Exhibit 10.1


 


SECURITIES
PURCHASE AGREEMENT


 


This Securities Purchase Agreement
(this “Agreement”) is dated as of May 30, 2022, between Rockwell Medical, Inc., a Delaware corporation (the “Company”),
and the purchaser identified on the signature pages hereto (including its successors and assigns, the “Purchaser”).


 


WHEREAS, subject to the terms
and conditions set forth in this Agreement and pursuant to an effective registration statement under the Securities Act of 1933, as amended
(the “Securities Act” or “Act”) and the rules and regulations (the “Rules and Regulations”)
of the Securities and Exchange Commission (the “Commission”) thereunder, the Company desires to issue
and sell to the Purchaser, and the Purchaser desires to purchase from the Company, securities of the Company as more fully described in
this Agreement.


 


NOW, THEREFORE, IN CONSIDERATION
of the mutual covenants contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which are
hereby acknowledged, the Company and the Purchaser agree as follows:


 


ARTICLE I.

DEFINITIONS


 


1.1             
 Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following
terms have the meanings set forth in this Section 1.1:


 


“Acquiring Person”
shall have the meaning ascribed to such term in Section 4.5.


 


“Affiliate”
means any Person that, directly or indirectly through one or more intermediaries, controls or is controlled by or is under common control
with a Person as such terms are used in and construed under Rule 405 under the Securities Act.


 


“Board
of Directors” means the board of directors of the Company.


 


“Business
Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day
on which banking institutions in the State of New York are authorized or required by law or other governmental action to close; provided,
however, for clarification, commercial banks shall not be deemed to be authorized or required by law to remain closed due to “stay
at home”, “shelter-in-place”, “non-essential employee”  or any other similar orders or restrictions
or the closure of any physical branch locations at the direction of any governmental authority so long as the electronic funds transfer
systems (including for wire transfers) of commercial banks in The City of New York generally are open for use by customers on such day.


 


“Closing”
means the closing of the purchase and sale of the Securities pursuant to Section 2.1.


 


“Closing
Date” means the Trading Day on which all of the Transaction Documents have been executed and delivered by the applicable
parties thereto, and all conditions precedent to (i) the Purchaser’s obligations to pay the Subscription Amount and (ii) the
Company’s obligations to deliver the Securities, in each case, have been satisfied or waived, but in no event later than the
second (2nd) Trading Day following the date hereof.


 






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“Common
Stock” means the common stock of the Company, par value $0.0001 per share, and any other class of securities into which such
securities may hereafter be reclassified or changed.


 


“Common
Stock Equivalents” means any securities of the Company or its subsidiaries which would entitle the holder thereof to acquire
at any time Common Stock, including, without limitation, any debt, preferred stock, right, option, warrant or other instrument that is
at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.


 


“Company
Counsel” means Gibson, Dunn & Crutcher, LLP.


 


“Disclosure
Schedules” means the Disclosure Schedules of the Company delivered concurrently herewith.


 


“Disclosure
Time” means, (i) if this Agreement is signed on a day that is not a Trading Day or after 9:00 a.m. (New York City time) and
before midnight (New York City time) on any Trading Day, 9:01 a.m. (New York City time) on the Trading Day immediately following the date
hereof, unless otherwise instructed as to an earlier time by the Placement Agent, and (ii) if this Agreement is signed between midnight
(New York City time) and 9:00 a.m. (New York City time) on any Trading Day, no later than 9:01 a.m. (New York City time) on the date hereof,
unless otherwise instructed as to an earlier time by the Placement Agent.


 


“Exchange
Act” means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.


 


“Exempt
Issuance” means (i) the issuance of securities to directors, officers, employees and consultants of the Company pursuant to
employee benefit plans, equity incentive plans or other employee compensation plans existing on the date hereof and as described in the
Prospectus or pursuant to Nasdaq Rule 5635(c)(4), (ii) securities pursuant to the exercise, exchange or conversion of any options, warrants,
restricted stock units, rights or convertible securities outstanding on the date hereof, provided that such options, warrants, restricted
stock units, rights or convertible securities have not been amended since the date of this Agreement to increase the number of such securities
or to decrease the exercise price, exchange price or conversion price of such securities or to extend the term of such securities, and
(iii) securities issued in connection with any joint venture, commercial or collaborative relationship, or the acquisition or license
by the Company of the securities, businesses, property or other assets of another person, provided that such issuance is approved by the
majority of the disinterested directors of the Company and provided that such securities are issued as “restricted securities”
(as defined in Rule 144) and carry no registration rights that require or permit the filing of any registration statement in connection
therewith during the prohibition period in Section 4.12(a) herein.


 






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“Lock-Up
Agreement” means the Lock-Up Agreement, dated as of the date hereof, by and among the Company and the Company’s directors
and officers, in the form of Exhibit B attached hereto.


 


“Material
Adverse Effect” shall have the meaning assigned to such term in Section 3.1(a).


 


“Per Share
Purchase Price” equals $1.39, subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations
and other similar transactions of the Common Stock that occur after the date of this Agreement and prior to the Closing Date.


 


“Person”
means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company,
joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.


 


“Pre-Funded
Warrants” means the Pre-Funded Common Stock purchase warrants delivered to the Purchasers at the Closing in accordance with
Section 2.2(a) hereof, in the form of Exhibit A attached hereto.


 


“Prospectus”
means the final base prospectus filed for the Registration Statement, including all information, documents and exhibits filed with or
incorporated by reference into such base prospectus.


 


“Prospectus
Supplement” means the supplement to the Prospectus complying with Rule 424(b) of the Securities Act that is filed with the Commission
and delivered by the Company to the Purchaser at the Closing, including all information, documents and exhibits filed with or incorporated
by reference into such supplement to the Prospectus.


 


“Purchaser
Party” shall have the meaning ascribed to such term in Section 4.8.


 


“Registration
Statement” means the effective registration statement with Commission (File No. 333-259923), including all information, documents
and exhibits filed with or incorporated by reference into such registration statement, which registers the sale of the Shares, the Pre-Funded
Warrants and the Warrant Shares to the Purchaser.


 


“Rule 144”
means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time,
or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.


 


“Rule 424”
means Rule 424 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended or interpreted from time to time,
or any similar rule or regulation hereafter adopted by the Commission having substantially the same purpose and effect as such Rule.


 


“Securities”
means the Shares, the Pre-Funded Warrants, the Warrants and the Warrant Shares.


 






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“Shares”
means the shares of Common Stock issued or issuable to the Purchaser pursuant to this Agreement.


 


“Short
Sales” means all “short sales” as defined in Rule 200 of Regulation SHO under the Exchange Act (but shall not be
deemed to include locating and/or borrowing shares of Common Stock). 


 


“Subscription
Amount” means, as to the Purchaser, the aggregate amount to be paid for Shares and Pre-Funded Warrants purchased hereunder as
specified below the Purchaser’s name on the signature page of this Agreement and next to the heading “Subscription Amount,”
in United States dollars and in immediately available funds.


 


“Trading
Day” means a day on which the principal Trading Market is open for trading.


 


“Trading
Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date
in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market or the New York Stock
Exchange (or any successors to any of the foregoing).


 


“Transaction
Documents” means this Agreement, the Pre-Funded Warrants, all exhibits and schedules thereto and hereto and any other documents
or agreements executed in connection with the transactions contemplated hereunder.


 


“Transfer
Agent” means American Stock Transfer & Trust Company.


 


“Variable
Rate Transaction” shall have the meaning ascribed to such term in Section 4.12(b).


 


“Warrant
Shares” means the shares of Common Stock issuable upon exercise of the Pre-Funded Warrants.


 


ARTICLE II.

PURCHASE AND SALE


 


2.1              Closing.
On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company agrees to sell, and the Purchaser
agrees to purchase, an aggregate of $12,000,000 of Shares and Pre-Funded Warrants with an allocation between the Shares and the
Pre-Funded Warrants such that the Purchaser’s Subscription Amount would not cause the Purchaser’s beneficial ownership
of the shares of Common Stock to exceed the Beneficial Ownership Limitation. The “Beneficial Ownership
Limitation” shall be 4.99% (or, at the election of the Purchaser at Closing, 9.99%) of the number of shares of the Common
Stock outstanding immediately after giving effect to the issuance of the Securities on the Closing Date. The Purchaser’s
Subscription Amount as set forth on the signature page hereto executed by the Purchaser shall be made available for “Delivery
Versus Payment” (“DVP”) settlement with the Company or its designees. The Company shall deliver to the
Purchaser its respective Shares and Pre-Funded Warrants as determined pursuant to Section 2.2(a), and the Company and the Purchaser
shall deliver the other items set forth in Section 2.2 deliverable at the Closing. Upon satisfaction of the covenants and conditions
set forth in Sections 2.2 and 2.3, the Closing shall occur at the offices of the Placement Agent or such other location as the
parties shall mutually agree. Unless otherwise directed by the Placement Agent, settlement of the Shares shall occur via DVP (i.e.,
on the Closing Date, the Company shall issue the Shares registered in the Purchaser’s name and address and released by the
Transfer Agent directly to the account(s) at the Placement Agent identified by the Purchaser; upon receipt of such Shares, the
Placement Agent shall promptly electronically deliver such Shares to the Purchaser, and payment therefor shall be made by the
Placement Agent (or its clearing firm) by wire transfer to the Company).


 






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2.2             
Deliveries.


 


(a)              
On or prior to the Closing Date, the Company shall deliver or cause to be delivered to the Purchaser the following:


 


(i)                
this Agreement duly executed by the Company;


 


(ii)             
a legal opinion of Company Counsel, directed to the Purchaser, in a form reasonably acceptable to the Purchaser;


 


(iii)           
the Company shall have provided the Purchaser with the Company’s wire instructions, on Company letterhead and executed by
the Chief Executive Officer or Chief Financial Officer;


 


(iv)            
subject to the last sentence of Section 2.1, a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer
Agent to deliver on an expedited basis via The Depository Trust Company Deposit or Withdrawal at Custodian system (“DWAC”)
Shares equal to the Purchaser’s Subscription Amount divided by the Per Share Purchase Price, registered in the name of the Purchaser;


 


(v)              
a Pre-Funded Warrant registered in the name of the Purchaser to purchase up to a number of shares of Common Stock equal to the
difference between (A) the Purchaser’s Subscription Amount divided by the Per Share Purchase Price and (B) the number of Shares
otherwise issuable to the Purchaser that would cause the Purchaser’s beneficial ownership of Common Stock to be more than the Beneficial
Ownership Limitation with an exercise price equal to $0.0001 per share of Common Stock, subject to adjustment therein;


 


(vi)            
the Lock-Up Agreements; and


 


(vii)         
the Prospectus and Prospectus Supplement (which may be delivered in accordance with Rule 172 under the Securities Act).


