--12-31false000178774000017877402025-02-102025-02-10
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Date of Report (Date of earliest event reported): February 10, 2025 |
Tivic Health Systems, Inc.
(Exact name of Registrant as Specified in Its Charter)
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Delaware |
001-41052 |
81-4016391 |
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
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47685 Lakeview Blvd. |
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Fremont, California |
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94538 |
(Address of Principal Executive Offices) |
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(Zip Code) |
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Registrant’s Telephone Number, Including Area Code: 888 276-6888 |
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s) |
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Name of each exchange on which registered
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Common Stock, par value $0.0001 per share |
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TIVC |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Item 1.01. |
Entry into a Material Definitive Agreement. |
Exclusive License Agreement
On February 11, 2025, Tivic Health Systems, Inc., a Delaware corporation (the “Company”) entered into an exclusive license agreement (the “License Agreement”) with Statera Biopharma, Inc. (“Statera”) whereby the Company acquired (i) an exclusive worldwide license to the proprietary Toll-like Receptor 5 (“TLR5”) agonist program of Statera known as Entolimod (the “Licensed Molecules”) as it relates to the Acute Radiation Syndrome (“ARS”) indication (the “Initial Indication”) and (ii) an exclusive option (the “Exclusive Option”) to acquire the exclusive worldwide license to additional indications, including Lymphocyte Exhaustion, Immunosenescence, Neutropenia and/or Vaccine Adjuvant (the “Subsequent Indications”) and to the TLR5 agonist program of Statera known as Entolasta, in each case as described in more detail below. The License Agreement transaction was consummated concurrently therewith on February 11, 2025 (the “Closing Date”).
Under the terms of the License Agreement, Statera has granted the Company an exclusive worldwide license, with the right to grant and authorize sublicenses, under Statera’s patents and know-how to develop, test, make and use Entolimod to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit the product as it relates to the Initial Indication during the term of the License Agreement.
As consideration for the License Agreement, the Company agreed to pay Statera a license fee of $1,500,000 consisting of (i) $300,000 in cash consideration and (ii) $1,200,000 in stock consideration, as described below. The Company remains liable to Statera for certain royalty payments on net sales for ARS as monotherapy, and, if it exercises the Exclusive Option, net sales for all Subsequent Indications, within certain royalty periods.
The License Agreement further provides the Company with the Exclusive Option to expand the Initial Indications to include the treatment of the Subsequent Indications or to expand the use from a monotherapy to include uses as Vaccine Adjuvant, or several or all of them, at any time during the term of the License Agreement, and on one or more occasions, at its discretion. As part of exercise of the Exclusive Option, the license grant would be expanded to include uses of Entolasta, in addition to Entolimod, both for ARS and for the Subsequent Indications.
In conjunction with the License Agreement, Statera additionally transferred to the Company the title to fifteen kilograms (15kg) of frozen manufactured Entolimod lots and associated quality records associated with their production and applicable verification records (the “Materials”). In connection with this acquisition of ownership of the Materials, the Company will be negotiating a $1 per year lease with an affiliate of Statera for the proper care, storage and handling of the Materials.
The License Agreement also includes a buyout provision (the “Buyout”) by which the Company maintains the right to acquire from Statera at any time all right, title and interest in and to all technology licensed or otherwise subject to the Exclusive Option under the License Agreement. Should the Company elect to invoke this buyout right, it must provide Statera with a buyout payment equal to (a) the lesser of (i) the aggregate amount of payments due to Statera for achievement of all milestone events (described below) less the amount of payments paid for the achievement of one or more of such milestone events, and (ii) an amount negotiated in good faith and mutually agreed by the parties in writing as representing the risk adjusted net present value of the aggregate royalties that would have been payable absent such exercise; less (b) the amount of payments paid or payable by the Company to extinguish an existing lien on the licensed technology.
The License Agreement obligates the Company to develop and commercialize the licensed products, at its own cost and expense, inclusive of licensed products with respect to any Subsequent Indications obtained upon exercise of an Exclusive Option. In the development and commercialization process, the Company is obligated to meet certain milestones, and must provide Statera with certain milestone payments upon accomplishing each milestone as outlined below.
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Event |
Payment |
Validation of current inventory of Materials for distribution and sales |
$750,000 |
Filing of BLA with FDA for Acute Radiation Syndrome |
$1,000,000 |
Total Acute Radiation Syndrome Development Milestones |
$1,750,000 |
Upon exercise of an Exclusive Option with respect to one or more Subsequent Indications, the following corresponding applicable milestones and milestone payments become obligations of the Company as well:
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Event |
Payment |
File IND and Initiate Phase 2 Clinical Study for Neutropenia |
$500,000 |
Phase III Completion - successfully meets endpoint required to secure FDA approval for treatment of Neutropenia |
$750,000 |
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File BLA with FDA and achieve FDA Approval for Neutropenia |
$1,500,000 |
File IND and Initiate Phase 2 study of Lymphocyte Exhaustion |
$500,000 |
Phase III Completion - successfully meets endpoint required by FDA for treatment of Lymphocyte Exhaustion |
$750,000 |
File BLA with FDA and achieve FDA Approval for Lymphocyte Exhaustion |
$1,500,000 |
IND approval and initiation of Phase 3 study as a Vaccine Adjuvant |
$500,000 |
File US BLA with FDA and achieve FDA Approval for use as a Vaccine Adjuvant |
$500,000 |
Total Potential Development Milestones for additional Indications (as applicable) |
$6,500,000 |
In conjunction with the License Agreement, Statera may nominate one (1) individual to sit on the Company’s Board of Directors (the “Board”). Statera’s nominee must have the relevant industry experience in biopharmaceuticals, meet all requirements for service as an Independent Board Member, as defined by Nasdaq listing requirements. Approval of such Statera nominee shall be at the sole reasonable discretion of the Board.
Reference is made to the discussion of the Series A Preferred Stock in Item 5.03 of this Current Report on Form 8-K, which is incorporated into this Item 1.01 by reference.
Craft Capital Management LLC (“Craft”) acted as financial advisor to the Company in connection with the License Agreement. As partial compensation for services rendered by Craft, the Company paid Craft a cash fee of $105,000 equal to seven percent (7%) of the value of the initial license fee under the License Agreement.
Pursuant to the License Agreement, the Company has agreed to hold a stockholders’ meeting within 120 days of the Closing Date to submit the approval of the conversion of shares of Series A Preferred Stock into shares of Company common stock in accordance with the rules of the Nasdaq Stock Market LLC (the “Conversion Proposal”) to its stockholders for their consideration. In connection therewith, the Company has agreed to file a proxy statement on Schedule 14A with the Securities and Exchange Commission (the “SEC”). If the requisite stockholder approval is not obtained within the time period referenced above, then the Company shall convene additional stockholder meetings every 90 days thereafter until the requisite stockholder approval is obtained.
The Board approved the License Agreement and the related transactions, and the consummation of the License Agreement was not subject to approval of Company stockholders.
The foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the License Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Securities Purchase Agreement
On February 11, 2025, the Company entered into a Securities Purchase Agreement (the “Securities Purchase Agreement”) with Statera. Pursuant to the Securities Purchase Agreement, the Company agreed to issue and sell to Statera an aggregate of (i) 945,785 shares of Company common stock and (ii) 359.6691 shares of Series A Preferred Stock (collectively, the “Securities”) for an aggregate price of approximately $1.2 million. Each share of Series A Preferred Stock is convertible into 10,000 shares of common stock, as described below. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series A Preferred Stock are set forth in the Certificate of Designation (as defined and described below).
The Securities Purchase Agreement also provides Statera with registration rights related to the Securities. Specifically, the Company is required to prepare and file a resale registration statement with the SEC within 60 calendar days following the Closing Date (the “Filing Deadline”), with respect to the common stock and the shares of common stock underlying the Series A Preferred Stock.
The closing of the issuance of Securities occurred concurrently with the Closing Date of the License Agreement on February 11, 2025.
The foregoing summary of the Securities Purchase Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Securities Purchase Agreement, a copy of which is filed as Exhibit 10.2 to this Current Report on Form 8-K and is incorporated herein by reference.
The License Agreement has been filed herewith to provide investors and security holders with information regarding its terms. It is not intended to provide any other factual information about the Company or Statera. The License Agreement and Securities Purchase Agreement contain representations, warranties and covenants that the Company and Statera made to each other as of specific dates. The assertions embodied in those representations, warranties and covenants were made solely for purposes of the License Agreement and
Securities Purchase Agreement between the Company and Statera and may be subject to important qualifications and limitations agreed to by the Company and Statera in connection with negotiating its terms, including being qualified by confidential disclosures exchanged between the parties in connection with the execution of the License Agreement and Securities Purchase Agreement. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to investors or securityholders. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the License Agreement and Securities Purchase Agreement, which subsequent information may or may not be fully reflected in the Company’s public disclosures. For the foregoing reasons, no person should rely on the representations and warranties as statements of factual information at the time they were made or otherwise.
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Item 3.02 |
Unregistered Sales of Equity Securities |
The information contained in Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.02.
Pursuant to the Securities Purchase Agreement, the Company issued the Securities to Statera, which represented that it was an “accredited investor,” as defined in Regulation D, and was acquiring the Securities for investment only and not with a view towards, or for resale in connection with, the public sale or distribution thereof. Such issuances were exempt from the registration requirements of the Securities Act in reliance in Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.
Neither the shares of common stock or Series A Preferred Stock issued under the Securities Purchase Agreement have been registered under the Securities Act and none of such Securities may be offered or sold in the United States absent registration or an exemption from registration under the Securities Act and any applicable state securities laws.
Neither this Current Report on Form 8-K nor any of the exhibits attached hereto will constitute an offer to sell or the solicitation of an offer to buy shares of common stock, Series A Preferred Stock or any other securities of the Company.
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Item 5.03. |
Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
Certificate of Designation
On February 10, 2025, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of the Series A Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) with the Secretary of State of the State of Delaware in connection with the License Agreement referenced in Item 1.01 above. The Certificate of Designation provides for the designation of 6,000 shares of the Company’s Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (the “Series A Preferred Stock”).
Holders of Series A Preferred Stock are entitled to receive dividends on shares of Series A Preferred Stock equal to, on an as-if-converted-to-Common-Stock basis, and in the same form as dividends actually paid on shares of the Common Stock.
Except as otherwise required by law, the Series A Preferred Stock does not have voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company will not, without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series A Preferred Stock, (i) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, amend or repeal any provision of, or add any provision to, the Charter or bylaws of the Company, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of preferred stock, in each case if any such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series A Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series A Preferred Stock, or (iii) enter into any agreement with respect to any of the foregoing.
The Series A Preferred Stock does not have a preference upon any liquidation, dissolution or winding-up of the Company.
Following stockholder approval of the Conversion Proposal, each share of Series A Preferred Stock will automatically convert into 10,000 shares of Common Stock, subject to certain limitations, including that a holder of Series A Preferred Stock is prohibited from converting shares of Series A Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder, together with its affiliates, would beneficially own more than a specified percentage (to be established by the holder between 4.9% and 19.9%) of the total number of shares of Common Stock issued and outstanding immediately after giving effect to such conversion.
The foregoing description of the Series A Preferred Stock does not purport to be complete and is qualified in its entirety by reference to the full text of the Certificate of Designation, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated herein by reference.
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Item 7.01. |
Regulation FD Disclosure. |
Press Release
On February 12, 2025, the Company issued a press release announcing the License Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in Item 7.01 of this Current Report on Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K, is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section. Furthermore, the information in Item 7.01 of this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the filings of the Company under the Securities Act.
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Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits
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Exhibit Number |
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Description |
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3.1 |
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Certificate of Designation of Series A Non-Voting Convertible Preferred Stock of Tivic Health Systems, Inc., dated February 10, 2025. |
10.1* |
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Exclusive License Agreement, dated February 11, 2025, by and between the Tivic Health Systems, Inc. and Statera Biopharma, Inc. |
10.2* |
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Securities Purchase Agreement, dated February 11, 2025, by and between the Tivic Health Systems, Inc. and Statera Biopharma, Inc. |
99.1 |
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Press Release of Tivic Health Systems, Inc., dated February 12, 2025. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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Certain annexes, schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant agrees to furnish supplementally a copy of any omitted attachment to the SEC on a confidential basis upon request. |
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Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit have been omitted by means of marking such portions with asterisks as the identified confidential portions are both not material and are the type of information that the registrant treats as private or confidential. The registrant agrees to supplementally furnish an unredacted copy of this exhibit to the SEC upon its request. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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TIVIC HEALTH SYSTEMS, INC. |
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Date: |
February 12, 2025 |
By: |
/s/ Jennifer Ernst |
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Name: Jennifer Ernst Title: Chief Executive Officer |
Exhibit 3.1
tivic health systems, inc.
CERTIFICATE OF DESIGNATION OF PREFERENCES,
RIGHTS AND LIMITATIONS
OF
SERIES a NON-VOTING CONVERTIBLE PREFERRED STOCK
Pursuant to Section 151 of the
General Corporation Law of the State of Delaware
THE UNDERSIGNED DOES HEREBY CERTIFY, on behalf of Tivic Health Systems, Inc., a Delaware corporation (the “Corporation”), that the following resolution was duly adopted by the Board of Directors of the Corporation (the “Board of Directors”), in accordance with the provisions of Section 151 of the General Corporation Law of the State of Delaware (the “DGCL”), via unanimous written consent on February 9, 2025, which resolution provides for the creation of a series of the Corporation’s Preferred Stock, par value $0.0001 per share, which is designated as “Series A Non-Voting Convertible Preferred Stock,” with the preferences, rights and limitations set forth therein relating to dividends, conversion, redemption, dissolution and distribution of assets of the Corporation.
WHEREAS: the Amended and Restated Certificate of Incorporation of the Corporation, as amended (the “Certificate of Incorporation”), provides for a class of its authorized stock known as Preferred Stock, consisting of 10,000,000 shares, $0.0001 par value per share (the “Preferred Stock”), issuable from time to time in one or more series.
RESOLVED: that, pursuant to authority conferred upon the Board of Directors by the Certificate of Incorporation, (i) a series of Preferred Stock of the Corporation be, and hereby is authorized by the Board of Directors, (ii) the Board of Directors hereby authorizes the issuance of 6,000 shares of “Series A Non-Voting Convertible Preferred Stock” pursuant to the terms of the Securities Purchase Agreement, dated as of the date hereof, by and among the Corporation and the initial Holders (as defined below) (the “Purchase Agreement”) and the Exclusive License Agreement, dated as of February 10, 2025, by and between the Corporation and Statera Biopharma, Inc., a Delaware corporation (the “License Agreement”), and (iii) the Board of Directors hereby fixes the designations, powers, preferences and relative, participating, optional or other special rights, and the qualifications, limitations or restrictions thereof, of such shares of Preferred Stock, in addition to any provisions set forth in the Certificate of Incorporation that are applicable to the Preferred Stock of all classes and series, as follows:
TERMS OF SERIES A NON-VOTING CONVERTIBLE PREFERRED STOCK
1. Definitions. For the purposes hereof, the following terms shall have the following meanings:
“Business Day” means any day other than a Saturday, Sunday or other day on which banks in Philadelphia, PA, are authorized or obligated by Law to be closed.
“Closing Sale Price” means, for any security as of any date, the last closing trade price for such security immediately prior to 4:00 p.m., New York City time, on the principal Trading Market where such security is listed or traded, as reported by Bloomberg, L.P. (or an equivalent, reliable reporting service), or if the foregoing do not apply, the last trade price of such security in the over-the-counter market on the electronic bulletin board for such security as reported by Bloomberg, L.P., or, if no last trade price is reported for such security by Bloomberg, L.P., the average of the bid prices of any market makers for such security as reported on the OTC Pink Market by OTC Markets Group, Inc. If the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing bases, the Closing Sale Price of such security on such date shall be the fair market value as determined in good faith by the Board of Directors of the Corporation.
“Commission” means the United States Securities and Exchange Commission.
“Common Stock” means the Corporation’s common stock, par value $0.0001 per share, and stock of any other class of securities into which such securities may hereafter be reclassified or changed.
“Conversion Shares” means, collectively, the shares of Common Stock issuable upon conversion of the shares of Series A Non-Voting Preferred Stock in accordance with the terms hereof.
“Conversion Shares Registration Statement” means a registration statement that registers the resale of all Conversion Shares of the Holders, who shall be named as “selling stockholders” therein and meets the requirements of the Purchase Agreement.
“Exchange Act” means the Securities Exchange Act of 1934.
“Holder” means a holder of shares of Series A Non-Voting Preferred Stock.
“Person” means an individual or corporation, partnership, trust, incorporated or unincorporated association, joint venture, limited liability company, joint stock company, government (or an agency or subdivision thereof) or other entity of any kind.
“Trading Day” means a day on which the principal Trading Market is open for business.
“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, OTC Markets or the New York Stock Exchange (or any successors to any of the foregoing).
2. Designation, Amount and Par Value. The series of Preferred Stock shall be designated as the Corporation’s Series A Non-Voting Convertible Preferred Stock (the “Series A Non-Voting Preferred Stock”) and the number of shares so designated shall be 6,000. Each share of Series A Non-Voting Preferred Stock shall have a par value of $0.0001 per share.
3. Dividends. Holders shall be entitled to receive, and the Corporation shall pay, dividends on shares of the Series A Non-Voting Preferred Stock (on an as-if-converted-to-Common-Stock basis, without regard to the Beneficial Ownership Limitation (as defined below)) equal to and in the same form, and in the same manner, as dividends (other than dividends on shares of the Common Stock payable in the form of Common Stock) actually paid on shares of the Common Stock when, as and if such dividends (other than dividends payable in the form of Common Stock) are paid on shares of the Common Stock. Other than as set forth in the previous sentence, no other dividends shall be paid on shares of Series A Non-Voting Preferred Stock, and the Corporation shall pay no dividends (other than dividends payable in the form of Common Stock) on shares of the Common Stock unless it simultaneously complies with the previous sentence.
4. Voting Rights.
4.1 Except as otherwise provided herein or as otherwise required by the DGCL, the Series A Non-Voting Preferred Stock shall have no voting rights. However, as long as any shares of Series A Non-Voting Preferred Stock are outstanding, the Corporation shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Non-Voting Preferred Stock: (i) alter or change adversely the powers, preferences or rights given to the Series A Non-Voting Preferred Stock or alter or amend this Certificate of Designation, amend or repeal any provision of, or add any provision to, the Certificate of Incorporation or Amended and Restated Bylaws of the Corporation, or file any articles of amendment, certificate of designations, preferences, limitations and relative rights of any series of Preferred Stock, if such action would adversely alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series A Non-Voting Preferred Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Certificate of Incorporation or by merger, consolidation, recapitalization, reclassification, conversion or otherwise, (ii) issue further shares of Series A Non-Voting Preferred Stock or increase or decrease (other than by conversion) the number of authorized shares of Series A Non-Voting Preferred Stock or (iii) enter into any agreement with respect to any of the foregoing. Holders of shares of Common Stock acquired upon the conversion of shares of
Series A Non-Voting Preferred Stock shall be entitled to the same voting rights as each other holder of Common Stock, except that such holders may not vote such shares upon the proposal for Stockholder Approval (as defined below) in accordance with Rule 5635 of the listing rules of The Nasdaq Stock Market LLC.
4.2 Any vote required or permitted under Section 4.1 may be taken at a meeting of the Holders or through the execution of an action by written consent in lieu of such meeting, provided that the consent is executed by Holders representing a majority of the outstanding shares of Series A Non-Voting Preferred Stock.
5. Rank; Liquidation.
5.1 The Series A Non-Voting Preferred Stock shall rank on parity with the Common Stock as to distributions of assets upon liquidation, dissolution or winding up of the Corporation, whether voluntarily or involuntarily.
5.2 Upon any liquidation, dissolution or winding-up of the Corporation, whether voluntary or involuntary (a “Liquidation”), each Holder shall be entitled to receive out of the assets, whether capital or surplus, of the Corporation the same amount that a holder of Common Stock would receive if the Series A Non-Voting Preferred Stock were fully converted (disregarding for such purpose any Beneficial Ownership Limitations) to Common Stock which amounts shall be paid pari passu with all holders of Common Stock, plus an additional amount equal to any dividends declared on but unpaid to such shares. If, upon any such Liquidation, the assets of the Corporation shall be insufficient to pay the Holders of shares of the Series A Non-Voting Preferred Stock the amount required under the preceding sentence, then all remaining assets of the Corporation shall be distributed ratably to the Holders and the holders of Common Stock in accordance with the respective amounts that would be payable on all such securities if all amounts payable thereon were paid in full. For the avoidance of any doubt, a Fundamental Transaction shall not be deemed a Liquidation unless the Corporation expressly declares that such Fundamental Transaction shall be treated as if it were a Liquidation.
6. Conversion.
6.1 Automatic Conversion on Stockholder Approval. Effective as of 5:00 p.m. Eastern time on the third Business Day after the date that the Corporation’s stockholders approve the conversion of the Series A Non-Voting Preferred Stock into shares of Common Stock in accordance with the listing rules of the Nasdaq Stock Market (the “Stockholder Approval”), each share of Series A Non-Voting Preferred Stock then outstanding shall automatically convert into a number of shares of Common Stock equal to the Conversion Ratio (as defined below), subject to the Beneficial Ownership Limitation (the “Automatic Conversion”). In determining the application of the Beneficial Ownership Limitations solely with respect to the Automatic Conversion, the Corporation shall calculate beneficial ownership for each Holder assuming beneficial ownership by such Holder of: (x) the number of shares of Common Stock issuable to such Holder in such Automatic Conversion, plus (y) any additional shares of Common Stock for which a Holder has provided the Corporation with prior written notice of beneficial ownership within 30 days prior to the date of Stockholder Approval (a “Beneficial Ownership Statement”) and assuming the conversion of all shares of Series A Non-Voting Preferred Stock held by all other Holders less the aggregate number of shares of Series A Non-Voting Preferred Stock held by all other Holders that will not convert into shares of Common Stock on account of the application of any Beneficial Ownership Limitations applicable to any such other Holders. If a Holder fails to provide the Corporation with a Beneficial Ownership Statement within 30 days prior to the date of Stockholder Approval, upon request to the Holder by the Corporation, then the Corporation shall presume the Holder’s beneficial ownership of Common Stock (excluding the Conversion Shares) to be the number of shares previously reported to the Corporation. The shares of Series A Non-Voting Preferred Stock that are converted in the Automatic Conversion are referred to as the “Converted Stock”. The Conversion Shares shall be issued as follows:
6.1.1 Converted Stock that is registered in book entry form shall be automatically cancelled upon the Automatic Conversion and converted into the corresponding amount of Conversion Shares, which shares shall be issued in book entry form and without any action on the part of the Holders, unless such Holder provides the Corporation with the account of the Holder’s prime broker with DTC through its Deposit Withdrawal Agent Commission system (a “DWAC Delivery”).
6.1.2 Converted Stock that is issued in certificated form shall be deemed converted into the corresponding Conversion Shares on the date of Automatic Conversion and the Holder’s rights as a holder of such shares of Converted Stock shall cease and terminate on such date, excepting only the right to receive the Conversion Shares upon the Holder tendering to the Corporation (or its designated agent) the stock certificate(s) (duly endorsed) representing such certificated Converted Stock.
6.2 Conversion at Option of Holder. Subject to Section 6.1 and Section 6.4, each share of Series A Non-Voting Preferred Stock then outstanding shall be convertible, at any time and from time to time following 5:00 p.m. Eastern time on the third Business Day after the date that the Stockholder Approval is obtained by the Corporation, at the option of the Holder thereof, into a number of shares of Common Stock equal to the Conversion Ratio, subject to the Beneficial Ownership Limitation (each, an “Optional Conversion”). Holders shall effect conversions by providing the Corporation with the form of conversion notice attached hereto as Annex A (a “Notice of Conversion”), duly completed and executed. Provided the Corporation’s transfer agent is participating in the Depository Trust Company (“DTC”) Fast Automated Securities Transfer program, the Notice of Conversion may specify, at the Holder’s election, whether the applicable Conversion Shares shall be credited to the account of the Holder’s prime broker with DTC through its DWAC Delivery. The date on which an Optional Conversion shall be deemed effective (the “Conversion Date”) shall be the Trading Day that the Notice of Conversion, completed and executed, is sent via email to, and received during regular business hours by, the Corporation; provided, that the original certificate(s) (if any) representing such shares of Series A Non-Voting Preferred Stock being converted, duly endorsed, and the accompanying Notice of Conversion, are received by the Corporation within two (2) Trading Days thereafter. In all other cases, the Conversion Date shall be defined as the Trading Day on which the original certificate(s) (if any) representing such shares of Series A Non-Voting Preferred Stock being converted, duly endorsed, and the accompanying Notice of Conversion, are received by the Corporation. The calculations set forth in the Notice of Conversion shall control in the absence of manifest or mathematical error.
6.3 Conversion Ratio. The “Conversion Ratio” for each share of Series A Non-Voting Preferred Stock shall be 6,000 shares of Common Stock issuable upon the conversion (the “Conversion”) of each share of Series A Non-Voting Preferred Stock, subject to adjustment as provided herein.
6.4 Beneficial Ownership Limitation. Notwithstanding anything herein to the contrary, the Corporation shall not effect any conversion of any share of Series A Non-Voting Preferred Stock, including pursuant to Section 6.1, and a Holder shall not have the right to convert any portion of the Series A Non-Voting Preferred Stock pursuant to Section 6.2, to the extent that, after giving effect to such attempted conversion set forth on an applicable Notice of Conversion (as defined in the Certificate of Designation) with respect to the Series A Preferred Stock, such Holder (or any of such Holder’s affiliates or any other Person who would be a beneficial owner of Common Stock beneficially owned by the Holder for purposes of Section 13(d) or Section 16 of the Exchange Act and the applicable rules and regulations of the Commission, including any “group” of which the Holder is a member (the foregoing, “Attribution Parties”)) would beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation. For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially owned by such Holder and its Attribution Parties shall include the number of shares of Common Stock issuable upon conversion of the Series A Non-Voting Preferred Stock subject to the Notice of Conversion or the Automatic Conversion, as applicable, with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which are issuable upon (A) conversion of the remaining, unconverted Series A Non-Voting Preferred Stock beneficially owned by such Holder or any of its Attribution Parties, and (B) exercise or conversion of the unexercised or unconverted portion of any other securities of the Corporation (including any warrants) beneficially owned by such Holder or any of its Attribution Parties that are subject to and would exceed a limitation on conversion or exercise similar to the limitation contained herein. Except as set forth in the preceding sentence, for purposes of this Section 6.4, beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the applicable rules and regulations of the Commission, and the terms “beneficial ownership” and “beneficially own” have the meanings ascribed to such terms therein. In addition, for purposes hereof, “group” has the meaning set forth in Section 13(d) of the Exchange Act and the applicable rules and regulations of the Commission. For purposes of this Section 6.4, in determining the number of outstanding shares of Common Stock, a Holder may rely on the number of outstanding shares of Common Stock as stated in the most recent of the following: (A) the Corporation’s most recent periodic or annual filing with the Commission, as the case may be, (B) a more recent public announcement by the Corporation that is filed with the
Commission, or (C) a more recent notice by the Corporation or the Corporation’s transfer agent to the Holder setting forth the number of shares of Common Stock then outstanding. Upon the written request of a Holder (which may be by email), the Corporation shall, within two (2) Trading Days thereof, confirm in writing to such Holder (which may be via email) the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to any actual conversion or exercise of securities of the Corporation, including shares of Series A Non-Voting Preferred Stock, by such Holder or its Attribution Parties since the date as of which such number of outstanding shares of Common Stock was last publicly reported or confirmed to the Holder. The “Beneficial Ownership Limitation” shall initially be set at 9.9% for each Holder and its Attribution Parties and may be adjusted at the discretion of the Holder to a percentage between 4.9% and 19.9% of the number of shares of Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock pursuant to the Automatic Conversion or such Notice of Conversion (as applicable), to the extent permitted by this Section 6.3. The Corporation shall be entitled to rely on representations made to it by the Holder in any Notice of Conversion regarding its Beneficial Ownership Limitation. Notwithstanding the foregoing, by written notice to the Corporation, (i) which will not be effective until the sixty-first (61st) day after such written notice is delivered to the Corporation, the Holder may reset the Beneficial Ownership Limitation percentage to a higher percentage, not to exceed 19.9%, to the extent then applicable and (ii) which will be effective immediately after such notice is delivered to the Corporation, the Holder may reset the Beneficial Ownership Limitation percentage to a lower percentage (but in no event less than 4.9%) provided that such decrease shall not become effective until the later of (x) 5:00 p.m. Eastern time on the third Business Day after the date of the Stockholder Approval and (y) if Stockholder Approval is not obtained within six months after the initial issuance of the Series A Non-Voting Preferred Stock, the date that is three Business Days after the date that is six months after the initial issuance of the Series A Non-Voting Preferred Stock. Upon such a change by a Holder of the Beneficial Ownership Limitation, not to exceed 19.9%, the Beneficial Ownership Limitation may not be further amended by such Holder without first providing the minimum notice required by this Section 6.4. Notwithstanding the foregoing, at any time following notice of a Fundamental Transaction, the Holder may waive and/or change the Beneficial Ownership Limitation effective immediately upon written notice to the Corporation and may reinstitute a Beneficial Ownership Limitation at any time thereafter effective immediately upon written notice to the Corporation. The provisions of this Section 6.4 shall be construed, corrected and implemented in a manner so as to effectuate the intended Beneficial Ownership Limitation herein contained and the shares of Common Stock underlying the securities in excess of the Beneficial Ownership Limitation shall not be deemed to be beneficially owned by the Holder for any purpose including for purposes of Section 13(d) or Rule 16a-1(a)(1) of the Exchange Act.
6.5 Mechanics of Conversion.
6.5.1 Delivery of Certificate or Electronic Issuance. Upon Conversion not later than (i) two (2) Trading Days and (ii) the number of Trading Days comprising the Standard Settlement Period (as defined below) after the applicable Conversion Date, or if the Holder requests the issuance of physical certificate(s), two (2) Trading Days after receipt by the Corporation of the original certificate(s) representing such shares of Series A Non-Voting Preferred Stock being converted, duly endorsed, and the accompanying Notice of Conversion (the “Share Delivery Date”), the Corporation shall either: (a) deliver, or cause to be delivered, to the converting Holder a physical certificate or certificates representing the number of Conversion Shares being acquired upon the conversion of shares of Series A Non-Voting Preferred Stock, or (b) in the case of a DWAC Delivery (if so requested by the Holder), electronically transfer such Conversion Shares by crediting the account of the Holder’s prime broker with DTC through its DWAC system. If in the case of any Notice of Conversion such certificate or certificates for the Conversion Shares are not delivered to or as directed by or, in the case of a DWAC Delivery, such shares are not electronically delivered to or as directed by, the applicable Holder by the Share Delivery Date, the applicable Holder shall be entitled to elect to rescind such Notice of Conversion by written notice to the Corporation at any time on or before its receipt of such certificate or certificates for Conversion Shares or electronic receipt of such shares, as applicable, in which event the Corporation shall promptly return to such Holder any original Series A Non-Voting Preferred Stock certificate delivered to the Corporation and such Holder shall promptly return to the Corporation any Common Stock certificates or otherwise direct the return of any shares of Common Stock delivered to the Holder through the DWAC system, representing the shares of Series A Non-Voting Preferred Stock unsuccessfully tendered for conversion to the Corporation. As used herein, “Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, on the Corporation’s principal Trading Market with respect to the Common Stock as in effect on the Conversion Date.
6.5.2 Obligation Absolute. Subject to Section 6.4 and subject to Holder’s right to rescind a Notice of Conversion pursuant to Section 6.5.1, the Corporation’s obligation to issue and deliver the Conversion Shares upon conversion of Series A Non-Voting Preferred Stock in accordance with the terms hereof are absolute and unconditional, irrespective of any action or inaction by a Holder to enforce the same, any waiver or consent with respect to any provision hereof, the recovery of any judgment against any Person or any action to enforce the same, or any setoff, counterclaim, recoupment, limitation or termination, or any breach or alleged breach by such Holder or any other Person of any obligation to the Corporation or any violation or alleged violation of law by such Holder or any other Person, and irrespective of any other circumstance which might otherwise limit such obligation of the Corporation to such Holder in connection with the issuance of such Conversion Shares. Subject to Section 6.4 and subject to Holder’s right to rescind a Notice of Conversion pursuant to Section 6.5.1, in the event a Holder shall elect to convert any or all of its Series A Non-Voting Preferred Stock, the Corporation may not refuse conversion based on any claim that such Holder or anyone associated or affiliated with such Holder has been engaged in any violation of law, agreement or for any other reason, unless an injunction from a court, on notice to Holder, restraining and/or enjoining conversion of all or part of the Series A Non-Voting Preferred Stock of such Holder shall have been sought and obtained by the Corporation, and the Corporation posts a surety bond for the benefit of such Holder in the amount of 150% of the value of the Conversion Shares into which would be converted the Series A Non-Voting Preferred Stock which is subject to such injunction, which bond shall remain in effect until the completion of arbitration/litigation of the underlying dispute and the proceeds of which shall be payable to such Holder to the extent it obtains judgment. In the absence of such injunction, the Corporation shall, subject to Section 6.4 and subject to Holder’s right to rescind a Notice of Conversion pursuant to Section 6.5.1, issue Conversion Shares upon a properly noticed conversion.
6.5.3 Reservation of Shares Issuable Upon Conversion. The Corporation covenants that at all times it will reserve and keep available out of its authorized and unissued shares of Common Stock for the sole purpose of issuance upon conversion of the Series A Non-Voting Preferred Stock, free from preemptive rights or any other actual contingent purchase rights of Persons other than the Holders of the Series A Non-Voting Preferred Stock, not less than such aggregate number of shares of the Common Stock as shall be issuable (taking into account the adjustments of Section 7) upon the conversion of all outstanding shares of Series A Non-Voting Preferred Stock. The Corporation covenants that all shares of Common Stock that shall be so issuable shall, upon issue, be duly authorized, validly issued, fully paid and non-assessable and, if the Conversion Shares Registration Statement is then effective under the Securities Act, shall be registered for public resale in accordance with such Conversion Shares Registration Statement (subject to such Holder’s compliance with its obligations under the Purchase Agreement and applicable securities laws).
6.5.4 Fractional Shares. No fractional shares of Common Stock shall be issued upon conversion of the Series A Non-Voting Preferred Stock, no certificates or scrip for any such fractional shares shall be issued and no cash shall be paid for any such fractional shares. Any fractional shares of Common Stock that a Holder of Series A Non-Voting Preferred Stock would otherwise be entitled to receive shall be aggregated with all fractional shares of Common Stock issuable to such Holder and any remaining fractional shares shall be rounded up to the nearest whole share. Whether or not fractional shares would be issuable upon such conversion shall be determined on the basis of the total number of shares of Series A Non-Voting Preferred Stock the Holder is at the time converting into Common Stock and the aggregate number of shares of Common Stock issuable upon such conversion.
6.5.5 Transfer Taxes. The issuance of certificates for shares of the Common Stock upon conversion of the Series A Non-Voting Preferred Stock shall be made without charge to any Holder for any documentary stamp or similar taxes that may be payable in respect of the issue or delivery of such certificates, provided that the Corporation shall not be required to pay any tax that may be payable in respect of any transfer involved in the issuance and delivery of any such certificate upon conversion in a name other than that of the registered Holder(s) of such shares of Series A Non-Voting Preferred Stock and the Corporation shall not be required to issue or deliver such certificates unless or until the Person or Persons requesting the issuance thereof shall have paid to the Corporation the amount of such tax or shall have established to the satisfaction of the Corporation that such tax has been paid.
6.6 Status as Stockholder. Upon each Conversion Date, (i) the shares of Series A Non-Voting Preferred Stock being converted shall be deemed converted into shares of Common Stock and (ii) the Holder’s
rights as a holder of such converted shares of Series A Non-Voting Preferred Stock shall cease and terminate, excepting only the right to receive certificates for such shares of Common Stock and to any remedies provided herein or otherwise available at law or in equity to such Holder because of a failure by the Corporation to comply with the terms of this Certificate of Designation. In all cases, the Holder shall retain all of its rights and remedies for the Corporation’s failure to convert Series A Non-Voting Preferred Stock. In no event shall the Series A Non-Voting Preferred Stock convert into shares of Common Stock prior to the Stockholder Approval.
7. Certain Adjustments.
7.1 Stock Dividends and Stock Splits. If the Corporation, at any time while this Series A Non-Voting Preferred Stock is outstanding: (A) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Corporation upon conversion of this Series A Non-Voting Preferred Stock) with respect to the then outstanding shares of Common Stock; (B) subdivides outstanding shares of Common Stock into a larger number of shares; or (C) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares, then the Conversion Ratio shall be multiplied by a fraction of which the numerator shall be the number of shares of Common Stock (excluding any treasury shares of the Corporation) outstanding immediately after such event and of which the denominator shall be the number of shares of Common Stock outstanding immediately before such event (excluding any treasury shares of the Corporation). Any adjustment made pursuant to this Section 7.1 shall become effective immediately after the record date for the determination of stockholders entitled to receive such dividend or distribution and shall become effective immediately after the effective date in the case of a subdivision or combination.
7.2 Fundamental Transaction. If, at any time while this Series A Non-Voting Preferred Stock is outstanding, (A) the Corporation effects any merger or consolidation of the Corporation with or into another Person or any stock sale to, or other business combination (including, without limitation, a reorganization, recapitalization, spin-off, share exchange or scheme of arrangement) with or into another Person (other than such a transaction in which the Corporation is the surviving or continuing entity and its Common Stock is not exchanged for or converted into other securities, cash or property), (B) the Corporation effects any sale, lease, transfer or exclusive license of all or substantially all of its assets in one transaction or a series of related transactions, (C) any tender offer or exchange offer (whether by the Corporation or another Person) is completed pursuant to which more than 50% of the Common Stock not held by the Corporation or such Person is exchanged for or converted into other securities, cash or property, or (D) the Corporation effects any reclassification of the Common Stock or any compulsory share exchange pursuant (other than as a result of a dividend, subdivision or combination covered by Section 7.1) to which the Common Stock is effectively converted into or exchanged for other securities, cash or property (in any such case, a “Fundamental Transaction”), then, upon any subsequent conversion of this Series A Non-Voting Preferred Stock the Holders shall have the right to receive, in lieu of the right to receive Conversion Shares, for each Conversion Share that would have been issuable upon such conversion immediately prior to the occurrence of such Fundamental Transaction, the same kind and amount of securities, cash or property as it would have been entitled to receive upon the occurrence of such Fundamental Transaction if it had been, immediately prior to such Fundamental Transaction, the holder of one share of Common Stock (the “Alternate Consideration”). For purposes of any such subsequent conversion, the determination of the Conversion Ratio shall be appropriately adjusted to apply to such Alternate Consideration based on the amount of Alternate Consideration issuable in respect of one share of Common Stock in such Fundamental Transaction, and the Corporation shall adjust the Conversion Ratio in a reasonable manner reflecting the relative value of any different components of the Alternate Consideration. If holders of Common Stock are given any choice as to the securities, cash or property to be received in a Fundamental Transaction, then the Holders shall be given the same choice as to the Alternate Consideration it receives upon any conversion of this Series A Non-Voting Preferred Stock following such Fundamental Transaction. To the extent necessary to effectuate the foregoing provisions, any successor to the Corporation or surviving entity in such Fundamental Transaction shall file a new certificate of designations with the same terms and conditions and issue to the Holders new preferred stock consistent with the foregoing provisions and evidencing the Holders’ right to convert such preferred stock into Alternate Consideration. The terms of any agreement to which the Corporation is a party and pursuant to which a Fundamental Transaction is effected shall include terms requiring any such successor or surviving entity to comply with the provisions of this Section 7.2 and insuring that this Series A Non-Voting Preferred Stock (or any such replacement security) will be similarly adjusted upon any subsequent transaction analogous to a Fundamental Transaction. The Corporation shall cause to be delivered to each Holder, at
its last address as it shall appear upon the stock books of the Corporation, written notice of any Fundamental Transaction at least 10 calendar days prior to the date on which such Fundamental Transaction is expected to become effective or close.
7.3 Calculations. All calculations under this Section 7 shall be made to the nearest cent or the nearest 1/100th of a share, as the case may be. For purposes of this Section 7, the number of shares of Common Stock deemed to be issued and outstanding as of a given date shall be the sum of the number of shares of Common Stock (excluding any treasury shares of the Corporation) issued and outstanding.
8. Redemption. The shares of Series A Non-Voting Preferred Stock shall not be redeemable; provided, however, that the foregoing shall not limit the ability of the Corporation to purchase or otherwise deal in such shares to the extent otherwise permitted hereby and by law.
9. Transfer. A Holder may transfer any shares of Series A Non-Voting Preferred Stock together with the accompanying rights set forth herein, held by such holder without the consent of the Corporation; provided that such transfer is in compliance with applicable securities laws. The Corporation shall in good faith (a) do and perform, or cause to be done and performed, all such further acts and things, and (b) execute and deliver all such other agreements, certificates, instruments and documents, in each case, as any holder of Series A Non-Voting Preferred Stock may reasonably request in order to carry out the intent and accomplish the purposes of this Section 9. The transferee of any shares of Series A Non-Voting Preferred Stock shall be subject to the Beneficial Ownership Limitation applicable to the transferor as of the time of such transfer.
10. Series A Non-Voting Preferred Stock Register. The Corporation shall maintain at its principal executive offices (or such other office or agency of the Corporation as it may designate by notice to the Holders in accordance with Section 11), a register for the Series A Non-Voting Preferred Stock, in which the Corporation shall record (a) the name, address, and electronic mail address of each holder in whose name the shares of Series A Non-Voting Preferred Stock have been issued and (b) the name, address, and electronic mail address of each transferee of any shares of Series A Non-Voting Preferred Stock. The Corporation may deem and treat the registered Holder of shares of Series A Non-Voting Preferred Stock as the absolute owner thereof for the purpose of any conversion thereof and for all other purposes. The Corporation shall keep the register open and available at all times during business hours for inspection by any holder of Series A Non-Voting Preferred Stock or his, her or its legal representatives.
11. Notices. Any notice required or permitted by the provisions of this Certificate of Designation to be given to a Holder of shares of Series A Non-Voting Preferred Stock shall be mailed, postage prepaid, to the post office address last shown on the records of the Corporation, or given by electronic communication in compliance with the provisions of the Delaware General Corporation Law, and shall be deemed sent upon such mailing or electronic transmission.
12. Book-Entry; Certificates. The Series A Non-Voting Preferred Stock will be issued in book-entry form; provided that, if a Holder requests that such Holder’s shares of Series A Non-Voting Preferred Stock be issued in certificated form, the Corporation will instead issue a stock certificate to such Holder representing such Holder’s shares of Series A Non-Voting Preferred Stock. To the extent that any shares of Series A Non-Voting Preferred Stock are issued in book-entry form, references herein to “certificates” shall instead refer to the book-entry notation relating to such shares.
13. Waiver. Any waiver by the Corporation or a Holder of a breach of any provision of this Certificate of Designation shall not operate as or be construed to be a waiver of any other breach of such provision or of any breach of any other provision of this Certificate of Designation or a waiver by any other Holders, other than as expressly set forth herein. The failure of the Corporation or a Holder to insist upon strict adherence to any term of this Certificate of Designation on one or more occasions shall not be considered a waiver or deprive that party (or any other Holder) of the right thereafter to insist upon strict adherence to that term or any other term of this Certificate of Designation. Any waiver by the Corporation or a Holder must be in writing. Notwithstanding any provision in this Certificate of Designation to the contrary, any provision contained herein and any right of the Holders of Series A Non-Voting Preferred Stock granted hereunder may be waived as to all shares of Series A Non-Voting Preferred Stock (and the Holders thereof) upon the written consent of the Holders of not less than a majority
of the shares of Series A Non-Voting Preferred Stock then outstanding, provided, however, that the Beneficial Ownership Limitation applicable to a Holder, and any provisions contained herein that are related to such Beneficial Ownership Limitation, cannot be modified, waived or terminated without the consent of such Holder, provided further, that any proposed waiver that would, by its terms, have a disproportionate and materially adverse effect on any Holder shall require the consent of such Holder(s).
14. Severability. Whenever possible, each provision hereof shall be interpreted in a manner as to be effective and valid under applicable law, but if any provision hereof is held to be prohibited by or invalid under applicable law, then such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating or otherwise adversely affecting the remaining provisions hereof.
15. Status of Converted Series A Non-Voting Preferred Stock. If any shares of Series A Non-Voting Preferred Stock shall be converted or redeemed by the Corporation, such shares shall, to the fullest extent permitted by applicable law, be retired and cancelled upon such acquisition, and shall not be reissued as a share of Series A Non-Voting Preferred Stock. Any share of Series A Non-Voting Preferred Stock so acquired shall, upon its retirement and cancellation, and upon the taking of any action required by applicable law, resume the status of authorized but unissued shares of preferred stock and shall no longer be designated as Series A Non-Voting Preferred Stock.
16. Headings. The headings contained herein are for convenience only, do not constitute a part of this Certificate of Designation and shall not be deemed to limit or affect any of the provisions hereof.
[Remainder of Page Intentionally Left Blank]
IN WITNESS WHEREOF, Tivic Health Systems, Inc. has caused this Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock to be duly executed by its Chief Executive Officer on February 10, 2025.
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tivic health systems, INC. |
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By: |
/s Jennifer Ernst |
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Name: |
Jennifer Ernst |
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Title: |
CEO |
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ANNEX A
NOTICE OF CONVERSION
(TO BE EXECUTED BY THE REGISTERED HOLDER IN ORDER TO CONVERT SHARES OF SERIES A NON-VOTING CONVERTIBLE PREFERRED STOCK)
The undersigned Holder hereby irrevocably elects to convert the number of shares of Series A Non-Voting Preferred Stock indicated below, represented in book-entry form, into shares of common stock, par value $0.0001 per share (the “Common Stock”), of Tivic Health Systems, Inc., a Delaware corporation (the “Corporation”), as of the date written below. If securities are to be issued in the name of a Person other than the undersigned, the undersigned will pay all transfer taxes payable with respect thereto. Capitalized terms utilized but not defined herein shall have the meaning ascribed to such terms in that certain Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock (the “Certificate of Designation”) filed by the Corporation with the Secretary of State of the State of Delaware on February 10, 2025.
As of the date hereof, the number of shares of Common Stock beneficially owned by the undersigned Holder (together with such Holder’s Attribution Parties), including the number of shares of Common Stock issuable upon conversion of the Series A Non-Voting Preferred Stock subject to this Notice of Conversion, but excluding the number of shares of Common Stock which are issuable upon (A) conversion of the remaining, unconverted Series A Non-Voting Preferred Stock beneficially owned by such Holder or any of its Attribution Parties, and (B) exercise or conversion of the unexercised or unconverted portion of any other securities of the Corporation (including any warrants) beneficially owned by such Holder or any of its Attribution Parties that are subject to a limitation on conversion or exercise similar to the limitation contained in Section 6.4 of the Certificate of Designation, is _____. For purposes hereof, beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the applicable regulations of the Commission. In addition, for purposes hereof, “group” has the meaning set forth in Section 13(d) of the Exchange Act and the applicable regulations of the Commission.
CONVERSION CALCULATIONS:
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Date to Effect Conversion: |
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Number of shares of Series A Non-Voting Preferred Stock owned prior to Conversion: |
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Number of shares of Series A Non-Voting Preferred Stock to be Converted: |
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Number of shares of Common Stock to be Issued: |
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Address for delivery of physical certificates: |
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For DWAC Delivery, please provide the following:
Broker No.: ________________
Account No.: _______________
[HOLDER]
Exhibit 10.1
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL AND IS THE TYPE OF INFORMATION THAT THE REGISTRANT CUSTOMARILY AND ACTUALLY TREATS AS PRIVATE AND CONFIDENTIAL. REDACTED INFORMATION IS INDICATED BY [***].
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (“Agreement”) is entered into by and between Statera Biopharma, Inc., a Delaware corporation, with an address at 2580 East Harmony Road, Suite 316, Fort Collins CO 80528 (“Licensor”), and Tivic Health Systems, Inc., a Delaware corporation, with an address at 47685 Lakeview Blvd., Fremont CA 94538 (“Licensee”) and made effective as of February 11, 2025 (“Effective Date”). Licensor and Licensee may hereinafter be individually referred to as a “Party” or collectively as “Parties.”
RECITALS
A. Licensor is the owner of or controls the Licensed Patents and Licensed Know-How and has developed the Licensed Molecules (as such terms are defined below), which are proprietary TLR5 recombinant protein agonists intended to trigger NF-kB signaling and mobilize innate immune response to drive the expression of numerous genes, including inhibitors of apoptosis, scavengers of reactive oxygen species, and a spectrum of protective or regenerative cytokines for prolonged antitumor effect, and to provide protection from radio and chemotherapy side effects;
B. Licensee desires to obtain a worldwide, royalty bearing, exclusive license, under Licensed Patents 1 and Licensed Know-How to use Entolimod for the treatment of Acute Radiation Syndrome and an exclusive option to expand the license to also be under Licensed Patents 2 and Licensed Know-How and to include the additional Indications and to obtain a worldwide, royalty bearing, exclusive license, under Licensed Patents 2 and Licensed Know-How to use Entolasta for the treatment of the Indications (as such terms are defined below); and
C. Licensor is willing to grant a worldwide, royalty bearing, exclusive license, under Licensed Patents 1 and Licensed Know-How, to Licensee to use Entolimod for the treatment of Acute Radiation Syndrome and an exclusive option for Licensee to expand the license to also be under Licensed Patents 1 and Licensed Know-How and to include the additional Indications and for Licensee to obtain a worldwide, royalty bearing, exclusive license, under Licensed Patents 2 and Licensed Know-How to use Entolasta for the treatment of the Indications, in each case, on the terms and subject to the conditions set forth herein.
