		President, Chief Executive Officer and Director		September 19, 2024
Geoffrey Dow		(Principal Executive Officer)
/s/ Tyrone Miller		Chief Financial Officer		September 19, 2024
Tyrone Miller		(Principal Financial and Accounting Officer)
/s/ Charles Allen		Director		September 19, 2024
Charles Allen
/s/ Cheryl Xu		Director		September 19, 2024
Cheryl Xu
/s/ Stephen Toovey		Director		September 19, 2024
Stephen Toovey
*/s/ Paul Field		Director		September 19, 2024
Paul Field

 

* By:	/s/ Geoffrey Dow
	Geoffrey Dow
	Attorney-in-Fact

 

 

EXHIBIT INDEX

 

Exhibit No.		Description
4.1		Form of Pre-Funded Warrant (incorporated herein by reference to Exhibit 10.3 to the registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2024).
4.2		Form of Series A Warrant (incorporated herein by reference to Exhibit 10.4 to the registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2024).
4.3		Form of Series B Warrant (incorporated herein by reference to Exhibit 10.5 to the registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2024).
4.4		Form of Placement Agent Warrant (incorporated herein by reference to Exhibit 10.6 to the registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2024).
5.1*		Opinion of Sichenzia Ross Ference Carmel LLP
10.1		Form of Securities Purchase Agreement (incorporated herein by reference to Exhibit 10.1 to the registrant’s Current Report on Form 8-K filed with the SEC on September 6, 2024).
10.2*		Clinical Trial Agreement, dated July 15, 2024, between 60 Degrees Pharmaceuticals, Inc. and Yale University
10.3*		Clinical Trial Agreement, dated July 15, 2024, between 60 Degrees Pharmaceuticals, Inc. and Rhode Island Hospital
23.1*		Consent of RBSM LLP dated as of September 19, 2024.
23.3*		Consent of Sichenzia Ross Ference Carmel LLP (to be included in Exhibit 5.1).
24.1		Power of Attorney (included on signature page).
107*		Filing Fee Table

 

*

Filed herewith

 

 

II-5

Exhibit 5.1

 

 

September 19, 2024

60 Degrees Pharmaceuticals, Inc.

1025 Connecticut Avenue NW Suite 1000

Washington, D.C.

 

Re: Registration Statement on Form S-3

 

To Whom It May Concern,

 

We are counsel to 60 Degrees Pharmaceuticals, Inc., a Delaware corporation (the “Company”), in connection with the filing and preparing of a registration statement on Form S-3, and as may be further amended or supplemented (the “Registration Statement”), to be filed with the Securities and Exchange Commission (the “Commission”) pursuant to the Securities Act of 1933, as amended (the “Act”), relating to the registration of up to an aggregate of 8,913,044 shares (the “Resale Shares”) of common stock, par value $0.0001 per share (the “Common Stock”), consisting of: (i) 2,898,551 shares of Common Stock issuable upon exercise of pre-funded warrants (the “Pre-Funded Warrants”), (ii) 2,898,551 shares of Common Stock issuable upon exercise of Series A warrants (the “Series A Warrants”), and (iii) 2,898,551 shares of Common Stock issuable upon exercise of Series B warrants (the “Series B Warrants”) and (iv) 217,391 share of Common Stock issuable upon the exercise of placement agent warrants (the “Placement Agent Warrants”, and together with the Pre-Funded Warrants, Series A Warrants and Series B Warrants, the “Warrants”). The Warrants were issued to the selling stockholders in connection with a private placement the Company completed on September 5, 2024.

 

In rendering the opinion set forth herein, we have examined originals or copies, certified or otherwise identified to our satisfaction, of such documents, corporate records, certificates of public officials and other instruments as we have deemed necessary or advisable. In such examination, we have assumed without verification the genuineness of all signatures, the legal capacity of natural persons, the authenticity of all documents submitted to us as originals, the conformity to the originals of all documents submitted to us as copies and the authenticity of the originals of such copies. As to questions of fact material to this opinion, we have relied on certificates or comparable documents of public officials and of officers and representatives of the Company.

 

We express no opinions other than as specifically set forth herein. We are opining solely on as to the General Corporation Law of the State of Delaware and we express no opinion as to whether the laws of any jurisdiction are applicable to the subject matter hereof. We are not rendering any opinion as to compliance with any federal or state law, rule or regulation relating to securities, or to the sale or issuance thereof. This opinion letter deals only with the specified legal issues expressly addressed herein, and you should not infer any opinion that is not explicitly stated herein from any matter addressed in this opinion letter.

 

On the basis of the foregoing, and in reliance thereon, we are of the opinion that:

 

upon exercise of the Warrants against payment of the exercise price therefor and in accordance with the terms of Warrants, the shares of Common Stock underlying the Warrants will be validly issued, fully paid and nonassessable.

 

 

 

1185 AVENUE OF THE AMERICAS | 31ST FLOOR | NEW YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

 

 

In rendering the foregoing opinion, we have assumed that at or prior to the time of the delivery of any Resale Shares, that the Registration Statement will have been declared effective under the Act and that the registration will apply to all of the Resale Shares and will not have been modified or rescinded and that there will not have occurred any change in law affecting the validity of the issuance of such Resale Shares.

 

We hereby consent to the filing of this opinion as an exhibit to the Registration Statement and to the references to our firm therein under the caption “Legal Matters.” In giving our consent, we do not thereby admit that we are experts with respect to any part of the Registration Statement within the meaning of the term “expert,” as used in Section 11 of the Securities Act or the rules and regulations promulgated thereunder by the Commission, nor do we admit that we are in the category of persons whose consent is required under Section 7 of the Securities Act or the rules and regulations thereunder.

 

This opinion is furnished to you in connection with the filing of the Registration Statement and is not to be used, circulated, quoted or otherwise relied upon for any other purpose.

 

		Very truly yours,
		/s/ Sichenzia Ross Ference Carmel LLP
		Sichenzia Ross Ference Carmel LLP

 

1185 AVENUE OF THE AMERICAS | 31ST FLOOR | NEW YORK, NY | 10036

T (212) 930-9700 | F (212) 930-9725 | WWW.SRFC.LAW

 

 

 

 

 

Exhibit 10.2

 

Specific information contained in this agreement has been excluded due to its non-material nature and because such information is considered private or confidential. Upon the request by Commission or its staff, the Company will quickly provide an unredacted copy of this agreement, along with analyses supporting its decisions on materiality and confidentiality.

 

CLINICAL TRIAL AGREEMENT

 

PROTOCOL NUMBER: TQ-BA-2024-1 (NCT06207370)

PROTOCOL TITLE: “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”

 

YALE UNIVERSITY

25 Science Park – 3^rd Floor

150 Munson Street

New Haven, CT 06511 (“INSTITUTION”)

 

and

 

60 Degrees Pharmaceuticals, Inc

1025 Connecticut Ave NW, Suite 1000

Washington DC, United States, 20036

(“SPONSOR”)

 

 

Table of Contents

 

Table of Contents
1. Performance of Study	3
2. Study Drug, Storage and Return, and Equipment	5
3. Payments	6
4. Term and Termination	7
5. Confidentiality	8
6. Publications	9
7. Intellectual Property	10
8. Warranty	10
9. Study Results, Records and Audits	12
10. Indemnification	13
11. Insurance	14
12. Miscellaneous	15

 

 

This Clinical Trial Agreement (this “Agreement”) is effective as of July 15, 2024(the “Effective Date”) and sets forth certain agreements by and between 60 DEGREES PHARMACEUTICALS, INC , having its principal place of business at 1025 Connecticut Ave NW, Washington DC, 20036 (“Sponsor”), and YALE UNIVERSITY, a non profit corporation organized and existing under and by virtue of a special charter granted by the General Assembly of the Colony and State of Connecticut, with offices located at 25 Science Park – 3rd Floor, 150 Munson Street, New Haven, CT 06511 (hereinafter referred to as “Institution”). Subsequent reference to Institution hereinafter shall imply the inclusion of Staff (defined in Section 1.3). The persons executing this Agreement hereby represent that they are authorized to do so for and on behalf of the above-named companies and organizations.

 

WHEREAS, Sponsor and Institution are hereinafter referred to individually as “Party” and collectively as “Parties;”

 

WHEREAS, Sponsor is arranging to use Institution as a clinical trial site to clinically conduct the study pursuant to the Protocol (as defined in Article 1 below) (the “Study”);

 

WHEREAS, the Study contemplated by this Agreement is of mutual interest and benefit to Institution and Sponsor, and will further the instructional and research objectives of Institution in a manner consistent with its status as a nonprofit educational, research and health care institution;

 

WHEREAS, Institution will enroll subjects, collect clinical trial data and execute specific clinical trial activities required by the Study; and

 

WHEREAS, Sponsor has contracted with Fast Track Drugs and Biologics LLC., a Maryland corporation with offices located at 20010 Fisher Avenue Suite G, Poolesville, MD, 20837 (“CRO”) to coordinate and/or perform certain activities as its clinical research organization including, but not limited to, regulatory activities, monitoring, site initiation and close-out visits, data analysis and audits required for the conduct of the Study.

 

NOW, THEREFORE, the Parties, in consideration of the mutual covenants and promises contained herein, have entered into this Agreement and do specifically agree as follows:

 

1. Performance of Study

 

1.1 Study Protocol. The scope and nature of the clinical trial to be performed will be in strict accordance with the Study, including Protocol Number TQ-BA-2024-1 (NCT06207370) entitled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”, and any subsequent amendments thereto, referenced and incorporated herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by Investigator. The Protocol will be considered final after it is signed by the Sponsor and approved by the pertinent Institutional Review Board (“IRB”). Thereafter, the Protocol may be amended only by the Sponsor and subsequent approval by the IRB. A copy of the signed Statement of Investigator (FDA Form 1572), the Protocol and any Protocol amendments will be maintained in the Investigator’s Study files. The Study will be conducted by the Institution under the direction of [____] (“Investigator”), an employee/faculty member of Institution.

 

 

1.2 Conduct of Study. Institution agree to conduct the Study in strict compliance with the Protocol, this Agreement and any amendments thereto, any and all applicable federal, state, and local laws, regulations, good clinical practices as adopted by current FDA regulations and statutes and regulations of the U.S., all reasonable written instructions of the Sponsor or its designee (e.g. CRO) and any other applicable professional standards. Institution also agrees specifically to conduct the Study in accordance with the Statement of Investigator, FDA Form 1572, which Investigator has completed, signed, and delivered to Sponsor prior to the commencement of the Study at Institution. The Institution further agrees that in the performance of the Study, it shall:

 

	(a)	Require the Investigator to exercise independent medical judgment as to the compatibility of each Study participant with Protocol requirements;
	(b)	Obtain a signed informed consent form (in a form approved by Sponsor) from each Study participant or his/her legally authorized representative and his/her caregiver in accordance with the Protocol, which has been approved by the IRB and Sponsor in accordance with 21 CFR §56, et. seq., or any successor thereto;
	(c)	Properly perform and direct or administer the Study in accordance with the Protocol, the applicable laws and regulations, the guideline published by the U.S. Food and Drug Administration (“FDA”) entitled, “Good Clinical Practices, Consolidated Guideline” as amended from time to time, and the other requirements as set forth therein;
	(d)	Review all Study participant case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits of original patient records, laboratory reports, or other raw data sources underlying data recorded on the CRFs;
	(e)	Submit all data and information, and undertake all activities, so that the timeline as defined in the schedule of assessments set forth in the Protocol and this Agreement are strictly met;
	(f)	Notify Sponsor and the IRB immediately upon becoming aware of any failures to comply with the Protocol;
	(g)	Maintain records of Study participant identification, clinical observations, laboratory tests, and drug receipt, storage, return and disposition as specified in the Protocol;
	(h)	Provide all reasonable cooperation with Sponsor and its designee in all of their efforts to monitor the Study;
	(i)	Pursuant to 21 CFR §312.66, assure that the IRB will comply with the requirements of 21 CFR §56, et. Seq.;
	(j)	Perform the services in relation to the Study with reasonable care, diligence and skill and ensure that personnel engaged by it in the provision of such Study services are competent and have appropriate professional qualifications, training and experience; and
	(k)	Upon request from Sponsor, Investigator will update his/her financial disclosure form in a timely matter one (1) year after Study completion.

 

1.3 Participating Staff. The Study shall be conducted under the immediate direction of the Investigator. Institution shall ensure that all Study Staff, including Investigator, personally perform their assigned Study tasks, as indicated in the Protocol and in accordance with this Agreement. Investigator shall qualify such personnel and oversee the work of other Study Staff. Investigator may have one or more sub-investigator(s) work on the Study; provided, however, that Investigator is responsible for all work conducted by sub-investigator. Any such sub-investigator shall be subject to all of the terms and conditions of this Agreement, including all obligations of Investigator. No sub-investigator may work on the Study unless he or she is qualified through experience and training to conduct clinical studies and agrees to be involved through completion of the Study. The sub-investigator’s name shall appear in the appropriate space on the FDA Form 1572. Notwithstanding the foregoing, Sponsor may disapprove any proposed sub-investigator within five (5) days of submission of FDA Form 1572. For purposes of this Agreement, “Staff” shall mean all Institution personnel including, but not limited to, faculty, researchers, investigators, sub-investigators, study coordinators and any other person performing services related to the Study on behalf of Institution, or to whom Institution provides access to Study materials or study drug (“Study Drug”).

 

 

1.4 Third Parties Staff. Institution shall ensure that any third-party personnel working, directly or indirectly, on the Study shall be competent, have appropriate professional qualifications, training and experience, and are bound by obligations of confidentiality and non-use with respect to Confidential Information (as defined by this Agreement) that are at least as restrictive as the obligations of confidentiality and non-use imposed by this Agreement. Institution shall ensure that such third-party are qualified and oversee their work.

