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

 

Date of Report (Date of earliest event reported): May 21, 2020

 

 

 

Gene Biotherapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-33635   27-007587

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

 

11230 Sorrento Valley Road, Suite 220

San Diego, California 92122

(Address of Principal Executive Offices) (Zip Code)

 

(858) 414-1477

(Registrant’s Telephone Number, Including Area Code)

 

(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 (see General Instruction A.2. below):

 

[  ] 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:

 

Title of Each Class  

 

Trading Symbol(s)

 

Name of each exchange on which

registered

Common Stock, $0.0001 par value   CRXM   N/A

 

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. [  ]

 

 

 

 

 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

Investment by Nostrum Pharmaceuticals LLC

 

On May 22, 2020, we entered into a Preferred Stock Purchase Agreement with Nostrum Pharmaceuticals, LLC, a Delaware limited liability company (“Nostrum”) pursuant to which we sold to Nostrum 1,700,000 shares of our newly designated Series B Convertible Preferred Stock, for a total purchase price of $1.7 million. Nostrum is the parent of Nostrum Laboratories, Inc., a privately-held pharmaceutical company engaged in the formulation and commercialization of specialty pharmaceutical products and controlled-release, orally administered, branded and generic drug products.

 

The Series B Convertible Preferred Stock is convertible into shares of our Common Stock at an initial conversion ratio of .0113 shares of Series B Convertible Preferred Stock for each share of Common Stock. Accordingly, the Series B Convertible Preferred Stock is currently convertible in the aggregate into 150,442,478 shares of our Common Stock.

 

We will use the proceeds from the sale of the Series B Convertible Preferred Stock to fund working capital requirements in preparation for conducting a Phase 3 clinical trial in the United States for our Generx® product candidate. We believe that Nostrum’s assets and experience in the formulation and commercialization of pharmaceutical products will facilitate the administration and completion of the Phase 3 clinical trial on a cost-effective basis.

 

Under the Preferred Stock Purchase Agreement, we have agreed to use our best efforts to become current in our reporting obligations under the Securities Exchange Act of 1934, as amended. We have engaged Marcum LLP as our independent public accounting firm to perform audits of our financial statements for the years ended December 31, 2017, 2018 and 2019. We intend to file a “super 10-K” report with the SEC covering each of those three fiscal years promptly following the completion of the audits, and thereafter to remain compliant with our public company reporting requirements.

 

We will need additional capital to complete the Phase 3 clinical trial for Generx. We anticipate raising that capital from the sale of additional debt or equity securities to Nostrum or to third parties. However, there are no agreements or arrangements in place with Nostrum or any third party for additional funding at this time. If we are able to secure additional financing, it may be on terms that are dilutive or otherwise unfavorable to existing stockholders.

 

On May 28, 2020, we issued a press release announcing the investment. A copy of the press release is attached as Exhibit 99.1 hereto.

 

Transactions with Shanxi Taxus Pharmaceuticals Co., Ltd.

 

In connection with the Preferred Stock Purchase Agreement, we entered into certain arrangements with Shanxi Taxus Pharmaceuticals Co., Ltd. (“Shanxi”). Shanxi has previously paid a subscription of $600,000 to acquire shares of our Common Stock or shares of capital stock in our Angionetics Inc. subsidiary. On April 10, 2020 we entered into a Reaffirmation and Ratification Agreement with Shanxi (the “Ratification Agreement”) confirming that we have applied the $600,000 payment to the purchase of license rights to our Generx® product candidate in greater China and have assigned our residual rights to Excellagen to Shanxi. We previously entered into a strategic cooperation agreement and a subscription agreement with Shanxi. Mr. Jiayue Zhang, a member of our Board of Directors, is the Chairman and substantial stockholder of Shanxi. In connection with the entry into the agreements described below, we terminated all prior agreements with Shanxi and entered into a mutual release of claims.

 

On April 10, 2020, our Angionetics, Inc. subsidiary entered into a Distribution and License Agreement with Shanxi, as amended by the First Amendment to Distribution and License Agreement dated April 14, 2020 (as amended, the “Shanxi License Agreement”), granting Shanxi certain license rights with respect to our Generx product candidate. The distribution and license rights commence only after we obtain U.S. FDA approval for marketing and sale of Generx in the United States. The license rights include (a) a non-exclusive right to manufacture Generx products in China, and (b) an exclusive right to market and sell Generx products in Singapore, Macau, Hong Kong, Taiwan, any other municipality other than mainland China where Chinese (Mandarin or Cantonese) is the common language, the Russian Federation and the Commonwealth of Independent States (i.e., Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan). The Shanxi License Agreement provides for a royalty ranging from 5% up to 10% based on the level of annual net sales of the Generx product sold by Shanxi in the licensed territory.

 

-2-

 

 

On April 10, 2020, our Activation Therapeutics, Inc. subsidiary entered into a License and Patent Assignment Agreement with Shanxi (the “Shanxi Assignment Agreement”) pursuant to which we transferred of all of our assets related to our Excellagen product to Shanxi. We had previously sold our Excellagen product to U.S.-based Olaragen Therapeutix, Inc. (“Olaragen”), but retained rights to manufacture, use and sell the product in Greater China, the Russian Federation and the Commonwealth of Independent States. Under the terms of the Assignment Agreement, we transferred all of our license rights to manufacture, use, market and sell Excellagen to Shanxi. We also assigned to Shanxi a Chinese patent that we received on Excellagen. In July 2018, we sold Excellagen to Olaragen for $4,000,000. At closing, we received a cash payment of $650,000. Based on the terms of the Shanxi Assignment Agreement, we retain the right to receive from Olaragen up to $3,350,000, based on a 10% royalty from the future from worldwide sales outside of China.

 

Following the Shanxi Assignment Agreement, our ongoing business is currently focused solely on the development of our Generx product candidate.

 

References to Agreements

 

The foregoing descriptions of the Preferred Stock Purchase Agreement, the Ratification Agreement, the Shanxi License Agreement and the Shanxi Assignment Agreement do not purport to be complete and are qualified in their entirety by reference to the copies of the agreements attached to this report as Exhibits 10.1 through 10.5 and incorporated by reference.

 

The agreements have been included to provide investors and stockholders with information regarding their respective terms. Those agreements are not intended to provide any other factual information about our company or Nostrum. The representations, warranties and covenants contained in those agreements were made only for purposes of those agreements and as of specific dates, were solely for the benefit of the parties to those agreements, may be subject to limitations agreed upon by the contracting parties, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under any of the agreements and should not rely on the representations, warranties or covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the agreements, which subsequent information may or may not be fully reflected in our public disclosures.

 

Forward-Looking Statements

 

This document contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. In addition, when or if used in this communication, the words “will,” “may,” “would,” “approximate,” “expect,” “intend,” and similar expressions and their variants may identify forward-looking statements. Examples of forward-looking statements include statements relating to (a) our having or securing the capital necessary to support our future operations; (b) our ability to successfully initiate and complete the Phase 3 clinical trial for Generx® or any other clinical trials; and (c) the strategic focus and plans for our company following the investment by Nostrum. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including the risk factors included in the Company’s periodic reports filed with the SEC. Forward looking statements are based on information available and assumptions as of the date of this report. Except as required by applicable law, we do not undertake any obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

 

Item 3.02 Unregistered Sales of Equity Securities.

 

On May 22, 2020 we sold 1,700,000 shares of our newly designated Series B Preferred Stock to Nostrum in exchange for $1,700,000 in cash. There were no underwriting discounts or commissions. The sale was conducted as a privately negotiated transaction with a single investor, pursuant to the exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended.

 

-3-

 

 

Item 3.03 Material Modification to Rights of Security Holders.

 

The shares of Series B Convertible Preferred Stock have a liquidation preference over holders of our Common Stock or any other class of junior stock. In the event of any liquidation, dissolution or winding up of our company, the holders of our Series B Convertible Preferred Stock will first be entitled to be paid an amount equal to $1.00 per share plus any other fees, liquidated damages or dividends then owing, before our remaining assets will be distributed among the holders of our Common Stock or the other classes or series of shares of our capital stock.

 

Item 5.01 Changes in Control of Registrant.

 

The sale of the Series B Convertible Preferred Stock resulted in a change of control in our company. The 1,700,000 shares of Series B Convertible Preferred Stock issued to Nostrum vote on an as converted basis with the equivalence of 150,442,478 shares of Common Stock.

 

Concurrently with the sale of the Series B Convertible Preferred Stock, Nostrum acquired 220 shares of our Series A Convertible Preferred Stock from Sabby Master Heathcare Ltd. and agreed to purchase the remaining 570 shares of Series A Convertible Preferred Stock that are outstanding and held by Sabby. As a result of the issuance of the Series B Convertible Preferred Stock, each share of our Series A Convertible Preferred Stock became convertible into 88,496 shares of our Common Stock. The Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock restricts Nostrum from converting any Series A Preferred Stock if Nostrum would beneficially own a number of shares of Common Stock in excess of 9.99% of the shares of Common Stock then issued and outstanding. As a result of its ownership of the Series B Convertible Preferred Stock, Nostrum is currently limited in its entirety from converting any shares of Series A Convertible Preferred Stock. The Series A Convertible Preferred Stock has no voting rights on general corporate matters, provided that the Series A Convertible Preferred Stock contain customary protective provisions. We were not a party to, and did not receive any proceeds from, the sale of the Series A Convertible Preferred Stock between Nostrum and Sabby.

 

We currently have 14,489,399 shares of Common Stock outstanding. Consequently, Nostrum’s current investment in the Series B Convertible Preferred Stock represents control of 91.2 percent of the voting power of the Company.

 

Nostrum acquired the Series B Convertible Preferred Stock in exchange for $1.7 million, which was funded from working capital. We are not aware of any other transaction that could result in a subsequent change in control of the Company.

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Board of Directors

 

On May 22, 2020, Andrew Leitch, John Wallace, Jiayue Zhang and Wei-Wei Zhang resigned from their positions as members of the Company’s Board of Directors. The resignations were required under the terms of the Preferred Stock Purchase Agreement; none of the resigning directors resigned as the result of any disagreement with the Company on any matter relating to the Company’s operations, policies or procedures. Christopher J. Reinhard and Murray Hutchinson each remain a director of the Company.

 

On May 22, 2020, at the request of Nostrum, James Grainer and Kaushik K. Vyas were appointed to the Company’s Board of Directors and James L. Grainer was appointed to serve as Chairman of the Board.

 

James L. Grainer, currently serves as the Chief Financial Officer of Nostrum and its various subsidiaries including Nostrum Laboratories, Inc. He has been Chief Financial Officer of Nostrum since 2015. Prior to joining Nostrum, Mr. Grainer served as the Chief Financial Officer of Chatterjee Asset Management (2007-2015), President and Chief Financial Officer of Greenshift Corporation (2004-2007), Managing Director at Zanett Securities (2001-2004) and Managing Director of Prudential Securities (1993-2001).

 

Kaushik K. Vyas, currently serves as the Chief Executive Officer of Nostrum Energy, LLC a majority owned subsidiary of Nostrum Pharmaceuticals LLC and is a member of the Board of Directors of Nostrum Pharmaceuticals LLC. Mr. Vyas has served as the Chief Executive Officer of Nostrum Energy LLC since 2012. From 1995 to 2012 Mr. Vyas was employed by Science Applications International Corporation (NYSE: SAIC), a government services and information technology company, in a variety of positions culminating in Corporate VP.

 

-4-

 

 

Following these resignations and appointments, the Board of Directors is currently comprised of four members consisting of Messrs. Grainer, Hutchinson, Reinhard and Vyas.

 

Executive Officers

 

On May 22, 2020, the following individuals have been appointed the executive officers of the Company to serve until the next annual meeting of the Board of Directors and until their successors are duly elected and qualified:

 

  Chief Executive Officer Christopher J. Reinhard
  Chief Financial Officer James L. Grainer
  Chief Scientific Officer Ronald J. Shebuski
  Chief Operating Officer Lois Chandler
  Secretary James L. Grainer

 

Ronald J. Shebuski, Phd. currently serves as the Company’s Chief Scientific Officer. Dr. Shebuski has over 25 years of experience in the pharmaceutical industry. From 2016 to 2020 he served as the Vice President of Research and Development for InspiRx, Inc. From 1998 to 2016 he established Cardiovascular Research Consulting, LLC, an advisory firm serving small, mid and large pharma companies in many aspects of drug discovery. From 1990 to 1998 he served as the Director of Cardiovascular Therapeutics at Pharmacia & Upjohn, where he managed the team responsible for FDA approval of the Class III anti-arrhythmic agent, Corvert®. Prior to Pharmacia & Upjohn, Dr. Shebuski was a Senior Scientist responsible for leading cardiovascular drug discovery teams at Merck Research Laboratories and Smith Kline & French in the Philadelphia area. His primary field of research has focused on thrombosis and the development of effective new thrombolytic, anti-platelet and anti-coagulant therapies. At Merck, Ron led the in vivo discovery and development effort which culminated in the identification and eventual FDA approval of the anti-platelet GPIIb/IIIa antagonist, Aggrastat®. He also led development teams in identification of novel factor Xa and P- selectin antagonists at Merck and Pharmacia & Upjohn, respectively. Dr. Shebuski received his B.S. Degree in Microbiology from the University of Wisconsin at Madison and Ph.D. Degree in Pharmacology from the University of Minnesota Medical School. Further, Dr. Shebuski is expert in FDA regulations and has an ongoing appointment (since 2009) with FDA as a Special Government Employee (SGE) in the CardioRenal Division of CDER (Center for Drug Evaluation and Research).

 

Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year

 

Amendment to Certificate of Incorporation

 

On May 21, 2020, we amended our Certificate of Incorporation with the filing of a Certificate of Designation to establish the rights, privileges and preferences of a new class of our preferred stock designated Series B Convertible Preferred Stock. The material terms and provisions of the shares of our Series B Convertible Preferred Stock are summarized below.

 

Dividends. Each share of our Series B Convertible Preferred Stock is entitled to receive dividends when, as, and if dividends are paid on shares of our Common Stock. Dividends are payable on each share Series B Convertible Preferred Stock on an “as-converted” basis, in the same amount and form as dividends actually paid on shares of our Common Stock. We have never paid dividends on shares of our common stock and we do not intend to do so for the foreseeable future.

 

Voting Rights. Each share of our Series B Convertible Preferred Stock will have the same voting rights as shares of our Common Stock, on an “as-converted” basis, and will vote on all matters with the Common Stock as a single class. In addition, the Series B Convertible Preferred Stock has voting rights that require the approval of a majority of the outstanding shares of Series B Convertible Preferred Stock for any action to: (1) alter or change adversely the powers, preferences or rights given to the shares of our Series B Convertible Preferred Stock or alter or amend its certificate of designation, (2) authorize or create any class of shares ranking as to dividends, redemption or distribution of assets upon liquidation senior to, or otherwise pari passu with, the shares of our Series B Convertible Preferred Stock, (3) amend our Certificate of Incorporation or other charter documents in any manner that adversely affects any rights of the holders of our Series B Convertible Preferred Stock, (4) increase the number of authorized shares of our Series B Convertible Preferred Stock, or (5) enter into any agreement with respect to any of the foregoing.

 

-5-

 

 

Conversion. The shares of our Series B Convertible Preferred Stock are convertible at any time at the option of the holder into shares of our Common Stock at a ratio determined by dividing the Stated Value of such share of Series B Preferred Stock by the conversion price of $0.0113 per share of Common Stock. Accordingly, each share of our Series B Convertible Preferred Stock is initially convertible into 88.5 shares of our Common Stock. The conversion price is subject to adjustment in the case of share splits, share dividends, combinations of shares and similar recapitalization transactions. In addition, if the Company sells shares of Common Stock or Common Stock equivalents at a price less than the current conversion price, the conversion price of the Series B Convertible Preferred Stock will be reduced to equal eighty percent (80%) of the price at which such Common Stock or Common Stock equivalents are sold.

 

Liquidation. The Series B Convertible Preferred Stock has a liquidation preference. Upon any liquidation, dissolution or winding up of our company, after payment or provision for payment of our debts and other liabilities and before any distribution or payment is made to the holders of our common stock or any junior securities, the holders of our Series B Convertible Preferred Stock will first be entitled to be paid an amount equal to $1.00 per share plus any other fees, liquidated damages or dividends then owing, before our remaining assets will be distributed among the holders of the other classes or series of shares of our capital stock in accordance with our Certificate of Incorporation.

 

The foregoing description of the Certificate of Designation does not purport to be complete and is qualified in its entirety by reference to the complete Certificate of Designation which is filed as Exhibit 3.1 to this report and incorporated herein by reference.

 

Amendment to Bylaws

 

On May 22, 2020, the Board amended the Company’s bylaws to eliminate the classified Board. Directors will each serve one year terms until the next annual meeting of stockholders or until their successors are duly elected and qualified.

 

Item 9.01 Financial Statements and Exhibits

 

(d) Exhibits

 

Exhibit No.   Description
3.1   Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock
10.1   Preferred Stock Purchase Agreement dated May 22, 2020 for the purchase of Series B Convertible Preferred Stock
10.2   Reaffirmation and Ratification Agreement dated April 10, 2020 between Gene Biotherapeutics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.
10.3   Distribution and License Agreement dated April 10, 2020 between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.
10.4   Amendment No. 1 to Distribution and License Agreement dated April 14, 2020 between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.
10.5   License and Patent Assignment Agreement dated April 10, 2020 between Activation Therapeutics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd.

 

-6-

 

 

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.

 

Date: May 28, 2020 GENE BIOTHERAPEUTICS, INC.
     
  By: /s/ Christopher J. Reinhard
    Christopher J. Reinhard
    Chief Executive Officer

 

-7-

 

 

Exhibit 3.1

 

GENE BIOtherapeutics, inc.

 

CERTIFICATE OF DESIGNATION OF PREFERENCES,

RIGHTS AND LIMITATIONS

OF

SERIES B CONVERTIBLE PREFERRED STOCK

 

PURSUANT TO SECTION 151 OF THE

Delaware GENERAL CORPORATION LAW

 

The undersigned, Christopher J. Reinhard and Lois Chandler, do hereby certify that:

 

1. They are the President and Secretary, respectively, of Gene Biotherapeutics, Inc., a Delaware corporation (the “Corporation”).

 

2. The Corporation is authorized to issue 40,000,000 shares of preferred stock, 4,012 of which have been issued.

 

3. The following resolutions were duly adopted by the board of directors of the Corporation (the “Board of Directors”):

 

WHEREAS, the certificate of incorporation of the Corporation provides for a class of its authorized stock known as preferred stock, consisting of 40,000,000 shares, $0.0001 par value per share, issuable from time to time in one or more series;

 

WHEREAS, the Board of Directors is authorized to provide for the issuance of the shares of preferred stock in series and to establish, from time to time, the number of shares to be included in each such series, and to fix the designation, powers, preferences and rights of the shares of each such series and any qualifications, limitations or restrictions thereon;;and

 

WHEREAS, it is the desire of the Board of Directors, pursuant to its authority as aforesaid, to fix the rights, preferences, restrictions and other matters relating to a series of preferred stock which shall consist of 1,700,000 shares of the preferred stock which the Corporation has the authority to issue, as follows:

 

NOW, THEREFORE, BE IT RESOLVED, that the Board of Directors does hereby provide for the issuance of a series of preferred stock to be designated as “Series B Convertible Preferred Stock” for cash or exchange of other securities, rights or property and does hereby fix and determine the rights, preferences, restrictions and other matters relating to such series of preferred stock as follows:

 

TERMS OF SERIES B CONVERTIBLE PREFERRED STOCK

 

Section 1. Definitions. For the purposes hereof, the following terms shall have the following meanings:

 

-1-

 

 

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

 

Alternate Consideration” shall have the meaning set forth in Section 7(e).

 

Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.

 

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.

 

Common Stock Equivalents” means any securities of the Corporation or the Subsidiaries which would entitle the holder thereof to acquire at any time Common Stock, including, without limitation, any debt, preferred stock, rights, options, warrants or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Common Stock.

 

Conversion Date” shall have the meaning set forth in Section 6(a).

 

Conversion Price” shall have the meaning set forth in Section 6(b).

 

Conversion Shares” means the shares of Common Stock issuable upon conversion of the shares of Series B Preferred Stock in accordance with the terms hereof.

 

Exempt Issuance” means the issuance of (a) shares of Common Stock or options to employees, officers or directors of the Corporation pursuant to any stock or option plan duly adopted by a majority of the non-employee members of the Board of Directors of the Corporation or a majority of the members of a committee of non-employee directors established for such purpose, (b) securities upon the exercise or exchange of or conversion of any securities issued pursuant to the Purchase Agreement and/or other securities exercisable or exchangeable for or convertible into shares of Common Stock issued and outstanding on the date of the Purchase Agreement, provided that such securities have not been amended since the date of the Purchase Agreement to increase the number of such securities or to decrease the exercise price, exchange price or conversion price of any such securities, (c) securities issued pursuant to a merger, consolidation, acquisition or similar business combination approved by the Board of Directors provided that any such issuance shall only be to a Person (or to the equityholders of a Person) which is, itself or through its subsidiaries, an operating company or an asset in a business synergistic with the business of the Corporation and shall provide to the Corporation additional benefits in addition to the investment of funds, but shall not include a transaction in which the Corporation is issuing securities primarily for the purpose of raising capital or to an entity whose primary business is investing in securities and (d) securities issued to banks, equipment lessors or other financial institutions in connection with credit agreements, debt financings, equipment lease financings or other commercial transactions made to the Company which are approved by the Board of Directors.