 


(b)              
On or prior to the Closing Date, the Purchaser shall deliver or cause to be delivered to the Company the following:


 


(i)                
this Agreement duly executed by the Purchaser; and


 





(ii)             
 the Purchaser’s Subscription Amount, which shall be made available for DVP settlement with the Company or its designees.


 






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2.3             
Closing Conditions.


 


(a)           The
obligations of the Company hereunder in connection with the Closing are subject to the following conditions being met:


 


(i)            
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material
Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Purchaser contained herein
(unless as of a specific date therein in which case they shall be accurate as of such date);


 


(ii)           
all obligations, covenants and agreements of the Purchaser required to be performed at or prior to the Closing Date shall have
been performed; and


 


(iii)          
the delivery by the Purchaser of the items set forth in Section 2.2(b) of this Agreement.


 


(b)          
The obligations of the Purchaser in connection with the Closing are subject to the following conditions being met:


 


(i)            
the accuracy in all material respects (or, to the extent representations or warranties are qualified by materiality or Material
Adverse Effect, in all respects) when made and on the Closing Date of the representations and warranties of the Company contained herein
(unless as of a specific date therein in which case they shall be accurate as of such date);


 


(ii)           
all obligations, covenants and agreements of the Company required to be performed at or prior to the Closing Date shall have been
performed;


 


(iii)          
the delivery by the Company of the items set forth in Section 2.2(a) of this Agreement;


 


(iv)          
there shall have been no Material Adverse Effect with respect to the Company since the date hereof; and


 


(v)            from
the date hereof to the Closing Date, trading in the Common Stock shall not have been suspended by the Commission or the
Company’s principal Trading Market, and, at any time prior to the Closing Date, trading in securities generally as reported by
Bloomberg L.P. shall not have been suspended or limited, or minimum prices shall not have been established on securities whose
trades are reported by such service, or on any Trading Market, nor shall a banking moratorium have been declared either by the
United States or New York State authorities nor shall there have occurred any material outbreak or escalation of hostilities or
other national or international calamity of such magnitude in its effect on, or any material adverse change in, any financial market
which, in each case, in the reasonable judgment of the Purchaser, makes it impracticable or inadvisable to purchase the Securities
at the Closing.


 






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ARTICLE III.

REPRESENTATIONS AND WARRANTIES


 


3.1             
Representations and Warranties of the Company. Except as set forth in the SEC Reports or the Disclosure Schedules, which
Disclosure Schedules shall be deemed a part hereof and shall qualify any representation or otherwise made herein to the extent of the
disclosure contained in the corresponding section of the Disclosure Schedules, the Company hereby makes the following representations
and warranties to the Purchaser:


 


(a)              
Organization and Good Standing. Each of the subsidiaries of the Company are set forth on Schedule 3.1(a). Each of
the Company and its subsidiaries has been duly organized and is validly existing as a corporation in good standing under the laws of its
jurisdiction of incorporation. Each of the Company and its subsidiaries has full corporate power and authority to own its properties and
conduct its business as currently being carried on and as described in the Registration Statement, the Prospectus and the Prospectus Supplement,
and is duly qualified to do business as a foreign corporation in good standing in each jurisdiction in which it owns or leases real property
or in which the conduct of its business makes such qualification necessary and in which the failure to so qualify would have (a) a material
adverse effect upon the business, management, properties, operations, condition (financial or otherwise) or results of operations of the
Company and its subsidiaries, taken as a whole, or (b) a material adverse effect on the Company’s ability to perform in any material
respect on a timely basis its obligations under the Transaction Documents (“Material Adverse Effect”).
All of the issued and outstanding shares of capital stock of each of the Company’s subsidiaries have been duly and validly authorized
and issued and are fully paid and nonassessable, and, except as otherwise described in the Registration Statement, the Prospectus and
the Prospectus Supplement, the Company owns of record and beneficially, free and clear of any security interests, claims, liens, proxies,
equities or other encumbrances, all of the issued and outstanding shares of such stock.


 


(b)              
No Violations or Defaults. Neither the Company nor any of its subsidiaries (A) is in violation of its respective charters,
bylaws or other organizational documents, (B) is in breach of or otherwise in default and no event has occurred which, with notice
or lapse of time or both, would constitute such a default, in the performance or observance of any term, covenant or condition contained
in any contract, indenture, mortgage, deed of trust, loan agreement, lease or other agreement or instrument to which it is a party or
by which it is bound or to which any of its material property or assets is subject, (C) is in violation in any respect of any law,
ordinance, governmental rule, regulation or court order, decree or judgment to which it or its property or assets may be subject, including
the Sarbanes–Oxley Act; or (D) is in violation of any applicable requirements set forth in the rules of the Exchange Act; except,
in the case of clauses (B), (C) and (D) of this paragraph (b), for any breaches, violations or defaults which, singularly or
in the aggregate, would not have a Material Adverse Effect.


 






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(c)              
 Authorization; No Conflicts; Authority. This Agreement has been duly authorized, executed and delivered by the Company,
and constitutes a valid, legal and binding obligation of the Company, enforceable in accordance with its terms, except as rights to indemnity
hereunder may be limited by federal or state securities laws and except as such enforceability may be limited by bankruptcy, insolvency,
reorganization or similar laws affecting the rights of creditors generally and subject to general principles of equity. Warrants have
been duly authorized, and when executed and delivered by the Company, shall constitute a valid, legal and binding obligation of the Company,
enforceable in accordance with their terms, except as such enforceability may be limited by bankruptcy, insolvency, reorganization or
similar laws affecting the rights of creditors generally and subject to general principles of equity. The execution, delivery and performance
of the Transaction Documents and the consummation of the transactions herein and therein contemplated will not (A) conflict with or result
in a breach or violation of any of the terms or provisions of, or constitute a default under, or result in the creation or imposition
of any lien, charge or encumbrance upon any property or assets of the Company or any of its subsidiaries pursuant to any indenture, mortgage,
deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which
the Company or any of its subsidiaries is bound or to which any of the property or assets of the Company or any of its subsidiaries is
subject, (B) result in any violation of the provisions of the Company’s charter or by-laws or (C) result in the violation of any
law or statute or any judgment, order, rule, regulation or decree of any court or arbitrator or federal, state, local or foreign governmental
agency or regulatory authority having jurisdiction over the Company or any of its subsidiaries or any of their properties or assets (each,
a “Governmental Authority”), except in the case of clause (A) or (C) as would not result in a Material Adverse Effect.
No consent, approval, authorization or order of, or registration or filing with any Governmental Authority is required for the execution,
delivery and performance of this Agreement or for the consummation of the transactions contemplated hereby, including the issuance or
sale of the Shares by the Company, except such as may be required under the Act, the rules of the Financial Industry Regulatory Authority
(“FINRA”) or state securities or blue sky laws; and the Company has full power and authority to enter into this the
Transaction Documents and to consummate the transactions contemplated hereby and thereby, including the authorization, issuance and sale
of the Securities as contemplated by this Agreement.


 






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(d)               Issuance
of the Securities; Registration. The Shares are duly authorized and, when issued and paid for in accordance with the applicable
Transaction Documents, will be duly and validly issued, fully paid and nonassessable, free and clear of all Liens imposed by the
Company. When paid for and issued in accordance with this Agreement, the Warrants will constitute valid and binding obligations of
the Company, enforceable against the Company in accordance with their respective terms, except: (i) as such enforceability may
be limited by bankruptcy, insolvency, reorganization or similar laws affecting the rights of creditors generally and subject to
general principles of equity. The Warrant Shares, when issued in accordance with the terms of the Warrants, will be validly
issued, fully paid and nonassessable, free and clear of all Liens imposed by the Company. The Company has reserved from its duly
authorized capital stock the maximum number of Shares issuable pursuant to this Agreement and, on the Authorized Share Increase
Date, shall reserve from its duly authorized capital stock the maximum number of Warrant Shares issuable pursuant to the Warrants.
The Company has prepared and filed the Registration Statement in conformity with the requirements of the Securities Act, which
became effective on October 8, 2021, including the Prospectus, and such amendments and supplements thereto as may have been required
to the date of this Agreement. The Company was at the time of the filing of the Registration Statement eligible to use Form S-3. The
Registration Statement is effective under the Securities Act and no stop order preventing or suspending the effectiveness of the
Registration Statement or suspending or preventing the use of the Prospectus has been issued by the Commission and no proceedings
for that purpose have been instituted or, to the knowledge of the Company, are threatened by the Commission. The Company, if
required by the rules and regulations of the Commission, shall file the Prospectus Supplement with the Commission pursuant to Rule
424(b). At the time the Registration Statement and any amendments thereto became effective, at the date of this Agreement and at the
Closing Date, the Registration Statement and any amendments thereto conformed and will conform in all material respects to the
requirements of the Securities Act and did not and will not contain any untrue statement of a material fact or omit to state any
material fact required to be stated therein or necessary to make the statements therein not misleading; and the Prospectus and any
amendments or supplements thereto, at the time the Prospectus or any amendment or supplement thereto was issued and at the Closing
Date, conformed and will conform in all material respects to the requirements of the Securities Act and did not and will not contain
an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the
light of the circumstances under which they were made, not misleading.


 


(e)               Capitalization.
The capitalization of the Company as of the date hereof is as set forth on Schedule 3.1(e). All of the issued and outstanding
shares of capital stock of the Company, including the outstanding shares of Common Stock, are duly authorized and validly issued,
fully paid and nonassessable, have been issued in compliance with all federal and state and foreign securities laws, were not issued
in violation of or subject to any preemptive rights or other rights to subscribe for or purchase securities that have not been
waived in writing, and the holders thereof are not subject to personal liability by reason of being such holders; the capital stock
of the Company, including the Common Stock and the Warrants, conforms in all material respects to the description thereof in the
Registration Statement, the Prospectus and the Prospectus Supplement. Except as set forth on Schedule 3.1(e), (A) there are
no preemptive rights or other rights to subscribe for or to purchase, or any restriction upon the voting or transfer of, any shares
of Common Stock pursuant to the Company’s charter, by-laws or any agreement or other instrument to which the Company or
any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound; and (B) neither the filing of
the Registration Statement nor the offering or sale of the Securities as contemplated by this Agreement gives rise to any rights for
or relating to the registration of any shares of Common Stock or other securities of the Company (collectively
 “Registration Rights”). Except as a result of the purchase and sale of the Securities, the $7,500,000 of shares
of Series X Convertible Preferred Stock issuable to DaVita, Inc., or as set forth on Schedule 3.1(e), there are no
outstanding options, warrants, scrip rights to subscribe to, calls or commitments of any character whatsoever relating to, or
securities, rights or obligations convertible into or exercisable or exchangeable for, or giving any Person any right to subscribe
for or acquire, any shares of Common Stock or the capital stock of any subsidiary, or contracts, commitments, understandings or
arrangements by which the Company or any Subsidiary is or may become bound to issue additional shares of Common Stock or Common
Stock Equivalents or capital stock of any Subsidiary. Except as set forth on Schedule 3.1(e), there are no outstanding
securities or instruments of the Company or any subsidiary with any provision that adjusts the exercise, conversion, exchange or
reset price of such security or instrument upon an issuance of securities by the Company or any subsidiary. Except for the
Authorized Share Approval, no further approval or authorization of any stockholder, the Board of Directors or others is required for
the issuance and sale of the Securities. There are no stockholders agreements, voting agreements or other similar agreements with
respect to the Company’s capital stock to which the Company is a party or, to the knowledge of the Company, between or among
any of the Company’s stockholders.