 

1.5 Replacement of Investigator. In addition to any other remedy which may be available to Sponsor, in the event Investigator becomes either unwilling or unable to perform the duties required by this Agreement, Institution shall immediately notify Sponsor of such circumstance. In addition, upon request by Sponsor, Institution will cooperate, in good faith and expeditiously, to find a replacement Investigator acceptable to Sponsor. Institution’s and Investigator’s cooperation in finding an acceptable replacement does not negate their obligations under this Agreement or by law or regulation.

 

1.6 Notification of Adverse Events. Investigator shall immediately notify Sponsor and the Institution’s IRB in writing of any serious adverse drug experience within twenty-four (24) hours of learning of the event. For serious adverse drug experiences, Institution and Investigator shall assist in the investigation of the medical circumstances and shall provide Sponsor with all requested information so that Sponsor can submit any required IND Safety Report to FDA within fifteen (15) days of its initial receipt of the information. For fatal or life-threatening experiences, Institution and Investigator shall provide Sponsor with all requested information so that Sponsor can submit any required Telephone and Facsimile Transmittal Safety Report to FDA within seven (7) days of its initial receipt of the information. Institution shall follow-up with any Study participant who experienced an adverse drug experience and continue to provide Sponsor with updates.

 

1.7 Protocol Deviation. Prospective Protocol waivers or deviations will not be granted by Sponsor under any circumstance. Deviations from the Protocol which are medically necessary for a Study participant’s safety in cases of emergency are not considered failure to comply with the Protocol. If, during the course of a Study participant’s post-randomization participation in the Study, it is discovered that the Study participant did not meet all eligibility criteria, s/he will be discontinued, unless the discontinuation presents an unacceptable medical risk.  The justification to allow the Study participant to continue in the Study will be made by the Sponsor, with medical input from the Investigator, and will be documented.   If the Study participant is allowed to remain in the Study, this will be reported as a major Protocol deviation and not a waiver. All follow-up safety assessments must be completed and documented as outlined in the Protocol. Other Protocol deviations will be tracked and corrective measures will be put in place to prevent such deviations from being repeated.

 

1.8 Safety Monitoring Reports. Sponsor agrees to provide Institution with any data and safety monitoring reports related to the Clinical Trial, and Institution agrees they will be submitted to the IRB as required. During the Clinical trial and for at least two (2) years following the completion of the Clinical Trial at all sites, Sponsor shall promptly provide Institution and Principal Investigator with the written report of any findings, including Clinical Trial results and any routine monitoring findings in site monitoring reports, and data safety monitoring committee reports including, but not limited to, data and safety analyses, and any Clinical Trial information that may (i) affect the safety and welfare of current or former Enrolled Participants, or (ii) influence the conduct of the Clinical Trail. Institution and/or Principal Investigator will communicate findings to the IRB and Enrolled Participants, as appropriate.

 

2. Study Drug, Storage and Return, and Equipment

 

2.1 Study Drug. Investigator shall use the Study Drug only pursuant to and in accordance with the Protocol and this Agreement, and for no other purpose. Institution shall notify Sponsor and Institution’s IRB regarding any use of the Study Drug without obtaining informed consent as soon as possible, but no later than five (5) business days after becoming aware of such use.

 

 

2.2 Storage. Institution shall keep all Study Drug in a locked, secured area at all times, within the temperatures required in the Protocol for storage of the Study Drug and maintain complete, up-to-date records showing receipt of shipments of the Study Drug, dispensing and accountability of the Study Drug, and returns of the Study Drug as required by the Protocol, applicable federal, state, and local laws, regulations, and guidelines. Furthermore, Institution shall store all Study Drug in either a central pharmacy where a qualified pharmacist supervises dispensing, or in a restricted area and dispensed under the direct supervision of Investigator.

 

2.3 Equipment. Sponsor may provide, or arrange for a vendor to provide, certain equipment, if applicable, for use by Investigator and Staff during the conduct of the Study (“Equipment”). During the term of this Agreement, Staff, including Investigator, may use the Equipment only for purposes of this Study in accordance with the Protocol. Until the termination of this Agreement, this Equipment remains the property of Sponsor or the respective vendor that has provided the Equipment, as applicable. The Equipment shall be returned upon request by Sponsor, at Sponsor’s expense, to Sponsor or the vendor, promptly upon early termination of this Agreement or at the completion of the Study. Institution agrees to return the Equipment in the manner directed by Sponsor or the vendor in substantially the same condition as when received by Institution and/or Investigator, minus reasonable wear and tear. Institution agrees to be financially responsible to cover any loss or destruction to Equipment while in Institution’s care and control, which exceeds ordinary wear and tear and/or lacks a reasonable causal relationship to proper performance of the Study. Institution further agrees that unless otherwise authorized in writing by Sponsor, Institution will not alter the Equipment in any way nor install any components or software, if applicable. Any software provided to Institution may not be duplicated. Institution shall not have any liability for damages of any sort, including personal injury or property damage, resulting from the use of Equipment except to the extent that such damages were caused by the negligence or willful misconduct of Institution.

 

2.4 Return of Study Drug and Sponsor Property. Upon completion of the Study or earlier termination of this Agreement, all unused Study Drug, devices, Equipment, and related materials and all copies of Confidential Information, including Sponsor Technology (as defined below), that were furnished to Investigator shall be returned to Sponsor, at Sponsor’s request except for record copies which the Investigator is required to retain by law or regulation. Notwithstanding the foregoing, Institution may retain a copy of the Confidential Material in its secure files to maintain its rights and obligations under this Agreement. Regarding all unused Study Drug, the Investigator shall, upon the written direction and approval of Sponsor, either (i) return all such material back to the Sponsor at Sponsor’s expense; (ii) destroy, at the site where the Study is being conducted, such material in a manner that does not expose humans to risk from the compound or drug and according to applicable laws and regulations; or (iii) dispose of such materials in another method that that does not expose humans to risk from the compound or drug. In cases of (ii) or (iii), a certificate of destruction/disposition shall be sent to Sponsor upon such action.

 

3. Payments

 

3.1 In consideration for performance of the Study, Sponsor will pay the Party identified as “Payee” in accordance with the Payment Schedule attached as Appendix I (“Payment Schedule”) and the Budget attached as Appendix II (“Budget”), and each made a part hereof. The Parties acknowledge that the Payee is the appropriate payee under this Agreement and that the Payee is authorized to receive all the payments for the services performed under this Agreement. The Budget may be modified only upon the prior written consent of the Parties. Investigator acknowledges and agrees that the Payment Schedule and Budget includes Sponsor’s entire payment obligation for the performance of the Study pursuant to this Agreement. CRO may process payments to the Payee on behalf of the Sponsor.

 

 

3.2 Institution agrees that its judgment with respect to the advice and care of each Study participant will not be affected by the compensation it receives from this Agreement, that such compensation does not exceed the fair market value of the services they are providing, and that no payments are being provided to it for the purpose of inducing them to purchase or prescribe any drugs, devices or products. If the Sponsor provides any free products or items for use in the Study, Institution agrees that it will not bill any Study participant, insurer or governmental agency, or any other third party, for such free products or items. Institution agrees that it will not bill any Study participant, insurer, or governmental agency for any visits, services or expenses incurred during the Study for which they have received compensation from Sponsor, or which are not part of the ordinary care they would normally provide for the Study participant.

 

3.3 The Payee information needs to be completed below and on an IRS Form W-9 and returned to Sponsor for the Agreement to be effective. This information will be used for preparation of Federal Form 1099 which will be issued to Payee documenting the payments made to the Payee in each calendar year.

 

4. Term and Termination

 

4.1 Term. The term of this Agreement shall begin upon the Effective Date. Unless terminated earlier, this Agreement will terminate when (a) Institution has submitted all CRFs to Sponsor, has resolved all data clarification queries, has submitted the closeout report to the IRB and Sponsor, has returned all Equipment and Study materials to Sponsor, and has met all other close-out obligations; and (b) all payments, reimbursements and refunds have been made.

 

4.2 Termination by Sponsor. This Agreement may be terminated by Sponsor at any time for any reason upon thirty (30) day written notice to Institution.

 

4.3 Termination by Institution. This Agreement may be terminated by the Institution upon prior written notice to Sponsor if any of the following conditions occur:

 

(a)

If the authorization and approval to conduct the Study in the United States is withdrawn by the FDA; or

 

(b)

If the emergence of any unexpected or unanticipated significant safety issue with the Study Drug and/or Study Device is of such magnitude or incidence in the reasonable opinion of the Investigator, Sponsor or the data safety monitoring board to support termination.

 

4.4 Effect of Termination. In the event of expiry or termination of this Agreement for any reason, Institution shall, and shall procure, the prompt return to Sponsor of all Sponsor property as detailed in Section 2.4. The Institution and Investigator may retain only the relevant Study information and data to the extent and for the duration required by applicable law or regulation or as otherwise permitted under this Agreement. Institution shall (i) use all reasonable efforts to conclude work on the Study, (ii) stop enrollment of Study participants, (iii) not incur additional expenses, or enter into any further commitments with regard to the Study after receiving or providing a notice of termination, and (iv) reasonably cooperate with the Sponsor and its designee to allow for a close-out site visit. In the event of termination, the sum payable under this Agreement shall be limited to prorated fees based on actual work performed pursuant to the Protocol as determined in accordance with the Budget. Such payment shall be paid upon satisfaction of all outstanding obligations of Institution, including, but not limited to, return of all Equipment and Study materials to Sponsor. Institution will be entitled to payment for non-cancelable and non-refundable Study participant-related expenses only if properly substantiated, reasonably incurred in accordance with the Study through the date of termination and within the Budget. Any funds not due to Institution but already paid to Institution shall be returned to CRO and Sponsor by the earlier of ninety (90) days from the Institution close-out visit or from the notice of termination.

 

 

5. Confidentiality

 

5.1 All information, including, but not limited to, documents, descriptions, data, CRFs, photographs, videos and instructions, Study Drug Sponsor Technology (as defined in Article 7 below) and Confidential Information (as defined below), provided to or made available to Institution or Investigator by Sponsor or its agents (whether verbal, written or electronic) shall be the property of Sponsor.

 

5.2. “Confidential Information” means all confidential information, material or data related to the Study, including Sponsor Technology, whether provided by or on behalf of Sponsor to the Institution after the Effective Date which: (a) by appropriate marking, is identified as confidential and proprietary at the time of disclosure; or (b) if disclosed orally, is identified at the time of disclosure as confidential and is subsequently reduced to a marked writing within thirty (30) days of such disclosure. Sponsor will make reasonable efforts to mark Confidential Information as stated in (a) and (b) above. The absence of such marking will not preclude information from being treated as confidential if information disclosed (written or verbal) is such that a reasonable person knowledgeable in the field of clinical trial research would consider it to be confidential or proprietary from the context or circumstances of such disclosure., Confidential Information may include without limitation, any information and data concerning the Study Drug, Study results, reports, Study strategies, the existence or terms of the Protocol or this Agreement, exclusive of patient medical records.

 

5.3 Institution shall maintain in strict confidence all of the Confidential Information, including the Sponsor Technology, and not disclose or disseminate to any third party or use for any purpose other than the performance of the Study or as permitted under this Agreement any of the same. Such Confidential Information, including the Sponsor Technology, shall remain the confidential and proprietary property of Sponsor, and shall be disclosed only on a need-to-know basis and only to the Investigator and his/her Staff who have a need to know such Confidential Information for the purposes of performing the Study according to this Agreement and the Protocol, or as otherwise permitted under this Agreement, who are bound by confidentiality terms at least as strict as those herein (individually, a “Required Disclosee”). Institution will inform and advise each Required Disclosee of the obligations under this Agreement with respect to the Confidential Information and each Required Disclosee shall be bound by such obligations in a like fashion.

 

5.4 Institution each shall use the same degree of care to protect the Confidential Information as it uses to protect its own confidential information, but in no event less than a reasonable amount of care. Institution shall be responsible for any breach of this Agreement by its Staff to the extent permitted by applicable law. Institutionagrees to immediately notify Sponsor in the event of any loss or unauthorized disclosure of any Confidential Information.

 

5.5 The foregoing obligation of non-disclosure shall not apply to Confidential Information, including the Sponsor Technology, that:

 

(a)

was generally known to the public prior to the Effective Date of this Agreement;

 

(b)

becomes generally known to the public through no unlawful or unauthorized act or omission of Institution or any of its Staff, including Investigator, or in violation of this Agreement;

 

(c)

was independently developed by Institution, without reliance upon or reference to Confidential Information as evidenced by its written records;

 

(d)

was already known by Institution, as evidenced by its written records; or

 

(e)

was disclosed to Institution or Investigator without restriction by a third party who had the apparent right to make such disclosure.

 

 

5.6 If Institution is requested to produce any of the Confidential Information pursuant to a legal or governmental proceeding, Institution shall give Sponsor adequate prior notice of such requirement, to the extent that Institution is provided wth sufficient notice to comply with this provision, and shall use its reasonable efforts to assist Sponsor in objecting to such request. If Institution is compelled to disclose any of the Confidential Information pursuant to such legal or governmental proceeding, Institution shall use its reasonable efforts to assist Sponsor in obtaining confidential treatment for such disclosed Confidential Information. Any Confidential Information so disclosed shall still be subject to the terms of this Agreement.

 

5.7 Injunctive Relief. Institution acknowledges and agrees that any violation of the terms of this Agreement relating to the disclosure or use of Confidential Information, including the Sponsor Technology, may result in irreparable injury and damage to Sponsor not adequately compensable in money damages, and for which Sponsor may have no adequate remedy at law. Institution acknowledges and agrees, therefore, that if those disclosure terms are violated, Sponsor may need to seek injunctions, orders, or decrees in order to protect the Confidential Information and the Sponsor Technology.

 

5.8 Privacy Laws. Institution agrees to take all reasonable steps to protect the confidentiality of any patient health and medical information (“PHI”) that it has access to and comply with all applicable privacy laws, including, but not limited to the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations. Sponsor shall collect, use, store, access, and disclose PHI collected from Study subjects only as permitted by the IRB approved informed consent form or HIPAA authorization form obtained from a Study subject.

 

5.9 Existence of Agreement. Institution may acknowledge the Sponsor’s support, including but not limited to financial support as may be required by academic journals, professional societies, funding agencies, and applicable regulations. Notwithstanding anything to the contrary in this Agreement, Institution may publicly post information about the Study to appear on Institution’s clinical trials directory/website. Additionally, notwithstanding anything herein to the contrary, Institution shall have the right to post Sponsor’s name, the Study title, and the Study period, and funding amount, on Institution publicly accessible lists of research conducted by the Institution.

 

6. Publications

 

6.1 Institution or Investigator may publish the results of Study, relative to his/her own Study participant(s), subject to the terms of this Section 6. At least ninety (90) days prior to submitting a manuscript to a publisher or other outside persons (i.e., reviewer(s)) or prior to any public presentation, a copy of the manuscript or presentation will be provided to Sponsor by the Institution or Investigator for review and comment. Sponsor shall have forty-five (45) days to review and comment on the provided materials. If during the review period, Sponsor notifies Institution that it desires patent applications to be filed on any Inventions (as defined in Article 7 below) disclosed or contained in the manuscript or presentation, Institution will defer publication or other disclosure for a period, not to exceed an additional forty-five (45) days, sufficient to permit Sponsor or its designee to file or have filed any desired patent applications. Institution agrees, following a request from Sponsor, to delete any Confidential Information from any publication or presentation to the extent such deletion does not preclude the complete and accurate presentation and interpretation of the Study results. The Institution and Investigator each acknowledges that if the Study is part of a multi-center study, then any publication by the Institution or the Investigator of the results of the Study conducted at the Institution shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within eighteen (18) months from completion of the Study for all sites in the Study, or if the Sponsor informs Institution or Investigator that no such multi-center publication will be forthcoming, then the Institution or Investigator may publish individually in accordance with the requirements of this Article.

 

6.2 Sponsor may use, refer to, and disseminate reprints of scientific, medical, and other published articles relating to the Study, which disclose the name of Investigator and Institution, consistent with U.S. copyright laws.

 

 

7. Intellectual Property

 

7.1 Sponsor Technology. For purposes of this Agreement, the term “Sponsor Technology” shall mean all data, materials, information, know-how, methods or techniques, whether or not patented or patentable, copyrighted or copyrightable, pertaining to the research, development, manufacture, or use of compounds obtained or developed by, or on behalf of, Sponsor arising outside of the research conducted under this Agreement. In the performance of this Agreement, Sponsor may disclose Sponsor Technology to Investigator. Sponsor Technology shall remain the confidential and proprietary property of Sponsor. Institution agrees that Sponsor is the sole and exclusive owner of the Sponsor Technology, whether or not patented or subject to copyright or patent protection; and that the Sponsor Technology may be commercially valuable.

 

7.2 Patent Rights. It is expressly agreed that neither Sponsor, on the one hand, or Investigator and/or Institution, on the other hand, transfers to the other, by operation of this Agreement, any patent right, copyright or other proprietary right which any such Party owns as of the Effective Date, except as specifically set forth herein.

 

7.3 Inventions. The ownership of any information, inventions, improvements, new uses, or discoveries (whether patentable, copyrightable, or not), innovations, suggestions, ideas, communications and reports (collectively “Inventions”), conceived, reduced to practice, made or developed by the Institution or Investigator and/or all individuals or entities either employed by, appointed by, or subcontracted by Institution, that incorporate or require the Study Drug or its use or that reflect any reduction to practice of any aspect of the Protocol, belong to the Sponsor, and Institution agrees to, and shall require Investigator and/or all individuals or entities either employed by, appointed by, or contracted by Institution to assign all of their interests therein without compensation from Sponsor or its nominee whenever requested to do so by Sponsor. Institution agrees to, and shall require Investigator and/or all individuals or entities either employed by, appointed by, or contracted by Institution to execute any and all applications, assignments, or other instruments and live testimony which Sponsor shall deem reasonably necessary to apply for and obtain Letter Patent of the United States or of any foreign country or to otherwise protect the Sponsor’s interest therein, and Sponsor shall reimburse Institution for its employees, faculty, or subcontractors time devoted to said activities.

 

7.4 Further, Institution will disclose to Sponsor any and all Inventions conceived, reduced to practice, made or developed by the Investigator or Institution, as a result of conducting the Study. However, if the Institution obtains ownership of any invention arising from research conducted under the Study that is not an Invention, Sponsor shall be granted the first opportunity to acquire an exclusive license for use of the invention (an “Option”) based on good faith negotiations between the Institution and Sponsor, for a period not to exceed ninety (90) days after Sponsor’s exercise of such Option. Such Option must be exercised within ninety (90) days after Sponsor’s receipt of an Invention disclosure from Institution.

 

8. Warranty

 

8.1 Study Drug. Sponsor makes no representations or warranties, expressed or implied, related to the Study Drug and/or Study Device, including without limitation, any warranty or merchantability for fitness for a particular purpose, or non-infringement.

 

8.2 Appropriate Training and Licenses. Institution certifies that Institution, Investigator and the Staff have, and will maintain throughout the conduct of the Study, all training, information, business, professional and other licenses, approvals, or certifications that are necessary for safely, adequately and lawfully performing the Study. Institution further certifies that Investigator and Staff are Institution’s employees and/or faculty and are subject to Institution’s direct control and supervision.

 

 

8.3 No Conflicts. Institution certifies that neither it, or the Investigator, has no material obligation to any third party that would prevent it from performing its duties and obligations under this Agreement. Institution will not enter into any material obligations to any third party that would prevent it from performing its duties and obligations under this Agreement. If Institution is affiliated with a third party, Institution represents that (i) Institution has complied with any and all applicable policies and procedures of such third party pertaining to proposed agreements for services, (ii) to the extent necessary or required, received approval from such third party to enter into this Agreement and be bound by the terms herein, (iii) receipt, generation and use of Confidential Information hereunder will not conflict with any agreement Institution or Investigator has with any third party to which Institution or Investigator is employed or affiliated, and (iv) no third party shall have any interest or rights in Confidential Information or any Inventions. Institution further certifies that it is not (y) currently involved in, nor is aware of, any pending litigation proceedings relating to, respectively, the Institution’s or the Investigator’s role in the conduct of a human clinical trial. Institution further certifies that it has a written and enforced policy and administrative process for identifying and managing financial conflicts of interest. As part of Institution’s standard process, investigators are required to disclose, through a written disclosure form, significant financial interests that relate to their research and other Institution responsibilities. In accordance with Institution’s policy, its Conflict of Interest Committee (or its designees) determine whether significant financial interests present a conflict of interest and by what means such conflicts should be managed or avoided.

 

8.4 Criminal and Civil Liability. INSTITUTION AND INVESTIGATOR UNDERSTAND AND ACKNOWLEDGE THAT FABRICATION, FALSIFICATION OR ALTERATION BY INSTITUTION, INVESTIGATOR OR ANY STAFF, OF ANY PATIENT DATA OR OTHER INFORMATION PROVIDED BY INSTITUTION OR INVESTIGATOR PURSUANT TO THIS AGREEMENT CAN RESULT IN CRIMINAL ACTIONS AND SANCTIONS AGAINST INSTITUTION AND INVESTIGATOR AND IN EACH SUCH PARTY HAVING CIVIL LIABILITY TO SPONSOR.

 

8.5 Form 1572. Institution certifies and represents that (i) the statements on the FDA Form 1572 are true and accurate in all respects, (ii) the Investigator is trained and qualified to conduct clinical trials within the jurisdiction in which the Investigator shall perform the Study, and (iii) Staff shall be appropriately trained in International Conference on Harmonisation-Good Clinical Practice (“ICH GCP”) as adopted by the FDA, the Protocol and the Study procedures.

 

8.6 Health Care Provider Payment Tracking. Institution understands and agrees that for purposes of complying with reporting obligations under the Patient Protection and Affordable Care Act of 2010 (together with any regulations and official guidelines promulgated thereunder) and any applicable state reporting requirements, Sponsor may collect, aggregate and report any and all payments made pursuant to this Agreement.

 

8.7 Business and Financial Disclosure. Institution represent and certifies that neither it nor any of its Staff, including Investigator, are officials, agents, representatives or employees of any foreign government or political party or any international public organization where they may be in positions of official government authority able to use that position to help Sponsor obtain or maintain business or obtain a business advantage. Investigator and Institution further represent and certify that they have not and agree that they shall not make any payment or any offer or promise for payment, either directly or indirectly, of money or other assets, to government or political party officials, officials of international organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing, for the purpose of influencing decisions or actions or where such payment would constitute violation of any law, including but not limited to applicable anti-bribery/anti-corruption laws.

 

 

8.8 Debarment and Disqualification. Institution represents and warrants that it, and its Staff, is not currently:

 

(i)

an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application (a “Debarred Individual”), or an employer, employee, or partner of a Debarred Individual; or

 

(ii)

a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from submitting or assisting in the submission of any abbreviated drug application (a “Debarred Entity”), or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity.

 

(iii)

an individual or corporation, partnership, or association that has been barred from participation in a “Federal Health Care Program” (as defined in 42 U.S.C. § 1320a(7b(f)), as amended from time to time or in any other governmental payment program.

 

Institution further represents and certifies that it, and it Staff, including Investigator, have not engaged in any conduct or activity which could lead to any of the above-mentioned disqualifications or debarment actions and that it has no notice that FDA or another regulatory authority intends to seek disqualification or debarment. Institution shall notify Sponsor within ten (10) days of any actual or threatened disqualification, debarment or other ban of the Institution, Investigator or Staff that comes to its attention during the course of the Study.

 

8.9 Compliance with Laws. Institution represents and certifies that it, and each of its Staff, including Investigator, will comply with all applicable laws, rules and regulations and guidelines relating to the conduct of clinical investigations, including, without limitation 21 CFR Parts 50, 54, 56 and 312, the IHC GCP and other good clinical and medical practice requirements, including ISO 14155:2020 for medical device studies, if applicable.

 

9. Study Results, Records and Audits

 

9.1 Use of Study Results. All data and information generated by Institution as a result of conducting the Study in accordance with the Protocol (“Study Results”) shall be the property of Sponsor. Study Results does not include original Study subject or patient medical records, research notebooks, source documents, or other routine internal documents kept in the Institution’s ordinary course of business operations, which shall remain the sole and exclusive property of the Institution or medical provider. Sponsor shall own and have the right to use the Study Results in accordance with the signed informed consent and authorization form, applicable laws, and the terms of this Agreement. Notwithstanding any licenses or other rights granted to Sponsor herein, but in accordance with the confidentiality and publication sections herein, Institution shall retain the right to use the Study Results and results for its publication, IRB, regulatory, legal, clinical, educational, and internal research purposes.

 

9.2 Records. Institution shall maintain all records required to be maintained by all applicable laws and regulations, including, but not limited to, CRFs, safety reports, annual reports and any other documentation or materials related to the Study and Institution’s Study file, which should include all Study-related correspondence. Investigator shall sign statements in each Study participant’s CRF (i) attesting to Investigator’s review of the data; and (ii) that the data constitutes an accurate accounting of the treatment, care, and events surrounding the Study participant’s involvement in the Study. All Study records shall be complete and up to date. Institution will retain all records for the Study produced pursuant to this Agreement for the longer of: (a) five (5) years after the FDA approves a New Drug Application for the Study Drug and indication that is the subject of the Study, or (b) the record retention period mandated by all applicable laws or regulations. Institution will contact Sponsor in writing at least sixty (60) days before the planned destruction of any Study records. At Sponsor’s request, Institution will deliver such records to Sponsor at Sponsor’s cost. Institution shall promptly notify Sponsor of any accidental loss or destruction of Study records. Notwithstanding anything herein, Institution and Investigator shall not destroy any Study material, information, data or records without providing appropriate notice and opportunity for the Sponsor to respond.

 

 

9.3 Study Documents. Institution will prepare, maintain and retain complete, current, accurate, attributable, organized and legible source documents, CRFs, regulatory documents and other Study documents as required by the Protocol and ICH GCP.

 

9.4 Inspection by Sponsor. During the term of this Agreement , Institution will permit Sponsor and Sponsor’s representatives to examine or audit the work performed hereunder, the use of Sponsor’s funds, the facilities systems and equipment at or with which the work is conducted and records related to such work, at mutually agreeable times during regular business hours to determine that the project assignment is being conducted in accordance with the agreed requirements and that the facilities are adequate. If records pertaining to the Study are kept electronically, Institution shall provide Sponsor’s representatives access to such systems for monitoring and auditing purposes. Institution shall make Investigator and other appropriate Staff available to Sponsor’s representatives, as reasonably necessary, to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Sponsor or its designee, Institution and Investigator shall correct any errors or omissions in such records and reports.

 

9.5 Inspection by Regulatory Authority. Institution shall notify Sponsor immediately by telephone or facsimile if the FDA or other duly authorized authority requests permission to or does inspect Institution’s facilities or research records during the term of this Agreement and will, to the extent allowed by law, provide in writing to Sponsor copies of all materials, correspondence, statements, forms, and records which Investigator or Institution receives, obtains or generates pursuant to any such inspection. Institution, to the extent allowed by law, shall allow Sponsor to be present and provide assistance with any such inspection.

