exhibit101atmagreementju






  Exhibit 10.1  AT THE MARKET OFFERING AGREEMENT    June 4, 2021    H.C. Wainwright & Co., LLC  430 Park Avenue  New York, NY 10022    Ladies and Gentlemen:           Caladrius Biosciences, Inc., a corporation organized under the laws of Delaware  (the “Company”), confirms its agreement (this “Agreement”) with H.C. Wainwright &  Co., LLC (the “Manager”) as follows:    1. Definitions. The terms that follow, when used in this Agreement and any  Terms Agreement, shall have the meanings indicated.    “Accountants” shall have the meaning ascribed to such term in Section  4(m).    “Act” shall mean the Securities Act of 1933, as amended, and the rules  and regulations of the Commission promulgated thereunder.     “Action” shall have the meaning ascribed to such term in Section 3(p).    “Affiliate” shall have the meaning ascribed to such term in Section 3(o).    “Applicable Time” shall mean, with respect to any Shares, the time of sale  of such Shares pursuant to this Agreement or any relevant Terms Agreement.      “Base Prospectus” shall mean the base prospectus contained in the  Registration Statement at the Execution Time.     “Board” shall have the meaning ascribed to such term in Section 2(b)(iii).     “Broker Fee” shall have the meaning ascribed to such term in Section  2(b)(v).    “Business Day” shall mean any day other than Saturday, Sunday or other  day on which commercial banks in The City of New York are authorized or  required by law to remain closed; provided, however, that, for purposes of clarity,  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  





 






 2  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.     “Commission” shall mean the United States Securities and Exchange  Commission.    “Common Stock” shall have the meaning ascribed to such term in Section  2.    “Common Stock Equivalents” shall have the meaning ascribed to such  term in Section 3(g).    “Company Counsel” shall have the meaning ascribed to such term in  Section 4(l).    “DTC” shall have the meaning ascribed to such term in Section 2(b)(vii).    “Effective Date” shall mean each date and time that the Registration  Statement and any post-effective amendment or amendments thereto became or  becomes effective.    “Exchange Act” shall mean the Securities Exchange Act of 1934, as  amended, and the rules and regulations of the Commission promulgated  thereunder.     “Execution Time” shall mean the date and time that this Agreement is  executed and delivered by the parties hereto.     “Free Writing Prospectus” shall mean a free writing prospectus, as defined  in Rule 405.     “GAAP” shall have the meaning ascribed to such term in Section 3(n).    “Incorporated Documents” shall mean the documents or portions thereof  filed with the Commission on or prior to the Effective Date that are incorporated  by reference in the Registration Statement or the Prospectus and any documents  or portions thereof filed with the Commission after the Effective Date that are  deemed to be incorporated by reference in the Registration Statement or the  Prospectus.    “Intellectual Property Rights” shall have the meaning ascribed to such  term in Section 3(v).    





 






 3  “Issuer Free Writing Prospectus” shall mean an issuer free writing  prospectus, as defined in Rule 433.    “Losses” shall have the meaning ascribed to such term in Section 7(d).    “Material Adverse Effect” shall have the meaning ascribed to such term in  Section 3(b).    “Material Permits” shall have the meaning ascribed to such term in  Section 3(t).    “Maximum Amount” shall have the meaning ascribed to such term in  Section 2.    “Net Proceeds” shall have the meaning ascribed to such term in Section  2(b)(v).    “Permitted Free Writing Prospectus” shall have the meaning ascribed to  such term in Section 4(g).    “Placement” shall have the meaning ascribed to such term in Section 2(c).    “Proceeding” shall have the meaning ascribed to such term in Section  3(b).    “Prospectus” shall mean the Base Prospectus, as supplemented by the  most recently filed Prospectus Supplement (if any).    “Prospectus Supplement” shall mean each prospectus supplement relating  to the Shares prepared and filed pursuant to Rule 424(b) from time to time.    “Registration Statement” shall mean the shelf registration statement (File  Number 333-254971) on Form S-3, including exhibits and financial statements  and any prospectus supplement relating to the Shares that is filed with the  Commission pursuant to Rule 424(b) and deemed part of such registration  statement pursuant to Rule 430B, as amended on each Effective Date and, in the  event any post-effective amendment thereto becomes effective, shall also mean  such registration statement as so amended.    “Representation Date” shall have the meaning ascribed to such term in  Section 4(k).    “Required Approvals” shall have the meaning ascribed to such term in  Section 3(e).    





 






 4  “Rule 158”, “Rule 164”, “Rule 172”, “Rule 173”, “Rule 405”, “Rule 415”,  “Rule 424”, “Rule 430B” and “Rule 433” refer to such rules under the Act.      “Sales Notice” shall have the meaning ascribed to such term in Section  2(b)(i).    “SEC Reports” shall have the meaning ascribed to such term in Section  3(m).    “Settlement Date” shall have the meaning ascribed to such term in Section  2(b)(vii).    “Subsidiary” shall have the meaning ascribed to such term in Section 3(a).    “Terms Agreement” shall have the meaning ascribed to such term in  Section 2(a).    “Time of Delivery” shall have the meaning ascribed to such term in  Section 2(c).    “Trading Day” means a day on which the Trading Market is open for  trading.    “Trading Market” means the Nasdaq Capital Market.    2. Sale and Delivery of Shares. The Company proposes to issue and sell  through or to the Manager, as sales agent and/or principal, from time to time during the  term of this Agreement and on the terms set forth herein, up to the lesser of such number  of shares (the “Shares”) of the Company’s common stock, $0.001 par value per share  (“Common Stock”), that does not exceed (a) the number or dollar amount of shares of  Common Stock registered on the Registration Statement, pursuant to which the offering  is being made, (b) the number of authorized but unissued shares of Common Stock (less  the number of shares of Common Stock issuable upon exercise, conversion or exchange  of any outstanding securities of the Company or otherwise reserved from the Company’s  authorized capital stock), or (c) the number or dollar amount of shares of Common Stock  that would cause the Company or the offering of the Shares to not satisfy the eligibility  and transaction requirements for use of Form S-3, including, if applicable, General  Instruction I.B.6 of Registration Statement on Form S-3 (the lesser of (a), (b) and (c), the  “Maximum Amount”).  Notwithstanding anything to the contrary contained herein, the  parties hereto agree that compliance with the limitations set forth in this Section 2 on the  number and aggregate sales price of Shares issued and sold under this Agreement shall be  the sole responsibility of the Company and that the Manager shall have no obligation in  connection with such compliance.    (a) Appointment of Manager as Selling Agent; Terms Agreement.  For  purposes of selling the Shares through the Manager, the Company hereby  





 






 5  appoints the Manager as exclusive agent of the Company for the purpose of  selling the Shares of the Company pursuant to this Agreement and the Manager  agrees to use its commercially reasonable efforts to sell the Shares on the terms  and subject to the conditions stated herein. The Company agrees that, whenever it  determines to sell the Shares directly to the Manager as principal, it will enter into  a separate agreement (each, a “Terms Agreement”) in substantially the form of  Annex I hereto, relating to such sale in accordance with Section 2 of this  Agreement.    (b) Agent Sales.  Subject to the terms and conditions and in reliance  upon the representations and warranties herein set forth, the Company will issue  and agrees to sell Shares from time to time through the Manager, acting as sales  agent, and the Manager agrees to use its commercially reasonable efforts to sell,  as sales agent for the Company, on the following terms:     (i) The Shares are to be sold on a daily basis or otherwise as  shall be agreed to by the Company and the Manager on any day that (A) is  a Trading Day, (B) the Company has instructed the Manager by telephone  (confirmed promptly by electronic mail) to make such sales (“Sales  Notice”) and (C) the Company has satisfied its obligations under Section 6  of this Agreement.  The Company will designate the maximum amount of  the Shares to be sold by the Manager daily (subject to the limitations set  forth in Section 2(d)) and the minimum price per Share at which such  Shares may be sold.  Subject to the terms and conditions hereof, the  Manager shall use its commercially reasonable efforts to sell on a  particular day all of the Shares designated for the sale by the Company on  such day. The gross sales price of the Shares sold under this Section 2(b)  shall be the market price for the shares of Common Stock sold by the  Manager under this Section 2(b) on the Trading Market at the time of sale  of such Shares.    (ii) The Company acknowledges and agrees that (A) there can  be no assurance that the Manager will be successful in selling the Shares,  (B) the Manager will incur no liability or obligation to the Company or  any other person or entity if it does not sell the Shares for any reason other  than a failure by the Manager to use its commercially reasonable efforts  consistent with its normal trading and sales practices and applicable law  and regulations to sell such Shares as required under this Agreement, and  (C) the Manager shall be under no obligation to purchase Shares on a  principal basis pursuant to this Agreement, except as otherwise  specifically agreed by the Manager and the Company pursuant to a Terms  Agreement.    (iii) The Company shall not authorize the issuance and sale of,  and the Manager shall not be obligated to use its commercially reasonable  efforts to sell, any Share at a price lower than the minimum price therefor  





 






 6  designated from time to time by the Company’s Board of Directors (the  “Board”), or a duly authorized committee thereof, or such duly authorized  officers of the Company, and notified to the Manager in writing. The  Company or the Manager may, upon notice to the other party hereto by  telephone (confirmed promptly by electronic mail), suspend the offering  of the Shares for any reason and at any time; provided, however, that such  suspension or termination shall not affect or impair the parties’ respective  obligations with respect to the Shares sold hereunder prior to the giving of  such notice.    (iv) The Manager may sell Shares by any method permitted by  law deemed to be an “at the market offering” as defined in Rule 415 under  the Act, including without limitation sales made directly on the Trading  Market, on any other existing trading market for the Common Stock or to  or through a market maker.  The Manager may also sell Shares in privately  negotiated transactions, provided that the Manager receives the  Company’s prior written approval for any sales in privately negotiated  transactions and if so provided in the “Plan of Distribution” section of the  Prospectus Supplement or a supplement to the Prospectus Supplement or a  new Prospectus Supplement disclosing the terms of such privately  negotiated transaction.    (v) The compensation to the Manager for sales of the Shares  under this Section 2(b) shall be a placement fee of 3% of the gross sales  price of the Shares sold pursuant to this Section 2(b) (“Broker Fee”). The  foregoing rate of compensation shall not apply when the Manager acts as  principal, in which case the Company may sell Shares to the Manager as  principal at a price agreed upon at the relevant Applicable Time pursuant  to a Terms Agreement. The remaining proceeds, after deduction of the  Broker Fee and deduction of any transaction fees imposed by any clearing  firm, execution broker, or governmental or self-regulatory organization in  respect of such sales, shall constitute the net proceeds to the Company for  such Shares (the “Net Proceeds”).    (vi) The Manager shall provide written confirmation (which  shall be by electronic mail) to the Company following the close of trading  on the Trading Market each day in which the Shares are sold under this  Section 2(b) setting forth the number of the Shares sold on such day, the  aggregate gross sales proceeds and the Net Proceeds to the Company, and  the compensation payable by the Company to the Manager with respect to  such sales.    (vii) Unless otherwise agreed between the Company and the  Manager, settlement for sales of the Shares will occur at 10:00 a.m. (New  York City time) on the second (2nd) Trading Day (or such earlier day as is  industry practice for regular-way trading) following the date on which  