 






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(f)               
SEC Reports. The Company has filed all reports, schedules, forms, statements and other documents required to be filed by
the Company under the Securities Act and the Exchange Act, including pursuant to Section 13(a) or 15(d) thereof, for the two years preceding
the date hereof (or such shorter period as the Company was required by law or regulation to file such material) (the foregoing materials,
including the exhibits thereto and documents incorporated by reference therein, together with the Prospectus and the Prospectus Supplement,
being collectively referred to herein as the “SEC Reports”) on a timely basis or has received a valid extension of
such time of filing and has filed any such SEC Reports prior to the expiration of any such extension. As of their respective dates, the
SEC Reports complied in all material respects with the requirements of the Securities Act and the Exchange Act, as applicable, and none
of the SEC Reports, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated
therein or necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
The Company has never been an issuer subject to Rule 144(i) under the Securities Act.


 


(g)               Financial
Statements. The financial statements of the Company, together with the related notes, set forth or incorporated by reference in
the Registration Statement, the Prospectus and the Prospectus Supplement comply in all material respects with the requirements of
the Securities Act and the Exchange Act and fairly present the financial condition of the Company and its consolidated subsidiaries
as of the dates indicated and the results of operations and changes in cash flows for the periods therein specified in conformity
with generally accepted accounting principles in the United States consistently applied throughout the periods involved; the
supporting schedules included in the Registration Statement present fairly the information required to be stated therein; all
non-GAAP financial information included in the Registration Statement, the Prospectus and the Prospectus Supplement complies with
the requirements of Regulation G and Item 10 of Regulation S-K under the Act; and, except as disclosed in the Registration
Statement, the Prospectus and the Prospectus Supplement, there are no material off-balance sheet arrangements (as defined in
Regulation S-K under the Act, Item 303(a)(4)(ii)) or any other relationships with unconsolidated entities or other persons, that may
have a material current effect or, to the Company’s knowledge, material future effect on the Company’s financial
condition, results of operations, liquidity, capital expenditures, capital resources or significant components of revenue or
expenses. No other financial statements or schedules are required to be included in the Registration Statement, the Prospectus or
the Prospectus Supplement. To the Company’s knowledge, Marcum, LLP, which has expressed its opinion with respect to the
financial statements and schedules filed as a part of the Registration Statement and included in the Registration Statement, the
Prospectus and the Prospectus Supplement is (x) an independent public accounting firm within the meaning of the Act and the Rules
and Regulations, (y) a registered public accounting firm (as defined in Section 2(a)(12) of the Sarbanes-Oxley Act of 2002 (the
 “Sarbanes-Oxley Act”)) and (z) not in violation of the auditor independence requirements of the Sarbanes-Oxley
Act.


 






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(h)              
Absence of Certain Events; Undisclosed Events, Liabilities or Developments. Except as set forth on Schedule 3.1(h),
subsequent to the respective dates as of which information is given in the Prospectus and the Prospectus Supplement, neither the Company
nor any of its subsidiaries has incurred any material liabilities or obligations, direct or contingent, or entered into any material transactions,
or declared or paid any dividends or made any distribution of any kind with respect to its capital stock; and there has not been any change
in the capital stock (other than a change in the number of outstanding shares of Common Stock due to the issuance of shares upon the exercise
of outstanding options or warrants, settlement of restricted stock units or conversion of convertible securities), or any material change
in the short-term or long-term debt (other than as a result of the conversion of convertible securities), or any issuance of options,
warrants, restricted stock units, convertible securities or other rights to purchase the capital stock, of the Company or any of its subsidiaries,
or any event or development that has had a Material Adverse Effect or any development which could reasonably be expected to result in
any Material Adverse Effect. Except for (i) the issuance of the Securities contemplated by this Agreement, or (ii) as set forth on Schedule
3.1(h), no event, liability, fact, circumstance, occurrence or development has occurred or exists or is reasonably expected to occur
or exist with respect to the Company or its Subsidiaries or their respective businesses, prospects, properties, operations, assets or
financial condition that would be required to be disclosed by the Company under applicable securities laws at the time this representation
is made or deemed made that has not been publicly disclosed at least one (1) Trading Day prior to the date that this representation is
made.


 


(i)                 Absence
of Proceedings. Except as set forth on Schedule 3.1(i), there is not pending or, to the knowledge of the Company,
threatened or contemplated, any action, suit or proceeding (a) to which the Company or any of its subsidiaries is a party or (b)
which has as the subject thereof any officer or director of the Company or any subsidiary, any employee benefit plan sponsored by
the Company or any subsidiary or any property or assets owned or leased by the Company or any subsidiary before or by any court or
Governmental Authority, or any arbitrator, which, individually or in the aggregate, might result in any Material Adverse Effect, or
would materially and adversely affect the ability of the Company to perform its obligations under the Transaction Documents or which
are otherwise material in the context of the sale of the Securities. There are no current or, to the knowledge of the Company,
pending, legal, governmental or regulatory actions, suits or proceedings (x) to which the Company or any of its subsidiaries is
subject or (y) which has as the subject thereof any officer or director of the Company or any subsidiary, any employee plan
sponsored by the Company or any subsidiary or any property or assets owned or leased by the Company or any subsidiary, that are
required to be described in the Registration Statement, Prospectus and the Prospectus Supplement by the Securities Act or by the
Rules and Regulations and that have not been so described.


 






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(j)                
Labor Relations. No labor dispute with the employees of the Company or any of its subsidiaries exists or, to the Company’s
knowledge, is threatened or imminent, and the Company is not aware of any existing or imminent labor disturbance by the employees of any
of its or its subsidiaries’ principal suppliers, contractors or customers, that could have a Material Adverse Effect.


 


(k)              
Compliance with Laws. The Company and each of its subsidiaries holds, and is operating in compliance in all material respects
with, all franchises, grants, authorizations, licenses, permits, easements, consents, certificates and orders of any Governmental Authority
or self-regulatory body required for the conduct of its business and all such franchises, grants, authorizations, licenses, permits,
easements, consents, certifications and orders are valid and in full force and effect; and neither the Company nor any of its subsidiaries
has received notice of any revocation or modification of any such franchise, grant, authorization, license, permit, easement, consent,
certification or order or has reason to believe that any such franchise, grant, authorization, license, permit, easement, consent, certification
or order will not be renewed in the ordinary course; and the Company and each of its subsidiaries is in compliance in all material respects
with all applicable federal, state, local and foreign laws, regulations, orders and decrees.


 


(l)                
Compliance with Environmental Laws. Except as disclosed in the Prospectus and the Prospectus Supplement, neither the Company
nor any of its subsidiaries is in violation of any statute, any rule, regulation, decision or order of any Governmental Authority or any
court, domestic or foreign, relating to the use, disposal or release of hazardous or toxic substances or relating to the protection or
restoration of the environment or human exposure to hazardous or toxic substances (collectively, “Environmental Laws”),
owns or operates any real property contaminated with any substance that is subject to any environmental laws, is liable for any off-site
disposal or contamination pursuant to any Environmental Laws, or is subject to any claim relating to any Environmental Laws, which violation,
contamination, liability or claim would individually or in the aggregate, have a Material Adverse Effect; and the Company is not aware
of any pending investigation which might lead to such a claim. Neither the Company nor any of its subsidiaries anticipates incurring any
material capital expenditures relating to compliance with Environmental Laws.


 


(m)             Ownership
of Assets. The Company and its subsidiaries have good and marketable title to all property (whether real or personal) described
in the Registration Statement, the Prospectus and the Prospectus Supplement as being owned by them, in each case free and clear of
all liens, claims, security interests, other encumbrances or defects except such as are described in the Registration Statement, the
Prospectus and the Prospectus Supplement or as would not, individually or in the aggregate, result in a Material Adverse Effect. The
property held under lease by the Company and its subsidiaries is held by them under valid, subsisting and enforceable leases with
only such exceptions with respect to any particular lease as do not interfere in any material respect with the conduct of the
business of the Company or its subsidiaries.


 






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(n)              
Intellectual Property The Company and each of its subsidiaries owns, possesses, or can acquire on reasonable terms, all
Intellectual Property (as defined below) necessary for the conduct of the Company’s and it subsidiaries’ business as now conducted
or as described in the Registration Statement, the Prospectus and the Prospectus Supplement to be conducted, except as such failure to
own, possess, or acquire such rights would not result in a Material Adverse Effect. Furthermore, except as described in the Registration
Statement, the Prospectus and the Prospectus Supplement, (A) to the Knowledge (as defined herein) of the Company, there is no infringement,
misappropriation or violation by third parties of any such Intellectual Property, except as such infringement, misappropriation or violation
would not result in a Material Adverse Effect; (B) there is no pending or, to the Knowledge of the Company, threatened, action, suit,
proceeding or claim by others challenging the Company’s or any of its subsidiaries’ rights in or to any such Intellectual
Property, and the Company is unaware of any objective facts which would form a reasonable basis for any such claim; (C) the Intellectual
Property owned by the Company and its subsidiaries, and to the Knowledge of the Company, the Intellectual Property licensed to the Company
and its subsidiaries, has not been adjudged invalid or unenforceable, in whole or in part, and there is no pending or, to the Knowledge
of the Company, threatened action, suit, proceeding or claim by others challenging the validity or scope of any such Intellectual Property;
(D) there is no pending or, to the Knowledge of the Company, threatened action, suit, proceeding or claim by others that the Company or
any of its subsidiaries infringes, misappropriates or otherwise violates any Intellectual Property or other proprietary rights of others,
and neither the Company or any of its subsidiaries has received any written notice of such claim; and (E) to the Company’s knowledge,
no employee of the Company or any of its subsidiaries is in or has ever been in violation of any term of any employment contract, patent
disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure agreement or
any restrictive covenant to or with a former employer where the basis of such violation relates to such employee’s employment with
the Company or any of its subsidiaries or actions undertaken by the employee while employed with the Company or any of its subsidiaries,
except as such violation would not result in a Material Adverse Effect. “Intellectual Property” shall mean all patents,
patent applications, trademarks, trademark registrations, service marks, service mark registrations, trade names, copyrights, copyright
registrations, licenses, inventions, trade secrets, Internet domain names, Internet domain name registrations, technology, registrations,
trade secret rights, know-how and other intellectual property.


 


(o)               Insurance.
The Company and each of its subsidiaries carries, or is covered by, insurance from reputable insurers in such amounts and covering
such risks as is adequate for the conduct of its business and the value of its properties and the properties of its subsidiaries and
as is customary for companies engaged in similar businesses in similar industries; all policies of insurance and any fidelity or
surety bonds insuring the Company or any of its subsidiaries or its business, assets, employees, officers and directors are in full
force and effect; the Company and its subsidiaries are in compliance with the terms of such policies and instruments in all material
respects; there are no claims by the Company or any of its subsidiaries under any such policy or instrument as to which any
insurance company is denying liability or defending under a reservation of rights clause; neither the Company nor any of its
subsidiaries has been refused any insurance coverage sought or applied for; and neither the Company nor any of its subsidiaries has
reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain
similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse
Effect.


 






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(p)              
Internal Accounting Controls. The Company and its subsidiaries maintain a system of internal accounting controls sufficient
to provide reasonable assurances that (i) transactions are executed in accordance with management’s general or specific authorization;
(ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting
principles in the United States and to maintain accountability for assets; (iii) access to assets is permitted only in accordance
with management’s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing
assets at reasonable intervals and appropriate action is taken with respect to any differences. Except as disclosed in the Registration
Statement, the Prospectus and the Prospectus Supplement, the Company’s internal control over financial reporting is effective and
none of the Company, its board of directors and audit committee is aware of any “significant deficiencies” or “material
weaknesses” (each as defined by the Public Company Accounting Oversight Board) in its internal control over financial reporting,
or any fraud, whether or not material, that involves management or other employees of the Company and its subsidiaries who have a significant
role in the Company’s internal controls; and since the end of the latest audited fiscal year, there has been no change in the Company’s
internal control over financial reporting (whether or not remediated) that has materially affected, or is reasonably likely to materially
affect, the Company’s internal control over financial reporting. The Company’s board of directors has, subject to the exceptions,
cure periods and the phase in periods specified in the applicable stock exchange rules (“Exchange Rules”),
validly appointed an audit committee to oversee internal accounting controls whose composition satisfies the applicable requirements of
the Exchange Rules and the Company’s board of directors and/or the audit committee has adopted a charter that satisfies the requirements
of the Exchange Rules.


 


(q)              
Certain Fees. Except as set forth in the Prospectus Supplement, no brokerage or finder’s fees or commissions are or
will be payable by the Company or any subsidiary to any broker, financial advisor or consultant, finder, placement agent, investment banker,
bank or other Person with respect to the transactions contemplated by the Transaction Documents. The Purchaser shall have no obligation
with respect to any fees or with respect to any claims made by or on behalf of other Persons for fees of a type contemplated in this Section
that may be due in connection with the transactions contemplated by the Transaction Documents.


 


(r)               
Investment Company. The Company is not and, after giving effect to the offering and sale of the Securities, will not be
an “investment company,” as such term is defined in the Investment Company Act of 1940, as amended.


 






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(s)               
 Listing and Maintenance Requirements. The Common Stock is registered pursuant to Section 12(b) or 12(g) of the Exchange
Act, and the Company has taken no action designed to, or which to its knowledge is likely to have the effect of, terminating the registration
of the Common Stock under the Exchange Act nor has the Company received any notification that the Commission is contemplating terminating
such registration. The Company has not, in the 12 months preceding the date hereof, received notice from any Trading Market on which the
Common Stock is or has been listed or quoted to the effect that the Company is not in compliance with the listing or maintenance requirements
of such Trading Market. The Company is, and has no reason to believe that it will not in the foreseeable future continue to be, in compliance
with all such listing and maintenance requirements. The Common Stock is currently eligible for electronic transfer through the Depository
Trust Company or another established clearing corporation and the Company is current in payment of the fees to the Depository Trust Company
(or such other established clearing corporation) in connection with such electronic transfer.


 


(t)                
Application of Takeover Protections. The Company and the Board of Directors have taken all necessary action, if any, in
order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights
agreement) or other similar anti-takeover provision under the Company’s certificate of incorporation (or similar charter documents)
or the laws of its state of incorporation that is or could become applicable to the Purchaser as a result of the Purchaser and the Company
fulfilling their obligations or exercising their rights under the Transaction Documents, including without limitation as a result of the
Company’s issuance of the Securities and the Purchaser’s ownership of the Securities up to a Beneficial Ownership level of
9.99%.


 


(u)               Disclosure.
Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, the Company
confirms that neither it nor any other Person acting on its behalf has provided to the Purchaser or its agents or counsel with any
information that it believes constitutes or might constitute material, non-public information which is not otherwise disclosed in
the Prospectus Supplement. The Company understands and confirms that the Purchaser will rely on the foregoing representation in
effecting transactions in securities of the Company. All of the disclosure furnished by or on behalf of the Company to the Purchaser
regarding the Company and its subsidiaries, their respective businesses and the transactions contemplated hereby, including the
Disclosure Schedules to this Agreement, when taken together as a whole, is true and correct and does not contain any untrue
statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light
of the circumstances under which they were made, not misleading. The press releases disseminated by the Company during the twelve
months preceding the date of this Agreement taken as a whole do not contain any untrue statement of a material fact or omit to state
a material fact required to be stated therein or necessary in order to make the statements therein, in the light of the
circumstances under which they were made and when made, not misleading. The Company acknowledges and agrees that no Purchaser makes
or has made any representations or warranties with respect to the transactions contemplated hereby other than those specifically set
forth in Section 3.2 hereof.



 






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(v)              
No Integrated Offering. Assuming the accuracy of the Purchaser’s representations and warranties set forth in Section
3.2, neither the Company, nor any of its Affiliates, nor any Person acting on its or their behalf has, directly or indirectly, made any
offers or sales of any security or solicited any offers to buy any security, under circumstances that would cause this offering of the
Securities to be integrated with prior offerings by the Company for purposes of any applicable shareholder approval provisions of any
Trading Market on which any of the securities of the Company are listed or designated.


 


(w)            
Solvency. Based on the consolidated financial condition of the Company as of the Closing Date, after giving effect to the
receipt by the Company of the proceeds from the sale of the Securities hereunder and the receipt of $7,500,000 from the offering and sale
of Series X Convertible Preferred Stock to DaVita, Inc., (i) the fair saleable value of the Company’s assets exceeds the amount
that will be required to be paid on or in respect of the Company’s existing debts and other liabilities (including known contingent
liabilities) as they mature, (ii) the Company’s assets do not constitute unreasonably small capital to carry on its business as
now conducted and as proposed to be conducted including its capital needs taking into account the particular capital requirements of the
business conducted by the Company, consolidated and projected capital requirements and capital availability thereof, and (iii) the current
cash flow of the Company, together with the proceeds the Company would receive, were it to liquidate all of its assets, after taking into
account all anticipated uses of the cash, would be sufficient to pay all amounts on or in respect of its liabilities when such amounts
are required to be paid. The Company does not intend to incur debts beyond its ability to pay such debts as they mature (taking into account
the timing and amounts of cash to be payable on or in respect of its debt). The Company has no knowledge of any facts or circumstances
which lead it to believe that it will file for reorganization or liquidation under the bankruptcy or reorganization laws of any jurisdiction
within one year from the Closing Date. The SEC Reports set forth as of the date hereof all outstanding secured and unsecured Indebtedness
of the Company or any subsidiary, or for which the Company or any subsidiary has commitments. For the purposes of this Agreement, “Indebtedness”
means (x) any liabilities for borrowed money or amounts owed in excess of $50,000 (other than trade accounts payable incurred in the ordinary
course of business), (y) all guaranties, endorsements and other contingent obligations in respect of indebtedness of others, whether or
not the same are or should be reflected in the Company’s consolidated balance sheet (or the notes thereto) or disclosed the SEC
Reports, except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary
course of business; and (z) the present value of any lease payments in excess of $50,000 due under leases required to be capitalized in
accordance with United States generally accepted accounting principles. Neither the Company nor any subsidiary is in default with respect
to any Indebtedness.


 






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(x)               Tax
Status. The Company and its subsidiaries (A) have timely filed all federal, state, local and foreign income and franchise tax
returns required to be filed and (B) are not in default in the payment of any taxes which were payable pursuant to said returns or
any assessments with respect thereto, other than any which the Company or any of its subsidiaries is contesting in good faith;
except those, in each of the cases described in clauses (A) and (B) of this paragraph (x), that would not, singularly or in the
aggregate, have a Material Adverse Effect. There is no pending dispute with any taxing authority relating to any of such returns,
and the Company has no knowledge of any proposed liability for any tax to be imposed upon the properties or assets of the Company
for which there is not an adequate reserve reflected in the Company’s financial statements included in the Registration
Statement, the Prospectus and the Prospectus Supplement.


 


(y)              
Anti-Bribery and Anti-Money Laundering Laws. Each of the Company, its subsidiaries, its affiliates and any of their respective
officers, directors, supervisors, managers, agents, or employees, each in their respective roles with the Company, has not violated, its
participation in the offering will not violate, and the Company and each of its subsidiaries has instituted and maintains policies and
procedures designed to ensure continued compliance with, each of the following laws: anti-bribery laws, including but not limited to,
any applicable law, rule, or regulation of any locality in which the Company does business, including but not limited to any applicable
law, rule, or regulation promulgated to implement the OECD Convention on Combating Bribery of Foreign Public Officials in International
Business Transactions, signed December 17, 1997, including the U.S. Foreign Corrupt Practices Act of 1977 (the “FCPA”),
as amended, the U.K. Bribery Act 2010 (to the extent applicable), or any other applicable law, rule or regulation of similar purposes
and scope, or anti-money laundering laws, including but not limited to, applicable federal, state, international, foreign or other laws,
regulations or government guidance regarding anti-money laundering, including, without limitation, Title 18 US. Code section 1956 and
1957, the Patriot Act, the Bank Secrecy Act, and international anti-money laundering principles or procedures by an intergovernmental
group or organization, such as the Financial Action Task Force on Money Laundering, of which the United States is a member and with which
designation the United States representative to the group or organization continues to concur, all as amended, and any executive order,
directive, or regulation pursuant to the authority of any of the foregoing, or any orders or licenses issued thereunder.