 

-2-

 

 

Fundamental Transaction” means a transaction in which (a) the Corporation, directly or indirectly, in one or more related transactions effects any merger or consolidation of the Corporation with or into another Person, (b) the Corporation, directly or indirectly, effects any sale, lease, license, assignment, transfer, conveyance or other disposition of all or substantially all of its assets in one or a series of related transactions, (c) any, direct or indirect, purchase offer, tender offer or exchange offer (whether by the Corporation or another Person) is completed pursuant to which holders of Common Stock are permitted to sell, tender or exchange their shares for other securities, cash or property and has been accepted by the holders of 50% or more of the outstanding Common Stock, (d) the Corporation, directly or indirectly, in one or more related transactions effects any reclassification, reorganization or recapitalization of the Common Stock or any compulsory share exchange pursuant to which the Common Stock is effectively converted into or exchanged for other securities, cash or property, (e) the Corporation, directly or indirectly, in one or more related transactions consummates a stock or share purchase agreement or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement) with another Person whereby such other Person acquires more than 50% of the outstanding shares of Common Stock (not including any shares of Common Stock held by the other Person or other Persons making or party to, or associated or affiliated with the other Persons making or party to, such stock or share purchase agreement or other business combination).

 

Holder” shall have the meaning given such term in Section 2.

 

Junior Securities” means the Series A Preferred Stock, Common Stock and all other Common Stock Equivalents of the Corporation other than those securities which are explicitly senior or pari passu to the Series B Preferred Stock in liquidation preference.

 

Liquidation” shall have the meaning set forth in Section 5.

 

Notice of Conversion” shall have the meaning set forth in Section 6(a).

 

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.

 

Purchase Agreement” means the Preferred Stock Purchase Agreement, dated as of May 22, 2020, among the Corporation and the original Holders (as hereinafter defined), as amended, modified or supplemented from time to time in accordance with its terms.

 

Securities” means the Series B Preferred Stock and the Conversion Shares.

 

Securities Act” means the U.S. Securities Act of 1933, as amended.

 

Series A Preferred Stock” means the Series A Convertible Preferred Stock, par value $.0001, of the Company.

 

Series B Preferred Stock” shall have the meaning set forth in Section 2.

 

Stated Value” shall have the meaning set forth in Section 2.

 

Subsidiary” means any subsidiary of the Corporation as defined in the Purchase Agreement and shall, where applicable, also include any direct or indirect subsidiary of the Corporation formed or acquired after the date of the Purchase Agreement.

 

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 OTC Market, 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).

 

Transfer Agent” means Pacific Stock Transfer, or any successor transfer agent of the Company.

 

Section 2. Designation, Amount and Par Value. The series of preferred stock shall be designated as its Series B Convertible Preferred Stock (the “Series B Preferred Stock”) and the number of shares so designated shall be 1,700,000 (which shall not be subject to increase without the written consent of all of the holders of the Series B Preferred Stock (each, a “Holder” and collectively, the “Holders”)). Each share of Series B Preferred Stock shall have a par value of $0.0001 per share and a stated value equal to $1.00 (the “Stated Value”).

 

-3-

 

 

Section 3. Dividends. Holders shall be entitled to receive, and the Corporation shall pay, dividends on shares of Series B Preferred Stock equal (on an as-if-converted-to-Common-Stock basis) to and in the same form as dividends (other than dividends in the form of Common Stock) actually paid on shares of the Common Stock when, as and if such dividends (other than dividends 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 B Preferred Stock; and the Corporation shall pay no dividends (other than dividends in the form of Common Stock) on shares of the Common Stock or unless it simultaneously complies with the previous sentence.

 

Section 4. Voting Rights.

 

a) On any matter presented to the stockholders of the Corporation for their action or consideration at any meeting of stockholders of the Corporation (or by written consent of stockholders in lieu of meeting), each Holder of outstanding shares of Series B Preferred Stock shall be entitled to cast the number of votes equal to the number of whole shares of Common Stock into which the shares of Series B Preferred Stock held by such Holder are convertible as of the record date for determining stockholders entitled to vote on such matter. Except as provided by law or by the other provisions of this Certificate of Designation, Holders of Series B Preferred Stock shall vote together with the holders of Common Stock as a single class and on an as-converted to Common Stock basis.

 

b) As long as any shares of Series B 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 B Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series B Preferred Stock or alter or amend this Certificate of Designation, (b) authorize or create any class of stock ranking as to dividends, redemption or distribution of assets upon a Liquidation (as defined in Section 5) senior to, or otherwise pari passu with, the Series B Preferred Stock, (c) amend its certificate of incorporation or other charter documents in any manner that adversely affects any rights of the Holders, (d) increase the number of authorized shares of Series B Preferred Stock, or (e) enter into any agreement with respect to any of the foregoing.

 

Section 5. Liquidation. Upon any liquidation, dissolution or winding-up of the Corporation, whether voluntary or involuntary (a “Liquidation”), the Holders shall be entitled to receive out of the assets, whether capital or surplus, of the Corporation an amount equal to the Stated Value, plus any other fees, liquidated damages or dividends then due and owing thereon under this Certificate of Designation, for each share of Series B Preferred Stock before any distribution or payment shall be made to the holders of any other series of preferred stock or any Junior Securities, and if the assets of the Corporation shall be insufficient to pay in full such amounts, then the entire assets to be distributed to the Holders shall be ratably distributed among the Holders in accordance with the respective amounts that would be payable on such shares if all amounts payable thereon were paid in full. A Fundamental Transaction shall not be deemed a Liquidation.

 

-4-

 

 

Section 6. Conversion.

 

a) Conversions at Option of Holder. Each share of Series B Preferred Stock shall be convertible, at any time and from time to time at the option of the Holder thereof, into that number of shares of Common Stock determined by dividing the Stated Value of such share of Series B Preferred Stock by the Conversion Price. Holders shall effect conversions by providing the Corporation with the form of conversion notice attached hereto as Annex A (a “Notice of Conversion”). Each Notice of Conversion shall specify the number of shares of Series B Preferred Stock to be converted, the number of shares of Series B Preferred Stock owned prior to the conversion at issue, the number of shares of Series B Preferred Stock to be owned subsequent to the conversion at issue and the date on which such conversion is to be effected, which date may not be prior to the date the applicable Holder delivers such Notice of Conversion to the Corporation (such date, the “Conversion Date”). If no Conversion Date is specified in a Notice of Conversion, the Conversion Date shall be the date that such Notice of Conversion to the Corporation is deemed delivered hereunder. 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. The calculations and entries set forth in the Notice of Conversion shall control in the absence of manifest or mathematical error. To effect conversions of shares of Series B Preferred Stock, a Holder shall not be required to surrender the certificate(s) representing the shares of Series B Preferred Stock to the Corporation unless all of the shares of Series B Preferred Stock represented thereby are so converted, in which case such Holder shall deliver the certificate representing such shares of Series B Preferred Stock promptly following the Conversion Date at issue. Shares of Series B Preferred Stock converted into Common Stock in accordance with the terms hereof shall be canceled and shall not be reissued.

 

b) Conversion Price. The conversion price for the Series B Preferred Stock shall equal $0.0113, subject to adjustment as provided in Section 7 herein (the “Conversion Price”).

 

c) Mechanics of Conversion. The Corporation shall promptly, and in any event with two (2) Trading Days after each conversion date deliver, or cause to be delivered, to the converting Holder the number of Conversion Shares being acquired upon the conversion of the Series B Preferred Stock. For so long as the Conversion Shares are subject to restrictions on transfer pursuant to the Securities Act, any certificate representing the Conversion Shares will bear an appropriate legend. From and after such time as the Conversion Shares are freely transferrable without restriction under the Securities Act. The Corporation shall use its best efforts to deliver the Conversion Shares electronically through the Depository Trust Company or another established clearing corporation performing similar functions.

 

-5-

 

 

d) Status of Conversion Shares. The Corporation covenants that all shares of Common Stock that are issuable upon conversion of the Series B Preferred Stock, when issued in accordance with terms of this Certificate of Designation and the Corporation’s certificate of incorporation shall, upon issue, be duly authorized, validly issued, fully paid and nonassessable.

 

e) Fractional Shares. No fractional shares or scrip representing fractional shares shall be issued upon the conversion of the Series B Preferred Stock. As to any fraction of a share which the Holder would otherwise be entitled to purchase upon such conversion, the Corporation shall at its election, either pay a cash adjustment in respect of such final fraction in an amount equal to such fraction multiplied by the Conversion Price or round up to the next whole share.

 

f) Transfer Taxes and Expenses. The issuance of Conversion Shares on conversion of the Series B 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 Conversion Shares, 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 Conversion Shares upon conversion in a name other than that of the Holders of such shares of Series B Preferred Stock and the Corporation shall not be required to issue or deliver such Conversion Shares 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. The Corporation shall pay all Transfer Agent fees required for same-day processing of any Notice of Conversion.

 

Section 7. Certain Adjustments.

 

a) Stock Dividends and Stock Splits. If the Corporation, at any time while this Series B Preferred Stock is outstanding: (i) pays a stock dividend or otherwise makes a distribution or distributions payable in shares of Common Stock on shares of Common Stock or any other Common Stock Equivalents (which, for avoidance of doubt, shall not include any shares of Common Stock issued by the Corporation upon conversion of this Series B Preferred Stock), (ii) subdivides outstanding shares of Common Stock into a larger number of shares, (iii) combines (including by way of a reverse stock split) outstanding shares of Common Stock into a smaller number of shares, or (iv) issues, in the event of a reclassification of shares of the Common Stock, any shares of capital stock of the Corporation, then the Conversion Price 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 before such event, and of which the denominator shall be the number of shares of Common Stock outstanding immediately after such event. Any adjustment made pursuant to this Section 7(a) 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, combination or re-classification.

 

-6-

 

 

b) Subsequent Equity Sales. If, at any time while this Series B Preferred Stock is outstanding, the Corporation sells, grants any option to purchase, reprices, or otherwise disposes of or issues, any Common Stock or Common Stock Equivalents entitling any Person to acquire shares of Common Stock at an effective price per share (the “Base Price”) that is lower than the then Conversion Price, then the Conversion Price shall be reduced to equal eighty percent (80%) of the Base Price; provided, however, that no adjustment to the Conversion Price will be made under this Section 7(b) in respect of an Exempt Issuance.

 

c) Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 7(a) above, if at any time the Corporation grants, issues or sells any Common Stock Equivalents or rights to purchase stock, warrants, securities or other property pro rata to the record holders of any class of shares of Common Stock (the “Purchase Rights”), then the Holder of will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon complete conversion of such Holder’s Series B Preferred Stock (without regard to any limitations on exercise hereof) immediately before the date on which a record is taken for the grant, issuance or sale of such Purchase Rights, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the grant, issue or sale of such Purchase Rights.

 

d) Pro Rata Distributions. During such time as this Series B Preferred Stock is outstanding, if the Corporation shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, stock or other securities, property or options by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction) (a “Distribution”), at any time after the issuance of this Series B Preferred Stock, then, in each such case, the Holder shall be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder had held the number of shares of Common Stock acquirable upon complete conversion of this Series B Preferred Stock immediately before the date of which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares of Common Stock are to be determined for the participation in such Distribution.

 

e) Fundamental Transaction. If, at any time while this Series B Preferred Stock is outstanding, the Corporation engages in a Fundamental Transaction, then, upon any subsequent conversion of this Series B Preferred Stock, the Holder shall have the right to receive, for each Conversion Share that would have been issuable upon such conversion immediately prior to the occurrence of such Fundamental Transaction, the number of shares of Common Stock of the successor or acquiring corporation or of the Corporation, if it is the surviving corporation, and any additional consideration (the “Alternate Consideration”) receivable as a result of such Fundamental Transaction by a holder of the number of shares of Common Stock for which this Series B Preferred Stock is convertible immediately prior to such Fundamental Transaction. For purposes of any such conversion, the determination of the Conversion Price 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 apportion the Conversion Price among the Alternate Consideration 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 Holder shall be given the same choice as to the Alternate Consideration it receives upon any conversion of this Series B 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 Designation 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.

 

-7-

 

 

f) 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.

 

g) Notice to the Holders.

 

i. Adjustment to Conversion Price. Whenever the Conversion Price is adjusted pursuant to any provision of this Section 7, the Corporation shall promptly deliver to each Holder a notice setting forth the Conversion Price after such adjustment and setting forth a brief statement of the facts requiring such adjustment.

 

ii. Notice to Allow Conversion by Holder. If (A) the Corporation shall declare a dividend (or any other distribution in whatever form) on the Common Stock, (B) the Corporation shall declare a special nonrecurring cash dividend on or a redemption of the Common Stock, (C) the Corporation shall authorize the granting to all holders of the Common Stock of rights or warrants to subscribe for or purchase any shares of capital stock of any class or of any rights, (D) the approval of any stockholders of the Corporation shall be required in connection with any reclassification of the Common Stock, any consolidation or merger to which the Corporation is a party, any sale or transfer of all or substantially all of the assets of the Corporation, or any compulsory share exchange whereby the Common Stock is converted into other securities, cash or property or (E) the Corporation shall authorize the voluntary or involuntary dissolution, liquidation or winding up of the affairs of the Corporation, then, in each case, the Corporation shall cause to be filed at each office or agency maintained for the purpose of conversion of this Series B Preferred Stock, and shall cause to be delivered to each Holder at its last address as it shall appear upon the stock books of the Corporation, at least five (5) Business Days prior to the applicable record or effective date hereinafter specified, a notice stating (x) the date on which a record is to be taken for the purpose of such dividend, distribution, redemption, rights or warrants, or if a record is not to be taken, the date as of which the holders of the Common Stock of record to be entitled to such dividend, distributions, redemption, rights or warrants are to be determined or (y) the date on which such reclassification, consolidation, merger, sale, transfer or share exchange is expected to become effective or close, and the date as of which it is expected that holders of the Common Stock of record shall be entitled to exchange their shares of the Common Stock for securities, cash or other property deliverable upon such reclassification, consolidation, merger, sale, transfer or share exchange, provided that the failure to deliver such notice or any defect therein or in the delivery thereof shall not affect the validity of the corporate action required to be specified in such notice. The Holder shall remain entitled to convert shares of this Series B Preferred Stock (or any part hereof) during the 5 Business Day period commencing on the date of such notice through the effective date of the event triggering such notice except as may otherwise be expressly set forth herein.

 

-8-

 

 

Section 8. Miscellaneous.

 

a) Notices. Any and all notices or other communications or deliveries to be provided by the Holders hereunder including, without limitation, any Notice of Conversion, shall be in writing and delivered personally, by email, or sent by a nationally recognized overnight courier service, addressed to the Corporation, at the principal executive offices of the Corporation as specified in the Purchase Agreement, Attention: Chief Executive Officer, or such other address as the Corporation may specify for such purposes by notice to the Holders delivered in accordance with this Section 8. Any and all notices or other communications or deliveries to be provided by the Corporation hereunder shall be in writing and delivered personally, by email, or sent by a nationally recognized overnight courier service addressed to each Holder at the address of such Holder appearing on the books of the Corporation, or if no such address appears on the books of the Corporation, at the principal place of business of such Holder, as set forth in the Purchase Agreement. Any notice or other communication or deliveries hereunder shall be deemed given and effective on the earliest of (a) the date of transmission, if such notice or communication is delivered via email prior to 5:30 p.m. (New York City time) on any date, (ii) the next Trading Day after the date of transmission, if such notice or communication is delivered via email on a day that is not a Trading Day or later than 5:30 p.m. (New York City time) on any Trading Day, (b) the second Trading Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service, or (c) upon actual receipt by the party to whom such notice is required to be given.

 

b) Lost or Mutilated Preferred Stock Certificate. If a Holder’s Series B Preferred Stock certificate shall be mutilated, lost, stolen or destroyed, the Corporation shall execute and deliver, in exchange and substitution for and upon cancellation of a mutilated certificate, or in lieu of or in substitution for a lost, stolen or destroyed certificate, a new certificate for the shares of Series B Preferred Stock so mutilated, lost, stolen or destroyed, but only upon receipt of evidence of such loss, theft or destruction of such certificate, and of the ownership hereof reasonably satisfactory to the Corporation.

 

c) Governing Law. All questions concerning the construction, validity, enforcement and interpretation of this Certificate of Designation 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 conflict of laws thereof.

 

d) 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. 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 on any other occasion. Any waiver by the Corporation or a Holder must be in writing.

 

e) Next Business Day. Whenever any payment or other obligation hereunder shall be due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day.

 

f) Status of Converted Preferred Stock. Shares of Series B Preferred Stock may only be issued pursuant to the Purchase Agreement. If any shares of Series B Preferred Stock shall be converted or reacquired by the Corporation, such shares shall resume the status of authorized but unissued shares of preferred stock and shall no longer be designated as Series B Convertible Preferred Stock.

 

 

*********************

 

-9-

 

 

RESOLVED, FURTHER, that the Chief Executive Officer and the Secretary of the Corporation are authorized and directed to prepare and file this Certificate of Designation of Preferences, Rights and Limitations in accordance with the foregoing resolution and the provisions of Delaware law.

 

IN WITNESS WHEREOF, the undersigned have executed this Certificate this 21st day of May, 2020.

 

/s/ Christopher J. Reinhard   /s/ Christopher J. Reinhard
Name: Christopher J. Reinhard   Name: Christopher J. Reinhard
Title: Chief Executive Officer   Title: Secretary

 

-10-

 

 

ANNEX A

 

NOTICE OF CONVERSION

 

(To be Executed by the Registered Holder in order to Convert Shares of Preferred Stock)

 

The undersigned hereby elects to convert the number of shares of Series B Convertible Preferred Stock indicated below into shares of common stock, par value $0.0001 per share (the “Common Stock”), of Gene Biotherapeutics, Inc., a Delaware corporation (the “Corporation”), according to the conditions hereof, as of the date written below. If shares of Common Stock 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 and is delivering herewith such certificates and opinions as may be required by the Corporation in accordance with the Purchase Agreement. No fee will be charged to the Holders for any conversion, except for any such transfer taxes.

 

Conversion calculations:

 

Date to Effect Conversion: _____________________________________________  
 
Number of shares of Preferred Stock owned prior to Conversion: _______________  
 
Number of shares of Preferred Stock to be Converted: ________________________  
 
Stated Value of shares of Preferred Stock to be Converted: ____________________  
 
Number of shares of Common Stock to be Issued: ___________________________  
 
Applicable Conversion Price:____________________________________________  
 
Number of shares of Preferred Stock subsequent to Conversion: ________________  
 

Address for Delivery: ______________________

or

DWAC Instructions:

Broker no: _________

Account no: ___________

 

  [HOLDER
     
  By:              
    Name:
    Title:

 

-11-

 

Exhibit 10.1

 

PREFERRED STOCK PURCHASE AGREEMENT

 

This Preferred Stock Purchase Agreement (this “Agreement”) is made as of May 22, 2020, by and among Gene Biotherapeutics, Inc. a Delaware corporation with its principal office at 11230 Sorrento Valley Road Suite #220, San Diego, CA 92122 (“CRXM” or the “Company”) and Nostrum Pharmaceuticals, LLC Delaware limited liability company with its principal office at 1370 Hamilton Street Somerset NJ, 08873 (“NPLLCor the “Purchaser”).

 

RECITALS

 

A. The Company has authorized the sale and issuance to the Purchaser of 1,700,000 shares (the “Shares”) of Series B Convertible Preferred Stock, $0.0001 par value per share, of the Company (the “Series B Preferred Stock”), in a private placement pursuant to an exemption from the registration requirements of Section 5 of the Securities Act (as defined below) contained in Section 4(a)(2) thereof and/or Regulation D thereunder.

 

B. The Company has created the Series B Preferred Stock by filing a Certificate of Designation of Preferences, Rights and Limitations relating to the Series B Preferred Stock (the “Series B Certificate of Designation”) with the Secretary of State of the State of Delaware in substantially the form annexed hereto as Exhibit A, prior to the execution and delivery of this Agreement. The Shares will be convertible into shares of common stock, $0.0001 par value per share, of the Company (the “Common Stock”) at an initial conversion ratio of .0113 and will have the other designations, relative rights, preferences and limitations set forth in the Series B Certificate of Designation.

 

C. The Company desires to sell to the Purchaser, and the Purchaser desires to purchase from the Company, the Shares on the terms and subject to the conditions set forth in this Agreement.

 

TERMS AND CONDITIONS

 

Now, therefore, in consideration of the foregoing recitals and the mutual covenants and agreements contained herein, the parties, intending to be legally bound, do hereby agree as follows:

 

1. Definitions and Interpretive Principles.

 

1.1 Definitions. Capitalized terms used in this Agreement, and not otherwise defined herein, shall have the meanings ascribed to such terms in Schedule A.

 

1.2 General Interpretive Principles. Whenever used in this Agreement, except as otherwise expressly provided or unless the context otherwise requires, any noun or pronoun shall be deemed to include the plural as well as the singular and to cover all genders. The name assigned this Agreement and the section captions used herein are for convenience of reference only and shall not be construed to affect the meaning, construction or effect hereof. Whenever the words “include,” “includes,” or “including” are used in this Agreement, they shall be deemed to be followed by the words “without limitation.” Unless otherwise specified, the terms “hereto,” “hereof,” “herein” and similar terms refer to this Agreement as a whole (including the exhibits, schedules and disclosure statements hereto), and references herein to Articles or Sections refer to Articles or Sections of this Agreement. The language used in this Agreement shall be deemed to be the language chosen by the parties hereto to express their mutual intent, and no rule of strict construction shall be applied against any Person.