NOW, THEREFORE, for and in consideration of the premises and mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby expressly agree as set forth below.
AGREEMENT
1.1“Accounting Standards” means, with respect to a Party, United States generally accepted accounting principles (US GAAP) or such other internationally recognized accounting standards (e.g., IFRS), as such Party uses for its accounting or financial reporting obligations, in each case, consistently applied.
1.2“Acute Radiation Syndrome” also known as acute radiation sickness means the acute illness caused by radiation exposure of the body or most of the body by a high dose of penetrating radiation in a very short period of time.
1.3“Affiliate” means, with respect to a Person, any other Person of which (a) more than fifty percent (50%) of the voting stock or other equity ownership thereof, whether directly or indirectly, is owned or controlled by, or under common control with, such Person, or which owns or controls more than fifty percent (50%) of the voting stock or other equity ownership of such Person, provided that, in either of the foregoing, if less than fifty percent (50%), the maximum percentage permitted by law, or (b) has other comparable ownership interest with respect to any Person other than a corporation, or the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Person, whether through the ownership of voting securities, by contract or otherwise. Notwithstanding the foregoing, (i) Affiliates of a Party will exclude Persons who are financial investors of such Party or under common control of such financial investors (in each case, other than such Party and its subsidiary entities), and (ii) the Parties shall not be deemed to be Affiliates of each other.
1.4“Applicable Law” means, with respect to a given country or jurisdiction, the applicable Laws that may be in effect from time to time in such country or jurisdiction and that relate to a Party’s activities under this Agreement, including any Laws of the Regulatory Authorities of such country or jurisdiction.
1.5“Beneficial Ownership Limitation” shall initially be set at 9.9% for Licensor, or, in the event of a dividend or distribution of Common Stock by Licensor, Licensor’s stockholders, and may be adjusted at the discretion of the holder to a percentage between 4.9% and 19.9% of the number of Common Stock outstanding immediately after giving effect to the issuance of Common Stock upon conversion of Convertible Preferred Stock of the Licensee. Notwithstanding the foregoing, by written notice to the Licensee, (i) which will not be effective until the sixty-first (61st) day after such written notice is delivered to the Licensee, the holder may reset the Beneficial Ownership Limitation percentage to a higher percentage, not to exceed 19.9%, to the extent then applicable and (ii) which will be effective immediately after such notice is delivered to the Licensee, the holder may reset the Beneficial Ownership Limitation percentage to a lower percentage (but in no event less than 4.9%) provided that such decrease shall not become effective until the 5:00 p.m. Eastern time on the third business day after the date of the Stockholder Approval.
1.6“Bill of Sale” means a bill of sale transferring ownership of the Materials to Licensee in substantially the form attached hereto as Exhibit C.
1.7“BLA” means a Biologics License Application in the United States, or an equivalent application filed with the applicable Regulatory Authority outside the United States to obtain permission to market a biological product.
1.8“Buyout Payment” means (a) the lesser of (1) the aggregate amount of payments due to Licensor under Section 5.3 for achievement of all listed milestone events therein less the amount of payments paid to Licensor under Section 5.3 for the achievement of one or more of such milestone events prior to the Buyout Closing Date; and (2) the Royalty NPV Amount, less (b) the amount of payments paid
or payable by Licensee to Avenue Capital as required to extinguish the lien as described under Section 9.2(b).
1.9“Certificate of Designation” means the Certificate of Designation of Preferences, Rights and Limitations of Series A Non-Voting Convertible Preferred Stock in the form attached hereto as Exhibit G.
1.10“CMC Information” means information related to the chemistry, manufacturing and controls (“CMC”) of the Licensed Products, as specified by the applicable Regulatory Authority.
1.11“Commercially Reasonable Efforts” means, with respect to a Party, efforts and resources consistent with the efforts and resources that such Party and its Affiliates typically commit to a product or compound owned by it or to which it has rights (but not less than the diligent good faith efforts and resources commonly applied by a biopharmaceutical or biotechnology company with experienced staff to a product or compound owned by it or to which it has rights), in each case, to a product or compound which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety or efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory structure involved, the profitability of the applicable products, and other relevant factors.
1.12“Common Stock” means the issued and outstanding Common Stock of Licensee, par value $0.0001.
1.13“Confidential Information” means any confidential information of a Party its Affiliate or Sublicensee relating to any use, process, method, compound, research project, work in process, future development, scientific, engineering, manufacturing, marketing, business plan, financial or personnel matter relating to the disclosing party, its present or future products, sales, suppliers, customers, employees, investors or business, whether in oral, written, graphic, electronic, or any other form, in each case, which is disclosed to the other Party or its representative and marked confidential or designated by the disclosing party as being confidential prior to disclosure, or which is marked confidential and provided to the other Party or its representative within thirty (30) days of such disclosure, or which would reasonably be expected to be valuable and proprietary confidential information of the other Party its Affiliate or Sublicensee.
1.14“Convertible Preferred Stock” means Licensee’s non-voting convertible preferred stock, par value $0.0001 per share, with the rights, preferences, powers and privileges specified in the Certificate of Designation.
1.15“Data” means all data, including CMC data, experimental data, non-clinical data, preclinical data and clinical data, generated by or on behalf of a Party or its Affiliates or their respective sublicensees pursuant to activities conducted under this Agreement. For clarity, Data does not include any patentable inventions.
1.16“Entolasta” means the TLR5 agonist owned or controlled by Licensor known, as of the Effective Date, as “Entolasta”, as such compound is further described on Exhibit F.
1.17“Entolimod” means the TLR5 agonist owned or controlled by Licensor known as of the Effective Date, as “Entolimod”, as such compound is further described on Exhibit F.
1.18“Field” means any and all uses in humans or animals for the applicable Indication(s), initially as a monotherapy, and following the exercise of the Exclusive Option for Vaccine Adjuvant, as a monotherapy or as a Vaccine Adjuvant.
1.19“First Commercial Sale” means with respect to any Licensed Product and any country in the Territory, the first sale of such Licensed Product to a third party in such country, after such Licensed Product has been granted Regulatory Approval by the competent Regulatory Authority in such country.
1.20“Foreground IP” means any and all data, results, discovery, finding, process, improvement, method, composition of matter, article of manufacture, patentable or otherwise, that are developed, invented, reduced to practice, or otherwise generated by either Party exercising its rights or carrying out its obligations under this Agreement, whether directly or via its Affiliates, agents, contractors or Sublicensees, including all right, title and interest in and to the corresponding Intellectual Property Rights therein.
1.21“Governmental Authority” means any multi-national, national, federal, state, local, municipal, provincial or other Governmental Authority of any nature (including any governmental division, prefecture, subdivision, department, agency, bureau, branch, office, commission, council, court or other tribunal).
1.22“Immunosenescence” means the immune dysfunction that occurs with age and includes remodeling of lymphoid organs, leading to changes in the immune function of the elderly.
1.23“IND” means an Investigational New Drug Application in the United States, or an equivalent application filed with the applicable Regulatory Authority outside the United States to commence human clinical testing of a Licensed Product.
1.24“Indication(s)” means (i) initially, Acute Radiation Syndrome; and (ii) upon exercise of the Exclusive Option, as applicable, Lymphocyte Exhaustion, Immunosenescence, Neutropenia or Vaccine Adjuvant, or several or all of them, as exercised in each case by Licensee pursuant to Section 2.4.
1.25“Intellectual Property Rights” (or “IP”) means patents, utility certificates, utility models, industrial design rights, copyrights, database rights, trade secrets, any protection offered by law to information, and all registrations, applications, renewals, extensions, combinations, divisions, continuations or reissues of any of the foregoing.
1.26“Laws” means all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any federal, national, multinational, state, provincial, county, municipal, city or other political subdivision, domestic or foreign.
1.27“Lease Agreement” means the lease agreement to be entered into by the Parties and Licensor’s Affiliate, ImQuest Biosciences, which provides for a lease by ImQuest Biosciences to Licensee, for $1 per year, of the storage premises where the Materials, Data and CMC Information are held, and
continued storage and handling of the Materials and proper care of all related filings with Regulatory Authorities, Data and CMC Information, and providing for insurance to cover the Materials and Data and CMC Information, in form and substance to be negotiated in good faith and mutually agreed by the Parties as promptly as practicable following the Effective Date.
1.28“License Fee” means, collectively, (i) the License Fee Stock Consideration; and (ii) the License Fee Cash Consideration.
1.29“License Fee Cash Consideration” means Three Hundred Thousand U.S. Dollars ($300,000 USD) in immediately available funds.
1.30“License Fee Stock Consideration” means (a) 945,785 shares of Common Stock (“Common Stock Payment Shares”), which shares shall represent a number of shares equal to no more than 9.9% of the outstanding shares of Common Stock as of immediately before the Effective Date and (b) 359.6691 shares of Convertible Preferred Stock (“Preferred Stock Payment Shares”). Each Preferred Stock Payment Share shall be convertible into 10,000 shares of Common Stock, subject to and contingent upon Stockholder Approval of the issuance of shares of Common Stock to the Licensor upon conversion of any and all shares of Convertible Preferred Stock in accordance with the terms of the Certificate of Designation (the “Stock Conversion Proposal”).
1.31“Licensed Know-How” means any data, information, knowledge, methods (including methods of manufacture, use or administration or dosing), practices, results, techniques, and trade secrets, including analytical and quality control data, analytical methods (including applicable reference standards), assays, batch records, chemical structures and formulations, compositions of matter, formulae, materials, manufacturing data, pharmacological, toxicological and clinical test data and results, processes, reports, research data, research tools, sequences, standard operating procedures, and techniques, which are owned or controlled by Licensor or its Affiliates, as of the Effective Date or after the Effective Date during the term of this Agreement, in each case, which directly relate to the Licensed Molecules and which are necessary or reasonably useful for the development, manufacture or commercialization of the Licensed Products in the Field in the Territory.
1.32“Licensed Molecule” (individually) or “Licensed Molecules” (collectively) means, as the context requires, (i) Entolimod, (ii) Entolasta, or (iii) both of them.
1.33“Licensed Patents” means (a) initially, Licensed Patents 1; and (b) upon exercise of the Exclusive Option, as applicable, (i) Licensed Patents 1 and (ii) Licensed Patents 2, collectively.
1.34“Licensed Patents 1” means
(a)The patents and patent applications set forth in Exhibit A-1;
(b)any divisional and continuation of the patent applications arising from subsection (a), and continuation-in-part that contains a claim entitled to the benefit of the priority date of the patent applications listed in subsection (a);
(c)the foreign patent applications associated with the patent applications referenced in subsections (a) and (b);
(d)the patents issued from the patent applications referenced in subsections (a) through (c); and
(e)the reissues, reexaminations, restorations (including supplemental protection certificates) and extensions of any patent or patent application set forth in subsections (a) through (d)
1.35“Licensed Patents 2” means
(a)The patents and patent applications set forth in Exhibit A-2;
(b)any divisional and continuation of the patent applications arising from subsection (a), and continuation-in-part that contains a claim entitled to the benefit of the priority date of the patent applications listed in subsection (a);
(c)the foreign patent applications associated with the patent applications referenced in subsections (a) and (b);
(d)the patents issued from the patent applications referenced in subsections (a) through (c); and
(e)the reissues, reexaminations, restorations (including supplemental protection certificates) and extensions of any patent or patent application set forth in subsections (a) through (d).
1.36“Licensed Product” means (i) initially, any drug, vaccine, blood component, gene therapy or other product or therapy in the Field, in any dose, form, presentation or formulation, in each case: (a) the manufacture, use, sale or other exploitation of which would infringe any Valid Claim under Licensed Patents 1; or (b) which otherwise contains Entolimod; and (ii) following an exercise of the Exclusive Option, as applicable, any drug, vaccine, blood component, gene therapy or other product or therapy in the Field (after giving effect to such exercise), in any dose, form, presentation or formulation, in each case: (i) the manufacture, use, sale or other exploitation of which would infringe any Valid Claim; or (ii) which otherwise contains one or more Licensed Molecules.
1.37“Licensed Technology” means the Licensed Patents and Licensed Know-How.
1.38“Lymphocyte Exhaustion” means the progressive loss of lymphocyte functionalities and reduced proliferative capability of lymphocytes triggered by chronic antigen stimulation due to chronic infections or cancers.
1.39“Materials” means (i) the frozen manufactured Entolimod lots, as more fully set forth in Exhibit B, and (ii) all associated quality records associated with their production and applicable verification records, in each case, owned or controlled by Licensor.
1.40“NDA” means a New Drug Application in the United States, or an equivalent application filed with the applicable Regulatory Authority outside the United States to obtain permission to market a drug for one or more specified indications.
1.41“Net Sales” means the gross amount invoiced by Licensee and/or its Affiliates or Sublicensees for or in connection with sales of the Licensed Product(s) to any person, entity or party that is not an Affiliate, after deduction of the following to the extent applicable to such sales and deducted in accordance with the Accounting Standards of Licensor:
(a)all customary trade, case and quantity credits, discounts, refunds or rebates reflected in written documentation;
(b)actual allowances or credits for returns, including without limitation amounts received for sales which become the subject of a subsequent temporary or partial recall by a regulatory agency for safety or efficacy reasons outside the control of Licensee to the extent that each is included in Licensee’s or an Affiliate’s billings, provided, however, that amounts set aside for temporary recalls are added back to Net Sales should the temporary recall be cancelled;
(c)cost of freight, postage, and freight insurance, (if paid by seller) to the extent that each is included in Licensee’s or an Affiliate’s billings; and
(d)sales taxes, value added taxes, excise taxes, and customs duties directly imposed and with reference to particular sales.
A sale or transfer to an Affiliate for re-sale by such Affiliate shall not be considered a sale for the purpose of this provision, but the resale by such Affiliate to a third party shall be a sale for such purposes. Any amounts received by Licensee, its Affiliates in exchange for Licensed Products transferred or provided to any person or entity for use in testing, clinical trials, or as marketing samples to develop or promote the Licensed Products are included in the definition of Net Sales.
1.42“Neutropenia” means the presence of abnormally few neutrophils in the blood, leading to increased susceptibility to infection.
1.43“Person” means a corporation, partnership, joint venture or other entity.
1.44“Regulatory Approval” means, with respect to a particular country, any approval, product, or establishment license, registration, or authorization of the applicable Regulatory Authority necessary for the commercial sale of a Licensed Product in such country.
1.45“Regulatory Authority” means, in a particular country, any applicable Governmental Authority involved in granting Regulatory Approval in such country.
1.46“Royalty NPV Amount” means, in the event Licensee exercises the Buyout, an amount negotiated in good faith and mutually agreed by the Parties in writing as representing the risk adjusted net present value of the aggregate royalties that would have been payable under this Agreement absent such exercise; provided, that if the Parties do not mutually agree in writing on the Royalty NPV Amount
within ninety (90) days following such exercise, either Party may, by written notice to the other Party, refer the determination of the Royalty NPV Amount to arbitration as provided on Exhibit D.
1.47“Royalty Period” means, with respect to each Licensed Product, on a country-by-country basis, the period commencing upon the First Commercial Sale of such Licensed Product in such country and ending upon the later of (i) the expiration of the last-to-expire Valid Claim covering such Licensed Product in such country, (ii) the expiration of biological products exclusivity for such Licensed Product provided by Section 351(k)(7) of the Public Health Service Act or the period of drug product exclusivity provided by Section 505(c)(3)(E) and 505(j)(5)(F) of the Federal Food, Drug, and Cosmetic Act, or foreign equivalent, as applicable, in such country, and (iii) the tenth (10th) anniversary of the First Commercial Sale of such Licensed Product in such country.
1.48“Stockholder Approval” means the affirmative vote of a majority of the Common Stock present or represented and entitled to vote at a meeting of stockholders of Licensee to approve, for purposes of the Nasdaq Stock Market Rules, the conversion of Convertible Preferred Stock into Common Stock.
1.49“Sublicense” means an agreement into which Licensee or its Affiliate or Sublicensee enters into with any third party that (i) grants, directly or indirectly, rights under the rights and licenses granted to Licensee hereunder, including rights to use the Licensed Technology to develop, test, make or use a Licensed Molecule or to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit a Licensed Product, in the Field in the Territory; (ii) granting an option to such rights; or (iii) forbearing the exercise of any rights, granted to Licensee under this Agreement.
1.50“Sublicensee” means a third party that obtains a Sublicense.
1.51“Subsequent Stock Consideration” means, in the event the Licensee decides not to pay some or all of each of the milestone payments or Buyout Payment in cash, the value of such amount in Licensee stock, as follows:
(a)Licensee will issue to Licensor a number of shares of Convertible Preferred Stock (or such subsequent series on identical terms as the Convertible Preferred Stock), to be convertible into Common Stock upon Stockholder Approval, subject to the Beneficial Ownership Limitation; and
(b)The price per share for the Subsequent Stock Consideration will be calculated based on the twenty (20) trading day volume weighted average price (“VWAP”) prior to the date of achievement by a Licensed Product of the applicable milestone event or Licensee’s exercise of the Buyout.
1.52“Territory” means worldwide.
1.53“TLR5” means Toll-like Receptor 5.
1.54“Vaccine Adjuvant” means uses as an additional ingredient in or added to a vaccine to improve the immune response to the vaccine’s antigens.
1.55“Valid Claim” means a claim of (i) a pending patent application included within the Licensed Patents, which claim is pending in good faith; or (ii) an issued patent included within the Licensed Patents, which claim has not lapsed, been canceled or become abandoned and has not been declared invalid or unenforceable by an unreversed and unappealable decision or judgment of a court or other appropriate body of competent jurisdiction, and which has not been admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.
1.56“VWAP” means the volume weighted average price per share of Common Stock for such date on the trading market on which the Common Stock is then listed or quoted as reported by Bloomberg L.P. (based on a Trading Day from 9:30 a.m. (New York City time) to 4:00 p.m. (New York City time).
1.57Additional Definitions. The following table identifies the location of additional definitions set forth in the subsequent Sections of this Agreement:
|
|
Defined Term |
Section |
Buyout |
2.3 |
Buyout Closing Date |
2.3(a) |
Claim |
8.1 |
Combination Licensed Product |
5.3 |
Exclusive Option |
2.4 |
Infringement Notice |
6.5(a) |
Licensed Product IP |
6.4(b) |
Licensee Indemnitees |
8.1 |
Licensee Patent Costs |
6.2(b) |
Licensor Indemnitees |
8.2 |
Losses |
8.1 |
(a)Subject to the terms and conditions of this Agreement, Licensor hereby grants to Licensee during the term of this Agreement:
(i)a royalty-bearing, exclusive license in the Territory, with the right to grant and authorize Sublicenses in accordance with Section 2.2, under Licensed Patents 1 to develop, test, make and use Entolimod to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit Licensed Product in the Field in the Territory; and
(ii)a royalty-bearing, exclusive license in the Territory, with the right to grant and authorize Sublicenses in accordance with Section 2.2, to use the Licensed Know-How to develop, test, make and use Entolimod to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit Licensed Product in the Field in the Territory.
(b)Effective upon the exercise of an Exclusive Option in accordance with Section 2.4 with respect to any of the additional Indications, then (1) the Field applicable to the license under Section 2.1(a) shall automatically be expanded to include such additional Indication(s); and (2) the license rights as set forth in Section 2.1(a) shall automatically be expanded to include (A) a license under Patent Rights 2 (for clarity, in addition to Patent Rights 1); and (B) rights to develop, test, make and use Entolasta (for clarity, in addition to Entolimod), to develop, test, make, have made, use, sell, offer for sale, import and otherwise exploit Licensed Product in the Field in the Territory.
(c)Effective upon the exercise of an Exclusive Option in accordance with Section 2.4 with respect to uses of Licensed Molecule and Licensed Product as a Vaccine Adjuvant, the Field applicable to the license under Section 2.1(a) (as such license may otherwise be expanded as described in 2.1(b)) shall automatically be expanded to include uses of Licensed Molecule and Licensed Product as a Vaccine Adjuvant (for clarity, in addition to as a monotherapy) in the Field in the Territory.
(a)For so long as Licensee is in full compliance with all of its obligations under this Agreement, Licensee may grant Sublicenses under the Licensed Technology to the Licensed Molecules, but only to the extent necessary to develop, make, have made, use, market, sell, offer for sale and import Licensed Products in the Territory for use in the Field. Licensee agrees to forward to Licensor a copy of each fully executed Sublicense within thirty (30) days of execution of such agreement.
(b)Licensee will not grant in any Sublicense any rights which are inconsistent with the rights granted to and obligations imposed on Licensee under this Agreement.
(c)Any Sublicense granted hereunder shall be consistent with and subject to the terms and conditions of this Agreement. Licensee will continue to be responsible for full performance of its obligations under this Agreement. In the event that any action of inaction by a Sublicensee would qualify as a breach of the terms of this Agreement if Licensee itself had undertaken such action or inaction, then Licensee shall take all actions reasonably available under or with respect to the Sublicense (including such actions reasonably requested by Licensor) to cause the Sublicensee to comply with the terms of this Agreement as promptly as practical, including, but not limited to, termination.
2.3Buyout. Licensor does hereby grant to Licensee the right, but not the obligation, to acquire all right, title and interest in and to the Licensed Technology and to all related filings with Regulatory Authorities, Data and CMC Information related to the Licensed Molecules (the “Buyout”). Licensee may exercise the Buyout at any time during the term of this Agreement. Following exercise of the Buyout, as provided below, Licensee shall acquire all right, title and interest in the Licensed Technology and all related filings with Regulatory Authorities, Data and CMC Information related to the Licensed Molecules upon (i) the receipt by each Party of any approvals required under Applicable Law, (ii) the payment to Licensor of the Buyout Payment, and (iii) closing of the transfer of title to the Licensed Technology on the Closing Buyout Date.
(a)If Licensee desires to exercise the Buyout, it shall send written notice to Licensor during the term of this Agreement, setting forth a proposed date (“Buyout Closing Date”) for the closing
of transfer of title to the Licensed Technology and all related filings with Regulatory Authorities, Data and CMC Information related to the Licensed Molecules and payment of the Buyout Price which shall be no later than ninety (90) days after the notice of exercise (or, if later, thirty (30) days following mutual agreement on, or determination in accordance with Exhibit D of, the Royalty NPV Amount).
(b)On such Buyout Closing Date, Licensee shall pay to Licensor the Buyout Payment, in either cash or Subsequent Stock Consideration, and Licensor shall transfer all right, title and interest in and to the Licensed Patents to Licensee by execution and delivery of a written assignment of the Licensed Patents in form recordable in the USPTO reasonably satisfactory to Licensee’s counsel, and Licensee shall be authorized to immediately file such assignment in the USPTO. Licensor shall also execute and deliver such other documents and instruments as shall be reasonably necessary to effect the transfer of all right, title and interest in and to the Licensed Technology in accordance with Applicable Law and all related filings with Regulatory Authorities, Data and CMC Information to Licensee, in accordance with this Agreement, in the form provided by Licensee’s counsel and mutually agreed by Licensor, and shall deliver to Licensee all tangible embodiments of the Licensed Know-How and Data and CMC Information in Licensor’s possession and control.
(c)The assignment and transfer of title from Licensor to Licensee shall be free and clear of all licenses, contracts, liens, claims, and encumbrances (except as would not, individually or in the aggregate, interfere or be reasonably expected to interfere with Licensor’s use of the Licensed Technology in any material respect or with the rights granted to Licensee or Licensee’s use of the Licensed Technology as contemplated hereunder in any material respect). From and after such assignment and transfer, Licensor shall be excluded from practicing under the Licensed Patents or from any use of the Licensed Know-How and Data and CMC Information (except as necessary for Licensor to comply with its obligations hereunder or Applicable Law) and all of the foregoing, to the extent relating to the Licensed Technology and not published or publicly available, shall be deemed to be Confidential Information of Licensee. Following such assignment and transfer of title, Licensor shall not challenge the title of Licensee in and to the Licensed Know-How and Data and CMC Information.
(d)During the period commencing on the Effective Date, and continuing during the term of this Agreement, Licensor shall maintain all right, title and interest in and to the Licensed Technology and the and Data and CMC Information Patent free and clear of all liens, claims and encumbrances (except (i) obligations created or expressly contemplated by this Agreement, and (ii) as would not, individually or in the aggregate, interfere or be reasonably expected to interfere with Licensor’s use of the Licensed Technology in any material respect or with the rights granted to Licensee or Licensee’s use of the Licensed Technology as contemplated hereunder in any material respect); Licensor shall not license, sublicense, transfer, assign, sell or otherwise dispose of or impair title to the Licensed Technology or Data and CMC Information or enter into any contract to do so; and Licensor shall not practice under, manufacture, sell, distribute or market any products under the foregoing in the Field in the Territory.
(e)For the avoidance of doubt, following the exercise of the Buyout, on the Buyout Closing Date, this Agreement shall be automatically terminated and have no further force or effect except as set forth in Section 10.7(c).
