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Verastem, Inc. 5.00% Convertible Senior Notes due 2048 Placement Agent Agreement

Key Takeaway: 5.00% Convertible Senior Notes due 2048 Placement Agent Agreement Lazard Fr res & Co. LLC 30 Rockefeller Plaza New York, New York 10112 Ladies and Gentlemen: 1. Introduction. Verastem, Inc., a Delaware corporation (the Company ), proposes, subject to the terms and condition

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5.00% Convertible Senior Notes due 2048
Placement Agent Agreement
Lazard Fr res & Co. LLC
30 Rockefeller Plaza
New York, New York 10112
Ladies and Gentlemen:
1. Introduction. Verastem, Inc., a Delaware corporation (the Company ), proposes, subject to the terms and conditions stated herein, to issue and sell to certain investors (collectively, the Investors ) an aggregate of $150,000,000 principal amount of its 5.00% convertible senior notes due 2048 (the Offered Securities ), which shall be convertible into shares of Common Stock of the Company, par value $0.0001 ( Common Stock, and any shares of Common Stock issuable upon conversion of the Offered Securities, the Underlying Shares ), and in certain cases, cash (the offer and sale of the Offered Securities is referred to herein as the Offering ). All references herein to a principal amount of Offered Securities refer to the face principal amount of such Offered Securities. Lazard Fr res & Co. LLC has agreed to act as placement agent (the Placement Agent ) in accordance with the terms and conditions hereof.
2. Representations and Warranties of the Company. The Company represents and warrants to, and agrees with the Placement Agent that:
(a) Filing and Effectiveness of Registration Statement; Certain Defined Terms. The Company has filed with the Commission a registration statement on Form S-3 (No. 333-226322) which has been declared effective by the Commission, including a related prospectus or prospectuses, covering the registration of the Offered Securities under the Securities Act, which has become effective. Registration Statement at any particular time means such registration statement in the form then filed with the Commission, including any amendment and supplement thereto, any document incorporated by reference therein and all 430B Information and all 430C Information with respect to such registration statement, that in any case has not been superseded or modified. Registration Statement without reference to a time means the Registration Statement as of the Applicable Time. For purposes of this definition, 430B Information shall be considered to be included in the Registration Statement as of the time specified in Rule 430B.
For purposes of this Agreement:
430B Information means information included in a prospectus then deemed to be a part of the Registration Statement pursuant to Rule 430B(e) or retroactively deemed to be a part of the Registration Statement pursuant to Rule 430B(f).
430C Information means information included in a prospectus then deemed to be a part of the Registration Statement pursuant to Rule 430C.
Applicable Time means 7:00 p.m. (Eastern time) on October 11, 2018.
Base Prospectus means the base prospectus contained in the Registration Statement at the time of its initial effectiveness, dated August 3, 2018.
Closing Date has the meaning defined in Section 4 hereof.
Commission means the Securities and Exchange Commission.
Covered Exempt Written Communication, as used herein, means (i) each Exempt Written Communication that is not a Permitted Exempt Written Communication and (ii) each Permitted Exempt Written Communication.
Disclosure Package means, collectively, any Permitted Free Writing Prospectus issued at or prior to the Applicable Time, the Preliminary Prospectus, any document incorporated by reference therein, and the other information, if any, stated in Schedule I to this Agreement.
Documents means, collectively, this Agreement, the Indenture and the Offered Securities.
Exchange Act means the Securities Exchange Act of 1934, as amended.
Exempt Oral Communication means each oral communication, if any, made prior to the filing of the Registration Statement by the Company or any person authorized to act on behalf of the Company made to one or more QIBs and/or one or more IAIs to determine whether such investors might have an interest in a contemplated securities offering.
Exempt Written Communication, as used herein, means each written communication, if any, by the Company or any person authorized to act on behalf of the Company made to one or more qualified institutional buyers ( QIBs ), as defined in Rule 144A under the Securities Act, and/or one or more institutions that are accredited investors ( IAIs ), as defined in Rule 501(a) under the Securities Act, to determine whether such investors might have an interest in a contemplated securities offering.
Final Prospectus means the prospectus supplement relating to the Offered Securities that is first filed pursuant to Rule 424(b) after the Applicable Time, together with the Base Prospectus (including any document incorporated by reference therein).
Indenture means that certain Indenture, to be dated as of October 17, 2018, between the Company and the Trustee, as amended and supplemented by the First Supplemental Indenture thereto, to be dated as of October 17, 2018, between the Company and the Trustee.
Issuer Free Writing Prospectus means any issuer free writing prospectus, as defined in Rule 433, relating to the Offered Securities in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company s records pursuant to Rule 433(g).
Permitted Exempt Written Communication means the documents listed on Schedule I attached hereto.
Permitted Free Writing Prospectuses, means the documents listed on Schedule I attached hereto and each road show (as defined in Rule 433 under the Securities Act), if any, related to the Offering contemplated hereby that is a written communication (as defined in Rule 405 under the Securities Act). The Placement Agent has not offered or sold and will not offer or sell, without the Company s consent, any Offered Securities by means of any free writing prospectus (as defined in Rule 405 under
the Securities Act) that is required to be filed by the Placement Agent with the Commission pursuant to Rule 433 under the Securities Act, other than a Permitted Free Writing Prospectus.
Preliminary Prospectus means the preliminary prospectus supplement relating to the Offered Securities that is used prior to the Applicable Time, together with the Base Prospectus (including any document incorporated by reference therein).
Prospectus Supplement means the final prospectus supplement relating to the Offered Securities filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act on or before the second business day after the date hereof (or such earlier time as may be required under the Securities Act) in the form furnished by the Company to the Placement Agent in connection with the Offering.
Rules and Regulations means the rules and regulations of the Commission.
Securities Act means the Securities Act of 1933, as amended.
Securities Laws means, collectively, the Sarbanes-Oxley Act of 2002 ( Sarbanes-Oxley ), the Securities Act, the Exchange Act, the Rules and Regulations, the auditing principles, rules, standards and practices applicable to auditors of issuers (as defined in Sarbanes-Oxley) promulgated or approved by the Public Company Accounting Oversight Board and the rules of the Nasdaq Stock Market LLC.