 

10. Indemnification

 

10.1 Sponsor will defend, indemnify and hold harmless the Investigator, Institution and its Staff, trustees, officers, directors, employees, agents, successors, heirs and assigns (collectively, the “Institution Indemnitees”) from and against all claims, demands, actions, suits and proceedings (“Claims”) that may be brought or instituted against any Institution Indemnitee by a third party, and all judgments, damages, losses, liabilities, costs and expenses incurred by any of the Institution Indemnitees resulting therefrom, by reason of (i) personal injury (including death) to any person or damage to property which directly result from the performance of the Study in accordance with the Protocol, (ii) Sponsor’s use of Study data and results, including PHI, and Inventions, except to the extent that such Claims arise out of or result from (i) the negligence, recklessness, criminal act or willful misconduct of any Institution Indemnitee, (ii) any failure by an Institution Indemnitee to use the Study Drug and/or Study Device and conduct the Study in accordance with this Agreement, the Protocol, other written information, instructions or warnings furnished by Sponsor, and all applicable laws, rules or regulations, or (iii) any other material breach of the Agreement by any Institution Indemnitee.

 

10.2 Subject to the applicable state-mandated limits, and without waiving any immunities provided under applicable law (including constitutional provisions, statutes and case law) regarding the status, powers and authority of the Institution or the Institution’s principal(s), Institution shall indemnify, hold harmless and defend Sponsor and CRO, their directors, officers, employees, agents, successors, heirs, and assigns (“Sponsor’s Indemnitees” and “CRO’s Indemnitees”) from and against any Claims alleged to be caused by or arising from INSTITUTION’s negligence or willful misconduct, except to the extent that such Claims arise out of or result from Sponsor’s or CRO’s negligence or willful misconduct.

 

 

10.3 Indemnification Process. For this indemnification to apply, an indemnitee must immediately notify the indemnifying Party in writing upon receipt of notice of any Claim, but in no event later than ten (10) days after such receipt, and must permit indemnifying Party’s attorneys and personnel, at indemnifying Party’s discretion and cost, to handle and control the defense of such Claim, provided, however, that failure to provide such notice shall not relieve indemnifying Party of its indemnification obligations except to the extent that the indemnifying Party’s ability to defend such Claim is materially, adversely affected by such failure. Indemnifying Party shall not make any settlement admitting fault or incur any liability on the part of the indemnified Party without indemnified Party’s prior written consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall cooperate with indemnifying Party in all reasonable respects regarding the defense of any such Claim, at indemnifying Party’s expense. The indemnified Party shall be entitled to retain counsel of its choice at its own expense. In the event a Claim falls under this indemnification clause, in no event shall the indemnified Party compromise, settle or otherwise admit any liability with respect to any Claim without the prior written consent of the indemnifying Party, and such consent not to be unreasonably withheld or delayed.

 

EXCEPT FOR (I) THE PARTIES’ OBLIGATIONS TO INDEMNIFY EACH OTHER PURSUANT TO THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE FOR SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF THE SAME.

 

10.4 Subject Injury. The Sponsor shall reimburse or otherwise pay for reasonable and necessary medical expenses incurred by Study participants for any medical care, including hospitalization, in the diagnosis and treatment of adverse reactions arising directly from the Study Drug following administration in connection with the Protocol or any procedure required by the Protocol that the Study participant would not have undergone but for their participation in the Study, to the extent such expenses (i)  are not the result of the negligence or intentional misconduct of any Staff or Investigator or Institution, (ii) are not the result of Institution’s deviation from the Protocol, or other written instructions consistent with the Protocol provided to Institution, and (iii) are not the result of the Study participant’s negligence or failure to follow the Investigator or Staff’s instructions. The Parties agree that natural progression of an underlying pre-existing condition does not constitute such an adverse reaction, unless such underlying pre-existing condition was exacerbated by the Study participants participation in the Study. In addition, adverse reactions resulting solely from Institution’s negligence or intentional wrongful act are excluded from the Sponsor’s obligation. Alleged lack of efficacy of the Study drug and/or Study Device and/or any consequences resulting therefrom shall not constitute an adverse reaction. Sponsor will not provide compensation or reimbursement for any other injury-related costs or expenses, such as lost wages, pain and suffering compensation, or any other consequential or indirect damages.

 

11. Insurance

 

11.1 Institution certifies and represents that it possesses and shall carry at its own expense from a reputable insurance company, comprehensive general liability insurance with limits of not less than $1,000,000 per occurrence and $3,000,000 annual aggregate for each Investigator performing services under this Agreement, and ensure that professional malpractice insurance (or similar errors and omissions insurance) with limits of not less than $1,000,000 per occurrence and $3,000,000 annual aggregate is maintained. Institution’s insurance covers the Study, and specifically covers the actions of the Investigator, any sub-investigators and other Study personnel, and is not materially encumbered by existing claims. In addition, Institution shall secure and maintain in full force and effect workers’ compensation insurance in the amount required by the laws of the state in which Institution is located. Institution shall maintain all such coverage for the duration of this Agreement and for five (5) years thereafter. Upon request, Institution shall furnish to Sponsor evidence indicating that such insurance is in force, which shall indicate any deductible and/or self-insured retention.

 

 

11.2 Sponsor has procured, and will maintain for the duration of the Study, a policy or program of insurance at levels commercially reasonable for this Study. 

 

12. Miscellaneous

 

12.1 Publicity. No Party to this Agreement shall use the name, trade name, service names, trademarks or service marks of any other Party in connection with any press release, advertising or promotion of any product or service without the prior written permission of such Party except as required by law or regulation.

 

12.2 Independent Contractors. Each Party to this Agreement shall act as an independent contractor and shall not be construed for any purpose as the partner, agent, employee, servant, or representative of the other Parties. Accordingly, the employee(s) of one Party shall not be considered to be employee(s) of any other Parties, and no Party shall enter into any contract or agreement with a third party which purports to obligate or bind the Party to this Agreement. Sponsor shall not be responsible for any employee benefits, pensions, workers’ compensation, withholding, or employment-related taxes as to the Institution or the Investigator or any of their employees or agents.

 

12.3 Complete Agreement, Amendment. The Parties agree that this Agreement, including the Appendices hereto, constitutes the sole, full, and complete Agreement by and between the Parties and supersedes all other written and oral agreements and representations between the Parties with respect to the subject matter herein. In the event of a conflict between the Protocol and this Agreement, the terms of the Agreement will govern; provided, however, that in the case of any such conflict relating to clinical matters, the terms of the Protocol shall prevail. No amendments, changes, additions, deletions, or modifications to or of this Agreement shall be valid unless reduced to writing and signed by authorized representatives of the Parties.

 

12.4 Notices. Any notices or communications concerning this Agreement should be in writing and shall be deemed to have been given when (i) mailed by bonded courier:

 

To Sponsor:		60 Degrees Pharmaceuticals, Inc
		1025 Connecticut Ave NW, Suite 1000
		Washington DC, 20036
		Attn: [____]
		Email: [____]
		Phone: [____]
To CRO:		[____]
		Chief Operating Officer
		Fast-Track Drugs & Biologics, LLC
		20010 Fisher Avenue, Suite G
		Poolesville, MD, 20837
		Phone: [____]
		Fax: [____]
		Email: [____]
To Institution:		Yale University
		Attn: [____]
		Office of Sponsored Projects
		25 Science Park – 3rd Floor
		150 Munson Street
		New Haven, CT -6511
		Attn: [____]
		Email: [____]
With a copy to Investigator:		[____]

 

 

12.5 Binding Effect and Survival. This Agreement shall be binding upon the Parties, their legal representatives, successors, and assigns. The obligations of the Parties contained in Articles 2, 3, 4, 5, 6, 7, 10, 11 and 12 shall survive the termination or expiration of this Agreement.

 

12.6 Waiver. Failure to insist upon compliance with any of the terms and conditions of this Agreement shall not constitute a general waiver or relinquishment of any such terms or conditions, and the same shall remain at all times in full force and effect.

 

12.7 Severability. In the event one or more of the provisions of this Agreement should, for any reason, be held to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining terms and provisions shall not be affected or impaired thereby and the Parties will attempt to agree upon a valid, legal and enforceable provision that is a reasonable substitute therefore, and upon so agreeing, shall incorporate such substitute provision in this Agreement.

 

12.8 Assignment. It is expressly understood by the Parties hereto that Institution may not assign, delegate, subcontract or transfer any of its rights or obligations under this Agreement to any Party without the express prior written consent of Sponsor.

 

12.9 Force Majeure. No Party shall be responsible to the others for any delay in the performance of, or failure to perform, this Agreement where such delay or failure is caused by circumstances beyond the reasonable control of the affected Party including, without limitation, strikes, lockouts or any other labor disruptions, war, civil commotion, natural disaster, pandemics or epidemics, or acts of God. In the event of any such delay or failure in performance, the affected party shall be granted an extension of time for performance that is equitable in light of the cause of the delay.

 

12.10 Effective Upon Execution; Authority. This Agreement shall not be considered accepted, approved, or otherwise effective until signed below by the appropriate Parties. Each of the Parties hereto represents and certifies that the person signing below on such Party’s behalf has the authority to enter into this Agreement.

 

12.11 Counterparts. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of the Parties. This Agreement may be executed by wet ink or authenticated electronic signature and exchanged by facsimile or electronically via PDF copies, and in two or more counterparts, each of which will be deemed an original document, and all of which, together with this writing, will be deemed one instrument.

 

12.12 Heading. Headings used in this Agreement are for reference purposes only and shall not be used to be duly executed this Agreement as of the Effective Date above.

 

(Signature Page Follows)

 

 

IN TESTIMONY WHEREOF, Sponsor, Institution and Investigator have caused this Agreement to be executed as of the Effective Date.

 

For Sponsor:			For Institution
60 DEGREES PHARMACEUTICALS INC			YALE UNIVERSITY
By:			By:
Name:			Name:
Title:			Title:
Date:			Date:

 

	INVESTIGATOR
	By:
	Name:
	Date:

 

LIST OF APPENDICES

 

Appendix I: Payment Schedule

Appendix II: Budget

 

 

APPENDIX I – PAYMENT SCHEDULE

 

Payments: Payment should be made to the following:

 

Payee:

[____]   Payee Bank Account Details: [____]

 

The Parties further agree that CRO and Sponsor assume no liability for incorrect payee details provided by Institution.

 

Invoices: Please send original, correct and itemized invoices monthly to the following:

 

60 Degrees Pharmaceuticals, Inc

Attention: [____]

Email: [____]

 

Electronic invoice submissions shall include: Protocol number, site number, and last name of Investigator in the subject line of the e-mail. Failure to adhere to these terms may delay the processing and payment of the electronically submitted invoice.

 

Invoices from Payee shall include:

 

	●	Payee name (as shown in this Appendix I)
	●	Protocol number
	●	Invoice date
	●	Date & itemized description of services provided
	●	Applicable supporting documents/third party invoices
	●	Total amount payable

 

Invoices shall be paid within forty-five (45) days of receipt by CRO.

 

Enrollment: Institution acknowledges that this is a Study designed to evaluate a set number of Study participants as identified in the Study Protocol. Institution will be expected to apply best efforts for enrollment as provided for under the Agreement. When enrollment of the target number of Study participants for the entire Study is complete, Institution will be notified and instructed not to continue enrolling Study participants, unless otherwise agreed to in writing.

 

 

The Study shall be payable as follows:

 

Cost per Subject: The amount to be paid to the Institution per completed Study participant is $ [____] and outlined on the Budget. Payments will be made on a monthly basis in US dollars and will be prorated based on completed visits entered in the Study participant electronic case report forms (“eCRFs”) in the prior month.

 

Screen Failures: [____]. Sponsor written approval is required for any additional payment of Screen Failures. For purposes of this Agreement, a Screen Failure shall mean any Study participant, who initially appears to meet the criteria for pre-screening, signs the informed consent form, completes the screening visit but who does not randomize into the Study. Payment for Screen Failures will be payable based on data entered into the Study participant eCRF system, and upon the receipt and verification of such data by CRO.

 

Administrative Start-Up Fee: [____] will be payable to the Institution upon execution of this Agreement, receipt of IRB approval, completion of all regulatory documents and Site Initiation Visit (“SIV”), and upon the receipt, verification and processing of an undisputed invoice by CRO.

 

IRB Fees: Central IRB is defined as the IRB selected by the Sponsor, and to whom Sponsor is making submissions on behalf of sites using this Central IRB. Central IRB fees will be reimbursed directly to the IRB by Sponsor or its representative. In such cases, Institution’s Human resources Protection Program (“HRPP”) retains responsibility for administrative review of a Central IRB submission, and Sponsor therefore agrees, in accord with the terms above, to remit payment to Institution at prevailing rates for its administrative review by Institution’s HRPP of the external IRB submission. If the Parties decide to submit the Study to Institution’s local IRB, then local IRB Fees will be submitted by the Institution and reimbursable directly to the Institution upon the receipt of correct and itemized invoices by CRO.

 

Subject/Caregiver Stipends: Study participant and/or Caregiver stipends will be paid to Institution at the rate stated in the Budget based on completed visits. In the event that any Study participant stipend is paid by CRO to Institution but not actually paid to the Study participant by the Institution, Institution will promptly refund that amount to CRO.

 

Unscheduled Visits: An “Unscheduled Visit” means a Study participant visit which is not expressly set forth in the Protocol but is conducted for the well-being of the Study participant. Institution shall be reimbursed for actual unscheduled procedures performed in accordance with the Budget. Unscheduled Visits will be reimbursed and prorated at the rate set forth in Budget. In the event a medically necessary procedure is not included in the Budget, Institution must receive prior written approval for the compensation amount before such procedure is performed, except in cases of emergency or cases that are medically time sensitive. Payment will be made following the receipt, verification and processing of an itemized undisputed invoice by CRO.