 


(z)              
Acknowledgment Regarding Purchaser’s Purchase of Securities. The Company acknowledges and agrees that the Purchaser
is acting solely in the capacity of an arm’s length purchaser with respect to the Transaction Documents and the transactions contemplated
thereby. The Company further acknowledges that the Purchaser is not acting as a financial advisor or fiduciary of the Company (or in any
similar capacity) with respect to the Transaction Documents and the transactions contemplated thereby and any advice given by the Purchaser
or any of its respective representatives or agents in connection with the Transaction Documents and the transactions contemplated thereby
is merely incidental to the Purchaser’s purchase of the Securities. The Company further represents to the Purchaser that the Company’s
decision to enter into this Agreement and the other Transaction Documents has been based solely on the independent evaluation of the transactions
contemplated hereby by the Company and its representatives.


 






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(aa)           
Acknowledgment Regarding Purchaser’s Trading Activity. Anything in this
Agreement or elsewhere herein to the contrary notwithstanding (except for Sections 3.2(f) and 4.14 hereof), it is understood and
acknowledged by the Company that: (i) the Purchaser has not been asked by the Company to agree, nor has the Purchaser agreed, to desist
from purchasing or selling, long and/or short, securities of the Company, or “derivative” securities based on securities
issued by the Company or to hold the Securities for any specified term; (ii) past or future open market or other transactions by the
Purchaser, specifically including, without limitation, Short Sales or “derivative” transactions, before or after the closing
of this or future private placement transactions, may negatively impact the market price of the Company’s publicly-traded securities;
(iii) the Purchaser, and counter-parties in “derivative” transactions, if any, to which the Purchaser is a party, directly
or indirectly, presently may have a “short” position in the Common Stock, and (iv) the Purchaser shall not be deemed to have
any affiliation with or control over any arm’s length counter-party in any “derivative” transaction. The Company further
understands and acknowledges that (y) the Purchaser may engage in hedging activities at various times during the period that the Securities
are outstanding, and (z) such hedging activities (if any) could reduce the value of the existing stockholders’ equity interests
in the Company at and after the time that the hedging activities are being conducted. The Company acknowledges that such aforementioned
hedging activities do not constitute a breach of any of the Transaction Documents.


 


(bb)          
Regulation M Compliance.  The Company has not, and to its knowledge no one acting on its behalf has, (i) taken, directly
or indirectly, any action designed to cause or to result in the stabilization or manipulation of the price of any security of the Company
to facilitate the sale or resale of any of the Securities, (ii) sold, bid for, purchased, or, paid any compensation for soliciting purchases
of, any of the Securities, or (iii) paid or agreed to pay to any Person any compensation for soliciting another to purchase any other
securities of the Company, other than, in the case of clauses (ii) and (iii), compensation paid to the Company’s placement agent
in connection with the placement of the Securities.


 


(cc)            FDA
and Regulatory Matters. Except as set forth in the Prospectus and the Prospectus Supplement, there is no legal or governmental
proceeding to which the Company or any of its subsidiaries is a party or of which any property or assets of the Company or any of
its subsidiaries or any officer or director of the Company, in their roles as such, or any employee benefit plan sponsored by the
Company, is the subject, including any proceeding before the United States Food and Drug Administration of the U.S. Department of
Health and Human Services (the “FDA”) or comparable federal, state, local or foreign governmental
authorities (it being understood that the interaction between the Company and the FDA and such comparable governmental bodies
relating to the clinical development and product approval process shall not be deemed proceedings for purposes of this
representation), which is required to be described in the Registration Statement, the Prospectus or the Prospectus Supplement or a
document incorporated by reference therein and is not described therein, or which, singularly or in the aggregate, if determined
adversely to the Company or any of its subsidiaries, could reasonably be expected to have a Material Adverse Effect; and to the
Company’s knowledge after reasonable investigation (“Knowledge”), no such proceedings are threatened by
governmental authorities. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations,
orders and decrees governing its business as prescribed by the FDA, or any other federal, state or foreign agencies or bodies
engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly
or in the aggregate, have a Material Adverse Effect. All preclinical and clinical studies conducted by or on behalf of the Company
to support approval for commercialization of the Company’s products have been conducted by the Company, or to the
Company’s Knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and
regulations, except for such failure or failures to be in compliance as could not reasonably be expected to have, singularly or in
the aggregate, a Material Adverse Effect.


 






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The
Company and each of its subsidiaries possess all licenses, certificates, authorizations and permits issued by, and have made all declarations
and filings with, the appropriate local, state, federal or foreign governmental or regulatory agencies or bodies (including, without limitation,
those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar
to those performed by the FDA) that are necessary for the ownership or lease of their respective properties or the conduct of their respective
businesses as described in the Registration Statement, the Prospectus and the Prospectus Supplement (collectively, the “Governmental
Permits”), except where any failures to possess or make the same would not, singularly or in the aggregate, have a Material
Adverse Effect. The Company and its subsidiaries are in compliance with all such Governmental Permits and all such Governmental Permits
are valid and in full force and effect, except where the noncompliance, validity or failure to be in full force and effect would not,
singularly or in the aggregate, have a Material Adverse Effect. Neither the Company nor any subsidiary has received notification of any
revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental Permit and
to the Knowledge of the Company, no event has occurred that allows or results in, or after notice or lapse of time or both would allow
or result in, revocation, modification, suspension, termination or invalidation (or proceedings related thereto) of any such Governmental
Permit and the Company has no reason to believe that any such Governmental Permit will not be renewed, except where such revocation, modification,
suspension, termination, invalidation or nonrenewal would not, singularly or in the aggregate, have a Material Adverse Effect.


 


The
Company and its subsidiaries, and to the Company’s Knowledge, its directors, officers, employees or agents, each in their respective
roles with the Company, are and have been in compliance in all material respects with applicable federal, state, local and foreign health
care regulatory laws, including without limitation, laws related to fraud and abuse, payment transparency, and privacy and security of
protected health information (collectively, “Health Care Laws”). The Company and its subsidiaries have not received
written notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court,
arbitrator or governmental or regulatory authority or third party alleging that the Company, its subsidiaries or its personnel have violated
any applicable Health Care Law, nor, to the Company’s Knowledge, has any such claim, action, suit, proceeding, hearing, enforcement,
investigation, arbitration or other action been threatened, which, individually or in the aggregate, might result in any Material Adverse
Effect.


 






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The
studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the Prospectus and the
Prospectus Supplement (the “Company Studies and Trials”) were and, if still pending, are being conducted in all material
respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific
standards; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the Registration
Statement, the Prospectus and the Prospectus Supplement are accurate in all material respects; the Company has no knowledge of any other
studies or trials not described in the Prospectus and the Prospectus Supplement, the results of which are inconsistent with or call in
question the results described or referred to in the Registration Statement, the Prospectus and the Prospectus Supplement; and the Company
has not received any notices or correspondence from the FDA or any foreign, state or local governmental authority exercising comparable
authority requiring the termination, suspension or material modification of any Company Studies and Trials that termination, suspension
or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are
no reasonable grounds for the same.


 


Except as disclosed
in the Registration Statement, the Prospectus and the Prospectus Supplement, the Company has not granted rights to develop, manufacture,
produce, assemble, distribute, license, market or sell its products or product candidates to any other person and is not bound by any
agreement that affects the exclusive right of the Company to develop, manufacture, produce, assemble, distribute, license, market or sell
its products or product candidates.


 


(dd)          
Stock Option Plans. Except as described in the Registration Statement, the Prospectus and the Prospectus Supplement, there
are no options, warrants, restricted stock units, agreements, contracts or other rights in existence to purchase or acquire from the Company
or any subsidiary of the Company any shares of the capital stock of the Company or any subsidiary of the Company. The description of the
Company’s stock option, stock bonus and other stock plans or arrangements (the “Company Stock Plans”), and the
options (the “Options”) or other rights granted thereunder, set forth in the Registration Statement, the Prospectus
and the Prospectus Supplement accurately and fairly presents the information required to be shown with respect to such plans, arrangements,
options and rights. Each grant of an Option (A) was duly authorized no later than the date on which the grant of such Option was by its
terms to be effective by all necessary corporate action, including, as applicable, approval by the board of directors of the Company (or
a duly constituted and authorized committee thereof) and any required shareholder approval by the necessary number of votes or written
consents, and the award agreement governing such grant (if any) was duly executed and delivered by each party thereto and (B) was
made in accordance with the terms of the applicable Company Stock Plan, and all applicable laws and regulatory rules or requirements,
including all applicable federal securities laws.


 


(ee)            Office
of Foreign Assets Control. Neither the Company nor any subsidiary nor, to the Company’s knowledge, any director, officer,
agent, employee or affiliate of the Company or any subsidiary is currently subject to any U.S. sanctions administered by the Office
of Foreign Assets Control of the U.S. Treasury Department (“OFAC”).


 






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(ff)             
U.S. Real Property Holding Corporation. The Company is not and has never been a U.S. real property holding corporation within
the meaning of Section 897 of the Internal Revenue Code of 1986, as amended, and the Company shall so certify upon a Purchaser’s
request.


 


(gg)          
Bank Holding Company Act. Neither the Company nor any of its subsidiaries or Affiliates is subject to the Bank Holding Company
Act of 1956, as amended (the “BHCA”) and to regulation by the Board of Governors of the Federal Reserve System (the
 “Federal Reserve”). Neither the Company nor any of its subsidiaries or Affiliates owns or controls, directly or indirectly,
five percent (5%) or more of the outstanding shares of any class of voting securities or twenty-five percent (25%) or more of the total
equity of a bank or any entity that is subject to the BHCA and to regulation by the Federal Reserve. Neither the Company nor any of its
subsidiaries or Affiliates exercises a controlling influence over the management or policies of a bank or any entity that is subject to
the BHCA and to regulation by the Federal Reserve.


 


(hh)          
No Disagreements with Accountants and Lawyers.There are no disagreements of any kind presently existing, or reasonably
anticipated by the Company to arise, between the Company and the accountants and lawyers formerly or presently employed by the Company
and the Company is current with respect to any fees owed to its accountants and lawyers which could affect the Company’s ability
to perform any of its obligations under any of the Transaction Documents.