Statutory Prospectus with reference to any particular time means the prospectus relating to the Offered Securities that is included in the Registration Statement, including any document incorporated by reference therein, immediately prior to that time, including all 430B Information and all 430C Information with respect to the Registration Statement. For purposes of the foregoing definition, 430B Information shall be considered to be included in the Statutory Prospectus only as of the actual time that form of prospectus (including a prospectus supplement) is filed with the Commission pursuant to Rule 424(b) and not retroactively.
Trustee means Wilmington Trust, National Association.
Transactions means, collectively, the transactions contemplated by this Agreement, the Indenture and the Offered Securities.
Unless otherwise specified, a reference to a Rule is to the indicated Rule under the Securities Act. Any reference herein to the Registration Statement, any Base Prospectus, any Preliminary Prospectus, the Prospectus Supplement, the Final Prospectus or any Permitted Free Writing Prospectus shall be deemed to refer to and include the documents, if any, incorporated by reference therein pursuant to Item 12 of Form S-3 (the Incorporated Documents ).
(b) The Registration Statement has heretofore become effective under the Securities Act; no order of the Commission preventing or suspending the use of any Base Prospectus, any Preliminary Prospectus, the Prospectus Supplement, the Final Prospectus or any Permitted Free Writing Prospectus has been issued, no stop order suspending the effectiveness of the Registration Statement, has been issued, and no proceedings for such purpose have been instituted or, to the Company s knowledge, are contemplated by the Commission.
(c) The Registration Statement complied in all material respects with the requirements of the Securities Act when it became effective and at the Applicable Time; the conditions to the use of Form S-3 in connection with the Offering as contemplated hereby have been satisfied; the
Registration Statement meets, and the Offering as contemplated hereby complies with, the requirements of Rule 415 under the Securities Act; the Registration Statement did not, when it became effective, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; each Preliminary Prospectus complied, at the time it was filed with the Commission, in all material respects, with the requirements of the Securities Act; the Disclosure Package, as of the Applicable Time, did not include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; each of the Prospectus Supplement and the Final Prospectus will comply, as of the date that it is filed with the Commission and the time of purchase, with the requirements of the Securities Act (including, without limitation, Section 10(a) of the Securities Act); the Final Prospectus, as of its date, the date that it is filed with the Commission and the time of purchase will not, as then amended or supplemented, include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided, however, that the Company makes no representation or warranty in this Section 3(c) with respect to any statement contained in the Registration Statement, the Disclosure Package or the Final Prospectus made in reliance upon and in conformity with information relating to the Placement Agent and furnished in writing by or on behalf of you to the Company expressly for use in the Registration Statement, the Disclosure Package or the Final Prospectus; each Incorporated Document, at the time such document was filed, or will be filed, with the Commission or at the time such document became or becomes effective, as applicable, complied or will comply, in all material respects, with the requirements of the Exchange Act and did not or will not, as applicable, include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(d) Prior to the execution of this Agreement, the Company has not, directly or indirectly, offered or sold any Offered Securities by means of any prospectus (within the meaning of the Securities Act) or used any prospectus (within the meaning of the Securities Act) in connection with the offer or sale of the Offered Securities, in each case other than the Preliminary Prospectuses and the Permitted Free Writing Prospectuses, if any and, the Permitted Exempt Written Communications, if any; the Company has not, directly or indirectly, prepared, used or referred to any Permitted Free Writing Prospectus except in compliance with Rules 164 and 433 under the Securities Act; assuming that such Permitted Free Writing Prospectus is so sent or given after the Registration Statement was filed with the Commission (and after such Permitted Free Writing Prospectus was, if required pursuant to Rule 433(d) under the Securities Act, filed with the Commission), the sending or giving, by the Placement Agent, of any Permitted Free Writing Prospectus will satisfy the provisions of Rule 164 and Rule 433 (without reliance on subsections (b), (c) and (d) of Rule 164); the conditions set forth in one or more of subclauses (i) through (iv), inclusive, of Rule 433(b)(1) under the Securities Act are satisfied, and neither the Company nor the Placement Agent is disqualified, by reason of subsection (f) or (g) of Rule 164 under the Securities Act, from using, in connection with the offer and sale of the Offered Securities, free writing prospectuses (as defined in Rule 405 under the Securities Act) pursuant to Rules 164 and 433 under the Securities Act; the Company is not an ineligible issuer (as defined in Rule 405 under the Securities Act) as of the eligibility determination date for purposes of Rules 164 and 433 under the Securities Act with respect to the offering of the Offered Securities contemplated by the Registration Statement, without taking into account any determination by the Commission pursuant to Rule 405 under the Securities Act that it is not necessary under the circumstances that the Company be considered an ineligible issuer ; the parties hereto agree and understand that the content of any and all road shows (as defined in Rule 433 under the Securities Act), Exempt
Oral Communications and Covered Exempt Written Communications related to the offering of the Offered Securities contemplated hereby is solely the property of the Company.
(e) The Company is subject to, and is in full compliance in all material respects with, the reporting requirements of Section 13 and Section 15(d), as applicable, of the Exchange Act.
(f) None of the Transactions or the application of the proceeds of the Offered Securities will violate or result in a violation of Regulation T (12 C.F.R. Part 220), Regulation U (12 C.F.R. Part 221) or Regulation X (12 C.F.R. Part 224) of the Board of Governors of the Federal Reserve System.
(g) Except as otherwise disclosed in the Registration Statement, the Disclosure Package and the Final Prospectus, there are no outstanding loans, advances (except advances for business expenses in the ordinary course of business) or guarantees of indebtedness by the Company or any affiliate of the Company to or for the benefit of any of the officers or directors of the Company or any affiliate of the Company or any of their respective family members.
(h) Each Permitted Exempt Written Communication, if any, when taken together with the Disclosure Package, did not as of its date include an untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading.
(i) The Company has, prior to the date of the Preliminary Prospectus, furnished to you a list containing the names of the recipients of all Covered Exempt Written Communications and all Exempt Oral Communications; if any; the Company has not authorized anyone other than the Placement Agent to engage in any Exempt Oral Communication or Exempt Written Communication; the Company hereby reconfirms that the Placement Agent has been authorized to act on its behalf in undertaking any Exempt Oral Communications or Exempt Written Communications.