 

-1-

 

 

2. Purchase of the Shares.

 

2.1 Agreement to Sell and Purchase. At the Closing (as hereinafter defined), the Company will issue and sell to the Purchaser, and the Purchaser will purchase from the Company, the Shares for an aggregate purchase price of $1,700,000 (the “Purchase Price”) or $1.00 for each Share.

 

2.2 Closing; Closing Date. The completion of the sale and purchase of the Shares (the “Closing”) shall be held simultaneously with the execution and delivery of this Agreement, or at such other time as the Company and the Purchaser may agree (the “Closing Date”).

 

2.3 Delivery of the Shares. At the Closing, subject to the terms and conditions hereof, the Company will deliver to the Purchaser a stock certificate or certificates dated the Closing Date representing the Shares, in such denominations and registered in such name(s) as the Purchaser may designate by written notice to the Company, (each such certificate is hereinafter referred to as a “Certificate”), against payment of the Purchase Price in cash in the form of a wire transfer to a bank designated in writing by the Company, unless other means of payment shall have been agreed upon by the Purchaser and the Company.

 

3. Representations and Warranties of the Company. The Company hereby represents and warrants to the Purchaser the following:

 

3.1 Authorization. All corporate action on the part of the Company, its officers, directors and shareholders necessary for the authorization, execution, delivery and performance of this Agreement and the transactions contemplated hereby including the authorization and filing of the Series B Certificate of Designation has been taken. The Company has heretofore received from its shareholders all required approvals necessary for the Company’s execution, delivery and performance of its obligations under this Agreement and the transactions contemplated hereby including the authorization and filing of the Series B Certificate of Designation. The Company has the requisite corporate power to enter into this Agreement and carry out and perform its obligations under this Agreement. At the Closing, the Company will have the requisite corporate power to issue and sell the Shares. This Agreement has been duly authorized, executed and delivered by the Company and, upon due execution and delivery by the Purchaser, this Agreement will be a valid and binding agreement of the Company, enforceable against the Company in accordance with its terms, except as rights to indemnity hereunder may be limited by federal or state securities laws and except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by equitable principles.

 

3.2 Valid Issuance; Reservation of Conversion Shares. The Shares, when issued, sold and delivered in accordance with the terms and for the consideration set forth in this Agreement, will be validly issued, fully paid and nonassessable and free from all taxes, liens, claims, encumbrances and charges with respect to the issue thereof; provided, however, that the Shares will be subject to restrictions on transfer under state and/or federal securities laws. The Conversion Shares, when issued and delivered in accordance with the terms of the Series B Certificate of Designation will be validly issued, fully paid and nonassessable and free from all taxes, liens, claims, encumbrances and charges with respect to the issue thereof; provided, however, that the Securities will be subject to restrictions on transfer under state and/or federal securities laws. Prior to the Closing, the Company will have filed with the Secretary of State of the State of Delaware, the Series B Certificate of Designation. The Company will, at all times while the Shares are outstanding, reserve for issuance a sufficient number of shares of Common Stock to accommodate the conversion in full of the then outstanding Shares. Not less than 150,442,478 shares of Common Stock have been duly reserved for issuance upon the conversion of the Shares.

 

-2-

 

 

3.3 No Conflict with Other Instruments. Except as set forth on Schedule 3.3, the execution, delivery and performance of this Agreement, the issuance and sale of the Shares to be sold by the Company hereunder and the consummation of the actions contemplated by this Agreement will not (A) result in any violation of, be in conflict with, or constitute a default under, with or without the passage of time or the giving of notice of: (i) any provision of the Company’s charter documents as in effect on the date hereof (as amended to include the Series B Certificate of Designation ); (ii) any provision of any Governmental Order to which the Company or any of its Subsidiaries are a party or by which they are bound; (iii), any bond, debenture, note or other evidence of indebtedness, or any lease, contract, mortgage, indenture, deed of trust, loan agreement, joint venture or other agreement, instrument or commitment to which the Company or any Subsidiary is a party or by which they or their respective properties are bound; or (iv) any Law applicable to the Company or any of its Subsidiaries; or (B) result in the creation or imposition of any Encumbrance upon any of the properties or assets of the Company or any of its Subsidiaries or any acceleration of indebtedness pursuant to any obligation, agreement or condition contained in any bond, debenture, note or any other evidence of indebtedness or any indenture, mortgage, deed of trust or any other agreement or instrument to which the Company or any of its Subsidiaries are a party or by which they are bound or to which any of the property or assets of the Company or any Subsidiary is subject. No consent, approval, authorization or other order of, or registration, qualification or filing with, any regulatory body, administrative agency, or other governmental body is required for the execution and delivery of this Agreement by the Company and the valid issuance or sale of the Securities by the Company pursuant to this Agreement, except for the filing of the Series B Certificate of Designation with the Delaware Secretary of State and the filing of a Form D or similar limited offering exemption form under applicable federal and state securities laws.

 

3.4 Certificate of Incorporation; Bylaws. The Company has made available to the Purchaser true, correct and complete copies of the Certificate of Incorporation and Bylaws of the Company, as in effect on the date hereof.

 

3.5 Organization, Good Standing and Qualification. The Company is a corporation duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as now conducted. The Company and each of its Subsidiaries has full power and authority to own, operate and occupy its properties and to conduct its business as presently conducted and is duly qualified to transact business and is in good standing in each jurisdiction where the ownership of its properties or conduct of its business makes such qualification to transact business necessary, except where the failure to be so qualified would not materially and adversely affect the business, operations or financial condition of the Company.

 

-3-

 

 

3.6 SEC Filings. The Company currently is, and since August 14, 2017 has been, delinquent with its filings with the SEC. As used herein, the “Company SEC Documents” means all reports, schedules, forms, statements and other documents filed or furnished, as applicable, by the Company under the Securities Act and/or the Exchange Act prior to August 14, 2017. None of the Company SEC Documents, when filed, contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary to make the statements therein in light of the circumstances under which they were made not misleading.

 

3.7 Financial Statements; Settlement of Claims.

 

(a) Complete copies of (i) the Company’s unaudited financial statements consisting of the balance sheet of the Company as at December 31 in each of the years 2018 and 2017 and the related statements of operations and cash flow for the years then ended (the “Annual Financial Statements”) and (ii) the Company’s unaudited financial statements consisting of the balance sheet of the Company as at May 31, 2019 and the related statement of income for the five (5) months then ended (the “Interim Financial Statements” and, together with the Annual Financial Statements, the “Financial Statements”). The Financial Statements are attached to Schedule 3.7(a). The balance sheet of the Company as of May 31, 2019 is referred to herein as the “Balance Sheet” and the date thereof as the “Balance Sheet Date”. The Financial Statements: (i) were prepared from the books and records of the Company; and (ii) fairly present the consolidated financial position of the Company and its Subsidiaries as of the respective dates thereof and the consolidated results of operations and cash flows of the Company and its Subsidiaries for the periods covered thereby.

 

(b) Schedule 3.7(b) sets forth a correct and complete list of all creditor claims against the Company.

 

(c) Schedule 3.7(c) sets forth a correct and complete list of all claims by employees and former employees of the Company for accrued and unpaid deferred salary.

 

3.8 Books and Records. The books, records and accounts of the Company and its subsidiaries accurately and fairly reflect, in reasonable detail, the transactions in, and dispositions of, the assets of, and the operations of, the Company and its subsidiaries.

 

3.9 Capitalization. The authorized capital stock of the Company, consists of (i) 200,000,000 shares of Common Stock of which (A) 14,489,399 shares are issued and outstanding as of the date of this Agreement, and (B) 19,188,222 shares are reserved for issuance upon the exercise or conversion, as the case may be, of the options, warrants or other convertible securities outstanding as of the date of this Agreement which are set forth on Schedule 3.9; and (ii) 40,000,000 shares of Preferred Stock, of which 790 shares of Series A Preferred Stock are issued and outstanding as of the date of this Agreement and no shares of Series A Preferred Stock are reserved for issuance as of the date of this Agreement. Schedule 3.9 sets forth, for each Subsidiary of the Company, the amount of its authorized capital stock or other equity or ownership interests, the amount of its outstanding capital stock or other equity or ownership interests, and the record and beneficial owners of its outstanding capital stock or other equity or ownership interests. All issued and outstanding shares of capital stock of the Company and each Subsidiary has been duly authorized and validly issued, are fully paid and non-assessable, have been issued and sold in compliance with the registration requirements of the federal and state securities laws, and were not issued in violation of any preemptive rights or similar rights to subscribe for or purchase securities. Except as set forth on Schedule 3.9, there are no (i) outstanding rights (including, without limitation, preemptive rights), warrants or options to acquire, or instruments convertible into or exchangeable for, any unissued shares of capital stock or other equity interest in the Company or any Subsidiary, or any contract, commitment, agreement, understanding or arrangement of any kind to which the Company or any Subsidiary is a party and relating to the issuance or sale of any capital stock or convertible or exchangeable security of the Company or any Subsidiary; or (ii) obligations of the Company or any Subsidiary to purchase redeem or otherwise acquire any of its outstanding capital stock or any interest therein or to pay any dividend or make any other distribution in respect thereof. Except as set forth on Schedule 3.9, there are no anti-dilution or price adjustment provisions, co-sale rights, registration rights, rights of first refusal or other similar rights contained in the terms governing any outstanding security of the Company that will be triggered by the issuance of the Securities and no person has any right to cause the Company to effect the registration under the Securities Act of any securities of the Company. No shares of capital stock or other equity or ownership interests of the Company or any of its Subsidiaries have been issued in violation of any rights, agreements, arrangements or commitments under any provision of applicable Law, the certificate of incorporation or bylaws or equivalent organizational documents of the Company or any of its Subsidiaries or any contract to which the Company or any of its Subsidiaries is a party or by which the Company or any of its Subsidiaries is bound.

 

-4-

 

 

3.10 Subsidiaries. Each Subsidiary of the Company is duly incorporated or organized, validly existing and in good standing under the laws of its jurisdiction of incorporation or organization and has all requisite power and authority to carry on its business as now conducted. Each Subsidiary of the Company is duly qualified to transact business and is in good standing in each jurisdiction where the ownership of its properties or conduct of its business makes such qualification to transact business necessary, except where the failure to be so qualified would not materially and adversely affect the business, operations or financial condition of the Company. Except for the Company’s ownership interest in the Subsidiaries, neither the Company nor any of its Subsidiaries directly or indirectly owns any equity, partnership, membership or similar interest in, or any interest convertible into, exercisable for the purchase of or exchangeable for any such equity, partnership, membership or similar interest, or is under any current or prospective obligation to form or participate in, provide funds to, make any loan, capital contribution or other investment in or assume any liability or obligation of, any Person. The Company has made available to the Purchaser true, correct and complete copies of the charter, bylaws or other organizational documents of each Subsidiary, as in effect on the date hereof.

 

3.11 Title to Assets. The Company has good and marketable title to all of the assets and properties which it purports to own including those assets and properties which are reflected on the Financial Statements, free and clear of all encumbrances, except for (a) liens for current taxes not yet due and payable or for taxes the validity of which is being contested in good faith by appropriate proceedings, and (b) encumbrances which individually or in the aggregate do not materially and adversely affect the business, operations or financial condition of the Company.

 

3.12 No Preemptive Rights. The issuance, sale and delivery of the Shares in accordance with the terms hereof and the issuance, sale and delivery of the Conversion Shares in accordance with the terms of the Series B Certificate of Designation will not be subject to preemptive rights of shareholders of the Company.

 

3.13 Offering. Assuming the accuracy of the representations of the Purchaser in this Agreement on the date hereof, the offer, issue and sale of the Securities are and will be exempt from the registration and prospectus delivery requirements of the Securities Act. Neither the Company, nor any of its affiliates, nor any person acting on its or their behalf, has directly or indirectly made any offers or sales of any security or solicited any offers to buy any security under circumstances that would require registration under the Securities Act of the issuance of the Securities to the Purchaser. The Company has not taken any action to sell, offer for sale or solicit offers to buy any securities of the Company which would bring the offer, issuance or sale of the Securities within the provisions of Section 5 of the Securities Act, unless such offer, issuance or sale was or shall be within the exemptions of Section 4 of the Securities Act.

 

3.14 Contracts. Except as set forth on Schedule 3.14, neither the Company nor any Subsidiary is a party to any Contract.

 

3.15 Litigation; Governmental Orders. Except as set forth on Schedule 3.15, (a) there are no Actions pending or, to the Company’s Knowledge, threatened against or by the Company or any of its Subsidiaries affecting any of their properties or assets (or by or against the Company, its Subsidiaries or any Affiliate thereof and relating to the Company or its Subsidiaries), and (b), no event has occurred or circumstances exist that may give rise to, or serve as a basis for, any such Action. There are no outstanding Governmental Orders and no unsatisfied judgments, penalties or awards against or affecting the Company, any of its Subsidiaries or any of their properties or assets.

 

3.16 Compliance with Laws. Neither the Company nor any of its Subsidiaries is in violation of its Certificate of Incorporation or Bylaws (or similar organizational documents). Except as set forth on Schedule 3.16, the Company and its Subsidiaries currently are, and in the past have been, conducting their business in compliance with all applicable Laws. Each of the Company and its Subsidiaries has all Permits necessary for the operation of the business of the Company and its Subsidiaries as currently conducted.

 

3.17 No Material Changes. Since December 31, 2018, there has been no material adverse change in the assets, liabilities, business, properties, operations, financial condition or results of operations of the Company or any of its Subsidiaries.

 

3.18 Undisclosed Liabilities. The Company has no Liabilities except (a) those which are adequately reflected or reserved against in the Balance Sheet as of the Balance Sheet Date, and (b) those which have been incurred in the ordinary course of business consistent with past practice of the Company since the Balance Sheet Date and which are not, individually or in the aggregate, material in amount.

 

-5-

 

 

3.19 Transactions With Affiliates. Except as set forth on Schedule 3.19, there are no Contracts or other transactions between or among (i) the Company or any of its Subsidiaries, on the one hand, and (ii) any officer, director, employee or present or former stockholder of the Company or any of its Subsidiaries (including any spouse, parent, sibling or descendants of any such natural persons, or trust or other entity in which any such natural persons or such other individuals owns or otherwise holds any beneficial interest in) or Affiliate of the Company, on the other hand.

 

3.20 Intellectual Property.

 

(a) The Company and each of its Subsidiaries has ownership or license or legal right to use, all patent, copyright, trade secret, know-how trademark, trade name customer lists, designs, manufacturing or other processes, computer software, systems, data compilation, research results or other proprietary rights set forth on Schedule 3.20(a) (collectively “Intellectual Property”).

 

(b) The Company and each of its Subsidiaries has taken all reasonable steps required in accordance with sound business practice and business judgment to establish and preserve its ownership of the Intellectual Property.

 

(c) To the Knowledge of the Company, the Intellectual Property does not infringe any intellectual property of any other Person. To the Knowledge of the Company, no other Person is infringing any rights of the Company or its Subsidiaries to the Intellectual Property.

 

(d) No Actions are pending or, to the Knowledge of the Company, threatened, which challenge the rights of the Company or any of its Subsidiaries to the use of the Intellectual Property. Except with respect to the licensed Intellectual Property identified on Schedule 3.20(f), the Company and each of its Subsidiaries is the exclusive owner of each item of Intellectual Property and has the right to use, free and clear of material claims or rights of other Persons, all of its Intellectual Property. Each item of Intellectual Property is validly existing and in full force and effect and will be validly existing and in full force and effect immediately following the Closing.

 

(e) Neither the Company nor any of its Subsidiaries is making unauthorized use of any confidential information or trade secrets of any Person. The activities of any of the employees or former employees on behalf of the Company or of any of its Subsidiaries do not violate and have not violated any Contracts or arrangements between such employees or former employees and third parties related to confidential information or trade secrets of third parties or that restrict any such employee’s engagement in business activity of any nature.

 

(f) Schedule 3.20(f) sets forth a true and complete list of all licenses or other agreements under which (i) the Company or any Subsidiaries employs rights in Intellectual Property, or (ii) the Company or any Subsidiaries has granted rights to others in Intellectual Property owned or licensed by the Company or any Subsidiaries. All of the licenses or other agreements set forth on Schedule 3.20(f), are in full force and effect, and there is no default and there exists no condition which, with the passage of time or otherwise, would constitute a default by the Company or any Subsidiaries of the Company with respect thereto.

 

-6-

 

 

3.21 Taxes. The Company and each of its Subsidiaries has filed all federal, state, local and foreign income and franchise tax returns and has paid all taxes shown as due thereon through the calendar year ended December 31, 2017. The Company has incurred significant net operating losses to date. The Company does not owe any federal, state, local or foreign income taxes for any period after December 31, 2017.

 

3.22 Transfer Taxes. On the Closing Date, all stock transfer or other taxes (other than income taxes) that are required to be paid in connection with the sale and transfer of the Securities hereunder will be, or will have been, fully paid or provided for by the Company and the Company will have complied with all laws imposing such taxes.

 

3.23 Investment Company. The Company (including its Subsidiaries) is not an “investment company” or an “affiliated person” of, or “promoter” or “principal underwriter” for an investment company, within the meaning of the Investment Company Act of 1940 and will not be deemed an “investment company” as a result of the consummation of the transactions contemplated by this Agreement.

 

3.24 Foreign Corrupt Practices. Neither the Company nor any of its Subsidiaries nor any director, officer, agent, employee or other Person acting on behalf of the Company or any of its Subsidiaries has, in the course of its actions for, or on behalf of, the Company or any of its Subsidiaries (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977; or (iv) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee.

 

3.25 Regulatory Compliance.

 

(a) The Company has obtained a Fast Track designation for the Phase 3 clinical investigation of Generx (Ad5FGF-4) cardiovascular angiogenic gene therapy (“Generx”).

 

(b) The Company and Angionetics, Inc. are in compliance with all FDA and similar state and local requirements applicable to (i) the testing and development of Generx and (ii) maintenance, compilation and filing of reports with regard to Generx.

 

(c) All of the studies and tests in relation to Generx conducted by or on behalf of Company and Angionetics, Inc. were, or are being, conducted in accordance with applicable Laws and in accordance with the prevailing scientific standards applicable to the conduct of such studies and activities. All required pre-clinical toxicology studies and non-clinical laboratory studies sponsored by or on behalf of Company, Angionetics, Inc. or otherwise conducted with respect to Generx have been, or are being, conducted in compliance with the FDA’s Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices in the United States. Each clinical trial conducted by or on behalf of Company and Angionetics, Inc. with respect to Generx was, or is being, conducted in accordance with its clinical trial protocol, and in compliance with all applicable Laws and Company has filed all required notices (and made available to Purchaser copies thereof) of adverse drug or product experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Company and Angionetics, Inc. with respect to Generx.

 

-7-

 

 

(d) The Company and Angionetics, Inc. are in compliance with all applicable reporting requirements, including applicable adverse event reporting requirements under applicable Law. All filings with and submissions to the FDA made by the Company and Angionetics, Inc. with regard to Generx were true, accurate and complete in all material respects as of the date made, and, to the extent required to be updated, as so updated remain true, accurate and complete in all material respects as of the date hereof and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not misleading. The Company has heretofore made available to the Purchaser correct and complete copies of all correspondence, filings and reports between the Company and the FDA with respect to Generx.

 

(e) The Company has not received any notice from the FDA alleging any violation of any Laws or Permits by the Company, or taking or threatening to take, any action to suspend clinical trials of Generx, or otherwise restrict the research or clinical study of Generx. There have been no adverse regulatory actions taken (or, to the Knowledge of the Company, threatened) by the FDA with respect to Generx. To Company’s Knowledge, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such actions.

 

(f) None of the Company nor its directors, officers, employees, agents, representatives or consultants are under investigation by the FDA.

 

(g) The Company has provided to the Purchaser correct and complete copies of all information relating to adverse drug experiences obtained or otherwise received by the Company or Angionetics, Inc. from any source with respect to Generx.

 

3.26 Takeover Statutes. The Board has taken all actions necessary so that the restrictions contained in Section 203 of the DGCL applicable to a “business combination” (as defined in Section 203) shall not apply to the transactions contemplated by this Agreement including the issuance of the Shares to the Purchaser and, to Company’s Knowledge, no other “fair price”, “moratorium”, “control share acquisition” or other similar anti-takeover law (collectively, “Takeover Laws”) are applicable to transactions between Purchaser and the Company.

 

3.27 No Brokers. No broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement based on arrangements made by the Company.

 

3.28 Full Disclosure. No representation or warranty by the Company in this Agreement and no statement contained in the Schedules to this Agreement or any certificate or other document furnished or to be furnished to Purchaser pursuant to this Agreement contains any untrue statement of a material fact, or omits to state a material fact necessary to make the statements contained therein, in light of the circumstances in which they are made, not misleading. To the Knowledge of the Company, there is no event or circumstance that the Company has not disclosed to Purchaser which could reasonably be expected to have a material adverse change in the assets, liabilities, business, properties, operations, financial condition or results of operations of the Company or any of its Subsidiaries.

 

-8-

 

 

4. Representations and Warranties of the Purchaser. The Purchaser hereby represents and warrants to the Company the following:

 

4.1 Organization, Good Standing and Qualification. The Purchaser is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware and has all requisite corporate power and authority to carry on its business as now conducted.