 






 7  such sales are made (each, a “Settlement Date”). On or before the Trading  Day prior to each Settlement Date, the Company will, or will cause its  transfer agent to, electronically transfer the Shares being sold by crediting  the Manager’s or its designee’s account (provided that the Manager shall  have given the Company written notice of such designee at least one  Trading Day prior to the Settlement Date) at The Depository Trust  Company (“DTC”) through its Deposit and Withdrawal at Custodian  System or by such other means of delivery as may be mutually agreed  upon by the parties hereto which Shares in all cases shall be freely  tradable, transferable, registered shares in good deliverable form. On each  Settlement Date, the Manager will deliver the related Net Proceeds in  same day funds to an account designated by the Company. The Company  agrees that, if the Company, or its transfer agent (if applicable), defaults in  its obligation to deliver duly authorized Shares on a Settlement Date, in  addition to and in no way limiting the rights and obligations set forth in  Section 7 hereto, the Company will (i) hold the Manager harmless against  any loss, claim, damage, or reasonable, documented expense (including  reasonable and documented legal fees and expenses), as incurred, arising  out of or in connection with such default by the Company, and (ii) pay to  the Manager any commission, discount or other compensation to which  the Manager would otherwise have been entitled absent such default.    (viii) At each Applicable Time, Settlement Date, and  Representation Date, the Company shall be deemed to have affirmed each  representation and warranty contained in this Agreement as if such  representation and warranty were made as of such date, modified as  necessary to relate to the Registration Statement and the Prospectus as  amended as of such date (except for any representation and warranty  which is as of a specific date, in which case such representation and  warranty shall be affirmed as of such specific date). Any obligation of the  Manager to use its commercially reasonable efforts to sell the Shares on  behalf of the Company shall be subject to the continuing accuracy of the  representations and warranties of the Company herein, to the performance  by the Company of its obligations hereunder and to the continuing  satisfaction of the additional conditions specified in Section 6 of this  Agreement.    (ix) If the Company shall declare or make any dividend or other  distribution of its assets (or rights to acquire its assets) to holders of shares  of Common Stock, by way of return of capital or otherwise (including,  without limitation, any distribution of cash, stock or other securities,  property or options by way of a dividend, spin off, reclassification,  corporate rearrangement, scheme of arrangement or other similar  transaction) (a “Distribution” and the record date for the determination of  stockholders entitled to receive the Distribution, the “Record Date”), the  Company hereby covenants that, in connection with any sales of Shares  





 






 8  pursuant to a Sales Notice on the Record Date, the Company covenants  and agrees that the Company shall issue and deliver such Shares to the  Manager on the Record Date and the Record Date shall be the Settlement  Date and the Company shall cover any additional costs of the Manager in  connection with the delivery of Shares on the Record Date.     (c) Term Sales.  If the Company wishes to sell the Shares pursuant to  this Agreement but other than as set forth in Section 2(b) of this Agreement (each,  a “Placement”), the Company will notify the Manager of the proposed terms of  such Placement. If the Manager, acting as principal, wishes to accept such  proposed terms (which it may decline to do for any reason in its sole discretion)  or, following discussions with the Company wishes to accept amended terms, the  Manager and the Company will enter into a Terms Agreement setting forth the  terms of such Placement. The terms set forth in a Terms Agreement will not be  binding on the Company or the Manager unless and until the Company and the  Manager have each executed such Terms Agreement accepting all of the terms of  such Terms Agreement. In the event of a conflict between the terms of this  Agreement and the terms of a Terms Agreement, the terms of such Terms  Agreement will control.  A Terms Agreement may also specify certain provisions  relating to the reoffering of such Shares by the Manager. The commitment of the  Manager to purchase the Shares pursuant to any Terms Agreement shall be  deemed to have been made on the basis of the representations and warranties of  the Company herein contained and shall be subject to the terms and conditions  herein set forth. Each Terms Agreement shall specify the number of the Shares to  be purchased by the Manager pursuant thereto, the price to be paid to the  Company for such Shares, any provisions relating to rights of, and default by,  underwriters acting together with the Manager in the reoffering of the Shares, and  the time and date (each such time and date being referred to herein as a “Time of  Delivery”) and place of delivery of and payment for such Shares. Such Terms  Agreement shall also specify any requirements for opinions of counsel,  accountants’ letters and officers’ certificates pursuant to Section 6 of this  Agreement and any other information or documents required by the Manager.    (d) Maximum Number of Shares.  Under no circumstances shall the  Company cause or request the offer or sale of any Shares if, after giving effect to  the sale of such Shares, the aggregate amount of Shares sold pursuant to this  Agreement would exceed the lesser of (A) together with all sales of Shares under  this Agreement, the Maximum Amount, (B) the amount available for offer and  sale under the currently effective Registration Statement and (C) the amount  authorized from time to time to be issued and sold under this Agreement by the  Board, a duly authorized committee thereof or a duly authorized executive  committee, and notified to the Manager in writing.  Under no circumstances shall  the Company cause or request the offer or sale of any Shares pursuant to this  Agreement at a price lower than the minimum price authorized from time to time  by the Board, a duly authorized committee thereof or a duly authorized executive  officer, and notified to the Manager in writing. Further, under no circumstances  





 






 9  shall the Company cause or permit the aggregate offering amount of Shares sold  pursuant to this Agreement to exceed the Maximum Amount.    (e) Regulation M Notice.  Unless the exceptive provisions set forth in  Rule 101(c)(1) of Regulation M under the Exchange Act are satisfied with respect  to the Shares, the Company shall give the Manager at least one Business Day’s  prior notice of its intent to sell any Shares in order to allow the Manager time to  comply with Regulation M.    3. Representations and Warranties.  The Company represents and warrants  to, and agrees with, the Manager at the Execution Time and on each such time the  following representations and warranties are repeated or deemed to be made pursuant to  this Agreement, as set forth below or in the Registration Statement, the Prospectus or the  Incorporated Documents.    (a) Subsidiaries.  All of the direct and indirect material subsidiaries  (individually, a “Subsidiary”) of the Company are set forth on Exhibit 21.1 to the  Company’s most recent Annual Report on Form 10-K filed with the Commission.   The Company owns, directly or indirectly, all of the capital stock or other equity  interests of each Subsidiary free and clear of any “Liens” (which for purposes of  this Agreement shall mean a lien, charge, security interest, encumbrance, right of  first refusal, preemptive right or other restriction), and all of the issued and  outstanding shares of capital stock of each Subsidiary are validly issued and are  fully paid, non-assessable and free of preemptive and similar rights to subscribe  for or purchase securities.      (b) Organization and Qualification.  The Company and each of the  Subsidiaries is an entity duly incorporated or otherwise organized, validly existing  and in good standing under the laws of the jurisdiction of its incorporation or  organization, with the requisite power and authority to own and use its properties  and assets and to carry on its business as currently conducted.  Neither the  Company nor any Subsidiary is in violation nor default of any of the provisions of  its respective certificate or articles of incorporation, bylaws or other  organizational or charter documents.  Each of the Company and the Subsidiaries  is duly qualified to conduct business and is in good standing as a foreign  corporation or other entity in each jurisdiction in which the nature of the business  conducted or property owned by it makes such qualification necessary, except  where the failure to be so qualified or in good standing, as the case may be, could  not have or reasonably be expected to result in: (i) a material adverse effect on the  legality, validity or enforceability of this Agreement, (ii) a material adverse effect  on the results of operations, assets, business, prospects or condition (financial or  otherwise) of the Company and the Subsidiaries, taken as a whole, from that set  forth in the Registration Statement, the Base Prospectus, any Prospectus  Supplement, the Prospectus or the Incorporated Documents, or (iii) a material  adverse effect on the Company’s ability to perform in any material respect on a  timely basis its obligations under this Agreement (any of (i), (ii) or (iii), a  





 






 10  “Material Adverse Effect”) and no “Proceeding” (which for purposes of this  Agreement shall mean any action, claim, suit, investigation or proceeding  (including, without limitation, an informal investigation or partial proceeding,  such as a deposition), whether commenced or threatened) has been instituted in  any such jurisdiction revoking, limiting or curtailing or seeking to revoke, limit or  curtail such power and authority or qualification.    (c) Authorization and Enforcement.  The Company has the requisite  corporate power and authority to enter into and to consummate the transactions  contemplated by this Agreement and otherwise to carry out its obligations  hereunder.  The execution and delivery of this Agreement by the Company and  the consummation by it of the transactions contemplated hereby have been duly  authorized by all necessary action on the part of the Company and no further  action is required by the Company, the Board or the Company’s stockholders in  connection herewith other than in connection with the Required Approvals.  This  Agreement has been duly executed and delivered by the Company and, when  delivered in accordance with the terms hereof, will constitute the valid and  binding obligation of the Company enforceable against the Company 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.    (d) No Conflicts.  The execution, delivery and performance by the  Company of this Agreement, the issuance and sale of the Shares and the  consummation by it of the transactions contemplated hereby do not and will not  (i) conflict with or violate any provision of the Company’s or any Subsidiary’s  certificate or articles of incorporation, bylaws or other organizational or charter  documents, or (ii) conflict with, or constitute a default (or an event that with  notice or lapse of time or both would become a default) under, result in the  creation of any Lien upon any of the properties or assets of the Company or any  Subsidiary, or give to others any rights of termination, amendment, anti-dilution  or similar adjustments, acceleration or cancellation (with or without notice, lapse  of time or both) of, any agreement, credit facility, debt or other instrument  (evidencing a Company or Subsidiary debt or otherwise) or other understanding  to which the Company or any Subsidiary is a party or by which any property or  asset of the Company or any Subsidiary is bound or affected, or (iii) subject to the  Required Approvals, conflict with or result in a violation of any law, rule,  regulation, order, judgment, injunction, decree or other restriction of any court or  governmental authority to which the Company or a Subsidiary is subject  (including federal and state securities laws and regulations), or by which any  property or asset of the Company or a Subsidiary is bound or affected; except in  the case of each of clauses (ii) and (iii), such as could not have or reasonably be  expected to result in a Material Adverse Effect.  