(j) Each Covered Exempt Written Communication, if any, does not as of the date hereof conflict with the information contained in the Registration Statement, the Preliminary Prospectus and the Final Prospectus.
(k) As of the date of this Agreement, the Company has an authorized and outstanding capitalization and an indebtedness as set forth in the sections of the Registration Statement, the Disclosure Package and the Final Prospectus entitled The Offering, Capitalization, Description of Notes, Description of Other Indebtedness and Description of Capital Stock , and, as of the time of purchase and any additional time of purchase, as the case may be, the Company shall have an authorized and outstanding capitalization and an indebtedness as set forth in the sections of the Registration Statement, the Disclosure Package and the Final Prospectus entitled The Offering, Capitalization, Description of Notes, Description of Other Indebtedness and Description of Capital Stock (subject, in each case, to the issuance of shares of Common Stock upon exercise of stock options and warrants and settlement of restricted stock units granted under existing equity plans described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus, the grant of awards under existing equity incentive plans described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus and the grant of stock options pursuant to the Company s inducement award programs, as described in the Company s registration statements on Form S-8 filed with the Commission); all of the issued and outstanding shares of capital stock, including the Common Stock, of the Company have been duly authorized and validly issued and are fully paid and non-assessable, have been issued in compliance with all applicable securities laws and were
not issued in violation of any preemptive right, resale right, right of first refusal or similar right; the Underlying Shares are duly listed, and admitted and authorized for trading, subject to official notice of issuance, on the Nasdaq Global Market.
(l) The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the State of Delaware, with full corporate power and authority to own, lease and operate its properties and conduct its business as described in the Registration Statement, the Disclosure Package and the Final Prospectus, to execute, deliver and perform its obligations under this Agreement and the Indenture and to issue, sell and deliver the Offered Securities as contemplated herein.
(m) The Company is duly qualified to do business as a foreign corporation and is in good standing in the Commonwealth of Massachusetts, and each other jurisdiction where the ownership or leasing of its properties or the conduct of its business requires such qualification, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, either (i) have a material adverse effect on (A) the properties, business, financial condition, results of operations, or prospects of the Company and the Subsidiary, taken as a whole, or (B) the consummation of any of the Transactions, (ii) prevent or materially interfere with consummation of any of the Transactions or (iii) result in the delisting of shares of Common Stock from the Nasdaq Global Market (the occurrence of any such effect or any such prevention or interference or any such result described in the foregoing clauses (i), (ii) and (iii) being herein referred to as a Material Adverse Effect ).
(n) The Company has no subsidiaries (as defined under the Securities Act) other than Verastem Securities Company (the Subsidiary ); the Company owns all of the issued and outstanding capital stock of the Subsidiary; other than (i) the capital stock of the Subsidiary and (ii) Permitted Investments, the Company does not own, directly or indirectly, any shares of stock or any other equity interests or long-term debt securities of any corporation, firm, partnership, joint venture, association or other entity; complete and correct copies of the charters and the bylaws of the Company and the Subsidiary and all amendments thereto have been made available to you, and no changes therein will be made on or after the date hereof through and including the consummation of the offer and sale of the Offered Securities; the Subsidiary has been duly incorporated and is validly existing as a corporation in good standing under the laws of the Commonwealth of Massachusetts, with full corporate power and authority to own, lease and operate its properties and to conduct its business as described in the Registration Statement, the Disclosure Package and the Final Prospectus; the Subsidiary is duly qualified to do business as a foreign corporation and is in good standing in each jurisdiction where the ownership or leasing of its properties or the conduct of its business requires such qualification, except where the failure to be so qualified and in good standing would not, individually or in the aggregate, have a Material Adverse Effect; all of the outstanding shares of capital stock of the Subsidiary have been duly authorized and validly issued, are fully paid and non-assessable, have been issued in compliance with all applicable securities laws, were not issued in violation of any preemptive right, resale right, right of first refusal or similar right and are owned by the Company subject to no security interest, other encumbrance or adverse claims; and no options, warrants or other rights to purchase, agreements or other obligations to issue or other rights to convert any obligation into shares of capital stock or ownership interests in the Subsidiary are outstanding. For purposes of this Agreement, Permitted Investments means (i) U.S. Treasury bills, notes and bonds; (ii) U.S. agency debt obligations; (iii) corporate debt obligations rated (x) A3/A- or better by Moody s or Standard & Poor s, or (y) P-1 by Moody s or A-1 or better by Standard & Poor s; (iv) bank debt obligations rated (x) A3/A- or better by Moody s or Standard & Poor s, or (y) P-1 by Moody s or A-1 or better by Standard & Poor s; (v) taxable and tax-exempt municipal debt obligations rated
(x) Aa3/AA- or better by Moody s or Standard & Poor s, (y) MIG1 or VMIG1 by Moody s or SP-1 or better by Standard & Poor s, or (z) P-1 by Moody s or A-1 or better by Standard & Poor s; (vi) shares of SEC-registered money market funds with a net asset value of $1.00/share and a minimum of $1 billion in assets; (vii) repurchase agreements collateralized at a minimum 102% with U.S. Treasury bills, notes or bonds, U.S. agency debt obligations, or cash; (viii) asset- backed securities collateralized by non-mortgage consumer receivables rated (x) AAA by Moody s or Standard & Poor s or (y) P-1 by Moody s or A-1+ by Standard & Poor s; and (ix) asset-backed commercial paper rated P-1 by Moody s or A-1 or better by Standard & Poor s.
(o) The Underlying Shares have been duly and validly authorized and, when issued and delivered upon conversion of the Offered Securities in accordance with the Indenture, will be duly and validly issued, fully paid and non-assessable and free of preemptive rights, resale rights, rights of first refusal and similar rights; the Underlying Shares, when issued and delivered in accordance with the Indenture, will be free of any restriction upon the voting or transfer thereof pursuant to the Delaware General Corporation Law or the Company s charter or bylaws or any agreement or other instrument to which the Company is a party.
(p) The capital stock of the Company, including the Underlying Shares, conforms in all material respects to each description thereof, if any, contained or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus.
(q) There is no franchise, contract or other document of a character required to be described in the Registration Statement or Prospectus, or to be filed as an exhibit thereto, which is not described or filed as required (and the Disclosure Package contains in all material respects the same description of the foregoing matters contained in the Final Prospectus).