 

Final Payment: The final payment will be payable upon completion of the close-out visit and the following: (i) return of all final Study documentation, samples, materials and equipment (ii) the accountability of all used and unused Study Drug, (iii) submission of all completed and correct eCRFs/queries to Sponsor and/or CRO, and (iv) submission to Sponsor and/or CRO of responses to any clarification requests made by CRO or Sponsor regarding Study data or records. All invoices for Study payments, as outlined in this payment schedule, must be submitted to Sponsor within ninety (90) days of the Institution’s Study close-out visit. Invoices received after this time will not be reimbursed.

 

No other additional funding requests will be considered without the prior written consent of Sponsor.

 

Exhibit 10.3

 

Specific information contained in this agreement has been excluded due to its non-material nature and because such information is considered private or confidential. Upon the request by Commission or its staff, the Company will quickly provide an unredacted copy of this agreement, along with analyses supporting its decisions on materiality and confidentiality.

 

CLINICAL TRIAL AGREEMENT

 

PROTOCOL NUMBER: TQ-BA-2024-1 (NCT06207370)

PROTOCOL TITLE: “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”

 

Rhode Island Hospital

593 Eddy Street

 

Providence, RI 02903

USA

(“INSTITUTION”)

 

and

 

60 Degrees Pharmaceuticals, Inc

1025 Connecticut Ave NW, Suite 1000

Washington DC, United States, 20036

(“SPONSOR”)

 

 

Table of Contents

 

Table of Contents

 

1. Performance of Study		3
2. Study Drug, Storage and Return, and Equipment		6
3. Payments		7
4. Term and Termination		8
5. Confidentiality		9
6. Publications		11
7. Intellectual Property		11
8. Warranty		12
9. Study Results, Records and Audits		14
10. Indemnification		15
11. Insurance		16
12. Miscellaneous		16

 

 

This Clinical Trial Agreement (this “Agreement”) is effective as of the last date of signature (the “Effective Date”) and sets forth certain agreements by and between 60 DEGREES PHARMACEUTICALS, INC , having its principal place of business at 1025 Connecticut Ave NW, Washington DC, 20036 (“Sponsor”), and Rhode Island Hospital with a principal place of business at 593 Eddy Street, Providence RI 02903 (hereinafter referred to as “Institution”), The persons executing this Agreement hereby represent that they are authorized to do so for and on behalf of the above-named companies and organizations.

 

WHEREAS, Sponsor and Institution are hereinafter referred to individually as “Party” and collectively as “Parties;”

 

WHEREAS, [____], an agent of the institution, shall serve as the Principal Investigator of the Study (“Investigator”);

 

WHEREAS, Sponsor is arranging to use Institution as a clinical trial site to clinically conduct the study pursuant to the Protocol (as defined in Article 1 below) (the “Study”);

 

WHEREAS, the Investigator acknowledges having read and understood the Protocol and any documents appended to the Protocol, as well as this Agreement.

 

WHEREAS, Institution will enroll subjects, collect clinical trial data and execute specific clinical trial activities required by the Study.

 

WHEREAS, Sponsor has contracted with Fast Track Drugs and Biologics LLC., a Maryland corporation with offices located at 20010 Fisher Avenue Suite G, Poolesville, MD, 20837 (“CRO”) to coordinate and/or perform certain activities as its clinical research organization including, but not limited to, regulatory activities, monitoring, site initiation and close-out visits, data analysis and audits required for the conduct of the Study.

 

NOW, THEREFORE, the Parties, in consideration of the mutual covenants and promises contained herein, have entered into this Agreement and do specifically agree as follows:

 

1. Performance of Study

 

1.1 Study Protocol. The scope and nature of the clinical trial to be performed will be in strict accordance with the Study, including Protocol Number TQ-BA-2024-1 (NCT06207370) entitled, “Double-blind Placebo-controlled Study to Assess the Safety and Efficacy of Oral Tafenoquine plus Standard of Care versus Placebo plus Standard of Care in Patients Hospitalized for Babesiosis”, and any subsequent amendments thereto, referenced and incorporated herein (the “Protocol”). The Protocol fully details the clinical research activities and responsibilities to be undertaken, pursued, and followed with all due diligence by Investigator. The Protocol will be considered final after it is signed by the Sponsor and approved by the pertinent Institutional Review Board (“IRB”). Thereafter, the Protocol may be amended only by the Sponsor and subsequent approval by the IRB. A copy of the signed Statement of Investigator (FDA Form 1572) or Investigator Agreement for medical device studies, the Protocol and any Protocol amendments will be maintained in the Investigator’s Study files.

 

 

1.2 Conduct of Study. Institution agrees, and Investigator acknowledges that each shall conduct the Study in strict compliance with the Protocol, this Agreement and any amendments thereto, any and all applicable federal, state, and local laws, regulations, good clinical practices, all reasonable written instructions of the Sponsor or its designee (e.g. CRO) and any other relevant professional standards. Investigator shall also conduct the Study in accordance with the Statement of Investigator, FDA Form 1572 (or Investigator Agreement for medical device studies), which Investigator has completed, signed, and delivered to Sponsor prior to the commencement of the Study at the Investigator’s site. Further, the Institution agrees, and Investigator acknowledges that in the performance of the Study, each shall:

 

(a)

Exercise independent medical judgment as to the compatibility of each Study participant with Protocol requirements (applicable to Investigator only);

 

(b)

Obtain a signed informed consent form (in a form approved by Sponsor) from each Study participant or his/her legally authorized representative and his/her caregiver in accordance with the Protocol, which has been approved by the IRB and Sponsor in accordance with 21 CFR §56, et. seq., or any successor thereto;

 

(c)

Properly perform and direct or administer the Study in accordance with the Protocol, the applicable laws and regulations, the guideline published by the U.S. Food and Drug Administration (“FDA”) entitled, “Good Clinical Practices, Consolidated Guideline” as amended from time to time, and the other requirements as set forth therein, including ISO 14155:2020 for medical device studies, if applicable;

 

(d)

Review all Study participant case report forms (hereinafter “CRFs”) to assure their accuracy and completeness, and assist Sponsor’s representatives and clinical monitors upon request in promptly resolving any discrepancies or errors on CRFs and in performing random audits of original patient records, laboratory reports, or other raw data sources underlying data recorded on the CRFs;

 

(e)

Submit all data and information, and undertake all activities, so that the timeline as defined in the schedule of assessments set forth in the Protocol and this Agreement are strictly met;

 

(f)

Notify Sponsor and the IRB promptly of any failures to comply with the Protocol;

 

(g)

Maintain records of Study participant identification, clinical observations, laboratory tests, and drug receipt, storage, return and disposition as specified in the Protocol;

 

(h)

Provide all reasonable cooperation with Sponsor and its designee in all of their efforts to monitor the Study;

 

(i)

Pursuant to 21 CFR §312.66, assure that the IRB will comply with the requirements of 21 CFR §56, et. Seq.;

 

(j)

Perform the services in relation to the Study with reasonable care, diligence and skill and ensure that personnel engaged by it in the provision of such Study services are competent and have appropriate professional qualifications, training and experience (Only applicable to Institution); and

 

(k)

Upon request from Sponsor, Investigator will update his/her financial disclosure form in a timely matter one (1) year after Study completion.

 

 

1.3 Participating Staff. The Study shall be conducted under the immediate direction of the Investigator. Institution and Investigator shall ensure that all Staff personally perform their assigned Study tasks, as indicated in the Protocol and in accordance with this Agreement. Investigator shall qualify such personnel and oversee their work. Investigator may have one or more sub-investigator(s) work on the Study; provided, however, that Investigator is responsible for all work conducted by sub-investigator. Any such sub-investigator shall be subject to all of the terms and conditions of this Agreement, including all obligations of Investigator. No sub-investigator may work on the Study unless he or she is qualified through experience and training to conduct clinical studies and agrees to be involved through completion of the Study. The sub-investigator’s name shall appear in the appropriate space on the FDA Form 1572 or Investigator Agreement for medical device studies. Notwithstanding the foregoing, Sponsor may disapprove any proposed sub-investigator within five (5) days of submission of FDA Form 1572 or Investigator Agreement for medical device studies. For purposes of this Agreement, “Staff” shall mean all Institution personnel including, but not limited to, researchers, investigators, sub-investigators, study coordinators and any other person performing services related to the Study on behalf of Institution, or to whom Institution provides access to Study materials or study drug (“Study Drug”).

 

1.4 Third Parties Staff. Institution shall ensure that any third-party personnel working, directly or indirectly, on the Study shall be competent, have appropriate professional qualifications, training and experience, and are bound by obligations of confidentiality and non-use with respect to Confidential Information (as defined by this Agreement) that are at least as restrictive as the obligations of confidentiality and non-use imposed by this Agreement. Investigator shall qualify such personnel and oversee their work.

 

1.5 Replacement of Investigator. In addition to any other remedy which may be available to Sponsor, in the event Investigator becomes either unwilling or unable to perform the duties required by this Agreement, Institution shall promptly notify Sponsor of such circumstance. In addition, upon request by Sponsor, Institution will cooperate, in good faith and expeditiously, to find a replacement Investigator acceptable to Sponsor. Institution’s and Investigator’s cooperation in finding an acceptable replacement does not negate their obligations under this Agreement or by law or regulation.

 

1.6 Notification of Adverse Events. Investigator shall promtly notify Sponsor and the Institution’s IRB in writing of any serious adverse drug experience within twenty-four (24) hours of learning of the event. For serious adverse drug experiences, Institution and Investigator shall assist in the investigation of the medical circumstances and shall provide Sponsor with all requested information so that Sponsor can submit any required IND Safety Report to FDA within fifteen (15) days of its initial receipt of the information. For fatal or life-threatening experiences, Institution and Investigator shall provide Sponsor with all requested information so that Sponsor can submit any required Telephone and Facsimile Transmittal Safety Report to FDA within seven (7) days of its initial receipt of the information. Investigator shall follow-up with any Study participant who experienced an adverse drug experience and continue to provide Sponsor with updates.

 

1.7 Protocol Deviation. Prospective Protocol waivers or deviations will not be granted by Sponsor under any circumstance. deviations from the Protocol which are medically necessary for a Study participant’s safety in cases of emergency are not considered failure to comply with the Protocol. If, during the course of a Study participant’s post-randomization participation in the Study, it is discovered that the Study participant did not meet all eligibility criteria, s/he will be discontinued, unless the discontinuation presents an unacceptable medical risk. The justification to allow the Study participant to continue in the Study will be made by the Sponsor and Investigator, with medical input from the Investigator, and will be documented. If the Study participant is allowed to remain in the Study, this will be reported as a major Protocol deviation and not a waiver. All follow-up safety assessments must be completed and documented as outlined in the Protocol. Other Protocol deviations will be tracked and corrective measures will be put in place to prevent such deviations from being repeated.

 

 

2. Study Drug, Storage and Return, and Equipment

 

2.1 Study Drug. Investigator shall use the Study Drug and/or Study Device only pursuant to and in accordance with the Protocol and this Agreement, and for no other purpose. Institution and Investigator shall notify Sponsor and Institution’s IRB regarding any use of the Study Drug and/or Study Device without obtaining informed consent as soon as possible, but no later than five (5) business days after such use. Any use of the Study Drug and/or Study Device other than as specified in the Protocol shall constitute a material breach of this Agreement.

 

2.2 Storage. Institution and Investigator shall keep all Study Drug and/or Study Device in a locked, secured area at all times, within the temperatures required in the Protocol for storage of the Study Drug and maintain complete, up-to-date records showing receipt of shipments of the Study Drug, dispensing and accountability of the Study Drug and/or Study Device, and returns of the Study Drug as required by the Protocol, applicable federal, state, and local laws, regulations, and guidelines. Furthermore, Institution shall store all Study Drug and/or Study Device in either a central pharmacy where a qualified pharmacist supervises dispensing, or in a restricted area and dispensed under the direct supervision of Investigator.

 

2.3 Equipment. Sponsor may provide, or arrange for a vendor to provide, certain equipment, if applicable, for use by Investigator and Staff during the conduct of the Study (“Equipment”). During the term of this Agreement, Investigator and Staff may use the Equipment only for purposes of this Study in accordance with the Protocol. Until the termination of this Agreement, this Equipment remains the property of Sponsor or the respective vendor that has provided the Equipment, as applicable. The Equipment shall be returned upon request by Sponsor, to Sponsor or the vendor, promptly upon early termination of this Agreement or at the completion of the Study, at the expense of the Sponsor. Institution agrees to return the Equipment in the reasonable manner directed by Sponsor or the vendor in substantially the same condition as when received by Institution and/or Investigator, minus reasonable wear and tear. Institution agrees to be financially responsible to cover any loss or destruction to Equipment while in Institution’s and Investigator’s care, which exceeds ordinary wear and tear and/or lacks a reasonable causal relationship to proper performance of the Study. Institution further agrees that unless otherwise authorized in writing by Sponsor, Institution and Investigator will not alter the Equipment in any way nor install any components or software, if applicable. Any software provided to Institution and/or Investigator may not be duplicated. Sponsor shall not have any liability for damages of any sort, including personal injury or property damage, resulting from the use of Equipment except to the extent that such damages were caused by the gross negligence or willful misconduct of Sponsor.

