0001173313 false 0001173313 2022-06-21 2022-06-21 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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): June 21, 2022

 

ABVC BIOPHARMA, INC.

(Exact name of registrant as specified in its charter)

 

Nevada   333-91436   26-0014658
(State or other jurisdiction
of incorporation)
  (Commission File Number)   (IRS Employer
Identification No.)

 

44370 Old Warm Springs Blvd.

Fremont, CA

  94538
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number including area code: (510) 668-0881

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol   Name of each exchange on which registered
Common Stock, par value $0.001 per share   ABVC   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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

 

Item 8.01 Other Information

 

On June 10, 2022, ABVC BioPharma, Inc. (the “Company”) expanded its co-development partnership with Rgene Corporation (“Rgene”). BioKey, Inc., a California corporation and wholly-owned subsidiary of the Company (“BioKey”), entered into a Clinical Development Service Agreement with Rgene (“Service Agreement”) to guide certain Rgene drug products, RGC-1501 for the treatment of Non-Small Cell Lung Cancer (NSCLC), RGC-1502 for the treatment of pancreatic cancer and RGC 1503 for the treatment of colorectal cancer patients, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements (the “Rgene Studies”). Under the terms of the Service Agreement, BioKey is eligible to receive payments totaling up to $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained during the agreement period.

 

Through a series of transactions over the past 5 years, the Company and Rgene have co-developed the three drug products covered by the Service Agreement, which has resulted in the Company owning 31.62% of Rgene.

 

As part of the Rgene Studies, the Company agreed to loan $1.0 million to Rgene, for which Rgene has provided the Company with a 5% working capital convertible loan (the “Note”). If the Note is fully converted, the Company will own an additional 6.4% of Rgene. Rgene will repay the Company in two equal installments in the second and third quarter of fiscal 2022. The Company may convert the Note at any time into shares of Rgene’s common stock at either (i) a fixed conversion price equal to $1.00 per share or (ii) 20% discount of the stock price of the then most recent offering, whichever is lower; the conversion price is subject to adjustment as set forth in the Note. The Note includes standard events of default, as well as a cross default provision pursuant to which a breach of the Service Agreement will trigger an event of default under the Note if not cured after 5 business days of written notice regarding the breach is provided. Upon an event of default, the outstanding principal and any accrued and unpaid interest shall be immediately due and payable.    

 

Rgene has further agreed, effective July 1, 2022, to provide the Company with a seat on Rgene’s Board of Directors until the loan is repaid in full. The Company has nominated Dr. Jiang, its Chief Strategy Officer and Director to occupy that seat; Dr. Jiang is also one of the Company’s largest shareholders, owning 12.8% of the Company.

 

BLEX 404, a new drug under clinical development covered by the Service Agreement, is extracted from Maitake mushroom (Grifola frondosa), an edible mushroom. Its immunological effects and the safety have been demonstrated in two Phase I/II clinical studies performed at Memorial Sloan Kettering Cancer Center (MSKCC) with breast cancer and myelodysplastic syndromes (MDS) patients.

 

The Service Agreement shall remain in effect until the expiration date of the last patent and automatically renew for 5 more years unless terminated earlier by either party with six months written notice. Either party may terminate the Service Agreement for cause by providing 30 days written notice.

 

On June 21, 2022, the Company issued a press release regarding the Rgene Studies. A copy of the press release is being filed as Exhibit 99.1 attached hereto and is incorporated by reference herein.

 

The Rgene Studies is a related party transaction and will be conducted at arm’s length. In addition to the Company’s board of directors approving the Rgene Studies, the Company’s audit committee and special committee also approved it. The Board believes it is in the Company’s best interest for BioKey to proceed with the Rgene Studies.

 

A copy of the Service Agreement and Note is attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively and is incorporated by reference herein.

 

1

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number
  Exhibit
10.1   Clinical Development Service Agreement with Rgene (portions of the exhibit have been omitted because they (i) are not material and (ii) is the type of information that the registrant treats as private or confidential.)
10.2   Promissory Note dated June 16, 2022
99.1   Press Release dated June 21, 2022
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

2

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

  

  ABVC BioPharma, Inc.
     
June 21, 2022 By: /s/ Howard Doong
    Howard Doong
    Chief Executive Officer

 

 

3

 

Exhibit 10.1

 

**CERTAIN INFORMATION, MARKED BY [***], HAS BEEN EXCLUDED BECAUSE IT BOTH (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.**

 

Clinical Development Service Agreement

 

This Clinical Development Service Agreement (“Agreement”) shall be signed by the following parties on or before June 10, 2022:

 

RGENE Corporation. (“RGENE”), a company organized and existing under the Laws of Taiwan, Republic of China, with its registered office at 5F, No. 148, Songjiang Rd., Zhongshan Dist., Taipei City 104492, Taiwan (R.O.C.) and

 

BioKey, Inc. (“BioKey”), a company incorporated under the Laws of California and having its principal place of business at 44370 Old Warm Springs Blvd., Fremont, CA 94538, USA

 

RGENE and BioKey shall be referred to individually as a “Party” and collectively as the “Parties”.