 






 11    (e) Filings, Consents and Approvals.  The Company is not required to  obtain any consent, waiver, authorization or order of, give any notice to, or make  any filing or registration with, any court or other federal, state, local or other  governmental authority or other “Person” (defined as 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, including the Trading Market) in  connection with the execution, delivery and performance by the Company of this  Agreement, other than (i) the filings required by this Agreement, (ii) the filing  with the Commission of the Prospectus Supplement, (iii) the filing of  application(s) to and approval by the Trading Market for the listing of the Shares  for trading thereon in the time and manner required thereby, and (iv) such filings  as are required to be made under applicable state securities laws and the rules and  regulations of the Financial Industry Regulatory Authority, Inc. (“FINRA”)  (collectively, the “Required Approvals”).    (f) Issuance of Shares.  The Shares are duly authorized and, when  issued and paid for in accordance with this Agreement, will be duly and 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 of Common Stock issuable pursuant to this  Agreement.  The issuance by the Company of the Shares has been registered  under the Act and all of the Shares are freely transferable and tradable by the  purchasers thereof without restriction (other than any restrictions arising solely  from an act or omission of such a purchaser).  The Shares are being issued  pursuant to the Registration Statement and the issuance of the Shares has been  registered by the Company under the Act.  The “Plan of Distribution” section  within the Registration Statement permits the issuance and sale of the Shares as  contemplated by this Agreement.  Upon receipt of the Shares, the purchasers of  such Shares will have good and marketable title to such Shares and the Shares  will be freely tradable on the Trading Market.     (g) Capitalization.  The capitalization of the Company is as set forth in  the SEC Reports as of the date set forth therein.  The Company has not issued any  capital stock since its most recently filed periodic report under the Exchange Act,  other than pursuant to the exercise of employee stock options under the  Company’s stock option plans, the issuance of shares of Common Stock to  employees pursuant to the Company’s employee stock purchase plan and pursuant  to the conversion and/or exercise of securities exercisable, exchangeable or  convertible into Common Stock (“Common Stock Equivalents”) outstanding as of  the date of the most recently filed periodic report under the Exchange Act.  No  Person has any right of first refusal, preemptive right, right of participation, or any  similar right to participate in the transactions contemplated by this Agreement.   Except as set forth in the SEC Reports, there are no outstanding options, warrants,  scrip rights to subscribe to, calls or commitments of any character whatsoever  





 






 12  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.  The issuance  and sale of the Shares will not obligate the Company or any Subsidiary to issue  shares of Common Stock or other securities to any Person. 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.  There are no outstanding securities or instruments of the Company or  any Subsidiary that contain any redemption or similar provisions, and there are no  contracts, commitments, understandings or arrangements by which the Company  or any Subsidiary is or may become bound to redeem a security of the Company  or such Subsidiary. The Company does not have any stock appreciation rights or  “phantom stock” plans or agreements or any similar plan or agreement. All of the  outstanding shares of capital stock of the Company are duly authorized, validly  issued, fully paid and nonassessable, have been issued in compliance with all  federal and state securities laws, and none of such outstanding shares was issued  in violation of any preemptive rights or similar rights to subscribe for or purchase  securities.  No further approval or authorization of any stockholder or the Board is  required for the issuance and sale of the Shares.  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.    (h) Registration Statement.  The Company meets the requirements for  use of Form S-3 under the Act and has prepared and filed with the Commission  the Registration Statement, including a related Base Prospectus, for registration  under the Act of the offering and sale of the Shares.  Such Registration Statement  is effective and available for the offer and sale of the Shares as of the date hereof.  As filed, the Base Prospectus contains all information required by the Act and the  rules thereunder, and, except to the extent the Manager shall agree in writing to a  modification, shall be in all substantive respects in the form furnished to the  Manager prior to the Execution Time or prior to any such time this representation  is repeated or deemed to be made. The Registration Statement, at the Execution  Time, each such time this representation is repeated or deemed to be made, and at  all times during which a prospectus is required by the Act to be delivered  (whether physically or through compliance with Rule 172, 173 or any similar  rule) in connection with any offer or sale of the Shares, meets the requirements set  forth in Rule 415(a)(1)(x). The initial Effective Date of the Registration Statement  was not earlier than the date three years before the Execution Time.  The  Company meets the transaction requirements as set forth in General Instruction  I.B.1 of Form S-3.    





 






 13  (i) Accuracy of Incorporated Documents.  The Incorporated  Documents, when they were filed with the Commission, conformed in all material  respects to the requirements of the Exchange Act and the rules thereunder, and  none of the Incorporated Documents, when they were filed with the Commission,  contained any untrue statement of a material fact or omitted to state a material fact  necessary to make the statements therein, in light of the circumstances under  which they were made not misleading; and any further documents so filed and  incorporated by reference in the Registration Statement, the Base Prospectus, the  Prospectus Supplement or the Prospectus, when such documents are filed with the  Commission, will conform in all material respects to the requirements of the  Exchange Act and the rules thereunder, as applicable, and will not contain any  untrue statement of a material fact or omit to state a material fact necessary to  make the statements therein, in light of the circumstances under which they were  made, not misleading.     (j) Ineligible Issuer.  (i) At the earliest time after the filing of the  Registration Statement that the Company or another offering participant made a  bona fide offer (within the meaning of Rule 164(h)(2)) of the Shares and (ii) as of  the Execution Time and on each such time this representation is repeated or  deemed to be made (with such date being used as the determination date for  purposes of this clause (ii)), the Company was not and is not an Ineligible Issuer  (as defined in Rule 405), without taking account of any determination by the  Commission pursuant to Rule 405 that it is not necessary that the Company be  considered an Ineligible Issuer.    (k) Free Writing Prospectus.  The Company is eligible to use Issuer  Free Writing Prospectuses.  Each Issuer Free Writing Prospectus does not include  any information the substance of which conflicts with the information contained  in the Registration Statement, including any Incorporated Documents and any  prospectus supplement deemed to be a part thereof that has not been superseded  or modified; and each Issuer Free Writing Prospectus does not contain any untrue  statement of a material fact or omit to state any material fact necessary in order to  make the statements therein, in the light of the circumstances under which they  were made, not misleading. The foregoing sentence does not apply to statements  in or omissions from any Issuer Free Writing Prospectus based upon and in  conformity with written information furnished to the Company by the Manager  specifically for use therein.  Any Issuer Free Writing Prospectus that the  Company is required to file pursuant to Rule 433(d) has been, or will be, filed  with the Commission in accordance with the requirements of the Act and the rules  thereunder.  Each Issuer Free Writing Prospectus that the Company has filed, or is  required to file, pursuant to Rule 433(d) or that was prepared by or behalf of or  used by the Company complies or will comply in all material respects with the  requirements of the Act and the rules thereunder.  The Company will not, without  the prior consent of the Manager, prepare, use or refer to, any Issuer Free Writing  Prospectuses.    





 






 14  (l) Proceedings Related to Registration Statement.  The Registration  Statement is not the subject of a pending proceeding or examination under  Section 8(d) or 8(e) of the Act, and the Company is not the subject of a pending  proceeding under Section 8A of the Act in connection with the offering of the  Shares. The Company has not received any notice that the Commission has issued  or intends to issue a stop-order with respect to the Registration Statement or that  the Commission otherwise has suspended or withdrawn the effectiveness of the  Registration Statement, either temporarily or permanently, or intends or has  threatened in writing to do so.      (m) SEC Reports.  The Company has filed all reports, schedules,  forms, statements and other documents required to be filed by the Company under  the 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  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 financial statements of the Company included in the SEC  Reports comply in all material respects with applicable accounting requirements  and the rules and regulations of the Commission with respect thereto as in effect  at the time of filing.  Such financial statements have been prepared in accordance  with United States generally accepted accounting principles applied on a  consistent basis during the periods involved (“GAAP”), except as may be  otherwise specified in such financial statements or the notes thereto and except  that unaudited financial statements may not contain all footnotes required by  GAAP, and fairly present in all material respects the financial position of the  Company and its consolidated Subsidiaries as of and for the dates thereof and the  results of operations and cash flows for the periods then ended, subject, in the  case of unaudited statements, to normal, immaterial, year-end audit adjustments.    (n)  [RESERVED]    (o) Material Changes; Undisclosed Events, Liabilities or  Developments.  Since the date of the latest audited financial statements included  within the SEC Reports, except as disclosed in an SEC Report filed prior to the  date hereof or applicable Sales Notice, (i) there has been no event, occurrence or  development that has had or that could reasonably be expected to result in a  Material Adverse Effect, (ii) the Company has not incurred any material liabilities  





 






 15  (contingent or otherwise) other than (A) trade payables and accrued expenses  incurred in the ordinary course of business consistent with past practice and (B)  liabilities not required to be reflected in the Company’s financial statements  pursuant to GAAP or disclosed in filings made with the Commission, (iii) the  Company has not altered its method of accounting, (iv) the Company has not  declared or made any dividend or distribution of cash or other property to its  stockholders or purchased, redeemed or made any agreements to purchase or  redeem any shares of its capital stock and (v) the Company has not issued any  equity securities to any officer, director or “Affiliate” (defined as 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 144 under the Act), except pursuant to existing Company  equity compensation plans.  The Company does not have pending before the  Commission any request for confidential treatment of information.  Except for the  issuance of the Shares contemplated by this Agreement or as set forth in the SEC  Reports, 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 1 Trading Day  prior to the date that this representation is made.    (p) Litigation.  Except as set forth in the SEC Reports, there is no  action, suit, inquiry, notice of violation, proceeding or investigation pending or, to  the knowledge of the Company, threatened against or affecting the Company, any  Subsidiary or any of their respective properties before or by any court, arbitrator,  governmental or administrative agency or regulatory authority (federal, state,  county, local or foreign) (collectively, an “Action”).  None of the Actions set forth  in the SEC Reports, (i) adversely affects or challenges the legality, validity or  enforceability of this Agreement or the Shares or (ii) could, if there were an  unfavorable decision, have or reasonably be expected to result in a Material  Adverse Effect.  Neither the Company nor any Subsidiary, nor, to the knowledge  of the Company, any director or officer thereof, is the subject of any Action  involving a claim of violation of or liability under federal or state securities laws  or a claim of breach of fiduciary duty.  There has not been, and to the knowledge  of the Company, there is not pending or contemplated, any investigation by the  Commission involving the Company or any current or former director or officer  of the Company.  The Commission has not issued any stop order or other order  suspending the effectiveness of any registration statement filed by the Company  or any Subsidiary under the Exchange Act or the Act.    (q) Labor Relations.  No labor dispute exists or, to the knowledge of  the Company, is imminent with respect to any of the employees of the Company,  which could reasonably be expected to result in a Material Adverse Effect.  None  of the Company’s or its Subsidiaries’ employees is a member of a union that  





 






 16  relates to such employee’s relationship with the Company or such Subsidiary, and  neither the Company nor any of its Subsidiaries is a party to a collective  bargaining agreement, and the Company and its Subsidiaries believe that their  relationships with their employees are good.  To the knowledge of the Company,  no executive officer of the Company or any Subsidiary, is, in violation of any  material term of any employment contract, confidentiality, disclosure or  proprietary information agreement or non-competition agreement, or any other  contract or agreement or any restrictive covenant in favor of any third party, and  the continued employment of each such executive officer does not subject the  Company or any of its Subsidiaries to any liability with respect to any of the  foregoing matters.  The Company and its Subsidiaries are in compliance with all  U.S. federal, state, local and foreign laws and regulations relating to employment  and employment practices, terms and conditions of employment and wages and  hours, except where the failure to be in compliance would not, individually or in  the aggregate, reasonably be expected to have a Material Adverse Effect.    (r) Compliance.  Neither the Company nor any Subsidiary: (i) is in  default under or in violation of (and no event has occurred that has not been  waived that, with notice or lapse of time or both, would result in a default by the  Company or any Subsidiary under), nor has the Company or any Subsidiary  received notice of a claim that it is in default under or that it is in violation of, any  indenture, loan or credit agreement or any other agreement or instrument to which  it is a party or by which it or any of its properties is bound (whether or not such  default or violation has been waived), (ii) is in violation of any judgment, decree  or order of any court, arbitrator or other governmental authority or (iii) is or has  been in violation of any statute, rule, ordinance or regulation of any governmental  authority, including without limitation all foreign, federal, state and local laws  relating to taxes, environmental protection, occupational health and safety,  product quality and safety and employment and labor matters, except in each case  as would not have or reasonably be expected to result in a Material Adverse  Effect.  (s) Environmental Laws. The Company and its Subsidiaries (i) are in  compliance with all federal, state, local and foreign laws relating to pollution or  protection of human health or the environment (including ambient air, surface  water, groundwater, land surface or subsurface strata), including laws relating to  emissions, discharges, releases or threatened releases of chemicals, pollutants,  contaminants, or toxic or hazardous substances or wastes (collectively,  “Hazardous Materials”) into the environment, or otherwise relating to the  manufacture, processing, distribution, use, treatment, storage, disposal, transport  or handling of Hazardous Materials, as well as all authorizations, codes, decrees,  demands, or demand letters, injunctions, judgments, licenses, notices or notice  letters, orders, permits, plans or regulations, issued, entered, promulgated or  approved thereunder (“Environmental Laws”); (ii) have received all permits  licenses or other approvals required of them under applicable Environmental  Laws to conduct their respective businesses; and (iii) are in compliance with all  terms and conditions of any such permit, license or approval where in each clause  