2.4Exclusive Option. Licensee shall have the exclusive right to expand the Indications under the Field, to include the treatment of Lymphocyte Exhaustion, Immunosenescence or Neutropenia or to expand the Field to include uses as Vaccine Adjuvant, or several or all of them, at any time during the term of this Agreement, and on one or more occasions, in Licensee’s sole discretion in each case (the “Exclusive Option”), as follows.
(a)Should Licensee elect to exercise the Exclusive Option with respect to Lymphocyte Exhaustion, Immunosenescence, Neutropenia or use as Vaccine Adjuvant, Licensee shall give Licensor written notice to such effect identifying in each case, which indication or if use as Vaccine Adjuvant is subject to the exercise, then use as Vaccine Adjuvant (such notice, an “Exercise Notice”).
(b)Upon delivery of an Exercise Notice, Licensee shall undertake all obligations under Section 3 with respect to the development and commercialization of Licensed Products for the Indication or use as Vaccine Adjuvant as set forth in the applicable Exercise Notice.
(c)During the term of this Agreement, Licensor shall not license, transfer or otherwise convey any rights to use the Licensed Molecules for any of the above Indications, or as a Vaccine Adjuvant, to any other Person.
2.5Data Access. Licensor shall provide Licensee with reasonable access to all available information regarding the Licensed Technology in Licensor’s possession and control, including, but not limited to, all such prosecution history of the Licensed Patents and all such prior regulatory filings by Licensor with respect to any of the Licensed Molecules.
2.6Materials. On the Effective Date, Licensor is transferring ownership of the Materials to Licensee in accordance with the Bill of Sale. The Parties shall enter into the Lease Agreement as promptly as practicable following the Effective Date. Following the Effective Date, the Parties will work together in good faith to ensure continued proper storage and handling of Materials at all times, including in connection with any transfer of the Materials to Licensee, as will be more fully set forth in the Lease Agreement or otherwise mutually agreed by the Parties in writing.
(a)Board of Directors Seat. In conjunction with the license grant set forth in Section 2.1, Licensor may nominate one (1) individual to sit on Licensee’s Board of Directors. Licensor’s nominee must have the relevant industry experience in biopharmaceuticals, meet all requirements for service as an Independent Board Member as defined by Nasdaq listing requirements, and preference shall be given to an individual with the ability to chair an audit or compensation committee. Approval of such Licensor nominee shall be at the sole reasonable discretion of Licensee’s Board of Directors acting in good faith.
(b)Licensor Team. Licensor shall designate key personnel, including Licensor’s current chief executive officer, to join Licensee and be principally responsible for Licensee’s activities towards developing Licensed Products hereunder. Licensee and such designated key personnel shall negotiate in good faith the terms of employment or consulting agreements to provide services to Licensee in support of Licensee’s development efforts of Licensed Products hereunder; provided that Licensee shall retain the sole discretion regarding its acceptance of financial and other terms of such engagement.
Provided that Licensor and relevant personnel agree to financial and other terms of such engagement, then Licensor shall employ or otherwise engage such key personnel as may be set forth in a mutually agreed written agreement setting forth such agreed financial and other terms of engagement.
2.8No Other Rights. The license granted hereunder shall not be construed to confer any rights, other than those affirmatively granted hereunder, to Licensee by implication, estoppel or otherwise as to any technology not specifically set forth in this Agreement.
3.DEVELOPMENT AND COMMERCIALIZATION
3.1Commercially Reasonable Efforts. Licensee shall be solely responsible for the development and commercialization of Licensed Products in the Field in the Territory, at its own cost and expense, including all non-clinical and clinical studies and collection of CMC Information, as necessary to obtain Regulatory Approval for Licensed Products (i) in the United States and (ii) in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment and commercialize any Licensed Product that receives Regulatory Approval in the applicable country or jurisdiction. Such efforts include, but are not limited to:
(a)maintaining a continuous effort for development, manufacture and sale of Licensed Products;
(b)obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products in the Territory, in compliance with this Agreement and under supervision of the Licensor;
(c)reasonably filling the market demand for Licensed Products following commencement of marketing at any time during the term of the Licensed Agreement;
(d)implementing and conducting technology transfer as required for the manufacture of Licensed Product in the Territory.
Upon exercise of the Exclusive Option for an Indication or for use as Vaccine Adjuvant, as applicable, Licensee shall be obligated to develop Licensed Products for such Indication or for use as Vaccine Adjuvant and to file all regulatory filings with FDA as necessary to obtain Regulatory Approval for such Licensed Product for such Indication or for use as Vaccine Adjuvant the United States and to file all regulatory filings with applicable Regulatory Authorities in the other countries in the Territory reasonably selected by Licensee in good faith, consistent with Licensee’s obligation to use Commercially Reasonable Efforts hereunder. Licensee shall use its Commercially Reasonable Efforts to develop and commercialize Licensed Products on a schedule that is consistent with sound and reasonable business practices and judgment.
3.2Development Records. Licensee shall maintain complete, current and accurate records of all Data and other information resulting from Licensed Product development activities conducted by Licensee, its Affiliates and Sublicensees. Such records shall fully and properly reflect all work done and
results achieved in the performance of the development activities in good scientific manner appropriate for regulatory and patent purposes. Licensee shall document all non-clinical studies and clinical trials in formal written study records in accordance with all Applicable Law and in accordance with applicable national and international guidelines. All such Data shall be owned by the Licensee and shall be provided to Licensor on a regular basis, as soon as practicable after each development milestone. Licensee shall, at its sole cost and expense, promptly provide Licensor with copies of all Data and access to regulatory materials related to all Licensed Products generated by or on behalf of Licensee or its Affiliates or Sublicensees in the performance of development activities of the Licensed Products.
3.3Data Exchange. Licensor shall, at Licensee’s cost and expense, provide Licensee with copies of all Data and access to regulatory materials for Licensed Products generated by or on behalf of Licensor or its Affiliates in the performance of development activities of the Licensed Products outside of the Field, if applicable.
4.1Regulatory Responsibilities.
(a)Licensee will be responsible, at its sole cost and expense, for the conduct of all regulatory activities required to obtain and maintain Regulatory Approval of Licensed Products in the Field in the Territory, including the preparation and submission of all regulatory materials and all communications and interactions with Regulatory Authorities as necessary to obtain Regulatory Approval for Licensed Products in the Territory, and with the maintenance of any and all Regulatory Approvals.
(b)Licensor shall provide reasonable assistance and cooperation to Licensee (subject to Licensee’s reimbursement of Licensor’s out-of-pocket expenses related thereto). In order to address questions Licensee may receive from a Regulatory Authority in the Territory, Licensor will assist in the preparation of responses based on information that would be found in: various technical reports, notebooks, executed batch records, master batch records, SOPs, validation protocols and reports, vendor certificates, and third party study reports and other CMC related documents not otherwise already provided to Licensee. Any such transfer of CMC Information as set forth in this Section 4.1 is conditioned on Licensee establishing appropriate firewalls or equivalent means to ensure that such CMC Information is protected from unauthorized disclosure and is used only for legal and regulatory compliance purposes and not for any other purpose. In furtherance of the foregoing, Licensee shall ensure that any CMC Information provided by or on behalf of Licensor pursuant to this Section 4.1 shall only be disclosed to those identified personnel of Licensee (or a designated agreed third party) who (a) have a need to know the same to comply with the above obligations, and (b) have been fully informed of and acknowledge the highly sensitive and proprietary nature of such information and the need to maintain its secrecy and avoid inappropriate usage or disclosure, by using the firewall or equivalent means.
4.2Regulatory Information Sharing. Licensee shall (a) provide Licensor with English translations, along with the original documents (in the electronic format in which it has been prepared by Licensee), of all materials submitted to a Regulatory Authority in the Territory in connection with obtaining or maintaining any regulatory approval for Licensed Products in the Field in the Territory; and (b) shall
keep Licensor informed of any material verbal or written communication or question relating to Licensed Products received by Licensee from any Regulatory Authority in the Territory.
4.3Meetings. Licensee shall lead all interactions with Regulatory Authorities in the Territory with respect to Licensed Products. Licensee shall keep Licensor reasonably informed of regulatory developments related to Licensed Products in the Field in the Territory and shall promptly notify Licensor in writing of any such development that is, or would reasonably be expected to be, material to the development, manufacture, commercialization or other exploitation of a Licensed Product.
4.4Right of Reference to Regulatory Materials. Each Party hereby grants to the other Party the right of reference to all regulatory materials pertaining to Licensed Products submitted by or on behalf of such Party. The receiving Party may use such right of reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval of Licensed Products in its respective territory. Each Party shall support the other Party, as reasonably requested by such other Party and at such other Party’s expense, in obtaining Regulatory Approvals in such other Party’s territory, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approval in such territory, all in accordance with the terms and conditions of this Agreement.
5.1License Fee. As consideration of the grant of the license under this Agreement, Licensee shall pay Licensor:
(a)the License Fee Cash Consideration (less any unrecouped Licensee Patent Costs) within thirty (30) days following the Effective Date; and
(b)the License Fee Stock Consideration (less any unrecouped Licensee Patent Costs).
(a)With respect to each Licensed Product, Licensee shall pay Licensor, during the applicable Royalty Period, the following royalties:
(i)for Acute Radiation Syndrome as a monotherapy, [***] percent ([***]%) of Net Sales of such Licensed Product on a country-by-country basis (less any unrecouped Licensee Patent Costs);
(ii)for all other Indications and for uses as Vaccine Adjuvant, [***] percent ([***]%) of Net Sales of such Licensed Product on a country-by-country basis (less any unrecouped Licensee Patent Costs).
(b)If a royalty must be paid to a third party by Licensee or its Affiliates to use a Licensed Patent in a given country or jurisdiction in the Territory, then the royalty payable to Licensor pursuant to this Agreement for the applicable Licensed Product in the applicable country or jurisdiction shall be reduced by [***] percent ([***]%) of the applicable third party royalty actually paid to such third party by or on behalf of Licensee.
(c)Should no Valid Claims cover Licensed Products in a country, then the royalty rates set forth above shall immediately be reduced by Fifty Percent (50%) until a Valid Claim in such country covers Licensed Products.
(d)Notwithstanding the above, in no instance shall the royalty payable to Licensor ever be reduced to less than [***] percent ([***]%) of the amount otherwise set forth in Sections 5.2(a)(i) or 5.2(a)(ii) above.
(e)Licensor may, at its sole discretion, and without limiting its obligation to pay royalties under this Agreement, pre-pay royalties to be applied to future royalty payouts.
(a)Licensee shall pay to Licensor the payments set forth in the table below (less any unrecouped Licensee Patent Costs and unrecouped amounts paid or payable to Avenue Capital by Licensee as required to extinguish the lien as described under Section 9.2(b)), in each case in either the form of cash or Subsequent Stock Consideration, at the discretion of the Licensee within forty-five (45) days of Licensee, its Affiliate or Sublicensee, first achieving an applicable given milestone event below by a Licensed Product incorporating Entolimod. Licensee may, at its sole discretion, accelerate milestone payments in advance of milestone achievements.
|
|
Event |
Payment |
Validation of current inventory of Materials for distribution and sales |
$750,000 |
Filing of BLA with FDA for Acute Radiation Syndrome |
$1,000,000 |
Total Acute Radiation Syndrome Development Milestones |
$1,750,000 |
(b)Effective only following the exercise of an Exclusive Option in accordance with Section 2.4 hereunder with respect to any of the additional Indications Licensee shall pay to Licensor the corresponding payments set forth in the table below (less any unrecouped Licensee Patent Costs and unrecouped amounts paid or payable to Avenue Capital by Licensee as required to extinguish the lien as described under Section 9.2(b)), with respect to the Indication(s) subject to the exercised Exclusive Option only, in each case in either the form of cash or Subsequent Stock Consideration, at the discretion of the Licensee within forty-five (45) days following Licensee, its Affiliate or Sublicensee, first achieving an applicable given milestone event below by a Licensed Product incorporating Entolimod or Entolasta for the applicable Indication, as the case may be. Licensee may, at its sole discretion, accelerate milestone payments in advance of milestone achievements.
|
|
Event |
Payment |
File IND and Initiate Phase 2 Clinical Study for Neutropenia |
$500,000 |
|
|
Phase III Completion - successfully meets endpoint required to secure FDA approval for treatment of Neutropenia |
$750,000 |
File BLA with FDA and achieve FDA Approval for Neutropenia |
$1,500,000 |
File IND and Initiate Phase 2 study of Lymphocyte Exhaustion |
$500,000 |
Phase III Completion - successfully meets endpoint required by FDA for treatment of Lymphocyte Exhaustion |
$750,000 |
File BLA with FDA and achieve FDA Approval for Lymphocyte Exhaustion |
$1,500,000 |
IND approval and initiation of Phase 3 study as a Vaccine Adjuvant |
$500,000 |
File US BLA with FDA and achieve FDA Approval for use as a Vaccine Adjuvant |
$500,000 |
Total Potential Development Milestones for additional Indications (as applicable) |
$6,500,000 |
5.4Combination Products. If Licensee or its Affiliates or Sublicensee sell a Licensed Product as a Vaccine Adjuvant or in a formulation that includes active pharmaceutical ingredients other than those covered by the Licensed Patents or Licensed Know-How that contribute significant and material value to said Licensed Product (“Combination Licensed Product”), then in lieu of the royalty rate calculated in accordance with Section 5.2, the applicable royalty rate on the Net Sales of such Combination Licensed Product shall be calculated as the product obtained by multiplying the royalty rate calculated in accordance with Section 5.2 by the fraction A/(A+B), in which A is the value of the Licensed Technology licensed under this Agreement and B is the value of the vaccine (in the case of use as a Vaccine Adjuvant) or other included active pharmaceutical ingredient(s); provided, however, that in no event shall the royalty rate payable to Licensor for Net Sales of Combination Licensed Products ever be reduced to less than [***] percent ([***]%) of the royalty rate otherwise calculated in accordance with Section 5.2. For purposes of this Section 5.4 the “value” of a vaccine (in the case of use as a Vaccine Adjuvant) or each active pharmaceutical ingredient contributing value to the Licensed Product shall mean, in the case of a vaccine, the average sales price of the vaccine when not combined with the Licensed Product being used as a Vaccine Adjuvant, or in the case of other active pharmaceutical ingredients, that component’s contribution to the combined value of the Combination Licensed Product. Furthermore, carriers, diluents, solvents and other such constituents of a potential Licensed Product shall be deemed not to contribute significant and material value to said Licensed Product.
(a)Within thirty (30) days of each calendar quarter during the term of this Agreement and following termination for so long as Net Sales of Licensed Products take place, Licensee shall provide Licensor a report, as applicable, in sufficient detail to permit confirmation of the accuracy of the royalty payment made, including: (a) the amount of gross sales and Net Sales of Licensed Products, as
applicable, on a country by country basis in the Territory, (b) an itemized calculation showing the deductions from gross sales (by each major category as set forth in the definition of Net Sales herein) to determine Net Sales, (c) a calculation of any reduction to the royalties as permitted, including for any unrecouped Licensee Patent Costs or for unrecouped amounts paid or payable by Licensee to Avenue Capital as required to extinguish the lien as described under Section 9.2(b), and (d) a calculation of the amount of royalties due to Licensor in U.S. Dollars, including the application of any exchange rate used.
(b)Payment of the royalties specified in Section 5.2 shall be made by Licensee to Licensor on a quarterly basis, no later than thirty (30) days following the end of each calendar quarter, and in each case will cover the Net Sales of Licensed Products sold by Licensee and/or its Affiliates or Sublicensees in such quarter. After termination or expiration of this Agreement, a final payment shall be made by Licensee covering the whole or partial calendar quarter.
5.6Form of Payment. All royalty payments due hereunder and any payments due for milestone events under Section 5.3, which are not paid in Subsequent Stock Consideration, are expressed in and shall be paid by wire transfer or check payable in United States Dollars, without deduction of exchange, collection or other charges, to Licensor, or to the account of Licensor at such other bank as Licensor may from time to time designate by written notice to Licensee.
5.7Exchange Rate. Conversion of payments from any foreign currency shall be made at the rate of exchange reported in The Wall Street Journal (on website: https://www.wsj.com/market-data/currencies/exchangerates or such successor URL as may be used by The Wall Street Journal during the term of this Agreement) on the last business day of the applicable calendar quarter.
5.8Taxes. All payments due to Licensor shall be paid exclusive of, and without reduction for, any taxes arising, assessed or payable with respect to such payments (other than U.S. income taxes due on Licensor’s income therefrom) which shall be the sole responsibility of, and paid by, Licensee.
5.9Records And Inspection.
(a)Licensee shall maintain or cause to be maintained a true and correct set of records pertaining to the Net Sales of Licensed Products by Licensee and/or its Affiliates or Sublicensee under this Agreement. Such records shall be kept at Licensee’s principal place of business or the appropriate principal place of business of the appropriate Affiliate or Sublicensee to which this Agreement relates.
(b)During the term of this Agreement, Licensee agrees to permit an independent certified public accountant or other independent agent selected and paid by Licensor, and reasonably acceptable to Licensee, to have access during ordinary business hours to such records as are maintained by Licensee, or its Affiliates or Sublicensee, as may be necessary, in the opinion of such party, to determine the correctness of any report and/or payment made under this Agreement. Such audits may be exercised no more than once in any twelve (12) month period upon at least thirty (30) days prior written notice to Licensee. Any and all information learned or acquired by Licensor’s agent or accountant pursuant to any such inspection shall be treated the same as Confidential Information of Licensee, in accordance with the provisions of Section 7 below. Before undertaking any such inspection, Licensor’s agent or accountant
shall agree in writing to be bound by the terms of this Section and Section 7 below. Licensor shall bear the full cost of such audit.
(c)Licensor shall use commercially reasonable efforts to cooperate fully with Licensee in the event that a Governmental Authority requires an audit of Licensor or the Licensed Molecules, including providing all necessary information and documentation required by Applicable Law, including historical financial records, as applicable, granting access to relevant personnel and facilities, and taking any other actions reasonably requested by Licensee pursuant to such audit. This includes providing further assurances, such as executing additional documents or taking further actions, as may be necessary under Applicable Law or reasonably requested by Licensee to fulfill the purpose of this audit clause and comply with Applicable Laws.
6.1Background Intellectual Property. Each Party shall own and retain all right, title and interest in and to any and all information, inventions, patents and other Intellectual Property Rights owned or otherwise controlled by such Party (other than pursuant to the license grants set forth in this Agreement) outside of this Agreement.
6.2Patent Prosecution and Maintenance.
(a)Licensor shall have the first right, but not the obligation, to file, prosecute and maintain all Licensed Patents at Licensor’s sole expense. Licensor shall prosecute and maintain Licensed Patents in the Territory using counsel to be chosen by Licensor and to which Licensee has no reasonable objection. Licensor will consult and cooperate with Licensee in directing patent counsel to prepare, file, prosecute and maintain regarding preparation, filing, prosecution and maintenance of the Licensed Patents in the Territory and Licensor shall reasonably consider all recommendations provided by Licensee with regard to the further prosecution and maintenance of the Licensed Patents in the Territory. Licensee shall be provided with copies of all documents relating to the filing, prosecution, and maintenance of Licensed Patents in the Territory in sufficient time to review such documents and comment thereon, if desired by Licensee, prior to filing, provided, however, that if Licensee has not commented on such documents prior to the deadline for filing a response with the relevant government patent office, Licensor shall be free to respond without consideration of Licensee's comments. Licensee shall keep this documentation confidential in accordance with Section 7 herein.
(b)Licensor may cease prosecution or maintenance of any Licensed Patent in the Territory that it is responsible for prosecuting or maintaining pursuant to this Section on a country-by-country basis by providing Licensee written notice at least sixty (60) days in advance of any filing or payment due date. If Licensor elects to cease prosecution or maintenance of the relevant Licensed Patent in a country in the Territory, Licensee shall have the right, but not the obligation, at its sole discretion and cost, to continue prosecution or maintenance of such Licensed Patent and in such country. If Licensee elects to continue prosecution or maintenance or elects to file additional applications following Licensor’s election to cease prosecution or maintenance pursuant to this Section, Licensor shall transfer the applicable patent files to Licensee or its designee and execute such documents and perform such acts at Licensee’s expense as may be reasonably necessary to allow Licensee to initiate or continue such filing,
prosecution or maintenance at Licensee’s sole expense. Notwithstanding such filing, prosecution or maintenance of Licensed Patents at Licensee’s sole expense, such Licensed Patents shall remain the property of Licensor and subject to the license granted herein; provided that all costs incurred by Licensee with respect to any such patent expenses (“Licensee Patent Costs”) shall be recouped in full as a credit against any payments due to Licensor hereunder.
6.3Cooperation. Licensor and Licensee shall cooperate fully in the preparation, filing, prosecution and maintenance of Licensed Patents and of all patents and patent applications licensed to Licensee. Each Party shall provide to the other timely notice as to all matters which come to its attention and which may affect the preparation, filing, prosecution or maintenance of any such patent applications or patents.
(a)Except as set forth below, ownership of all Foreground IP shall follow inventorship.
(b)As between the Parties, any Foreground IP generated, developed, conceived or reduced to practice (constructively or actually) specifically in connection with the development or manufacture of any Licensed Product shall be solely and exclusively owned by Licensee.
(a)In the event that Licensor or Licensee learns of infringement of potential commercial significance of any Licensed Patent in the Territory, the knowledgeable Party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”). During the term of this Agreement, neither Licensor nor Licensee will notify a possible infringer in the Territory of infringement or put such infringer on notice of the existence of any Licensed Patents without first obtaining consent of the other, which consent shall not be unreasonably withheld. Both Licensor and Licensee will use their diligent efforts to cooperate with each other to terminate such infringement without litigation.
(b)If infringing activity of potential commercial significance of any Licensed Patent in the Territory by the infringer has not been abated within ninety (90) days following the date the Infringement Notice takes effect and such infringement occurs within the Field, Licensee may institute suit for patent infringement against the infringer. Licensor may voluntarily join such suit but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of Licensee’s suit, or any judgment rendered in that suit.
(c)If (i) the infringement of the Licensed Patents in the Territory takes place outside of the Field, or, (ii) if the infringement the Licensed Patents in the Territory takes place within of the Field and within one hundred and twenty (120) days following the date the Infringement Notice takes effect, the infringing activity of potential commercial significance by the infringer has not been abated and if Licensee has not brought suit against the infringer or begun negotiations regarding the terms under which Licensee would grant a Sublicense to the infringer, then, in each case, Licensor may institute suit for patent infringement against the infringer.
(d)Any recovery or settlement received in connection with any suit filed under this Section will first be shared by Licensor and Licensee equally to cover the litigation costs each incurred, and next shall be paid to Licensor or Licensee to cover any litigation costs it incurred in excess of the litigation costs of the other. Any recovery in excess of litigation costs will be shared between equally between Licensee and Licensor. Licensor and Licensee agree to be bound by all determinations of patent infringement, validity, and enforceability (but no other issue) resolved by any adjudicated judgment in a suit brought in compliance with this Section.
(e)Each Party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the Party who initiated the suit (unless such suit is being jointly prosecuted by the Parties). The Party controlling the litigation proceedings shall keep the non-controlling Party reasonably informed of the progress of such action.
(f)Any litigation proceedings will be controlled by the Party bringing the suit. In no event may Licensee admit liability or wrongdoing on behalf of Licensor without Licensor’s prior written consent.
7.1Treatment of Confidential Information. During the term of this Agreement, and for a period of five (5) years after this Agreement expires or terminates, a Party receiving Confidential Information of the other Party shall (a) maintain in confidence such Confidential Information to the same extent such receiving Party maintains its own proprietary information (but at a minimum each Party shall use reasonable efforts); (b) not disclose such Confidential Information to any third party without prior written consent of the other Party to this Agreement; and (c) not use such Confidential Information for any purpose except those permitted by this Agreement. A Party shall have no such obligation with respect to any portion of such Confidential Information which:
(a)is publicly disclosed by the disclosing Party, or is otherwise publicly disclosed without the fault of the receiving Party, either before or after it becomes known to the receiving Party; or
(b)was known to the receiving Party prior to when it was received from the disclosing Party, as evidenced by contemporaneous written records; or
(c)is subsequently disclosed to the receiving Party in good faith by a third party who has a right to make such a disclosure; or
(d)has been published by a third party which had a right to do so; or
(e)has been independently developed by the receiving Party without the aid, application or use of Confidential Information from the disclosing Party, such independent development being performed solely by persons not having access whatsoever to the disclosing Party’s Confidential Information, as evidenced by contemporaneous written evidence of same; or
(f)is required by law to be disclosed, but then only to the limited extent of such legally required disclosure; provided, however, that the other Party shall be given prompt notice of any such legally required disclosure.
