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 30, 2017 (May 26, 2017)

 

AMERICAN BRIVISION (HOLDING) CORPORATION
(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.)

 

11 Sawyers Peak Drive

Goshen, NY 10924

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code:  (845) 291-1291

 

 

 

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)

 

 

 

 

 

Item 8.01. Other Events.

 

American BriVision Corporation (the “Company”, “we” or “us”) holds the exclusive global license from BioLite Inc. (“BioLite”) for drug and therapeutic use of the Sixth Product according to the Addendum, which was entered on January 12 2017, to the collaborative agreement previously entered with BioLite on December 29, 2015, as amended May 6, 2016.

 

On May 26, 2017, we entered into a co-development agreement (the “Co-Dev Agreement”) with Rgene Corporation, a corporation incorporated under the laws of Taiwan (along with “Rgene”, collectively the “Parties”), to co-develop and commercialize certain products that are included in the Sixth Product as defined in the Addendum.

 

Under the terms of the Co-Dev Agreement, Rgene will pay to the Company $3,000,000 in cash or stock by August 15, 2017 in three installments. The Company is entitled to receive 50% of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both Parties.

 

The foregoing descriptions of the Co-Dev Agreement are summaries and are qualified in their entirety by reference to such document, which is filed herewith as Exhibits 99.1 and is incorporated herein by reference.

 

Forward Looking Statements

 

This Form 8-K contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are generally identified by the words “will,” “expects,” “anticipates,” “believes,” “estimates” or similar expressions. These forward-looking statements reflect management’s view of future events and are subject to risks, uncertainties, assumptions and other important factors, many of which may be beyond our control, and could cause actual results to differ materially from those expressed or implied in these forward-looking statements. Factors that could cause actual results to differ from such statements include, but are not limited to: an adverse decision or decisions following a review of additional safety information, or findings regarding a clinical benefit that are inconsistent with those of recent publications. The forward- looking statements contained herein represent management’s judgment of the Company as of the date hereof. We disclaim any intent or obligation to update any forward-looking statement except to the extent required by law.

 

Item 9.01 Exhibits

 

Exhibit 99.1 Co-Development Agreement with Rgene Corporation, dated May 26, 2017

 

2

 

 

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.

  

  American BriVision (Holding) Corporation
     
Date: May 30, 2017 By: /s/ Eugene Jiang
    Eugene Jiang
    Chief Executive Officer and Chairman

 

 

3

 

Exhibit 99.1

 

CO-DEVELOPMENT AGREEMENT

 

Made and entered as of this 26th day of May 2017 (“the Effective Date”)

 

BY AND BETWEEN

 

American BriVision Corporation , a company incorporated under the laws of USA and having it principle place of business at 11 Sawyers Peak Drive, Goshen, NY 10924 USA (“ ABVC ”)

 

AND

 

Rgene Corporation, a company incorporated under the laws of Taiwan and having its principle place of business at Rm. D110, No.2, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 302, Taiwan (“Rgene”)

 

WITNESSETH:

 

WHEREAS , ABVC and Rgene are thereafter referred to as the “ Parties ”. ABVC and Rgene each is thereafter referred to as “ Party

 

WHEREAS, ABVC has been granted global licensing rights and/or established its own technology to co-develop and use proprietary technology and confidential information for the following products ( “Product” ):

 

1. New Drug of “ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy”

 

2. New Drug of “ABV-1511 Pancreatic Cancer Combination Therapy”

 

3. New Drug of “ABV-1527 Ovary Cancer Combination Therapy”

 

And its related intellectual property rights, and has developed it for medical use.

 

  1  

 

 

WHEREAS, Rgene is a biotech company, and is in the business of research, development and marketing of, among others, new drugs;

 

WHEREAS, Rgene is willing to co-develop and commercialize Product in certain Territory (as defined hereafter);

 

WHEREAS, the Parties agreed to jointly codevelop and commercialize Product in such Territory and enter the Co-Development Agreement and IP right and Obligation for the licensed product will be shared 50%-50% between ABVC and Rgene .

 

WHEREAS, the parties agree this jointly Co-Development Agreement will be led by Rgene . 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 the purpose of this Co-Development 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.

 

1.3 “Data” shall mean any and 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 Co-Development Agreement.

 

  2  

 

 

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 “Territory” shall mean global market .

 

2. Agreement Grants to Rgene.

 

2.1 ABVC hereby grants Rgene right to co-develop Product, in the Field and in the Territory under the Intellectual Property, Confidential Information, Data and Trademark, to co-develop of Product .

 

2.2 Total payment will be calculated based on Cost-plus Valuation Method. The valuation of those three products shall be based on the consensus of the Parties.

 

  3  

 

 

3. Payment

 

3.1 Total payment is three (3) Million U.S. Dollars (non-refundable, before tax) in cash or stock of Rgene with equivalent value.

 

3.2 This payment for the compensation of ABVC past research efforts and contributions made by ABVC before the Agreement is signed by the Parties and it does not relate to any future commitments made by the Parties in the Agreement.

 

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

 

3.3.1 First payment 3% of total contract amount shall be paid upon the signing of this Co-Development Agreement by both Parties.

 

3.3.1.1 after receiving first payment, ABVC will deliver all Data to Rgene in one week.

 

3.3.1.2 Upon receive all data, Rgene shall submit IND package to FDA in 60 days.

 

3.3.2 The rest 97% of total amount , Rgene should pay in one time or divide different installment before August 15, 2017.

 

4. Future income and development cost

 

4.1 ABVC is entitled to receive 50% of the future net licensing income or net sales profit.

 

4.2 Development cost shall be shared by both parties, 50% each.

 

  4  

 

 

5. Confidentiality

 

The Parties agree that during the term of this Co-Development Agreement and thereafter ten (10) years Confidential Information exchanged during the course of this Co-Development Agreement and will be accorded confidential treatment and shall not be used for any other purpose than the performance of this Co-Development 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;

 

(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 ABVC or Rgene 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 ABVC or Rgene for the use thereof upon executing a separate confidentiality disclosure agreement.

 

  5  

 

 

6. Duration and Termination

 

6.1 Duration

 

This Co-Development Agreement shall, once signed by both Parties, remain in effect until the expiration date of the last paten and automatically renew for 5 more years unless either Party gives the other Party six (6) month written notice of termination prior to the expiration date of the term.

 

6.2 Termination for Cause

 

This Co-Development Agreement can be terminated by either Party for any of the following causes by giving to the other Party (“Breaching Party”) thirty (30) day 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 thirty (30) day 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 thirty (30) days 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 thirty (30) days of filling.

 

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

 

  6  

 

 

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 ABVC:

 

American BriVision Corporation

11 Sawyers Peak Drive,

Goshen, NY 10924 USA

Attention: Eugene Jiang

CEO

 

If to Rgene :

 

Rgene Corporation

Room D110, No.2, Sec. 2, Shengyi Road,

Zhubei City, Hsinchu County 302, Taiwan

Attention: Da-ponny Yang

Chairman

 

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 State of New York, USA.

 

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 the State of New York (USA).

 

  7  

 

 

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

 

AMERICAN BRIVISION CORPORATION   RGENE CORPORATION
         
By:

/s/ Eugene Jiang

  By: /s/ Da-ponny Yang
 

Eugene Jiang

    Da-ponny Yang
 

CEO

    Chairman
         
  Date: May 26, 2017     Date: May 26, 2017

 

 

8