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): March 29, 2017

 

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

 

British Columbia, Canada   000-37769   N/A

(State or other jurisdiction

of incorporation)

 

(Commission File
Number)

 

(IRS Employer

Identification No.)

 

222 Third Street, Suite 2241

Cambridge, Massachusetts

 

02142

(Address of principal executive offices)   (Zip Code)

 

(617) 830-3031

(Registrant’s telephone number, including area code)

 

N/A

(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))

 

 

 

 
 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On March 29, 2017, Variation Biotechnologies Inc. (“VBI Cda”), a wholly-owned subsidiary of VBI Vaccines Inc. (the “Company”), entered into an amendment (the “Amendment”), effective January 1, 2017, to its consulting agreement with F. Diaz-Mitoma Professional Corporation pursuant to which Dr. Francisco Diaz-Mitoma serves as the Company’s Chief Medical Officer (the “Consulting Agreement”). Pursuant to the Amendment, (i) the term of the Consulting Agreement was extended until December 31, 2017, constituting a one year term, (ii) the cash consulting fee was increased from CAD $40,000 to CAD $41,080 per month and (iii) VBI Cda agreed to pay a performance-based bonus for 2016 services equal to USD $115,733. In addition, VBI Cda agreed to cause the Company to issue Dr. Diaz-Mitoma, as the designee of his professional corporation, pursuant to the VBI Vaccines Inc. Incentive Plan, (a) 12,500 common shares of the Company and (b) 20,000 stock options to purchase common shares of the Company, subject to the terms and conditions of the applicable option agreement.

 

The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment, which is filed with this Current Report on Form 8-K as Exhibit 10.2.

 

Item 7.01 Regulation FD Disclosure.

 

On March 30, 2017, the Company issued a press release. A copy of the press release is furnished herewith as Exhibit 99.1 and incorporated by reference in this Item 7.01.

 

The information disclosed under this Item 7.01, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and shall not be deemed “filed” with the U.S. Securities and Exchange Commission (the “SEC”) nor incorporated by reference into any filing made under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
10.1+   Consulting Agreement with F. Diaz-Mitoma Professional Corporation (incorporated by reference to Exhibit 10.42 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on March 20, 2017).
     
10.2*+   Amendment to Consulting Agreement with F. Diaz-Mitoma Professional Corporation.
     
99.1**   Press Release dated March 30, 2017.

 

* Filed herewith

** Furnished herewith

+ Indicates a management contract or compensatory plan.

 

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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.

 

  VBI Vaccines Inc.
     
Date: March 30, 2017 By: /s/ Jeff Baxter
    Jeff Baxter
    President and Chief Executive Officer

 

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EXHIBIT INDEX

 

Exhibit No.   Description
     
10.1+   Consulting Agreement with F. Diaz-Mitoma Professional Corporation (incorporated by reference to Exhibit 10.42 to the annual report on Form 10-K (SEC File No. 001-37769), filed with the SEC on March 20, 2017).
     
10.2*+   Amendment to Consulting Agreement with F. Diaz-Mitoma Professional Corporation.
     
99.1**   Press Release dated March 30, 2017.

 

* Filed herewith

** Furnished herewith

+ Indicates a management contract or compensatory plan.

 

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AMENDMENT TO CONSULTING AGREEMENT

 

This Amendment to Consulting Agreement (the “ Amendment ”), effective as of January, 1 st , 2017 (the “ Effective Date ”), is by and between Variation Biotechnologies Inc., a corporation incorporated pursuant to the laws of Canada (the “ Company ”) having an address of 310 Hunt Club Road East, Ottawa, Ontario K1V 1C1 and F. Diaz-Mitoma Professional Corporation (Ontario corporation number 002356634) having an address of 210 Barrow Crescent, Kanata, Ontario K2L 2C7 (“ Consultant ”). The Consultant and Company are sometimes referred to as a “ Party” and are collectively referred to as the “ Parties” .