Notwithstanding the foregoing, Licensee may disclose Licensor’s Confidential Information to the extent that such disclosure is reasonably necessary, in accordance with the term and conditions of this Agreement, to (a) seek or maintain Regulatory Approval for Licensed Products, or (b) for compliance with applicable governmental regulations; provided that, if Licensee intends to make any such disclosure, it shall give reasonable advance written notice to Licensor of such intention. Furthermore, nothing in this Section 7.1 shall be construed to preclude Licensee from disclosing Licensor’s Confidential Information to third parties in connection with the development and commercialization of Licensed Products including, without limitation, development, marketing and promotion in connection therewith, or in the process of obtaining private or public financing, as long as such third party(ies) agrees in writing to be bound by confidentiality provisions no less strict than those set forth in this Section 7.1.
7.2Publicity. Any publication, news release or other public announcement relating to this Agreement, including without limitation, entering to into this Agreement, or to the performance hereunder, shall first be reviewed and approved by both Parties, which approval shall not be unreasonably withheld. Notwithstanding the foregoing, neither Party will be prevented from, at any time, furnishing any information to any governmental or regulatory authority, including the United States Securities and Exchange Commission or any other foreign stock exchange regulatory authority, that it is by law, regulation, rule or other legal process obligated to disclose. Either Party shall be entitled to disclose the substance of this Agreement to its shareholders (and to prospective shareholders to whom its stock is offered for purchase) under a confidentiality agreement consistent with this Agreement. Each Party shall also be entitled to provide a copy of this Agreement to applicable Governmental Authorities as expressly required under Applicable Law.
8.INDEMNITY AND INSURANCE
8.1Licensor Indemnification. Licensor hereby agrees to indemnify and hold harmless Licensee and its Affiliates and their respective directors, officers, researchers, scientists, employees and agents (collectively, the “Licensee Indemnitees”) from and against any losses, claims, damages, costs, and expenses (including attorneys’ fees) (collectively, “Losses”) to which any Licensee Indemnitee may become subject as a result of any claim, demand, action, or other proceeding (each, a “Claim”) by any third party to the extent such Losses arise out of or are incurred in connection with: (i) a breach of any of the obligations of or the warranties given by Licensor pursuant to this Agreement; and (ii) the willful misconduct or negligent acts of or violation of Applicable Law by Licensor or its Affiliates.
8.2Licensee Indemnification. Licensee hereby agrees to indemnify and hold harmless Licensor and its Affiliates and their respective directors, officers, researchers, scientists, employees and agents (collectively, the “Licensor Indemnitees”) from and against any Losses to which any Licensor Indemnitee may become subject as a result of any Claim by any third party to the extent such Losses arise out of or are incurred in connection with: (i) a breach of any of the obligations of or the warranties given by Licensee pursuant to this Agreement; and (ii) the willful misconduct or negligent acts of or violation of
Applicable Law by Licensee or its Affiliates; but excluding Losses arising from or relating to the breach of this Agreement by Licensor or the gross negligence or willful misconduct of any Licensor Indemnitees.
8.3Indemnification Process. The Party that intends to claim indemnification under this Section shall promptly notify the indemnifying Party in writing of any Claim in respect of which the indemnified Party intends to claim such indemnification, and the indemnifying Party shall have sole control of the defense and/or settlement thereof, using counsel selected by the indemnifying Party. The indemnity obligations under this Section shall not apply to amounts paid in settlement of any action with respect to a Claim if such settlement is effected without the prior express written consent of the indemnifying Party, which consent shall not be unreasonably withheld or delayed. The indemnifying Party may not settle or otherwise consent to an adverse judgment in any action with respect to a Claim that diminishes the rights or interests of the indemnified Party without the prior express written consent of the indemnified Party, which consent shall not be unreasonably withheld or delayed. The failure to deliver notice to the indemnifying Party within a reasonable time after notice of any such Claim, or the commencement of any action with respect to such Claim, to the extent prejudicial to the indemnifying Party’s ability to defend such Claim, shall relieve such indemnifying Party of any liability to the indemnifying Party under this Section with respect thereto. The indemnified Party, its employees and agents, shall at the indemnifying Party’s expense, reasonably cooperate with the indemnifying Party and its legal representatives in the investigation and defense of any Claim.
8.4Insurance. From and after the time that Licensee or any of its Affiliates begin human clinical trials on any Licensed Product, Licensee shall use reasonable commercial efforts to obtain and maintain insurance covering the insurable interest of the clinical trial’s participants related to harm to their life or health resulting from the conduct of a clinical trial of a pharmaceutical product for medical use, with reputable and financially secure insurance carriers in an amount which is customarily carried by companies at a comparable stage of development of new pharmaceutical products. Such coverage(s) shall be purchased from a carrier, or carriers, deemed reasonably acceptable to Licensor and shall name Licensor as additional insured. Upon request by Licensor, Licensee shall provide to Licensor copies of said policies of insurance.
9.1Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party, as follows:
(a)It is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated;
(b)(i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar Laws affecting creditors' rights and remedies generally;
(c)The execution and delivery of this Agreement, and the license granted pursuant to this Agreement (i) do not and will not conflict with or violate any requirement of Applicable Law existing as of the Effective Date; (ii) do not and will not conflict with or violate the certificate of incorporation or by-laws (or other constitutional documents) of such Party; and (iii) do not and will not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date;
(d)Neither such Party nor any of its Affiliates is under any obligation to any Person, contractual or otherwise, that is in violation of the terms of this Agreement or that would impede the fulfillment of such Party’s obligations hereunder;
(e)Neither such Party nor any of its Affiliates is debarred or disqualified under any Applicable Laws; and
(f)No authorization, consent, approval of a third party, nor any license, permit, exemption of or filing or registration with or notification to any court or Governmental Authority is or will be necessary for the (i) valid execution and delivery of this Agreement by such Party; or (ii) the consummation by such Party of the transactions contemplated hereby.
9.2Additional Representations and Warranties of Licensor. Licensor represents and warrants to Licensee, as of the Effective Date, as follows:
(a)Exhibit A-1 sets forth a true and correct listing of all Licensed Patents that claim or cover or, as to patent applications, if issued as they currently exist, would claim or cover Entolimod for use with Acute Radiation Syndrome. In each country or jurisdiction in the Territory where Licensed Patents 1 have been issued or applied for, such Licensed Patents are being diligently prosecuted in each country in respect of which applications have been made in the respective patent offices in accordance with all Applicable Laws;
(b)Exhibit A-2 sets forth a true and correct listing of all Licensed Patents that claim or cover or, as to patent applications, if issued as they currently exist, would claim or cover Entolasta or that would otherwise claim or cover use of Licensed Molecules for Lymphocyte Exhaustion, Immunosenescence, Neutropenia or as Vaccine Adjuvant. In each country or jurisdiction in the Territory where Licensed Patents 2 have been issued or applied for, such Licensed Patents are being diligently prosecuted in each country in respect of which applications have been made in the respective patent offices in accordance with all Applicable Laws;
(c)Except as expressly contemplated by this Section 9.2(c) or Section 9.2(d) below, Licensor owns all right, title and interest in and to the Licensed Technology and the Licensed Technology is not subject to any liens in favor of, or claims over ownership by, any other Person. The lien held by Avenue Capital in the approximate amount of Four Million Dollars ($4,000,000.00) covering the Licensed Technology either has been extinguished prior to the Effective Date or is in the process of being extinguished by Licensor, in which case, notwithstanding anything else to the contrary herein, any and all payments due hereunder to Licensor may be considered paid in full by Licensee through Licensee’s
payment of such amounts directly to Avenue Capital as part of the process of extinguishing such lien and obtaining requisite lien releases from Avenue Capital;
(d)Licensor has the full right and power to grant the license to Licensee as set forth in this Agreement and, except for the licenses under Patent Rights 1 and assignments under Patent Rights 2 previously granted to Genome Protection, Inc., has not granted to any other Person any rights or licenses conflicting with the rights Licensor purports to grant to Licensee pursuant to this Agreement. Licensor shall use commercially reasonable efforts, as promptly as practicable following the Effective Date, to enter into documents, obtain a declaratory judgment from a court of competent jurisdiction, or otherwise demonstrate in a manner reasonably acceptable to Licensee, that Licensor has or has recovered and is the exclusive holder, without restriction, of any and all rights to uses of the Licensed Molecules previously licensed and/or assigned to Genome Protection, Inc.;
(e)To Licensor’s best knowledge, after making reasonable inquiry, the Licensed Technology does not infringe third party Intellectual Property Rights and Licensor has not received any claim challenging its ownership of the Licensed Technology and is not aware of any facts or circumstances which, with the passage of time, the giving of notice, or both, would give rise to such claim. To Licensor’s best knowledge, after making reasonable inquiry, the research, development, use, sale, offer for sale, import, export or other exploitation by Licensee and its Affiliates and Sublicensees of the Licensed Products in the Field as contemplated hereunder will not infringe any issued patent rights controlled by a third party or the claims included in any published patent application in the Territory. Licensor has not received any written notice from any third party asserting or alleging that (i) any research, development or manufacture of any product by Licensor incident to its TLR5 agonist program infringed or misappropriated the Intellectual Property Rights of such third party or (ii) the research, development or manufacture of any Licensed Product as contemplated by this Agreement would infringe any third party Intellectual Property Rights;
(f)To Licensor’s best knowledge, after making reasonable inquiry, no third party has taken any action before any patent and trademark office (or similar Governmental Authority) to challenge the validity or enforceability of any Licensed Patents, and no third party has otherwise asserted in writing to Licensor that the issued Licensed Patents Rights are invalid or unenforceable;
(g)To Licensor’s best knowledge, after making reasonable inquiry, the conception, development and reduction to practice of the inventions claimed in the Licensed Patents or otherwise contained in the Licensed Technology has not constituted or involved the misappropriation of trade secrets or other proprietary rights or property of any third party. There are no claims, judgments or settlements against, or amounts with respect thereto owed by, Licensor or any of its Affiliates relating to the Licensed Technology;
(h)To Licensor’s best knowledge, after making reasonable inquiry, no third party is infringing, threatening to infringe or misappropriating or threatening to misappropriate any Licensed Technology. Neither Licensor nor any of its Affiliates have received any written notice of any unauthorized use, infringement, misappropriation, or dilution by any third party, including any current or former employee or consultant of Licensor or its Affiliates, of any Licensed Technology.
(i)all issued patents within the Licensed Patents disclosed in Exhibit A are valid, enforceable and subsisting and in each country or jurisdiction in the Territory where Licensed Patents have been issued or applied for, such Licensed Patents have been filed and maintained properly and correctly and all applicable fees have been paid on or before the due date for payment, except as would not result in the abandonment or invalidity of any Licensed Patent or any claim thereof, any loss of priority in respect of any Licensed Patent or any other material and adverse effect on any Patent;
(j)the inventors named in the Licensed Patents are all of the true inventors for such Licensed Patents. Each of such inventors has assigned to Licensor all of his or her right, title and interest to such Licensed Patents;
(k)All current and former employees and paid consultants (in the case of academic consultants, those acting outside the scope of their academic affiliation) of Licensor and its Affiliates who are or have been involved in the conception, evaluation, reduction to practice, or development of Licensed Technology have executed written contracts or are otherwise obligated to protect the confidential status and value thereof and to vest in Licensor exclusive ownership of such Licensed Technology;
(l)Except as set forth in Exhibit E, no funding, facilities, or personnel of any Governmental Authority or any public or private educational or research institutions were used to develop or create any Licensed Technology, and neither Licensor nor any of its Affiliates has entered into a government funding relationship that would result in rights to the Licensed Technology residing in the U.S. Government, the National Institutes of Health, the National Institute for Drug Abuse, or other agency, and the licenses granted hereunder are not subject to overriding obligations to the U.S. Government as set forth in Public Law 96-517 (35 U.S.C. §§ 200-204), or any similar obligations under the laws of any other country in the Territory; and
(m)Licensor has complied in all material respects with all Applicable Laws in connection with the prosecution of each such Licensed Patents, including the duty of disclosure and duty of candor owed to any patent office pursuant to such Applicable Laws.
9.3Limitation Of Liability. NEITHER PARTY SHALL BE ENTITLED TO RECOVER FROM THE OTHER PARTY ANY SPECIAL, INCIDENTAL, INDIRECT, EXEMPLARY, CONSEQUENTIAL OR PUNITIVE DAMAGES IN CONNECTION WITH THIS AGREEMENT OR ANY LICENSE GRANTED HEREUNDER EXCEPT FOR DAMAGES ARISING FROM A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER SECTION 7 OR A WILLFUL BREACH OF THE LICENSE GRANT OR RESTRICTIONS AS SET FORTH UNDER SECTION 2 OR OF THE OWNERSHIP PROVISIONS UNDER SECTION 6.
10.1Term. Subject to Licensee’s earlier exercise of the Buyout, the term of this Agreement shall begin on the Effective Date and, unless earlier terminated, shall continue on a Licensed Product-by-Licensed Product until the expiration of all of Licensee’s payment obligations to Licensor upon the lapse of the Royalty Period. Thereafter, upon such expiration of this Agreement for such Licensed Products, any and all licenses granted by Licensor to Licensee with respect to such Licensed Product in the Territory shall
continue and become fully paid-up, royalty-free, irrevocable, perpetual, freely transferable, and with the right to grant sublicenses through all tiers.
10.2Termination by Notice. Notwithstanding any provision herein, Licensee may terminate this Agreement in part or in its entirety, at any time by giving Licensor at least sixty (60) days’ prior written notice.
(a)If Licensee at any time defaults in the payment of any sum when due hereunder and fails to make such payment within sixty (60) days after receipt of written notice thereof by Licensor, Licensor may, at its option, terminate this Agreement and all licenses granted herein upon written notice.
(b)If either Party at any time commits a breach of any of the terms, covenants or provisions of this Agreement (other than Licensee’s payment obligations), and such breaching Party fails to cure any such breach within sixty (60) days after receipt of written notice thereof by the non-breaching Party, the non-breaching Party may, at its option, terminate this Agreement and all licenses granted herein upon written notice.
10.4Unilateral Termination by Licensor. In addition to termination for breach of obligations, Licensor shall be entitled to terminate this Agreement should Licensee, by the six (6) month anniversary of the Effective Date, fail to use Commercially Reasonable Efforts to develop and commercialize Licensed Products or otherwise to make any progress towards the development of Licensed Products consistent with sound and reasonable business practices and judgment, and fail to agree with Licensor in the subsequent sixty (60) days on a development schedule for Licensed Products. Upon such termination, the license rights shall revert back to Licensor.
10.5Default for Bankruptcy.
(a)Each Party shall have the right, at its option, to the extent permitted under Applicable Law to terminate this Agreement upon the filing or initiation by the other Party of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided, however, that in the case of any involuntary bankruptcy proceeding such right to terminate shall only become effective if the Party consents to the involuntary bankruptcy or such proceeding is not dismissed within ninety (90) days after the filing thereof.
(b)Upon early termination of this Agreement by a Party under this Section 10.5, all licenses and rights to licenses granted under or pursuant to this Agreement by the other Party to such Party are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Code, licenses of rights to “intellectual property” as defined under Section 101(35A) of the Code. Such other Party agrees that such Party, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Code, and that upon commencement of a bankruptcy proceeding by or against such other Party under the Code, such Party shall be entitled to a complete duplicate of, or complete access to (as such Party deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly
delivered to such Party (i) upon any such commencement of a bankruptcy proceeding upon written request therefor by such Party, unless such other Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under subsection (ii) above, upon the rejection of this Agreement by or on behalf of such other Party upon written request therefor by such Party. Notwithstanding the foregoing, Licensee reserves the right to exercise the Buyout incident to any bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by Licensor.
10.6Effect of Termination.
(a)Except as provided under Section 10.5 above, upon any other termination of this Agreement other than due to a Buyout, as of the date of termination set forth in Licensee’s termination notice (in the case of termination by Licensee) or receipt by Licensee of notice of such termination (in the case of a termination by Licensor), Licensee and its Affiliates shall immediately cease exploiting any of the Licensed Patents and return all copies of the same to Licensor and cease production of all Licensed Products; provided, however, that Licensee, its Affiliates and each Sublicensee may dispose of any Licensed Products manufactured as of the date of termination, and may complete manufacture of Licensed Products then in the process of manufacture, and sell them, provided that Licensee shall pay to Licensor running royalties in accordance with Section 5.2 with respect thereto and otherwise complies with the terms of this Agreement.
(b)Upon the automatic termination of this Agreement upon a Buyout, on the Buyout Closing Date, the obligations and rights of the Parties under Sections 1, 2.3(b), 2.3(c), 2.3(e) 6.1, 6.4, 7.1, 8.1, 8.2, 8.3, 9.1, 9.2, 9.3, 10.5, 10.6, 10.7 and 11 shall survive expiration or termination of this Agreement.
(a)No termination of this Agreement shall constitute a termination or a waiver of any rights of either Party against the other Party accruing prior to the time of such termination.
(b)Except in the event of a termination following Buyout, the obligations and rights of the Parties under Sections 1, 5.2 (for the duration of permitted Net Sales following termination), 5.6, 5.7, 5.8, 5.9, 6.1, 6.4, 6.5, 7.1, 8.1, 8.2, 8.3, 9.3, 10.5, 10.6, 10.7 and 11 shall survive expiration or termination of this Agreement.
11.1Independent Contractors. The Parties hereby acknowledge and agree that each is an independent contractor and that neither Party shall be considered to be the agent, representative, master or servant of the other Party for any purpose whatsoever, and that neither Party has any authority to enter into a contract, to assume any obligation or to give warranties or representations on behalf of the other Party without the prior written consent of the other Party. Nothing in this relationship shall be construed to create a joint venture, agency, partnership, fiduciary or other similar relationship between the Parties.
11.2Entire Agreement. The terms and conditions herein constitute the entire agreement between the Parties and shall supersede all previous agreements, either oral or written, between the Parties hereto and/or their Affiliates with respect to the subject matter hereof.
11.3Non-Waiver. The Parties covenant and agree that if a Party fails or neglects for any reason to take advantage of any of the terms provided for the termination of this Agreement or if a Party, having the right to declare this Agreement terminated, shall fail to do so, any such failure or neglect by such Party shall not be a waiver or be deemed or be construed to be a waiver of any cause for the termination of this Agreement subsequently arising, or as a waiver of any of the terms, covenants or conditions of this Agreement or of the performance thereof. None of the terms, covenants and conditions of this Agreement may be waived by a Party except by its written consent.
11.4Reformation. Any provision of this Agreement, which is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability shall not invalidate or render unenforceable such provision in any other jurisdiction. Should any provision of this Agreement be so held to be unenforceable, such provision, if permitted by law, shall be considered to have been superseded by a legally permissible and enforceable clause which corresponds most closely to the intent of the Parties as evidenced by the provision held to be unenforceable.
11.5Modification. No amendment or modification of this Agreement shall be effective unless in writing signed by the Parties hereto and it expressly refers to this Agreement. No provision of this Agreement shall be varied, contradicted or explained by any oral agreement, course of dealing or performance or any other matter not set forth in an agreement in writing and signed by the Parties.
11.6Assignability. Licensee shall have the right to assign the license granted hereunder or this Agreement without the prior written consent of Licensor by providing Licensor or its successor interest with a written notice to such effect and subject to the assignee agreeing in writing to assume all obligations due from Licensee hereunder.
11.7Force Majeure. No liability hereunder shall result to a Party by reason of delay in performance to the extent caused by circumstances beyond the reasonable control of the Party, including, without limitation, acts of God, fire, flood, war, civil unrest, labor unrest, acts of Governmental Authorities including any closures due to pandemics, or terrorism.
(a)Any payment, notice or other communication pursuant to this Agreement shall be mailed by certified or registered mail, postage prepaid, or delivered by overnight delivery service addressed as follows or to such other address designated by written notice given to the other Party or faxed to the other party if the sender has evidence of successful transmission:
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If to Licensor: Statera Biopharma, Inc. 2580 East Harmony Road, Suite 316 |
If to Licensee: Tivic Health Systems, Inc. 47685 Lakeview Blvd |
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Fort Collins, CO 80528 Attn: Michael Handley |
Fremont, CA 94538 Attn: Jennifer Ernst |
(b)Any such payment, notice or other communication shall be effective upon receipt.
11.9Governing Law. This Agreement shall be governed by, and shall be construed and enforced in accordance with, the internal laws of Delaware without regard to conflicts of laws or rules of any jurisdiction without regard to its conflict of laws rules. This Agreement is subject to all U.S. federal laws, including, but not limited to, the Export Administration Act of the United States of America. No conflict-of-laws rule or Laws that might refer such construction and interpretation to the laws of another state, republic, country or country shall be considered.
11.10Headings. The headings for each Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Section.
11.11Language. All interactions between Licensee and Licensor relating to this Agreement shall take place in the English language. All documents, instruction and assistance that Licensor provides shall be in the English language.
11.12Counterparts. This Agreement may be signed in two counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument. Signatures may be transmitted by facsimile, thereby constituting the valid signature and delivery of this Agreement.
[Signatures on Next Page]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed and delivered by their duly authorized officers effective as of the Effective Date.
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Statera Biopharma, Inc. By: /s/ Michael Handley__________ Name: Michael Handley Title: Chief Executive Officer |
Tivic Health Systems, Inc. By: /s/ Jennifer Ernst Name: Jennifer Ernst Title: Chief Executive Officer |
EXHIBIT A-1
LICENSED PATENTS 1
EXHIBIT A-2
LICENSED PATENTS 2
EXHIBIT B
MATERIALS
EXHIBIT C
BILL OF SALE
EXHIBIT D
ARBITRATION PROCEDURES
EXHIBIT E
GOVERNMENTAL AUTHORITY
FUNDING ARRANGEMENTS
EXHIBIT F
LICENSED MOLECULES
EXHIBIT G
FORM OF CERTIFICATE OF DESIGNATION
Exhibit 10.2
SECURITIES PURCHASE AGREEMENT
This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of February 11, 2025, by and among TIVIC HEALTH SYSTEMS, INC., a Delaware corporation (the “Company”), and Statera Biopharma, Inc. (each, including its successors and assigns, a “Purchaser” and collectively, the “Purchasers”).
RECITALS
A. The Company and each Purchaser is executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended, and the rules and regulations thereunder (the “Securities Act”), and Rule 506 of Regulation D (“Regulation D”) as promulgated by the United States Securities and Exchange Commission (the “Commission”) under the Securities Act.
B. Each Purchaser, severally and not jointly, wishes to purchase, and the Company wishes to issue and sell, upon the terms and conditions stated in this Agreement, an aggregate of (1) 945,785 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”) and (2) 359.6691 shares of Series A Non-Voting Convertible Preferred Stock, par value $0.0001 per share (and including any other class of securities into which the Series A Preferred Stock may hereafter be reclassified or changed into, the “Series A Preferred Stock” and, together with the Common Stock, the “Securities”) of the Company, having the designation, preferences, conversion or other rights, voting powers, restrictions, limitations as to dividends, qualifications and terms and conditions as specified in the Certificate of Designation, in the form attached hereto as Exhibit A (the “Certificate of Designation”), which will be convertible into shares (the “Conversion Shares”) of the Company’s Common Stock, in accordance with the terms set forth in the Certificate of Designation.
C. Pursuant to the terms and conditions of the Certificate of Designation, the conversion of the Series A Preferred Stock shall be subject to receipt of the Requisite Stockholder Approval (as defined herein).
D. Concurrently with the execution and delivery of this Agreement, the Company is entering into a License Agreement by and between the Company and Statera Biopharma, Inc., a Delaware corporation (“Statera”) (the “License Agreement”), pursuant to which the Company is obtaining an exclusive license to certain molecules held by Statera.
NOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, the Company and each Purchaser, severally and not jointly, hereby agree as follows:
Article 1
DEFINITIONS
1.1 Definitions. In addition to the terms defined elsewhere in this Agreement, for all purposes of this Agreement, the following terms shall have the meanings indicated in this Section 1.1:
“Affiliate” means, with respect to any Person, any other Person that, directly or indirectly through one or more intermediaries, Controls, is controlled by or is under common control with such Person, as such terms are used in and construed under Rule 405 under the Securities Act.
“Agreement” has the meaning set forth in the Preamble.
“Board of Directors” means the board of directors of the Company.
“Business Day” means any day except Saturday, Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.
“Certificate of Designation” has the meaning set forth in the Recitals.
“Closing” has the meaning set forth in Section 2.2(a).
“Closing Date” has the meaning set forth in Section 2.2(a).
“Commission” has the meaning set forth in the Recitals.
“Common Stock” has the meaning set forth in the Recitals.
“Company” has the meaning set forth in the Preamble.
“Company Deliverables” has the meaning set forth in Section 2.3(a).
“Company’s Knowledge” means with respect to any statement made to the Company’s Knowledge, that the statement is based upon the actual knowledge, or knowledge that would have been acquired after reasonable inquiry, of the executive officers or directors of the Company having responsibility for the matter or matters that are the subject of the statement.
“Contract” means, with respect to any Person, any written or oral agreement, contract, subcontract, lease (whether for real or personal property), mortgage, license, or other legally binding commitment or undertaking of any nature to which such Person is a party or by which such Person or any of its assets are bound or affected under applicable Law.
“Control” (including the terms “controlling”, “controlled by” or “under common control with”) means the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, by Contract or otherwise.