(r) This Agreement has been duly authorized, executed and delivered by the Company. The Indenture has been duly and validly authorized by the Company and, at the Closing Date, will have been duly executed and delivered by the Company and will constitute a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms, except that the enforcement thereof may be subject to (i) bankruptcy, insolvency, reorganization, receivership, moratorium, fraudulent conveyance, fraudulent transfer or other similar laws now or hereafter in effect relating to creditors rights generally and (ii) general principles of equity (whether applied by a court of law or equity) and the discretion of the court before which any proceeding therefor may be brought. When executed and delivered, this Agreement and the Indenture will conform in all material respects to the descriptions thereof in the Registration Statement, the Disclosure Package and the Final Prospectus.
(s) Neither the Company nor the Subsidiary is in breach or violation of or in default under (nor has any event occurred which, with notice, lapse of time or both, would result in any breach or violation of, constitute a default under or give the holder of any indebtedness (or a person acting on such holder s behalf) the right to require the repurchase, redemption or repayment of all or a part of such indebtedness under) (A) its respective charter or bylaws, (B) any indenture, mortgage, deed of trust, bank loan or credit agreement or other evidence of indebtedness, or any license, lease, contract or other agreement or instrument to which it is a party or by which it or any of its properties may be bound or affected, (C) any applicable federal, state, local or foreign law, regulation or rule, (D) any applicable rule or regulation of any self-regulatory organization or other non-governmental regulatory authority (including, without limitation, the rules and regulations of the Nasdaq Global Market), or (E) any decree, judgment or order applicable to it or any of its properties, except, in the case of the foregoing clauses (B), (C), (D) and (E), for any
such breach, violation, default or event that would not, individually or in the aggregate, have a Material Adverse Effect.
(t) The execution, delivery and performance of this Agreement, the issuance and sale of the Offered Securities and the consummation of the Transactions will not conflict with, result in any breach or violation of or constitute a default under (nor constitute any event which, with notice, lapse of time or both, would result in any breach or violation of, constitute a default under or give the holder of any indebtedness (or a person acting on such holder s behalf) the right to require the repurchase, redemption or repayment of all or a part of such indebtedness under (such event a Debt Repayment Triggering Event ), or result in the creation or imposition of a lien, charge or encumbrance on any property or assets of the Company or the Subsidiary pursuant to) (A) the charter or bylaws of the Company or the Subsidiary, (B) any indenture, mortgage, deed of trust, bank loan or credit agreement or other evidence of indebtedness, or any license, lease, contract or other agreement or instrument to which the Company or the Subsidiary is a party or by which either of them or any of their respective properties may be bound or affected, (C) any applicable federal, state, local or foreign law, regulation or rule, (D) any applicable rule or regulation of any self-regulatory organization or other non-governmental regulatory authority (including, without limitation, the rules and regulations of the Nasdaq Global Market), or (E) any decree, judgment or order applicable to the Company or the Subsidiary or any of their respective properties, except, in the case of the foregoing clauses (B), (C), (D) and (E), for any such conflict, breach, violation, default or event that would not, individually or in the aggregate, have a Material Adverse Effect.
(u) No approval, authorization, consent or order of or filing with any federal, state, local or foreign governmental or regulatory commission, board, body, authority or agency, or of or with any self- regulatory organization or other non-governmental regulatory authority (including, without limitation, the Nasdaq Global Market) having jurisdiction over the Company, or approval of the stockholders of the Company, is required in connection with the issuance and sale of the Offered Securities or the consummation by the Company of the Transactions, other than (i) the registration of the Offered Securities under the Securities Act, which as been effected (or, with respect to any registration statement to be filed hereunder pursuant to Rule 462(b) under the Securities Act, will be effected in accordance herewith), (ii) any necessary qualification under the securities or blue sky laws of the various jurisdictions in which the Offered Securities are being offered by the Placement Agent, (iii) under the Conduct Rules of the Financial Industry Regulatory Authority, Inc. ( FINRA ), (iv) any listing applications and related consents or any notices required by Nasdaq Global Market with respect to the Underlying Shares, (v) filings with the Commission pursuant to Rule 424(b) under the Securities Act or (vi) filings with the Commission on Form 8-K with respect to the Documents.
(v) Except as described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus, (i) no person has the right, contractual or otherwise, to cause the Company to issue or sell to it any shares of Common Stock or shares of any other capital stock or other equity or debt interests of the Company, (ii) no person has any preemptive rights, resale rights, rights of first refusal or other rights to purchase any shares of Common Stock or shares of any other capital stock of or other equity or debt interests in the Company and (iii) no person has the right to act as an underwriter or as a financial advisor to the Company in connection with the offer and sale of the Offered Securities; no person has the right, contractual or otherwise, to cause the Company to register under the Securities Act any shares of Common Stock or shares of any other capital stock of or other equity or debt interests in the Company, or to include any such shares or interests in the Registration Statement or the Offering contemplated by this Agreement, except any such right that has been validly waived in writing as of the date of this Agreement, copies of such waivers to have been made available to you; no person has the
right, contractual or otherwise, to cause the Company to register under the Securities Act any shares of Common Stock or shares of any other capital stock of or other equity or debt interests in the Company, or to include any such shares or interests in any other offering of securities of the Company.
(w) Each of the Company and the Subsidiary has all necessary licenses, authorizations, consents and approvals and has made all necessary filings required under any applicable law, regulation or rule, and has obtained all necessary licenses, authorizations, consents and approvals from other persons, in order to conduct their respective businesses, except where failure to have, make or obtain the same would not, individually or in the aggregate, have a Material Adverse Effect; neither the Company nor the Subsidiary is in violation of, or in default under, or has received notice of any proceedings relating to revocation or modification of, any such license, authorization, consent or approval or any federal, state, local or foreign law, regulation or rule or any decree, order or judgment applicable to the Company or the Subsidiary, except where such violation, default, revocation or modification would not, individually or in the aggregate, have a Material Adverse Effect.