 

2.4 Return of Study Drug and Sponsor Property. Upon completion of the Study or earlier termination of this Agreement, all unused Study Drug, devices, Equipment, and related materials and all copies of Confidential Information, including Sponsor Technology (as defined below), that were furnished to Investigator shall be returned to Sponsor, at the expense of the Sponsor, except for record copies which the Investigator is required to retain by law or regulation. Notwithstanding the foregoing, nothing shall require the deletion or destruction of Confidential Information stored in the ordinary course of business on Receiving Party’s IT system, provided that the Confidential Information is stored in a manner that prevents unauthorized access or use of Confidential Information. Regarding all unused Study Drug, the Investigator shall, upon the written direction and approval of Sponsor, either (i) return all such material back to the Sponsor at Sponsor’s expense; (ii) destroy, at the site where the Study is being conducted, such material in a manner that does not expose humans to risk from the compound or drug and according to applicable laws and regulations; or (iii) dispose of such materials in another method that that does not expose humans to risk from the compound or drug. In cases of (ii) or (iii), a certificate of destruction/disposition shall be sent to Sponsor upon such action.

 

 

3. Payments

 

3.1 In consideration for performance of the Study, Sponsor will pay the Party identified as “Payee” in accordance with the Payment Schedule attached as Appendix I (“Payment Schedule”) and the Budget attached as Appendix II (“Budget”), and each made a part hereof. The Parties acknowledge that the Payee is the appropriate payee under this Agreement and that the Payee is authorized to receive all the payments for the services performed under this Agreement. If the Investigator is not the Payee, then the Payee’s obligation to reimburse the Investigator will be determined by a separate agreement between Investigator and Payee, which may involve different payment amounts and different payment intervals than the payments made by Sponsor to the Payee. Investigator acknowledges that if Investigator is not the Payee, Sponsor will not pay Investigator even if the Payee fails to reimburse Investigator. The Budget may be modified only upon the prior written consent of the Parties. Institution agrees and Investigator acknowledges that the Payment Schedule and Budget includes Sponsor’s entire payment obligation for the performance of the Study pursuant to this Agreement. CRO may process payments to the Payee on behalf of the Sponsor.

 

3.2 Institution agrees and Investigator acknowledges that their judgment with respect to the advice and care of each Study participant will not be affected by the compensation they receive from this Agreement, that such compensation does not exceed the fair market value of the services they are providing, and that no payments are being provided to them for the purpose of inducing them to purchase or prescribe any drugs, devices or products. If the Sponsor provides any free products or items for use in the Study, Institution agrees that it will not bill any Study participant, insurer or governmental agency, or any other third party, for such free products or items. Institution agrees that it will not bill any Study participant, insurer, or governmental agency for any visits, services or expenses incurred during the Study for which they have received compensation from Sponsor, or which are not part of the ordinary care they would normally provide for the Study participant.

 

3.3 Institution acknowledges that it has advised Payee that Payee is accepting tax liability for the work performed under this Agreement. The Payee information needs to be completed below and on an IRS Form W-9 and returned to Sponsor for the Agreement to be effective. This information will be used for preparation of Federal Form 1099 which will be issued to Payee documenting the payments made to the Payee in each calendar year.

 

3.4 If any invoice or payment is disputed, Sponsor will notify Institution within (15) fifteen business days of receipt of invoice or payment due date. In the event parties are in dispute over whether payment for any item or service is due, all non-disputed amounts shall be paid in accordance with the regularly scheduled payment as detailed in the [budget/payment schedule] attached herein. The parties shall use good faith efforts to reach agreement on the disputed portion of the invoice or payment as soon as practical, but no later than (30) days of dispute notification.

 

 

Institution reserves the right to suspend the Study if there are undisputed amounts more than 90 days past due per the terms of the [budget/payment schedule], if Institution determines that Sponsor is unreasonably withholding payments and reimbursement of expenses in breach of this Agreement, or if Sponsor does not notify Institution of disputed amounts within (15) fifteen days of receipt of invoice or due date of payment. Institution shall ensure that such suspension does not affect the health or safety of currently enrolled subjects.

 

Notwithstanding the foregoing, in the event Sponsor notifies Institution of a fee dispute in accordance with this section 3.4 and Sponsor pays the undisputed portion of the payment or invoice, Institution will take no action to suspend the Study for non-payment of such disputed fees, unless the parties fail to reach resolution using good faith efforts.

 

If such good faith efforts do not solve the dispute either party may choose to pursue legal action in a court of law or equity to assert or enforce a claim it has against the other party in this agreement. The right to pursue legal action is in addition to any and all other rights and remedies available under this Agreement.

 

4. Term and Termination

 

4.1 Term. The term of this Agreement shall begin upon the Effective Date. Unless terminated earlier, this Agreement will terminate when (a) Institution has submitted all CRFs to Sponsor, has resolved all data clarification queries, has submitted the closeout report to the IRB and Sponsor, has returned all Equipment and Study materials to Sponsor, and has met all other close-out obligations; and (b) all payments, reimbursements and refunds have been made.

 

4.2 Termination by Sponsor. This Agreement may be terminated by Sponsor at any time for any reason upon 30 days written notice to Institution and Investigator. The Sponsor may terminate the Study without 30 days notice if any of the following conditions occur:

 

(a)

If the authorization and approval to conduct the Study in the United States is withdrawn by the FDA; or

 

(b)

If the emergence of any unexpected or unanticipated significant safety issue with the Study Drug and/or Study Device is of such magnitude or incidence in the reasonable opinion of the Investigator, Sponsor or the data safety monitoring board to support termination.

 

4.3 Termination by Institution. This Agreement may be terminated by the Institution at any time for any reason upon 30 days prior written notice to Sponsor. The Institution may terminate the Study without 30 days notice if any of the following conditions occur::

 

(c)

If the authorization and approval to conduct the Study in the United States is withdrawn by the FDA; or

 

(d)

If the emergence of any unexpected or unanticipated significant safety issue with the Study Drug and/or Study Device is of such magnitude or incidence in the reasonable opinion of the Investigator, Sponsor or the data safety monitoring board to support termination.

 

 

4.4 Effect of Termination. In the event of expiry or termination of this Agreement for any reason, Institution and Investigator shall, and shall procure, the prompt return to Sponsor of all Confidential Information, Equipment and Inventions (as defined herein) provided to Institution or Investigator or generated by Institution or Investigator in connection with the provision of the Study services. The Institution and Investigator may retain only the relevant Study information and data to the extent and for the duration required by applicable law or regulation. Investigator shall (i) use all reasonable efforts to conclude work on the Study, (ii) stop enrollment of Study participants, (iii) not incur additional expenses, or enter into any further commitments with regard to the Study after receiving or providing a notice of termination, and (iv) reasonably cooperate with the Sponsor and its designee to allow for a close-out site visit. In the event of termination, the sum payable under this Agreement shall be limited to prorated fees based on actual work performed pursuant to the Protocol as determined in accordance with the Budget. Such payment shall be paid upon satisfaction of all outstanding obligations of Investigator and Institution, including, but not limited to, return of all Equipment and Study materials to Sponsor, at the expense of the Sponsor. Institution will be entitled to payment for non-cancelable Study participant-related expenses only if properly substantiated, reasonably incurred in accordance with the Study through the date of termination and within the Budget. Any funds not due to Institution but already paid to Institution shall be returned to CRO and Sponsor by the earlier of thirty (30) days from the Institution close-out visit or from the notice of termination.

 

5. Confidentiality

 

5.1 All information, including, but not limited to, documents, descriptions, data, CRFs, photographs, videos and instructions, Study Drug and/or Study Device, materials and patient specimens, Sponsor Technology (as defined in Article 7 below) and Confidential Information (as defined below), provided to or made available to Institution or Investigator by Sponsor or its agents (whether verbal, written or electronic) or generated by Institution, Investigator or their respective Staff shall be the property of Sponsor.

 

5.2. “Confidential Information” means all information, material or data related to the Study, including Sponsor Technology, whether provided by or on behalf of Sponsor (either before or after execution of this Agreement), or developed for Sponsor, or generated by Institution and/or Investigator in accordance with this Agreement, whether in writing, electronic, oral or visual transmission, including without limitation, any information and data concerning the Study Drug and/or Study Device, Study results, reports, Study strategies, the existence or terms of the Protocol or this Agreement, exclusive of patient medical records.

 

5.3 Investigator and Institution shall maintain in strict confidence all of the Confidential Information, including the Sponsor Technology, and not disclose or disseminate to any third party or use for any purpose other than the performance of the Study any of the same. Such Confidential Information, including the Sponsor Technology, shall remain the confidential and proprietary property of Sponsor, and shall be disclosed only on a need-to-know basis and only to the Investigator and his/her Staff who have a need to know such Confidential Information for the purposes of performing the Study according to this Agreement and the Protocol who are bound by confidentiality terms at least as strict as those herein (individually, a “Required Disclosee”). Institution will inform and advise each Required Disclosee of the obligations under this Agreement with respect to the Confidential Information and each Required Disclosee shall be bound by such obligations in a like fashion.

 

5.4 Investigator and Institution each shall use the same degree of care to protect the Confidential Information as it uses to protect its own confidential information, but in no event less than a reasonable amount of care. Institution shall be responsible for any breach of this Agreement by its Investigator, agents and Staff to the extent permitted by applicable law. Institution agrees to promptly notify Sponsor in the event of any loss or unauthorized disclosure of any Confidential Information.

 

 

5.5 The foregoing obligation of non-disclosure shall not apply to Confidential Information, including the Sponsor Technology, that Institution or Investigator is able to demonstrate by written evidence:

 

(a)

was generally known to the public prior to the Effective Date of this Agreement;

 

(b)

becomes generally known to the public through no unlawful or unauthorized act or omission of Institution or Investigator or any of the Institution’s agents or Staff, or in violation of this Agreement;

 

(c)

was independently developed by Institution, without reliance upon or reference to Confidential Information as evidence by its written records; or

 

(d)

was disclosed to Institution or Investigator without restriction by a third party who had the right to make such disclosure.

 

5.6 If Institution or Investigator is requested to produce any of the Confidential Information pursuant to a legal or governmental proceeding, Institution shall, as allowable by law, give Sponsor prior notice of such requirement. If Institution is compelled to disclose any of the Confidential Information pursuant to such legal or governmental proceeding, Institution shall furnish only that portion of the Confidential Information which it is legally required to disclose. Any Confidential Information so disclosed shall still be subject to the terms of this Agreement.

 

5.7 Injunctive Relief. Institution acknowledges and agrees that any violation of the terms of this Agreement relating to the disclosure or use of Confidential Information, including the Sponsor Technology, may result in irreparable injury and damage to Sponsor not adequately compensable in money damages, and for which Sponsor may have no adequate remedy at law. Institution acknowledges and agrees, therefore, that if those disclosure terms are violated, Sponsor may need to seek injunctions, orders, or decrees in order to protect the Confidential Information and the Sponsor Technology.

 

5.8 Privacy Laws. Institution agrees, on behalf of itself and its Investigator to take all reasonable steps to protect the confidentiality of any patient health and medical information that it has access to and comply with all applicable privacy laws, including, but not limited to the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations. Institution consents to the sharing of their personal data, as defined under any applicable privacy laws, with Sponsor.

 

5.9 Existence of Agreement. Investigator and Institution shall not disclose the existence of this Agreement, except to the extent required by academic policies, law or regulation.

 

 

6. Publications

 

6.1 Institution and Investigator may publish the results of Study, relative to his/her own Study participant(s. At least thirty (30) days prior to submitting a manuscript to a publisher or other outside persons (i.e., reviewer(s)) or prior to any public presentation, a copy of the manuscript or presentation will be provided to Sponsor by the Institution or Investigator for review and comment. Sponsor shall have thirty (30) days to review and comment on the provided materials. If, within the 30-day period, Sponsor requests that any Confidential Information be removed or provides any comments, Institution shall remove all such Confidential Information and Institution will consider any such comments in good faith but is under no obligation to incorporate such comments. If during the review period, Sponsor notifies Institution that it desires patent applications to be filed on any Inventions (as defined in Article 7 below) disclosed or contained in the manuscript or presentation, Institution will defer publication or other disclosure for a period, not to exceed an additional sixty (60) days, sufficient to permit Sponsor or its designee to file or have filed any desired patent applications. . The Institution and Investigator each understands that if the Study is part of a multi-center study, then any publication by the Institution or the Investigator of the results of the Study conducted at the Institution shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within eighteen (18) months from completion of the Study for all sites in the Study, then the Institution or Investigator may publish individually in accordance with the requirements of this Article.

 

6.2 Subject to the rights of any third- party publisher, Sponsor may use, refer to, and disseminate reprints of scientific, medical, and other published articles relating to the Study, which disclose the name of Investigator and Institution, consistent with U.S. copyright laws.

 

7. Intellectual Property

 

7.1 Sponsor Technology. For purposes of this Agreement, the term “Sponsor Technology” shall mean all data, materials, information, know-how, methods or techniques, whether or not patented or patentable, copyrighted or copyrightable, pertaining to the research, development, manufacture, or use of compounds obtained or developed by, or on behalf of, Sponsor. In the performance of this Agreement, Sponsor may disclose Sponsor Technology to Investigator. Sponsor Technology shall remain the confidential and proprietary property of Sponsor. Institution agrees and Investigator acknowledges that Sponsor is the sole and exclusive owner of the Sponsor Technology, whether or not patented or subject to copyright or patent protection; and that the Sponsor Technology is commercially valuable.

 

7.2 Patent Rights. It is expressly agreed that neither Sponsor, on the one hand, or Institution, on the other hand, transfers to the other, by operation of this Agreement, any patent right, copyright or other proprietary right which any such Party owns as of the Effective Date, except as specifically set forth herein.