 

WHEREAS , the Company and Consultant are parties to a certain Consulting Agreement dated July 1, 2016 (the “ Consulting Agreement ”);

 

AND WHEREAS , the Consultant and the Company wish to amend the Consulting Agreement on the terms and conditions set out in this Amendment;

 

NOW THEREFORE , in consideration of the mutual covenants contained herein, the Parties agree as follows:

 

1. Amendment to Section 1(a). As of the Effective Date, Section 1(a) of the Consulting Agreement shall be deleted in its entirety and replaced with the following:

 

  (a) Term . This Agreement shall be in effect beginning on the Effective Date and, unless terminated earlier pursuant to the provisions of this Section 1, shall continue until December 31, 2017 (the “ Term ”). This Agreement may be renewed any number of times, with or without a short interruption in continuity of Services (as defined below), by written notice from the Company which is accepted by signature of the Consultant.

 

2. Amendment to Section 5. As of the Effective Date, Section 5 of the Consulting Agreement shall be deleted in its entirety and replaced with the following:

 

5. Payment for Consulting Services .

 

  (a) Consideration. As consideration for the Services, the Company shall pay Consultant a fee of $41,080.00 per month (plus any HST or GST payable).
   
  (b) Invoicing. The Consultant shall submit invoices to the Company on a monthly basis, within fifteen (15) days of the last business day of each month. This Agreement shall govern all invoices submitted by Consultant to the Company and no terms appearing on invoices shall serve to modify or add to the terms of this Agreement.
   
  (c) Expenses . Company agrees to reimburse Consultant for all reasonable out-of-pocket expenses incurred by Consultant in the course of provision of the Services in accordance with the Company’s expense policy, and for professional fees ordinarily incurred by physicians in order to practice medicine in the Province of Ontario. Any expenses which are eligible for reimbursement hereunder shall be paid upon submission of an Expense Statement in the form provided by the Company, supported by appropriate documentation.
   
  (d) Performance Incentives . The Company agrees to provide Consultant, or to a designee of the Consultant who is a Consultant’s Employee (as defined below) with the performance incentives described in Appendix C attached hereto.

 

 
 

 

3. Amendment to Section 6. As of the Effective Date, Section 6 of the Consulting Agreement shall be deleted in its entirety and replaced with the following:

 

6. Independent-Consultant Relationship. The parties expressly intend, understand and agree that Consultant’s status in relation to the Company, and of each employee of the Consultant (each a “ Consultant’s Employee ”) who performs Services on the Consultant’s behalf pursuant to this Agreement, throughout the Term will be that of an independent contractor, and that none of this Agreement, the provision or performance of Services to be rendered hereunder by Consultant or any Consultant’s Employee, or the grant of any performance incentives by the Company pursuant to paragraph 5(d) of this Agreement, will for any purpose whatsoever alone or in combination create an employment relationship between the Consultant or Consultant’s Employee and the Company. As an independent contractor, neither the Consultant nor any Consultant’s Employee shall be entitled to receive any vacation pay, overtime pay or severance pay from the Company. The Consultant will have exclusive responsibility for payment of all federal and provincial income taxes or other taxes, such as GST, applicable to the compensation to be provided to the Consultant hereunder by the Company as well as the exclusive responsibility to pay any other assessments and/or contributions that may be required in respect of Consultant’s provision of the Services, including, but not limited to, pursuant to any applicable employment insurance legislation, pension legislation, health benefits legislation, workers’ compensation legislation, or with respect to any other mandatory withholdings that may be applicable to the Services. If the Company incurs liability for any taxes (including sums required to be withheld by Company and remitted to any government entity and amounts payable for value added or services taxes), assessments or contributions relating to Consultant’s provision of Services hereunder, or to a Consultant’s Employee’s performance of Services on the Consultant’s behalf hereunder, and for any interest and penalties with respect to the foregoing, Consultant shall forthwith reimburse Company for the total amount of such liability, assessments, contributions, interest and penalties and the Company shall be authorized to deduct any such sums from amounts payable to Consultant hereunder. Consultant acknowledges that the Consultant will not receive any employee benefits from the Company, and that, as an independent contractor, he will have exclusive responsibility to obtain and make payment for health insurance, life insurance, and any other benefits that the Consultant wishes to receive. Further, Consultant acknowledges and agrees that, except as specifically authorized by the Company, Consultant is not permitted, and shall not seek to, bind the Company under any contract or other obligation.