(x) There are no actions, suits, claims, investigations or proceedings pending to which the Company or the Subsidiary or, to the Company s knowledge, any of their respective directors or officers is or would be a party or of which any of their respective properties is or would be subject at law or in equity, before or by any federal, state, local or foreign governmental or regulatory commissions, board, body, authority or agency, or before or by any self-regulatory organization or other non-governmental regulatory authority (including, without limitation, the Nasdaq Global Market), except any such action, suit, claim, investigation or proceeding which, if resolved adversely to the Company or the Subsidiary, would not, individually or in the aggregate, have a Material Adverse Effect (assuming, with respect to any such action, suit, claim, investigation or proceeding to which the Company or the Subsidiary is a party, that such action, suit, claim, investigation or proceeding was resolved adversely to the Company or the Subsidiary, as the case may be); and, to the Company s knowledge, no such actions, suits, claims, investigations or proceedings are threatened or contemplated.
(y) Ernst & Young LLP, whose report on the financial statements of the Company is included or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus, are independent registered public accountants as required by the Securities Act and by the rules of the Public Company Accounting Oversight Board.
(z) The financial statements included or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus, together with the related notes and schedules, present fairly the financial position of the Company as of the dates indicated and the results of operations, cash flows and changes in stockholders equity of the Company for the periods specified and have been prepared in compliance in all material respects with the requirements of the Securities Act and Exchange Act and in conformity with generally accepted accounting principles of the United States, applied on a consistent basis throughout the periods involved ( GAAP ), except as otherwise disclosed therein and, in the case of unaudited, interim financial statements, subject to normal year-end audit adjustments and the exclusion of certain footnotes; all pro forma financial statements or data included or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus, if any, comply in all material respects with the requirements of the Securities Act and the Exchange Act, to the extent applicable, and the assumptions used in the preparation of such pro forma financial statements and data are reasonable, the pro forma adjustments used therein are appropriate to give effect to the transactions or circumstances described therein and the pro forma adjustments have been
properly applied to the historical amounts in the compilation of those statements and data; the other financial data contained or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus, are accurately and fairly presented in all material respects and prepared on a basis consistent with the financial statements and books and records of the Company; there are no financial statements (historical or pro forma) that are required to be included or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus that are not included or incorporated by reference as required; and the Company and the Subsidiary do not have any material liabilities or obligations, direct or contingent (including any off-balance sheet obligations), not described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus.
(aa) Except as disclosed in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus, each stock option granted under any equity incentive plan of the Company (each, a Stock Plan ) was granted with a per share exercise price no less than the fair market value per share of Common Stock on the grant date of such option, and no such grant involved any back-dating or similar practice with respect to the effective date of such grant; except as would not, individually or in the aggregate, have a Material Adverse Effect, each such option (i) was granted in compliance with applicable law and with the applicable Stock Plan(s), (ii) was duly approved by the board of directors (or a duly authorized committee thereof or by an executive officer pursuant to Section 157(c) of the Delaware General Corporation Law) of the Company and (iii) has been properly accounted for in the Company s financial statements in accordance with GAAP and disclosed in the Company s filings with the Commission.
(bb) Subsequent to the respective dates as of which information is given in the Registration Statement, the Disclosure Package and the Final Prospectus, in each case excluding any amendments or supplements to the foregoing made after the execution of this Agreement, there has not been (i) any material adverse change, or any development that would be reasonably expected to result in a material adverse change, in the business, properties, management, financial condition or results of operations of the Company and the Subsidiary taken as a whole, (ii) any transaction to which the Company is a party which is material to the Company and the Subsidiary taken as a whole, (iii) any obligation or liability, direct or contingent (including any off-balance sheet obligations), incurred by the Company or the Subsidiary, which is material to the Company and the Subsidiary taken as a whole, (iv) any change in the capital stock or outstanding indebtedness of the Company or the Subsidiary (other than the issuance of shares of Common Stock upon exercise of stock options or vesting of restricted stock units granted under existing equity plans described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus and the grant of awards under equity incentive plans described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus, and the grant of stock options pursuant to the Company s inducement award programs, as described in the Company s registration statements on Form S-8 filed with the Commission, in each case in the ordinary course of business) or (v) any dividend or distribution of any kind declared, paid or made on the capital stock of the Company.
(cc) The Company has obtained for the benefit of the Placement Agent the agreement (a Lock-Up Agreement ), in the form set forth as Exhibit A hereto, of each person listed on Schedule II hereto (each a Locked-Up Person ).
(dd) Neither the Company nor the Subsidiary is and, after giving effect to the Offering and the application of the proceeds thereof, neither of them will be, an investment company or an entity controlled by an investment company, as such terms are defined in the Investment Company Act of 1940, as amended (the Investment Company Act ).
(ee) Each of the Company and the Subsidiary has good title to all personal property described in the Registration Statement, the Disclosure Package and the Final Prospectus as being owned by it, free and clear of all liens, claims, security interest or other encumbrances, except those that do not materially interfere with the use or proposed use of such property by the Company or the Subsidiary, respectively, or as would not materially or adversely affect the value of such property; neither the Company nor the Subsidiary owns any real property; all the real property described in the Registration Statement, the Disclosure Package and the Final Prospectus as being held under lease by the Company or the Subsidiary is held thereby under valid, subsisting and enforceable leases.
