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): June 30, 2017

 

 

AMPIO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in Charter)

 

 

 

Delaware   001-35182   26-0179592

(State or other jurisdiction of

incorporation or organization)

 

(Commission

File No.)

 

(IRS Employer

Identification No.)

373 Inverness Parkway, Suite 200

Englewood, Colorado 80112

(Address of principal executive offices, including zip code)

(720) 437-6500

(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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

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.

On June 30, 2017, Ampio Pharmaceuticals, Inc. (the “Company”) entered into an Addendum No. 7 (the “Addendum”) to the Sponsored Research Agreement, dated September 1, 2009 (as amended, the “Research Agreement”), by and between the Company and Trauma Research LLC (“Trauma Research”). Pursuant to the Addendum, the Research Agreement was terminated effective July 5, 2017. Trauma Research is an entity controlled by the Company’s director and Chief Scientific Officer, David Bar-Or, M.D. Trauma Research previously conducted drug and biomarker discovery and development programs for the Company at Trauma Research’s research facilities and the Company provided funding and some scientific personnel under the Research Agreement.

The description of the Addendum set forth herein does not purport to be complete and is qualified in its entirety by reference to the full text thereof, which is attached hereto as Exhibit 10.1.

The information set forth under Item 5.02 of this Current Report on Form 8-K is hereby incorporated in this Item 1.01 by reference.

 

Item 1.02 Termination of a Material Definitive Agreement.

The information set forth under Item 1.01 of this Current Report on Form 8-K with respect to the Addendum and the termination of the Research Agreement is hereby incorporated in this Item 1.02 by reference.

 

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

On June 30, 2017 the Company entered into an amendment to the Employment Agreement, effective August 1, 2010, with David Bar-Or, M.D., the Chief Scientific Officer and a director of the Company (the “Amendment”). Under the Amendment, the term of Dr. Bar-Or’s Employment Agreement was extended through July 31, 2018.

The description of the Amendment set forth herein does not purport to be complete and is qualified in its entirety by reference to the full text thereof, which is attached hereto as Exhibit 10.2.

 

Item 9.01 Financial Statements and Exhibits.

 

Exhibit Number    Description
10.1    Addendum No. 7, dated June 30, 2017, to the Sponsored Research Agreement, dated September 1, 2009, by and between Ampio Pharmaceuticals, Inc. and Trauma Research LLC.
10.2    Amendment to Employment Agreement between Ampio Pharmaceuticals, Inc. and David Bar-Or, M.D., dated June 30, 2017.


SIGNATURE

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.

 

AMPIO PHARMACEUTICALS, INC.
By:  

/s/ Thomas E. Chilcott, III

  Thomas E. Chilcott, III
  Chief Financial Officer

Dated: July 6, 2017


EXHIBIT INDEX

 

Exhibit Number    Description
10.1    Addendum No. 7, dated June 30, 2017, to the Sponsored Research Agreement, dated September 1, 2009, by and between Ampio Pharmaceuticals, Inc. and Trauma Research LLC.
10.2    Amendment to Employment Agreement between Ampio Pharmaceuticals, Inc. and David Bar-Or, M.D., dated June 30, 2017.

Exhibit 10.1

Sponsored Research Agreement

Addendum No. 7 (Termination)

June 30, 2017

This addendum is being entered into to modify the Sponsored Research Agreement (SRA) dated September 1, 2009 made by and between Trauma Research LLC (“TRLLC”) and Ampio Pharmaceuticals, Inc. (the “Company” or “Ampio”, formerly DMI Life Sciences, Inc.)

Whereas, the SRA was entered into as of September 1, 2009; and

Whereas , the SRA has been amended and modified pursuant to Addendum No. 1, thereto executed as of June 1, 2012, Addendum No. 2 thereto executed as of June 15, 2013, Addendum No. 3, dated as of September 1, 2013 and Addendum No.4, dated as of March 17, 2014 and Addendum No. 5, dated as of March 31, 2014; and

Whereas , the parties agree that the previous research performed at TRLLC to date has discovered and elucidated critically important mechanism of actions (MOA) of Ampion TM for the treatment of osteoarthritis of the knee (OAK) and published those studies in peer reviewed journals, in satisfaction of a key element of obtaining regulatory approval of the drug and acceptance by potential commercial partners of the Company, and

Whereas the parties hereto (“the Parties) agree that now that the Company has obtained FDA agreement for a clinical trial design for a final pivotal study that, if successful, will provide the basis for the filing of a Biologics License Application (BLA) for the commercialization of the drug, and

Whereas the two major tasks ahead for the Company, which should be executed concurrently, are the managing of the final pivotal clinical trial, and the completion of the Chemistry, Manufacturing and Controls (CMC) requirements of the FDA, including the Bio-Assay that allows Quality Control release of Ampion TM production lots, and

Whereas the effort to accomplish these two major tasks by the end of 2017 will require the Company to focus all of its limited financial resources on the engagement of technical staff, or outside contractors, that possess the requisite skills and experience to perform these tasks successfully and rapidly, and

Whereas , both parties intend to explore a new set of research projects to be undertaken by TRLLC, and funded by Ampio, once the Ampion TM BLA has been filed and accepted by the FDA, and a subsequent significant financing of Ampio has been accomplished, and

Whereas the parties hereto desire to amend the SRA in the manner set forth below

Now, Therefore, in consideration of the mutual covenants contained herein, and in accordance with Section 12.2 of the SRA, the Parties do hereby amend and revise the SRA as follows.

1.     Amendments

1.1     Section 3.4 of the Agreement will remain deleted in its entirety.


1.2     Attachment B of the Agreement shall be amended to read in its entirety as

Attachment B

Changes in Status of Ampio Employees Previously loaned out to TRLLC

Six current Ampio employees (Raphael Bar-Or, Leonard Rael, Gregory Thomas, Kristin Salattolo, Elizabeth (Gersch) Frederick and Melissa Hausburg) have previously been loaned out to TRLLC for research projects, under the direct and exclusive supervision of Ampio Chief Science Officer, David Bar-Or, MD.

From July 5, 2017 forward, Leonard Rael, Kristin Salattolo and Melissa Hausburg will become full time, directly paid employees of TRLLC. Ampio will maintain health benefits for each employee until July 31, 2017 to allow TRLLC time to arrange for similar coverage at TRLLC.

Current Ampio employee Rafael Bar-Or will split his employment evenly between TRLLC and Ampio, working 20 hours per week in the Ampio facility under the supervision of Dr. Bar-Or, or a manager of Michael Macaluso’s choice. The schedule of hours worked at the Ampio facility will be decided by Mr. Macaluso. Ampio will pay Raphael Bar-Or half his current salary amounting to $75,000 a year. Ampio will maintain his current health benefits.

Ampio will not allow the stock options for all six of these individuals to lapse during the term of the TRLLC agreement.

Should Ampio require any services from the individuals now working at TRLLC, they will be provided under the terms of Ampio’s independent contractor agreements for an hourly rate no different than their current annual rates and require Dr. Bar-Or’s permission if the service would take place during normal working hours.

Also from July 5, 2017 forward Ampio employees Greg Thomas and Elizabeth Frederick will maintain their current salary and benefits packages but report for work full time at the Ampio Facility reporting to Dr. David Bar-Or.

2.     Miscellaneous

2.1     As specifically amended hereby the SRA shall be terminated at the end of the business day of July 5, 2017

2.2     This amendment may be executed in any number of counterparts and, when so executed, all of the counterparts shall constitute a single instrument binding upon all Parties notwithstanding that all Parties are not signatory to the original or to the same counterpart. In the event any provision of this amendment is determined to be invalid or unenforceable, such provision shall be deemed severed from the remainder of this Amendment and replaced with a valid and enforceable provision as similar in intent as reasonably possible to the provision so severed, and shall not cause the invalidity or unenforceability of the remainder of this amendment.

2.3     The Parties agree to execute any additional documents reasonably necessary to effect the intention of the Parties hereto.


In Witness whereof, the parties have caused this addendum No.7 to the SRA to be executed as of June 30, 2017

 

Trauma Research, LLC       Ampio Pharmaceuticals, Inc.

/s/ David Bar-Or

     

/s/ Michael Macaluso

David Bar-Or, M.D.       Michael Macaluso
Manager       CEO

Exhibit 10.2

AMENDMENT TO EMPLOYMENT AGREEMENT

This Amendment to the Employment Agreement (the “Employment Agreement”), effective as of August 1, 2010 by and between Ampio Pharmaceuticals, Inc., a Delaware corporation (the “Company”), and David Bar-Or M.D. (the “Executive”) is made as of June 30, 2017 (“Amendment Date”).

WHEREAS , the Company and the Executive (together the “Parties”) entered into the Employment Agreement;

WHEREAS , the Company and the Executive desire to extend the term of the Employment Agreement through July 31, 2018; and

WHEREAS , the Parties have agreed to modify the Employment Agreement.

NOW, THEREFORE , the Parties agree as follows:

1.     The first sentence of Section 1 of the Employment Agreement shall be replaced in its entirety with the following sentence:

“The Company hereby agrees to employ Employee and Employee hereby accepts such employment with the Company for the period of 84 months beginning on the Effective Date.”

2.     All other provisions of the Employment Agreement shall remain in full force and effect.

IN WITNESS WHEREOF , the parties hereby have executed this Amendment as of the Amendment Date written above.

 

AMPIO PHARMACEUTICALS, INC.
By:  

/s/ Philip H Coelho

Its:   Chairman of the Compensation Committee

/s/ David Bar-Or

David Bar-Or, M.D.