“Delaware Courts” means Court of Chancery of the State of Delaware, the United States District Court for the District of Delaware, or the Superior Court of the State of Delaware.
“Effect” means any effect, change, event, circumstance, state of fact, occurrence or development.
“Effective Date” means the date on which the initial Registration Statement required by Section 4.1(b) is first declared effective by the Commission.
“Encumbrance” means any lien, pledge, hypothecation, charge, mortgage, security interest, lease, exclusive license, option, easement, reservation, servitude, adverse title, claim, infringement, interference, option, right of first refusal, preemptive right, community property interest or restriction or encumbrance of any nature (including any restriction on the voting of any security, any restriction on the transfer of any security or other asset, any restriction on the receipt of any income derived from any asset, any restriction on the use of any asset and any restriction on the possession, exercise or transfer of any other attribute of ownership of any asset).
“Exchange Act” means the Securities Exchange Act of 1934, as amended, or any successor statute, and the rules and regulations promulgated thereunder.
“Extended Stockholder Approval Period” has the meaning set forth in Section 4.11.
“GAAP” means generally accepted accounting principles and practices in effect from time to time within the United States applied consistently throughout the period involved.
“Governmental Authority” means any: (a) nation, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature, (b) federal, state, local, municipal, foreign, supra-national or other government, (c) governmental or quasi-governmental authority of any nature (including any governmental division, department, agency, commission, bureau, instrumentality, official, ministry, fund, foundation, center,
organization, unit, body or entity and any court or other tribunal, and any taxing authority) or (d) self-regulatory organization (including Nasdaq).
“Irrevocable Transfer Agent Instructions” means, with respect to the Company, the Irrevocable Transfer Agent Instructions, in substantially the form of Exhibit B, executed by the Company and delivered to and acknowledged in writing by the Transfer Agent.
“Law” means any federal, state, national, supra-national, foreign, local or municipal or other law, statute, constitution, principle of common law, resolution, ordinance, code, edict, decree, rule, regulation, ruling, order, judgment or requirement issued, enacted, adopted, promulgated, implemented or otherwise put into effect by or under the authority of any Governmental Authority (including under the authority of Nasdaq or the Financial Industry Regulatory Authority, Inc.).
“License Agreement” has the meaning set forth in the Recitals.
“Material Adverse Effect” means any Effect, individually or together with any other Effect, that (a) has had, has, or would reasonably be expected to have a material adverse effect on the business, condition (financial or otherwise), general affairs, management, assets, liabilities, results of operations, earnings, prospects or properties of the Company or its Subsidiaries, taken as a whole; provided, however, that Effects arising or resulting from the following shall not be taken into account in determining whether there has been a Material Adverse Effect: (1) the announcement or disclosure of the sale of the Securities or other transactions contemplated by this Agreement, (2) the taking of any action, or the failure to take any action, by the Company that is required to comply with the terms of this Agreement, (3) any natural disaster or epidemics, pandemics or other force majeure events, or any act or threat of terrorism or war, any armed hostilities or terrorist activities (including any escalation or general worsening of any of the foregoing) anywhere in the world or any governmental or other response or reaction to any of the foregoing, (4) any change in GAAP or applicable Law or the interpretation thereof, (5) general economic or political conditions or conditions generally affecting the industries in which the Company and its Subsidiaries operate or (6) any change in the cash position of the Company and its Subsidiaries which results from operations in the ordinary course of business; except in each case with respect to clauses (3), (4) and (5), (x) to the extent disproportionately affecting the Company and its Subsidiaries, taken as a whole, relative to other similarly situated companies in the industries in which the Company and its Subsidiaries operate and (y) the underlying cause of such Effect may be considered except to the extent such underlying cause would otherwise be excluded in accordance with the foregoing; or (b) prevents, materially adversely delays or materially adversely impedes, or could reasonably be expected to prevent, materially adversely delay or materially adversely impede the performance by the Company of its obligations under this Agreement and the other Transaction Documents, including, without limitation, the issuance and sale of the Securities and the Conversion Shares.
“Nasdaq” means The Nasdaq Stock Market.
“Outside Date” means the fifteenth (15th) day following the date of this Agreement.
“Person” means an individual or a 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.
“Press Release” has the meaning set forth in Section 4.5.
“Principal Trading Market” means the Trading Market on which the Common Stock is primarily listed on and quoted for trading, which, as of the date of this Agreement and the Closing Date, shall be the Nasdaq Capital Market.
“Proceeding” means an action, claim, suit, investigation or proceeding (including, without limitation, an investigation or partial proceeding, such as a deposition), whether commenced or threatened.
“Purchaser” or “Purchasers” has the meaning set forth in the Preamble.
“Purchaser Deliverables” has the meaning set forth in Section 2.3(b).
“Registrable Securities” means all of (i) the Common Stock issued hereunder, (ii) the Conversion Shares and (iii) any securities issued or issuable upon any stock split, dividend or other distribution, recapitalization or similar event with respect to the foregoing, provided that, with respect to a particular Holder, such Holder’s Common Stock or Series A Preferred Stock referenced in the preceding clauses (i) to (ii) shall cease to be Registrable Securities upon the earlier to occur of the following: (A) a sale pursuant to a Registration Statement or Rule 144 under the Securities Act (in which case, only such security sold by the Holder shall cease to be a Registrable Security); and (B) such Common Stock or Series A Preferred Stock become eligible for resale by the Holder under Rule 144 without the requirement for the Company to be in compliance with the current public information required thereunder and without volume or manner-of-sale restrictions, pursuant to a written opinion letter of counsel for the Company to such effect, addressed, delivered and reasonably acceptable to the Transfer Agent.
“Registration Statement” has the meaning set forth in Section 4.1(a).
“Regulation D” has the meaning set forth in the Recitals.
“Requisite Stockholder Approval” has the meaning set forth in Section 4.11.
“Rule 144” means Rule 144 promulgated by the Commission pursuant to the Securities Act, as such Rule may be amended from time to time, or any similar rule or regulation hereafter adopted by the Commission having substantially the same effect as such Rule.
“SEC Reports” has the meaning set forth in Section 3.1(f).
“Securities” has the meaning set forth in the Recitals.
“Securities Act” has the meaning set forth in the Recitals.
“Series A Preferred Stock” has the meaning set forth in the Recitals, and also includes any other class of securities into which the Series A Preferred Stock may hereafter be reclassified or changed into.
“Short Sales” include, without limitation, (i) all “short sales” as defined in Rule 200 promulgated under Regulation SHO under the Exchange Act, whether or not against the box, and all types of direct and indirect stock pledges, forward sale contracts, options, puts, calls, short sales, swaps, “put equivalent positions” (as defined in Rule 16a-1(h) under the Exchange Act) and similar arrangements (including on a total return basis), and (ii) sales and other transactions through non-U.S. broker dealers or non-U.S. regulated brokers (but shall not be deemed to include the location and/or reservation of borrowable shares of Common Stock).
“Stockholder Meeting” has the meaning set forth in Section 4.11.
“Stockholder Meeting Deadline” has the meaning set forth in Section 4.11.
“Subscription Amount” means, with respect to each Purchaser, the aggregate value of consideration transferred for the Securities purchased hereunder as indicated on Annex A opposite such Purchaser’s name, in the form of the consideration set forth in the License Agreement for the grant of the license to the Company as provided therein, which amount represents the number of Securities being purchased by such Purchaser multiplied by the per Security price of $0.264173.
“Subsidiary” means any subsidiary of the Company.
“Trading Day” means a day on which the principal Trading Market is open for business.
“Trading Market” means any of the following markets or exchanges on which the Common Stock is listed or quoted for trading on the date in question: the NYSE American, the Nasdaq Capital Market, the Nasdaq Global
Market, the Nasdaq Global Select Market, or the New York Stock Exchange (or any successors to any of the foregoing).
“Transaction Documents” means this Agreement, the schedules and exhibits attached hereto, the Certificate of Designation, the Irrevocable Transfer Agent Instructions and any other documents or agreements explicitly contemplated hereunder.
“Transfer Agent” means Equiniti, the current transfer agent of the Company, or any successor transfer agent for the Company.
Article 2
PURCHASE AND SALE
2.1 Purchase and Sale. On the Closing Date, upon the terms and subject to the conditions set forth herein, the Company will issue and sell to the Purchasers, and the Purchasers will purchase, severally and not jointly, the number of Securities set forth opposite the names of each such Purchaser under the heading “Number of Securities Purchased” for the Subscription Amount set forth on Annex A attached hereto.
2.2 Closing.
(a) Closing. The closing of the purchase and sale of the Securities (the “Closing”) shall take place remotely via the electronic exchange of documents and signatures simultaneously with the execution and delivery of this Agreement (the “Closing Date”), or at such other time and place as mutually agreed by the Company and Purchasers, but in no event later than the fifteenth (15th) Business Day following the date of this Agreement.
(b) Payment. Within two Business Days following the Closing Date, (i) each Purchaser shall deliver, or cause to be delivered, its execution of the License Agreement as consideration for its Subscription Amount, in the amount set forth in the “Aggregate Purchase Price (Subscription Amount)” column opposite each Purchaser’s name in the table set forth on Annex A; and (ii) the Company shall deliver, or cause to be delivered, to each Purchaser against payment therefor a book-entry statement dated the Closing Date from the Transfer Agent evidencing the number of Securities set forth opposite such Purchaser’s name on Annex A, registered in the name of such Purchaser (or its nominee in accordance with its delivery instructions), free and clear of any liens or restrictions (other than those arising under state and federal securities laws and bearing the legend set forth in Section 4.1(b).
2.3 Closing Deliverables.
(a) On or prior to the Closing, the Company shall issue, deliver or cause to be delivered to each Purchaser the following (the “Company Deliverables”):
(i) this Agreement, duly executed by the Company;
(ii) a copy of the duly executed Irrevocable Transfer Agent Instructions acknowledged in writing by the Transfer Agent instructing the Transfer Agent to deliver, on an expedited basis, of the issuance of the number of Securities set forth opposite the name of such Purchaser under the heading “Number of Securities Purchased” on Annex A attached hereto, registered in the name of such Purchaser (or its nominee, as directed by the Purchaser) as set forth on such Purchaser’s signature page hereto;
(iii) the Compliance Certificate referred to in Section 5.1(h);
(iv) a certificate of the Secretary of the Company, in a form reasonably acceptable to the Purchasers, dated as of the Closing Date, (A) certifying the resolutions adopted by the Board of Directors or a duly authorized committee thereof approving the transactions contemplated by this Agreement, the other Transaction Documents and the issuance of the Securities and the Conversion Shares, and the License Agreement, (B) certifying the current versions of the certificate of incorporation, as amended, and bylaws of the Company, (C) certifying as to the signatures and authority of persons signing the Transaction Documents and related documents on
behalf of the Company and (D) certifying that the conditions to the Closing set forth in Section 2.2(a) and Section 2.2(b) of this Agreement have been fulfilled;
(vi) a certificate evidencing the incorporation and good standing of the Company issued by the Secretary of State of the State of Delaware, as of a date within three (3) Business Days of the Closing Date and a certificate evidencing the Company’s qualification as a foreign corporation and good standing issued by the Secretary of State (or comparable office) of each jurisdiction in which the Company is qualified to do business as a foreign corporation, as of a date within three (3) Business Days of the Closing Date;
(vii) the opinion of the Company’s legal counsel dated as of the Closing in form and substance reasonably satisfactory to the Company; and
(viii) a certified copy of the Certificate of Designation, as filed with the Secretary of State of the State of Delaware.
(b) On or prior to the Closing, each Purchaser shall deliver or cause to be delivered to the Company the following (the “Purchaser Deliverables”):
(i) this Agreement, duly executed by such Purchaser; and
(ii) the License Agreement, duly executed by such Purchaser.
Article 3
REPRESENTATIONS AND WARRANTIES
3.1 Representations and Warranties of the Company. Except as previously disclosed in the SEC Reports, the Company hereby represents and warrants the following as of the date hereof and the Closing Date (except for the representations and warranties that speak as of a specific date, which shall be made as of such date) to each of the Purchasers:
(a) Due Organization; Subsidiaries. Each of the Company and its Subsidiaries is a corporation or limited liability company duly incorporated or formed, validly existing and in good standing under the Laws of the jurisdiction of its incorporation or organization and has all necessary corporate power and authority: (i) to conduct its business in the manner in which its business is currently being conducted and as proposed to be conducted as described in the SEC Reports, (ii) to own or lease and use its property and assets in the manner in which its property and assets are currently owned or leased and used and (iii) to perform its obligations under all Contracts by which it is bound. Each of the Company and the Subsidiaries is licensed and qualified to do business, and is in good standing (to the extent applicable in such jurisdiction), under the Laws of all jurisdictions where the nature of its business or the manner in which its business is currently being conducted requires such licensing or qualification other than in jurisdictions where the failure to be so qualified individually or in the aggregate would not have or reasonably be expected to have a Material Adverse Effect.
(b) Authorization; Enforcement; Validity. The Company has the requisite corporate power and authority to enter into the Transaction Documents and to perform its obligations under and consummate the transactions contemplated hereby or thereby. All corporate action on the part of the Company, its directors and stockholders necessary for the authorization, execution, sale, issuance and delivery of the Securities and, subject to the Requisite Stockholder Approval, the Conversion Shares contemplated herein has been taken. Each of the Transaction Documents have been (or upon delivery will have been) duly executed and delivered by the Company and is, or when delivered in accordance with the terms hereof or thereof, will constitute the legal, valid and binding obligation of the Company enforceable against the Company in accordance with its respective terms, except (i) as such enforceability may be limited by applicable bankruptcy, examinership, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of, creditors’ rights and remedies or by other equitable principles of general application, (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.
(c) No Conflicts. The execution, delivery and performance by the Company of the Transaction Documents and the issuance, sale and delivery of the securities to be sold by the Company under the Transaction Documents (including, subject to the Company obtaining Requisite Stockholder Approval, the issuance of Conversion Shares upon the conversion of the Securities), the performance by the Company of its obligations under the Transaction Documents and the consummation of the transactions contemplated hereby or thereby (including without limitation, the issuance of the Securities and the reservation for issuance of the Conversion Shares) do not and will not conflict with, result in the breach or violation of, or constitute (with or without the giving of notice or the passage of time or both) a violation of, or default under, (i) any bond, debenture, note or other evidence of indebtedness, or under any lease, license, franchise, permit, indenture, mortgage, deed of trust, loan agreement, joint venture or other Contract, agreement or instrument to which the Company or any of its Subsidiaries is a party or by which it or its properties may be bound or affected, (ii) the Company’s restated certificate of incorporation, as amended (the “Certificate of Incorporation”), the Company’s bylaws, as amended (the “Bylaws”), or the equivalent document with respect to any of the Company’s Subsidiaries, as amended and as in effect on the date hereof, or (iii) subject to the Requisite Stockholder Approval, any statute or Law, judgment, decree, rule, regulation, ordinance or order of any court or governmental or regulatory body (including Nasdaq), governmental agency, arbitration panel or authority applicable to the Company, any of its subsidiaries or their respective properties, except in the case of clauses (i) and (iii) for such conflicts, breaches, violations or defaults that would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d) Filings, Consents and Approvals. Except for any Current Report on Form 8-K or Notice of Exempt Offering of Securities on Form D to be filed by the Company in connection with the transaction contemplated hereby, any required filing with Nasdaq (other than the Listing of Additional Shares notification form for the listing of the Conversion Shares), the Requisite Stockholder Approval, the filing of the Certificate of Designation and the Registration Statement required to be filed pursuant to Section 4.1, neither the Company nor any of its Subsidiaries is required to give any notice to, or make any filings with, or obtain any authorization, consent, or approval of any government or governmental agency in order to consummate the transactions contemplated by the Transaction Documents. Assuming the accuracy of the representations of the Purchasers in Section 3.2, no consent, approval, authorization or other order of, or registration, qualification or filing with, any court, regulatory body, administrative agency, self-regulatory organization, stock exchange or market (including Nasdaq), or other governmental body is required for the execution and delivery of the Transaction Documents, the valid issuance, sale and delivery of the Securities to be sold pursuant to the Transaction Documents (including, subject to the Company obtaining the Requisite Stockholder Approval, the issuance of Conversion Shares upon conversion of the Securities) other than such as have been or will be made or obtained, or for any securities filings required to be made under federal or state securities laws applicable to the offering of the Securities or the issuance of Conversion Shares upon conversion of the Securities (other than the Requisite Stockholder Approval and filings that have been made, or will be made, pursuant to the rules and regulations of Nasdaq). The Company and its Subsidiaries are unaware of any facts or circumstances that might prevent the Company from obtaining or effecting any of the registration, application or filings pursuant to this Section 3.1(d).
(e) Issuance of the Securities and Conversion Shares. The issuance of the Securities has been duly authorized, and the Securities, when issued and paid for in accordance with the terms of the Transaction Documents, will be duly and validly issued, fully paid and nonassessable and free and clear of any Encumbrances, preemptive rights or restrictions (other than as provided in the Certificate of Designation or any restrictions on transfer generally imposed under applicable securities laws). The issuance of the Conversion Shares has been duly authorized and the Conversion Shares, subject to receipt of the Requisite Stockholder Approval, when issued in accordance with the terms of the Certificate of Designation, will be duly authorized, validly issued, fully paid and non-assessable, and shall be free and clear of any Encumbrances, preemptive rights or restrictions (other than as provided in this Agreement or any restrictions on transfer generally imposed under applicable securities laws). The Company has reserved such number of shares of Common Stock sufficient to enable full conversion of all of the Securities to the extent allowable prior to receipt of the Requisite Stockholder Approval and, upon receipt of the Requisite Stockholder Approval, the Company shall have reserved such number of shares of Common Stock sufficient to enable the full conversion of all of the Securities.
(f) SEC Reports; Disclosure Materials. The Company has filed or furnished, as applicable, on a timely basis all forms, statements, schedules, certifications, reports and other documents required to be filed or furnished by it with the Commission under the Exchange Act or the Securities Act since January 1, 2024
(collectively, and in each case including all exhibits and schedules thereto and documents incorporated by reference therein, the “SEC Reports”). As of the time it was filed with the Commission (or, if amended or superseded by a filing prior to the date of this Agreement, then on the date of such filing), each of the SEC Reports complied in all material respects with the applicable requirements of the Securities Act or the Exchange Act (as the case may be) and as of the time they were filed, none of the SEC Reports 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. There are no material outstanding or unresolved comments in comment letters from the staff of the Division of Corporation Finance of the Commission with respect to any of the SEC Reports. The Company meets the requirements for use of Form S-3 under the Securities Act.
(g) Private Placement. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2 of this Agreement, no registration under the Securities Act is required for the offer and sale of the Securities by the Company to the Purchasers under the Transaction Documents (including, subject to the Company obtaining Requisite Stockholder Approval, the issuance of Conversion Shares upon the conversion of the Securities). The issuance and sale of the Securities hereunder (including, subject to the Company obtaining Requisite Stockholder Approval, the issuance of Conversion Shares upon the conversion of the Securities) does not contravene the rules and regulations of the Trading Market.
(h) Registration Rights. Other than each of the Purchasers, no Person has any right to cause the Company to effect the registration under the Securities Act of the offer and sale of any securities of the Company other than those offers and sales which are currently registered on an effective registration statement on file with the Commission.
(i) Listing and Maintenance Requirements. The Company’s Common Stock is registered pursuant to Section 12(b) or Section 12(g) of the Exchange Act, and the Company has taken no action designed to terminate the registration of the Common Stock under the Exchange Act. Concurrently with the closing of this Agreement, the Company will file with Nasdaq an additional shares listing application covering Conversion Shares and has not received any objections from Nasdaq with respect to such application with respect to the transactions contemplated hereby or by the License Agreement.
(j) Disclosure. The Company confirms that it has not provided, and to the Company’s Knowledge, none of its officers or directors nor any other Person acting on its or their behalf has provided any Purchaser or its respective agents or counsel with any information that it believes constitutes material, non-public information except insofar as the existence, provisions and terms of the Transaction Documents, the License Agreement, and the proposed transactions hereunder and thereunder may constitute such information, all of which will be disclosed by the Company in the Press Release as contemplated by Section 4.5 hereof. The Company understands and confirms that the Purchasers will rely on the foregoing representations in effecting transactions in securities of the Company.
(k) No Integrated Offering. Assuming the accuracy of the Purchasers’ representations and warranties set forth in Section 3.2, and except with respect to the capital stock to be issued pursuant to the License Agreement, none of the Company, its Subsidiaries nor, to the Company’s Knowledge, any of its Affiliates or any Person acting on its behalf has, directly or indirectly, at any time within the past six (6) months, made any offers or sales of any Company security or solicited any offers to buy any security under circumstances that would (i) eliminate the availability of the exemption from registration under the Securities Act, including Regulation D, in connection with the offer and sale by the Company of the Securities as contemplated hereby or (ii) cause the offering of the Securities pursuant to the Transaction Documents to be integrated with prior offerings by the Company for purposes of any applicable law, regulation or stockholder approval provisions, including, without limitation, under the rules and regulations of any Trading Market on which any of the securities of the Company are listed or designated.
(l) No General Solicitation. Neither the Company nor, to the Company’s Knowledge, any person acting on behalf of the Company has, directly or indirectly, offered or sold any of the Securities or Conversion Shares, or solicited any offers to buy any Securities or Conversion Shares, under any circumstances that
would require registration under the Securities Act of the Securities or the Conversion Shares, including by any form of general solicitation or general advertising.
(m) No Disqualification Events. No “bad actor” disqualifying event described in Rule 506(d)(1)(i)-(viii) of the Securities Act (a “Disqualification Event”) is applicable to the Company or, to the Company’s Knowledge, any Company Covered Person (as defined below), except for a Disqualification Event as to which Rule 506(d)(2)(ii)-(iv) or (d)(3), is applicable. “Company Covered Person” means, with respect to the Company as an “issuer” for purposes of Rule 506 promulgated under the Securities Act, any person listed in the first paragraph of Rule 506(d)(1). The Company is not aware of any Person (other than any Company Covered Person) that has been or will be paid (directly or indirectly) remuneration for solicitation of purchasers in connection with the sale of the Securities or the Conversion Shares pursuant to this Agreement. The Company has complied, to the extent applicable, with its disclosure obligations under Rule 506(e).
3.2 Representations and Warranties of the Purchasers. Each Purchaser hereby, for itself and for no other Purchaser, represents and warrants to the Company as follows:
(a) Organization; Authority. Such Purchaser is an entity duly organized, validly existing and in good standing under the Laws of the jurisdiction of its organization with the requisite corporate or, if such Purchaser is not a corporation, such partnership, limited liability company or other applicable power and authority to enter into and to consummate the transactions contemplated by the applicable Transaction Documents and otherwise to carry out its obligations hereunder and thereunder. The execution and delivery of this Agreement by such Purchaser and performance by such Purchaser of the transactions contemplated by this Agreement have been duly authorized by all necessary corporate or, if such Purchaser is not a corporation, such partnership, limited liability company or other applicable like action, on the part of such Purchaser. Each Transaction Document to which it is a party has been duly executed by such Purchaser, and when delivered by such Purchaser in accordance with the terms hereof, will constitute the valid and legally binding obligation of such Purchaser, enforceable against it in accordance with its terms, except (i) as such enforceability may be limited by applicable bankruptcy, examinership, insolvency, reorganization, moratorium, liquidation or similar laws relating to, or affecting generally the enforcement of, creditors’ rights and remedies or by other equitable principles of general application, (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.
(b) No Conflicts. The execution, delivery and performance by such Purchaser of this Agreement and the consummation by such Purchaser of the transactions contemplated hereby and thereby will not (i) result in a violation of the organizational documents of such Purchaser, (ii) conflict with, or constitute a default (or an event which with notice or lapse of time or both would become a default) under, or give to others any rights of termination, amendment, acceleration or cancellation of, any agreement, indenture or instrument to which such Purchaser is a party, or (iii) result in a violation of any Law, rule, regulation, order, judgment or decree (including U.S. federal and state securities laws) applicable to such Purchaser, except in the case of clauses (ii) and (iii) above, for such conflicts, defaults, rights or violations which would not, individually or in the aggregate, reasonably be expected to have a material adverse effect on the ability of such Purchaser to perform its obligations hereunder.
(c) Investment Intent. Such Purchaser understands that the Securities are (and the Conversion Shares will be) “restricted securities” and the offer and sale thereof have not been registered under the Securities Act or any applicable U.S. state securities law and is acquiring the Securities as principal for its own account and not with a view to, or for distributing or reselling such Securities (or the Conversion Shares) or any part thereof in violation of the Securities Act or any applicable U.S. state or other securities laws, provided, however, that by making the representations herein, such Purchaser does not agree to hold any of the Securities or Conversion Shares for any minimum period of time and reserves the right, subject to the provisions of this Agreement, at all times to sell or otherwise dispose of all or any part of such Securities or Conversion Shares pursuant to an effective registration statement under the Securities Act or under an exemption from such registration and in compliance with applicable U.S. federal, state and other securities laws. Such Purchaser is acquiring the Securities hereunder in the ordinary course of its business.