(ff) Except (A) as described in the Registration Statement, the Disclosure Package and the Final Prospectus or (B) as would not, individually or in the aggregate, have a Material Adverse Effect, (i) the Company or the Subsidiary owns the inventions, patent applications, patents, trademarks (both registered and unregistered), tradenames, service names, copyrights, trade secrets and other proprietary information (collectively, Intellectual Property ) described in the Registration Statement, the Disclosure Package and the Final Prospectus as being owned by it and owns or has obtained valid and enforceable licenses for, or other rights to use, all Intellectual Property used in, or necessary for, the conduct of the businesses of the Company and the Subsidiary as currently conducted or as proposed to be conducted (including the commercialization of products or services described in the Registration Statement, the Disclosure Package and the Final Prospectus as under development) (collectively, Company Intellectual Property ), except as enforceability may be limited by bankruptcy, insolvency or similar laws affecting the rights of creditors generally and general equitable principles; (ii) there are no third parties who have, or, to the Company s knowledge, will be able to establish, rights to use any Company Intellectual Property that is owned or purported to be owned by the Company or the Subsidiary, other than any co- owner of any patent or patent application constituting Intellectual Property who is listed as such on the records of the U.S. Patent and Trademark Office (the PTO ), and, to the Company s knowledge, no third party has any ownership interest in or to any Company Intellectual Property that is exclusively licensed to the Company or the Subsidiary, except for, and to the extent of, the ownership rights of the owners of the Company Intellectual Property which the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus disclose is licensed to the Company or the Subsidiary; (iii) to the Company s knowledge, there is no infringement, misappropriation or other violation by any third parties of any Company Intellectual Property owned by or exclusively licensed to the Company or the Subsidiary; (iv) neither the Company nor the Subsidiary has received any notice from, and there is no pending or, to the Company s knowledge, threatened action, suit, proceeding or claim by, others challenging the Company s or the Subsidiary s rights in or to any Company Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (v) neither the Company nor the Subsidiary has received any notice from, and there is no pending or, to the Company s knowledge, threatened action, suit, proceeding or claim by, others challenging the validity, enforceability or scope of any Company Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (vi) neither the Company nor the Subsidiary has received any notice from, and there is no pending or, to the Company s knowledge, threatened action, suit, proceeding or claim by, others that the Company or the Subsidiary infringes, misappropriates or otherwise violates, or would, upon the commercialization of any product or service described in the Registration Statement, the Disclosure Package and the Final Prospectus as under development, infringe, misappropriate or violate, any Intellectual Property of others, and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (vii) each of the Company and the Subsidiary has complied with the applicable terms of each agreement pursuant to which Company Intellectual Property has been
licensed to such entity, and all such agreements are in full force and effect; (viii) to the Company s knowledge, there is no patent or patent application that contains claims that, if practiced, would infringe the issued or pending claims of any patents or patent applications included in the Company Intellectual Property or that challenges the validity, enforceability or scope of any of the Company Intellectual Property; (ix) the manufacture, use and sale of the product candidates described in the Registration Statement, the Disclosure Package and the Final Prospectus as under development by the Company or the Subsidiary fall within the scope of the claims of one or more patents or patent applications owned by, or exclusively licensed to, the Company or the Subsidiary, as the case may be; (x) each of the Company and the Subsidiary has complied and, to the Company s knowledge, each of their respective licensors has complied, with its duty of candor and disclosure to the PTO with respect to all patent applications owned or exclusively licensed to such entity and included in the Company Intellectual Property and filed with the PTO; (xi) all conditions stated in any license agreement under which Company Intellectual Property is licensed to the Company or the Subsidiary that are required to be satisfied in order for the Company or the Subsidiary, as applicable, to retain exclusive rights have been timely satisfied; (xii) to the Company s knowledge, the issued patents owned by or exclusively licensed to the Company or the Subsidiary are valid and enforceable and the Company is unaware of any facts that would preclude the issuance of a valid and enforceable patent on any pending patent application owned by the Company or the Subsidiary; (xiii) the Company has taken reasonable steps necessary to secure interests of each of the Company and the Subsidiary in the Company Intellectual Property purported to be owned by such entity from the employees, consultants, agents and contractors of such entity; (xiv) there are no outstanding options, licenses or agreements of any kind relating to the Company Intellectual Property owned by the Company or the Subsidiary that are required to be described in the Registration Statement, the Disclosure Package and the Final Prospectus that are not so described therein; (xv) neither the Company nor the Subsidiary is a party to or bound by any options, licenses or agreements with respect to the Intellectual Property of any other person or entity that are required to be described in the Registration Statement, the Disclosure Package and the Final Prospectus that are not so described therein; and (xvi) no government funding, facilities or resources of a university, college, other educational institution or research center was used in the development of any Company Intellectual Property that is owned or purported to be owned by the Company or the Subsidiary that would confer upon any governmental agency or body, university, college, other educational institution or research center any claim or right in or to any such Company Intellectual Property.
(gg) Neither the Company nor the Subsidiary is engaged in any unfair labor practice; except for matters which would not, individually or in the aggregate, have a Material Adverse Effect, (i) there is (A) no unfair labor practice complaint pending or, to the Company s knowledge, threatened against the Company or the Subsidiary before the National Labor Relations Board, and no grievance or arbitration proceeding arising out of or under collective bargaining agreements is pending or, to the Company s knowledge, threatened, (B) no strike, labor dispute, slowdown or stoppage pending or, to the Company s knowledge, threatened against the Company or the Subsidiary and (C) no union representation dispute currently existing concerning the employees of the Company or the Subsidiary, (ii) to the Company s knowledge, no union organizing activities are currently taking place concerning the employees of the Company or the Subsidiary and (iii) there has been no violation of any federal, state, local or foreign law relating to discrimination in the hiring, promotion or pay of employees, any applicable wage or hour laws or any provision of the Employee Retirement Income Security Act of 1974, as amended, or the rules and regulations promulgated thereunder concerning the employees of the Company or the Subsidiary.
(hh) The Company and the Subsidiary and their respective properties, assets and operations are in compliance with, and the Company and the Subsidiary hold all permits, authorizations and approvals required under, Environmental Laws (as defined below), except to the extent that failure to so comply or to hold such permits, authorizations or approvals would not, individually or in the aggregate, have a Material Adverse Effect; there are no past, present or, to the Company s knowledge, reasonably anticipated future events, conditions, circumstances, activities, practices, actions, omissions or plans that would reasonably be expected to give rise to any material costs or liabilities to the Company or the Subsidiary under, or to interfere with or prevent compliance by the Company or the Subsidiary with, Environmental Laws; except as would not, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor the Subsidiary (i) is the subject of any investigation, (ii) has received any notice or claim, (iii) is a party to or affected by any pending or, to the Company s knowledge, threatened action, suit or proceeding, (iv) is bound by any judgment, decree or order or (v) has entered into any agreement, in each case relating to any alleged violation of any Environmental Law or any actual or alleged release or threatened release or cleanup at any location of any Hazardous Materials (as defined below) (as used herein, Environmental Law means any federal, state, local or foreign law, statute, ordinance, rule, regulation, order, decree, judgment, injunction, permit, license, authorization or other binding requirement, or common law, relating to health, safety or the protection, cleanup or restoration of the environment or natural resources, including those relating to the distribution, processing, generation, treatment, storage, disposal, transportation, other handling or release or threatened release of Hazardous Materials, and Hazardous Materials means any material (including, without limitation, pollutants, contaminants, hazardous or toxic substances or wastes) that is regulated by or may give rise to liability under any Environmental Law).