 

Whereas RGENE has been established its own technology and owned exclusive licensing rights to use the proprietary technologies and confidential information for the following products (“Product”):

 

1.RGC-1501: NSCLC

 

2.RGC-1502: Pancreatic Cancer

 

3.RGC-1503: Colorectal Cancer

 

Whereas BioKey is a CDMO service provider for nutritional and pharmaceutical products, as well as medical devices.

 

Whereas BioKey is willing to provide clinical development service of Product in the Field (as defined hereafter) to RGENE;

 

Whereas RGENE agrees to use BioKey’s experience and capability and enters into the Agreement. Herein, it is agreed as follows:

 

1. Definitions and Interpretation

 

1.1 “Confidential Information” shall mean all confidential, proprietary, trade secret, or non-public information, data and experience, whether of scientific, technical, engineering, operational or economic nature, disclosed by one of the Parties (the “Disclosing Party”) to the other Party (the “Recipient”) for this Clinical Development Service Agreement.

 

1.2 “Confidential Materials” shall mean any document, diskette, tape, writing or other tangible item to the extent that such item contains or embodies any Confidential Information, whether in printed, handwritten, electronic, coded, magnetic or other form and whether delivered by a Disclosing Party or made by a Recipient.

 

CONFIDENTIAL1RGENE /BioKey

 

 

1.3 “Data” shall mean all research data, technical data, test and development data, CMC (chemistry, manufacturing and control), pre-clinical and clinical data, formulations, processes, ideas, protocols, regulatory files and the like which are developed by either Party under the Development Program in connection with its performance of this Clinical Development Agreement.

 

1.4 “Field” shall mean drug and therapeutic use of the Product based upon the Health Registration Approval and in no event include the use of the Product for functional food, health food nor health supplement.

 

1.5 “Intellectual Property” shall mean any patent, copyright, mask work, trade secret, trademark or other proprietary right; including, without limitation, all domestic and foreign applications and registrations therefore, and all renewals and extensions relating thereto; with respect to patent application and patents, all domestic and foreign divisional, continuations, continuations-in-part, substitutions, reissues, re-examinations, renewals and extensions relating thereto; all goodwill associated therewith, and all benefits, privileges, causes of action and remedies relating to any of the foregoing proprietary rights (including, without limitation, the right to use for all past, current or future infringements or violations of the foregoing proprietary rights, and the right to settle and retain proceeds from any such actions).

 

1.6 “CTA” means clinical trial application to be required before execution of any clinical trial;

 

1.7 “Approval” means any and all approvals, permits, operating licenses, ratifications, registrations, consents, record-filings or other form of permission issued by any regulatory or government body in USTaiwan or PRC in the exercise of its functions under the applicable law, and “Approve” shall be construed accordingly;

 

1.8 “Clinical Development Service” means all the strategic planning, project management and coordination provided by ABVC for the said service.

 

1.9 “Pass-through Cost” means all the incurred cost during the execution of clinical studies including the clinical drug supplies and drug formulation development.

 

2. Agreement to BioKey

 

2.1 RGENE agrees to use BioKey’s experience and capability and enters into the Clinical Development Service Agreement.

 

CONFIDENTIAL2RGENE /BioKey

 

 

3. Payment

 

3.1 Total service payment to BioKey for BioKey’s Clinical Development Service is three million U .S. dollars (USD3,000,000).

 

3.2 Per the good relationship in between both Parties, the payment shall be in installments as follow:

 

3.2.1 First payment: [***]% in cash of total contract amount shall be paid no later than [***] ([***]) days after the Effective Date.

 

3.2.2 After making first payment, RGENE will deliver all Data to BioKey within [***] ([***]) days.

 

3.2.3 The rest [***]% of total amount: RGENE should pay according to the Service milestones described in Exhibit A. BioKey will issue an invoice for the applicable amount payable for each milestone and present the deliverables evidencing the completion of such milestone.

 

3.3 If any payment made under this Agreement shall be subject to withholding tax under the applicable law, each payment will be less any such applicable withholding tax.

 

4. Development responsibilities

 

4.1 BioKey will utilize its global clinical development capability and be responsible to develop Product to the completions of Phase II clinical studies under US IND.