 

 
 

 

4 . Addition of Appendix C. As of the Effective Date, the Consulting Agreement shall be amended by the addition thereto of Appendix C, which shall thereafter form part of the Consulting Agreement, and the content of which shall be as shown in Schedule A to this Amendment.

 

5. Consulting Agreement to Remain in Full Effect. Except as amended by this Amendment, the Consulting Agreement shall continue to be in full force and effect, without amendment, and is hereby ratified and confirmed. The Consulting Agreement shall henceforth be read and construed in conjunction with this Amendment.

 

6. Governing Law. This Amendment shall be governed by and construed in accordance with the laws of the Province of Ontario and the federal laws of Canada applicable therein.

 

7. Further Assurances. Each Party shall do such further acts and execute such further documents as may be required to give effect to this Amendment and carry out the intent thereof.

 

8. Binding Effect. This Amendment shall be binding on and inure to the benefit of the Parties and their respective successors and assigns.

 

9. Execution and Counterparts. This Amendment may be executed in counterparts, including counterpart signature pages or counterpart facsimile or scanned signature pages (each of which shall be deemed an original), all of which together shall constitute one and the same instrument.

 

( Signature page follows. )

 

 
 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment to be duly executed by their respective authorized officers as of the Effective Date.

 

VARIATION BIOTECHNOLOGIES INC.

 

  By: /s/ Egidio Nascimento
  Name:  Egidio Nascimento
  Title: CFO
  Dated: March 29, 2017

 

F. DIAZ-MITOMA PROFESSIONAL CORPORATION

 

  By: /s/ Dr. Francisco Diaz-Mitoma
  Name:  Dr. Francisco Diaz-Mitoma 
  Title: President
  Dated: March 29, 2017

 

 
 

 

Schedule A

 

Appendix C – Performance Incentives

 

  1. Bonus payable as of January 26, 2017 - $115,733 USD.
     
  2. The Company shall cause VBI Vaccines Inc., a British Columbia corporation (the “ Parent ”), to issue Francisco Diaz-Mitoma, as designee of Consultant, 12,500 common shares of Parent with an issuance date of January 26, 2017, such issuance to be pursuant to the VBI Vaccines Inc. Incentive Plan, effective May 6, 2016, as amended on June 23, 2016 (as so amended, the “ Plan ”). Such common shares shall bear the appropriate legend to indicate such shares are “control securities” as defined in General Instruction C.1(a) of Form S-8.
     
  3. The Company shall cause the Parent to grant to Francisco Diaz-Mitoma, as designee of Consultant, 20,000 stock options (the “ Options ”), each Option exercisable for one common share of Parent, to be granted effective as of January 26, 2017, which was the date on which the board of directors of Parent approved such grant, and to be subject to the provisions of the Plan. Conditions regarding the Options and their exercise, including the exercise price, the term of the Options and the timing of vesting shall be set out in an Option Agreement between the Parent and Francisco Diaz-Mitoma. The common shares issuable upon exercise of the Options shall bear the appropriate legend to indicate such shares are “control securities” as defined in General Instruction C.1(a) of Form S-8.

 

 
 

 

Exhibit 99.1

 

VBI Vaccines Appoints Avi Mazaltov as Global Head of Manufacturing and

SciVac General Manager; Rehovot, Israel Site

 

CAMBRIDGE, MA (March 30, 2017) – VBI Vaccines Inc. (Nasdaq: VBIV) (TSX: VBV) (“VBI”) and SciVac Ltd. (“SciVac”), a wholly owned subsidiary of VBI, are pleased to announce the appointment of Avi Mazaltov as the Global Head of Manufacturing and General Manager of the SciVac manufacturing site in Rehovot, Israel.

 

In this new role, Mr. Mazaltov will define and manage VBI’s manufacturing activities, including SciVac’s manufacturing and commercialization operations in Israel.

 

Mr. Mazaltov comes to VBI from Omrix Biopharmaceuticals (a Johnson & Johnson company) where he served as the General Manager and Director of Operations for three different sites. At Omrix, Mr. Mazaltov was responsible for Biosurgery operations in Israel, and was a member of the Biosurgery leadership team. Prior to joining Omrix, Mr. Mazaltov held various other high-ranking operational roles including President of the Operations and Infrastructures division at Alvarion Technologies, and Director of Global Manufacturing at Teva Pharmaceuticals.

 

“We’re excited to welcome Avi as the newest member of the management team,” said Jeff Baxter, VBI’s President and CEO. “Avi has been in the pharmaceutical industry for over 25 years and brings significant operating and manufacturing experience to our company. Avi will play an important role as we expand our Sci-B-Vac™ manufacturing capabilities and as we continue to develop our Phase III clinical study plans in Europe, the United States, and Canada.

 

About VBI Vaccines Inc.

 

VBI Vaccines Inc. (“VBI”) is a commercial-stage biopharmaceutical company developing a next generation of vaccines to address unmet needs in infectious disease and immuno-oncology. VBI’s first marketed product is Sci-B-Vac™, a hepatitis B (“HBV”) vaccine that mimics all three viral surface antigens of the hepatitis B virus; Sci-B-Vac is approved for use in Israel and 14 other countries. VBI’s eVLP Platform technology allows for the development of enveloped (“e”) virus-like particle (“VLP”) vaccines that closely mimic the target virus to elicit a potent immune response. VBI is advancing a pipeline of eVLP vaccines, with lead programs in cytomegalovirus (“CMV”) and glioblastoma multiforme (“GBM”). VBI is also advancing its LPV™ Thermostability Platform, a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety. VBI is headquartered in Cambridge, MA with research operations in Ottawa, Canada and research and manufacturing facilities in Rehovot, Israel.

 

Website Home: https://www.vbivaccines.com/

News and Insights: https://www.vbivaccines.com/wire/

Investors: https://www.vbivaccines.com/investors/

 

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VBI Contact

 

Perri Maduri, Communications Executive

Phone: (617) 830-3031

Email: info@vbivaccines.com

 

VBI Investor Contact

 

Nell Beattie

Director, Corporate Development and Investor Relations

Email: ir@vbivaccines.com

 

Cautionary Statement on Forward-looking Information

 

Certain statements in this news release contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 or forward-looking information under applicable Canadian securities legislation (collectively, “forward-looking statements”) that may not be based on historical fact, but instead relate to future events, including without limitation statements containing the words “believe”, “may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”, “expect” and similar expressions. All statements other than statements of historical fact included in this release are forward-looking statements, including statements regarding: Mr. Mazaltov’s ability to assist VBI with the manufacturing of Sci-B-Vac and its other products.

 

Such forward-looking statements are based on a number of assumptions, including assumptions regarding the successful development and/or commercialization of the company’s products, including the receipt of necessary regulatory approvals; general economic conditions; that the parties’ respective businesses are able to operate as anticipated without interruptions; competitive conditions; and changes in applicable laws, rules and regulations.

 

Although management believes that the assumptions made and expectations represented by such statements are reasonable, there can be no assurance that a forward-looking statement contained herein will prove to be accurate. Actual results and developments may differ materially from those expressed or implied by the forward-looking statements contained herein and even if such actual results and developments are realized or substantially realized, there can be no assurance that they will have the expected consequences or effects. Factors which could cause actual results to differ materially from current expectations include: the failure to successfully develop or commercialize the company’s products; adverse changes in general economic conditions or applicable laws, rules and regulations; and other factors detailed from time to time in the company’s reports filed with the U.S Securities and Exchange Commission and the Canadian Securities Commissions.

 

Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements and information, which are qualified in their entirety by this cautionary statement. All forward-looking statements and information made herein are based on the company’s current expectations, and the company undertakes no obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

 

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