 






 17  (i), (ii) and (iii), the failure to so comply would be reasonably expected to have,  individually or in the aggregate, a Material Adverse Effect.    (t) Regulatory Permits.  The Company and the Subsidiaries possess all  certificates, authorizations and permits issued by the appropriate federal, state,  local or foreign regulatory authorities necessary to conduct their respective  businesses as described in the SEC Reports, except where the failure to possess  such permits could not reasonably be expected to result in a Material Adverse  Effect (“Material Permits”), and neither the Company nor any Subsidiary has  received any notice of proceedings relating to the revocation or modification of  any Material Permit.    (u) Title to Assets.  The Company and the Subsidiaries have good and  marketable title in fee simple to all real property owned by them and good and  marketable title in all personal property owned by them that is material to the  business of the Company and the Subsidiaries, in each case free and clear of all  Liens, except for (i) Liens as do not materially affect the value of such property  and do not materially interfere with the use made and proposed to be made of  such property by the Company and the Subsidiaries and (ii) Liens for the payment  of federal, state or other taxes, for which appropriate reserves have been made  therefor in accordance with GAAP and, the payment of which is neither  delinquent nor subject to penalties.  Any real property and facilities held under  lease by the Company and the Subsidiaries are held by them under valid,  subsisting and enforceable leases with which the Company and the Subsidiaries  are in compliance.    (v) Intellectual Property.  To the Company’s knowledge, the Company  and the Subsidiaries have, or have rights to use, all patents, patent applications,  trademarks, trademark applications, service marks, trade names, trade secrets,  inventions, copyrights, licenses and other intellectual property rights and similar  rights necessary or required for use in connection with their respective businesses  as described in the SEC Reports and which the failure to so have could have a  Material Adverse Effect (collectively, the “Intellectual Property Rights”).  None  of, and neither the Company nor any Subsidiary has received a notice (written or  otherwise) that any of, the Intellectual Property Rights has expired, terminated or  been abandoned, or is expected to expire or terminate or be abandoned, within  two (2) years from the date of this Agreement, except as would not be reasonably  expected to have a Material Adverse Effect.  Neither the Company nor any  Subsidiary has received, since the date of the latest audited financial statements  included within the SEC Reports, a written notice of a claim or otherwise has any  knowledge that the Intellectual Property Rights violate or infringe upon the rights  of any Person, except as could not have or reasonably be expected to not have a  Material Adverse Effect.  To the knowledge of the Company, all such Intellectual  Property Rights are enforceable and there is no existing infringement by another  Person of any of the Intellectual Property Rights.  The Company and its  Subsidiaries have taken reasonable security measures to protect the secrecy,  





 






 18  confidentiality and value of all of their intellectual properties, except where  failure to do so could not, individually or in the aggregate, reasonably be expected  to have a Material Adverse Effect.    (w) Insurance.  The Company and the Subsidiaries are insured by  insurers of recognized financial responsibility against such losses and risks and in  such amounts as are prudent and customary in the businesses in which the  Company and the Subsidiaries are engaged, including, but not limited to, directors  and officers insurance coverage.  Neither the Company nor any Subsidiary has  been advised 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 without a significant  increase in cost.    (x) Affiliate Transactions.  Except as set forth in the SEC Reports,  none of the officers or directors of the Company or any Subsidiary and, to the  knowledge of the Company, none of the employees of the Company or any  Subsidiary is presently a party to any transaction with the Company or any  Subsidiary (other than for services as employees, officers and directors), including  any contract, agreement or other arrangement providing for the furnishing of  services to or by, providing for rental of real or personal property to or from,  providing for the borrowing of money from or lending of money to or otherwise  requiring payments to or from any officer, director or such employee or, to the  knowledge of the Company, any entity in which any officer, director, or any such  employee has a substantial interest or is an officer, director, trustee, stockholder,  member or partner, in each case in excess of $120,000 other than for (i) payment  of salary or consulting fees for services rendered, (ii) reimbursement for expenses  incurred on behalf of the Company and (iii) other employee benefits, including  stock option agreements under any stock option plan of the Company.    (y) Sarbanes Oxley Compliance.  The Company and the Subsidiaries  are in compliance in all material respects with any and all applicable requirements  of the Sarbanes-Oxley Act of 2002 that are effective as of the date hereof, and any  and all applicable rules and regulations promulgated by the Commission  thereunder that are effective as of the date hereof.  Except as disclosed in the SEC  Reports, the Company and the Subsidiaries maintain a system of internal  accounting controls sufficient to provide reasonable assurance that: (i)  transactions are executed in accordance with management’s general or specific  authorizations, (ii) transactions are recorded as necessary to permit preparation of  financial statements in conformity with GAAP and to maintain asset  accountability, (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 the existing assets at reasonable  intervals and appropriate action is taken with respect to any differences. The  Company and the Subsidiaries have established disclosure controls and  procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the  





 






 19  Company and the Subsidiaries and designed such disclosure controls and  procedures to ensure that information required to be disclosed by the Company in  the reports it files or submits under the Exchange Act is recorded, processed,  summarized and reported, within the time periods specified in the Commission’s  rules and forms.  The Company’s certifying officers have evaluated the  effectiveness of the disclosure controls and procedures of the Company and the  Subsidiaries as of the end of the period covered by the most recently filed periodic  report under the Exchange Act (such date, the “Evaluation Date”).  The Company  presented in its most recently filed periodic report under the Exchange Act the  conclusions of the certifying officers about the effectiveness of the disclosure  controls and procedures based on their evaluations as of the Evaluation Date.   Since the Evaluation Date, there have been no changes in the internal control over  financial reporting (as such term is defined in the Exchange Act) of the Company  and its Subsidiaries that have materially affected, or is reasonably likely to  materially affect, the internal control over financial reporting of the Company and  its Subsidiaries.    (z) Certain Fees.  Other than payments to be made to the Manager, 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 this Agreement.  The Manager 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 this Agreement.    (aa) No Other Sales Agency Agreement.  The Company has not entered  into any other sales agency agreements or other similar arrangements with any  agent or any other representative in respect of at the market offerings of the  Shares.    (bb) [RESERVED]    (cc) Listing and Maintenance Requirements.  The Common Stock is  listed on the Trading Market and the issuance of the Shares as contemplated by  this Agreement does not contravene the rules and regulations of the Trading  Market.  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  





 






 20  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.    (dd) Application of Takeover Protections.  The Company and the Board  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 Shares.    (ee) Solvency.  Based on the consolidated financial condition of the  Company as of the date hereof, (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 date hereof.  The SEC Reports sets 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), 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 GAAP.  Neither the Company nor any Subsidiary is in default  with respect to any Indebtedness.    





 






 21  (ff) Tax Status.  Except for matters that would not, individually or in  the aggregate, have or reasonably be expected to result in a Material Adverse  Effect, the Company and its Subsidiaries each (i) has made or filed all United  States federal, state and local income and all foreign income and franchise tax  returns, reports and declarations required by any jurisdiction to which it is subject,  (ii) has paid all taxes and other governmental assessments and charges that are  material in amount, shown or determined to be due on such returns, reports and  declarations and (iii) has set aside on its books provision reasonably adequate for  the payment of all material taxes for periods subsequent to the periods to which  such returns, reports or declarations apply.  There are no unpaid taxes in any  material amount claimed to be due by the taxing authority of any jurisdiction, and  the officers of the Company or of any Subsidiary know of no basis for any such  claim.    (gg) Foreign Corrupt Practices.  Neither the Company nor any  Subsidiary, nor to the knowledge of the Company or any Subsidiary, any agent or  other person acting on behalf of the Company or any Subsidiary, has (i) directly  or indirectly, used any funds for unlawful contributions, gifts, entertainment or  other unlawful expenses related to foreign or domestic political activity, (ii) made  any unlawful payment to foreign or domestic government officials or employees  or to any foreign or domestic political parties or campaigns from corporate funds,  (iii) failed to disclose fully any contribution made by the Company or any  Subsidiary (or made by any person acting on its behalf of which the Company is  aware) which is in violation of law, or (iv) violated in any material respect any  provision of the Foreign Corrupt Practices Act of 1977, as amended.    (hh) Accountants.  The Company’s independent registered public  accounting firm is set forth in the SEC Reports.  To the knowledge and belief of  the Company, such accounting firm (i) is a registered public accounting firm as  required by the Exchange Act and (ii) shall express its opinion with respect to the  financial statements to be included in the Company’s Annual Report on Form 10- K for the fiscal year ending December 31, 2021.    (ii) 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  Shares, (ii) sold, bid for, purchased, or, paid any compensation for soliciting  purchases of, any of the Shares, 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  Manager in connection with the Shares.    (jj) FDA.  As to each product subject to the jurisdiction of the U.S.  Food and Drug Administration (“FDA”) under the Federal Food, Drug and  Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is  





 






 22  manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the  Company or any of its Subsidiaries (each such product, a “Pharmaceutical  Product”), such Pharmaceutical Product is being manufactured, packaged,  labeled, tested, distributed, sold and/or marketed by the Company in compliance  with all applicable requirements under FDCA and similar laws, rules and  regulations relating to registration, investigational use, premarket clearance,  licensure, or application approval, good manufacturing practices, good laboratory  practices, good clinical practices, product listing, quotas, labeling, advertising,  record keeping and filing of reports, except where the failure to be in compliance  would not have a Material Adverse Effect.  There is no pending, completed or, to  the Company's knowledge, threatened, action (including any lawsuit, arbitration,  or legal or administrative or regulatory proceeding, charge, complaint, or  investigation) against the Company or any of its Subsidiaries, and none of the  Company or any of its Subsidiaries has received any notice, warning letter or  other communication from the FDA or any other governmental entity, which (i)  contests the premarket clearance, licensure, registration, or approval of, the uses  of, the distribution of, the manufacturing or packaging of, the testing of, the sale  of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws  its approval of, requests the recall, suspension, or seizure of, or withdraws or  orders the withdrawal of advertising or sales promotional materials relating to,  any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical  investigation by the Company or any of its Subsidiaries, (iv) enjoins production at  any facility of the Company or any of its Subsidiaries, (v) enters or proposes to  enter into a consent decree of permanent injunction with the Company or any of  its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or  regulations by the Company or any of its Subsidiaries, and which, either  individually or in the aggregate, would have a Material Adverse Effect.  The  properties, business and operations of the Company have been and are being  conducted in all material respects in accordance with all applicable laws, rules and  regulations of the FDA.  The Company has not been informed by the FDA that the  FDA will prohibit the marketing, sale, license or use in the United States of any  product proposed to be developed, produced or marketed by the Company nor has  the FDA expressed any concern as to approving or clearing for marketing any  product being developed or proposed to be developed by the Company.    (kk) Stock Option Plans. Each stock option granted by the Company  under the Company’s stock option plan was granted (i) in accordance with the  terms of the Company’s stock option plan and (ii) with an exercise price at least  equal to the fair market value of the Common Stock on the date such stock option  would be considered granted under GAAP and applicable law. No stock option  granted under the Company’s stock option plan has been backdated.  The  Company has not knowingly granted, and there is no and has been no Company  policy or practice to knowingly grant, stock options prior to, or otherwise  knowingly coordinate the grant of stock options with, the release or other public  announcement of material information regarding the Company or its Subsidiaries  or their financial results or prospects.   