 

4.2 Due Execution. All company action on the part of the Purchaser, its officers, directors and members necessary for the authorization, execution, delivery and performance of this Agreement has been taken. The Purchaser has the requisite corporate power to enter into this Agreement and carry out and perform its obligations under this Agreement. This Agreement has been duly authorized, executed and delivered by the Purchaser and, upon due execution and delivery by the Company, this Agreement will be a valid and binding agreement of the Purchaser, enforceable against the Purchaser in accordance with its terms, except as rights to indemnity hereunder may be limited by federal or state securities laws and except as enforceability may be limited by bankruptcy, insolvency, reorganization, moratorium or similar laws affecting creditors’ rights generally or by equitable principles.

 

4.3 No Conflict with Other Instruments. The execution, delivery and performance of this Agreement and the consummation of the actions contemplated by this Agreement will not (A) result in any violation of, be in conflict with, or constitute a default under, with or without the passage of time or the giving of notice of: (i) any provision of the Purchaser’s charter documents as in effect on the date hereof; (ii) any provision of any Governmental Order to which the Purchaser is a party or by which it is bound; (iii) any bond, debenture, note or other evidence of indebtedness, or any lease, contract, mortgage, indenture, deed of trust, loan agreement, joint venture or other agreement, instrument or commitment to which the Purchaser is a party or by which its properties are bound; or (iv) any Law applicable to the Purchaser. No consent, approval, authorization or other order of, or registration, qualification or filing with, any Governmental Authority is required for the execution and delivery of this Agreement by the Purchaser.

 

4.4 No Brokers. No broker, finder or investment banker is entitled to any brokerage, finder’s or other fee or commission in connection with the transactions contemplated by this Agreement based on arrangements made by the Purchaser.

 

4.5 Investment Representations. In connection with the sale and issuance of the Securities, the Purchaser makes the following representations:

 

(a) Investment for Own Account. The Purchaser is acquiring the Securities for its own account, not as nominee or agent, and not with a view to, or for resale in connection with, any distribution or public offering thereof within the meaning of the Securities Act; provided, however, that by making the representations herein, the Purchaser does not agree to hold any of the Securities for any minimum or specific term and reserves the right to dispose of the securities at any time in accordance with or pursuant to a registration statement or an exemption from the registration requirements of the Securities Act.

 

-9-

 

 

(b) Financial Sophistication; Due Diligence. The Purchaser is familiar with the term “accredited investor” as defined in Rule 501(a) of Regulation D promulgated under the Securities Act and is an “accredited investor” within the meaning of such term. The Purchaser has such knowledge and experience in financial or business matters that it is capable of evaluating the merits and risks of the investment in connection with the transactions contemplated in this Agreement. The Purchaser has, in connection with its decision to purchase the Securities, relied only upon the representations and warranties contained herein. Further, the Purchaser has had such opportunity to obtain additional information and to ask questions of, and receive answers from, the Company, concerning the terms and conditions of the investment and the business and affairs of the Company, as the Purchaser considers necessary in order to form an investment decision.

 

5. Closing Deliverables.

 

5.1 Closing Deliverables of the Company. At the Closing, the Company shall deliver to Purchaser the following:

 

(a) the Certificate(s);

 

(b) a copy of resolutions adopted by the Board, certified by the Secretary of the Corporation, authorizing this Agreement and issuance of the Shares and appointing James Grainer and Kaushik Vyas as directors of the Company;

 

(c) evidence of filing of the Series B Certificate of Designation with the Secretary of State of the State of Delaware substantially in the form of Exhibit A attached hereto.;

 

(d) an opinion of legal counsel to the Company, dated as of the Closing Date, substantially in the form Exhibit B attached hereto;

 

(e) a letter executed by each creditor of the Company agreeing to settle the amount of such creditor’s claim against the Company for the settlement amount set forth on Schedule 3.7(b) on the terms and conditions substantially in the form of Exhibit C annexed hereto;

 

(f) a letter executed by each employee and former employee of the Company agreeing to defer such employee’s or former employee’s claim for accrued and unpaid deferred salary from the Company (all such letters are included in Exhibit D annexed hereto);

 

(g) a letter executed by each holder of Company warrants or options agreeing to waive any rights to anti-dilution adjustment with respect to such warrants or options as a result of the issuance and sale of the Securities to the Purchaser (all such letters are included in Exhibit E annexed hereto);

 

(h) letters from Leitch, Wallace, Zhang and Zhang resigning as officers and directors of the Company effective at the Closing Date;

 

-10-

 

 

(i) a Reaffirmation and Ratification Agreement between the Company and Shanxi Taxus Pharmaceuticals Co., Ltd. (Exhibit F-1 annexed hereto with respect to cancellation of the issuance of shares of Common Stock in consideration of $600,000 previously paid by Shenzhen Qianhai Taxus to the Company);

 

(j) a Distribution and License Agreement between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd., (Exhibit F-2 annexed hereto with respect to the Generx product candidate);

 

(k) Amendment No.1 to Distribution and License Agreement between Angionetics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd., (Exhibit F-3 annexed hereto with respect to the Generx product candidate);

 

(l) a License and Patent Assignment Agreement between Activation Therapeutics, Inc. and Shanxi Taxus Pharmaceuticals Co., Ltd., (Exhibit F-4 with respect to the Excellagen product);

 

(m) agreements with New York University and the University of California settling the amount of each such creditor’s claim against the Company for the amounts set forth on Exhibit C and otherwise on the terms and conditions contained in the form of Exhibit G annexed hereto;

 

(n) a good standing certificate (or its equivalent) from the Secretary of State of the State of Delaware for the Company and each of its Subsidiaries; and

 

(o) a duly executed counterpart of this Agreement.

 

5.2 Closing Deliverables of the Purchaser. At the Closing, the Purchaser shall deliver to Company the following::

 

(a) payment of the Purchase Price in cash in the form of a wire transfer; and

 

(b) a duly executed counterpart of this Agreement.

 

6. Additional Covenants.

 

6.1 SEC Filings. The Company has engaged Marcum, LLP (“Marcum”) to prepare the Company’s financial statements for the years ended December 31, 2017, 2018 and 2019 that are required to be filed with Securities and Exchange Commission (“SEC”) pursuant to the Exchange Act in order to cause the Company to become current with its reporting obligations. The expense incurred for such financial statement preparation, up to $120,000, will be paid by the Company from the proceeds of the sale of the Shares. It is understood that the Company is delinquent in its SEC reporting obligations and the Company and its officers and directors shall use their reasonable best efforts to assist Marcum so as to ensure that the Company becomes current with such obligations. Within four (4) Business Days after the Closing, the Company will file a current report on Form 8-K disclosing the change of control contemplated by this Agreement.

 

-11-

 

 

6.2 Further Assurances. Following the Closing, each of the parties hereto shall, and shall cause their respective Affiliates to, execute and deliver such additional documents, instruments, conveyances and assurances and take such further actions as may be reasonably required to carry out the provisions hereof and give effect to the transactions contemplated by this Agreement.

 

7. Indemnification.

 

7.1 Survival. The representations and warranties, covenants and agreements contained herein shall survive the Closing and shall remain in full force and effect following the Closing Date. Notwithstanding the preceding sentence, any representation or warranty in respect of which indemnity may be sought under this Agreement shall survive the time at which it would otherwise terminate pursuant to the preceding sentence, if notice of the inaccuracy or breach thereof giving rise to such right of indemnity shall have been given in reasonable detail to the party against whom such indemnity may be sought prior to such time.

 

7.2 Indemnification

 

(a) Indemnification By Company. Subject to the other terms and conditions of this Article VII, the Company shall indemnify and defend Purchaser and its Affiliates and their respective Representatives (collectively, the “Purchaser Indemnitees”) against, and shall hold each of them harmless from and against, and shall pay and reimburse each of them for, any and all Losses incurred or sustained by, or imposed upon, the Purchaser Indemnitees based upon, arising out of, with respect to or by reason of:

 

(i) any inaccuracy in or breach of any of the representations or warranties of the Company contained in this Agreement or in any certificate or instrument delivered by or on behalf of the Company pursuant to this Agreement; or

 

(ii) any breach or non-fulfillment of any covenant, agreement or obligation to be performed by the Company pursuant to this Agreement.

 

(b) Indemnification By Purchaser. Subject to the other terms and conditions of this Article VII, the Purchaser shall indemnify and defend the Company against, and shall hold the Company harmless from and against, and shall pay and reimburse the Company for, any and all Losses incurred or sustained by, or imposed upon, the Company based upon, arising out of, with respect to or by reason of:

 

(i) any inaccuracy in or breach of any of the representations or warranties of the Purchaser contained in this Agreement or in any certificate or instrument delivered by or on behalf of the Purchaser pursuant to this Agreement; or

 

(ii) any breach or non-fulfillment of any covenant, agreement or obligation to be performed by the Purchaser pursuant to this Agreement.

 

7.3 Procedures. The party seeking indemnification under Section 7.2 agrees to give reasonably prompt notice to the party against whom indemnity is sought of the assertion of any claim, or the commencement of any suit, action or proceeding in respect of which indemnity may be sought under such Section. The indemnifying party may at its election participate in and control the defense of any such suit, action or proceeding at its own expense; provided that the indemnified party may participate, at its own expense, in the defense of such claim. The indemnifying party shall not be liable under Section 7.2 for any settlement effected without its consent of any claim, litigation or proceeding in respect of which indemnity may be sought hereunder.

 

-12-

 

 

7.4 Certain Limitations. For purposes of this Article VII, any inaccuracy in or breach of any representation or warranty and the amount of a party’s Losses shall be determined without regard to any materiality, material adverse effect or other similar qualification contained in or otherwise applicable to such representation or warranty.

 

7.5 Payments. Once a Loss is agreed to by the Company and the Purchaser or finally adjudicated to be payable pursuant to this Article VII, the Company or the Purchaser, as the case may be, shall satisfy its obligations within five (5) Business Days of such agreement or final, non-appealable adjudication by wire transfer of immediately available funds.

 

7.6 Tax Treatment of Indemnification Payments. All indemnification payments made under this Agreement shall be treated by the parties as an adjustment to the Purchase Price for tax purposes, unless otherwise required by Law.

 

7.7 Effect of Investigation. Neither the representations, warranties and covenants of the Company, nor the right to indemnification of any Purchaser Indemnitee making a claim under this Article VII with respect thereto, shall be affected or deemed waived by reason of any investigation made by or on behalf of an Purchaser Indemnitee (including by any of its Representatives) or by reason of the fact that an Purchaser Indemnitee or any of its Representatives knew or should have known that any such representation or warranty is, was or might be inaccurate or by reason of an Purchaser Indemnitee’s waiver of any closing condition.

 

8. Miscellaneous.

 

8.1 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of New York, without regard to the choice of law provisions thereof, and the federal laws of the United States.

 

8.2 Jurisdiction. Except as otherwise expressly provided in this Agreement, the parties hereto agree that any suit, action or proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby may only be brought in a state or federal court of competent jurisdiction sitting in New York, New York and each of the parties hereby consents to the non-exclusive jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such suit, action or proceeding. Process in any such suit, action or proceeding may be served on any party anywhere in the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing, each party agrees that service of process on such party as provided in Section 8.10 shall be deemed effective service of process on such party.

 

8.3 Successors and Assigns. Except as otherwise expressly provided herein, the provisions hereof shall inure to the benefit of, and be binding upon, the successors, assigns, heirs, executors, and administrators of the parties hereto. Notwithstanding the foregoing, the Company may not assign this Agreement or any rights or obligations hereunder without the prior written consent of the Purchaser.

 

-13-

 

 

8.4 No Third Party Beneficiaries. This Agreement shall not confer any rights or remedies upon any Person other than the parties hereto and their respective heirs, personal legal representatives, successors and permitted assigns and the Purchaser Indemnitees.

 

8.5 Entire Agreement. This Agreement and the exhibits hereto, and the other documents delivered pursuant hereto, constitute the full and entire understanding and agreement among the parties with regard to the subjects hereof and no party shall be liable or bound to any other party in any manner by any representations, warranties, covenants, or agreements except as specifically set forth herein or therein.

 

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

 

8.7 Severability. In the event any provision of this Agreement shall be invalid, illegal, or unenforceable, it shall to the extent practicable, be modified so as to make it valid, legal and enforceable and to retain as nearly as practicable the intent of the parties, and the validity, legality, and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

 

8.8 Amendment and Waiver. Except as otherwise provided herein, any term of this Agreement may be amended and the observance of any term of this Agreement may be waived (either generally or in a particular instance, either retroactively or prospectively, and either for a specified period of time or indefinitely), with the written consent of the Company and the Purchaser.

 

8.9 Fees and Expenses. Except as otherwise set forth herein, the Company and Purchaser shall each bear its own expenses and legal fees incurred in connection with the negotiation, execution, delivery and performance of this Agreement. The Company will pay up to $75,000 of the Company’s legal and other expenses with respect to this Agreement and the transactions contemplated hereby from the proceeds of the sale of the Shares.

 

8.10 Notices. All notices, requests, consents and other communications hereunder shall be in writing, shall be delivered, if within the United States, by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, and shall be addressed as follows, or to such other address or addresses as may have been furnished in writing by a party to another party pursuant to this paragraph:

 

  if to the Company, to the address of the Company’s principal office set forth on the first page of this Agreement, Attention: Christopher Reinhard Chief Executive Officer, e-mail: creinhard@angionetics.com with a copy to Jamie Mercer, JMercer@sheppardmullin.com.
     
  if to the Purchaser, to the address of the Purchaser’s principal office set forth on the first page of this Agreement with a copy to Carlton Asher, Esq., asherlaw@att.net 110 E. 59th Street New York, New York 10022.

 

8.11 Counterparts. This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. Delivery of a signed Agreement by reliable electronic means, including facsimile, email, or any electronic signature complying with the U.S. federal ESIGN Act of 2000 (including DocuSign) shall be an effective method of delivering the executed Agreement. This Agreement may be stored by electronic means and either an original or an electronically stored copy of this Agreement can be used for all purposes, including in any proceeding to enforce the rights and/or obligations of the parties to this Agreement.

 

[The Remainder of this Page is Blank; Signature Pages Follow]

 

-14-

 

 

In witness whereof, the foregoing Preferred Stock Purchase Agreement is hereby executed as of the date first above written.

 

  Gene Biotherapeutics, Inc.
   
  By: /s/ Christopher Reinhard
  Name: Christopher Reinhard
  Title: Chief Executive Officer

 

-15-

 

 

In witness whereof, the foregoing Preferred Stock Purchase Agreement is hereby executed as of the date first above written.

 

  Nostrum Pharmaceuticals LLC
  Name of Investor
   
  By: /s/ Nirmal Mulye
  Name: Nirmal Mulye, Phd
  Title: President

 

-16-

 

 

Schedule A

 

Definitions

 

Action” means any claim, action, cause of action, demand, lawsuit, arbitration, inquiry, audit, notice of violation, proceeding, litigation, citation, summons, subpoena or investigation of any nature, civil, criminal, administrative, regulatory or otherwise, whether at law or in equity.

 

Affiliate” of a Person means any other Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with, such Person. The term “control” (including the terms “controlled by” and “under common control with”) means the possession, directly or indirectly, 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 .

 

Board” means the board of directors of the Company.

 

Business Day” means any day except Saturday, Sunday or any other day on which commercial banks located in New York, New York are authorized or required by Law to be closed for business.

 

Contracts” means all contracts, leases, deeds, mortgages, licenses, instruments, notes, loans, commitments, undertakings, indentures, joint ventures and all other agreements, commitments and legally binding arrangements, whether written or oral.

 

Conversion Shares” means the shares of Common Stock into which the Shares shall be convertible.

 

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

 

Dollars or $” means the lawful currency of the United States.

 

Encumbrance” means any charge, claim, community property interest, pledge, condition, equitable interest, lien (statutory or other), option, security interest, mortgage, easement, encroachment, right of way, right of first refusal, or restriction of any kind, including any restriction on use, voting, transfer, receipt of income or exercise of any other attribute of ownership.

 

FDA” means the U.S. Food and Drug Administration of the United States Department of Health and Human Services or any successor agency thereof performing similar functions.

 

FDCA means the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder.

 

Governmental Authority” means any federal, state, local or foreign government or political subdivision thereof, or any agency or instrumentality of such government or political subdivision, or any self-regulated organization or other non-governmental regulatory authority or quasi-governmental authority (to the extent that the rules, regulations or orders of such organization or authority have the force of Law), or any arbitrator, court or tribunal of competent jurisdiction.

 

-17-

 

 

Governmental Order” means any order, writ, judgment, injunction, decree, stipulation, determination or award entered by or with any Governmental Authority.

 

Knowledge of the Company or the Company’s Knowledge” or any other similar knowledge qualification, means the actual or constructive knowledge of any director or officer of the Company, after due inquiry.

 

Law” means any statute, law, ordinance, regulation, rule, code, order, constitution, treaty, common law, judgment, decree, other requirement or rule of law of any Governmental Authority.

 

Losses” means losses, damages, liabilities, deficiencies, Actions, judgments, interest, awards, penalties, fines, costs or expenses of whatever kind, including reasonable attorneys’ fees and the cost of enforcing any right to indemnification hereunder and the cost of pursuing any insurance providers; provided, that “Losses” shall not include punitive damages, except in the case of fraud or to the extent actually awarded to a Governmental Authority or other third party.

 

Permits” means all permits, licenses, franchises, approvals, authorizations, registrations, certificates, variances and similar rights obtained, or required to be obtained, from Governmental Authorities.

 

Person” means an individual, corporation, partnership, joint venture, limited liability company, Governmental Authority, unincorporated organization, trust, association or other entity.

 

Representative” means, with respect to any Person, any and all directors, officers, employees, consultants, financial advisors, counsel, accountants and other agents of such Person.

 

SEC” means the U.S. Securities and Exchange Commission.

 

Securities” means, collectively, the Shares and the Conversion Shares.

 

Securities Act” means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.

 

“Subsidiary” means the following subsidiaries of the Company: Angionetics, Inc. a Delaware corporation and Activation Therapeutics, Inc. a Delaware corporation.

 

-18-

 

 

Exhibit 10.2 

 

REAFFIRMATION AND RATIFICATION AGREEMENT

 

April 10, 2020

GENE BIOTHERAPEUTICS, iNC.
11568 Sorrento Valley Road
Suite Fourteen
San Diego, CA 92121

 

Ladies and Gentlemen:

 

Shanxi Taxus Pharmaceuticals Co., Ltd. (“Shanxi”) executed and delivered to Gene Biotherapeutics, Inc. (“Company”) a Restructuring Plan Settlement Letter dated December 19, 2019 (“Letter Agreement”) pursuant to which Shanxi agreed to cancel its $600,000 equity subscription with respect to the Company and treat the payment as an upfront license fee on the Excellagen and Generx licenses described in the Letter Agreement.

 

Concurrently herewith, Shanxi and Activation Therapeutics, Inc., a wholly-owned subsidiary of the Company (“Activation”), are entering into a certain Tri-Party Excellagen Agreement with respect to Excellagen (the “Excellagen License Agreement”) and Shanxi and Angionetics, Inc., a majority-owned subsidiary of the Company (“Angionetics”), are entering into a certain Distribution and License Agreement with respect to Generx (the “Generx License Agreement and, together with the Excellagen License Agreement, the “Definitive License Agreements”). To induce the Company to cause Activation and Angionetics to enter the Definitive License Agreements, Shanxi for and on behalf of itself and its present or former parents, subsidiaries, affiliates, officers, managers, members, successors and assigns (“Releasor Parties”) hereby:

 

(a) acknowledges, ratifies, reaffirms and confirms that any and all rights, agreements, arrangements or commitments of any kind or character relating to the capital stock of the Company or any of its subsidiaries (including without limitation, Angionetics and Activation) or obligating the Company or any of its subsidiaries (including, without limitation, Angionetics and Activation) to issue or sell any shares of capital stock of, or any other interest in, the Company or such subsidiary, are terminated and cancelled without any further force or effect; and

 

(b) releases, remises, acquits and forever discharges the Company, Angionetics, Activation, their subsidiaries and affiliates and each of their respective employees, agents, representatives, consultants, attorneys, fiduciaries, officers, directors, partners, predecessors, successors and assigns, subsidiary corporations, parent corporations, and related corporate divisions (all of the foregoing hereinafter called the “Released Parties”), from any and all actions and causes of action, judgments, executions, suits, debts, claims, demands, liabilities, obligations, damages and expenses of any and every character, known or unknown, direct and/or indirect, at law or in equity, of whatsoever kind or nature (the “Claims”), for or because of any matter or things done, omitted or suffered to be done by any of the Released Parties prior to and including the date of execution hereof, whether such Claims are matured or unmatured or known or unknown, excluding Claims arising out of a breach of any representations warranties or covenants contained in the Definitive License Agreements.

 

 

 

 

It is the intention of Shanxi that this letter agreement and the release set forth above shall constitute a full and final accord and satisfaction of all Claims they may have or hereafter be deemed to have against the Released Parties as set forth herein. In furtherance of this intention, Shanxi expressly waives any statutory or common law provision that would otherwise prevent the release set forth above from extending to Claims that are not currently known or suspected to exist in any Releasor’s favor at the time of executing this letter agreement and which, if known by Releasors or any of them, might have materially affected the agreement set forth herein. In furtherance of this intention, Shanxi hereby expressly waives any and all rights and benefits conferred upon you by Section 1542 of the California Civil Code, which provides:

 

A general release does not extend to claims which the creditor or releasing party does not know or suspect to exist in his or her favor at the time of executing the release, which if known by him or her must have materially affected his or her settlement with the debtor or released party.