 

4.2 RGENE will pay BioKey the service fee according to the deliverables described in 3.2.3 (see Exhibit A).

 

5. Confidentiality

 

The Parties agree that during the term of this Service Agreement and thereafter [***] Confidential Information exchanged during this Service Agreement and will be accorded confidential treatment and shall not be used for any other purpose than the performance of this Service Agreement and the exercise of the rights herein provided.

 

The Recipient’s obligation hereunder shall not apply to:

 

(a) Information which is now or hereafter becomes part of the public domain in other ways than by faults, acts or omissions of the Recipient;

 

(b) Information which the Recipient can show by sufficient evidence was in its own possession prior to the time of receipt from the Disclosing Party or is independently developed by or for the Recipient without reliance upon or use of any of the Disclosing Party’s Confidential Information or Confidential Materials;

 

CONFIDENTIAL3RGENE /BioKey

 

 

(c) Information which is required to be disclosed by statute or governmental rule or regulation or by a court or administrative body.

 

Nothing herein shall prevent RGENE or BioKey from disclosing any of such Confidential Information to the extent that (i) such Confidential Information is disclosed in connection with the securing of the IND or NDA, (ii) such information is disclosed for the purpose of obtaining a governmental approval for the manufacture and/or sale of or effectuating the development, marketing and promotion of any Product and/or API or (iii) such information is disclosed to the Sub-licensee(s) of RGENE or BioKey for the use thereof upon executing a separate confidentiality disclosure agreement.

 

6. Duration and Termination

 

6.1 Duration

 

This Collaborative Agreement shall, once signed by both Parties, remain in effect until the expiration date of the last patent and automatically renew for [***] unless either Party gives the other Party [***] written notice of termination prior to the expiration date of the term.

 

6.2 Termination for Cause

 

This Collaborative Agreement can be terminated by either Party for any of the following causes by giving to the other Party (“Breaching Party”) [***] written notice of its intention to terminate for such causes as follows:

 

(a)If Breaching Party materially breaches any provision of this Agreement and such breach is not cured within [***] following the written notice by Non-breaching Party; or

 

(b)If a Party is the subject of a voluntary petition in bankruptcy or any voluntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors, if such petition or proceeding is not dismissed within [***] of filing, or becomes the subject of any involuntary petition in bankruptcy or any involuntary proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors, if such petition or proceeding is not dismissed within [***] of filling.

 

Termination is not the sole or exclusive remedy under this Agreement and, whether or not termination is affected; all other rights and remedies at law or equity will remain available.

 

CONFIDENTIAL4RGENE /BioKey

 

  

7. Miscellaneous

 

7.1 Notice

 

All notices, requests, demands and other communications to be given in accordance with this Agreement shall be given in writing and/or by prepaid registered mail or receipt return requested to the other Party at the following addresses:

 

If to RGENE Corporation:

 

RGENE Corporation

5F, No. 148, Songjiang Rd., Zhongshan Dist., Taipei City 104492, Taiwan (R.O.C.)

Attention: Syi Su, Ph.D.

Title: CEO

 

If to BioKey:

 

BioKey, Inc.

44370 Old Warm Springs Blvd., Fremont, CA 94538

Attention: Chi-Hsin Richard King, Ph.D.

Title: CSO

 

7.2 Applicable Law

 

This Agreement and any disputes arising out of or relating thereto, including, without limitation, its interpretation, construction, performance, and enforcement shall be governed by and construed in accordance with the laws of Taiwan.

 

7.3 Dispute Dissolution

 

Both Parties shall endeavor to settle amicably and promptly any disputes, controversies and differences which may arise between the Parties out of or in relation to this Agreement or any breach thereof. In case such an amicable settlement is not attained, the matter shall be finally settled by arbitration according to the Rules of Conciliation and Arbitration of the International Chamber of Commerce, which rules shall be deemed incorporated into this paragraph. The place of arbitration will be Taipei (Taiwan).

 

7.4 Addendum or amendment may be added upon mutual agreement of the parties.

 

CONFIDENTIAL5RGENE /BioKey

 

 

IN WITNESS WHEREOF the Parties hereto have caused this Collaborative Agreement to be executed, in duplicate, each Party taking a copy, as of the Effective Date.

 

RGENE Corporation

 

By: /s/ Syi Su, Ph.D.  
     
Name:  Syi Su, Ph.D.  
     
Title: CEO  
     
Date: June 8, 2022  

 

BioKey, Inc.

 

By: /s/ TS Jiang  
     
Name:  TS Jiang, Ph. D., EMBA  
     
Title: CEO  
     
Date: 6/10/2022  

 

CONFIDENTIAL6RGENE /BioKey

 

 

Exhibit A

 

Milestone payments based upon the development stages of Product

 

Within [***] days after the Effective Date [***]% of Total Payment
(1) An additional US FDA/TFDA IND approval [***]% of Total Payment

(2) The first Phase IIA under US FDA/TFDA

completion

[***]% of Total Payment

(3) The first Phase IIB under US FDA/TFDA

completion

[***]% of Total Payment
TOTAL 100%

 

CONFIDENTIAL7RGENE /BioKey

 

Exhibit 10.2

 

RGENE Corporation 

Promissory Note

 

Principal Amount: $1,000,000 U.S. Dollars    Issuance Date:  June 16, 2022

 

FOR VALUE RECEIVED,  RGENE Corporation, a Taiwan corporation (the “Company”), hereby promises to pay to the order of ABVC BioPharma, Inc. or its registered assigns (“Holder”) the amount set out above as the Principal Amount (the “Principal”) when due, whether upon the Maturity Date (as defined below) or earlier in accordance with the terms hereof, and to pay interest (“Interest”) on any outstanding Principal at the applicable Interest Rate (as defined below) from the date set out above as the Issuance Date (the “Issuance Date”) until the same becomes due and payable, whether upon the Maturity Date, acceleration or otherwise (in each case in accordance with the terms hereof). The amount set out above will be delivered from the Holder to the Company by 2 installments, $500,000 in Q2-2022 and remaining $500,000 in Q3-2022. This Promissory Note, including all Promissory Notes issued in exchange, transfer or replacement hereof, is referred to as this “Note”. Certain capitalized terms used herein are defined in Section 19.

 

1. PAYMENTS OF PRINCIPAL. Subject to the conversion of the Note as described in Section 5, the Company shall pay to the Holder an amount in cash representing all outstanding Principal and accrued and unpaid Interest on June 15, 2023, the twelve (12) month anniversary of the Issuance Date (the “Maturity Date”).

 

2. INTEREST RATE. Interest shall accrue on the unpaid principal balance of this Note at the rate of five percent (5%) per annum (the “Interest Rate”). Interest shall be calculated from and include the Issuance Date and shall be calculated on an actual/360-day basis and shall be payable on the Maturity Date.

 

3. RIGHTS UPON EVENT OF DEFAULT.

 

(a) Event of Default. Each of the following events shall constitute an “Event of Default”:

 

(i) the Company’s failure to pay to the Holder any amount of Principal, Interest, or other amounts when and as due under this Note or any other Transaction Document or any other agreement, document, certificate or other instrument delivered in connection with the transactions contemplated hereby and thereby, except, in the case of a failure to pay Interest when and as due, in which case only if such failure remains uncured for a period of at least five (5) days from the date when a written notice regarding the failure to pay Interest is given by the Holder of the Note;

 

(ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings for the relief of debtors shall be instituted by or against by a third party, shall not be dismissed within thirty (30) days of their initiation;

 

1

 

 

(iii) the commencement by the Company of a voluntary case or proceeding under any applicable federal, state or foreign bankruptcy, insolvency, reorganization or other similar law or of any other case or proceeding to be adjudicated as bankrupt or insolvent, or the consent by it to the entry of a decree, order, judgment or other similar document in respect of the Company in an involuntary case or proceeding under any applicable federal, state or foreign bankruptcy, insolvency, reorganization or other similar law or to the commencement of any bankruptcy or insolvency case or proceeding against it, or the filing by it of a petition or answer or consent seeking reorganization or relief under any applicable federal, state or foreign law, or the consent by it to the filing of such petition or to the appointment of or taking possession by a custodian, receiver, liquidator, assignee, trustee, sequestrator or other similar official of the Company or of any substantial part of their properties, or the making by it of an assignment for the benefit of creditors, or the execution of a composition of debts, or the occurrence of any other similar federal, state or foreign proceeding, or the admission by it in writing of its inability to pay its debts generally as they become due, the taking of corporate action by the Company in furtherance of any such action or the taking of any action by any Person to commence a UCC foreclosure sale or any other similar action under federal, state or foreign law;

 

(iv) the entry by a court of (i) a decree, order, judgment or other similar document in respect of the Company of a voluntary or involuntary case or proceeding under any applicable federal, state or foreign bankruptcy, insolvency, reorganization or other similar law or (ii) a decree, order, judgment or other similar document adjudging the as bankrupt or insolvent, or approving as properly filed a petition seeking liquidation, reorganization, arrangement, adjustment or composition of or in respect of the Company under any applicable federal, state or foreign law or (iii) a decree, order, judgment or other similar document appointing a custodian, receiver, liquidator, assignee, trustee, sequestrator or other similar official of the Company or of any substantial part of their property, or ordering the winding up or liquidation of its affairs, and the continuance of any such decree, order, judgment or other similar document or any such other decree, order, judgment or other similar document unstayed and in effect for a period of thirty (30) consecutive days;

   

(v) other than as specifically set forth in another clause of this Section 3(a), the Company breaches any representation, warranty, covenant or other term or condition of any Transaction Document, except, in the case of a breach of a covenant or other term or condition that is curable, only if such breach remains uncured for a period of five (5) consecutive Business Days from the date when a written notice of such breach is provided;

 

(b) Notice of an Event of Default. As soon as possible and in any event within seven (7) days after the Company becomes aware that an Event of Default has occurred and has not been cured, the Company shall notify the Holder in writing of the nature, extent and time of and the facts surrounding such Event of Default, and the action, if any, that the Company proposes to take with respect to such Event of Default.