 

7.3 Inventions. The ownership of any information, inventions, improvements, new uses, or discoveries (whether patentable, copyrightable, or not), innovations, suggestions, ideas, communications and reports (collectively “Inventions”), conceived, reduced to practice, made or developed by the Institution or Investigator and/or all individuals or entities either employed by or subcontracted by Institution, as a result of or relating to the conduct of the Study or Study Drug and/or Study Device, belong to the Sponsor and Institution agrees to assign all of its interests therein without compensation from Sponsor or its nominee whenever requested to do so by Sponsor. Institution agrees it will execute any and all applications, assignments, or other instruments and live testimony which Sponsor shall deem necessary to apply for and obtain Letter Patent of the United States or of any foreign country or to otherwise protect the Sponsor’s interest therein, and Sponsor shall reimburse Institution for its time devoted to said activities.

 

 

7.4 Further, Institution will disclose to Sponsor any and all Inventions conceived, reduced to practice, made or developed by the Investigator or Institution, as a result of conducting the Study. However, if the Institution obtains ownership of any invention arising from research conducted under the Study, Sponsor shall be granted the first opportunity to acquire an exclusive license for use of the invention based on good faith negotiations between the Institution and Sponsor.

 

8. Warranty

 

8.1 Study Drug and/or Study Device. Sponsor makes no representations or warranties, expressed or implied, related to the Study Drug and/or Study Device, including without limitation, any warranty or merchantability for fitness for a particular purpose, or non-infringement.

 

8.2 Appropriate Training and Licenses. Institution warrants that Institution, Investigator and the Staff have, and will maintain throughout the conduct of the Study, all training, information, business, professional and other licenses, approvals, or certifications that are necessary for safely, adequately and lawfully performing the Study. . Institution considers Investigator to be its agent for purposes of research conducted pursuant to the Protocol, and, as such, Investigator is legally bound to follow Institution’s policies and procedures and to act under Institution’s direction with respect to the conduct of the research.

 

8.3 No Conflicts. Institution warrants that it is not a Party to any existing agreements that would prevent it from entering into and performing this Agreement. Institution will not enter into any other agreement that is in conflict with their obligations under this Agreement. If Institution is affiliated with a university or other third party, Institution represents that (i) Institution has complied with any and all applicable policies and procedures of such university or other third party pertaining to proposed agreements for services, (ii) to the extent necessary or required, received approval from such university or other third party to enter into this Agreement and be bound by the terms herein, (iii) receipt, generation and use of Confidential Information hereunder will not conflict with any agreement Institution or Investigator has with any university or third party to which Institution or Investigator is employed or affiliated, and (iv) no university or third party shall have any interest or rights in Confidential Information or any Inventions. Institution further warrants that it is not subject to (x) any conflicting obligations or legal impediment that might interfere with the performance of the Study or that might impair the acceptance of the resulting data by the FDA or (y) is currently involved in, nor is aware of, any pending litigation proceedings relating to, respectively, the Institution’s or the Investigator’s role in the conduct of a human clinical trial. Institution will notify Sponsor promptly of any conflicting obligations or legal impediments that may occur during the term of this Agreement.

 

8.4 Criminal and Civil Liability. INSTITUTION AND INVESTIGATOR UNDERSTAND AND ACKNOWLEDGE THAT FABRICATION, FALSIFICATION OR ALTERATION BY INSTITUTION, INVESTIGATOR OR ANY STAFF, OF ANY PATIENT DATA OR OTHER INFORMATION PROVIDED BY INSTITUTION OR INVESTIGATOR PURSUANT TO THIS AGREEMENT CAN RESULT IN CRIMINAL ACTIONS AND SANCTIONS AGAINST INSTITUTION AND INVESTIGATOR AND IN EACH SUCH PARTY HAVING CIVIL LIABILITY TO SPONSOR.

 

 

8.5 Form 1572 or Investigator Agreement for Medical Device Studies. Institution warrants and represents, on behalf of its Investigator, that (i) the statements on his/her FDA Form 1572 or Investigator Agreement for medical device studies are true and accurate in all respects, (ii) he/she is trained and qualified to conduct clinical trials within the jurisdiction in which the Investigator shall perform the Study, and (iii) Staff shall be appropriately trained in International Conference on Harmonisation-Good Clinical Practice (“ICH GCP”), the Protocol and the Study procedures.

 

8.6 Health Care Provider Payment Tracking. Institution understands and agrees that for purposes of complying with reporting obligations under the Patient Protection and Affordable Care Act of 2010 (together with any regulations and official guidelines promulgated thereunder) and any applicable state reporting requirements, Sponsor may collect, aggregate and report any and all payments made pursuant to this Agreement.

 

8.7 Business and Financial Disclosure. Institution represents and warrants that neither it nor any of its Investigator, agents or Staff are officials, agents, representatives or employees of any government or political party or any international public organization where they may be in positions of official government authority able to use that position to help Sponsor obtain or maintain business or obtain a business advantage. Institution further represents and warrants that both it and its Investigator have not and agree that they shall not make any payment or any offer or promise for payment, either directly or indirectly, of money or other assets, to government or political party officials, officials of international organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing, for the purpose of influencing decisions or actions or where such payment would constitute violation of any law, including but not limited to applicable anti-bribery/anti-corruption laws.

 

8.8 Debarment and Disqualification. Institution and Sponsor each represent and warrant that it, and each of its Staff, agents and representatives, have never been and are not currently:

 

(i)

an individual who has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application (a “Debarred Individual”), or an employer, employee, or partner of a Debarred Individual; or

 

(ii)

a corporation, partnership, or association that has been debarred by the FDA pursuant to 21 U.S.C. § 335a(a) or (b) from submitting or assisting in the submission of any abbreviated drug application (a “Debarred Entity”), or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity.

 

(iii)

an individual or corporation, partnership, or association that has been barred from participation in a “Federal Health Care Program” (as defined in 42 U.S.C. § 1320a(7b(f)), as amended from time to time or in any other governmental payment program.

 

Institution further represents and warrants, to the best of its knowledge, that it/he/she, and each of its Investigator and Staff, have not engaged in any conduct or activity which could lead to any of the above-mentioned disqualifications or debarment actions and that it has no notice that FDA or another regulatory authority intends to seek disqualification or debarment. Institution shall notify Sponsor within ten (10) days of any actual or threatened disqualification, debarment or other ban or investigation of the Institution, Investigator or Staff that comes to its attention during the course of the Study and for five (5) years thereafter.

 

 

8.9 Compliance with Laws. Institution represents and warrants that it/he/she, and each of its Investigator and Staff, will comply with all applicable laws, rules and regulations and guidelines relating to the conduct of clinical investigations, including, without limitation 21 CFR Parts 50, 54, 56 and 312, the IHC GCP and other good clinical and medical practice requirements, including ISO 14155:2020 for medical device studies, if applicable.

 

9. Study Results, Records and Audits

 

9.1 Use of Study Results. Sponsor shall have the unrestricted access and right to use all information resulting from the Study for any and all lawful purposes. Institution and Investigator shall have no right to use any information, data or results relating to the Study, except for patient care or in a publication subject to Article 6.

 

9.2 Records. Institution shall maintain all records required to be maintained by all applicable laws and regulations, including, but not limited to, CRFs, safety reports, annual reports and any other documentation or materials related to the Study and Institution’s Study file, which should include all Study-related correspondence. Investigator shall sign statements in each Study participant’s CRF (i) attesting to Investigator’s review of the data; and (ii) that the data constitutes an accurate accounting of the treatment, care, and events surrounding the Study participant’s involvement in the Study. All Study records shall be complete and up to date. Institution will retain all records for the Study produced pursuant to this Agreement for the longer of: (a) five (5) years after the FDA approves a New Drug Application for the Study Drug and indication that is the subject of the Study, or (b) the record retention period mandated by all applicable laws or regulations. Institution will contact Sponsor in writing at least sixty (60) days before the planned destruction of any Study records. At Sponsor’s request, Institution will deliver such records to Sponsor at Sponsor’s cost. Institution shall promptly notify Sponsor of any accidental loss or destruction of Study records. Notwithstanding anything herein, Institution and Investigator shall not destroy any Study material, information, data or records without the prior written consent by Sponsor. Any extension of the length of record retention requested by the Sponsor beyond what is described above shall be at the expense of the Sponsor.

 

9.3 Study Documents. Institution will prepare, maintain and retain complete, current, accurate, attributable, organized and legible source documents, CRFs, regulatory documents and other Study documents as required by the Protocol and ICH GCP.

 

9.4 Inspection by Sponsor. During the term of this Agreement, Institution will permit Sponsor and Sponsor’s representatives to examine or audit the work performed hereunder, the use of Sponsor’s funds, the facilities systems and equipment at or with which the work is conducted and records related to such work, upon reasonable advance notice during regular business hours to determine that the project assignment is being conducted in accordance with the agreed requirements and that the facilities being used directly for the performance of the protocol are adequate. If records pertaining to the Study are kept electronically, Institution shall provide Sponsor’s representatives access to such systems for monitoring and auditing purposes. Institution shall make Investigator and other appropriate Staff available to Sponsor’s representatives to discuss such records and reports and to resolve any questions relating to such records and reports. At the request of Sponsor or its designee, Institution and Investigator shall correct any errors or omissions in such records and reports.

 

 

9.5 Inspection by Regulatory Authority. Unless prohibited by law or regulatory authority, Investigator and Institution shall notify Sponsor promptly by telephone or facsimile if the FDA or other duly authorized authority requests permission to or does inspect Institution’s facilities or research records directly related to the Protocol during the term of this Agreement and will, to the extent allowed by law, provide in writing to Sponsor copies of all materials, correspondence, statements, forms, and records which Investigator or Institution receives, obtains or generates pursuant to any such inspection. Institution, to the extent allowed by law, shall allow Sponsor to be present and provide assistance with any such inspection.

 

10. Indemnification

 

10.1 Sponsor will defend, indemnify and hold harmless the Investigator, Institution and its Staff (collectively, the “Institution Indemnitees”) from and against all claims, demands, actions, suits and proceedings (“Claims”) that may be brought or instituted against any Institution Indemnitee by a third party, and all judgments, damages, losses, liabilities, costs and expenses incurred by any of the Institution Indemnitees resulting therefrom, by reason of personal injury (including death) to any person or damage to property which directly result from the performance of the Study in accordance with the Protocol, Sponsor’s use of data provided to it under this Agreement, Sponsor’s negligence, willful misconduct, and breach of the Agreement and applicable laws, and claims of patent infringement and unfair competition except to the extent that such Claims arise out of or result from (i) the negligence, recklessness, criminal act or willful misconduct of any Institution Indemnitee, (ii) any failure by an Institution Indemnitee to use the Study Drug and/or Study Device and conduct the Study in accordance with this Agreement, the Protocol, other written information, instructions or warnings furnished by Sponsor, and all applicable laws, rules or regulations, or (iii) any other breach of the Agreement by any Institution Indemnitee. A deviation from the protocol which is deemed medically necessary for the protection of subject safety shall not relieve the Sponsor of its obligations of indemnification.

 

10.2 Subject to the applicable state-mandated limits, and without waiving any immunities provided under applicable law (including constitutional provisions, statutes and case law) regarding the status, powers and authority of the Institution or the Institution’s principal(s), Institution shall indemnify, hold harmless and defend Sponsor and CRO, their directors, officers, employees, agents, successors, heirs, and assigns (“Sponsor’s Indemnitees” and “CRO’s Indemnitees”) from and against any Claims alleged to be caused by or arising from INSTITUTION’s Indemnified Actions.

 

10.3 Indemnification Process. For this indemnification to apply, an indemnitee must promptly notify the indemnifying Party in writing upon receipt of notice of any Claim, but in no event later than ten (10) days after such receipt, and must permit indemnifying Party’s attorneys and personnel, at indemnifying Party’s discretion and cost, to handle and control the defense of such Claim, provided, however, that failure to provide such notice shall not relieve indemnifying Party of its indemnification obligations except to the extent that the indemnifying Party’s ability to defend such Claim is materially, adversely affected by such failure. Indemnifying Party shall not make any settlement admitting fault or incur any liability on the part of the indemnified Party without indemnified Party’s prior written consent, such consent not to be unreasonably withheld or delayed. The indemnified Party shall cooperate with indemnifying Party in all reasonable respects regarding the defense of any such Claim, at indemnifying Party’s expense. The indemnified Party shall be entitled to retain counsel of its choice at its own expense. In the event a Claim falls under this indemnification clause, in no event shall the indemnified Party compromise, settle or otherwise admit any liability with respect to any Claim without the prior written consent of the indemnifying Party, and such consent not to be unreasonably withheld or delayed.

 

 

EXCEPT FOR (I) A PARTY’S INTENTIONAL MISCONDUCT, OR (II) THE PARTIES’ OBLIGATIONS TO INDEMNIFY EACH OTHER PURSUANT TO THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE FOR SPECIAL, CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT, EVEN IF ADVISED OF THE POSSIBILITY OF THE SAME.

 

10.4 Subject Injury. The Sponsor shall reimburse for reasonable and necessary medical expenses incurred by Study participants for any medical care, including hospitalization, in the diagnosis and treatment of injuries arising directly from the Study Drug and/or Study Device following administration in connection with the Protocol, or the proper performance of procedures which are specifically required by protocol and not part of the usual standard of care to the extent such expenses (ii) are not the result of the negligence or intentional misconduct of any Staff or Investigator or Institution, (iii) are not the result of a deviation from the Protocol, or other written instructions consistent with the Protocol provided to Institution, except for deviations deemed medically necessary for the protection of subject safety and (iv) are not the result of the Study participant’s negligence or failure to follow the Investigator or Staff’s instructions. The Parties agree that natural progression of an underlying pre-existing condition does not constitute such an injury. In addition, injuries resulting solely from Institution’s negligence or intentional wrongful act are excluded from the Sponsor’s obligation. Alleged lack of efficacy of the Study drug and/or Study Device and/or any consequences resulting therefrom shall not constitute an injury. Sponsor will not provide compensation or reimbursement for any other injury-related costs or expenses, such as lost wages, pain and suffering compensation, or any other consequential or indirect damages.