 

Shanxi understands, acknowledges and agrees that (a) the release set forth above may be pleaded as a full and complete defense and may be used as a basis for an injunction against any action, suit or other proceeding which may be instituted, prosecuted or attempted in breach of the provisions of such release; (b) no fact, event, circumstance, evidence or transaction which could now be asserted or which may hereafter be discovered shall affect in any manner the final, absolute and unconditional nature of the release set forth above; and (c) it will not sue (at law, in equity, in any regulatory proceeding or otherwise) any Released Party on the basis of any Claim waived, released and discharged by such Releasor Party in this letter agreement. If a Releasor Party or any of its successors, assigns or other legal representatives violates the covenant set forth in above, Shanxi agrees to pay, in addition to such other damages as any Released Party may sustain as a result of such violation, all attorneys’ fees and costs incurred by any Released Party as a result of such violation

 

[Remainder of Page Intentionally Left Blank]

 

 

 

 

This Reaffirmation and Ratification Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective heirs, administrators, executors, successors and assigns and shall be governed by and construed in accordance with the laws of the State of New York. Any signature delivered by a party by facsimile or electronic transmission shall be deemed to be an original signature hereto.

 

  Very truly yours,
   
  SHANXI TAXUS PHARMACEUTICALS CO., LTD.
   
  BY: /s/ Jiayue Zhang               
  NAME: Jiayue Zhang
  TITLE: Chairman and President

 

  Accepted and Agreed as of             , 2020:
   
  GENE BIOTHERAPEUTICS, INC.
   
  BY: /s/ Christopher Reinhard            
  NAME: Christopher Reinhard
  TITLE : Chief Executive Officer

 

 

 

 

 

 

 

Exhibit 10.3

 

DISTRIBUTION AND LICENSE AGREEMENT

 

THIS DISTRIBUTION AND LICENSE AGREEMENT (“Agreement”) dated as of April 10, 2020, is entered into between Angionetics Inc., a Delaware corporation having its principal place of business at 11568 Sorrento Valley Rd., Suite 14, San Diego, CA 92121 (“Angionetics”), a wholly-owned subsidiary of Gene Biotherapeutics, Inc., and Shanxi Taxus Pharmaceuticals Co., Ltd. (“Licensee”).

 

BACKGROUND

 

A. Angionetics is developing an angiogenic gene therapy treatment, known as Generx (as further defined below, the “Product”), Angionetics owns or controls certain know-how relating to such Product;

 

B. Licensee desires to manufacture Products in mainland China and to market and sell Products in the Territory (defined below), and Angionetics will provide the Licensee with certain rights to manufacture Products in mainland China and market and sell Products in the Territory (which excludes mainland China), all in accordance with this Agreement.

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and intending to be legally bound, the Parties hereby agree as follows:

 

ARTICLE 1

 

DEFINITIONS

 

1.1 “Affiliate” of a Party shall mean any person, corporation or other entity that, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party, as the case may be, for as long as such control exists. With respect to Licensee, Affiliate includes a company or other entity that is controlled by, or under common control with Shanxi Taxus Pharmaceuticals Co., Ltd., Taxus Pharmaceuticals, Inc. or Jiaye Zhang. As used in this Section 1,1, “control” shall mean: (a) to possess, directly or indirectly, the power to direct the management and policies of such person, corporation or other entity, whether through ownership of voting securities or by contract relating to voting rights or corporate governance; or (b) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage that is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital in such person, corporation or other entity.

 

1.2 “Angionetics IP Rights” shall mean the Angionetics Know-How and Angionetics Patents, including the Angionetics IP Rights in existence as of the Effective Date and set forth in Exhibit 1.2.

 

1.3 “Angionetics Know-How” shall mean all scientific, medical, technical, regulatory, manufacturing and other information relating to the Product (including Data): (a) to the extent Controlled by Angionetics or its Affiliates as of the Effective Date or during the term of this Agreement, and (b) that are necessary for Licensee to exercise its rights or perform its obligations under this Agreement.

 

-1-

 

 

1.4 “Angionetics Patents” shall mean all unexpired, non-abandoned, and otherwise enforceable Patents: (a) to the extent Controlled by Angionetics or its Affiliates during the term of this Agreement and (b) that would, but for the license granted hereunder, be infringed by use, development, manufacture, formulation, packaging, import, sale, distribution, promotion or marketing of the Product, for the purposes of use and/or sale in the Territory. As of the date of this Agreement (as set forth in the first sentence of the preamble), there are no Angionetics Patents.

 

1.5 “Applicable Laws” means the applicable provisions of any and all national, supranational, regional, state and local laws, treaties, statutes, rules, regulations, administrative codes, guidances, ordinances, judgments, decrees, directives, injunctions, orders, permits (including Marketing Approvals) of or from any court, arbitrator, Regulatory Authority or governmental agency or authority having jurisdiction over or related to the subject item.

 

1.6 “BLA” shall mean a biologic license application (or its equivalent) submitted to the applicable Regulatory Authority (e.g., the applicable food and drug administration in China or the Licensed Territory).

 

1.7 “CFDA” shall mean the China Food and Drug Administration, or any successor entity thereto performing similar functions.

 

1.8 “Commercially Reasonable Efforts” shall mean, with respect to the efforts to be expended by a Party with respect to any objective, those reasonable, good faith efforts to accomplish such objective as such Party would normally use to accomplish a similar objective under similar circumstances; Licensee will be deemed to have exercised Commercially Reasonable Efforts if Licensee has exercised those efforts normally used by a pharmaceutical or biotechnology company of similar size and similar resources, with respect to a compound, product or product candidate, as applicable of similar modality, which compound, product or product candidate is of similar market potential in such country, and is at a similar stage in its development or product life cycle, taking into account all relevant factors in effect at the time such efforts are to be expended. It is expressly understood that the use of Commercially Reasonable Efforts may result in ceasing the development, Regulatory Approval or commercialization of Products. Further, to the extent that the performance of a Party’s obligations hereunder is adversely affected by the other Party’s failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such Party has used its Commercially Reasonable Efforts to perform any such affected obligations.

 

1.9 “Compound” means Ad5FGF-4, alferminogene tadenovec, an angiogenic gene therapeutic, and natural evolutions thereof.

 

1.10 “Control” (including any variations such as “Controlled” and “Controlling”) shall mean, in the context of intellectual property rights, Data or information, possession of the ability to grant an assignment, license or sublicense to such intellectual property rights, Data and/or information, and/or to disclose and deliver such Data and/or information, as the case may be, of or within the scope set forth in this Agreement, without violating the terms of any agreement or other arrangement with any Third Party.

 

-2-

 

 

1.11 “Data” shall mean any and all research data, pharmacology data, preclinical data, clinical data and/or all regulatory documentation, information and submissions pertaining to, or made in association with an IND, Marketing Approval Application, Marketing Approval or the like for, the Compound or a Product, in each case that are Controlled by a Party as of the Effective Date or during the term of this Agreement. Data also shall include any such data generated by or under authority of Licensee or its Affiliates during the term of this Agreement.

 

1.12 “DLA” shall mean that certain Distribution and License Agreement by and between Angionetics and Pineworld Capital Limited, an Affiliate of Huapont.

 

1.13 “Effective Date” shall mean the date that both of the following conditions have been satisfied: (a) Angionetics obtains Huapont Consent (defined below); and (b) Angionetics obtains U.S. FDA approval for marketing and sale of the Compound in the United States.

 

1.14 “Field” shall mean a treatment for patients with refractory angina, with myocardial ischemia, and other adverse medical conditions resulting from cardiac microvascular insufficiency.

 

1.15 “First Commercial Sale” shall mean the first bona fide, arm’s length sale of a Product in the Territory following receipt of Marketing Approval of such Product anywhere in the Territory.

 

1.16 “First Royalty Term” shall mean the period of time commencing on the date of the First Commercial Sale and continuing until and including the later to occur of: (a) the expiration date of the last to expire of all Angionetics Patents covering the manufacture, use or sale of the Products, in each case, anywhere in the world; (b) the expiration date of Regulatory Exclusivity in the any jurisdiction within the Territory; and (c) the date that is fifteen (15) years after the date of the First Commercial Sale.

 

1.17 “Huapont” shall mean Huapont Life Sciences Co. Ltd.

 

1.18 “Huapont Consent” shall mean Huapont’s written acknowledgement, on behalf of itself and Pineworld, that this Agreement, including the license grant herein and both Parties’ exercise of rights and/or fulfilment of obligations set forth herein, does not breach the DLA or otherwise infringe, violate, limit, or otherwise encroach upon or contradict the rights granted to Pineworld Capital Limited under the DLA.

 

1.19 “IND” shall mean any Chinese or other application country filing with the CFDA or the applicable other Regulatory Agency that is comparable to an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 C.F.R. §321 before the commencement of clinical trials of a Product.

 

1.20 “Marketing Approval” shall mean all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country, excluding any governmental pricing and/or reimbursement approvals and/or authorizations.

 

-3-

 

 

1.21 “Marketing Approval Application” shall mean any application for a Marketing Approval.

 

1.22 “Net Proceeds” shall mean payments received by Licensee from a Third Party in exchange for the Sublicense of rights under this Agreement, in the form of cash or securities, in consideration for and to the extent reasonably allocable to grant of such Sublicense, after deducting all documented Product clinical and commercial development costs paid by Licensee during such period. For clarity, Net Proceeds will not include: (a) bona fide loans; (b) amounts paid for securities sold to a Sublicensee at fair market value; and (c) amounts received in connection with a merger, consolidation or sale of substantially all of the business or assets of Licensee.

 

1.23 “Net Sales” shall mean the cumulative gross amount billed or invoiced by Licensee, its Affiliates and/or Sublicensees for all sales of Products to Third Party customers in bona fide arm’s length transactions, less reasonable and customary deductions allowed to the Third Party customer by the selling party, to the extent actually taken by such Third Party, on such sales for:

 

(a) quantity, trade, cash or other discounts, allowances, credits or rebates (including customer rebates);

 

(b) amounts deducted, repaid or credited by reason of rejections or returns of goods and government mandated rebates, or because of chargebacks or retroactive price reductions;

 

(c) charges for freight, handling, postage, transportation, insurance and other shipping charges to the extent related to the transfer of Products and separately identified on the invoice or other documentation maintained in the ordinary course of business; and

 

(d) taxes, tariffs, duties or other governmental charges or assessments (including any sales, value added or similar taxes other than an income tax) imposed on the importation or sale of Products to Third Parties and separately identified on the invoice or other documentation maintained in the ordinary course of business.

 

To the extent applicable, components of Net Sales shall be determined in the ordinary course of business in accordance with historical practice and using the accrual method of accounting in accordance with generally accepted accounting principles in the Territory. For the purposes of calculating Net Sales, the Parties understand and agree that (i) sales between Licensee and its Affiliates for resale shall be excluded from the computation of Net Sales and no payments will be payable on such sales except where such Affiliates are end users; and (ii) Net Sales shall not include Products distributed for product development purposes, including for use in clinical trials, or for compassionate use programs. If a Product is sold or transferred for consideration other than cash, the Net Sales from such sale or transfer shall be deemed the then fair market value of such Product.

 

1.24 “Party” shall mean Angionetics or Licensee individually, and “Parties” shall mean Angionetics and Licensee collectively.

 

-4-

 

 

1.25 “Patent(s)” shall mean any patents and patent applications (whether provisional or nonprovisional), together with all additions, divisions, continuations, continuations-in-part, substitutions, reissues, re-examinations, extensions, registrations, patent term extensions, supplemental protection certificates and renewals of any of the foregoing.

 

1.26 “Product” shall mean any biopharmaceutical product containing the Compound, alone or in combination with one or more other active pharmaceutical ingredients, in any dosage form or formulation, including any lyophilized forms thereof. For the avoidance of doubt, Compound by itself constitutes Product.

 

1.27 “Regulatory Authority” shall mean the CFDA, or a regulatory body with similar regulatory authority in any other jurisdiction.

 

1.28 “Regulatory Exclusivity” shall mean any exclusive marketing rights or data exclusivity rights conferred by an applicable Regulatory Authority or other governmental authority in the Territory, including any regulatory data protection exclusivity and any extensions to such exclusivity rights.

 

1.29 “Second Royalty Term” shall mean the period of time commencing on the day after the last day of the First Royalty Term and continuing in perpetuity.

 

1.30 “Sublicensee” shall mean a Third Party, other than a distributor, that has been granted by Licensee a right to sell, market, distribute and/or promote a Product under the grants in Section 2.1; and “Sublicense” shall mean an agreement or arrangement granting such rights. As used in this Agreement, “Sublicensee” shall not include a wholesaler or reseller of the Product who does not market or promote the Product.

 

1.31 “Territory” shall mean Singapore, Macau, Hong Kong, Taiwan, any other municipality, other than mainland China, in each instance, where Chinese (Mandarin or Cantonese) is the common language, the Russian Federation and the Commonwealth of Independent States (i.e., Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Tajikistan, Turkmenistan, and Uzbekistan).

 

1.32 “Third Party” shall mean any person, corporation, joint venture or other entity, other than Angionetics, Licensee and their respective Affiliates.

 

ARTICLE 2

 

GRANT OF LICENSE

 

2.1 License. On the Effective Date and subject to the terms and conditions of this Agreement, Angionetics hereby grants to Licensee and its Affiliates a royalty-bearing right and license under the Angionetics IP to:

 

(a) develop, use, demonstrate, sell, offer for sale, market, distribute, and promote Products in the Territory for use in the Field,

 

(b) import Products into the Territory for use in the Field; and

 

-5-

 

 

(c) test and conduct independent Phase 3 clinical studies/trials on or Products in in the Territory (subject to Section 4.2); and

 

(d) manufacture, have manufactured, the Products solely in mainland China solely for use in the Territory and in the Field.

 

Notwithstanding anything herein to the contrary, all rights and licenses granted hereunder shall commence solely on the Effective Date. Licensee shall bear any and all costs necessary to exploit any and all licensed rights granted hereunder, including all costs associated with clinical studies/trials.

 

2.2 Affiliates; Sublicensees. Licensee shall have the right, in accordance with this Section 2.2, to extend the licenses granted under Section 2,1 above to its Affiliates, solely for so long as such entity remains an Affiliate of Licensee. Licensee shall not have the right to grant sublicenses under the license granted to Licensee under Section 2.1, without the prior written consent of Angionetics, which granted, withheld or delayed in the sole discretion of Angionetics. Licensee shall ensure that each of its Affiliates and sublicensees is bound by a written agreement containing provisions at least as protective of the Compound, Products and Angionetics as contained in this Agreement. In any event, Licensee shall remain responsible to Angionetics for all activities of its Affiliates and sublicensees to the same extent as if such activities had been undertaken by Licensee itself. For the avoidance of doubt, any extensions and sublicenses granted hereunder by Licensee shall automatically terminate upon the expiration or termination of this Agreement.

 

2.3 Activities Outside the Territory. Neither Licensee nor its Affiliates will develop, file for Marketing Approval with respect to, use, make, have made, market, import, export, distribute, promote or sell the Product (nor assist or facilitate any Third Party in doing any of the foregoing) anywhere in the world, except in the Territory.

 

2.4 No Other Rights. Except for the rights and licenses expressly granted in this Agreement, Angionetics retains all rights under its intellectual property including the Angionetics IP Rights, and no additional rights shall be deemed granted to Licensee by implication, estoppel or otherwise. For clarity, the licenses and rights granted in this Agreement shall not be construed to convey any licenses or rights under the Angionetics Patents with respect to any active pharmaceutical ingredient other than the Compound.

 

2.5 Exclusivity. The license rights granted to Licensee under Sections 2.1(a)-(c) are exclusive (including to the exclusion of Angionetics) during the First Royalty Term and non-exclusive during the Second Royalty Term. During the First Royalty Term of this Agreement, Angionetics agrees that neither it, nor any of its Affiliates, nor any Third Parties appointed by Angionetics or its Affiliates, will promote, distribute, sell or provide the Compound, the Product or any competing products in the same Field for use in the Territory. The license rights granted to Licensee under Section 2.1(d) are non-exclusive throughout the term (i.e., during both the First Royalty Term and the Second Royalty Term).

 

-6-

 

 

ARTICLE 3

 

GOVERNANCE

 

3.1 Joint Steering Committee.

 

(a) Within 30 days after the Effective Date, the Parties shall establish a committee (the “Joint Steering Committee” or “JSC”) to oversee the manufacturing of the Product in mainland China; the independent Phase 3 clinical studies on Products in the Territory; and the Marketing Approval, and commercialization of the Products in the Territory.

 

(b) Composition. The JSC will consist of two (2) representatives from each Party, and at least one representative from each Party shall be a vice president or director level employee of such Party. In case a representative of a Party is unavailable for a scheduled JSC meeting, upon reasonable notice to the other Party, such Party may substitute in place of such representative for such meeting, a competent person who is authorized by such Party to act on matters that will be presented to the JSC at such meeting. Either Party may also replace its respective JSC representatives at any time with prior notice to the other Party; provided that the criteria for composition of the JSC set forth in the first sentence of this Section 3.1(a) continues to be satisfied following any such replacement.

 

(c) Meetings. The JSC shall meet at least once each calendar quarter during the term of this Agreement, unless otherwise agreed by the Parties or such other frequency as Parties reasonably mutually agree. Such meeting(s) shall be conducted via teleconference, video conference, in person, or by other mutually agreeable means. At the discretion of each Party, other representatives of Angionetics or Licensee may attend JSC meetings as non-voting observers. Each Party shall bear its own personnel and travel costs and expenses relating to such Party’s participation in JSC meetings.

 

(d) Responsibility. The JSC will; (a) serve as a forum for keeping each Party informed as to material matters described in subsection 3.1(a); (b) serve as a forum for keeping each Party informed as to material matters in connection with the regulatory filings for Product in China and in the Territory; (c) facilitate the exchange of Data and other information and/or materials between the Parties; (d) review and approve manufacturing plans for the Product in mainland China for use and/or sale in the Territory; and (e) undertake and/or approve such other matters as are provided for the JSC under this Agreement, or otherwise agreed by the Parties.

 

(e) Decisions. The objective of the JSC shall be to seek to reach unanimous agreement on all matters. Each Party shall have one (1) vote on the JSC. If the JSC cannot reach agreement on any determination or decision within the scope of the JSCs authority within thirty (30) days after the date such matter was initially referred to the JSC, the dispute shall be referred to the CEO of Angionetics and the CEO of Licensee (the “Senior Executives”) who shall meet promptly and negotiate in good faith to resolve the dispute. If, despite such good faith efforts, the Parties are unable to resolve such dispute, then the dispute will be resolved in accordance with Article 14.

 

-7-

 

 

(f) Scope of Governance. Notwithstanding the creation of the JSC, each Party shall retain the rights, powers and discretion granted to it hereunder, and the JSC shall not be delegated or vested with such rights, powers or discretion unless such delegation or vesting is expressly provided herein or the Parties expressly so agree in writing. The JSC shall not have the power to amend or modify this Agreement or expand the scope of Article 2, and its decisions shall not be in contravention of any terms and conditions of this Agreement. It is understood and agreed that issues to be formally decided by the JSC are only those specific issues that are expressly provided in this Agreement to be decided by the JSC.

 

3.2 Withdrawal. Notwithstanding Section 3.1 above, it is understood that Angionetics’ participation in the JSC is not an obligation of, or a deliverable to be provided by, Angionetics under this Agreement and that such participation is a right of Angionetics that Angionetics may exercise or waive, in its discretion. At any time and for any reason, Angionetics shall have the right to withdraw from participation in the JSC upon notice to Licensee referencing this Section 3.2, which notice shall be effective immediately upon receipt (“Withdrawal Notice”). Following the issuance of a Withdrawal Notice, any plans (including development plans and commercialization plans), information, materials, know-how and/or other item that either Party is obligated to provide to the JSC shall be provided directly to the other Party and any decisions to be made by the JSC shall be made by the mutual agreement of both Parties, except that, if the Parties are unable to mutually agree following escalation of a matter to Senior Executives in accordance with Section 3.1(e) above, then the dispute will be resolved in accordance with Article 14.

 

ARTICLE 4

 

QUALITY; DEVELOPMENT; REGULATORY; COMMERCIALIZATION

 

4.1 Quality.

 

(a) All Compounds and Products manufactured hereunder will be manufactured in accordance with standards of and approvals of CFDA, the U.S. FDA and any other applicable Regulatory Agency and Licensee will permit all applicable Regulatory Agencies and other governing and applicable health authorities to access its manufacturing facilities for the purpose of routine inspections.

 

4.2 Development.

 

(a) In the Territory. As between the Parties, Licensee shall be responsible for and shall use Commercially Reasonable Efforts to conduct such clinical and or formulation studies/trials and to obtain such regulatory approvals, including Marketing Approvals and pricing and/or reimbursement approvals, as may be necessary to manufacture Product in mainland China and commercialize Product for at least one indication in the Territory and in the Field, including the responsibility to conduct independent Phase 3 clinical studies in the Territory. Notwithstanding anything herein to the contrary, all such studies are subject to review and pre-approval by Angionetics and will be consistent in design with the Angionetics planned U.S. FDA cleared Phase 3 study. Licensee agrees to keep Angionetics reasonably informed as to the progress of its manufacturing activities relating to Product in mainland China and clinical development, and regulatory activities relating to Product in the Territory, including its correspondence and meetings with Regulatory Authorities. It is understood and agreed that all development and manufacturing efforts for the Product for use in the Territory shall be at the sole cost and expense of Licensee at Licensee’s sole discretion.