(ii) All tax returns required to be filed by the Company or the Subsidiary have been timely filed, and all taxes and other assessments of a similar nature (whether imposed directly or through withholding) including any interest, additions to tax or penalties applicable thereto due or claimed to be due from such entities have been timely paid, other than those being contested in good faith and for which adequate reserves have been provided, except to the extent failure to file such return or make such payments would not, individually or in the aggregate, have a Material Adverse Effect.
(jj) Except as described in the Registration Statement, the Disclosure Package and the Final Prospectus, the Company maintains insurance covering the properties, operations, personnel and businesses of the Company and the Subsidiary as the Company reasonably deems adequate to insure against such losses and risks in accordance with customary industry practice to protect the Company and the Subsidiary and their respective businesses; all such insurance is fully in force on the date hereof and will be fully in force at the time of purchase and each additional time of purchase, if any; the Company has no reason to believe that it will not be able to renew any such insurance as and when such insurance expires or obtain similar coverage at reasonable cost from similar insurers.
(kk) Neither the Company nor the Subsidiary has sent any communication or received any written communication regarding termination of, or intent not to renew, any of the contracts or agreements referred to or described in the Disclosure Package, any Preliminary Prospectus, the Final Prospectus or any Permitted Free Writing Prospectus, or referred to or described in, or filed as an exhibit to, the Registration Statement or any Incorporated Document, and no such termination or non-renewal has been threatened by the Company or the Subsidiary or, to the Company s knowledge, threatened in writing by any other party to any such contract or agreement.
(ll) The Company has established and maintains a system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with management s general or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain accountability for assets; (iii) access to assets is permitted only in accordance with management s general or specific authorization; and (iv) the recorded accountability for assets is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
(mm) The Company has established and maintains disclosure controls and procedures (as such term is defined in Rules 13a-15 and 15d-15 under the Exchange Act) and internal control over financial reporting (as such term is defined in Rules 13a-15 and 15d-15 under the Exchange Act); such disclosure controls and procedures are designed to ensure that material information relating to the Company, including the Subsidiary, is made known to the Company s Chief Executive Officer and Chief Financial Officer by others within those entities, and such disclosure controls and procedures are effective to perform the functions for which they were established; the Company s independent registered public accountants and the Audit Committee of the Board of Directors of the Company have been advised of: (i) all significant deficiencies, if any, in the design or operation of internal controls which could adversely affect the Company s ability to record, process, summarize and report financial data; and (ii) all fraud, if any, whether or not material, that involves management or other employees who have a role in the Company s internal controls; at December 31, 2017, no material weakness (as such term is defined in Rule 1-02(a)(4) of Regulation S-X under the Securities Act) existed with respect to the Company s internal control over financial reporting and since the end of the Company s most recent audited fiscal year there have been no significant deficiencies or material weaknesses in the Company s internal control over financial reporting identified to or by the Company s independent registered accountants or audit committee or Board of Directors of the Company; since the date of the most recent evaluation of such disclosure controls and procedures and internal controls, there have been no significant changes in internal controls or in other factors that could significantly affect internal controls, including any corrective actions with regard to significant deficiencies and material weaknesses; and the Company has taken all necessary actions to ensure that, upon and at all times after the filing of the Registration Statement, the principal executive officers (or their equivalents) and principal financial officers (or their equivalents) of the Company have made all certifications required by Sarbanes-Oxley and any related rules and regulations promulgated by the Commission, and the statements contained in each such certification are complete and correct; the Company, the Subsidiary and the Company s directors and officers, in their capacities as such, are each, in compliance in all material respects with the applicable provisions of Sarbanes-Oxley and the rules and regulations promulgated thereunder.
(nn) Each forward-looking statement (within the meaning of Section 27A of the Securities Act or Section 21E of the Exchange Act) contained or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus has been made or reaffirmed with a reasonable basis and in good faith.
(oo) All statistical or market-related data included or incorporated by reference in the Registration Statement, the Disclosure Package and the Final Prospectus are based on or derived from sources that the Company reasonably believes to be reliable and accurate, and the Company has obtained the written consent to the use of such data from such sources to the extent required.
(pp) Neither the Company nor the Subsidiary nor, to the knowledge of the Company, any director, officer, agent, employee or affiliate of the Company or the Subsidiary has taken any action, directly or indirectly, while acting on behalf of the Company or the Subsidiary, that would result in a violation by such persons of the Foreign Corrupt Practices Act of 1977, as amended, and the rules and regulations thereunder; the Company is not aware of any such action, directly or indirectly, having been taken on behalf of the Company or the Subsidiary; and the Company and the Subsidiary and, to the knowledge of the Company, their respective affiliates have instituted and maintain policies and procedures designed to ensure continued compliance therewith.
(qq) The operations of the Company and the Subsidiary are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the USA Patriot Act, the Bank Secrecy Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the Money Laundering Laws ); and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator or non-governmental authority involving the Company or the Subsidiary with respect to the Money Laundering Laws is pending or, to the Company s knowledge, threatened.
(rr) Neither the Company nor the Subsidiary nor any of their respective affiliates, directors, officers, nor to the knowledge of the Company, any agent or employee of the Company or the Subsidiary is subject to any sanctions administered or enforced by the Office of Foreign Assets Control of the United States Treasury Department, the U.S. Department of State, the United Nations Security Council, the European Union, Her Majesty s Treasury or any other relevant sanctions authority; and the Company will not directly or indirectly use the proceeds of the Offering contemplated hereby, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity for the purpose of financing the activities of any person that is the target of sanctions administered or enforced by such authorities or in connection with any country or territory that is the target of country- or territory-wide OFAC sanctions (currently, Iran, Sudan, Syria, Cuba, North Korea, and the Crimea Region of Ukraine).
(ss) The Company acknowledges that, in accordance with the requirements of the USA Patriot Act, the Placement Agent is required to obtain, verify and record information that identifies its clients, including the Company, which information may include the name and address of its clients, as well as other information that will allow the Placement Agent to properly identify its clients.