 

11. Insurance

 

11.1 Institution warrants and represents that it possesses and shall carry at its own expense, comprehensive general liability insurance with limits of not less than $1,000,000 per occurrence and $3,000,000 annual aggregate for each Investigator performing services under this Agreement, and professional malpractice insurance (or similar errors and omissions insurance) with limits of not less than $8,000,000 per occurrence. Institution’s insurance covers the Study, and specifically covers the actions of the Investigator, any sub-investigators and other Study personnel, and is not materially encumbered by existing claims. In addition, Institution shall secure and maintain in full force and effect workers’ compensation insurance in the amount required by the laws of the state in which Institution is located. Institution shall maintain all such coverage for the duration of this Agreement and for five (5) years thereafter. Upon request, Institution shall furnish to Sponsor a certificate indicating that such insurance is in force, which shall indicate any deductible and/or self-insured retention. Institution shall provide Sponsor with at least thirty (30) days prior written notice of cancellation or any material change in the policy or policies of insurance required.

 

11.2 Sponsor has procured, and will maintain for the duration of the Study, a policy or program of insurance at levels commercially reasonable for this Study. 

 

12. Miscellaneous

 

12.1 Publicity. No Party to this Agreement shall use the name, trade name, service names, trademarks or service marks of any other Party in connection with any press release, advertising or promotion of any product or service without the prior written permission of such Party except as required by law or regulation. Institution may, without prior consent, disclose in Institution’s confidential internal reports or governmental reports and grant applications, its participation in the Study, not to exceed the information available at clinicaltrials.gov.

 

 

12.2 Independent Contractors. Each Party to this Agreement shall act as an independent contractor and shall not be construed for any purpose as the partner, agent, employee, servant, or representative of the other Parties. Accordingly, the employee(s) of one Party shall not be considered to be employee(s) of any other Parties, and no Party shall enter into any contract or agreement with a third party which purports to obligate or bind the Party to this Agreement. Sponsor shall not be responsible for any employee benefits, pensions, workers’ compensation, withholding, or employment-related taxes as to the Institution or the Investigator or any of their employees or agents.

 

12.3 Complete Agreement, Amendment. The Parties agree that this Agreement, including the Appendices hereto, constitutes the sole, full, and complete Agreement by and between the Parties and supersedes all other written and oral agreements and representations between the Parties with respect to the subject matter herein. In the event of a conflict between the Protocol and this Agreement, the terms of the Agreement will govern; provided, however, that in the case of any such conflict relating to clinical matters, the terms of the Protocol shall prevail. No amendments, changes, additions, deletions, or modifications to or of this Agreement shall be valid unless reduced to writing and signed by the Parties.

 

12.4 Notices. Any notices or communications concerning this Agreement should be in writing and shall be deemed to have been given when (i) mailed by U.S. Mail postage prepaid or bonded courier or (ii) delivered via facsimile with confirmed transmission report and forwarded to the following:

 

To Sponsor:		60 Degrees Pharmaceuticals, Inc
		1025 Connecticut Ave NW, Suite 1000
		Washington DC, 20036
		Attn: [____]
		Email: [____]
		Phone: [____]
To CRO:		[____]
		Chief Operating Officer
		Fast-Track Drugs & Biologics, LLC
		20010 Fisher Avenue, Suite G
		Poolesville, MD, 20837
		Phone: [____]
		Fax: [____]
		Email: [____]
To Institution:		Rhode Island Hospital
		Lifespan Office of Research
		Coro East, Suite 1A, Room 170
		167 Point Street, Box 42
		Providence, Rhode Island 02903
		Fax: [____]
To Investigator:		[____]
		Brown Medicine
		180 Corliss Street, 3rd Floor, Providence, RI 02904-2602
		Fax: [____]

 

 

12.5 Binding Effect and Survival. This Agreement shall be binding upon the Parties, their legal representatives, successors, and assigns. The obligations of the Parties contained in Articles 2, 3, 5, 6, 7, 10, 11 and 12 shall survive the termination or expiration of this Agreement.

 

12.6 Waiver. Failure to insist upon compliance with any of the terms and conditions of this Agreement shall not constitute a general waiver or relinquishment of any such terms or conditions, and the same shall remain at all times in full force and effect.

 

12.7 Severability. In the event one or more of the provisions of this Agreement should, for any reason, be held to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining terms and provisions shall not be affected or impaired thereby and the Parties will attempt to agree upon a valid, legal and enforceable provision that is a reasonable substitute therefore, and upon so agreeing, shall incorporate such substitute provision in this Agreement.

 

12.8 Assignment. It is expressly understood by the Parties hereto that Institution may not assign, delegate, subcontract or transfer any of its rights or obligations under this Agreement to any Party without the express prior written consent of Sponsor.

 

12.9 Force Majeure. No Party shall be responsible to the others for any delay in the performance of, or failure to perform, this Agreement where such delay or failure is caused by circumstances beyond the reasonable control of the affected Party including, without limitation, strikes, lockouts or any other labor disruptions, war, civil commotion, natural disaster, pandemics or epidemics, or acts of God. In the event of any such delay or failure in performance, the affected party shall be granted an extension of time for performance that is equitable in light of the cause of the delay. Any incident of Force Majeure will not constitute a breach of this Agreement and the time for performance will be extended accordingly; however, if it persists for more than thirty (30) days, then the parties may enter into discussions with a view to alleviating its effects and, if possible, agreeing on such alternative arrangements as may be reasonable in all of the circumstances.

 

12.10 Effective Upon Execution; Authority. This Agreement shall not be considered accepted, approved, or otherwise effective until signed below by the appropriate Parties. Each of the Parties hereto represents and warrants that the person signing below on such Party’s behalf has the authority to enter into this Agreement.

 

12.11 Counterparts. This Agreement shall become binding when any one or more counterparts hereof, individually or taken together, shall bear the signatures of the Parties. This Agreement may be executed by wet ink or authenticated electronic signature and exchanged by facsimile or electronically via PDF copies, and in two or more counterparts, each of which will be deemed an original document, and all of which, together with this writing, will be deemed one instrument.

 

12.12 Heading. Headings used in this Agreement are for reference purposes only and shall not be used to be duly executed this Agreement as of the Effective Date above.

 

12.13 Patient Safety. During and for a period of at least two (2) years after the completion of the study, Sponsor shall promptly (or in a timely manner appropriate to the level of risk involved,) report to the Institution and Investigator any information that could directly affect the health or safety of past or current study subjects or influence the conduct of the study, including but not limited to the study results and information in site monitoring reports and data safety monitoring committee reports as required by the protocol. In each case, the Institution and Principal Investigator shall be free to communicate these findings to each study subject and the IRB.

 

(Signature Page Follows)

 

 

IN TESTIMONY WHEREOF, Sponsor, Institution and Investigator have caused this Agreement to be executed as of the Effective Date.

 

For Sponsor:			For Institution:
60 DEGREES PHARMACEUTICALS INC			Rhode Island Hospital
By:			By:
Name:			Name:
Title:			Title:
Date:			Date:

 

	READ AND ACKNOWLEDGED:
	By:
	Name:
	Date:

 

LIST OF APPENDICES

 

Appendix I: Payment Schedule

Appendix II: Budget

 

 

 

APPENDIX I – PAYMENT SCHEDULE

 

Payments: Sponsor agrees that all payment remittances for electronic payments will include PI Name, Protocol number, and Invoice number. Payment should be made to the following:

 

Payee:

[____] Tax ID Number: [____] Payee Bank Account Details: [____]:

 

Invoices: Please send original, correct and itemized invoices monthly to the following:

 

60 Degrees Pharmaceuticals, Inc

[____]

 

Electronic invoice submissions shall include: Protocol number, site number, and last name of Investigator in the subject line of the e-mail. Failure to adhere to these terms may delay the processing and payment of the electronically submitted invoice.

 

Invoices from Payee shall include:

 

●

Payee name (as shown in this Appendix I)

 

●

Protocol number

 

	●	Invoice date

	●	Date & itemized description of services provided

●

Applicable supporting documents/third party invoices

 

●

Total amount payable

 

Invoices shall be paid within forty-five (45) days of receipt by CRO.

 

 

Enrollment: Institution acknowledges that this is a Study designed to evaluate a set number of Study participants as identified in the Study Protocol. Institution will be expected to apply best efforts for enrollment as provided for under the Agreement. When enrollment of the target number of Study participants for the entire Study is complete, Institution will be notified and instructed not to continue enrolling Study participants, unless otherwise agreed to in writing.

 

The Study shall be payable as follows:

 

Cost per Subject: The amount to be paid to the Institution per completed Study participant is $[____] and outlined on the Budget, less ten percent (10%) withholding. Payments will be made on a monthly basis in US dollars and will be prorated based on completed visits entered in the Study participant electronic case report forms (“eCRFs”) in the prior month. (Please see the Final Payment section below regarding payment of the 10% withheld.)

 

Screen Failures: Institution will be reimbursed a flat rate of $[____] for a maximum of [____] Screen Failures. Sponsor written approval is required for any additional payment of Screen Failures. For purposes of this Agreement, a Screen Failure shall mean any Study participant, who initially appears to meet the criteria for pre-screening, signs the informed consent form, completes the screening visit but who does not randomize into the Study. Payment for Screen Failures will be payable based on data entered into the Study participant eCRF system, and upon the receipt and verification of such data by CRO.

 

Administrative Start-Up Fee: [____] will be payable to the Institution upon execution of this Agreement, and upon the receipt, verification and processing of an undisputed invoice by CRO.

 

IRB Fees: Central IRB is defined as the IRB selected by the Sponsor, and to whom Sponsor is making submissions on behalf of sites using this Central IRB. Central IRB fees will be reimbursed directly to the IRB by Sponsor or its representative. Local IRB Fees will be submitted by the Institution and reimbursable directly to the Institution upon the receipt of correct and itemized invoices by CRO.

 

Subject/Caregiver Stipends: Study participant and/or Caregiver stipends will be paid to Institution at the rate stated in the Budget based on completed visits. In the event that any Study participant stipend is paid by CRO to Institution but not actually paid to the Study participant by the Institution, Institution will promptly refund that amount to CRO.

 

Unscheduled Visits: [____]. Institution shall be reimbursed for actual unscheduled procedures performed in accordance with . Unscheduled Visits will be reimbursed and prorated at the rate set forth in Budget. In the event a medically necessary procedure is not included in the Budget, Institution must receive prior written approval for the compensation amount before such procedure is performed, except in cases of emergency or cases that are medically time sensitive. Payment will be made following the receipt, verification and processing of an itemized undisputed invoice by CRO.

 

Final Payment: The final payment to include the ten percent (10%) withholding will be payable upon completion of the close-out visit and the following: (i) return of all final Study documentation, samples, materials and equipment (ii) the accountability of all used and unused Study Drug, (iii) submission of all completed and correct eCRFs/queries to Sponsor and/or CRO, and (iv) submission to Sponsor and/or CRO of responses to any clarification requests made by CRO or Sponsor regarding Study data or records. All invoices for Study payments, as outlined in this payment schedule, must be submitted to Sponsor within ninety (90) days of the Institution’s Study close-out visit. Invoices received after this time will not be reimbursed.

 

No other additional funding requests will be considered without the prior written consent of Sponsor.

 

 

Exhibit 23.1

 

CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

We consent to the incorporation by reference in this Registration Statement of 60 Degrees Pharmaceuticals, Inc. on Form S-3 of our reports dated April 1, 2024 relating to the financial statements of 60 Degrees Pharmaceuticals, Inc., as of December 31, 2023 and 2022 and for each of the years in the two-year period ended December 31, 2023 (which report includes an explanatory paragraph regarding the Company’s ability to continue as a going concern).

 

We also consent to the reference to us under the heading “Experts” in the Prospectus, which is part of this Registration Statement.

 

/s/ RBSM LLP

 

Las Vegas, Nevada

September 19, 2024

 

 

Exhibit 107

 

Calculation of Filing Fee Table

 

Form S-3

(Form Type)

 

60 Degrees Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

Table 1: Newly Registered Securities

 

		Security Type		Security Class Title		Fee Calculation Rule				Amount Registered			Proposed Maximum Offering Price Per Unit				Proposed Maximum Aggregate Offering Price			Fee Rate			Amount of Registration Fee
Fees to be paid		Equity		Common Stock, par value $0.0001 per share			457(c)			8,913,044	(1)		$	1.41	(2)		$	12,589,674.65		$	0.00014760		$	1,858.24
				Total Offering Amounts													$	12,589,674.65					$	1,858.24
				Total Fee Offsets														—						—
				Net Fee Due													$	12,589,674.65					$	1,858.24

 

(1)	Consists of an aggregate of 8,913,044 shares of Common Stock registered for sale by certain of the selling stockholders named in this registration statement including (i) 2,898,551 shares of Common Stock issuable upon exercise of pre-funded warrants held by certain selling stockholders, (ii) 2,898,551 shares of Common Stock issuable upon exercise of Series A warrants, (iii) 2,898,551 shares of Common Stock issuable upon exercise of Series B warrants and (iv) 217,391 share of Common Stock issuable upon the exercise of placement agent warrants that were issued to designees of H.C. Wainwright & Co., LLC.
(2)	Determined pursuant to Rule 457(c) under the Securities Act of 1933, as amended, solely for the purpose of calculating the registration fee. The price shown is the average of the high and low selling price of the Common Stock on September 17, 2024, which is a date within 5 business days prior to the date of filing of this Registration Statement, as reported on the Nasdaq Capital Market.

 

Table 2: Fee Offset Claims and Sources

N/A

 

Table 3: Combined Prospectuses

N/A