 

-8-

 

 

(b) Outside the Territory. Subject to Section 4.2(a), Angionetics or its licensee(s) shall be responsible for (i) all manufacturing of the Product outside of mainland China, and (ii) all development, and regulatory activities with respect to the Product outside the Territory.

 

(c) AFFIRM Study. Angionetics will undertake a planned AFFIRM Study (a summary of which is attached here as Exhibit 4.2), with any such modifications as deemed necessary by the Licensee and cleared by the applicable Regulatory Authorities. Angionetics agrees to provide Licensee with regular updates regarding the AFFIRM Study (not less than once per calendar quarter), and to provide Licensee with any information reasonably requested by Licensee regarding the AFFIRM Study.

 

(d) Reports. Licensee shall provide to Angionetics through the JSC an annual written report within thirty (30) days after each anniversary of the Effective Date, until the date of the First Commercial Sale, summarizing the development activities undertaken by Licensee and its Affiliates and Sublicensees in the preceding twelve-month period. The report may take the form of a PowerPoint (or similar) presentation.

 

4.3 Exchange of Data and Know-How.

 

(a) By Angionetics. On or after the Effective Date and upon request by Licensee, Angionetics shall provide Licensee with the Angionetics Know-How that is necessary for Licensee to manufacture the Product in mainland China and/or commercialize Product in the Territory for use in the Field, in each case consistent with Article 2, including, any and all Data from any and all worldwide clinical trials and preclinical studies of the Product conducted by Angionetics that are completed as of the Effective Date. Angionetics will support Licensee in preparing a BLA for the Territory.

 

(b) By Each Party. During the Term, each Party shall provide to the other Party, in a timely fashion and as promptly as possible, all Data Controlled by such Party, and any and all additional Angionetics Know-How that such Party reasonably considers as necessary for the other Party to develop and/or commercialize Product in the Territory (in the case of Licensee) or outside the Territory (in the case of Angionetics), for use by such other Party in accordance with this Section 4.3.

 

(c) Use; Disclosure. Licensee may use and disclose Angionetics Know-How to its Affiliates or Third Parties as required to obtain Marketing Approval for Products in the Territory and/or as necessary in performing its obligations and exercising its rights under and in accordance with this Agreement, in each case under confidentiality restrictions at least as protective of such information as the provisions of this Agreement, including for cross referencing drug master files or other regulatory filings by Licensee, its Affiliates and/or Sublicensees. Angionetics may only use, and disclose to Affiliates and/or Third Parties, Licensee Data provided by Licensee as is reasonably necessary for developing, and/or commercializing Product for use outside of the Territory; provided that such disclosure shall be made under confidentiality restrictions at least as protective of such information as the provisions of this Agreement.

 

-9-

 

 

4.4 Regulatory Matters. Licensee shall be responsible, at its expense, for filing, obtaining and maintaining approvals for the manufacture of the Compound and each Product in mainland China, and the development and commercialization of the Compound and each Product in the Territory, including any such IND, BLA or Marketing Approval, as well as pricing or reimbursement approvals in the Territory. Licensee shall be responsible for liaising with and managing all interactions with all applicable Regulatory Authorities in mainland China and the Territory. To the extent relating to the Compound and/or a Product within mainland China or the Territory, Licensee shall:

 

(a) through the JSC, keep Angionetics informed as to all material interactions with the CFDA and other Regulatory Authorities; and

 

(b) provide Angionetics with a copy of any material documents, information and correspondence submitted to the CFDA or any other Regulatory Authority within the Territory as soon as reasonably practicable, together with summaries thereof, to the extent such summaries exist.

 

4.5 Sharing of Regulatory Filings. Without limiting Section 4.3 above, each Party shall permit the other to access, and shall provide the other Party with sufficient rights to reference and use in association with exercising its rights and performing its obligations under this Agreement (including the right of Angionetics to commercialize the Product outside of the Territory), all of such Party’s, its Affiliates’ and, if applicable, its licensees’ Data, regulatory filings and regulatory communications associated with any submissions of BLAs or other regulatory approvals for the Product in such Party’s respective territory (i.e., in the Territory for non-manufacturing uses and in mainland China for manufacturing in the case of Licensee, and outside of the Territory in the case of Angionetics). If any information or data owned or Controlled by Angionetics or its Affiliates is required to be disclosed to a Regulatory Authority in mainland China or in the Territory, then Angionetics agrees to provide to such data or information to Licensee or the Regulatory Authority.

 

4.6 Commercialization in the Territory. Licensee or its Sublicensee(s) shall have the sole right to commercialize the Products in the Territory for use in the Field and shall use Commercially Reasonable Efforts to commercialize the Product in the Territory for use in the Field.

 

4.7 Reporting; Adverse Drug Reactions. Within one hundred eighty (180) days following the Regulatory Approval of the Product in mainland China and in the Territory, Angionetics will provide a draft Safety Data Exchange Agreement (SDEA) which shall be negotiated by the Parties in good faith and the Parties will enter into such Safety Data Exchange Agreement that more specifically sets forth the obligations of each Party with respect to the exchange of safety information and will require the Parties to comply with a standard operating procedure set forth therein governing the collection, investigation, reporting and exchange of safety information with respect to the Products, including but not limited to adverse events, product quality, and product complaints, sufficient to permit each Party (and in the case of Angionetics, any of its licensees of the Products outside the Territory) to comply with their respective legal obligations, all in accordance with Applicable Law. The SDEA will be promptly updated if required by changes in Applicable Law. Each Party shall keep the other Party informed about any adverse events of which such Party becomes aware or is informed regarding the use of Product in or outside the Territory. As between the Parties, Licensee shall be responsible for reporting all adverse events/experiences to the appropriate Regulatory Authorities in the Territory, and Angionetics shall be responsible for reporting all adverse events/experiences to the appropriate Regulatory Authorities in countries outside the Territory, in accordance with the appropriate laws and regulations of the relevant countries and authorities. Licensee shall ensure that its Affiliates comply with such safety reporting obligations in mainland China and in the Territory.

 

-10-

 

 

ARTICLE 5

 

PAYMENTS

 

5.1 Royalty Payments.

 

(a) Royalty Term. Subject to the terms and condition of this Agreement, in further consideration of the rights granted to Licensee under this Agreement, Licensee shall pay to Angionetics royalties commencing on the date of the First Commercial Sale and continuing in perpetuity based on Net Sales throughout the Territory. During the First Royalty Term, Licensee shall pay Angionetics royalties at the rates set out in Section 5.1(b). During the Second Royalty Term, Licensee shall pay Angionetics whatever royalties, taxes, tariffs, duties, charges, assessments or other amounts (on a net basis) Angionetics may then be obligated to pay Third Parties, including any governmental authorities and Regulatory Authorities, due to, based on, arising out of, or relating to the existence of this Agreement or the exercise of any rights thereunder (e.g., under an applicable contract or Applicable Law).

 

(b) First Royalty Rate. For any given year during the First Royalty Term, Licensee shall pay a progressive rate based on the cumulative amount of Net Sales accrued throughout the Territory during that year.

 

  Annual Cumulative Net Sales throughout the Territory Royalty Rate
  Portion of Annual Net Sales up to and including Fifty Million Dollars ($50,000,000) 5.0%
  Portion of Annual Net Sales greater than Fifty Million Dollars ($50,000,000) up to and including Two Hundred Million Dollars ($200,000,000) 6.0%
  Portion of Annual Net Sales greater than Two Hundred Million Dollars ($200,000,000) up to and including Four Hundred Fifty Million Dollars ($450,000,000) 8.0%
  Portion of Annual Net Sales greater than Four Hundred Fifty Million Dollars ($450,000,000) 10.0%

 

For example, if in a given year, the total amount of Net Sales is Eighty Million Dollars ($80,000,000), then Licensee shall pay a five percent (5%) royalty rate on Fifty Million Dollars ($50,000,000) and a six percent (6%) royalty rate on Thirty Million Dollars ($30,000,000).

 

Notwithstanding the foregoing, each of the rates set forth in the table above will be reduced by fifty percent (50%) upon both the occurrence of Regulatory Approval in each country in the Territory and the occurrence of commercial sales within each country in the Territory of a competitive angiogenic gene therapy product in the Field by a Third Party.

 

(c) Reports and Royalty Payment. Within forty-five (45) days after the end of each calendar quarter throughout the First Royalty Term and the Second Royalty Term, Licensee shall deliver to Angionetics a report setting out in reasonable detail the information necessary to calculate the royalty payments due under this Section 5.1 and specifically as to the Second Royalty Term, to permit Angionetics to determine if there are any payments due to Third Parties, in each case with respect to Net Sales made in that calendar quarter, including:

 

(i) units of the Product sold in the Territory during the relevant quarter;

 

(ii) gross sales of the Products in the Territory in the relevant calendar quarter;

 

(iii) Net Sales in the relevant calendar quarter on a Product-by-Product basis; and

 

(iv) all relevant deductions or credits due to Licensee in accordance with the terms of this Agreement.

 

Any amounts due under Section 5.1(a) for such calendar quarter shall accompany such statement.

 

5.2 Sublicense Payments. In addition to the royalty payments in Section 5.1, if Licensee grants a Sublicense to a Third Party then Licensee shall pay to Angionetics:

 

(a) Twenty-five percent (25%) of any Net Proceeds received by Licensee within forty-eight (48) months after the Effective Date; and

 

(b) Ten percent (10%) of any Net Proceeds received by Licensee more than forty-eight (48) months after the Effective Date.

 

-11-

 

 

ARTICLE 6

 

BOOKS AND RECORD

 

6.1 Payment Method. All payments under this Agreement shall be made by bank wire transfer in immediately available funds to an account designated by the Party to which such payments are due. Any payments or portions thereof due under this Agreement that are not paid by the date such payments are due under this Agreement shall bear interest at a rate equal to: (i) the prime rate as reported by Citibank N.A., plus one percent (1%) per year; or (ii) if lower, the maximum rate permitted by law; calculated on the number of days such payment is delinquent, compounded annually and computed on the basis of a three hundred sixty five (365) day year and the actual days elapsed. The applicable interest rate shall be adjusted each time there shall be a change in the prime rate announced by Citibank N.A. This Section 6.1 shall in no way limit any other remedies available to the Parties.

 

6.2 Withholding Taxes. If laws or regulations require withholding by Licensee of any taxes imposed upon Angionetics on account of any royalties or other payments paid under this Agreement, such taxes shall be deducted by Licensee as required by law from such payment and shall be paid by Licensee to the proper taxing authorities. Official receipts of payment of any withholding tax shall be secured and sent to Angionetics as evidence of such payment. The Parties will exercise their reasonable efforts to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of any applicable tax treaty, and shall cooperate in filing any forms required for such reduction.

 

6.3 U.S. Dollars. All dollar amounts specified in, and all payments made under this Agreement, shall be in U.S. dollars.

 

6.4 Records; Inspection. Licensee shall keep, and require its Affiliates to keep, complete, true and accurate books of accounts and records for the purpose of determining the amounts payable to Angionetics pursuant to this Agreement. Such books and records shall be kept for at least three (3) years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during the three (3) year period after Licensee’s payment of the amount to which such records relate or the due date of such payment, whichever is later, by an independent auditor chosen by Angionetics and reasonably acceptable to Licensee for the purpose of verifying the amounts payable by Licensee hereunder. Such inspections may be made no more than once each calendar year, at reasonable times and on thirty (30) days’ prior written notice. Such records for any particular calendar quarter shall be subject to no more than one inspection. The independent auditor shall be obligated to execute a reasonable confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section 6.4 shall be at the expense of Angionetics, unless a variation or error producing an underpayment in amounts payable exceeding five percent (5%) of the amount paid for a period covered by the inspection is established, in which case all reasonable costs relating to the inspection for such period and any unpaid amounts that are discovered shall be paid by Licensee, together with interest on such unpaid amounts at the rate set forth in Section 6.1 above. The Parties will endeavor in such inspection to minimize disruption of Licensee’s normal business activities to the extent reasonably practicable.

 

ARTICLE 7

 

MANUFACTURING, DELIVERY AND SUPPLY

 

7.1 Manufacturing by Angionetics. During the First Royalty Term of the Agreement, Angionetics shall be responsible to facilitate and coordinate the U.S.-based contract manufacturing of Products and will deliver, at Licensee’s sole discretion, either Compound as frozen bulk supply Ad5FGF-4 or vialed finished goods of the Generx Product, to Licensee through its manufacturing agreement with SAFC®, located in Carlsbad, California or other licensed manufacturer. If Licensee elects to receive frozen bulk supply Ad5FGF-4, then Licensee shall be responsible to hydrate, vial and package Product finished goods for the Territory. The transfer price that Licensee shall pay to Angionetics for fully-vialed finished goods shall be one hundred twenty percent (120%) of Angionetics’ out-of-pocket, comprehensive standard cost per unit manufacturing costs, with fifty percent (50%) payable prior to shipment with the remaining balance due within thirty (30) working days from Licensee’s receipt of the finished goods. Notwithstanding the foregoing, no more frequently than once per year, Angionetics will be permitted to increase the transfer price by an amount proportional to the then-current and demonstrable increase in manufacturing costs. In the event that Licensee establishes a manufacturing capability to utilize frozen bulk supply of Ad5FGF-4 to hydrate, vial and package finished Product, in accordance with the rules and regulations of the CFDA or any other applicable Regulatory Agency, Angionetics will agree to adjust the transfer price for Compound accordingly. Licensee shall bear all risk and costs associated to the shipment of finished goods from the U.S.-based manufacturing facility to the Licensee. Prior to the shipment of any Product for clinical trials, the Parties shall enter into a separate supply agreement (the “Supply Agreement”) which will include provisions related to forecasting, order, shipping, delivery, payment terms, quality control, audit rights, and regulatory responsibilities.

 

-12-

 

 

7.2 Technology Know-How. Angionetics agrees, upon Licensee’s request after the Effective Date, to provide Licensee with a copy of all copyable Angionetics Know-How related to manufacturing the Product to Licensee, and to use Commercially Reasonable Efforts to cause its third party contract manufacturer(s), including SAFC®, located in Carlsbad, California, to do the same.

 

ARTICLE 8

 

CONFIDENTIALITY

 

8.1 Confidential Information. Except as expressly provided in this Agreement, the Parties agree that the receiving Party shall not publish or otherwise disclose and shall not use for any purpose any information furnished to it by the other Party hereto pursuant to this Agreement (collectively, “Confidential Information”. Notwithstanding the foregoing, Confidential Information shall not include information that, in each case as demonstrated by written documentation;

 

(a) was already known to the receiving Party, other than under an obligation of confidentiality, at the time of disclosure or, as shown by written documentation, was developed by the receiving Party prior to its disclosure by the disclosing Party;

 

(b) was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party;

 

(c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement;

 

(d) was subsequently lawfully disclosed to the receiving Party by a person other than the disclosing Party, and who did not directly or indirectly receive such information from disclosing Party; or

 

-13-

 

 

(e) is developed by the receiving Party without use of or reference to any Confidential Information disclosed by the disclosing Party.

 

8.2 Permitted Disclosures. Notwithstanding the provisions of Section 8.1 above and subject to Sections 8.3 and 8.4 below, each Party hereto may use and disclose the other Party’s Confidential Information to its Affiliates, licensees, contractors and any other Third Parties to the extent such use and/or disclosure is reasonably necessary to exercise the rights granted to it, or reserved by it, under this Agreement (including in the case of Angionetics, in connection with the development, manufacture and/or commercialization of the Products for outside the Territory), prosecuting or defending litigation, complying with Applicable Laws, submitting information to tax or other governmental authorities or conducting clinical trials hereunder with respect to any Product. If a Party is required by law or regulations to make any such disclosure of the other Party’s Confidential Information, to the extent it may legally do so, it will give reasonable advance notice to such other Party of such disclosure and, save to the extent inappropriate in the case of patent applications or otherwise, will use its good faith efforts to secure confidential treatment of such Confidential Information prior to its disclosure (whether through protective orders or otherwise). For any other disclosures of the other Party’s Confidential Information, including to Affiliates, licensees, contractors and/or other Third Parties, a Party shall ensure that the recipient thereof is bound by a written confidentiality agreement as materially protective of such Confidential Information as this Article 8.

 

8.3 Confidential Terms. Each Party agrees not to disclose to any Third Party the terms of this Agreement without the prior written consent of the other Party hereto, except for permitted disclosures under Section 8.2 and that each Party may disclose the terms of this Agreement: to advisors (including financial advisors, attorneys and accountants), actual or potential acquisition partners or private investors, and others on a need to know basis, in each case under an appropriate confidentiality arrangement substantially equivalent to the terms of this Article 8. Notwithstanding the foregoing, the Parties shall agree upon a mutual press release to announce the execution of this Agreement. Thereafter, each Party may each disclose to Third Parties the information contained in such press release without the need for further approval by the other Party.

 

8.4 Publication of Product Information. Prior to the First Commercial Sale, Licensee may publish, publicly present and/or submit for written or oral publication a manuscript, abstract or the like that includes Data or other information relating to the Products that has not previously published pursuant to this Section 8.4 only upon the mutual agreement of the Parties. The contribution of each Party shall be noted in all publications or presentations by acknowledgment or co-authorship, whichever is appropriate. After First Commercial Sale, Licensee may publish, publicly present and/or submit for written or oral publication a manuscript, abstract or the like that includes Data or other information generated by Licensee or its Affiliates or Sublicensees relating to the Products that has not previously published pursuant to this Section 8.4 only upon the mutual agreement of the Parties.

 

8.5 Prior Non-Disclosure Agreements. Upon execution of this Agreement, the terms of this Article 8 shall supersede any prior non-disclosure, secrecy or confidentiality agreement between the Parties with respect to information relating to the Compound, Products and/or the business or operations of a Party. Any such information disclosed under such prior agreements shall be deemed disclosed under this Agreement.

 

-14-

 

 

ARTICLE 9

 

PATENT PROSECUTION AND IP ENFORCEMENT

 

9.1 Ownership of Inventions. As between the Parties, title to all inventions and other intellectual property made (a) solely by personnel of Licensee or any of its Affiliates in connection with this Agreement shall be owned by Licensee; (b) solely by personnel of Angionetics or any of its controlled Affiliates in connection with this Agreement shall be owned by Angionetics; and (c) jointly by personnel of Angionetics and Licensee (or their respective Affiliates) in connection with this Agreement shall be jointly owned by Angionetics and Licensee. Prosecution of any Patent with respect to such jointly owned inventions and intellectual property shall be solely as mutually agreed. Except as expressly provided in this Agreement, it is understood that neither Party shall have any obligation to obtain any approval of, nor pay a share of the proceeds to, the other Party to practice, enforce, license, assign or otherwise exploit such jointly-owned inventions or intellectual property, and each Party hereby waives any right it may have under the laws of any jurisdiction to require such approval or accounting.

 

9.2 Prosecution and Maintenance of Angionetics Patents.

 

(a) Angionetics Patent Rights. Angionetics shall have the sole and exclusive right, at its expense, to control the Prosecution and Maintenance of Patents included in the Angionetics Patents as of the Effective Date, or which may be filed in any country after the Effective Date. Angionetics shall consult with Licensee in good faith regarding the Prosecution and Maintenance of such Angionetics Patents in the Territory and shall take into account Licensee’s reasonable comments related to such matters to the extent such comments pertain to the Product, or a method of use or manufacture of any of the foregoing. If Angionetics determines not to file any Patent, or to abandon any Patent within the Angionetics Patents in the Territory, with respect to any Product, and/or manufacturing and/or use thereof in the Field, as applicable, Angionetics shall provide Licensee with at least sixty (60) days’ written notice of such decision, prior to the deadline for filing any such Patent or the date on which such abandonment would become effective. In such event, Licensee shall have the right, at its option, to control the Prosecution and Maintenance of such Patent. For the purposes of this Section 9.2, “Prosecution and Maintenance” (including variations such as “Prosecute and Maintain”) shall mean, with respect to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well as re-examinations, reissues and requests for Patent term extensions and the like with respect to such Patent, together with the conduct of interferences, the defense of oppositions and other similar proceedings with respect to a Patent.

 

(b) Licensee Patent Rights. Licensee may not file Prosecute or Maintain any Patents that discloses any Angionetics Know-How. Any Patent application covering any aspect of the Compound or any Product must be pre-approved by Angionetics. In no event will any Patent application filed by or on behalf of Licensee include any claims that in any way preclude or inhibit the rights of Angionetics or Huapont or either of their Affiliates to market and sell the Products in mainland China under that certain DLA.

 

-15-

 

 

(c) Cooperation. Each Party shall cooperate with the other Party in connection with all activities relating to the Prosecution and Maintenance of the Angionetics Patents undertaken by such other Party pursuant to this Section 9.2, including: (i) making available in a timely manner any documents or information such other Party reasonably requests to facilitate such other Party’s Prosecution and Maintenance of the Angionetics Patents pursuant to this Section 9.2; and (ii) if and as appropriate, signing (or causing to have signed) all documents relating to the prosecution and maintenance of any Angionetics Patents by such other Party. Each Party shall also promptly provide to the other Party all information reasonably requested by such other Party with regard to such Party’s activities pursuant to this Section 9.2. Licensee shall hold all information disclosed to it under this Section as Confidential Information.