Such Purchaser does not presently have any agreement, plan or understanding, directly or indirectly, with any Person to distribute or effect any distribution of any of the Securities (or any securities which are derivatives
thereof) to or through any person or entity in violation of federal securities law; such Purchaser is not a registered broker-dealer under Section 15 of the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer.
(d) Purchaser Status. At the time such Purchaser was offered the Securities, it was, and at the date hereof it is, an “accredited investor” as defined in Rule 501(a) under the Securities Act.
(e) General Solicitation. Such Purchaser is not purchasing the Securities as a result of any advertisement, article, notice or other communication regarding the Securities published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general advertisement. The purchase of the Securities by such Purchaser has not been solicited by or through anyone other than the Company or, on the Company’s behalf.
(f) Experience of Such Purchaser. Such Purchaser, either alone or together with its representatives, has such knowledge, sophistication and experience in business and financial matters so as to be capable of evaluating the merits and risks of the prospective investment in the Securities, and has so evaluated the merits and risks of such investment. Such Purchaser is able to bear the economic risk of an investment in the Securities.
(g) Access to Information. Such Purchaser acknowledges that it has had the opportunity to review the SEC Reports and has been afforded (i) the opportunity to ask such questions as it has deemed necessary of, and to receive answers from, representatives of the Company concerning the terms and conditions of the offering of the Securities and the merits and risks of investing in the Securities; (ii) access to information about the Company and the Subsidiaries and their respective financial condition, results of operations, business, properties, management and prospects sufficient to enable it to evaluate its investment; and (iii) the opportunity to obtain such additional information that the Company possesses or can acquire without unreasonable effort or expense that is necessary to make an informed investment decision with respect to the investment. Neither such inquiries nor any other investigation conducted by or on behalf of such Purchaser or its representatives or counsel shall modify, amend or affect such Purchaser’s right to rely on the truth, accuracy and completeness of the SEC Reports and the Company’s representations and warranties contained in the Transaction Documents. Such Purchaser has sought such accounting, legal and tax advice as it has considered necessary to make an informed decision with respect to its acquisition of the Securities.
(h) Certain Trading Activities. Other than with respect to the transactions contemplated herein, since the time that such Purchaser was first contacted by the Company or any other Person regarding the transactions contemplated hereby, the Purchaser has not, directly or indirectly, effected or agreed to effect any Short Sales. Other than to other Persons party to this Agreement and to the Purchaser’s representatives or agents, including, but not limited to, the Purchaser’s legal, tax and investment advisors, such Purchaser has maintained the confidentiality of all disclosures made to it in connection with this transaction (including the existence and terms of this transaction). Notwithstanding the foregoing, for avoidance of doubt, nothing contained herein shall constitute a representation or warranty, or preclude any actions, with respect to the identification of the availability of, or securing of, available shares to borrow in order to effect Short Sales or similar transactions in the future.
(i) Brokers and Finders. No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Purchaser for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Purchaser. No Purchaser shall have any obligation with respect to any fees, or with respect to any claims made by or on behalf of other Persons for fees, in each case of the type contemplated by this Section 3.2(i) that may be due in connection with the transactions contemplated by this Agreement or the Transaction Documents.
(j) Independent Investment Decision. Such Purchaser has independently evaluated the merits of its decision to purchase Securities pursuant to the Transaction Documents, and such Purchaser confirms that it has not relied on the advice of any other Purchaser’s business and/or legal counsel in making such decision. Such Purchaser understands that nothing in this Agreement or any other materials presented by or on behalf of the Company to the Purchaser in connection with the purchase of the Securities constitutes legal, tax or investment
advice. Such Purchaser has consulted such legal, tax and investment advisors as it, in its sole discretion, has deemed necessary or appropriate in connection with its purchase of the Securities.
(k) Reliance on Exemptions. Such Purchaser understands that the Securities are being offered and sold to it in reliance on specific exemptions from the registration requirements of United States federal and state securities laws and that the Company is relying in part upon the truth and accuracy of, and such Purchaser’s compliance with, the representations, warranties, agreements, acknowledgements and understandings of such Purchaser set forth herein in order to determine the availability of such exemptions and the eligibility of such Purchaser to acquire the Securities.
(l) No Governmental Review. Such Purchaser understands that no United States federal or state agency or any other government or governmental agency has passed on or made any recommendation or endorsement of the Securities or the fairness or suitability of the investment in the Securities nor have such authorities passed upon or endorsed the merits of the offering of the Securities.
(m) Regulation M. Such Purchaser is aware that the anti-manipulation rules of Regulation M under the Exchange Act may apply to sales of Securities and other activities with respect to the Securities by the Purchasers.
(n) Beneficial Ownership. The purchase by such Purchaser of the Securities issuable to it at the Closing will not result in such Purchaser (individually or together with any other Person with whom such Purchaser has identified, or will have identified, itself as part of a “group” in a public filing made with the Commission involving the Company’s securities) acquiring, or obtaining the right to acquire, beneficial ownership in excess of 19.999% of the outstanding shares of Common Stock or the voting power of the Company on a post transaction basis that assumes that such Closing shall have occurred. Such Purchaser does not presently intend to, alone or together with others, make a public filing with the Commission to disclose that it has (or that it together with such other Persons have) acquired, or obtained the right to acquire, as a result of such Closing when added to any other securities of the Company that it or they then own or have the right to acquire, beneficial ownership in excess of 19.999% of the outstanding shares of Common Stock or the voting power of the Company on a post transaction basis that assumes that each Closing shall have occurred.
(o) Residency. Such Purchaser’s residence (if an individual) or offices in which its investment decision with respect to the Securities was made (if an entity) are located at the address set forth under such Purchaser’s name on its signature page hereto or as otherwise specified below its address on its signature page hereto.
The Company and each of the Purchasers acknowledge and agree that no party to this Agreement has made or makes any representations or warranties with respect to the transactions contemplated hereby other than those specifically set forth in this Article 3 and the Transaction Documents.
Article 4
OTHER AGREEMENTS OF THE PARTIES
4.1 Registration Rights.
(a) Filing Obligations. On or prior to the sixtieth (60th) day after the Closing Date, the Company shall prepare and file with the Commission a Registration Statement covering the resale of all of the Registrable Securities for an offering to be made on a continuous basis pursuant to Rule 415 (the “Initial Registration Statement”). The Initial Registration Statement shall be on Form S-3 (except if the Company is then ineligible to register for resale the Registrable Securities on Form S-3, in which case such registration shall be on such other form available to register for resale the Registrable Securities as a secondary offering). Notwithstanding the registration obligations set forth in this Section 4.1, in the event the Commission informs the Company that all of the Registrable Securities cannot, as a result of the application of Rule 415, be registered for resale as a secondary offering on a single registration statement, the Company agrees to promptly (i) inform each of the Holders thereof and use its commercially reasonable efforts to file amendments to the Initial Registration Statement as required by the Commission and/or (ii) withdraw the Initial Registration Statement and file a new registration statement (a “New
Registration Statement,” and together with the Initial Registration Statement, the “Registration Statement”), in either case covering the maximum number of Registrable Securities permitted to be registered by the Commission, on Form S-3 or, if the Company is ineligible to register the Registrable Securities on Form S-3, such other form available to register for resale the Registrable Securities as a secondary offering
(b) Effectiveness. The Company shall use its commercially reasonable efforts to cause each Registration Statement to be declared effective by the Commission as soon as practicable and, with respect to the Initial Registration Statement or the New Registration Statement, as applicable (including filing with the Commission a request for acceleration of effectiveness in accordance with Rule 461 promulgated under the Securities Act), and shall use its commercially reasonable efforts to keep each Registration Statement continuously effective under the Securities Act until the earlier of (i) such time as all of the Registrable Securities covered by such Registration Statement have been publicly sold by the Holders; or (ii) the date that all Registrable Securities covered by such Registration Statement may be sold by non-affiliates without volume or manner-of-sale restrictions pursuant to Rule 144, without the requirement for the Company to be in compliance with the current public information requirement under Rule 144 (the “Effectiveness Period”). The Company shall request effectiveness of a Registration Statement as of 4:00 P.M. New York City time on a Trading Day. The Company shall promptly notify the Holders via e-mail of the effectiveness of a Registration Statement or any post-effective amendment thereto on the same Trading Day that the Company telephonically confirms effectiveness with the Commission, which date of confirmation shall initially be the date requested for effectiveness of such Registration Statement. The Company shall, by 9:30 A.M. New York City time on the first Trading Day after the Effective Date, file a final Prospectus with the Commission, as required by Rule 424(b) and shall provide the Purchasers with copies of the final Prospectus to be used in connection with the sale or other disposition of the securities covered thereby. The Company shall promptly inform each Holder in writing if, at any time during the Effectiveness Period, the Company does not satisfy the conditions specified in Rule 172 and, as a result thereof, the Holder is required to deliver a Prospectus in connection with any disposition of Registrable Securities.
(c) Registration Expenses. All fees and expenses incident to the Company’s performance of or compliance with its obligations under this Agreement (excluding any underwriting discounts and selling commissions and all legal fees and expenses of legal counsel for any Holder) shall be borne by the Company whether or not any Registrable Securities are sold pursuant to a Registration Statement. The fees and expenses referred to in the foregoing sentence shall include, without limitation, (i) all registration and filing fees (including, without limitation, fees and expenses of the Company’s counsel and independent registered public accountants (A) with respect to filings required to be made with any Trading Market on which the Common Stock are then listed for trading and (B) with respect to compliance with applicable state securities or blue sky laws (including, without limitation, fees and disbursements of counsel for the Company in connection with blue sky qualifications or exemptions of the Registrable Securities and determination of the eligibility of the Registrable Securities for investment under the laws of such jurisdictions as requested by the Holders), (ii) printing expenses (including, without limitation, expenses of printing certificates for Registrable Securities and of printing prospectuses if the printing of prospectuses is reasonably requested by the Holders of a majority of the Registrable Securities included in the Registration Statement), (iii) messenger, telephone and delivery expenses, (iv) fees, expenses and disbursements of counsel for the Company, (v) Securities Act liability insurance, if the Company so desires such insurance, and (vi) fees and expenses of all other Persons retained by the Company in connection with the registrations and consummation of the transactions contemplated by this Agreement. In addition, the Company shall be responsible for all of its internal expenses incurred in connection with the consummation of the transactions contemplated by this Agreement (including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties), the expense of any annual audit and the fees and expenses incurred in connection with the listing of the Registrable Securities on any securities exchange as required hereunder. In no event shall the Company be responsible for any underwriting, broker or similar fees or commissions of any Holder or, except to the extent provided for in the Transaction Documents, any legal fees or other costs of the Holders.
4.2 Transfer Restrictions.
(a) Compliance with Laws. Notwithstanding any other provision of this Article 4, each Purchaser covenants that the Securities and Conversion Shares may be disposed of only pursuant to an effective registration statement under, and in compliance with the requirements of, the Securities Act, or pursuant to an
available exemption from, or in a transaction not subject to, the registration requirements of the Securities Act, and in compliance with any applicable U.S. state and federal securities laws. In connection with any transfer of the Securities other than (i) pursuant to an effective registration statement, (ii) to the Company, (iii) pursuant to Rule 144 (provided that the Purchaser provides the Company with reasonable assurances (in the form of seller and, if applicable, broker representation letters) that the securities may be sold pursuant to such rule), or (iv) in connection with a bona fide pledge as contemplated in Section 4.2(b), the Company may require the transferor thereof to provide to the Company an opinion of counsel selected by the transferor and reasonably acceptable to the Company, the form and substance of which opinion shall be reasonably satisfactory to the Company, to the effect that such transfer does not require registration of such transferred Securities or Conversion Shares under the Securities Act and, as a condition of transfer, any such transferee shall agree in writing to be bound by the terms of this Agreement and the rights and obligations set forth in Section 4.1 and shall have the rights of a Purchaser under this Agreement and the rights and obligations set forth in Section 4.1 with respect to such transferred Securities or Conversion Shares.
(b) Legends. Certificates and book-entry statements evidencing the Securities and any Conversion Shares shall bear any legend as required by the “blue sky” Laws of any state and a restrictive legend in substantially the following form:
THE OFFER AND SALE OF THE SECURITIES REPRESENTED HEREBY TO WHICH THIS CONFIRMATION RELATES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED, OR THE SECURITIES LAWS OF ANY STATE OF THE UNITED STATES. THE SECURITIES MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED, HYPOTHECATED, TRANSFERRED OR ASSIGNED IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT FOR THE SECURITIES UNDER APPLICABLE SECURITIES LAWS, OR UNLESS OFFERED, SOLD, PLEDGED, HYPOTHECATED OR TRANSFERRED PURSUANT TO AN AVAILABLE EXEMPTION FROM THE REGISTRATION REQUIREMENTS OF THOSE LAWS. THE COMPANY AND ITS TRANSFER AGENT SHALL BE ENTITLED TO REQUIRE AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY AND THE TRANSFER AGENT THAT SUCH REGISTRATION IS NOT REQUIRED. NOTWITHSTANDING THE FOREGOING, THE SECURITIES MAY BE PLEDGED IN CONNECTION WITH A BONA FIDE MARGIN ACCOUNT OR OTHER LOAN OR FINANCING ARRANGEMENT SECURED BY THE SECURITIES.
The Company acknowledges and agrees that a Purchaser may from time to time pledge, and/or grant a security interest in, some or all of the legended Securities or Conversion Shares in connection with applicable securities laws, pursuant to a bona fide margin agreement in compliance with a bona fide margin loan. Such a pledge would not be subject to approval or consent of the Company and no legal opinion of legal counsel to the pledgee, secured party or pledgor shall be required in connection with the pledge, but such legal opinion shall be required in connection with a subsequent transfer or foreclosure following default by the Purchaser transferee of the pledge. No notice shall be required of such pledge, but Purchaser’s transferee shall promptly notify the Company of any such subsequent transfer or foreclosure. Each Purchaser acknowledges that the Company shall not be responsible for any pledges relating to, or the grant of any security interest in, any of the Securities or Conversion Shares or for any agreement, understanding or arrangement between any Purchaser and its pledgee or secured party. At the appropriate Purchaser’s expense, the Company will execute and deliver such reasonable documentation as a pledgee or secured party of Securities or Conversion Shares may reasonably request in connection with a pledge or transfer of the Securities or Conversion Shares, as applicable, including the preparation and filing of any required prospectus supplement under Rule 424(b)(3) of the Securities Act or other applicable provision of the Securities Act to appropriately amend the list of selling stockholders thereunder. Each Purchaser acknowledges and agrees that, except as otherwise provided in Section 4.2(c), any Securities or Conversion Shares subject to a pledge or security interest as contemplated by this Section 4.2(b) shall continue to bear the legend set forth in this Section 4.2(b) and be subject to the restrictions on transfer set forth in Section 4.2(b).
(c) Removal of Legends. Once a Registration Statement covering the resale of the Conversion Shares is declared effective, the Company shall remove all restrictive legends, including the legend set forth in Section 4.2(b) above (or, in the event that Conversion Shares are issued upon conversion after the
Registration Statement is declared effective, the Conversion Shares shall be issued without restrictive legends). Further, the Company shall remove all restrictive legends, including the legend set forth in Section 4.2(b) above, (i) following any sale of such Securities or Conversion Shares pursuant to Rule 144 or any other applicable exemption from the registration requirements of the Securities Act, or (ii) if such Conversion Shares are eligible for resale under Rule 144(b)(1) or any successor provision (or, in the event that Conversion Shares are issued upon conversion after the conditions set forth in clauses (i) and (ii) above, the Conversion Shares shall be issued without restrictive legends). Without limiting the foregoing, either (i) upon request of the Purchaser, upon receipt by the Company of an opinion of counsel reasonably satisfactory to the Company to the effect that such legend is no longer required under the Securities Act and applicable state securities laws or (ii) as contemplated by the Irrevocable Transfer Agent Instructions, the Company shall promptly cause the legend to be removed from any certificate for any Securities or Conversion Shares in accordance with the terms of this Agreement and deliver, or cause to be delivered, to any Purchaser new certificate(s) representing the Securities or Conversion Shares that are free from all restrictive and other legends or, at the request of such Purchaser, via DWAC transfer to such Purchaser’s account.
(d) Irrevocable Transfer Agent Instructions. The Company shall issue the Irrevocable Transfer Agent Instructions. The Company represents and warrants that no instruction other than the Irrevocable Transfer Agent Instructions referred to in this Section 4.2(d) (or instructions that are consistent therewith) will be given by the Company to its Transfer Agent in connection with this Agreement, and that the Securities and Conversion Shares shall otherwise be freely transferable on the books and records of the Company as and to the extent provided in this Agreement and the other Transaction Documents and applicable law. The Company acknowledges that a breach by it of its obligations under this Section 4.2(d) will cause irreparable harm to a Purchaser. Accordingly, the Company acknowledges that the remedy at law for a breach of its obligations under this Section 4.2(d) may be inadequate and agrees, in the event of a breach or threatened breach by the Company of the provisions of this Section 4.2(d) that a Purchaser shall be entitled, in addition to all other available remedies, to an order and/or injunction restraining any breach and requiring immediate issuance and transfer, without the necessity of showing irreparable harm or economic loss and without any bond or other security being required.
(e) Acknowledgement. Each Purchaser hereunder acknowledges its primary responsibilities under the Securities Act and accordingly will not sell or otherwise transfer the Securities or Conversion Shares or any interest therein without complying with the requirements of the Securities Act.
4.3 Furnishing of Information. In order to enable the Purchasers to sell the Securities and Conversion Shares under Rule 144, until such time as Purchaser may sell the Securities and Conversion Shares without limitation under Rule 144, the Company shall use its commercially reasonable efforts to timely file (or obtain extensions in respect thereof and file within the applicable grace period) all reports required to be filed by the Company after the date hereof pursuant to the Exchange Act and, if during such period, the Company is not required to file reports pursuant to the Exchange Act, it will prepare and furnish to the Purchasers and make publicly available in accordance with Rule 144(c) such information as is required for the Purchasers to sell the Securities and Conversion Shares under Rule 144.
4.4 Integration. The Company shall not, and shall use its commercially reasonable efforts to ensure that no Affiliate of the Company shall, sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that will be integrated with the offer or sale of the Securities in a manner that would require the registration under the Securities Act of the sale of the Securities to the Purchasers, or that will be integrated with the offer or sale of the Securities for purposes of the rules and regulations of any Trading Market such that it would require stockholder approval prior to the closing of such other transaction unless stockholder approval is obtained before the closing of such subsequent transaction; provided, however, that this Section 4.4 shall not limit the Company’s right to issue shares of capital stock pursuant to the License Agreement.
4.5 Securities Laws Disclosure; Publicity. By no later than 9:00 A.M., New York City time, on the fourth (4th) Trading Day immediately following the date hereof, the Company shall (a) issue a press release (the “Press Release”) disclosing all material terms of the transactions contemplated hereby and (b) file a Current Report on Form 8-K with the Commission describing the terms of the Transaction Documents (and including as exhibits to such Current Report on Form 8-K the material Transaction Documents (including, without limitation, this Agreement); provided that the Press Release shall not publicly disclose the name of any Purchaser or investment
adviser of any Purchaser, or include the name of any Purchaser or an Affiliate of any Purchaser without the prior written consent of such Purchaser. In addition, notwithstanding the foregoing, the Company shall not publicly disclose the name of any Purchaser or investment adviser of any Purchaser, or include the name of any Purchaser or an Affiliate of any Purchaser without the prior written consent of such Purchaser (i) in any press release or marketing materials or (ii) in any filing with the Commission or any regulatory agency or Trading Market, except as required by U.S. federal securities law (A) in connection with any registration statement contemplated by Section 4.1 hereof or the filing of final Transaction Documents (including signature pages thereto) with the Commission and (B) to the extent such disclosure is required by law, request of the Commission’s staff or Trading Market regulations, in which case the Company shall provide the Purchasers with prior written notice of such disclosure permitted under this subclause (ii). From and after the issuance of the Press Release, no Purchaser shall be in possession of any material, non-public information received from the Company, any Subsidiary or any of their respective officers, directors, employees or agents, that is not disclosed in the Press Release. Each Purchaser, severally and not jointly with the other Purchasers, covenants that until such time as the transactions contemplated by this Agreement are publicly disclosed by the Company pursuant to the Press Release, such Purchaser will maintain the confidentiality of the existence and terms of this transaction and the information provided in connection therewith; provided, however, that any disclosure may be made by the Purchaser to the Purchaser’s representatives or agents, including, but not limited to, the Purchaser’s legal, tax and investment advisors.
4.6 Non-Public Information. Except with respect to the material terms and conditions of the transactions contemplated by the Transaction Documents, including this Agreement, or as expressly required by any applicable securities law, the Company covenants and agrees that neither it, nor any other Person acting on its behalf, will provide any Purchaser or its agents or counsel with any information regarding the Company that the Company believes constitutes material non-public information without the express written (email being sufficient) consent of such Purchaser, unless prior thereto such Purchaser shall have committed to customary obligations regarding the confidentiality and use of such information The Company understands and confirms that each Purchaser shall be relying on the foregoing covenant in effecting transactions in securities of the Company.
4.7 Principal Trading Market Listing. The Company shall use its reasonable best efforts to take all steps necessary to cause the Conversion Shares to be approved for listing on the Principal Trading Market as promptly as possible.
4.8 Form D; Blue Sky. The Company agrees to timely file a Form D with respect to the Securities as required under Regulation D and to provide a copy thereof, promptly upon the written request of any Purchaser. The Company, on or before the Closing Date, shall take such action as the Company shall reasonably determine is necessary in order to obtain an exemption for or to qualify the Securities for sale to the Purchasers under applicable securities or “blue sky” Laws of the states of the United States (or to obtain an exemption from such qualification) and shall provide evidence of such actions promptly upon the written request of any Purchaser.
4.9 Short Sales After the Date Hereof. Such Purchaser shall not engage, directly or indirectly, in any transactions in the Company’s securities (including, without limitation, any Short Sales involving the Company’s securities) during the period from the date hereof until the earlier of such time as (i) the transactions contemplated by this Agreement are first publicly announced as required by and described in Section 4.5 or (ii) this Agreement is terminated in full pursuant to Section 6.16.
Notwithstanding the foregoing, no Purchaser makes any representation, warranty or covenant hereby that it will not engage in Short Sales in the securities of the Company after the time that the transactions contemplated by this Agreement are first publicly announced as described in Section 4.5.
4.10 Beneficial Ownership Limitation. Notwithstanding anything to the contrary set forth in the Certificate of Designation, the Company shall not effect any conversion of any share of Series A Preferred Stock, and a Purchaser shall not have the right to convert any portion of its Series A Preferred Stock, to the extent that, after giving effect to such attempted conversion set forth on an applicable Notice of Conversion (as defined in the Certificate of Designation) with respect to the Series A Preferred Stock, such Purchaser (or any of such Purchaser’s Affiliates or any other Person who would be a beneficial owner of Common Stock beneficially owned by the Purchaser for purposes of Section 13(d) or Section 16 of the Exchange Act and the applicable rules and regulations of the Commission, including any “group” of which the Purchaser is a member (the foregoing, “Attribution
Parties”)) would beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation (as defined below). For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially owned by such Purchaser and its Attribution Parties shall include the number of shares of Common Stock issuable upon conversion of the Series A Preferred Stock subject to the Notice of Conversion or the Automatic Conversion (as defined in the Certificate of Designation), as applicable, with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which are issuable upon (i) conversion of the remaining, unconverted Series A Preferred Stock beneficially owned by such Purchaser or any of its Attribution Parties, and (ii) exercise or conversion of the unexercised or unconverted portion of any other securities of the Company beneficially owned by such Purchaser or any of its Attribution Parties that are subject to and would exceed a limitation on conversion or exercise similar to the limitation contained herein. Except as set forth in the preceding sentence, for purposes of this Section 4.10, beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the applicable rules and regulations of the Commission, and the terms “beneficial ownership” and “beneficially own” have the meanings ascribed to such terms therein. In addition, for purposes hereof, “group” has the meaning set forth in Section 13(d) of the Exchange Act and the applicable rules and regulations of the Commission. For purposes of this Section 4.10, in determining the number of outstanding shares of Common Stock, a Purchaser may rely on the number of outstanding shares of Common Stock as stated in the most recent of the following: (i) the Company’s most recent periodic or annual filing with the Commission, as the case may be, (ii) a more recent public announcement by the Company that is filed with the Commission, or (iii) a more recent notice by the Company or the Transfer Agent to the Purchaser setting forth the number of shares of Common Stock then outstanding. For any reason at any time, upon the written request of a Purchaser (which may be by e-mail), the Company shall, within two (2) Trading Days of such request, confirm in writing to such Purchaser (which may be by e-mail) the number of shares of Common Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to any actual conversion or exercise of securities of the Company, including Series A Preferred Stock, by such Purchaser or its Attribution Parties since the date as of which such number of outstanding shares of Common Stock was last publicly reported or confirmed to the Purchaser. The “Beneficial Ownership Limitation” shall initially be set at 9.9% of the number of shares of the Common Stock outstanding or deemed to be outstanding as of the applicable measurement date. The Company shall be entitled to rely on representations made to it by any Purchaser in any Notice of Conversion regarding its Beneficial Ownership Limitation. Notwithstanding the foregoing, by written notice to the Company, (i) any Purchaser may reset the Beneficial Ownership Limitation percentage to a higher percentage, not to exceed 19.9%, which increase will not be effective until the sixty-first (61st) day after such written notice is delivered to the Company, and (ii) any Purchaser may reset the Beneficial Ownership Limitation percentage to a lower percentage provided that such decrease shall not become effective until the later of (x) 5:00 p.m. Eastern time on the third Business Day after the date of the Requisite Stockholder Approval, and if Requisite Stockholder Approval is not obtained within six months after the initial issuance of the Series A Preferred Stock, the date that is three Business Days after the date that is six months after the initial issuance of the Series A Preferred Stock. Upon such a change by a Purchaser of the Beneficial Ownership Limitation, not to exceed 19.9%, the Beneficial Ownership Limitation may not be further amended by such Purchaser without first providing the minimum notice required by this Section 4.10. Notwithstanding the foregoing, at any time following notice of a Fundamental Transaction (as defined in the Certificate of Designation), the Purchaser may waive and/or change the Beneficial Ownership Limitation effective immediately upon written notice to the Company and may reinstitute a Beneficial Ownership Limitation at any time thereafter effective immediately upon written notice to the Company. The provisions of this Section 4.10 shall be construed, corrected and implemented in a manner so as to effectuate the intended Beneficial Ownership Limitation herein contained and the shares of Common Stock underlying the Securities in excess of the Beneficial Ownership Limitation shall not be deemed to be beneficially owned by the Purchaser for any purpose including for purposes of Section 13(d) or Rule 16a-1(a)(1) of the Exchange Act.
4.11 Requisite Stockholder Approval. The Company shall hold a special meeting of stockholders (a “Stockholder Meeting”) within 120 days from the Closing (the “Stockholder Meeting Deadline”) for the purpose of obtaining stockholder approval of the conversion of all issued and outstanding Series A Preferred Stock into shares of Common Stock in accordance with the Nasdaq Stock Market Rules (the “Requisite Stockholder Approval”). The Company shall use its best efforts to solicit its stockholders’ approval of such resolution and to cause the Board of Directors to recommend to the stockholders that they approve such resolution. If the Requisite Stockholder Approval is not obtained on or prior to the Stockholder Meeting Deadline, the Company shall cause an additional Stockholder Meeting to be held within 90 days from the prior meeting (the “Extended Stockholder Approval Period”). If the Requisite Stockholder Approval is not obtained within the Extended Stockholder Approval Period,
then the Company shall convene additional stockholder meetings every 90 days thereafter until the Requisite Stockholder Approval is obtained. The Company shall enforce the terms of each Support Agreement, and shall not amend or waive any provision of any Support Agreement.
4.12 Conversion and Exercise Procedures. The form of Notice of Conversion included in the Certificate of Designation sets forth the totality of the procedures required of the Purchasers in order to convert the Securities. Without limiting the preceding sentence, no ink-original Notice of Conversion shall be required, nor shall any medallion guarantee (or other type of guarantee or notarization) of any Notice of Conversion form be required in order for the registered holder thereof to convert the Securities. No additional legal opinion, other information or instructions shall be required of a Purchaser to convert its Securities. The Company shall honor conversions of the Securities and shall deliver Conversion Shares in accordance with the terms, conditions and time periods set forth in the Transaction Documents.
Article 5
CONDITIONS PRECEDENT TO CLOSING
5.1 Conditions Precedent to the Obligations of the Purchasers to Purchase Securities. The obligation of each Purchaser to acquire Securities at the Closing is subject to the fulfillment to such Purchaser’s satisfaction, on or prior to the Closing Date, of each of the following conditions, any of which may be waived by such Purchaser (as to itself only):
(a) Representations and Warranties. The representations and warranties of the Company contained herein shall be true and correct in all respects (as of the date when made and as of the Closing Date, as though made on and as of such date, except for such representations and warranties that speak as of a specific date, which shall be true and correct in all respects as of such date.
(b) Performance. The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by it at or prior to the Closing.
(c) No Injunction. No statute, rule, regulation, order, executive order, decree, judgment, writ, order, ruling or injunction shall have been enacted, entered, promulgated, issued or endorsed by any court of competent jurisdiction or any Governmental Authority that enjoins, prevents or prohibits the consummation of any of the transactions contemplated by the Transaction Documents.
(d) Consents. The Company shall have obtained in a timely fashion any and all consents, permits, approvals, registrations and waivers necessary for consummation of the purchase and sale of the Securities (except for the Requisite Stockholder Approval), all of which shall be and remain so long as necessary in full force and effect.
(e) Adverse Changes. Since the date of execution of this Agreement, no event or series of events shall have occurred that has had or would reasonably be expected to have a Material Adverse Effect.
(f) No Suspensions of Trading in Common Stock; No Stop Orders. The Common Stock shall not have been suspended by the Commission or the Principal Trading Market from trading on the Principal Trading Market nor, except as previously disclosed in the SEC Reports, shall suspension by the Commission or the Principal Trading Market have been threatened, in writing by the Commission or the Principal Trading Market. No stop order shall have been imposed by Principal Trading Market, the Commission or any other Governmental Authority or regulatory body with respect to public trading in the Common Stock. Nasdaq shall have raised no objection to the consummation of the transactions contemplated by the Transaction Documents or the License Agreement.
(g) Company Deliverables. The Company shall have delivered the Company Deliverables in accordance with Section 2.3(a).
(h) Compliance Certificate. The Company shall have delivered to each Purchaser a certificate, dated as of the Closing Date and signed by its Chief Executive Officer and its Chief Financial Officer, dated as of the Closing Date, certifying to the fulfillment of the conditions specified in Sections 5.1(a), (b), (e) (f) and (i) in the form attached hereto as Exhibit C.
(i) License Agreement. The License Agreement shall have been consummated in accordance with the terms thereof.
(j) Termination. This Agreement shall not have been terminated as to such Purchaser in accordance with Section 6.16 herein.
5.2 Conditions Precedent to the Obligations of the Company to issue Securities. The Company’s obligation to issue the Securities at the Closing to each Purchaser is subject to the fulfillment to the satisfaction of the Company on or prior to the Closing Date of the following conditions, any of which may be waived by the Company:
(a) Representations and Warranties. The representations and warranties made by each Purchaser in Section 3.2 hereof shall be true and correct in all material respects (except for those representations and warranties which are qualified as to materiality, in which case such representations and warranties shall be true and correct in all respects) as of the date when made, and as of the Closing Date as though made on and as of such date, except for representations and warranties that speak as of a specific date, which shall be true and correct in all material respects (except for those representations and warranties which are qualified as to materiality or Material Adverse Effect, which representations and warranties shall be true and correct in all respects) as of such date.
(b) Performance. Such Purchaser shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the Transaction Documents to be performed, satisfied or complied with by such Purchaser at or prior to the Closing Date.
(c) No Injunction. No statute, rule, regulation, order, executive order, decree, judgment, writ, order, ruling or injunction shall have been enacted, entered, promulgated, issued or endorsed by any court of competent jurisdiction or any Governmental Authority that enjoins, prevents or prohibits the consummation of any of the transactions contemplated by the Transaction Documents.
(d) Purchasers Deliverables. Such Purchaser shall have delivered its Purchaser Deliverables in accordance with Section 2.3(b).
(e) License Agreement. The License Agreement shall have been consummated in accordance with the terms thereof (which shall not have been amended in any manner that is materially and adversely affects the Purchasers).
(f) Termination. This Agreement shall not have been terminated as to such Purchaser in accordance with Section 6.16 herein.
Article 6
MISCELLANEOUS
6.1 Fees and Expenses. The Company and the Purchasers shall each pay the fees and expenses of their respective advisers, counsel, accountants and other experts, if any, and all other expenses incurred by such party in connection with the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all Transfer Agent fees, stamp taxes and other taxes and duties levied in connection with the issuance and sale of the Securities to the Purchasers.
6.2 Entire Agreement. The Transaction Documents, together with the exhibits and schedules thereto, contain the entire understanding of the parties with respect to the subject matter hereof and thereof and supersede all prior agreements, understandings, discussions and representations, oral or written, with respect to such matters, which the parties acknowledge have been merged into such documents, exhibits and schedules. Before or at the
Closing, the Company and the Purchasers will execute and deliver to the other such further documents as may be reasonably requested in order to give practical effect to the intention of the parties under the Transaction Documents.
6.3 Notices. Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the earliest of (a) the date of transmission, if such notice or communication is delivered via electronic mail at the e-mail address specified in this Section 6.3 prior to 5:00 P.M., New York City time, on a Trading Day, (b) the next Trading Day after the date of transmission, if such notice or communication is delivered via electronic mail at the e- mail address or facsimile number specified in this Section 6.3 on a day that is not a Trading Day or later than 5:00 P.M., New York City time, on any Trading Day, (c) the Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service with next day delivery specified, or (d) upon actual receipt by the party to whom such notice is required to be given if delivered personally or if sent by U.S. certified or registered mail, return receipt requested; provided, in the case of clauses (a) and (b), that notice shall not be deemed given or effective if the sender receives an automatic system-generated response that such electronic mail was undeliverable. The address for such notices and communications shall be as follows:
If to the Company:
Tivic Health Systems, Inc.
47685 Lakeview Blvd.
Fremont, CA 94538
Attention: Jennifer Ernst
Email Address: jennifer.ernst@tivichealth.com
with a copy to (which shall not constitute notice):
Snell & Wilmer L.L.P.
3611 Valley Center Drive, Suite 500
San Diego, CA 92130
Attention: Christopher Tinen
Email: ctinen@swlaw.com
If to a Purchaser:
To the address set forth under such Purchaser’s name on its signature page hereto; or such other address as may be designated in writing hereafter, in the same manner, by such Person.
6.4 Amendments; Waivers; No Additional Consideration. 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 Purchasers of at least a majority in interest of the Securities still held by Purchasers, provided that (i) no amendment to Section 4.5, Section 4.6, Section 4.9, Section 4.10 Section 4.11, this Section 6.4 or Section 6.16 may be made without the consent of each Purchaser, or, in the case of a waiver, by the party against whom enforcement of any such waiver is sought and (ii) any proposed amendment that would, by its terms, have a disproportionate and materially adverse effect on any Purchaser shall require the consent of such Purchaser(s). 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 either party to exercise any right hereunder in any manner impair the exercise of any such right. No consideration shall be offered or paid to any Purchaser to amend or consent to a waiver or modification of any provision of any Transaction Document unless the same consideration is also offered to all Purchasers who then hold Securities.
6.5 Construction. The headings herein are for convenience only, do not constitute a part of this Agreement and shall not be deemed to limit or affect any of the provisions hereof. The language used in this Agreement will be deemed to be the language chosen by the parties to express their mutual intent, and no rules of strict construction will be applied against any party. This Agreement shall be construed as if drafted jointly by the
parties, and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement or any of the Transaction Documents. As used in this Agreement, the words “include” and “including,” and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be followed by the words “without limitation.”
6.6 Successors and Assigns. The provisions of this Agreement shall inure to the benefit of and be binding upon the parties and their successors and permitted assigns. This Agreement, or any rights or obligations hereunder, may not be assigned by the Company without the prior written consent of each Purchaser. Any Purchaser may assign its rights hereunder in whole or in part to any Person to whom such Purchaser assigns or transfers any Securities in compliance with the Transaction Documents and applicable law, provided such transferee shall agree in writing to be bound, with respect to the transferred Securities, by the terms and conditions of this Agreement that apply to the Purchasers.
6.7 No Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other Person.
6.8 Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Agreement shall be governed by and construed and enforced in accordance with the internal laws of the State of Delaware, without regard to the principles of conflicts of law thereof. Each party agrees that all Proceedings concerning the interpretations, enforcement and defense of the transactions contemplated by this Agreement and any other Transaction Documents (whether brought against a party hereto or its respective Affiliates, employees or agents) shall be commenced exclusively in the Delaware Courts. Each party hereto hereby irrevocably submits to the exclusive jurisdiction of the Delaware Courts for the adjudication of any dispute hereunder or in connection herewith or with any transaction contemplated hereby or discussed herein (including with respect to the enforcement of any of the Transaction Documents), and hereby irrevocably waives, and agrees not to assert in any Proceeding, any claim that it is not personally subject to the jurisdiction of any such Delaware Court, or that such Proceeding has been commenced in an improper or inconvenient forum. Each party hereto hereby irrevocably waives personal service of process and consents to process being served in any such Proceeding by mailing a copy thereof via registered or certified mail or overnight delivery (with evidence of delivery) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof. Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law.
EACH PARTY HERETO 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 OR THE TRANSACTIONS CONTEMPLATED HEREBY.
6.9 Survival. Subject to applicable statute of limitations, the representations, warranties, agreements and covenants contained herein shall survive the Closing and the delivery of the Securities.
6.10 Execution. This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission, or by e-mail delivery of a “.pdf” format data file, or by any electronic signature complying with the U.S. ESIGN Act of 2000, such signature shall create a legally valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf” signature page were an original thereof.
6.11 Severability. If any provision of this Agreement is held to be invalid or unenforceable in any respect, the validity and enforceability of the remaining terms and provisions of this Agreement shall not in any way be affected or impaired thereby and the parties will attempt to agree upon a valid and enforceable provision that is a reasonable substitute therefor, and upon so agreeing, shall incorporate such substitute provision in this Agreement.
6.12 Replacement of Securities. If any certificate or instrument evidencing any Securities or Conversion Shares is mutilated, lost, stolen or destroyed, the Company may issue or cause to be issued in exchange and substitution for and upon cancellation thereof, or in lieu of and substitution therefor, a new certificate or instrument, but only upon receipt of evidence reasonably satisfactory to the Company and the Transfer Agent of such loss, theft or destruction and the execution by the holder thereof of a customary lost certificate affidavit of that fact and an agreement to indemnify and hold harmless the Company and the Transfer Agent for any losses in connection therewith or, if required by the Transfer Agent, a bond in such form and amount as is required by the Transfer Agent. The applicants for a new certificate or instrument under such circumstances shall also pay any reasonable third-party costs associated with the issuance of such replacement Securities or Conversion Shares. If a replacement certificate or instrument evidencing any Securities or Conversion Shares is requested due to a mutilation thereof, the Company may require delivery of such mutilated certificate or instrument as a condition precedent to any issuance of a replacement.
6.13 Remedies. In addition to being entitled to exercise all rights provided herein or granted by Law, including recovery of damages, each of the Purchasers and the Company will be entitled to specific performance under the Transaction Documents, without the requirement of posting a bond. The parties agree that monetary damages may not be adequate compensation for any loss incurred by reason of any breach of obligations described in the foregoing sentence and hereby agree to waive in any action for specific performance of any such obligation (other than in connection with any action for a temporary restraining order) the defense that a remedy at law would be adequate.
6.14 Payment Set Aside. To the extent that the Company makes a payment or payments to any Purchaser pursuant to any Transaction Document or a Purchaser enforces or exercises its rights thereunder, and such payment or payments or the proceeds of such enforcement or exercise or any part thereof are subsequently invalidated, declared to be fraudulent or preferential, set aside, recovered from, disgorged by or are required to be refunded, repaid or otherwise restored to the Company, a trustee, receiver or any other person under any Law (including, without limitation, any bankruptcy law, state or federal law, common law or equitable cause of action), then to the extent of any such restoration the obligation or part thereof originally intended to be satisfied shall be revived and continued in full force and effect as if such payment had not been made or such enforcement or setoff had not occurred.
6.15 Adjustments in Share Numbers and Prices. In the event of any stock split, subdivision, dividend or distribution payable in shares of Common Stock (or other securities or rights convertible into, or entitling the holder thereof to receive directly or indirectly shares of Common Stock), combination or other similar recapitalization or event occurring after the date hereof and prior to the Closing, each reference in any Transaction Document to a number of shares or a price per share shall be deemed to be amended to appropriately account for such event.
6.16 Termination. This Agreement may be terminated and the sale and purchase of the Securities abandoned at any time prior to the Closing (i) automatically if the Closing has not been consummated on or prior to 5:00 P.M., New York City time, on Outside Date, (ii) by a Purchaser (with respect to itself) if any of the conditions set forth in Section 5.1 shall have become incapable of fulfillment, and shall not have been waived by such Purchaser, or (iii) automatically if the License Agreement is terminated in accordance with its terms; provided, however, that the right to terminate this Agreement under clause (ii) shall not be available to any Person whose failure to comply with its obligations under this Agreement has been the cause of or resulted in the failure of the Closing to occur on or before such time. Nothing in this Section 6.16 shall be deemed to release any party from any liability for any breach by such party of the terms and provisions of this Agreement or the other Transaction Documents or to impair the right of any party to compel specific performance by any other party of its obligations under this Agreement or the other Transaction Documents. Upon a termination in accordance with this Section 6.16, the Company and the terminating Purchaser(s) shall not have any further obligation or liability (including arising from such termination) to the other, and no Purchaser will have any liability to any other Purchaser under the Transaction Documents as a result therefrom.
6.17 Arm’s Length Transaction. The Company acknowledges and agrees that (a) the transactions described in this Agreement are an arm’s-length commercial transaction between the parties, (b) the Purchasers have not assumed nor will they assume an advisory or fiduciary responsibility in the Company’s favor with respect to any
of the transactions contemplated by this Agreement or the process leading thereto, and the Purchasers have no obligation to the Company with respect to the transactions contemplated by this Agreement except those obligations expressly set forth in this Agreement or the other Transaction Documents to which they are a party, and (c) the Company’s decision to enter into the Transaction Documents and the License Agreement has been based solely on the independent evaluation by the Company and its representatives.
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IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
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TIVIC HEALTH SYSTEMS, INC. |
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By: |
/s/ Jennifer Ernst |
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Name: |
Jennifer Ernst |
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Title: |
CEO |
IN WITNESS WHEREOF, the parties hereto have caused this Securities Purchase Agreement to be duly executed by their respective authorized signatories as of the date first indicated above.
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PURCHASER: |
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STATERA BIOPHARMA, INC. |
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By: |
/s/ Michael Handley |
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Name: |
Michael Handley |
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Title: |
Chief Executive Officer |
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Beneficial Ownership Limitation: 9.99% |
Annex A
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Purchaser |
Aggregate Purchase Price |
Number of Securities |
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(Subscription Amount) |
Purchased |
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Statera Biopharma, Inc. |
$1,200,000.00 |
945,785 shares of Common Stock |
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and |
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359.6691 shares of Series A Preferred Stock |
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Exhibit A
Certificate of Designation
Exhibit B
Irrevocable Transfer Agent Instructions
Exhibit C
Compliance Certificate
Exhibit 99.1
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Tivic Health Acquires Exclusive Worldwide Rights to
Phase III TLR5 Agonist from Statera Biopharma
Broad licensing agreement accelerates Tivic’s transformation into a diversified therapeutics company, adds late-stage immunotherapeutic to clinical pipeline. Potential for FDA approval within 24 months.
FREMONT, Calif., February 12, 2025 – Tivic Health Systems, Inc., (Nasdaq: TIVC) today announced it has acquired worldwide exclusive license rights from Statera Biopharma (OTC: STAB) to the late-stage Toll-like Receptor 5 (TLR5) agonist Entolimod for the treatment of acute radiation syndrome (ARS). In addition, the company has acquired an exclusive option to license five additional indications and clinical use cases for Entolimod and its derivative, Entalasta. This broad licensing agreement establishes Tivic as a diversified therapeutics company, with complementary bioelectronic and biologic product candidates in its clinical pipeline.
“Today, we have aggressively accelerated Tivic’s strategic transformation from a single-product, direct-to-consumer company to a diversified therapeutics company—one with a growing pipeline of clinically validated product candidates,” said Jennifer Ernst, Chief Executive Officer of Tivic. “Statera’s TLR5 immunotherapy program strongly complements our work on non-invasive vagus nerve stimulation, positioning us to address immune and autonomic dysregulation—and associated diseases—through both neural and molecular pathways.”
The lead product candidate in the licensing program is a TLR5 agonist, Entolimod for the treatment of acute radiation syndrome (ARS). Market research firm CoherentMI estimates the global acute radiation syndrome (ARS) market to be valued at USD 5.2 billion in 2024 with a compound annual growth rate of five percent from 2024 to 2031. CoherentMI goes on to identify Statera Biopharma as one of the key market leaders.
Entolimod and its immunologically optimized derivative, Entalasta, have been the subject of more than forty animal and human trials and $140 million of prior investment.
The FDA has granted Fast Track and Orphan Drug designation to Entolimod for the prevention or treatment of ARS and to prevent death following a potential lethal dose of total body ionization irradiation during or after a radiation disaster.
“Based on extensive prior research, development and numerous clinical trials of Entolimod, this important immunotherapy drug will now be advanced through the final steps toward a BLA filing and potential FDA approval under the skilled execution of the Tivic team,” added Michael K. Handley, Chief Executive Officer of Statera. “We believe this agreement has the potential to provide considerable value for both Statera and Tivic shareholders.”
About the TLR5 Immunotherapy Program
TLRs play a key role in the innate immune system. Entolimod’s mechanism of action provides unique, highly sought-after attributes in the treatment of radiation-related illness.
For ARS, animal studies have shown a three-fold increase in survival with a single dose 25-hours after exposure to lethal levels of radiation. Entolimod was effective without additional supportive care, showed gastrointestinal protective attributes, and exhibited no dose-limiting toxicity at even the highest dosing levels.
Other studies have shown the potential to address additional applications. Tivic has secured exclusive options to these indications subject to certain milestones and payment conditions. These include:
•Immunosenescence - the gradual age-related decline in the immune system's ability to fight infections and respond to vaccines.
•Lymphocyte exhaustion – a condition in which immune cells, particularly T cells, become less effective after being exposed to infection, cancer, and/or cancer treatments.
•Neutropenia - a condition characterized by an abnormally low number of neutrophils, which can result from chemotherapy, radiation, bone marrow disorders, and certain autoimmune conditions.
•Vaccine enhancement – use as a vaccine adjuvant to enhance immune response to vaccines.
•Chronic radiation syndrome - a condition caused by long-term exposure to low levels of radiation that gradually damages tissues and organs.
Terms of the Agreement
Under the agreement, Tivic will initially pay Statera $1,200,000 in equity consideration and $300,000 cash to Statera for the use of Entolimod to treat ARS. Tivic can, at its discretion, subsequently add one or more indications, as well as expand its license to include an Entolimod derivative, Entalasta, by exercising the exclusive options granted in the agreement. Tivic has no obligation to exercise such options on any specific timeline or at all; but should it do so, Tivic agrees to fund development of each such indication. Additional future payments will be royalty and milestone-driven, ensuring alignment with the clinical and commercial success of Entolimod and, after exercise of the option granted in the agreement, Entalasta.
Importantly, the structure of the agreement allows Tivic to strategically manage its investment while maximizing potential returns in line with shareholder interests. Select team members of Statera will join Tivic to establish Tivic’s biopharmaceutical capabilities and advance product candidates towards commercialization.
The transaction also includes exclusive rights and options for more than sixty patents and patents pending, associated know-how, and ownership of previously manufactured and tested materials.
Additional information about this news, including an informational PowerPoint presentation, will be available at: https://ir.tivichealth.com
Craft Capital Management LLC acted as the sole and exclusive investment banking firm in the transaction.
About Tivic Health
Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health takes a multi-pronged approach to treating diseases caused by immune dysregulation and dysautonomia. The complement of bioelectronic and biologic medicines allows Tivic to target disorders and disease via both neural pathways and molecular approaches.
Tivic Health’s first FDA approved product ClearUPTM is clinically proven to treat sinus pain and pressure. ClearUP is available through online retailers and commercial distributors. For more information about Tivic Health, visit: https://ir.tivichealth.com
About Statera Biopharma
Statera Biopharma, Inc. is a clinical-stage biopharmaceutical company developing novel immunotherapies targeting autoimmune, neutropenia/anemia, emerging viruses and cancers based on a proprietary platform designed to rebalance the body’s immune system and restore homeostasis. Statera has a large platform of toll-like receptor (TLR) agonists with TLR4 and TLR9 antagonists, and the TLR5 agonists, Entolimod and Entalasta. Statera has clinical and preclinical programs for Crohn’s disease (STAT-201), hematology (Entolimod) and inflammation (STAT-300) in addition to potential expansion into fibromyalgia and multiple sclerosis. To learn more about Statera, visit www.staterabiopharma.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tivic’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to Tivic's ability to maintain its Nasdaq listing; the development of Tivic’s vaccine candidates; the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any vaccine under development, there are significant risks in the development, regulatory approval, and commercialization of new products. Tivic does not undertake an obligation to update or revise any forward-looking statement. Investors should read Tivic’s filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading “Risk Factors”, as well as the company’s subsequent filings with the SEC. All of Tivic’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Investor Contact Information:
Hanover International, Inc.
ir@tivichealth.com
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