 


3.2             
Representations and Warranties of the Purchaser. The Purchaser hereby represents and warrants as of the date hereof and
as of the Closing Date to the Company as follows (unless as of a specific date therein, in which case they shall be accurate as of such
date):


 


(a)              
Organization; Authority. The Purchaser is either an individual or an entity duly incorporated or formed, validly existing
and in good standing under the laws of the jurisdiction of its incorporation or formation with full right, corporate, partnership, limited
liability company or similar power and authority to enter into and to consummate the transactions contemplated by the Transaction Documents
and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of the Transaction Documents and performance
by the Purchaser of the transactions contemplated by the Transaction Documents have been duly authorized by all necessary corporate, partnership,
limited liability company or similar action, as applicable, on the part of the Purchaser. Each Transaction Document to which it is a party
has been duly executed by the Purchaser, and when delivered by the Purchaser in accordance with the terms hereof, will constitute the
valid and legally binding obligation of the Purchaser, enforceable against it in accordance with its terms, except: (i) as limited by
general equitable principles and applicable bankruptcy, insolvency, reorganization, moratorium and other laws of general application affecting
enforcement of creditors’ rights generally, (ii) as limited by laws relating to the availability of specific performance, injunctive
relief or other equitable remedies and (iii) insofar as indemnification and contribution provisions may be limited by applicable law.


 






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(b)              
 Understandings or Arrangements. The Purchaser is acquiring the Securities as principal for its own account and has no direct
or indirect arrangement or understandings with any other persons to distribute or regarding the distribution of such Securities (this
representation and warranty not limiting the Purchaser’s right to sell the Securities pursuant to the Registration Statement or
otherwise in compliance with applicable federal and state securities laws). The Purchaser is acquiring the Securities hereunder in the
ordinary course of its business.


 


(c)              
Purchaser Status. At the time the Purchaser was offered the Securities, it was, and as of the date hereof it is, and on
each date on which it exercises any Warrants, it will be either: (i) an “accredited investor” as defined in Rule 501(a)(1),
(a)(2), (a)(3), (a)(7) or (a)(8) under the Securities Act or (ii) a “qualified institutional buyer” as defined in Rule 144A(a)
under the Securities Act.


 


(d)              
Experience of the Purchaser. The Purchaser, either alone or together with its representatives, has such knowledge, sophistication
and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment
in the Securities, and has so evaluated the merits and risks of such investment. The Purchaser is able to bear the economic risk of an
investment in the Securities and, at the present time, is able to afford a complete loss of such investment.


 


(e)              
Access to Information. The Purchaser acknowledges that it has had the opportunity to review the Transaction Documents (including
all exhibits and schedules thereto) and the SEC Reports and has been afforded, (i) the opportunity to ask such questions as it has deemed
necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities
and the merits and risks of investing in the Securities; (ii) access to information about the Company and its financial condition, results
of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity
to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary
to make an informed investment decision with respect to the investment. The Purchaser acknowledges and agrees that neither the Placement
Agent nor any Affiliate of the Placement Agent has provided the Purchaser with any information or advice with respect to the Securities
nor is such information or advice necessary or desired. Neither the Placement Agent nor any Affiliate has made or makes any representation
as to the Company or the quality of the Securities and the Placement Agent and any Affiliate may have acquired non-public information
with respect to the Company which the Purchaser agrees need not be provided to it. In connection with the issuance of the Securities to
the Purchaser, neither the Placement Agent nor any of its Affiliates has acted as a financial advisor or fiduciary to the Purchaser.


 


(f)                Certain
Transactions and Confidentiality. Other than consummating the transactions contemplated hereunder, the Purchaser has not, nor
has any Person acting on behalf of or pursuant to any understanding with the Purchaser, directly or indirectly executed any
purchases or sales, including Short Sales, of the securities of the Company during the period commencing as of the time that the
Purchaser first received a term sheet (written or oral) from the Company or any other Person representing the Company setting forth
the material terms of the transactions contemplated hereunder and ending immediately prior to the execution hereof. Other than to
other Persons party to this Agreement or to the Purchaser’s representatives, including, without limitation, its officers,
directors, partners, legal and other advisors, employees, agents and Affiliates, the Purchaser has maintained the confidentiality of
all disclosures made to it in connection with this transaction (including the existence and terms of this transaction).
Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute a representation or warranty,
or preclude any actions, with respect to locating or borrowing shares in order to effect Short Sales or similar transactions in the
future.


 






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The Company acknowledges and
agrees that the representations contained in this Section 3.2 shall not modify, amend or affect the Purchaser’s right to rely on
the Company’s representations and warranties contained in this Agreement or any representations and warranties contained in any
other Transaction Document or any other document or instrument executed and/or delivered in connection with this Agreement or the consummation
of the transactions contemplated hereby. Notwithstanding the foregoing, for the avoidance of doubt, nothing contained herein shall constitute
a representation or warranty, or preclude any actions, with respect to locating or borrowing shares in order to effect Short Sales or
similar transactions in the future.


 


ARTICLE IV.

OTHER AGREEMENTS OF THE PARTIES


 


4.1 
           Warrant Shares. If all or any portion of a Pre-Funded Warrant is exercised at a time when there is an effective registration
statement to cover the issuance or resale of the Warrant Shares or if the Pre-Funded Warrant is exercised via cashless exercise, the Warrant
Shares issued pursuant to any such exercise shall be issued free of all legends. If at any time following the date hereof the Registration
Statement (or any subsequent registration statement registering the sale or resale of the Warrant Shares) is not effective or is not otherwise
available for the sale or resale of the Warrant Shares, the Company shall immediately notify the holders of the Pre-Funded Warrants in
writing that such registration statement is not then effective and thereafter shall promptly notify such holders when the registration
statement is effective again and available for the sale or resale of the Warrant Shares (it being understood and agreed that the foregoing
shall not limit the ability of the Company to issue, or the Purchaser to sell, any of the Warrant Shares in compliance with applicable
federal and state securities laws). The Company shall use reasonable best efforts to keep a registration statement (including the Registration
Statement) registering the issuance of the Warrant Shares effective during the term of the Pre-Funded Warrants.


 


4.2             
Furnishing of Information. Until the earlier of the time that (i) the Purchaser owns no Securities and (ii) the Pre-Funded
Warrants have been exercised in full or expired, the Company covenants to timely file (or obtain extensions in respect thereof and file
within the applicable grace period) all reports required to be filed by the Company after the date hereof pursuant to the Exchange Act
even if the Company is not then subject to the reporting requirements of the Exchange Act.


 


4.3              Integration.
The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in
Section 2 of the Securities Act) that would be integrated with the offer or sale of the Securities for purposes of the rules and
regulations of any Trading Market such that it would require shareholder approval prior to the closing of such other transaction
unless shareholder approval is obtained before the closing of such subsequent transaction.


 






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4.4             
Securities Laws Disclosure; Publicity. The Company shall (a) by the Disclosure Time, issue a press release disclosing the
material terms of the transactions contemplated hereby, and (b) file a Current Report on Form 8-K, including the Transaction Documents
as exhibits thereto, with the Commission within the time required by the Exchange Act. From and after the issuance of such press release,
the Company represents to the Purchaser that it shall have publicly disclosed all material, non-public information delivered to the Purchaser
by the Company or any of its subsidiaries, or any of their respective officers, directors, employees or agents in connection with the
transactions contemplated by the Transaction Documents. The Company covenants and agrees that neither it, nor any other Person acting
on its behalf will provide the Purchaser or its respective agents or counsel with any information that constitutes, or the Company reasonably
believes constitutes, material non-public information, unless prior thereto the Purchaser shall have consented to the receipt of such
information and agreed with the Company to keep such information confidential. The Company understands and confirms that the Purchaser
shall be relying on the foregoing covenant in effecting transactions in securities of the Company. In addition, effective upon the issuance
of such press release, the Company acknowledges and agrees that any and all confidentiality or similar obligations under any agreement,
whether written or oral, between the Company, any of its subsidiaries or any of their respective officers, directors, agents, employees
or Affiliates on the one hand, and the Purchaser or any of its Affiliates on the other hand, shall terminate. The Company and the Purchaser
shall consult with each other in issuing any other press releases with respect to the transactions contemplated hereby, and neither the
Company nor the Purchaser shall issue any such press release nor otherwise make any such public statement without the prior consent of
the Company, with respect to any press release of the Purchaser, or without the prior consent of the Purchaser, with respect to any press
release of the Company, which consent shall not unreasonably be withheld or delayed, except if such disclosure is required by law, in
which case the disclosing party shall promptly provide the other party with prior notice of such public statement or communication. Notwithstanding
the foregoing, the Company shall not publicly disclose the name of the Purchaser, or include the name of the Purchaser in any filing with
the Commission or any regulatory agency or Trading Market, without the prior written consent of the Purchaser, except (a) as required
by federal securities law in connection with the filing of final Transaction Documents with the Commission and (b) to the extent such
disclosure is required by law or Trading Market regulations, in which case the Company shall provide the Purchaser with prior notice of
such disclosure permitted under this clause (b).


 


4.5             
Shareholder Rights Plan. No claim will be made or enforced by the Company or, with the consent of the Company, any other
Person, that the Purchaser is an “Acquiring Person” under any control share acquisition, business combination, poison
pill (including any distribution under a rights agreement) or similar anti-takeover plan or arrangement in effect or hereafter adopted
by the Company, or that the Purchaser could be deemed to trigger the provisions of any such plan or arrangement, by virtue of receiving
Securities under the Transaction Documents or under any other agreement between the Company and the Purchaser.


 






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4.6             
 Non-Public Information. Except with respect to the material terms and conditions of the transactions contemplated by the
Transaction Documents, which shall be disclosed pursuant to Section 4.4, the Company covenants and agrees that neither it, nor any other
Person acting on its behalf will provide the Purchaser or its agents or counsel with any information that constitutes, or the Company
reasonably believes constitutes, material non-public information, unless prior thereto the Purchaser shall have consented to the receipt
of such information and agreed with the Company to keep such information confidential. The Company understands and confirms that the Purchaser
shall be relying on the foregoing covenant in effecting transactions in securities of the Company. To the extent that the Company delivers
any material, non-public information to the Purchaser without the Purchaser’s consent, the Company hereby covenants and agrees that
the Purchaser shall not have any duty of confidentiality to the Company, any of its subsidiaries, or any of their respective officers,
directors, agents, employees or Affiliates, or a duty to the Company, any of its subsidiaries or any of their respective officers, directors,
agents, employees or Affiliates not to trade on the basis of, such material, non-public information, provided that the Purchaser shall
remain subject to applicable law. To the extent that any notice provided pursuant to any Transaction Document constitutes, or contains,
material, non-public information regarding the Company or any subsidiaries, the Company shall simultaneously file such notice with the
Commission pursuant to a Current Report on Form 8-K. The Company understands and confirms that the Purchaser shall be relying on the foregoing
covenant in effecting transactions in securities of the Company.