(tt) The Subsidiary is not currently prohibited, directly or indirectly, from paying any dividends to the Company, from making any other distribution on the Subsidiary s capital stock, from repaying to the Company any loans or advances to the Subsidiary from the Company or from transferring any of the Subsidiary s property or assets to the Company, except, in each case, as described in the Registration Statement (excluding the exhibits thereto), the Disclosure Package and the Final Prospectus.
(uu) The preclinical studies and clinical trials that are described in, or the results of which are referred to in, the Registration Statement, the Disclosure Package and the Final Prospectus were and, if still pending, are being conducted in all material respects in accordance with standard accepted medical and scientific research procedures and all applicable laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312.; the descriptions of and information regarding the results of such studies, tests and trials, and the data and results derived therefrom, contained in the
Registration Statement, the Disclosure Package and the Final Prospectus are accurate and complete, as of the date indicated, in all material respects and fairly present the data derived from such tests and trials, and neither the Company nor the Subsidiary, after due inquiry, has any knowledge of any other studies, tests, trials, publications, presentations or other information relating to the Company s products or product candidates not described in the Registration Statement, the Disclosure Package and the Final Prospectus the results of which reasonably call into question the results described or referred to in the Registration Statement, the Disclosure Package and the Final Prospectus; neither the Company nor the Subsidiary has received any notices or other correspondence from the Food and Drug Administration of the U.S. Department of Health and Human Services (the FDA ) or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, the Regulatory Agencies ) requiring or threatening the termination, suspension or material modification of any studies, tests or trials that are described or referred to in the Registration Statement, the Disclosure Package and the Final Prospectus; and the Company and the Subsidiary have operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
(vv) Except as described in the Registration Statement or the Final Prospectus, and except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) neither the Company nor the Subsidiary has received any written notice of adverse filing, warning letter, untitled letter or other correspondence or notice from any Regulatory Agency or other relevant regulatory authorities, or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority, alleging or asserting material noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) or similar state, federal or foreign law or regulation; (ii) neither the Company nor the Subsidiary has had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for Company products) subject to a governmental authority (including the FDA) shutdown or import or export prohibition, nor received any FDA Form 483 or other governmental authority notice of inspectional observations relating to a Company product; (iii) the Company and the Subsidiary, and to the Company s knowledge, their respective directors, officers, employees or agents, are and have been since January 1, 2014 in compliance in all material respects with applicable health care laws, including without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), the Public Health Service Act (42 U.S.C. 340B), the federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)), the Civil Monetary Penalties Law (42 U.S.C. 1320a-7a), the U.S. Civil False Claims Act (31 U.S.C. 3729 et seq.), the criminal False Claims Law (42 U.S.C. 1320a-7b(a)), the Physician Payments Sunshine Act (42 U.S.C. 1320a-7h), 18 U.S.C. 286 and 287, and the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 ( HIPAA ) (42 U.S.C. 1320d et seq.), the exclusion laws (42 U.S.C. 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. 17921 et seq.), the Medicaid Drug Rebate Program (42 U.S.C. 1396r-8) and any state supplemental rebate program, and Medicare average sales price reporting requirements (42 U.S.C. 1395w-3a), each as amended, and the regulations promulgated thereunder; and all other comparable local, state, federal, national, supranational and foreign laws, and the regulations promulgated thereunder, (collectively, Health Care Laws ); (iv) neither the Company nor the Subsidiary has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any U.S. or non-U.S. federal, national, state, provincial, local, municipal, international government or other governmental, administrative or regulatory authority, governmental, administrative or regulatory agency or body, department, board, bureau, agency or instrumentality, court, tribunal, arbitrator or arbitral body (public or private) or self-
regulatory organization (each, a Governmental Authority ) or third party alleging that any product, operation or activity is in violation of any Health Care Laws or has any knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) neither the Company nor the Subsidiary or any of their respective directors, officers, employees or, to the Company s knowledge, agents, is or has been debarred, suspended or excluded, or has been convicted of any crime or engaged in any conduct that would result in a debarment, suspension or exclusion from any federal or state government health care program; and (vi) the Company and the Subsidiary are not a party to nor have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any Governmental Authority.
(ww) Except as described in the Registration Statement or the Final Prospectus, and except as would not, individually or in the aggregate, have or may reasonably be expected to have a Material Adverse Effect: (i) there have been no recalls, field notifications, field corrections, market withdrawals or replacements, warnings, dear doctor letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Company products (collectively, Safety Notices ) (ii) such Safety Notices, if any, were resolved or closed, and (iii) to the Company s knowledge, there are no material complaints with respect to the Company products that are currently unresolved. To the Company s knowledge, there are no facts that would be reasonably likely to result in (i) a material Safety Notice with respect to the Company products, (ii) a material change in labeling of any the Company products, or (iii) a termination or suspension of marketing or testing of any of the Company products.
(xx) The issuance and sale of the Offered Securities as contemplated in the Documents will not cause any holder of any shares of capital stock, securities convertible into or exchangeable or exercisable for capital stock or options, warrants or other rights to purchase capital stock or any other securities of the Company to have any right to acquire any securities of the Company.
(yy) The Company has not received any notice the Nasdaq Stock Market LLC or its affiliates regarding the delisting of the Common Stock from the Nasdaq Global Market.
(zz) Except pursuant to this Agreement, neither the Company nor the Subsidiary has incurred any liability for any finder s or broker s fee or agent s commissions in connection with the execution and delivery of this Agreement or the consummation of the Transactions or by the Registration Statement.
(aaa) Neither the Company nor the Subsidiary nor any of their respective directors or officers, affiliates or controlling persons has taken, directly or indirectly, without giving effect to activities by the Placement Agent, any action designed, or which has constituted or might reasonably be expected to cause or result in the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Offered Securities.
(bbb) To the Company s knowledge, there are no affiliations or associations between (i) any member of FINRA and (ii) the Company or any of the Company s officers, directors or any beneficial owner of the Company s unregistered equity securities that were acquired at any time on or after the 180th day immediately preceding the date the Registration Statement was initially filed with the Commission, except as disclosed in writing to the Placement Agent or disclosed in the
Last updated: Oct 11, 2018