 

2

 

 

(c) Acceleration of Maturity Date. Upon the occurrence of an Event of Default, the entire unpaid and outstanding Principal plus any accrued and unpaid Interest shall be immediately due and payable.

 

4. NONCIRCUMVENTION. The Company hereby covenants and agrees that the Company will not, by amendment of its Certificate of Incorporation, or through any reorganization, transfer of assets, consolidation, merger, scheme of arrangement, dissolution, issue or sale of securities, or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Note, and will at all times in good faith carry out all of the provisions of this Note and take all action as may be required to protect the rights of the Holder of this Note.

 

5. PREPAYMENT; CONVERSION.

 

(a) Voluntary Prepayment. The Company may prepay the outstanding Principal and accrued but unpaid interest of this Note at any time, in whole or in part, without penalty or prepayment.

 

(b) Conversion. At any time during the Conversion Period as defined below, the Holder may convert the unpaid and outstanding Principal into shares of the Company’s common stock at either (i) a fixed conversion price equal to US $1 per share of Common Stock (the “Conversion Price”) or (ii) 20% discount of the stock price for the most recent offerings, whichever is lower. The Conversion Period shall commence on the Issuance Date and end on the Maturity Date of this Note.

 

(c) Mechanics of Conversion.

 

i. Conversion Shares Issuable Upon Conversion. The number of shares issuable upon a conversion (the “Conversion Shares”) pursuant to Section 5(b) hereunder shall be determined by the quotient obtained by dividing the outstanding principal amount of this Note and accrued but unpaid interest thereon to be converted by the Conversion Price.

 

ii. Delivery of Certificate Upon Conversion. Not later than seven (7) Business Days after each conversion date (the “Share Delivery Date”), the Company shall deliver, or cause to be delivered, to the Holder a certificate or certificates representing the Conversion Shares being acquired upon the conversion of this Note, in whole or in part.

 

iii. Fractional Shares. No fractional shares or scrip representing fractional shares shall be issued upon the conversion of this Note. As to any fraction of a share which the Holder would otherwise be entitled to receive upon such conversion, the Company 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.

 

3

 

 

(d) Certain Adjustments.

 

i. Stock Dividends and Stock Splits. If the Company, at any time while this Note is outstanding: (i) subdivides outstanding shares of common stock into a larger number of shares, (ii) combines (including by way of a reverse stock split) outstanding shares of common stock into a smaller number of shares or (iii) issues, in the event of a reclassification of shares of the common stock, any shares of capital stock of the Company, then the Fixed 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 Company) 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 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.

 

ii. Subsequent Rights Offerings. In addition to any adjustments pursuant to Section 5(d)(i) above, if at any time while the Note is outstanding the Company 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 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 this Note (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.

 

iii. Pro Rata Distributions. During such time as this Note is outstanding, if the Company shall declare or make any dividend or other distribution of its assets (or rights to acquire its assets) to holders of shares of common stock, by way of return of capital or otherwise (including, without limitation, any distribution of cash, 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 Note, 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 exercise of this Note (without regard to any limitations on exercise hereof) 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.

 

4

 

 

iv. Calculations. All calculations under this Section 5(d) 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 5(d), 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 Borrower) issued and outstanding.

 

v. Notice of Adjustment to Conversion Price. Whenever the Conversion Price is adjusted pursuant to any provision of this Section, the Company shall promptly deliver to each Holder a notice setting forth the Fixed Conversion Price with three (3) Business Days after such adjustment and setting forth a brief statement of the facts requiring such adjustment. Failure to provide such notice shall constitute an Event of Default, subject to be a three (3) Business Days’ curing period.

 

6. COVENANTS. Until so long as no Principal or accrued but unpaid interest remains outstanding:

 

(a) Preservation of Existence. The Company shall maintain and preserve its existence, rights and privileges, and become or remain duly qualified and in good standing in each jurisdiction in which the character of the properties owned or leased by it or in which the transaction of its business makes such qualification necessary.

 

(b) Use of Proceeds. The proceeds from this Note will be used for research and development expenses, as well as the working capital.