 


4.7             
Use of Proceeds. The Company will apply the net proceeds from the sale of the Securities to be sold by it hereunder for
the purposes set forth in the Prospectus Supplement and shall not use such proceeds: (a) for the satisfaction of any portion of the Company’s
debt (other than payment of trade payables in the ordinary course of the Company’s business and prior practices, as well as scheduled
principal and interest payments), (b) for the redemption of any Common Stock or Common Stock Equivalents, (c) for the settlement of any
outstanding litigation or (d) in violation of FCPA or OFAC regulations.


 


4.8              Indemnification
of the Purchaser. Subject to the provisions of this Section 4.8, the Company will indemnify and hold the Purchaser and its
directors, officers, shareholders, members, partners, employees and agents (and any other Persons with a functionally equivalent
role of a Person holding such titles notwithstanding a lack of such title or any other title), each Person who controls the
Purchaser (within the meaning of Section 15 of the Securities Act and Section 20 of the Exchange Act), and the directors, officers,
shareholders, agents, members, partners or employees (and any other Persons with a functionally equivalent role of a Person holding
such titles notwithstanding a lack of such title or any other title) of such controlling persons (each, a “Purchaser
Party”) harmless from any and all losses, liabilities, obligations, claims, contingencies, damages, costs and expenses,
including all judgments, amounts paid in settlements, court costs and reasonable attorneys’ fees and costs of investigation
that any such Purchaser Party may suffer or incur as a result of or relating to (a) any material breach of any of the
representations, warranties, covenants or agreements made by the Company in this Agreement or in the other Transaction Documents or
(b) any action instituted against the Purchaser Parties, or any of them or their respective Affiliates, by any stockholder of the
Company who is not an Affiliate of such Purchaser Party, with respect to any of the transactions contemplated by the Transaction
Documents (unless such action is solely based upon a material breach of such Purchaser Party’s representations, warranties or
covenants under the Transaction Documents or any agreements or understandings such Purchaser Party may have with any such
stockholder or any violations by such Purchaser Party of state or federal securities laws or any conduct by such Purchaser Party
which is finally judicially determined to constitute fraud, gross negligence or willful misconduct). If any action shall be brought
against any Purchaser Party in respect of which indemnity may be sought pursuant to this Agreement, such Purchaser Party shall
promptly notify the Company in writing, and the Company shall have the right to assume the defense thereof with counsel of its own
choosing reasonably acceptable to the Purchaser Party. Any Purchaser Party shall have the right to employ separate counsel in any
such action and participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such
Purchaser Party except to the extent that (x) the employment thereof has been specifically authorized by the Company in writing, (y)
the Company has failed after a reasonable period of time to assume such defense and to employ counsel or (z) in such action there
is, in the reasonable opinion of counsel, a material conflict on any material issue between the position of the Company and the
position of such Purchaser Party, in which case the Company shall be responsible for the reasonable fees and expenses of no more
than one such separate counsel. The Company will not be liable to any Purchaser Party under this Agreement (1) for any settlement by
a Purchaser Party effected without the Company’s prior written consent, which shall not be unreasonably withheld or delayed;
or (2) to the extent, but only to the extent that a loss, claim, damage or liability is attributable to any Purchaser Party’s
breach of any of the representations, warranties, covenants or agreements made by such Purchaser Party in this Agreement or in the
other Transaction Documents. The indemnification required by this Section 4.8 shall be made by periodic payments of the amount
thereof during the course of the investigation or defense, as and when bills are received or are incurred. The indemnity agreements
contained herein shall be in addition to any cause of action or similar right of any Purchaser Party against the Company or others
and any liabilities the Company may be subject to pursuant to law.


 






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4.9             
Reservation of Common Stock. As of the date hereof, the Company has reserved and the Company shall continue to reserve and
keep available at all times, free of preemptive rights, a sufficient number of shares of Common Stock for the purpose of enabling the
Company to issue Shares pursuant to this Agreement and the Warrant Shares pursuant to any exercise of the Pre-Funded Warrants.


 


4.10          Listing
of Common Stock. The Company hereby agrees to use reasonable best efforts to maintain the listing or quotation of the Common
Stock on the Trading Market on which it is currently listed, and concurrently with the Closing, the Company shall apply to list or
quote all of the Shares and Warrant Shares on such Trading Market and promptly secure the listing of all of the Shares and Warrant
Shares on such Trading Market. The Company further agrees, if the Company applies to have the Common Stock traded on any other
Trading Market, it will then include in such application all of the Shares and Warrant Shares, and will take such other action as is
necessary to cause all of the Shares and Warrant Shares to be listed or quoted on such other Trading Market as promptly as possible.
The Company will then take all action reasonably necessary to continue the listing and trading of its Common Stock on a Trading
Market and will comply in all respects with the Company’s reporting, filing and other obligations under the bylaws or rules of
the Trading Market. The Company agrees to maintain the eligibility of the Common Stock for electronic transfer through the
Depository Trust Company or another established clearing corporation, including, without limitation, by timely payment of fees to
the Depository Trust Company or such other established clearing corporation in connection with such electronic transfer.


 






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4.11         
Reserved.


 


4.12         
Subsequent Equity Sales.


 


(a)              
From the date hereof until ninety (90) days after the Closing, neither the Company nor any subsidiary shall (i) issue, enter into
any agreement to issue, or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents, but excluding
(x) the issuance of up to 7,500 shares of Series X Convertible Preferred Stock to DaVita, Inc., and (y) the offering and sale of Pre-Funded
Warrants and Common Stock Warrants in a concurrent private placement involving the Purchaser, or (ii) file or amend any registration statement
or prospectus, other than as necessary to maintain the registration of the Securities governed by this Agreement or pursuant to the Registration
Rights Agreement entered into as of the date hereof with the Purchaser.


 


(b)              
From the date hereof until the one (1) year anniversary of the Closing, the Company shall be prohibited from effecting or entering
into an agreement to effect any issuance by the Company or any of its Subsidiaries of Common Stock or Common Stock Equivalents (or a combination
of units thereof) involving a Variable Rate Transaction. “Variable Rate Transaction” means a transaction in which the
Company (i) issues or sells any debt or equity securities that are convertible into, exchangeable or exercisable for, or include the right
to receive additional shares of Common Stock either (A) at a conversion price, exercise price or exchange rate or other price that is
based upon and/or varies with the trading prices of or quotations for the shares of Common Stock at any time after the initial issuance
of such debt or equity securities, or (B) with a conversion, exercise or exchange price that is subject to being reset at some future
date after the initial issuance of such debt or equity security or upon the occurrence of specified or contingent events directly or indirectly
related to the business of the Company or the market for the Common Stock or (ii) enters into, or effects a transaction under, any agreement,
including, but not limited to, an equity line of credit, whereby the Company may issue securities at a future determined price. Any Purchaser
shall be entitled to obtain injunctive relief against the Company to preclude any such issuance, which remedy shall be in addition to
any right to collect damages.


 


(c)              
Notwithstanding the foregoing, this Section 4.12 shall not apply in respect of an Exempt Issuance, except that no Variable Rate
Transaction shall be an Exempt Issuance, and provided, further, that the Company shall be permitted to make offerings and sales of Common
Stock under an at-the-market offering facility commencing January 1, 2023.


 


4.13         
Reserved.


 






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4.14          Certain
Transactions and Confidentiality. The Purchaser covenants that neither it nor any Affiliate acting on its behalf or pursuant to
any understanding with it will execute any purchases or sales, including Short Sales of any of the Company’s securities during
the period commencing with the execution of this Agreement and ending at such time that the transactions contemplated by this
Agreement are first publicly announced pursuant to the initial press release as described in Section 4.4. The Purchaser covenants
that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company pursuant to the
initial press release as described in Section 4.4, the Purchaser will maintain the confidentiality of the existence and terms of
this transaction and the information included in the Disclosure Schedules. Notwithstanding the foregoing, and notwithstanding
anything contained in this Agreement to the contrary, the Company expressly acknowledges and agrees that (i) the Purchaser makes no
representation, warranty or covenant hereby that it will not engage in effecting transactions in any securities of the Company after
the time that the transactions contemplated by this Agreement are first publicly announced pursuant to the initial press release as
described in Section 4.4, (ii) the Purchaser shall not be restricted or prohibited from effecting any transactions in any securities
of the Company in accordance with applicable securities laws from and after the time that the transactions contemplated by this
Agreement are first publicly announced pursuant to the initial press release as described in Section 4.4, and (iii) the Purchaser
shall not have any duty of confidentiality or duty not to trade in the securities of the Company to the Company or its subsidiaries
after the issuance of the initial press release as described in Section 4.4.


 


4.15         
Capital Changes. Until the one-year anniversary of the Closing Date, the Company shall not undertake a reverse or forward
stock split or reclassification of the Common Stock without the prior written consent of the Purchaser, provided that no such consent
shall be required for a reverse stock split that is being implemented to satisfy applicable Nasdaq Stock Market listing requirements.


 


4.16         
Exercise Procedures. The form of Notice of Exercise included in the Pre-Funded Warrants set forth the totality of the procedures
required of the Purchaser in order to exercise the Pre-Funded Warrants. No additional legal opinion, other information or instructions
shall be required of the Purchaser to exercise its Pre-Funded Warrants. Without limiting the preceding sentences, no ink-original Notice
of Exercise shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Exercise
form be required in order to exercise the Pre-Funded Warrants. The Company shall honor exercises of the Pre-Funded Warrants and shall
deliver Warrant Shares in accordance with the terms, conditions and time periods set forth in the Transaction Documents.


 


ARTICLE V.

MISCELLANEOUS


 


5.1             
Termination.  This Agreement may be terminated by the Purchaser by written notice to the Company, if the Closing has
not been consummated on or before the fifth (5th) Trading Day following the date hereof; provided, however, that no such termination will
affect the right of any party to sue for any breach by any other party (or parties).


 


5.2              Fees
and Expenses. Except as expressly set forth in the Transaction Documents to the contrary, each party shall pay the fees and
expenses of its advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party incident to
the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all Transfer Agent fees
(including, without limitation, any fees required for same-day processing of any instruction letter delivered by the Company and any
exercise notice delivered by the Purchaser), stamp taxes and other taxes and duties levied in connection with the delivery of any
Securities to the Purchaser.