 






 23    (ll) 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”).    (mm) 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 the Manager’s request.    (nn) 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 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.    (oo) Money Laundering.  The operations of the Company and its  Subsidiaries are and have been conducted at all times in compliance with applicable  financial record-keeping and reporting requirements of the Currency and Foreign  Transactions Reporting Act of 1970, as amended, applicable money laundering  statutes and applicable rules and regulations thereunder (collectively, the “Money  Laundering Laws”), and no Action or Proceeding by or before any court or  governmental agency, authority or body or any arbitrator involving the Company or  any Subsidiary with respect to the Money Laundering Laws is pending or, to the  knowledge of the Company or any Subsidiary, threatened.    (pp) FINRA Member Shareholders.  There are no affiliations with any  FINRA member firm among the Company’s officers, directors or, to the  knowledge of the Company, any five percent (5%) or greater stockholder of the  Company, except as set forth in the Registration Statement, the Base Prospectus,  any Prospectus Supplement or the Prospectus.    4. Agreements. The Company agrees with the Manager that:     (a) Right to Review Amendments and Supplements to Registration  Statement and Prospectus.  During any period when the delivery of a prospectus  relating to the Shares is required (including in circumstances where such  requirement may be satisfied pursuant to Rule 172, 173 or any similar rule) to be  





 






 24  delivered under the Act in connection with the offering or the sale of Shares, the  Company will not file any amendment to the Registration Statement or  supplement (including any Prospectus Supplement) to the Base Prospectus unless  the Company has furnished to the Manager a copy for its review prior to filing  and will not file any such proposed amendment or supplement to which the  Manager reasonably objects (provided, however, that the Company will have no  obligation to provide the Manager any advance copy of such file or to provide the  Manager an opportunity to object to such filing if the filing does not name the  Manager and does not relate to the transaction herein provided). The Company  has properly completed the Prospectus, in a form approved by the Manager, and  filed such Prospectus, as amended at the Execution Time, with the Commission  pursuant to the applicable paragraph of Rule 424(b) by the Execution Time and  will cause any supplement to the Prospectus to be properly completed, in a form  approved by the Manager, and will file such supplement with the Commission  pursuant to the applicable paragraph of Rule 424(b) within the time period  prescribed thereby and will provide evidence reasonably satisfactory to the  Manager of such timely filing. The Company will promptly advise the Manager  (i) when the Prospectus, and any supplement thereto, shall have been filed (if  required) with the Commission pursuant to Rule 424(b), (ii) when, during any  period when the delivery of a prospectus (whether physically or through  compliance with Rule 172, 173 or any similar rule) is required under the Act in  connection with the offering or sale of the Shares, any amendment to the  Registration Statement shall have been filed or become effective (other than any  annual report of the Company filed pursuant to Section 13(a) or 15(d) of the  Exchange Act), (iii) of any request by the Commission or its staff for any  amendment of the Registration Statement, or for any supplement to the Prospectus  or for any additional information, (iv) of the issuance by the Commission of any  stop order suspending the effectiveness of the Registration Statement or of any  notice objecting to its use or the institution or threatening of any proceeding for  that purpose and (v) of the receipt by the Company of any notification with  respect to the suspension of the qualification of the Shares for sale in any  jurisdiction or the institution or threatening of any proceeding for such purpose.  The Company will use its commercially reasonable efforts to prevent the issuance  of any such stop order or the occurrence of any such suspension or objection to  the use of the Registration Statement and, upon such issuance, occurrence or  notice of objection, to obtain as soon as possible the withdrawal of such stop  order or relief from such occurrence or objection, including, if necessary, by filing  an amendment to the Registration Statement or a new registration statement and  using its commercially reasonable efforts to have such amendment or new  registration statement declared effective as soon as practicable.     (b) Subsequent Events.  If, at any time on or after an Applicable Time  but prior to the related Settlement Date, any event occurs as a result of which the  Registration Statement or Prospectus would include any untrue statement of a  material fact or omit to state any material fact necessary to make the statements  therein in the light of the circumstances under which they were made or the  





 






 25  circumstances then prevailing not misleading, the Company will (i) notify  promptly the Manager so that any use of the Registration Statement or Prospectus  may cease until such are amended or supplemented; (ii) amend or supplement the  Registration Statement or Prospectus to correct such statement or omission; and  (iii) supply any amendment or supplement to the Manager in such quantities as  the Manager may reasonably request.     (c) Notification of Subsequent Filings.  During any period when the  delivery of a prospectus relating to the Shares is required (including in  circumstances where such requirement may be satisfied pursuant to Rule 172, 173  or any similar rule) to be delivered under the Act, any event occurs as a result of  which the Prospectus as then supplemented would include any untrue statement of  a material fact or omit to state any material fact necessary to make the statements  therein in the light of the circumstances under which they were made not  misleading, or if it shall be necessary to amend the Registration Statement, file a  new registration statement or supplement the Prospectus to comply with the Act  or the Exchange Act or the respective rules thereunder, including in connection  with use or delivery of the Prospectus, the Company promptly will (i) notify the  Manager of any such event, (ii) subject to Section 4(a), prepare and file with the  Commission an amendment or supplement or new registration statement which  will correct such statement or omission or effect such compliance, (iii) use its  commercially reasonable efforts to have any amendment to the Registration  Statement or new registration statement declared effective as soon as practicable  in order to avoid any disruption in use of the Prospectus and (iv) supply any  supplemented Prospectus to the Manager in such quantities as the Manager may  reasonably request.    (d) Earnings Statements.  As soon as practicable, the Company will  make generally available to its security holders and to the Manager an earnings  statement or statements of the Company and its Subsidiaries which will satisfy the  provisions of Section 11(a) of the Act and Rule 158. For the avoidance of doubt,  the Company’s compliance with the reporting requirements of the Exchange Act  shall be deemed to satisfy the requirements of this Section 4(d).    (e) Delivery of Registration Statement.  Upon the request of the  Manager, the Company will furnish to the Manager and counsel for the Manager,  without charge, signed copies of the Registration Statement (including exhibits  thereto) and, so long as delivery of a prospectus by the Manager or dealer may be  required by the Act (including in circumstances where such requirement may be  satisfied pursuant to Rule 172, 173 or any similar rule), as many copies of the  Prospectus and each Issuer Free Writing Prospectus and any supplement thereto  as the Manager may reasonably request. The Company will pay the expenses of  printing or other production of all documents relating to the offering.     (f) Qualification of Shares.  The Company will arrange, if necessary,  for the qualification of the Shares for sale under the laws of such jurisdictions as  





 






 26  the Manager may designate and will maintain such qualifications in effect so long  as required for the distribution of the Shares; provided that in no event shall the  Company be obligated to qualify to do business in any jurisdiction where it is not  now so qualified or to take any action that would subject it to service of process in  suits, other than those arising out of the offering or sale of the Shares, in any  jurisdiction where it is not now so subject.     (g) Free Writing Prospectus.  The Company agrees that, unless it has  or shall have obtained the prior written consent of the Manager, and the Manager  agrees with the Company that, unless it has or shall have obtained, as the case  may be, the prior written consent of the Company, it has not made and will not  make any offer relating to the Shares that would constitute an Issuer Free Writing  Prospectus or that would otherwise constitute a “free writing prospectus” (as  defined in Rule 405) required to be filed by the Company with the Commission or  retained by the Company under Rule 433. Any such free writing prospectus  consented to by the Manager or the Company is hereinafter referred to as a  “Permitted Free Writing Prospectus.” The Company agrees that (i) it has treated  and will treat, as the case may be, each Permitted Free Writing Prospectus as an  Issuer Free Writing Prospectus and (ii) it has complied and will comply, as the  case may be, with the requirements of Rules 164 and 433 applicable to any  Permitted Free Writing Prospectus, including in respect of timely filing with the  Commission, legending and record keeping.    (h) Subsequent Equity Issuances.  The Company shall not deliver any  Sales Notice hereunder (and any Sales Notice previously delivered shall not apply  during such three Business Days) for at least three (3) Business Days prior to any  date on which the Company or any Subsidiary offers, sells, issues, contracts to  sell, contracts to issue or otherwise disposes of, directly or indirectly, any other  shares of Common Stock or any Common Stock Equivalents (other than the  Shares), subject to Manager’s right to waive this obligation, provided that,  without compliance with the foregoing obligation, (i) the Company may issue and  sell Common Stock pursuant to any employee equity plan, stock ownership plan,  dividend reinvestment plan or other similar plan of the Company in effect at the  Execution Time and the Company may issue Common Stock issuable upon the  conversion or exercise of Common Stock Equivalents outstanding at the  Execution Time and (ii) the Company may issue shares of Common Stock or any  Common Stock Equivalents in privately negotiated transactions to vendors,  service providers, strategic partners or potential strategic partners, provided that  such issuances are not made for capital raising purposes and are conducted in a  manner so as not to be integrated with the offering of Shares hereby and to not  constitute a distribution for purposes of Regulation M.    (i) Market Manipulation.  Until the termination of this Agreement, the  Company will not take, directly or indirectly, any action designed to or that would  constitute or that might reasonably be expected to cause or result in, under the  Exchange Act or otherwise, stabilization or manipulation in violation of the Act,  





 