 

7. Conversion Limitation. The Company shall not effect any conversion of this Note, and a Holder shall not have the right to convert any portion of this Note, to the extent that after giving effect to the conversion set forth on the applicable Notice of Conversion, the Holder (together with the Holder's Affiliates, and any Persons acting as a group together with the Holder or any of the Holder's Affiliates) would beneficially own in excess of the Beneficial Ownership Limitation (as defined below).  For purposes of the foregoing sentence, the number of shares of Common Stock beneficially owned by the Holder and its Affiliates shall include the number of shares of Common Stock issuable upon conversion of this Note with respect to which such determination is being made, but shall exclude the number of shares of Common Stock which are issuable upon (i) conversion of the remaining, unconverted principal amount of this Note beneficially owned by the Holder or any of its Affiliates and (ii) exercise or conversion of the unexercised or unconverted portion of any other securities of the Company subject to a limitation on conversion or exercise analogous to the limitation contained herein beneficially owned by the Holder or any of its Affiliates.  Except as set forth in the preceding sentence, for purposes of this Section, beneficial ownership shall be calculated in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder.  To the extent that the limitation contained in this Section applies, the determination of whether this Note is convertible (in relation to other securities owned by the Holder together with any Affiliates) and of which principal amount of this Note is convertible shall be in the sole discretion of the Holder, and the submission of a Notice of Conversion shall be deemed to be the Holder's determination of whether this Note may be converted (in relation to other securities owned by the Holder together with any Affiliates) and which principal amount of this Note is convertible, in each case subject to the Beneficial Ownership Limitation. To ensure compliance with this restriction, the Holder will be deemed to represent to the Company each time it delivers a Notice of Conversion that such Notice of Conversion has not violated the restrictions set forth in this paragraph and the Company shall have no obligation to verify or confirm the accuracy of such determination. In addition, a determination as to any group status as contemplated above shall be determined in accordance with Section 13(d) of the Exchange Act and the rules and regulations promulgated thereunder. For purposes of this Section, in determining the number of outstanding shares of Common Stock, the Holder may rely on the number of outstanding shares of Common Stock as stated in the most recent of the following: (i) the Company's most recent periodic or annual report filed with the Commission, as the case may be, (ii) a more recent public announcement by the Company, or (iii) a more recent written notice by the Company or the Company's transfer agent setting forth the number of shares of Common Stock outstanding.  Upon the written or oral request of a Holder, the Company shall within two Trading Days confirm orally and in writing to the Holder the number of shares of Common Stock then outstanding.  In any case, the number of outstanding shares of Common Stock shall be determined after giving effect to the conversion or exercise of securities of the Company, including this Note, by the Holder or its Affiliates since the date as of which such number of outstanding shares of Common Stock was reported. The “Beneficial Ownership Limitation” shall be 4.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock issuable upon conversion of this Note held by the Holder.  The Holder, upon not less than 61 days' prior notice to the Company, may increase or decrease the Beneficial Ownership Limitation provisions of this Section, provided that the Beneficial Ownership Limitation in no event exceeds 9.99% of the number of shares of the Common Stock outstanding immediately after giving effect to the issuance of shares of Common Stock upon conversion of this Note held by the Holder and the Beneficial Ownership Limitation provisions of this Section shall continue to apply.  Any such increase or decrease will not be effective until the 61st day after such notice is delivered to the Company.  The Beneficial Ownership Limitation provisions of this paragraph shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section to correct this paragraph (or any portion hereof) which may be defective or inconsistent with the intended Beneficial Ownership Limitation contained herein or to make changes or supplements necessary or desirable to properly give effect to such limitation. The limitations contained in this paragraph shall apply to a successor holder of this Note.

  

5

 

 

8. AMENDING THE TERMS OF THIS NOTE. The prior written consent of the Holder shall be required for any change or amendment to this Note. 

 

9. TRANSFER. This Note may be offered, sold, assigned or transferred by the Holder with the written consent of the Company, which such consent shall not be unreasonably withheld.

 

10. REISSUANCE OF THIS NOTE.

 

(a) Transfer. If this Note is to be transferred, the Holder shall surrender this Note to the Company, whereupon the Company will forthwith issue and deliver upon the order of the Holder a new Note (in accordance with Section 10(d)), registered as the Holder may request, representing the outstanding Principal being transferred by the Holder and, if less than the entire outstanding Principal is being transferred, a new Note (in accordance with Section 10(d)) to the Holder representing the outstanding Principal not being transferred. The Holder and any assignee, by acceptance of this Note, acknowledge and agree that, by reason of prepayment of any portion of this Note, the outstanding Principal represented by this Note may be less than the Principal stated on the face of this Note.