 






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5.3             
Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, the Prospectus and the Prospectus
Supplement, contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior
agreements and understandings, oral or written, with respect to such matters, which the parties acknowledge have been merged into such
documents, exhibits and schedules.


 


5.4             
Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall
be in writing and shall be deemed given and effective on the earliest of: (a) the time of transmission, if such notice or communication
is delivered via email at the email address as set forth on the signature pages attached hereto at or prior to 5:30 p.m. (New York City
time) on a Trading Day, (b) the next Trading Day after the time of transmission, if such notice or communication is delivered via email
at the email address as set forth on the signature pages attached hereto on a day that is not a Trading Day or later than 5:30 p.m. (New
York City time) on any Trading Day, (c) the second (2nd)Trading Day following the date of mailing, if sent by U.S. nationally
recognized overnight courier service or (d) upon actual receipt by the party to whom such notice is required to be given. The address
for such notices and communications shall be as set forth on the signature pages attached hereto. To the extent that any notice provided
pursuant to any Transaction Document constitutes, or contains, material, non-public information regarding the Company or any subsidiaries,
the Company shall simultaneously file such notice with the Commission pursuant to a Current Report on Form 8-K.


 


5.5             
Amendments; Waivers. No provision of this Agreement may be waived, modified, supplemented or amended except in a written
instrument signed, in the case of an amendment, by the Company and the Purchaser. No waiver of any default with respect to any provision,
condition or requirement of this Agreement shall be deemed to be a continuing waiver in the future or a waiver of any subsequent default
or a waiver of any other provision, condition or requirement hereof, nor shall any delay or omission of any party to exercise any right
hereunder in any manner impair the exercise of any such right.


 


5.6             
Headings. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed
to limit or affect any of the provisions hereof.


 


5.7             
Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors
and permitted assigns. The Company may not assign this Agreement or any rights or obligations hereunder without the prior written consent
of the Purchaser (other than by merger). The Purchaser may assign any or all of its rights under this Agreement to any Person to whom
the Purchaser assigns or transfers any Securities, provided that such transferee agrees in writing to be bound, with respect to the transferred
Securities, by the provisions of the Transaction Documents that apply to the “Purchaser.”


 


5.8              No
Third-Party Beneficiaries. The Placement Agent shall be the third-party beneficiary of the representations and warranties of the
Company in Section 3.1 and the representations and warranties of the Purchaser in Section 3.2. This Agreement is intended for the
benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any
provision hereof be enforced by, any other Person, except as otherwise set forth in Section 4.8 and this Section 5.8.


 






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5.9             
Governing Law. All questions concerning the construction, validity, enforcement and interpretation of the Transaction Documents
shall be governed by and construed and enforced in accordance with the internal laws of the State of New York, without regard to the principles
of conflicts of law thereof. Each party agrees that all legal Proceedings concerning the interpretations, enforcement and defense of the
transactions contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective
affiliates, directors, officers, shareholders, partners, members, employees or agents) shall be commenced exclusively in the state and
federal courts sitting in the City of New York. Each party hereby irrevocably submits to the exclusive jurisdiction of the state and federal
courts sitting in the City of New York, Borough of Manhattan for the adjudication of any dispute hereunder or in connection herewith or
with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents),
and hereby irrevocably waives, and agrees not to assert in any Action or Proceeding, any claim that it is not personally subject to the
jurisdiction of any such court, that such Action or Proceeding is improper or is an inconvenient venue for such Proceeding. Each party
hereby irrevocably waives personal service of process and consents to process being served in any such Action or Proceeding by mailing
a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect
for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice
thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any other manner permitted by law.
If any party shall commence an Action or Proceeding to enforce any provisions of the Transaction Documents, then, in addition to the obligations
of the Company under Section 4.8, the prevailing party in such Action or Proceeding shall be reimbursed by the non-prevailing party for
its reasonable attorneys’ fees and other costs and expenses incurred with the investigation, preparation and prosecution of such
Action or Proceeding.


 


5.10         
Survival. The representations and warranties contained herein shall survive the Closing and the delivery of the Securities.


 


5.11         
Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered
one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to each other party,
it being understood that the parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission
or by e-mail delivery of a “.pdf” format data file, such signature shall create a valid and binding obligation of the party
executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature
page were an original thereof.


 






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5.12          Severability.
If any term, provision, covenant or restriction of this Agreement is held by a court of competent jurisdiction to be invalid,
illegal, void or unenforceable, the remainder of the terms, provisions, covenants and restrictions set forth herein shall remain in
full force and effect and shall in no way be affected, impaired or invalidated, and the parties hereto shall use their commercially
reasonable efforts to find and employ an alternative means to achieve the same or substantially the same result as that contemplated
by such term, provision, covenant or restriction. It is hereby stipulated and declared to be the intention of the parties that they
would have executed the remaining terms, provisions, covenants and restrictions without including any of such that may be hereafter
declared invalid, illegal, void or unenforceable.


 


5.13         
Rescission and Withdrawal Right. Notwithstanding anything to the contrary contained in (and without limiting any similar
provisions of) any of the other Transaction Documents, whenever the Purchaser exercises a right, election, demand or option under a Transaction
Document and the Company does not timely perform its related obligations within the periods therein provided, then the Purchaser may rescind
or withdraw, in its sole discretion from time to time upon written notice to the Company, any relevant notice, demand or election in whole
or in part without prejudice to its future actions and rights; provided, however, that in the case of a rescission of an exercise of a
Pre-Funded Warrant, the Purchaser shall be required to return any shares of Common Stock subject to any such rescinded exercise notice
concurrently with the return to the Purchaser of the aggregate exercise price paid to the Company for such shares and the restoration
of the Purchaser’s right to acquire such shares pursuant to the Purchaser’s Pre-Funded Warrant (including, issuance of a replacement
warrant certificate evidencing such restored right).


 


5.14         
Replacement of Securities. If any certificate or instrument evidencing any Securities is mutilated, lost, stolen or destroyed,
the Company shall issue or cause to be issued in exchange and substitution for and upon cancellation thereof (in the case of mutilation),
or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to
the Company of such loss, theft or destruction. The applicant for a new certificate or instrument under such circumstances shall also
pay any reasonable third-party costs (including customary indemnity) associated with the issuance of such replacement Securities.


 


5.15         
Remedies. In addition to being entitled to exercise all rights provided herein or granted by law, including recovery of
damages, the Purchaser and the Company will be entitled to specific performance under the Transaction Documents. The parties agree that
monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations contained in the Transaction
Documents and hereby agree to waive and not to assert in any Action for specific performance of any such obligation the defense that a
remedy at law would be adequate.


 


5.16          Payment
Set Aside. To the extent that the Company makes a payment or payments to the Purchaser pursuant to any Transaction Document or
the Purchaser enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement or
exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from,
disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other Person
under any law (including, without limitation, any bankruptcy law, state or federal law, common law or equitable cause of action),
then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived and
continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.


 






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5.17         
Liquidated Damages. The Company’s obligations to pay any partial liquidated damages or other amounts owing under the
Transaction Documents is a continuing obligation of the Company and shall not terminate until all unpaid partial liquidated damages and
other amounts have been paid notwithstanding the fact that the instrument or security pursuant to which such partial liquidated damages
or other amounts are due and payable shall have been canceled.


 


5.18         
Saturdays, Sundays, Holidays, etc.If the last or appointed day for the taking of any action or the expiration of any
right required or granted herein shall not be a Business Day, then such action may be taken or such right may be exercised on the next
succeeding Business Day.


 


5.19         
Construction. The parties agree that each of them and/or their respective counsel have reviewed and had an opportunity to
revise the Transaction Documents and, therefore, the normal rule of construction to the effect that any ambiguities are to be resolved
against the drafting party shall not be employed in the interpretation of the Transaction Documents or any amendments thereto. In addition,
each and every reference to share prices and shares of Common Stock in any Transaction Document shall be subject to adjustment for reverse
and forward stock splits, stock dividends, stock combinations and other similar transactions of the Common Stock that occur after the
date of this Agreement.


 


5.20         
WAIVER OF JURY TRIAL.  IN ANY ACTION, SUIT, OR PROCEEDING IN ANY JURISDICTION BROUGHT BY ANY PARTY AGAINST ANY OTHER
PARTY, THE PARTIES EACH KNOWINGLY AND INTENTIONALLY, TO THE GREATEST EXTENT PERMITTED BY APPLICABLE LAW, HEREBY ABSOLUTELY, UNCONDITIONALLY,
IRREVOCABLY AND EXPRESSLY WAIVES FOREVER TRIAL BY JURY. 


 


(Signature Pages Follow)


 






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IN WITNESS WHEREOF, the
parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the
date first indicated above.


 


	rockwell medical, inc.	 
	 	 
	By:	/s/ Russell Skibsted	 
	 	Name: Russell Skibsted	 
	 	Title: Chief Financial Officer	 





 


[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK


SIGNATURE PAGE FOR PURCHASER FOLLOWS]


 






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[PURCHASER SIGNATURE PAGES TO RMTI SECURITIES PURCHASE
AGREEMENT]


 


IN WITNESS WHEREOF, the undersigned
have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated
above.


 


Name of Purchaser: Armistice Capital Master Fund Ltd.


 


	Signature of Authorized Signatory of Purchaser:  	/s/ Steven Boyd




 


Name of Authorized Signatory: Steven Boyd


 


Title of Authorized Signatory: CIO of Armistice Capital, LLC, the Investment
Manager


 


Subscription Amount: $12,000,000


 


Shares: 844,613


 


Pre-Funded Warrant Shares: 7,788,480
         Beneficial Ownership Blocker   ̈
4.99% or x  
9.99%


 


x 
Notwithstanding anything contained in this Agreement to the contrary, by checking this box (i) the obligations of the above-signed
to purchase the securities set forth in this Agreement to be purchased from the Company by the above-signed, and the obligations of
the Company to sell such securities to the above-signed, shall be unconditional and all conditions to Closing shall be disregarded,
(ii) the Closing shall occur by the second (2nd) Trading Day following the date of this Agreement and (iii) any condition to Closing
contemplated by this Agreement (but prior to being disregarded by clause (i) above) that required delivery by the Company or the
above-signed of any agreement, instrument, certificate or the like or purchase price (as applicable) shall no longer be a condition
and shall instead be an unconditional obligation of the Company or the above-signed (as applicable) to deliver such agreement,
instrument, certificate or the like or purchase price (as applicable) to such other party on the Closing Date.


 






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