 27  Exchange Act or the rules and regulations thereunder of the price of any security  of the Company to facilitate the sale or resale of the Shares or otherwise violate  any provision of Regulation M under the Exchange Act.    (j) Notification of Incorrect Certificate.  The Company will, at any  time during the term of this Agreement, as supplemented from time to time,  advise the Manager immediately after it shall have received notice or obtained  knowledge thereof, of any information or fact that would alter or affect any  opinion, certificate, letter and other document provided to the Manager pursuant  to Section 6 herein.     (k) Certification of Accuracy of Disclosure.  Upon commencement of  the offering of the Shares under this Agreement (and upon the recommencement  of the offering of the Shares under this Agreement following the termination of a  suspension of sales hereunder lasting more than 30 Trading Days), and each time  that (i) the Registration Statement or Prospectus shall be amended or  supplemented, other than by means of Incorporated Documents, (ii) the Company  files its Annual Report on Form 10-K under the Exchange Act, (iii) the Company  files its quarterly reports on Form 10-Q under the Exchange Act, (iv) the  Company files a Current Report on Form 8-K containing amended financial  information (other than information that is furnished and not filed), if the  Manager reasonably determines that the information in such Form 8-K is material,  or (v) the Shares are delivered to the Manager as principal at the Time of Delivery  pursuant to a Terms Agreement (such commencement or recommencement date  and each such date referred to in (i), (ii), (iii), (iv) and (v) above, a  “Representation Date”), unless waived by the Manager, the Company shall  furnish or cause to be furnished to the Manager forthwith a certificate dated and  delivered on the Representation Date, in form reasonably satisfactory to the  Manager to the effect that the statements contained in the certificate referred to in  Section 6 of this Agreement which were last furnished to the Manager are true  and correct at the Representation Date, as though made at and as of such date  (except that such statements shall be deemed to relate to the Registration  Statement and the Prospectus as amended and supplemented to such date) or, in  lieu of such certificate, a certificate of the same tenor as the certificate referred to  in said Section 6, modified as necessary to relate to the Registration Statement  and the Prospectus as amended and supplemented to the date of delivery of such  certificate.     (l) Bring Down Opinions; Negative Assurance.  At each  Representation Date, unless waived by the Manager, the Company shall furnish or  cause to be furnished forthwith to the Manager and to counsel to the Manager a  written opinion of counsel to the Company (“Company Counsel”) addressed to  the Manager and dated and delivered on such Representation Date, in form and  substance reasonably satisfactory to the Manager, including a negative assurance  representation. The requirement to furnish or cause to be furnished an opinion  (but not with respect to a negative assurance representation) under this Section  





 






 28  4(l) shall be waived for any Representation Date other than a Representation Date  on which a material amendment to the Registration Statement or Prospectus is  made or the Company files its Annual Report on Form 10-K or a material  amendment thereto under the Exchange Act, unless the Manager reasonably  requests such deliverable required this Section 4(l) in connection with a  Representation Date, upon which request such deliverable shall be deliverable  hereunder. The Manager hereby agrees that Company Counsel may provide a  reliance letter for a previously delivered opinion or negative assurance  representation, stating that such opinion or negative assurance representation may  continue to be relied on, in lieu of providing an opinion or negative assurance  representation on any such date.    (m) Auditor Bring Down “Comfort” Letter.  At each Representation  Date, unless waived by the Manager, the Company shall cause (1) the Company’s  auditors (the “Accountants”), or other independent accountants satisfactory to the  Manager forthwith to furnish the Manager a letter, and (2) the Chief Financial  Officer of the Company forthwith to furnish the Manager a certificate, in each  case dated on such Representation Date, in form satisfactory to the Manager, of  the same tenor as the letters and certificate referred to in Section 6 of this  Agreement but modified to relate to the Registration Statement and the  Prospectus, as amended and supplemented to the date of such letters and  certificate; provided, however, that the requirement to furnish or cause to be  furnished a “comfort” letter under this Section 4(m) shall be waived for any  Representation Date other than a Representation Date on which a material  amendment to the Registration Statement or Prospectus is made or the Company  files its Annual Report on Form 10-K or a material amendment thereto under the  Exchange Act, unless the Manager reasonably requests the deliverables required  by this Section 4(m) in connection with a Representation Date, upon which  request such deliverable shall be deliverable hereunder.    (n) Due Diligence Session.  Upon commencement of the offering of  the Shares under this Agreement (and upon the recommencement of the offering  of the Shares under this Agreement following the termination of a suspension of  sales hereunder lasting more than 30 Trading Days), and at each Representation  Date, unless waived by the Manager, the Company will conduct a due diligence  session, in form and substance, reasonably satisfactory to the Manager, which  shall include representatives of management and Accountants. The Company  shall cooperate timely with any reasonable due diligence request from or review  conducted by the Manager or its agents from time to time in connection with the  transactions contemplated by this Agreement, including, without limitation,  providing information and available documents and access to appropriate  corporate officers and the Company’s agents during regular business hours, and  timely furnishing or causing to be furnished such certificates, letters and opinions  from the Company, its officers and its agents, as the Manager may reasonably  request. The Company shall reimburse the Manager for Manager’s counsel’s fees  in each such Representation Date due diligence session, up to a maximum of  





 






 29  $2,500 per update, plus any reasonable incidental expense incurred by the  Manager in connection therewith.    (o) Acknowledgment of Trading.  The Company consents to the  Manager trading in the Common Stock for the Manager’s own account and for the  account of its clients at the same time as sales of the Shares occur pursuant to this  Agreement or pursuant to a Terms Agreement, provided that such activity is  conducted in accordance with applicable law and the rules of the Trading Market..     (p) Disclosure of Shares Sold.  The Company will disclose in its  Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q, as  applicable, the number of Shares sold through the Manager under this Agreement,  the Net Proceeds to the Company and the compensation paid by the Company  with respect to sales of Shares pursuant to this Agreement during the relevant  quarter; and, if required by any subsequent change in Commission policy or  request, more frequently by means of a Current Report on Form 8-K or a further  Prospectus Supplement.     (q) Rescission Right.  If to the knowledge of the Company, the  conditions set forth in Section 6 shall not have been satisfied as of the applicable  Settlement Date, the Company will offer to any person who has agreed to  purchase Shares from the Company as the result of an offer to purchase solicited  by the Manager the right to refuse to purchase and pay for such Shares.     (r) Bring Down of Representations and Warranties.  Each acceptance  by the Company of an offer to purchase the Shares hereunder, and each execution  and delivery by the Company of a Terms Agreement, shall be deemed to be an  affirmation to the Manager that the representations and warranties of the  Company contained in or made pursuant to this Agreement are true and correct as  of the date of such acceptance or of such Terms Agreement as though made at and  as of such date, and an undertaking that such representations and warranties will  be true and correct as of the Settlement Date for the Shares relating to such  acceptance or as of the Time of Delivery relating to such sale, as the case may be,  as though made at and as of such date (except in each such case (i) for any  representation and warranty which is as of a specific date, in which case such  representation and warranty shall be affirmed as of such specific date and (ii) that  such representations and warranties shall be deemed to relate to the Registration  Statement and the Prospectus as amended and supplemented relating to such  Shares).    (s) Reservation of Shares.  The Company shall ensure that there are at  all times sufficient shares of Common Stock to provide for the issuance, free of  any preemptive rights, out of its authorized but unissued shares of Common Stock  or shares of Common Stock held in treasury, of the maximum aggregate number  of Shares authorized for issuance by the Board pursuant to the terms of this  Agreement. The Company will use its commercially reasonable efforts to cause  





 






 30  the Shares to be listed for trading on the Trading Market and to maintain such  listing.     (t) Obligation Under Exchange Act.  During any period when the  delivery of a prospectus relating to the Shares is required (including in  circumstances where such requirement may be satisfied pursuant to Rule 172, 173  or any similar rule) to be delivered under the Act, the Company will file all  documents required to be filed with the Commission pursuant to the Exchange  Act within the time periods required by the Exchange Act and the regulations  thereunder.     (u) DTC Facility.  The Company shall cooperate with Manager and  use its commercially reasonable efforts to permit the Shares to be eligible for  clearance and settlement through the facilities of DTC.     (v) Use of Proceeds.  The Company will apply the Net Proceeds from  the sale of the Shares in the manner set forth in the Prospectus.     (w) Filing of Prospectus Supplement.  If the event any sales are made  pursuant to this Agreement which are not made in “at the market” offerings as  defined in Rule 415, including, without limitation, any Placement pursuant to a  Terms Agreement, the Company shall file a Prospectus Supplement describing  the terms of such transaction, the amount of Shares sold, the price thereof, the  Manager’s compensation, and such other information as may be required pursuant  to Rule 424 and Rule 430B, as applicable, within the time required by Rule 424.    (x) Additional Registration Statement.  To the extent that the  Registration Statement is not available for the sales of the Shares as contemplated  by this Agreement, the Company shall file a new registration statement with  respect to any additional shares of Common Stock necessary to complete such  sales of the Shares and shall cause such registration statement to become effective  as promptly as practicable. After the effectiveness of any such registration  statement, all references to “Registration Statement” included in this Agreement  shall be deemed to include such new registration statement, including all  documents incorporated by reference therein pursuant to Item 12 of Form S-3,  and all references to “Base Prospectus” included in this Agreement shall be  deemed to include the final form of prospectus, including all documents  incorporated therein by reference, included in any such registration statement at  the time such registration statement became effective.    5. Payment of Expenses. The Company agrees to pay the costs and expenses  incident to the performance of its obligations under this Agreement, whether or not the  transactions contemplated hereby are consummated, including without limitation: (i) the  preparation, printing or reproduction and filing with the Commission of the Registration  Statement (including financial statements and exhibits thereto), the Prospectus and each  Issuer Free Writing Prospectus, and each amendment or supplement to any of them;  





 






 31  (ii) the printing (or reproduction) and delivery (including postage, air freight charges and  charges for counting and packaging) of such copies of the Registration Statement, the  Prospectus, and each Issuer Free Writing Prospectus, and all amendments or supplements  to any of them, as may, in each case, be reasonably requested for use in connection with  the offering and sale of the Shares; (iii) the preparation, printing, authentication, issuance  and delivery of certificates for the Shares, including any stamp or transfer taxes in  connection with the original issuance and sale of the Shares; (iv) the printing (or  reproduction) and delivery of this Agreement, any blue sky memorandum (if reasonably  requested by the Manager) and all other agreements or documents printed (or reproduced)  and delivered in connection with the offering of the Shares; (v) the registration of the  Shares under the Exchange Act, if applicable, and the listing of the Shares on the Trading  Market; (vi) any registration or qualification of the Shares for offer and sale under the  securities or blue sky laws of the several states (including filing fees and the reasonable  fees and expenses of counsel for the Manager relating to such registration and  qualification); (vii)  the fees and expenses of the Company’s accountants and the fees and  expenses of counsel (including local and special counsel) for the Company; (viii) the  filing fee under FINRA Rule 5110; (ix) the reasonable fees and expenses of the  Manager’s counsel, not to exceed $50,000  (excluding any Representation Date due  diligence fees provided for under Section 4(n)), which amount shall be paid upon the  Execution Time; and (x) all other costs and expenses incident to the performance by the  Company of its obligations hereunder.    6. Conditions to the Obligations of the Manager. The obligations of the  Manager under this Agreement and any Terms Agreement shall be subject to (i) the  accuracy of the representations and warranties on the part of the Company contained  herein as of the Execution Time, each Representation Date, and as of each Applicable  Time, Settlement Date and Time of Delivery, (ii) the performance by the Company of its  obligations hereunder and (iii) the following additional conditions:    (a) Filing of Prospectus Supplement.  The Prospectus, and any  supplement thereto, required by Rule 424 to be filed with the Commission shall  have been filed in the manner and within the time period required by Rule 424(b)  with respect to any sale of Shares; each Prospectus Supplement shall have been  filed in the manner required by Rule 424(b) within the time period required  hereunder and under the Act; any other material required to be filed by the  Company pursuant to Rule 433(d) under the Act, shall have been filed with the  Commission within the applicable time periods prescribed for such filings by  Rule 433; and no stop order suspending the effectiveness of the Registration  Statement or any notice objecting to its use shall have been issued and no  proceedings for that purpose shall have been instituted or threatened.     (b) Delivery of Opinion.  The Company shall have caused the  Company Counsel to furnish to the Manager its opinion and negative assurance  statement, dated as of such date and addressed to the Manager in form and  substance acceptable to the Manager.    