 

9.3 Enforcement.

 

(a) Notice. Subject to the provisions of this Section 9.3, in the event that Licensee reasonably believes that any Angionetics IP Rights in the Territory are infringed by a Third Party, or any of the Angionetics IP Rights are subject to a declaratory judgment action in the Territory arising from such infringement, in each case with respect to the sale or use of a product containing a Compound (an “Infringing Product”), Licensee shall promptly notify Angionetics. Licensee shall have the initial right (but not the obligation), at its own expense, to enforce the Angionetics IP Rights with respect to such infringement or defend any declaratory judgment action with respect thereto in the Territory (for purposes of this Section 9.3, an “Enforcement Action”). Angionetics shall, at its expense, have the right to join in as a party and, in any event, shall give reasonable assistance to such Enforcement Action. Licensee shall keep Angionetics reasonably informed of the progress of any such Enforcement Action. Licensee agrees not to settle any Enforcement Action, or make any admissions or assert any position in such Enforcement Action, in a manner that would adversely affect validity, enforceability or scope of the Angionetics IP Rights, without the prior written consent of Angionetics, which shall not be unreasonably withheld or delayed.

 

(b) Initiating Enforcement Actions, In the event that Licensee fails to initiate an Enforcement Action to enforce the Angionetics IP Rights against an infringement by a Third Party in the Territory, which infringement consists of the sale or use of an Infringing Product in the Field in the Territory, within one hundred eighty (180) days after a request by Angionetics to initiate such Enforcement Action, Angionetics may initiate an Enforcement Action against such infringement at its own expense. Upon the request of Angionetics, Licensee shall cooperate in such Enforcement Action at Angionetics’ expense. Angionetics shall keep Licensee reasonably informed of the progress of any such Enforcement Action. Licensee shall, at its expense, have the right to join in as a party and to give reasonable assistance to such Enforcement Action. Angionetics agrees not to settle any Enforcement Action, or make any admissions or assert any position in such Enforcement Action, in a manner that would materially adversely affect the validity, enforceability or scope of any Angionetics IP Rights, without the prior written consent of Licensee.

 

(c) Recovery. Any amounts recovered by Licensee or Angionetics with respect to any litigation undertaken pursuant to Section 9.3 above or settlement thereof shall be retained by Angionetics shall be applied first to reimburse any actual outstanding legal expenses and out-of-pocket expenses of the action or proceeding incurred by either Party. Any amounts remaining shall be included in Net Sales.

 

-16-

 

 

(d) Cooperation. The Parties shall keep one another informed of the status of their respective activities regarding any litigation or settlement thereof concerning any Enforcement Actions described in this Section 9.3 controlled by such Party and shall assist one another and cooperate in any such litigation at the other’s reasonable request (including joining as a party to the extent necessary and requested by the other Party).

 

9.4 Third Party Infringement Claims. If the manufacture, sale or use of the Product for the Territory pursuant to this Agreement results in a claim, suit or proceeding alleging patent infringement against Angionetics or Licensee (or their respective Affiliates or licensees) (collectively, “Infringement Actions”), such Party shall promptly notify the other Party hereto in writing, the Party subject to such Infringement Action shall have the right to direct and control the defense thereof; provided, however, that the other Party may participate in the defense and/or settlement thereof at its own expense with counsel of its choice. In any event, the Party that is subject to the Infringement Action agrees to keep the other Party hereto reasonably informed of all material developments in connection with any such Infringement Action. The Party who is subject to the Infringement Action agrees not to settle such Infringement Action, or make any admissions or assert any position in such Infringement Action, in a manner that would adversely affect the other Party’s rights with respect to the Product in such other Party’s territory (i.e., in the case of Licensee, the Territory for commercialization and mainland China for manufacture, and in the case of Angionetics, countries outside of the Territory) without the prior written consent of the other Party, which shall not be unreasonably withheld or delayed.

 

ARTICLE 10

 

TERM AND TERMINATION

 

10.1 Term. This Agreement shall commence on the Effective Date, and unless terminated earlier as provided in this Article 10, shall continue in perpetuity unless terminated as set forth herein.

 

10.2 Breach. Either Party to this Agreement may terminate this Agreement in the event the other Party has materially breached or defaulted in the performance of any of its obligations hereunder, and such default has continued for ninety (90) days after written notice thereof was provided to the breaching Party by the non-breaching Party. Any such termination will become effective at the end of such ninety (90) day period unless the breaching Party has cured any such breach or default prior to the expiration of the ninety (90) day period.

 

10.3 Termination For Convenience. Licensee may terminate this Agreement in its entirety for any reason: (a) upon sixty (60) days’ prior written notice to Angionetics prior to the First Commercial Sale; and (b) upon one hundred twenty (120) days’ prior written notice to Angionetics following the First Commercial Sale.

 

10.4 Termination for Failure to Commercialize. Angionetics may terminate this Agreement in its entirety if Licensee fails to report any Net Sales over the course of two (2) consecutive quarterly royalty reports under Section 5.1(c). Termination in accordance with this Section 10.4 will be effective upon written notice to Licensee.

 

-17-

 

 

ARTICLE 11

 

EFFECT OF TERMINATION

 

11.1 Accrued Obligations. The expiration or termination of this Agreement for any reason shall not release either Party from any liability that, at the time of such expiration or termination, has already accrued to the other Party or that is attributable to a period prior to such expiration or termination, nor will any termination of this Agreement preclude either Party from pursuing all rights and remedies it may have under this Agreement, or at law or in equity, with respect to breach of this Agreement.

 

11.2 Rights on Termination. This Section 11.2 shall apply upon any termination of Licensee’s rights under this Agreement in its entirety.

 

(a) Wind-down Period.

 

(i) Development. In the event there are any on-going clinical or formulation trials/studies of Product in the Territory pending as of the date of termination, to the extent so requested by Angionetics, Licensee agrees to either promptly transition such clinical or formulation trials/studies to Angionetics (or its designee), or continue to conduct such clinical trials and/or formulation studies, at Angionetics’ expense, and otherwise in accordance with the terms and conditions of this Agreement in effect prior to its termination.

 

(ii) Commercialization. If this Agreement is terminated after the date of the First Commercial Sale in the Territory, then within thirty (30) days of expiration or termination of this Agreement, Licensee shall notify Angionetics of any quantity of the Product remaining in Licensee’s inventory and, if so requested by Angionetics, Licensee shall transfer to Angionetics (or its designee) all right, title and interest in and to any such quantities of the Product at a price equal to Licensee’s actual cost plus twenty percent (20%). Unless and until Angionetics elects to purchase any of the inventory, Licensee and its Affiliates may continue to distribute all Products within such inventory for which Marketing Approval has been obtained in the Territory in accordance with the terms and conditions of this Agreement, for a period not to exceed twelve (12) months after the effective date of such expiration or termination (for purposes of Section 11.2, the “Wind-down Period”). Notwithstanding any other provision of this Agreement, during the Wind-down Period, Licensee’s and its Affiliates’ rights with respect to the Product in the Territory shall terminate other than the right to sell, offer to sell, market, distribute and promote Products in the Territory for use in the Field, which shall automatically become non-exclusive. For the avoidance of doubt, Angionetics shall have the right to engage one or more other distributor(s) and/or licensee(s) of the Products in all or part of the Territory.

 

(b) Assignment of Regulatory Filings and Marketing Approvals. At Angionetics’ option, which shall be exercised by written notice to Licensee, Licensee shall, at its expense, assign or cause to be assigned to Angionetics or its designee (or to the extent not so assignable, Licensee shall take all reasonable actions to make available to Angionetics or its designee the benefits of) all regulatory filings and registrations (including INDs, MAAs and Marketing Approvals) for the any Product in mainland China and the Territory, including any such regulatory filings and registrations made or owned by its Affiliates. In each case, unless otherwise required by any Applicable Law or requested by Angionetics, the foregoing assignment (or availability) shall be made within ninety (90) days after the effective date of the termination of this Agreement. In addition, Licensee shall, at its expense, promptly provide to Angionetics (in electronic form, to the extent the same exists in electronic form) a copy of all Data pertaining to the Compound and/or Product, to the extent not previously provided to Angionetics and notwithstanding anything herein to the contrary, Angionetics shall have the right to use (and authorize the use of), and to disclose, and otherwise commercialize all such Data following termination of this Agreement, in any field and for any products.

 

-18-

 

 

(c) Transition. Licensee shall use Commercially Reasonable Efforts to cooperate with Angionetics and/or its designee to effect a smooth and orderly transition in the development, sale and on-going marketing, promotion and commercialization of the Product in the Territory.

 

(d) Return of Materials. Within fifteen (15) days after the end of the Wind- down Period (or after the expiration or termination of this Agreement, in the event there is no W1nd-down Period), Licensee shall, at its expense, destroy all tangible items comprising, bearing or containing any Confidential Information of Angionetics, that is in Licensee’s possession or return such Confidential Information to Angionetics, as Angionetics may direct, at Angionetics’ expense.

 

11.3 Survival. Upon the expiration or termination of this Agreement, all rights and obligations of the Parties under this Agreement shall terminate except those described in the following Sections: Sections 1.1-1.32, 2.3, 6.4 (solely for so long as specified therein), 8.1-8.3, 8.5, 9.1, the first sentence of 9.2(a), 9.2(b), 9.2(c) (solely with respect to any surviving portions of Section 9.2), 9.4 (solely with respect to Infringement Actions against Licensee), 11.1-11.3. 12.1-12.4, 13.1-13.4, 14.1-14.3, 15.1-15.11; and, in addition, to the extent that any Product is sold during the Wind-down Period defined in Section 11.2(a)(ii) above, the following Sections shall survive: Sections 5.1-5.2, and 6.1-6.3.

 

ARTICLE 12

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

12.1 General Representations. Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:

 

(a) Duly Organized. Such Party is a corporation duly organized, validly existing and is in good standing under the laws of the jurisdiction of its incorporation, is qualified to do business and is in good standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification and failure to have such would prevent such Party from performing its obligations under this Agreement.

 

(b) Due Execution; Binding Agreement. This Agreement is a legal and valid obligation binding upon such Party and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by such Party have been duly authorized by all necessary corporate action and do not and will not: (i) require any consent or approval of its stockholders; (ii) to such Party’s knowledge, violate any law, rule, regulation, order, writ, judgment, decree, determination or award of any court, governmental body or administrative or other agency having jurisdiction over such Party; nor (iii) conflict with, or constitute a default under, any agreement, instrument or understanding, oral or written, to which such Party is a party or by which it is bound.

 

-19-

 

 

12.2 Representations and Warranties of Angionetics. Angionetics represents, warrants to Licensee that, as of the Effective Date.

 

(a) it has the full right and authority to grant the rights and licenses as provided herein;

 

(b) to its knowledge, there are no actual, pending, alleged or threatened actions, suits, claims, interference or governmental investigations in the Territory involving the Compound, Product, the Angionetics Know-How by or against Angionetics, or any of its Affiliates. In particular, to its best knowledge, there is no pending or threatened product liability action nor intellectual property right litigation in the Territory in relation to the Products;

 

(c) there is no actual, pending, alleged or to the knowledge of Angionetics threatened infringement or misappropriation by a Third Party in the Territory of any of the Angionetics Know-How; and

 

(d) to the knowledge of Angionetics, the manufacture of the biopharmaceutical product consisting solely of Ad5FGF-4, alferminogene tadenovec, in mainland China and the use (by itself), sale or other disposition thereof in or for the Territory does not and will not infringe or misappropriate any Third Party intellectual property rights.

 

12.3 Representations and Warranties of Licensee. Licensee represents and warrants to Angionetics that, as of the Effective Date:

 

(a) it has the full right and authority to grant the rights granted herein;

 

(b) all necessary consents, approvals and authorizations of all Regulatory Authorities, other governmental authorities and other persons or entities required to be obtained by Licensee in order to enter into this Agreement have been obtained; and

 

(c) Licensee does not have any knowledge that any of Angionetics representations and warranties set forth in Sections 12.1 and 12.2 above are inaccurate.

 

12.4 DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTIES OF ANY KIND EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OR VALIDITY OF ANY PATENTS ISSUED OR PENDING.

 

-20-

 

 

ARTICLE 13

 

INDEMNIFICATION

 

13.1 Indemnification of Angionetics. Licensee shall indemnify and hold harmless each of Angionetics, its Affiliates and licensees and their respective directors, officers and employees and the successors and assigns of any of the foregoing (the “Angionetics Indemnitees”), from and against any and all liabilities, damages, penalties, fines, costs, expenses (including reasonable attorneys’ fees and other expenses of litigation) (“Liabilities”) from any claims, actions, suits or proceedings brought by a Third Party (a “Third Party Claim”) incurred by any Angionetics Indemnitee, arising from, or occurring as a result of: (a) the manufacture, use, marketing, distribution, import, and/or sale of Products by or under the authority of Licensee, or (b) any breach of any representations, warranties or covenants by Licensee in Section 12 above; except to the extent such Third Party Claims fall within the scope of Angionetics’ indemnification obligations set forth in Section 13.2 below.

 

13.2 Indemnification of Licensee. Angionetics shall indemnify and hold harmless each of Licensee, and its Affiliates and their respective directors, officers and employees and the successors and assigns of any of the foregoing (the “licensee Indemnitees”), from and against any and all Liabilities from any Third Party Claims incurred by any Licensee Indemnitee, arising from, or occurring as a result of: (a) the developing, making, having made, use, marketing, distribution or sale of any Product by Angionetics or its Product licensee(s) outside the Territory, or (b) any material breach of any representations, warranties or covenants by Angionetics in Article 10 above.

 

13.3 Procedure. A Party that intends to claim indemnification under Article 13 (the “Indemnitee”) shall promptly notify the other Party (the “Indemnitor”) in writing of any Third Party Claim, in respect of which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense and/or settlement thereof. The indemnity arrangement in Article 13 shall not apply to amounts paid in settlement of any action with respect to a Third-Party Claim, if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed unreasonably. The failure to deliver written notice to the Indemnitor within a reasonable time after the commencement of any action with respect to a Third Party Claim, if prejudicial to its ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee under Article 13, but the omission to so deliver written notice to the Indemnitor shall not relieve the Indemnitor of any liability that it may have to any Indemnitee otherwise than under Article 13. The Indemnitee under Article 13 shall cooperate fully with the Indemnitor and its legal representatives in the investigation of any action with respect to a Third-Party Claim covered by this indemnification.

 

13.4 No Consequential Damages. EXCEPT FOR EACH PARTY’S INDEMNIFICATION OBLIGATIONS HEREUNDER AND ANY LIABILITY FOR BREACH OF CONFIDENTIALITY, LIABILITY FOR BREACH OF APPLICABLE INFRINGEMENT OR MISAPPROPRIATION REPRESENTATIONS, LIABILITY DUE TO WILLFUL MISCONDUCT, INTENTIONALLY WRONGFUL ACTS OR OMISSIONS, A PARTY’S FRAUD, OR GROSS NEGLIGENCE, IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS REPRESENTATIVES BE LIABLE UNDER THIS AGREEMENT TO THE OTHER PARTY OR ANY THIRD PARTY FOR CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE, ARISING OUT OF, OR RELATING TO, AND/OR IN CONNECTION WITH ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (B) WHETHER OR NOT IT WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT OR OTHERWISE) UPON WHICH THE CLAIM IS BASED

 

-21-

 

 

ARTICLE 14

 

DISPUTE RESOLUTION

 

14.1 Senior Executives. In the event of any dispute between the Parties arising out of or in connection with this Agreement, either Party may, by written notice to the other, have such dispute referred to the CEO of Angionetics and the CEO of Licensee for attempted resolution by good faith negotiations within thirty (30) days after such notice is received, and, in such event, each Party shall cause its representative to meet and be available to attempt to resolve such issue. Notwithstanding the foregoing, neither Party shall be obligated to negotiate for more than thirty (30) days. If the Parties should resolve such dispute or claim, a memorandum setting forth their agreement will be prepared and signed by both Parties if requested by either Party.

 

14.2 Jurisdiction. Any dispute, controversy or claim with respect to the breach, interpretation, performance or enforcement of this Agreement, not resolved pursuant to Section 14.1 shall be subject to the exclusive jurisdiction of the courts of the State of New York sitting in City of New York and the United States District Court for the Southern District of New York, and each Party hereby submits to such jurisdiction for the resolution of such Dispute and hereby waives the defense of any inconvenient forum for the maintenance of any action or proceeding in such jurisdiction for such purpose.

 

14.3 Interim Relief. Notwithstanding anything in this Article 14 to the contrary, Licensee and Angionetics shall each have the right to apply to any court of competent jurisdiction for a temporary restraining order, preliminary injunction or other similar interim or conservatory relief, as necessary to protect the right or property of such Party.

 

ARTICLE 15

 

GENERAL PROVISIONS

 

15.1 Force Majeure. If the performance of any part of this Agreement (except for any payment obligation under this Agreement) by either Party is prevented, restricted, interfered with or delayed by reason of force majeure (including, fire, flood, embargo, power shortage or failure, acts of war, insurrection, riot, terrorism, strike, lockout or other labor disturbance or acts of God), the Party so affected shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay; provided that the affected Party shall use its reasonable efforts to avoid or remove such causes of nonperformance and shall continue performance with the utmost dispatch whenever such causes are removed.

 

-22-

 

 

15.2 Governing Law. This Agreement and all questions regarding its validity or interpretation, or the breach or performance of this Agreement, shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without reference to conflict of law principles. The U.N. Convention on the Sale of Goods shall not apply to this Agreement.

 

15.3 Waiver of Breach. Except as otherwise expressly provided in this Agreement, any term of this Agreement may be waived only by a written instrument executed by a duly authorized representative of the Party waiving compliance. The delay or failure of either Party at any time to require performance of any provision of this Agreement shall in no manner affect such Party’s rights at a later time to enforce the same. No waiver by either Party of any condition or term in any one or more instances shall be construed as a further or continuing waiver of such condition or term or of another condition or term.

 

15.4 Modification. No amendment or modification of any provision of this Agreement shall be effective unless in writing signed by a duly authorized representative of each Party. 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 a duly authorized representative of each Party.

 

15.5 Severability . In the event any provision of this Agreement should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions of this Agreement shall remain in full force and effect in such jurisdiction. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction.

 

15.6 Entire Agreement. This Agreement (including the Exhibits attached hereto) constitutes the entire agreement between the Parties relating to its subject matter and supersedes all prior or contemporaneous agreements, understandings or representations, either written or oral, between Angionetics and Licensee with respect to such subject matter.

 

15.7 Notices. Unless otherwise agreed by the Parties or specified in this Agreement, all notices and other communications between the Parties relating to, and all written documentation to be prepared and provided under, this Agreement shall be in the English language: (a) delivered personally; (b) sent by registered or certified mail (return receipt requested and postage prepaid); (c) sent by express courier service providing evidence of receipt, postage pre-paid where applicable; or (d) sent by facsimile (receipt verified and a copy promptly sent by another permissible method of providing notice described in paragraphs (a), (b) or (c) above), to the following addresses of the Parties or such other address for a Party as may be specified by like notice:

 

To Angionetics:

Angionetics, Inc. c/o Nostrum Pharmaceuticals LLC

1370 Hamilton Street

Somerset, NJ 08873 Attention: Nirmal Mulye, Ph.D

To Licensee:

Mr. Jiayue Zhang

Shanxi Taxus Pharmaceuticals Co., Ltd.

Shenzhen Stock Exchange, Room # 3406

Shennan Ave. 2012

Futian District, Shenzhen 518057

China

With a copy to:

Carlton R. Asher, Jr., Esq.

Law Offices of Carlton R. Asher, Jr.

110 East 59th Street, Suite 2200 New York, NY 10022

 

 

-23-

 

 

Any notice required or permitted to be given concerning this Agreement shall be effective upon receipt by the Party to whom it is addressed or within seven (7) days of dispatch whichever is earlier

 

15.8 Assignment. This Agreement shall not be assignable by either Party to any Third Party hereto without the written consent of the other Party hereto; except either Party may assign this Agreement without the other Party’s consent to an entity that acquires substantially all of the business or assets of the assigning Party, whether by merger, acquisition or otherwise, provided that the Party to whom this Agreement is assigned assumes this Agreement in writing or by operation of law. In addition, either Party shall have the right to assign this Agreement to one of its Affiliate upon written notice to the non-assigning Party, provided that the assigning Party guarantees the performance of this Agreement by such Affiliate. Subject to the foregoing, this Agreement shall inure to the benefit of each Party, its successors and permitted assigns. A Party assigning this Agreement shall provide written notice of any assignment to the other Party within five (5) business days after any such permitted assignment. Any assignment of this Agreement in contravention of this Section 15.8 shall be null and void.

 

15.9 No Partnership or Joint Venture. Nothing in this Agreement is intended, or shall be deemed, to establish a joint venture or partnership between Angionetics and Licensee. Neither Party to this Agreement shall have any express or implied right or authority to assume or create any obligations on behalf of, or in the name of, the other Party, or to bind the other Party to any contract, agreement or undertaking with any Third Party.

 

15.10 Interpretation. The captions to the several Articles and Sections of this Agreement are not a part of this Agreement but are included for convenience of reference and shall not affect its meaning or interpretation. In this Agreement: (a) the word “including” shall be deemed to be followed by the phrase “without limitation” or like expression; (b) the singular shall include the plural and vice versa; (c) masculine, feminine and neuter pronouns and expressions shall be interchangeable; and (d) the word “will” shall be construed as having the same meaning and effect as the word “shall.”