 

(b) Lost, Stolen or Mutilated Note. Upon receipt by the Company of evidence reasonably satisfactory to the Company of the loss, theft, destruction or mutilation of this Note (as to which a written certification and the indemnification contemplated below shall suffice as such evidence), and, in the case of loss, theft or destruction, of any indemnification undertaking by the Holder to the Company in customary and reasonable form and, in the case of mutilation, upon surrender and cancellation of this Note, the Company shall execute and deliver to the Holder a new Note (in accordance with Section 10(d)) representing the outstanding Principal.

 

(c) Note Exchangeable for Different Denominations. This Note is exchangeable, upon the surrender hereof by the Holder at the principal office of the Company, for a new Note or Notes (in accordance with Section 10(d) and in principal amounts of at least $1,000) representing in the aggregate the outstanding Principal of this Note, and each such new Note will represent such portion of such outstanding Principal as is designated by the Holder at the time of such surrender.

 

(d) Issuance of New Notes. Whenever the Company is required to issue a new Note pursuant to the terms of this Note, such new Note (i) shall be of like tenor with this Note, (ii) shall represent, as indicated on the face of such new Note, the Principal remaining outstanding (or in the case of a new Note being issued pursuant to Section 10(a) or Section 10(c), the Principal designated by the Holder which, when added to the principal represented by the other new Notes issued in connection with such issuance, does not exceed the Principal remaining outstanding under this Note immediately prior to such issuance of new Notes), (iii) shall have an issuance date, as indicated on the face of such new Note, which is the same as the Issuance Date of this Note, (iv) shall have the same rights and conditions as this Note, and (v) shall represent accrued and unpaid Interest, from the Issuance Date.

 

6

 

 

11. REMEDIES, CHARACTERIZATIONS, OTHER OBLIGATIONS, BREACHES AND INJUNCTIVE RELIEF. The remedies provided in this Note shall be cumulative and in addition to all other remedies available under this Note and any of the other Transaction Documents at law or in equity (including a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the Holder’s right to pursue actual and consequential damages for any failure by the Company to comply with the terms of this Note.

  

12. CONSTRUCTION; HEADINGS. This Note shall be deemed to be jointly drafted by the Company and the Holder and shall not be construed against any Person as the drafter hereof. The headings of this Note are for convenience of reference and shall not form part of, or affect the interpretation of, this Note. Terms used in this Note but defined in the other Transaction Documents shall have the meanings ascribed to such terms on the Closing Date in such other Transaction Documents unless otherwise consented to in writing by the Holder.

 

13. FAILURE OR INDULGENCE NOT WAIVER. No failure or delay on the part of the Holder in the exercise of any power, right or privilege hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any such power, right or privilege preclude other or further exercise thereof or of any other right, power or privilege. No waiver shall be effective unless it is in writing and signed by an authorized representative of the waiving party.

 

14. NOTICES; CURRENCY; PAYMENTS.

 

(a) Notices. Any notice or other communication required or permitted to be given hereunder shall be in writing sent by mail, facsimile with printed confirmation, nationally recognized overnight carrier or personal delivery and shall be effective upon actual receipt of such notice, to the following addresses until notice is received that any such address or contact information has been changed:

 

To the Company: RGENE Corporation.

                                5F, No. 148, Songjiang Rd., Zhongshan Dist., Taipei

                                City 104492, Taiwan (R.O.C.)

 

 

To Holder:             ABVC BioPharma, Inc.

                                 44370 Old Warm Springs Blvd.

                                 Fremont, CA 94538

 

(b) Currency. All dollar amounts referred to in this Note are in United States Dollars (“U.S. Dollars”), and all amounts owing under this Note shall be paid in U.S. Dollars. All amounts denominated in other currencies (if any) shall be converted in the U.S. Dollar equivalent amount in accordance with the Exchange Rate on the date of calculation (each, a “US Dollar Equivalent”). “Exchange Rate means, in relation to any amount of currency to be converted into U.S. Dollars pursuant to this Note, the U.S. Dollar exchange rate as published in the Wall Street Journal on the relevant date of calculation (it being understood and agreed that where an amount is calculated with reference to, or over, a period of time, the date of calculation shall be the final date of such period of time).

 

7

 

 

(c) Payments. Whenever any payment of cash is to be made by the Company to any Person pursuant to this Note, unless otherwise expressly set forth herein, such payment shall be made in lawful money of the United States of America by a certified check drawn on the account of the Company and sent via overnight courier service to such Person at such address as previously provided to the Company in writing (which address, in the case of each of the Purchasers, shall initially be as set forth in the Securities Purchase Agreement), provided that the Holder may elect to receive a payment of cash via wire transfer of immediately available funds by providing the Company with prior written notice setting out such request and the Holder’s wire transfer instructions. Whenever any amount expressed to be due by the terms of this Note is due on any day which is not a Business Day, the same shall instead be due on the next succeeding day which is a Business Day.

 

15. CANCELLATION. After all Principal, accrued Interest, and other amounts at any time owed on this Note have been paid in full or converted in full, this Note shall automatically be deemed canceled, shall be surrendered to the Company for cancellation and shall not be reissued.

 

16. WAIVER OF NOTICE. To the extent permitted by law, the Company hereby irrevocably waives demand, notice, presentment, protest and all other demands and notices in connection with the delivery, acceptance, performance, default or enforcement of this Note.

 

17. GOVERNING LAW. This Note shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to its principles regarding conflicts of law. Each party agrees that all legal proceedings concerning the interpretation, enforcement and defense of the transactions contemplated by any of the Transaction Documents (whether brought against a party hereto or its respective Affiliates, directors, officers, shareholders, employees or agents) shall be commenced in the state and federal courts sitting in the City of New York, Borough of Manhattan). 

 

18. MAXIMUM PAYMENTS. Nothing contained herein shall be deemed to establish or require the payment of a rate of interest or other charges in excess of the maximum permitted by applicable law. In the event that the rate of interest required to be paid or other charges hereunder exceed the maximum permitted by such law, any payments in excess of such maximum shall be credited against amounts owed by the Company to the Holder and thus refunded to the Company.

 

19. CERTAIN DEFINITIONS. For purposes of this Note, the following terms shall have the following meanings:

 

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

 

8

 

 

(b)  “Business Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City of New York are authorized or required by law to remain closed.

   

(c)“Maturity Date” shall mean the twelve (12) months anniversary after the Issuance Date.

  

(d)Person” means “person” as such term is used for purposes of Section 13(d) or 14(d) of the Securities Exchange Act of 1934, as amended, including any individual, corporation, limited liability company, partnership, trust, unincorporated organization, government or any agency or political subdivision thereof, or any other entity or any group of persons.

 

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

 

(f)“Transaction Documents” means, collectively, the Notes, the Securities Purchase Agreement and any other agreements and instruments entered into or delivered by any of the parties hereto in connection with the transactions contemplated hereby and thereby, as may be amended from time to time.

 

[signature page follows]

 

9

 

 

IN WITNESS WHEREOF, the Company has caused this Note to be duly executed as of the Issuance Date set out above.

 

  RGENE Corporation.
       
  By:   /s/ Syi Su, Ph.D.
    Name:  Syi Su, Ph.D.
    Title: Chief Executive Officer

 

 

 

10

 

 

Exhibit 99.1

 

ABVC BioPharma Expands Co-Development Partnership with Rgene Corporation

 

 

 

Fremont, CA (June 21, 2022) – ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that it has expanded its co-development partnership with Rgene Corporation. BioKey, ABVC’s wholly owned subsidiary based in Fremont, California, has entered into a Clinical Development Service Agreement with Rgene to guide three Rgene drug products, RGC-1501 for the treatment of Non-Small Cell Lung Cancer (NSCLC), RGC-1502 for the treatment of pancreatic cancer and RGC 1503 for the treatment of colorectal cancer patients, through completion of Phase II clinical studies under U.S. FDA IND regulatory requirements. Under the terms of the new Services Agreement, BioKey is eligible to receive payments totaling $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained during the agreement period.

 

Through a series of transactions over the past 5 years, ABVC and Rgene have co-developed the three drug products covered by the new Services Agreement resulting in ABVC owning 31.62% of Rgene. In a separate agreement, ABVC, will provide a one year, $1.0 million, working capital convertible loan to Rgene that, if fully converted, would result in ABVC owning an additional 6.4% of Rgene.  Rgene has further agreed, effective July 1, 2022, to provide a seat on the Rgene Board of Directors for Dr. TS Jiang until the loan is repaid in full.

 

BLEX 404, the new drug under clinical development covered by the service agreement, is extracted from Maitake mushroom (Grifola frondosa), an edible mushroom. Its immunological effects and the safety have been demonstrated in two Phase I/II clinical studies performed at Memorial Sloan Kettering Cancer Center (MSKCC) with breast cancer and myelodysplastic syndromes (MDS) patients.

 

“We are pleased to enter into this clinical development service contract with Rgene to advance three new oncology programs with our BLEX 404 drug”, said Dr. Howard Doong, Chief Executive Officer of the Company; “In addition, this contract will greatly enhance BioKey financial profitability going forward.”

 

About ABVC BioPharma

 

ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, it is focused on utilizing its licensed technology to conduct proof-of-concept trials through Phase II of the clinical development process at world-famous research institutions (such as Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center). For Vitargus®, the company intends to conduct the clinical trials through Phase III at various locations throughout the globe.

 

Forward-Looking Statements

 

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Contact:

 

ICR, LLC

Lucy Peng

Phone: +1 646-677-1872

Email: Lucy.Peng@icrinc.com