 






 32  (c) Delivery of Officer’s Certificate.  The Company shall have  furnished or caused to be furnished to the Manager a certificate of the Company  signed by the Chief Executive Officer or the President and the principal financial  or accounting officer of the Company, dated as of such date, to the effect that the  signers of such certificate have carefully examined the Registration Statement, the  Prospectus, any Prospectus Supplement and any documents incorporated by  reference therein and any supplements or amendments thereto and this Agreement  and that:     (i) the representations and warranties of the Company in this  Agreement are true and correct on and as of such date with the same effect  as if made on such date and the Company has complied with all the  agreements and satisfied all the conditions on its part to be performed or  satisfied at or prior to such date;     (ii) no stop order suspending the effectiveness of the  Registration Statement or any notice objecting to its use has been issued  and no proceedings for that purpose have been instituted or, to the  Company’s knowledge, threatened; and     (iii) since the date of the most recent financial statements  included in the Registration Statement, the Prospectus and the  Incorporated Documents, there has been no Material Adverse Effect on  the condition (financial or otherwise), earnings, business or properties of  the Company and its subsidiaries, taken as a whole, whether or not arising  from transactions in the ordinary course of business, except as set forth in  or contemplated in the Registration Statement and the Prospectus.     (d) Delivery of Accountants’ “Comfort” Letter.  The Company shall  have requested and caused the Accountants to have furnished to the Manager  letters (which may refer to letters previously delivered to the Manager), dated as  of such date, in form and substance satisfactory to the Manager, confirming that  they are independent accountants within the meaning of the Act and the Exchange  Act and the respective applicable rules and regulations adopted by the  Commission thereunder and that they have performed a review of any unaudited  interim financial information of the Company included or incorporated by  reference in the Registration Statement and the Prospectus and provide customary  “comfort” as to such review in form and substance satisfactory to the Manager.    (e) No Material Adverse Event.  Since the respective dates as of which  information is disclosed in the Registration Statement, the Prospectus and the  Incorporated Documents, except as otherwise stated therein, there shall not have  been (i) any material change or decrease in previously reported results specified in  the letter or letters referred to in paragraph (d) of this Section 6 or (ii) any change,  or any development involving a prospective change, in or affecting the condition  (financial or otherwise), earnings, business or properties of the Company and its  





 






 33  subsidiaries taken as a whole, whether or not arising from transactions in the  ordinary course of business, except as set forth in or contemplated in the  Registration Statement, the Prospectus and the Incorporated Documents  (exclusive of any amendment or supplement thereto) the effect of which, in any  case referred to in clause (i) or (ii) above, is, in the sole judgment of the Manager,  so material and adverse as to make it impractical or inadvisable to proceed with  the offering or delivery of the Shares as contemplated by the Registration  Statement (exclusive of any amendment thereof), the Incorporated Documents  and the Prospectus (exclusive of any amendment or supplement thereto).     (f) Payment of All Fees.  The Company shall have paid the required  Commission filing fees relating to the Shares within the time period required by  Rule 456(b)(1)(i) of the Act without regard to the proviso therein and otherwise in  accordance with Rules 456(b) and 457(r) of the Act and, if applicable, shall have  updated the “Calculation of Registration Fee” table in accordance with  Rule 456(b)(1)(ii) either in a post-effective amendment to the Registration  Statement or on the cover page of a prospectus filed pursuant to Rule 424(b).     (g) No FINRA Objections.  FINRA shall not have raised any objection  with respect to the fairness and reasonableness of the terms and arrangements  under this Agreement.     (h) Shares Listed on Trading Market.  The Shares shall have been  listed and admitted and authorized for trading on the Trading Market, and  satisfactory evidence of such actions shall have been provided to the Manager.     (i) Other Assurances.  Prior to each Settlement Date and Time of  Delivery, as applicable, the Company shall have furnished to the Manager such  further information, certificates and documents as the Manager may reasonably  request.    If any of the conditions specified in this Section 6 shall not have been fulfilled  when and as provided in this Agreement, or if any of the opinions and certificates  mentioned above or elsewhere in this Agreement shall not be reasonably satisfactory in  form and substance to the Manager and counsel for the Manager, this Agreement and all  obligations of the Manager hereunder may be canceled at, or at any time prior to, any  Settlement Date or Time of Delivery, as applicable, by the Manager. Notice of such  cancellation shall be given to the Company in writing or by telephone or facsimile  confirmed in writing.     The documents required to be delivered by this Section 6 shall be delivered to the  office of Ellenoff Grossman & Schole LLP, counsel for the Manager, at 1345 Avenue of  the Americas, New York, New York 10105, email: capmkts@egsllp.com, on each such  date as provided in this Agreement.     7. Indemnification and Contribution.   





 






 34    (a) Indemnification by Company.  The Company agrees to indemnify  and hold harmless the Manager, the directors, officers, employees and agents of  the Manager and each person who controls the Manager within the meaning of  either the Act or the Exchange Act against any and all losses, claims, damages or  liabilities, joint or several, to which they or any of them may become subject  under the Act, the Exchange Act or other Federal or state statutory law or  regulation, at common law or otherwise, insofar as such losses, claims, damages  or liabilities (or actions in respect thereof) arise out of or are based upon any  untrue statement or alleged untrue statement of a material fact contained in the  Registration Statement for the registration of the Shares as originally filed or in  any amendment thereof, or in the Base Prospectus, any Prospectus Supplement,  the Prospectus, any Issuer Free Writing Prospectus, or in any amendment thereof  or supplement thereto, or arise out of or are based upon the omission or alleged  omission to state therein a material fact required to be stated therein or necessary  to make the statements therein not misleading or result from or relate to any  breach of any of the representations, warranties, covenants or agreements made  by the Company in this Agreement, and agrees to reimburse each such  indemnified party for any legal or other expenses reasonably incurred by them in  connection with investigating or defending any such loss, claim, damage, liability  or action; provided, however, that the Company will not be liable in any such case  to the extent that any such loss, claim, damage or liability arises out of or is based  upon any such untrue statement or alleged untrue statement or omission or alleged  omission made therein in reliance upon and in conformity with written  information furnished to the Company by the Manager specifically for inclusion  therein. This indemnity agreement will be in addition to any liability that the  Company may otherwise have.     (b) Indemnification by Manager.  The Manager agrees to indemnify  and hold harmless the Company, each of its directors, each of its officers who  signs the Registration Statement, and each person who controls the Company  within the meaning of either the Act or the Exchange Act, to the same extent as  the foregoing indemnity from the Company to the Manager, but only with  reference to written information relating to the Manager furnished to the  Company by the Manager specifically for inclusion in the documents referred to  in the foregoing indemnity; provided, however, that in no case shall the Manager  be responsible for any amount in excess of the Broker Fee applicable to the  Shares and paid hereunder. This indemnity agreement will be in addition to any  liability which the Manager may otherwise have.     (c) Indemnification Procedures.  Promptly after receipt by an  indemnified party under this Section 7 of notice of the commencement of any  action, such indemnified party will, if a claim in respect thereof is to be made  against the indemnifying party under this Section 7, notify the indemnifying party  in writing of the commencement thereof; but the failure so to notify the  indemnifying party (i) will not relieve it from liability under paragraph (a) or (b)  





 






 35  above unless and to the extent it did not otherwise learn of such action and such  failure results in the forfeiture by the indemnifying party of substantial rights and  defenses and (ii) will not, in any event, relieve the indemnifying party from any  obligations to any indemnified party other than the indemnification obligation  provided in paragraph (a) or (b) above. The indemnifying party shall be entitled to  appoint counsel of the indemnifying party’s choice at the indemnifying party’s  expense to represent the indemnified party in any action for which  indemnification is sought (in which case the indemnifying party shall not  thereafter be responsible for the fees and expenses of any separate counsel  retained by the indemnified party or parties except as set forth below); provided,  however, that such counsel shall be reasonably satisfactory to the indemnified  party. Notwithstanding the indemnifying party’s election to appoint counsel to  represent the indemnified party in an action, the indemnified party shall have the  right to employ separate counsel (including local counsel), and the indemnifying  party shall bear the reasonable fees, costs and expenses of such separate counsel if  (i) the use of counsel chosen by the indemnifying party to represent the  indemnified party would present such counsel with a conflict of interest, (ii) the  actual or potential defendants in, or targets of, any such action include both the  indemnified party and the indemnifying party and the indemnified party shall  have reasonably concluded that there may be legal defenses available to it and/or  other indemnified parties which are different from or additional to those available  to the indemnifying party, (iii) the indemnifying party shall not have employed  counsel reasonably satisfactory to the indemnified party to represent the  indemnified party within a reasonable time after notice of the institution of such  action or (iv) the indemnifying party shall authorize the indemnified party to  employ separate counsel at the expense of the indemnifying party. An  indemnifying party will not, without the prior written consent of the indemnified  parties, settle or compromise or consent to the entry of any judgment with respect  to any pending or threatened claim, action, suit or proceeding in respect of which  indemnification or contribution may be sought hereunder (whether or not the  indemnified parties are actual or potential parties to such claim or action) unless  such settlement, compromise or consent includes an unconditional release of each  indemnified party from all liability arising out of such claim, action, suit or  proceeding.     (d) Contribution.  In the event that the indemnity provided in  paragraph (a), (b) or (c) of this Section 7 is unavailable to or insufficient to hold  harmless an indemnified party for any reason, the Company and the Manager  agree to contribute to the aggregate losses, claims, damages and liabilities  (including legal or other expenses reasonably incurred in connection with  investigating or defending the same) (collectively “Losses”) to which the  Company and the Manager may be subject in such proportion as is appropriate to  reflect the relative benefits received by the Company on the one hand and by the  Manager on the other from the offering of the Shares; provided, however, that in  no case shall the Manager be responsible for any amount in excess of the Broker  Fee applicable to the Shares and paid hereunder. If the allocation provided by the  





 