 

15.11 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument. Signatures to this Agreement delivered by facsimile or other form of electronic transmission (e.g., portable document format (PDF)) will be deemed binding as originals.

 

[Signature Page Follows]

 

-24-

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

 

ANGIONETICS, INC.  
     
BY: /s/ Christopher Reinhard  
NAME: Christopher Reinhard  
TITLE: Chief Executive Officer  

 

SHANXI TAXUS PHARMACEUTICALS CO., LTD.  
     
BY: /s/ Jiayue Zhang                 
NAME: Jiayue Zhang  
TITLE: Chairman and President  

 

-25-

 

 

Exhibit 10.4

 

FIRST AMENDMENT TO

 

DISTRIBUTION AND LICENSE AGREEMENT

 

The undersigned, Angionetics Inc., a Delaware corporation (“Angionetics”) and a wholly-owned subsidiary of Gene Biotherapeutics, Inc., and Shanxi Taxus Pharmaceuticals Co., Ltd., a China-based company (“Licensee”), desire to amend, as of April 14, 2020, the Distribution and License Agreement, dated as of April 10, 2020 (the “D&L Agreement”). Capitalized terms used but not otherwise defined herein shall have the respective meanings set forth in the D&L Agreement.

 

1. Amendments.

 

(a) A new Section 4.8 is added at the end of Article 4 of the D&L Agreement as follows:

 

“4.8 Actions Prior to the Effective Date. Prior to the Effective Date, Angionetics will cooperate with Licensee in activities described in this Section 4.8. Any activities conducted under this Section 4.8, although occurring prior the Effective Date remain subject to all terms of this Agreement, including without limitation Section 4.4, Section 4.5 and Section 8:

 

(a) Angionetics will provide Licensee with proprietary analytical and biological assay methodologies and specifications required to assist Licensee in its efforts to develop a lyophilized form of the Product, and grants Licensee the right to use such methodologies and specifications solely for the purpose of developing a lyophilized form of the Product. All laboratory work related to the development of a lyophilized form of the Product will be conducted in China and funded by Licensee. All intellectual property rights relating to a lyophilized form of the Product developed by Licensee, including the right to prosecute for Patent protection mainland China or in the Territory, to the extent required to manufacture Product in mainland China and commercialize Product in the Territory in the Field shall belong to Licensee. All other such Patents and other intellectual property rights shall belong to Angionetics and be deemed Angionetics IP Rights under this Agreement. Notwithstanding the foregoing and any Patent that Licensee may secure, each of Angionetics, any other China-based licensee and their respective affiliates, shall have the right to use the intellectual property rights manufacture the Product, or have the produce manufactured, in mainland China without any obligation to obtain any approval of, nor pay a share of the proceeds to, Licensee and Licensee hereby waives any right it may have under the laws of any jurisdiction to require such approval or accounting.”

 

(b) Angionetics will assist Licensee with Licensee’s filing of an IND relating to Generx with the CFDA based on information currently available to Angionetics. Licensee will provide Angionetics with a copy of any filing or correspondence before it is submitted to the CFDA and will not submit any filing or correspondence without Angionetics’ prior consent, which will not be unreasonably withheld or delayed. Each of Angionetics and any other China-based licensee, at their request, will be identified as co-sponsors of the application.”

 

  -1-  
 

  

(b) Section 10.1 of the D&L Agreement is hereby deleted in its entirety and the following is substituted in its place:

 

“10.1 Term. Except as provided in Section 4.8, this Agreement shall commence on the Effective Date, and unless terminated earlier as provided in this Article 10, shall continue in perpetuity unless terminated as set forth herein.”

 

2. Conflict. In the event of any conflict between this First Amendment to Distribution and License Agreement, the terms of this Amendment shall prevail.

 

3. References to the Agreement. From and after the date hereof, all references to the D&L Agreement contained in the D&L Agreement and each other agreement entered into in connection therewith shall be deemed to be references to the D&L Agreement after giving effect to this Amendment.

 

4. No Other Amendments. The parties hereby acknowledge and agree that this Amendment constitutes an amendment to the D&L Agreement in accordance with Section 15.4 thereof. Except as specifically amended by this Amendment, all other terms and provisions of the D&L Agreement shall remain in full force and effect in accordance with its terms.

 

5. Further Assurances. The parties shall do such further acts and things, and execute and deliver such additional conveyances, assignments, agreements and instruments, as may be reasonably requested in connection with the administration and enforcement of this Amendment and to permit the exercise thereof in compliance with any laws.

 

6. Notices. All notices, demands and requests of any kind to be delivered to any party in connection with this Amendment shall be delivered in accordance with the notice provisions contained in the D&L Agreement.

 

7. Captions. The captions of the Sections of this Amendment are solely for convenient reference and shall not be deemed to affect the meaning or interpretation of any Section hereof.

 

8. Counterparts. This Amendment may be executed and delivered by different parties hereto in separate counterparts, and delivered by means of facsimile transmission or other electronic transmission, each of which when so executed and delivered shall be deemed to be an original and all of which when taken together shall constitute one and the same agreement.

 

9. GOVERNING LAW. THIS AMENDMENT SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE DOMESTIC LAWS OF THE STATE OF NEW YORK WITHOUT GIVING EFFECT TO ANY CHOICE OF LAW OR CONFLICT OF LAW PROVISION OR RULE (WHETHER OF THE STATE OF NEW YORK OR ANY OTHER JURISDICTION) THAT WOULD CAUSE THE APPLICATION OF THE LAWS OF ANY JURISDICTION OTHER THAN THE STATE OF NEW YORK.

 

10. Entire Agreement. Except as otherwise expressly set forth herein, this Amendment and the D&L Agreement embody the complete agreement and understanding among the Parties with respect to the subject matter hereof and thereof and supersede and preempt any prior understandings, agreements or representations by or among the Parties, written or oral, which may have related to the subject matter hereof or thereof in any way.

 

[remainder of page intentionally blank; signature page follows]

 

  -2-  
 

 

IN WITNESS WHEREOF, the parties hereto have caused this First Amendment to Distribution and License Agreement to be duly executed as of the date first above written.

 

  ANGIONETICS, INC.
     
  By: /s/ Christopher Reinhard
  Name:  
  Title:  

 

  SHANXI TAXUS PHARMACEUTICALS CO., LTD.
     
  By: /s/ Ziajue Zhang                                 
  Name:  
  Title:  

 

  -3-  

 

 

 

 

 

 

Exhibit 10.5

 

LICENSE AND PATENT ASSIGNMENT AGREEMENT

 

This LICENSE AND PATENT ASSIGNMENT AGREEMENT (this “Agreement”) dated as of April 10, 2020 is made by Activation Therapeutics Inc., a Delaware corporation (“Activation”), on its own behalf and on behalf of its Affiliates and Shanxi Taxus Pharmaceuticals Co., Ltd., a company incorporated under the laws of the People’s Republic of China (“Shanxi”), with respect to the following facts:

 

BACKGROUND

 

A. Activation sold certain intellectual property rights regarding Excellegen®, an FDA cleared and approved formulated fibrillary collagen product for wound healing and treatment (“Excellagen”), to Olaragen Therapeutix, Inc., a Delaware limited liability Company (“Olaragen”) pursuant to that certain Asset Purchase Agreement dated as of July 15, 2018, as amended by that (a) certain side letter dated July 19, 2018 by and between Activation and Olaregen regarding Lynch Biologics and (b) that certain side letter dated April 2, 2019 by and between Gene Biotherapeutics Inc., on behalf of its wholly-owned subsidiary Activation, and Olaregen, each of which are attached to this Agreement as Exhibit A (as amended, the “APA”).

 

B. In connection with the APA, Activation and Olaregen entered into that certain License Agreement, effective as of the date of completion of the payment of the Purchase Price provided for under the APA (as amended, the “License Agreement”), pursuant to which Activation received a license back to certain intellectual property rights regarding Excellagen for use in the Retained Territories (as defined in the License Agreement), a copy of which is attached as Exhibit C to the APA.

 

C. Activation is the owner of record of Chinese Patent No. CN 1050079312(B), entitled “Flowable Formulations for Tissue Repair and Regeneration” (the “Chinese Patent”).

 

D. Gene Biotherapeutics Inc., a Delaware corporation and the parent company of Activation, and Shanxi are parties to that certain letter agreement dated December , 2019 (the “Settlement Agreement”), pursuant to which Gene Biotherapeutics, Inc. agreed to cause Activation to license its intellectual property rights regarding Excellagen and transfer the Chinese Patent to Shanxi, in exchange for a release of claim and other consideration specified therein.

 

NOW THEREFORE, in consideration of the mutual covenants contained herein, and intending to be legally bound, the parties agree as follows:

 

  -1-  
 

 

AGREEMENT

 

1. LICENSE ASSIGNMENT.
   
  1.1. Assignment of the License Agreement. Activation hereby conveys, sells, transfers and assigns to Shanxi all of Activation’s right, title and interest under the License Agreement solely with respect to development, manufacture and sale the Excellagen product in each of the Retained Territories and delegates any and all obligations and liabilities (if any) of Activation under the License Agreement with respect thereto.
   
  1.2 Assumption of License Obligations. Shanxi hereby accepts the assignment and assumes all of the obligations and liabilities of Activation under the License Agreement, arising after the date of this Agreement.
   
  1.3 Retention of Royalty Rights under APA. Activation retains, and this Assignment does not convey, sell, transfer, or assign any of Activation’s rights and/or obligations with respect to APA, including but not limited to any consideration or other amounts payable (whether or not yet payable) to Activation under the APA.

 

2. CHINESE PATENT ASSIGNMENT.
   
2.1. Assignment of Chinese Patent. Activation hereby conveys, sells, transfers and assigns to Shanxi all of Activation’s right, title, and interest (if any) in and to the Chinese Patent and all: (a) issuances, divisionals, continuations, continuations-in-part, reissues, extensions, reexaminations and renewals thereof; (b) all rights of Activation accruing under any of the foregoing provided by applicable law of any jurisdiction, by international treaties and conventions, and otherwise throughout the world; (c) any and all royalties, fees, income, payments, and other proceeds now or hereafter due or payable with respect to any and all of the foregoing; and (d) any and all claims and causes of action based on any of the foregoing, whether accruing before, on, or after the date hereof, including all rights to and claims for damages, restitution, and injunctive and other legal and equitable relief for past, present, and future infringement, misappropriation, violation, misuses, breach, or default, with the right but no obligation to sue for such legal and equitable relief and to collect, or otherwise recover any such damages.
   
2.2. Authorization. Activation authorizes and requests the applicable official at the China National Intellectual Property Administration whose duty is to register and record ownership in patent applications or patents to record Shanxi as the assignee and owner of any and all of Activation’s rights in the Chinese Patent.
   
3. WARRANTIES AND DISCLAIMERS.
   
3.1. Representations. Activation represents that (a) it is a corporation duly organized and validly existing in the State of Delaware, and (b) that the execution, delivery and performance of this Assignment has been approved by all necessary corporate action on the part of Activation.
   
3.2 Quitclaim; Disclaimer. ACTIVATION MAKES NO REPRESENTATION OR WARRANTY WHATSOEVER, EXPRESS OR IMPLIED, REGARDING EXCELLAGEN, THE APA, THE LICENSE AGREEMENT, OR THE CHINESE PATENT. ACTIVATION IS ASSIGNING AND SHANXI IS ASSUMING ITS RIGHTS UNDER THE LICENSE AGREEMENT AND THE CHINESE PATENT ON AN “AS IS/WHERE IS” BASIS WITH ALL FAULTS AND WITHOUT ANY EXPRESS, IMPLIED OR STATUTORY WARRANTIES WHATSOEVER INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE, ENFORCEABILITY, NON-INFRINGEMENT, OR ARISING FROM COURSE OF PERFORMANCE, DEALING, USAGE OR TRADE.

 

  -2-  
 

 

ARTICLE III. MISCELLANEOUS PROVISIONS.
   
3.1. Further Assurances. Activation shall execute and deliver any instruments and perform any acts which may be necessary to fully effectuate and record in any and all jurisdictions throughout the world the assignment of the rights, titles and interests assigned to Shanxi pursuant to this Assignment.
   
3.2. Assignability. This Agreement will be binding upon and inure to the benefit of the parties named herein and their respective successors and permitted assigns.
   
3.3. Entire Agreement. This Agreement contains the entire understanding among the parties and supersedes any prior written or oral agreements between them respecting the subject matter of this Agreement. There are no representations, agreements, arrangements, or understandings, oral or written, between the parties relating to the subject matter of this Agreement that are not fully set forth herein.
   
3.4 Amendments. This Agreement may not be modified or amended except by a written instrument signed by the parties. In addition, no waiver of any provision of this Agreement will be binding unless set forth in a writing signed by the party granting the waiver.
   
3.5. Governing Law. This Assignment will be construed and enforced in accordance with the laws of the State of New York, without reference to its rules of conflicts of laws.
   
3.6. Venue. Any dispute, controversy or claim with respect to this Agreement will be subject to the exclusive jurisdiction of the courts of the State of New York sitting in the City of New York and the United States District Court for the Southern District of New York. Each party hereto waives to the fullest extent possible, the defense of an inconvenient forum, and each agrees that a final judgment in any action will be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.
   
3.7. Waiver of Jury Trial. EACH OF THE UNDERSIGNED DO HEREBY KNOWINGLY, VOLUNTARILY AND INTENTIONALLY WAIVE THE RIGHT TO TRIAL BY JURY IN ANY ACTION OR PROCEEDING BASED ON OR WITH RESPECT TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED HEREBY OR RELATING OR INCIDENTAL HERETO.
   
3.8. Attorney’s Fees. In the event that any party institutes any legal suit, action or proceeding against the other party arising out of this Agreement, the prevailing party in the suit, action or proceeding shall be entitled to receive in addition to all other damages to which it may be entitled, the costs incurred by such party in conducting the suit, action or proceeding, including reasonable attorneys’ fees and expenses and court costs.
   
3.9 Counterparts. This Agreement may be executed in one or more counterparts, each of which will be deemed to be an original, but all of which will constitute one agreement. Photocopies, facsimile transmissions, or email transmissions of Adobe portable document format files (also known as “PDF” files) of signatures will be deemed original signatures and will be fully binding on the parties to the same extent as original signatures.

 

  -3-  
 

 

IN WITNESS WHEREOF, the Activation has caused this Assignment to be executed by its duly authorized representative as of the date first set forth above.

 

ACTIVATION THERAPEUTICS, INC.

 

by: /s/ Christopher Reinhard   
  Christopher Reinhard  
  Chief Executive Officer  

 

SHANXI TAXUS PHARMACEUTICALS CO., LTD.

 

by: /s/ Jiayue Zhang   
  Jiayue Zhang  
  Chairman and President  

 

  -4-  

 

 

Exhibit 99.1

 

 

Press / Investor Contact:

 

Gene Biotherapeutics Inc.

Tel: (858) 414.1477

Email: creinhard@angionetics.com

 

GENE BIOTHERAPEUTICS SECURES INVESTMENT FROM NOSTRUM PHARMACEUTICALS, LLC

 

SAN DIEGO, CA – May 28, 2020 – Gene Biotherapeutics Inc. (OTC:CRXM, formerly Taxus Cardium Pharmaceuticals Group Inc.) today announced that it has received a strategic investment from Nostrum Pharmaceuticals, LLC (“Nostrum”). Nostrum is the parent of Nostrum Laboratories, Inc., a privately-held pharmaceutical company engaged in the formulation and commercialization of specialty pharmaceutical products and controlled-release, orally administered, branded and generic drug products.

 

On May 22, 2020, Gene Biotherapeutics entered into a Preferred Stock Purchase Agreement with Nostrum selling 1,700,000 shares of newly designated Series B Convertible Preferred Stock, for a total purchase price of $1.7 million.

 

Gene Biotherapeutics will use the proceeds from the sale of the Series B Convertible Preferred Stock to fund working capital requirements in preparation for a Phase 3 clinical trial in the United States for its Generx® product candidate. In addition to its investment, Nostrum’s expertise in the formulation and commercialization of pharmaceutical products is expected to facilitate the administration and completion of the Phase 3 clinical trial on a cost-effective basis.

 

Nirmal Mulye, Ph.D, founder and majority shareholder of Nostrum, stated that “We will initially focus on advancing Generx into Phase 3 clinical and commercial development for the treatment of approximately 1.2 million U.S. patients with refractory angina due to advanced coronary artery disease.” Dr. Mulye further stated that “After its initial clinical success, Gene Biotherapeutics will continue with additional clinical research seeking to expand the medical applications for Ad5FGF-4, and consider the acquisition of other opportunities including new and innovative product candidates and technologies in the gene therapy and cardiovascular biologics spaces.”

 

Under the Preferred Stock Purchase Agreement, Gene Biotherapeutics also agreed to use its best efforts to become current in its reporting obligations under the Securities Exchange Act of 1934, as amended. The company has engaged its independent public accounting firm to complete its outstanding audits to insure compliance with SEC regulations.

 

In connection with the transaction, Gene Biotherapeutics has made changes to its Board of Directors and executive officers.

 

About Nostrum Pharmaceuticals LLC

 

Nostrum Pharmaceuticals, LLC through its subsidiary Nostrum Laboratories, Inc. is engaged in the formulation and commercialization of specialty pharmaceutical products and controlled-release, orally-administered, branded and generic drugs. Pharmaceutical companies are increasingly utilizing controlled-release drug delivery technologies to improve therapy. These technologies allow for the development of “patient-friendly” dosage forms, which reduce frequency of drug administration, thus improving patient compliance. Controlled-release pharmaceuticals can be especially beneficial for certain patient populations such as the elderly, who often require several medications with differing dosage regiments.

 

 

 

 

About the Generx® Ad5FGF-4 Product Candidate

 

The Generx Ad5FGF-4 product candidate is a first in class, single administration disease altering, clinical product candidate for the treatment of patients with myocardial ischemia and refractory angina due to advanced coronary artery disease. The Generx Ad5FGF-4 product candidate has been biologically engineered to enhance blood flow (perfusion) in ischemic regions of the heart by promoting the natural formation and growth of collateral blood vessels. This is achieved by stimulating and augmenting the heart’s innate natural capacity to enlarge pre-existing collateral arterioles, and to form new capillary vessels in ischemic regions of the heart.

 

The Generx Ad5FGF-4 product candidate is biologically engineered using an E1-region deleted, replication deficient adenovirus serotype 5 vector to express the 621 base pair gene encoding human fibroblast growth factor-4 (FGF-4) under the control of a modified cytomegalovirus (CMV) promoter. Ad5FGF-4 has also been engineered to include a signal peptide, which enables secretion of the FGF-4 protein from transfected cells (such as cardiac myocytes).

 

The Generx Ad5FGF-4 product candidate is administered by an interventional cardiologist into the coronary arteries under transient ischemic conditions through the use of a standard balloon catheter during a brief procedure similar to a diagnostic angiogram. The Ad5FGF-4 product candidate is distributed into the microcirculation of the heart and transfects cardiac cells by binding to cell surface coxsackievirus-adenovirus receptors (CAR). The company’s research shows that its catheter-based transient ischemia cardiac delivery technique is essential to expand the cellular gap junctions providing Ad5FGF-4 access to CAR receptors, and use of nitroglycerin boosts cell permeability during administration.

 

Overview of AFFIRM Phase 3 Clinical Study

 

The Ad5FGF-4 product candidate has been cleared by the U.S. FDA for evaluation in a Phase 3 clinical study of patients with refractory angina due myocardial ischemia resulting from late stage coronary artery disease (the “AFFIRM” study). The study has received Fast Track designation by the FDA, recognizing that refractory angina is a significant unmedical need. The AFFIRM clinical study protocol incorporates important research innovations that include: (1) enhanced cardiac delivery procedures utilizing standard balloon catheters, supported by research showing that transient ischemia is necessary for gene transfer to heart cells; and (2) a more comprehensively characterized target patient population based on Ad5FGF-4 responder data from the four prior FDA-cleared clinical studies. The study patient population will include patients with refractory angina and documented clinical evidence of myocardial ischemia within the past 6 months. Patients must have clinically significant limitation of physical activity due to angina (CCS Class 3 or 4) and angina-limited baseline exercise treadmill test (ETT) duration of 3-6 min. The primary efficacy endpoint is improvement in ETT duration at 6 months in patients receiving a single administration of Ad5FGF-4 compared to a placebo control group. Secondary efficacy endpoints include change in CCS angina class, change in weekly angina frequency and nitroglycerin usage, and change in quality of life assessed using the Seattle Angina Questionnaire (SAQ).

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to: (a) statements about the expected use of proceeds from the Nostrum investment; (b) statements about the anticipated benefits to be derived from the strategic relationship with Nostrum; (c) statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials for the company’s Generx product candidate; and (d) statements concerning the company’s ability to complete audits of its financial statements and to regain compliance with its SEC reporting requirements.

 

Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including: (a) unexpected safety or efficacy data observed during preclinical or clinical studies; (b) clinical trial site activation or enrollment rates that are lower than expected; (c) changes in expected or existing competition; (d) changes in the regulatory environment; (e) failure of collaborators to support or advance collaborations or product candidates; (f) unexpected litigation or other disputes; and (g) the company’s need to raise sufficient additional capital to adequately fund ongoing operations. These risks are not exhaustive, the company faces known and unknown risks, described in the company’s periodic filings with the SEC.

 

The forward-looking statements in this press release are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained in this press release to reflect any change in expectations, whether as a result of new information future events, or otherwise.