 36  immediately preceding sentence is unavailable for any reason, the Company and  the Manager severally shall contribute in such proportion as is appropriate to  reflect not only such relative benefits but also the relative fault of the Company on  the one hand and of the Manager on the other in connection with the statements or  omissions which resulted in such Losses as well as any other relevant equitable  considerations. Benefits received by the Company shall be deemed to be equal to  the total net proceeds from the offering (before deducting expenses) received by  it, and benefits received by the Manager shall be deemed to be equal to the Broker  Fee applicable to the Shares and paid hereunder as determined by this Agreement.  Relative fault shall be determined by reference to, among other things, whether  any untrue or any alleged untrue statement of a material fact or the omission or  alleged omission to state a material fact relates to information provided by the  Company on the one hand or the Manager on the other, the intent of the parties  and their relative knowledge, access to information and opportunity to correct or  prevent such untrue statement or omission. The Company and the Manager agree  that it would not be just and equitable if contribution were determined by pro rata  allocation or any other method of allocation which does not take account of the  equitable considerations referred to above. Notwithstanding the provisions of this  paragraph (d), no person guilty of fraudulent misrepresentation (within the  meaning of Section 11(f) of the Act) shall be entitled to contribution from any  person who was not guilty of such fraudulent misrepresentation. For purposes of  this Section 7, each person who controls the Manager within the meaning of either  the Act or the Exchange Act and each director, officer, employee and agent of the  Manager shall have the same rights to contribution as the Manager, and each  person who controls the Company within the meaning of either the Act or the  Exchange Act, each officer of the Company who shall have signed the  Registration Statement and each director of the Company shall have the same  rights to contribution as the Company, subject in each case to the applicable terms  and conditions of this paragraph (d).     8. Termination.     (a) The Company shall have the right, by giving written notice as  hereinafter specified, to terminate the provisions of this Agreement relating to the  solicitation of offers to purchase the Shares in its sole discretion at any time upon  five (5) Business Day’s prior written notice. Any such termination shall be  without liability of any party to any other party except that (i) with respect to any  pending sale, through the Manager for the Company, the obligations of the  Company, including in respect of compensation of the Manager, shall remain in  full force and effect notwithstanding the termination and (ii) the provisions of  Sections 5, 7, 8, 9, 10, 12, the second sentence of 13 and 14 of this Agreement  shall remain in full force and effect notwithstanding such termination.    (b) The Manager shall have the right, by giving written notice as  hereinafter specified, to terminate the provisions of this Agreement relating to the  solicitation of offers to purchase the Shares in its sole discretion at any time. Any  





 






 37  such termination shall be without liability of any party to any other party except  that the provisions of Sections 5, 7, 8, 9, 10, 12, the second sentence of 13 and 14  of this Agreement shall remain in full force and effect notwithstanding such  termination.     (c) This Agreement shall remain in full force and effect until such date  that this Agreement is terminated pursuant to Sections 8(a) or (b) above or  otherwise by mutual agreement of the parties, provided that any such termination  by mutual agreement shall in all cases be deemed to provide that Sections 5, 7, 8,  9, 10, 12, the second sentence of 13 and 14 shall remain in full force and effect.    (d) Any termination of this Agreement shall be effective on the date  specified in such notice of termination, provided that such termination shall not be  effective until the close of business on the date of receipt of such notice by the  Manager or the Company, as the case may be. If such termination shall occur  prior to the Settlement Date or Time of Delivery for any sale of the Shares, such  sale of the Shares shall settle in accordance with the provisions of Section 2(b) of  this Agreement.     (e) In the case of any purchase of Shares by the Manager pursuant to a  Terms Agreement, the obligations of the Manager pursuant to such Terms  Agreement shall be subject to termination, in the absolute discretion of the  Manager, by prompt oral notice given to the Company prior to the Time of  Delivery relating to such Shares, if any, and confirmed promptly by electronic  mail, if since the time of execution of the Terms Agreement and prior to such  delivery and payment, (i) trading in the Common Stock shall have been  suspended by the Commission or the Trading Market or trading in securities  generally on the Trading Market shall have been suspended or limited or  minimum prices shall have been established on such exchange, (ii) a banking  moratorium shall have been declared either by Federal or New York State  authorities or (iii) there shall have occurred any outbreak or escalation of  hostilities, declaration by the United States of a national emergency or war, or  other calamity or crisis the effect of which on financial markets is such as to make  it, in the sole judgment of the Manager, impractical or inadvisable to proceed with  the offering or delivery of the Shares as contemplated by the Prospectus  (exclusive of any amendment or supplement thereto).     9. Representations and Indemnities to Survive. The respective agreements,  representations, warranties, indemnities and other statements of the Company or its  officers and of the Manager set forth in or made pursuant to this Agreement will remain  in full force and effect, regardless of any investigation made by the Manager or the  Company or any of the officers, directors, employees, agents or controlling persons  referred to in Section 7, and will survive delivery of and payment for the Shares.     





 






 38  10. Notices. All communications hereunder will be in writing and effective  only on receipt, and will be mailed, delivered, e-mailed or facsimiled to the addresses of  the Company and the Manager, respectively, set forth on the signature page hereto.     11. Successors. This Agreement will inure to the benefit of and be binding  upon the parties hereto and their respective successors and the officers, directors,  employees, agents and controlling persons referred to in Section 7, and no other person  will have any right or obligation hereunder.     12. No Fiduciary Duty. The Company hereby acknowledges that (a) the  purchase and sale of the Shares pursuant to this Agreement is an arm’s-length  commercial transaction between the Company, on the one hand, and the Manager and  any affiliate through which it may be acting, on the other, (b) the Manager is acting solely  as sales agent and/or principal in connection with the purchase and sale of the Company’s  securities and not as a fiduciary of the Company and (c) the Company’s engagement of  the Manager in connection with the offering and the process leading up to the offering is  as independent contractors and not in any other capacity. Furthermore, the Company  agrees that it is solely responsible for making its own judgments in connection with the  offering (irrespective of whether the Manager has advised or is currently advising the  Company on related or other matters). The Company agrees that it will not claim that the  Manager has rendered advisory services of any nature or respect, or owe an agency,  fiduciary or similar duty to the Company, in connection with such transaction or the  process leading thereto.     13. Integration. This Agreement and any Terms Agreement supersede all prior  agreements and understandings (whether written or oral) between the Company and the  Manager with respect to the subject matter hereof. Notwithstanding anything herein to  the contrary, the letter agreement, dated February 11, 2021, by and between the Company  and the Manager shall continue to be effective and the terms therein shall continue to  survive and be enforceable by the Manager in accordance with its terms, provided that, in  the event of a conflict between the terms of the letter agreement and this Agreement, the  terms of this Agreement shall prevail.    14. 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 Manager.  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.    15. Applicable Law. This Agreement and any Terms Agreement will be  governed by and construed in accordance with the laws of the State of New York  applicable to contracts made and to be performed within the State of New York.  Each of  the Company and the Manager: (i) agrees that any legal suit, action or proceeding arising  out of or relating to this Agreement shall be instituted exclusively in New York Supreme  





 






 39  Court, County of New York, or in the United States District Court for the Southern  District of New York, (ii) waives any objection which it may have or hereafter to the  venue of any such suit, action or proceeding, and (iii) irrevocably consents to the  jurisdiction of the New York Supreme Court, County of New York, and the United States  District Court for the Southern District of New York in any such suit, action or  proceeding.  Each of the Company and the Manager further agrees to accept and  acknowledge service of any and all process which may be served in any such suit, action  or proceeding in the New York Supreme Court, County of New York, or in the United  States District Court for the Southern District of New York and agrees that service of  process upon the Company mailed by certified mail to the Company’s address shall be  deemed in every respect effective service of process upon the Company, in any such suit,  action or proceeding, and service of process upon the Manager mailed by certified mail to  the Manager’s address shall be deemed in every respect effective service process upon  the Manager, in any such suit, action or proceeding. If either party shall commence an  action or proceeding to enforce any provision of this Agreement, then the prevailing party  in such action or proceeding shall be reimbursed by the other party for its reasonable  attorney’s fees and other costs and expenses incurred with the investigation, preparation  and prosecution of such action or proceeding.    16. WAIVER OF JURY TRIAL. THE COMPANY HEREBY  IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY  APPLICABLE LAW, ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY  LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS  AGREEMENT, ANY TERMS AGREEMENT OR THE TRANSACTIONS  CONTEMPLATED HEREBY OR THEREBY.     17. Counterparts. This Agreement and any Terms Agreement may be signed  in one or more counterparts, each of which shall constitute an original and all of which  together shall constitute one and the same agreement, which may be delivered by  facsimile or in .pdf file via e-mail.    18. Headings. The section headings used in this Agreement and any Terms  Agreement are for convenience only and shall not affect the construction hereof.     *************************** 





 






 40    If the foregoing is in accordance with your understanding of our agreement,  please sign and return to us the enclosed duplicate hereof, whereupon this letter and your  acceptance shall represent a binding agreement among the Company and the Manager.       Very truly yours,    CALADRIUS BIOSCIENCES, INC.    By: /s/ Todd C. Girolamo  Name: Todd C. Girolamo  Title: Chief Legal Officer & SVP, Corporate Development    Address for Notice:    110 Allen Road, Second Floor  Basking Ridge, NJ 07920        The foregoing Agreement is hereby confirmed and accepted as of  the date first written above.     H.C. WAINWRIGHT & CO., LLC    By: /s/ Edward D. Silvera   Name: Edward D. Silvera  Title: Chief Operating Officer    Address for Notice:    430 Park Avenue  New York, New York 10022  Attention: Chief Executive Officer      





 






 41  Form of Terms Agreement  ANNEX I   CALADRIUS BIOSCIENCES, INC.  TERMS AGREEMENT    Dear Sirs:           Caladrius Biosciences, Inc. (the “Company”) proposes, subject to the  terms and conditions stated herein and in the At The Market Offering Agreement,  dated June 4, 2021 (the “At The Market Offering Agreement”), between the  Company and H.C. Wainwright & Co., LLC (“Manager”), to issue and sell to  Manager the securities specified in the Schedule I hereto (the “Purchased  Shares”).           Each of the provisions of the At The Market Offering Agreement not  specifically related to the solicitation by the Manager, as agent of the Company,  of offers to purchase securities is incorporated herein by reference in its entirety,  and shall be deemed to be part of this Terms Agreement to the same extent as if  such provisions had been set forth in full herein. Each of the representations and  warranties set forth therein shall be deemed to have been made at and as of the  date of this Terms Agreement and the Time of Delivery, except that each  representation and warranty in Section 3 of the At The Market Offering  Agreement which makes reference to the Prospectus (as therein defined) shall be  deemed to be a representation and warranty as of the date of the At The Market  Offering Agreement in relation to the Prospectus, and also a representation and  warranty as of the date of this Terms Agreement and the Time of Delivery in  relation to the Prospectus as amended and supplemented to relate to the Purchased  Shares.           An amendment to the Registration Statement (as defined in the At The  Market Offering Agreement), or a supplement to the Prospectus, as the case may  be, relating to the Purchased Shares, in the form heretofore delivered to the  Manager is now proposed to be filed with the Securities and Exchange  Commission.           Subject to the terms and conditions set forth herein and in the At The  Market Offering Agreement which are incorporated herein by reference, the  Company agrees to issue and sell to the Manager and the latter agrees to purchase  from the Company the number of shares of the Purchased Shares at the time and  place and at the purchase price set forth in the Schedule I hereto.   





 






 42            If the foregoing is in accordance with your understanding, please sign and return to  us a counterpart hereof, whereupon this Terms Agreement, including those provisions of  the At The Market Offering Agreement incorporated herein by reference, shall constitute  a binding agreement between the Manager and the Company.                CALADRIUS BIOSCIENCES, INC.        By:______       Name:         Title:         ACCEPTED as of the date first written above.              H.C. WAINWRIGHT & CO., LLC          By:__________________________________________       Name:       Title: