UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 


FORM 10-Q

 


(Mark One)

x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2014

 

OR

 

¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from              to             

 

Commission File Number: 001-35112

 


Medgenics, Inc.

(Exact name of registrant as specified in its charter)

 


 

Delaware   98-0217544

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

     

435 Devon Park Drive, Building 700

Wayne, Pennsylvania

 
19087
(Address of Principal Executive Offices)   (Zip Code)

 

(610) 254-4201

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name, former address and former fiscal year, if changed since last report)


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes         No   

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes         No   

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act (Check one):

 

Large accelerated filer ¨ Accelerated filer x
       
Non-accelerated filer ¨   (Do not check if a smaller reporting company) Smaller reporting company ¨

 

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2).    Yes     ☐   No   ☒

 

As of October 10, 2014, the registrant had 18,910,403 shares of common stock, $0.0001 par value, outstanding.

 

 

 
 

  

MEDGENICS, INC.

 

CONTENTS

 

    Page
     
PART I FINANCIAL INFORMATION  3
     
ITEM 1. Financial Statements  3
     
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations  19
     
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk  25
     
ITEM 4. Controls and Procedures  25
     
PART II OTHER INFORMATION  26
     
ITEM 1. Legal Proceedings  26
     
ITEM 1A. Risk Factors  26
     
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds  26
     
ITEM 3. Defaults Upon Senior Securities   26
     
ITEM 4. Mine Safety Disclosures   26
     
ITEM 5. Other Information   26
     
ITEM 6. Exhibits  27
     
Signatures   28

 

Unless the context otherwise requires, all references in this Quarterly Report on Form 10-Q to the “Company”, “Medgenics”, “we,” “us” and “our” refer to Medgenics, Inc., a Delaware corporation organized on January 27, 2000, and its wholly-owned subsidiary, Medgenics Medical Israel Ltd., a company organized under the laws of the State of Israel. We use BioPump TM , EPODURE TM and TARGT TM , as trademarks in the United States and elsewhere. All other trademarks or trade names referred to in this document are the property of their respective owners.

  

 
 

 

PART I — FINANCIAL INFORMATION

 

ITEM 1 — Financial Statements

   

MEDGENICS, INC. AND ITS SUBSIDIARY

 

INTERIM CONSOLIDATED FINANCIAL STATEMENTS

 

As of September 30, 2014

 

IN U.S. DOLLARS IN THOUSANDS

 

(Unaudited)

  

INDEX

 

    Page
     
     
Consolidated Balance Sheets   4 - 5
     
Consolidated Statements of Operations   6
     
Statements of Changes in Stockholders' Equity   7
     
Consolidated Statements of Cash Flows   8 - 9
     
Notes to the Interim Consolidated Financial Statements   10 – 18 

  

3
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)

 

    September 30,     December 31,  
    2014     2013  
    Unaudited        
ASSETS                
                 
CURRENT ASSETS:                
                 
 Cash and cash equivalents   $ 14,706     $ 22,390  
 Accounts receivable and prepaid expenses     511       202  
                 
Total current assets     15,217       22,592  
                 
LONG-TERM ASSETS:                
                 
 Restricted lease deposits     28       42  
 Severance pay fund     110       96  
 Property and equipment, net     484       357  
 Deferred costs     34       -  
                 
Total long-term assets     656       495  
                 
Total assets   $ 15,873     $ 23,087  

  

The accompanying notes are an integral part of the interim consolidated financial statements

 

4
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED BALANCE SHEETS
U.S. dollars in thousands (except share and per share data)

 

    September 30,     December 31,  
    2014     2013  
    Unaudited        
                 
LIABILITIES AND STOCKHOLDERS' EQUITY                
                 
CURRENT LIABILITIES:                
                 
Trade payables   $ 552     $ 1,062  
Other accounts payable and accrued expenses      1,971       1,952  
                 
Total current liabilities     2,523       3,014  
                 
LONG-TERM LIABILITIES:                
                 
Accrued severance pay     415       439  
Liability in respect of warrants     623       1,211  
                 
Total long-term liabilities     1,038       1,650  
                 
Total liabilities     3,561       4,664  
                 
STOCKHOLDERS' EQUITY:                
                 
Common stock - $0.0001 par value; 100,000,000 shares authorized;    18,917,403 shares issued and 18,908,903 shares
outstanding at September 30, 2014;18,497,307 shares issued and outstanding at December 31, 2013
    2       2  
Additional paid-in capital     106,252       100,126  
Accumulated deficit     (93,942 )     (81,705 )
                 
Total stockholders' equity     12,312       18,423  
                 
Total liabilities and stockholders' equity   $ 15,873     $ 23,087  

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

5
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF OPERATIONS
U.S. dollars in thousands (except share and per share data)

 

    Nine months ended
September 30,
    Three months ended
September 30,
 
    2014     2013     2014     2013  
    Unaudited  
                         
Research and development expenses   $ 6,378     $ 6,556     $ 2,281     $ 2,452  
                                 
Less:                                
Participation by the Office of the Chief Scientist     (1,898 )     (1,327 )     (716 )     (109 )
                                 
Research and development expenses, net     4,480       5,229       1,565       2,343  
                                 
General and administrative expenses     8,262       6,695       2,305       2,561  
                                 
Operating loss     (12,742 )     (11,924 )     (3,870 )     (4,904 )
                                 
Financial expenses     (92 )     (21 )     (64 )     (1,260 )
Financial income     605       29       896       21  
                                 
Loss before taxes on income     (12,229 )     (11,916 )     (3,038 )     (6,143 )
                                 
Taxes on income     8       5       2       -  
                                 
Loss   $ (12,237 )   $ (11,921 )   $ (3,040 )   $ (6,143 )
                                 
Basic loss per share   $ (0.65 )   $ (0.68 )   $ (0.16 )   $ (0.33 )
                                 
Diluted loss per share   $ (0.68 )   $ (0.68 )   $ (0.21 )   $ (0.33 )
                                 
Weighted average number of common stock used in computing basic loss per share     18,716,109       17,435,235       18,817,557       18,410,951  
Weighted average number of common stock used in computing diluted loss per share     18,863,403       17,468,255       18,938,723       18,410,951  

    

The accompanying notes are an integral part of the interim consolidated financial statements.

 

6
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY
U.S. dollars in thousands (except share and per share data)

 

    Common stock     Additional
paid-in
capital
    Accumulated
deficit
    Total
stockholders'
equity
 
    Shares     Amount                    
                               
Balance as of  December 31, 2012     12,307,808     $ 1     $ 66,509     $ (64,576 )   $ 1,934  
                                         
Issuance of common stock and warrants at $ 5.24 per share and
$ 0.01 per warrant
    6,070,000       1       28,820       -       28,821  
Stock based compensation related to the issuance of common
stock to consultants (**)
    55,000       (*)       594       -       594  
Stock based compensation related to the issuance and vesting of
restricted common stock to directors and an employee
    45,000       (*)       331       -       331  
Stock based compensation related to options and warrants granted
to consultants and employees
    -       -       2,176       -       2,176  
Exercise of  warrants and options     3,500       (*)       13       -       13  
Loss     -       -       -       (11,921 )     (11,921 )
                                         
Balance as of  September 30, 2013 (unaudited)     18,481,308     $ 2     $ 98,443     $ (76,497 )   $ 21,948  
                                         
Balance as of December 31, 2013     18,497,307     $ 2     $ 100,126     $ (81,705 )   $ 18,423  
                                         
Stock-based compensation related to the issuance and vesting of
restricted common stock to directors and an employee, net (***)
    23,000       (*)       371       -       371  
Stock-based compensation related to options and warrants granted to consultants, directors and employees     -       -       4,512       -       4,512  
Exercise of  warrants and options     364,096       (*)       1,243       -       1,243  
Loss     -       -       -       (12,237 )     (12,237 )
                                         
Balance as of  September 30, 2014 (unaudited)     18,884,403     $ 2     $ 106,252     $ (93,942 )   $ 12,312  

 

(* ) Represents an amount lower than $ 1.

(**) Includes stock based compensation for an additional 25,000 shares which were not issued as of September 30, 2013 and 2014.

(***) Does not include 24,500 restricted shares not yet vested.

 

The accompanying notes are an integral part of the interim consolidated financial statements.

 

7
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

  

    Nine months ended
September 30,
 
    2014     2013  
    Unaudited  
             
CASH FLOWS FROM OPERATING ACTIVITIES:                
                 
 Loss   $ (12,237 )   $ (11,921 )
                 
Adjustments to reconcile loss to net cash used in operating activities:                
                 
Depreciation     162       130  
Stock-based compensation related to options, warrants, common shares and restricted shares granted
to employees, directors and consultants
    4,883       3,101  
Change in fair value of warrants     (574 )     (20 )
Accrued severance pay, net     (439 )     (429 )
Exchange differences on a restricted lease deposit and on long term loan     (1 )     1  
Changes in operating assets and liabilities:                
Accounts receivable and prepaid expenses     (308 )     (447 )
Trade payables     (510 )     669  
Other accounts payable and accrued expenses     420       569  
Restricted lease deposits     14       (8 )
                 
Net cash used in operating activities     (8,590 )     (8,355 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
                 
Purchase of property and equipment     (289 )     (159 )
                 
Net cash used in investing activities   $ (289 )   $ (159 )

  

The accompanying notes are an integral part of the interim consolidated financial statements.

 

8
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands

 

    Nine months ended
September 30,
 
    2014     2013  
    Unaudited  
CASH FLOWS FROM FINANCING ACTIVITIES:                
                 
Proceeds from issuance of shares and warrants, net   $ -     $ 28,861  
Proceeds from exercise of options and warrants, net     1,229       13  
Deferred costs     (34 )     -  
                 
Net cash provided by financing activities     1,195       28,874  
                 
Increase (decrease)  in cash and cash equivalents     (7,684 )     20,360  
                 
Balance of cash and cash equivalents at the beginning of the period     22,390       6,431  
                 
Balance of cash and cash equivalents at the end of the period   $ 14,706     $ 26,791  
                 
Supplemental disclosure of cash flow information:                
                 
Cash paid during the period for taxes   $ 8     $ 5  

  

The accompanying notes are an integral part of the interim consolidated financial statements.

 

9
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 1:- GENERAL

 

a. Medgenics, Inc. (the "Company") was incorporated in January 2000 in Delaware. The Company has a wholly-owned subsidiary, Medgenics Medical Israel Ltd. (the "Subsidiary"), which was incorporated in Israel in March 2000. The Company and the Subsidiary are engaged in the research and development of products in the field of biotechnology and associated medical equipment.

 

The Company's common stock is traded on the NYSE MKT.

 

In April 2014, stockholders approved the cancellation of the Company's common stock from trading on the London Stock Exchange's Alternative Investment Market, or AIM. The last day of trading of the Company's common stock on AIM was April 15, 2014.

 

b.

As reflected in the accompanying financial statements, the Company incurred a loss for the nine month period ended September 30, 2014 of $12,237 and had a negative cash flow from operating activities of $8,590 during the nine month period ended September 30, 2014. The accumulated deficit as of September 30, 2014 is $93,942. The Company and the Subsidiary have not yet generated revenues from product sale. Management's plans also include seeking additional investments and commercial agreements to continue the operations of the Company and the Subsidiary.

 

The Company believes that its existing cash and cash equivalents, should be sufficient to meet its operating and capital requirements into the fourth quarter of 2015.

 

c. In April 2014, the Subsidiary received approval for an additional Research and Development program from the Office of the Chief Scientist (OCS) at the Ministry of Economy of Israel for the period from December 2013 through November 2014. The approval allows for a grant of up to approximately $2,200 based on research and development expenses, not funded by others, of up to $3,900.
     

During the nine months ended September 30, 2014, a total of $1,813 was received from the OCS and $8 recorded as a grant receivable.

 

10
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES

 

The accompanying unaudited interim financial statements of the Company, have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and the rules of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the audited financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2013 ("2013 Form 10-K") as filed with the SEC. In the opinion of management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of financial position and the results of operations for the interim periods presented have been reflected herein. The results of operations for interim periods are not necessarily indicative of the results to be expected for the full year. Notes to the financial statements that would substantially duplicate the disclosure contained in the audited financial statements for the most recent fiscal year as reported in the 2013 Form 10-K have been omitted.

 

Effective January 1, 2014, the Company adopted the authoritative guidance, issued by the Financial Accounting Standards Board (“FASB”) in July 2013, which requires that an unrecognized tax benefit, or portion of an unrecognized tax benefit, be presented as a reduction of a deferred tax asset for a net operating loss carryforward, a similar tax loss or a tax credit carryforward. If an applicable deferred tax asset is not available or a company does not expect to use the applicable deferred tax asset, the unrecognized tax benefit should be presented as a liability in the financial statements and should not be combined with an unrelated deferred tax asset. The adoption of this guidance had no impact on the Company's consolidated financial statements.

 

In June 2014 the FASB issued ASU 2014-10 regarding development stage entities. The ASU removes the definition of development stage entity, as was previously defined under U.S. GAAP, from the accounting standards codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP.

 

In addition, the ASU eliminates the requirements for development stage entities to (i) present inception-to-date information in the statement of income, cash flow and stockholders' equity, (ii) label the financial statements as those of a development stage entity, (iii) disclose a description of the development stage activities in which the entity is engaged, and (iv) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage.

 

The Company has applied the ASU effective from the financial statements as of June 30, 2014. 

 

NOTE 3:- COMMITMENTS AND CONTINGENCIES

 

a. In May 2014, the Company signed an agreement with the Board of Trustees of the Leland Stanford Junior University (“Stanford”). According to the agreement, Stanford granted the Company a non-exclusive license for a patent for commercial development, production and marketing of certain products based on its know-how. In consideration, the Company agreed to pay Stanford the following amounts:

 

11
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 3:- COMMITMENTS AND CONTINGENCIES (Cont.)

 

i) An issue royalty of $25 upon signing the agreement.

ii) License maintenance fees of:

1. $10 in May 2015 and May 2016

2. $20 in May 2017 and May 2018

3. $50 in May 2019 and each year thereafter

iii) Royalties at a rate of 1.5% of net sales.

iv) Milestone payments of:

1. $50 upon dosing of the first patient with a licensed product

2. $150 upon the first approval in the U.S. of a licensed product

3. $150 upon the first approval in Europe or Japan of a licensed product.

 

b. The license agreement with the University of Michigan was terminated effective August 13, 2014.

 

NOTE 4:- STOCKHOLDERS' EQUITY

 

a. Issuance of stock options, warrants and restricted shares to employees and directors:

 

1. In April 2014, stockholders approved an amendment to the Company's Stock Incentive Plan, increasing the number of shares authorized to be issued under such plan by 2,000,000 shares.

 

2. A summary of the Company's activity for restricted shares granted to employees and directors is as follows:

 

Restricted shares   Nine months ended
September 30, 2014
 
       
Number of restricted shares as of December 31, 2013     56,072  
Vested     (79,072 )
Forfeited     (8,500 )
Granted     56,000  
         
Number of restricted shares as of  September 30, 2014     24,500  

 

12
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 4:- STOCKHOLDERS' EQUITY (Cont.)

 

3. A summary of the Company's activity for options and warrants granted to employees and directors is as follows:

 

    Nine months ended
September 30, 2014
 
    Number of
options and warrants
    Weighted
Average
exercise price
    Weighted average remaining contractual terms (years)     Aggregate intrinsic value  
                         
Outstanding at December 31, 2013     7,366,043     $ 5.19                  
                                 
Granted     1,227,373     $ 6.71                  
                                 
Forfeited     (46,786 )   $ 5.76                  
                                 
Exercised     (311,506 )   $ 2.80                  
                                 
Outstanding at September 30, 2014     8,235,124     $ 5.50       7.02     $ 6,113  
                                 
Vested and expected to vest at September  30, 2014     8,005,976     $ 5.51       6.97     $ 5,997  
                                 
Exercisable at September 30, 2014     3,802,762     $ 5.77       5.00     $ 3,833  

  

Calculation of aggregate intrinsic value is based on the closing share price of the Company's common stock as reported on the NYSE MKT on September 30, 2014 ($5.19 per share).

 

As of September 30, 2014, there was $9,584 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to employees and directors. That cost is expected to be recognized over a weighted-average period of 1.6 years.

  

13
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 4:- STOCKHOLDERS' EQUITY (Cont.)

 

b. Issuance of shares, stock options and warrants to consultants:

 

A summary of the Company's activity for warrants and options granted to consultants is as follows:

 

    Nine months ended
September 30, 2014
 
    Number of
options and warrants
    Weighted
average
exercise price
    Weighted average remaining contractual terms (years)     Aggregate intrinsic value  
                         
Outstanding at December 31, 2013     579,674     $ 6.72                  
                                 
Forfeited     (80,782 )   $ 7.81                  
                                 
Exercised     (45,066 )   $ 6.04                  
                                 
Outstanding at September 30, 2014     453,826     $ 6.60       3.48     $ 232  
                                 
Exercisable at  September  30, 2014     423,733     $ 6.63       3.10     $ 232  

  

Calculation of aggregate intrinsic value is based on the closing share price of the Company's common stock as reported on the NYSE MKT on September 30, 2014 ($5.19 per share).

 

As of September 30, 2014, there was $96 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted to consultants. That cost is expected to be recognized over a weighted-average period of 1.8 years. 

 

c. Compensation expenses:

 

Compensation expense related to shares, warrants and options granted to employees, directors and consultants was recorded in the Statements of Operations in the following line items:

 

14
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 4:- STOCKHOLDERS' EQUITY (Cont.)

 

    Nine months ended
September 30,
    Three months ended
September 30,
 
    2014     2013     2014     2013  
    Unaudited     Unaudited  
                         
Research and development expenses   $ 829     $ 221     $ 336     $ 155  
General and administrative expenses     4,054       2,880       1,025       869  
                                 
    $ 4,883     $ 3,101     $ 1,361     $ 1,024  

 

15
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 4:- STOCKHOLDERS' EQUITY (Cont.)

 

d. Summary of options and warrants:

 

A summary of all the options and warrants outstanding as of September 30, 2014 is presented in the following table:

 

          As of September 30, 2014  
Options / Warrants   Exercise
Price per
Share ($)
    Options and
Warrants
Outstanding
    Options and
Warrants
Exercisable
    Weighted
Average
Remaining
Contractual
Terms (in years)
 
Options:                                
Granted to Employees and Directors     2.49-3.14       199,000       128,000       7.2  
      3.64-4.99       3,625,429       1,306,739       8.5  
      5.13-7.25       2,199,140       381,168       8.5  
      8.19-14.5       1,306,365       1,081,665       4.2  
              7,329,934       2,897,572          
Granted to Consultants                                
      5.13       15,280       10,187       7.5  
      6.29-6.65       44,068       19,068       7.8  
              59,348       29,255          
Total Options             7,389,282       2,926,827          
                                 
Warrants:                                
                                 
Granted to Employees and Directors     2.49       905,190       905,190       1.5  
                                 
Granted to Consultants     3.19-4.01       161,370       161,370       2.9  
      4.99       31,635       31,635       3.1  
      9.17-11.16       201,473       201,473       2.7  
              394,478       394,478          
                                 
Issued to Investors                                
      0.0002       35,922       35,922       1.5  
      4.54-6.00       3,229,771       3,229,771       1.5  
      6.78-8.34       8,360,034 (*)     8,360,034 (*)     3.2  
              11,625,727       11,625,727          
                                 
Total Warrants             12,925,395       12,925,395          
                                 
Total  Options and  Warrants             20,314,677       15,852,222          

 

(*) Represents warrants to purchase 4,666,226 shares of common stock.

 

16
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 5:- FAIR VALUE MEASUREMENTS

 

The Company classified certain warrants with down-round protection issued to the purchasers of convertible debentures in 2010 as a liability at their fair value according to ASC 815-40-15-7I. The liability in respect of these warrants will be remeasured at each reporting period until exercised or expired. Changes in the fair value of these warrants are reported in the statements of operations as financial income or expense.

 

The fair value of these warrants was estimated at September 30, 2014 and December 31, 2013 using the Binomial pricing model with the following assumptions:

 

    September 30,
2014
    December 31,
2013
 
             
Dividend yield     0 %     0 %
Expected volatility     52.1 %     78.1 %
Risk-free interest rate     0.1 %     0.3 %
Contractual life (in years)     1.0       1.7  

 

The changes in level 3 liabilities measured at fair value on a recurring basis:

 

    Fair value 
of liability 
in respect 
of warrants
 
Balance as of December 31, 2012   $ 1,931  
         
Change in the liability in respect of warrants     (20 )
         
Balance as of September 30, 2013 (unaudited)   $ 1,911  
         
Balance as of December 31, 2013   $ 1,211  
         
Change due to exercise of warrants     (14 )
         
Change in the liability in respect of warrants     (574 )
         
Balance as of September 30, 2014 (unaudited)   $ 623  

   

17
 

 

MEDGENICS, INC. AND ITS SUBSIDIARY

 

NOTES TO THE INTERIM CONSOLIDATED FINANCIAL STATEMENTS
U.S. dollars in thousands (except share and per share data)

 

NOTE 6:- LOSS PER SHARE

 

Details in the computation of diluted loss per share:

  

    Nine months ended September 30,  
    2014     2013  
    Weighted
average
number of
shares
    Loss     Weighted
average
number of
shares
    Loss  
    Unaudited  
For the computation of basic loss     18,716,109     $ 12,237       17,435,235     $ 11,921  
                                 
Effect of potential dilutive common shares issuable upon exercise of warrants classified as liability     147,294       574 (**)     33,020       20 (**)
                                 
For the computation of diluted loss     18,863,403     $ 12,811       17,468,255     $ 11,941  

  

    Three months ended September 30,  
    2014     2013  
    Weighted
average
number of
shares
    Loss     Weighted
average
number of
Shares
    Loss  
    Unaudited  
                         
For the computation of basic loss     18,817,557     $ 3,040       18,410,951     $ 6,143  
Effect of potential dilutive common shares issuable upon exercise of warrants classified as liability     121,166       880 (**)     - (*)     - (*)
                                 
For the computation of diluted loss     18,938,723     $ 3,920       18,410,951     $ 6,143  

 

(*) Anti-dilutive.
(**) Financial income resulted from changes in fair value of warrants classified as liability.

 

The total weighted average number of shares related to the outstanding options, warrants and restricted shares excluded from the calculations of diluted loss per share due to their anti-dilutive effect was 16,341,224 and 10,875,098 for the nine months ended September 30, 2014 and 2013, respectively.

 

- - - - -

 

18
 

 

ITEM 2 — Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q.

 

Forward Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements are often identified by the use of words such as, but not limited to, “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in the section titled “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2013, and any updates to those risk factors included in Part II, Item 1A of this Quarterly Report on Form 10-Q. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

 

Overview

 

We are an ex vivo gene therapy company, developing an innovative and proprietary platform technology offering what we believe to be a novel therapeutic approach for use in the $50 billion orphan and rare disease therapeutics markets. Our TARGT TM (Transduced Autologous Regenerative Gene Therapy) Platform Technology (previously called BioPump TM ) is designed to provide sustained protein and peptide therapy to treat a range of chronic diseases and conditions. We are currently studying our lead product TARGT epo (previously called EPODURE TM ) in a Phase 1/2 clinical trial in patients with Chronic Kidney Disease (CKD) and End Stage Renal Disease (ESRD), and we plan on studying TARGT epo in identified orphan populations of unmet need including ESRD patients who are hypo-responsive to recombinant humanized erythropoietin (rHuEPO), and Beta Thalassemia Intermedia patients. We have initiated in vivo proof of concept pre-clinical studies with several other orphan/rare disease candidates, and we anticipate initiating discussions with regulatory agencies for some of those programs in 2015.

 

Since our inception on January 27, 2000, we have focused our efforts on research and development and clinical trials and have received no revenue from product sales. We have funded our operations principally through equity and debt financings, participation from the Office of the Chief Scientist (OCS) in Israel and a collaborative agreement. Our operations to date have been primarily limited to organizing and staffing our company, developing the TARGT platform technology and its applications, developing and initiating clinical and pre-clinical trials for our product candidates, and improving and maintaining our patent portfolio.

 

We have generated significant losses to date, and we expect to continue to generate losses as we progress towards the commercialization of our product candidates.  We have incurred net losses of approximately $12.24 million for the nine month period ended September 30, 2014. As of September 30, 2014, we had stockholders’ equity of approximately $12.31 million.  We are unable to predict the extent of any future losses or when we will become profitable, if at all.

 

19
 

  

Recent Developments

 

In June 2014, the first patient was enrolled in our Phase 1/2 clinical trial of MDGN-201 (TARGT epo ). The aim of the ongoing trial is to validate the potential of our TARGT platform technology using a second generation viral vector, which was developed to enhance durability of the proposed therapeutic effect. The ongoing study will evaluate the potential of the updated platform to offer sustained production and delivery of endogenous erythropoietin (eEPO) to treat anemia in dialysis patients with ESRD or CKD. This open-label trial is expected to enroll up to 18 patients with either CKD or ESRD who require rHuEPO treatment for anemia. We expect that each patient will receive one or more TARGT epo microorgans and will be followed for at least one year. The trial endpoints include plasma eEPO levels, blood counts and safety assessment. On October 15, 2014, we announced initial clinical data on the first three patients of the Phase 1/2 trial. The three patients were 3.5, 2.5, and 1 month post implantation of TARGT epo microorgans. All patients were producing sustained physiological levels of eEPO, and all patients were meeting their targeted hemoglobin levels (9-12g/dl) due to red blood cell production stimulated by eEPO. No patient has required additional rHuEPO (e.g., EPREX) or a blood transfusion following the implantation of the TARGT epo microorgan(s). There have not been any reported treatment related safety issues. Finally, on October 15, 2014, we announced pre-clinical in vivo data that showed the TARGT platform was producing GLP-2 (glucagon-like peptide-2) in severe combined immunodeficiency (SCID) mouse models.

 

In April 2014, our wholly-owned subsidiary, Medgenics Medical Israel Ltd., which we refer to as MMI, was awarded a government grant of up to NIS 7.7 million (approximately $2.2 million) from the OCS. The grant will be used to cover research and development expenses for the 12-month period from December 2013 through November 2014 to support further research and clinical development of our TARGT platform technology with respect to the treatment of rare and orphan diseases and anemia. Under the terms of the OCS grant, MMI will be required to repay the grant in full, plus interest, through royalties on revenue received from commercializing the developed technology. The payment of royalties is contingent on such revenues and, in the absence of such revenues, no royalty payments to the OCS will be required. During the nine months ended September 30, 2014, MMI received $1.81 million under this and previous OCS grants.

 

Financial Operations Overview

 

Research and Development Expense

 

Research and development expense consists of: (i) internal costs associated with our development activities; (ii) payments we make to third party contract research organizations, contract manufacturers, clinical trial sites and consultants; (iii) technology and intellectual property license costs; (iv) manufacturing development costs; (v) personnel related expenses, including salaries, and other related costs, including stock-based compensation expense, for the personnel involved in product development; (vi) activities related to regulatory filings and the advancement of our product candidates through preclinical studies and clinical trials; and (vii) facilities and other allocated expenses, which include direct and allocated expenses for rent, facility maintenance, as well as laboratory and other supplies. All research and development costs are expensed as incurred.

 

Conducting a significant amount of development is central to our business model. Product candidates in later-stage clinical development generally have higher development costs than those in earlier stages of development, primarily due to the significantly increased size and duration of the clinical trials. We plan to increase our research and development expenses for the foreseeable future in order to complete the ongoing Phase 1/2 trial of TARGT epo with a new viral vector and implantation protocol, expand the study of TARGT epo into one or more Phase 2 trials in identified orphan disease populations, including ESRD patients who are hypo-responsive to rHuEPO and Beta Thalassemia Intermedia patients, and our earlier-stage research and development projects including in other targeted rare and orphan disease indications including TARGT GLP-2 for short bowel syndrome.

 

The process of conducting pre-clinical studies and clinical trials necessary to obtain regulatory approval is costly and time consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the quality of the product candidate’s early clinical data, investment in the program, competition, manufacturing capabilities and commercial viability. As a result of these uncertainties, together with the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of current or future clinical stages of our product candidates or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates. Development timelines, probability of success and development costs vary widely.

 

20
 

  

General and Administrative Expense

 

General and administrative expense consists primarily of salaries and other related costs, including stock-based compensation expense, for persons serving as our directors and in our executive, finance and accounting functions. Other general and administrative expense includes facility-related costs not otherwise included in research and development expense, costs associated with industry and trade shows, and professional fees for legal, accounting and consulting services. We expect that our general and administrative expenses will increase as we add personnel.

 

Financial Expenses and Income

 

Financial expenses consists primarily of warrant valuations.

 

Financial income consists primarily of warrant valuations and interest earned on our cash and cash equivalents.

 

Results of Operations for the Nine Months Ended September 30, 2014 and 2013

 

Research and Development Expenses

 

Gross research and development expenses for the nine months ended September 30, 2014 were $6.38 million, decreasing from $6.56 million for the same period in 2013 mainly due to a decrease in subcontractor costs. Research and development expenses, net for the nine months ended September 30, 2014 were $4.48 million, decreasing from $5.23 million for the same period in 2013 due to an increase of $0.57 million in the participation by the OCS in addition to the decrease in gross research and development expenses.

 

General and Administrative Expenses

 

General and administrative expenses for the nine months ended September 30, 2014 were $8.26 million, increasing from $6.70 million for the same period in 2013 primarily due to an increase in personnel and increased stock-based compensation expenses related to options granted to general and administrative personnel.

 

Financial Expenses and Income

 

Financial expenses for the nine months ended September 30, 2014 were $0.09 million, increasing from $0.02 million for the same period in 2013. The increase was mainly due to foreign currency exchange differences.

 

Financial income for the nine months ended September 30, 2014 was $0.61 million, increasing from $0.03 million for the same period in 2013. The increase was primarily due to the change in valuation of the warrant liability.

 

Results of Operations for the Three Months Ended September 30, 2014 and 2013

 

Research and Development Expenses

 

Gross research and development expenses for the three months ended September 30, 2014 were $2.28 million, decreasing from $2.45 million for the same period in 2013 due mainly to a decrease in subcontractor costs. Net research and development expenses for the three months ended September 30, 2014 decreased to $1.57 million from $2.34 million for the same period in 2013. The decrease in net research and development expenses was due to an increase of $0.61 million in the participation by the OCS in addition to the decrease in gross research and development expenses.

 

21
 

  

General and Administrative Expenses

 

General and administrative expenses for the three months ended September 30, 2014 were $2.31 million, decreasing from $2.56 million for the same period in 2013 primarily due to a decrease in professional fees.

 

Financial Expenses and Income

 

Financial expenses for the three months ended September 30, 2014 were $0.06 million, decreasing from $1.26 million for the same period in 2013. This decrease of $1.20 million was mainly due to the change in valuation of the warrant liability.

 

Financial income for the three months ended September 30, 2014 was $0.90 million increasing from $0.02 million for the same period in 2013. The increase was primarily due to the change in valuation of the warrant liability.

 

Liquidity and Capital Resources

 

Sources of Liquidity

 

Since the beginning of 2013, we have financed our operations primarily through a combination of equity issues and grants from the OCS.

 

We received $10.44 million from inception through September 30, 2014 from the OCS in development grants, of which $1.81 million was received during the nine months ended September 30, 2014 and $0.91 million was received during the nine months ended September 30, 2013.

 

In February 2013, we completed a registered public offering of 5,600,000 shares of common stock and 5,600,000 Series 2013-A warrants to purchase up to an aggregate of 2,800,000 shares of common stock. The net proceeds were approximately $26.55 million. The underwriters exercised their option in March 2013 with respect to an additional 470,000 shares of common stock and an additional 840,000 Series 2013-A warrants to purchase up to 420,000 shares of common stock, for additional net proceeds of approximately $2.27 million.

 

Cash Flows

 

We had cash and cash equivalents of $14.71 million at September 30, 2014 and $22.39 million at December 31, 2013. The decrease in our cash balance during the nine months ended September 30, 2014 was primarily the result of operating activities during the period.

 

Net cash used in operating activities of $8.59 million for the nine months ended September 30, 2014 and $8.36 million for the nine months ended September 30, 2013 primarily reflected our cash expenses for our operations.

 

Net cash used in investing activities of $0.29 million for the nine months ended September 30, 2014 and $0.16 million for the nine months ended September 30, 2013 relates mainly to our purchases of property and equipment.

 

Net cash provided by financing activities was $1.20 million for the nine months ended September 30, 2014 and $28.87 million for the nine months ended September 30, 2013. Our cash flows from financing activities during the nine months ended September 30, 2014 were primarily the result of the exercise of options and warrants while our cash flows from financing activities during the nine months ended September 30, 2013 were primarily the result of our registered public offering of common stock and Series 2013-A warrants during the period.

 

22
 

  

Funding Requirements

 

Our future capital requirements will depend on a number of factors, including our success in targeting rare and orphan disease candidates, the timing and outcome of clinical trials and regulatory approvals, the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing patent claims and other intellectual property rights, the acquisition of licenses to new products or compounds, the status of competitive products, the availability of financing, and our success in developing markets for our product candidates.

 

Without taking into account any revenue we may receive as a result of licensing or other commercialization agreements, we believe that cash on hand will be sufficient to enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2015. We have based this estimate on assumptions that may prove to be wrong and we could use our available resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenditures associated with our current and anticipated clinical trials.

 

We do not anticipate that we will generate revenue from the sale of products for at least four years; however, we may seek licensing or other commercialization agreements for existing and new TARGT applications. In the absence of additional funding or adequate funding from licensing or commercialization agreements, we expect our continuing operating losses to result in decreases, in our cash balances over the next several quarters.

 

Absent significant licensing or other commercialization arrangements, we will need to finance our future cash needs through public or private equity offerings or debt financings in the future. We do not currently have any commitments for future external funding beyond the OCS grant discussed above. We may need to raise additional funds more quickly if one or more of our assumptions prove to be incorrect, if we choose to expand our product development efforts more rapidly than we presently anticipate, or if we enter into additional collaboration or licensing agreements or acquire additional assets, and we may decide to raise additional funds even before we need them if the conditions for raising capital are favorable. We may seek to encourage holders of our warrants to exercise, sell additional equity or debt securities or obtain a bank credit facility. The sale of additional equity or debt securities, if convertible, could result in dilution to our stockholders. The incurrence of indebtedness would result in increased fixed obligations and could also result in covenants that would restrict our operations.

 

Our plans include seeking additional investments, commercial agreements, and targeted business development opportunities to expand our pipeline and continue our operations. However, while we continue to aggressively pursue these opportunities, there is no assurance that we will be successful in our efforts to raise the necessary capital, consummate targeted business development opportunities, and/or reach such commercial agreements to continue our planned research and development activities.

 

Critical Accounting Policies

 

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses. On an ongoing basis, we evaluate these estimates and judgments, including those described below. We base our estimates on our historical experience and on various other assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results and experiences may differ materially from these estimates.

 

While our significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this Quarterly Report on Form 10-Q, we believe that the following accounting policies are the most critical to aid you in fully understanding and evaluating our reported financial results and affect the more significant judgments and estimates that we use in the preparation of our financial statements.

 

23
 

  

Liability in Respect of Warrants

 

In the past, we issued warrants whose exercise price is subject to downward adjustment. In accordance with Accounting Standards Codification No. 815-40-15-7I, we classified these warrants as a liability at their fair value. The warrants liability will be remeasured at each reporting period until exercised or expired. The decrease in the fair value of the warrants of $0.57 million and $0.02 million during the nine months ended September 30, 2014 and 2013, respectively, are reported in the Statements of Operations as financial income.

 

We estimate the fair value of these warrants at the respective balance sheet dates using the Binomial option pricing model. We use a number of assumptions to estimate the fair value, including the remaining contractual terms of the warrants, risk-free interest rates, expected dividend yield and expected volatility of the price of the underlying common stock. These assumptions could differ significantly in the future, thus resulting in variability of the fair value which would impact the results of operations in the future.

 

Stock-Based Compensation

 

We account for stock options according to the Accounting Standards Codification No. 718 (ASC 718) “Compensation - Stock Compensation.” Under ASC 718, stock-based compensation cost is measured at grant date, based on the estimated fair value of the award, and is recognized as an expense over the employee’s requisite service period on a straight-line basis.

 

We account for stock options granted to non-employees on a fair value basis using an option pricing method in accordance with ASC 718. The initial non-cash charge to operations for non-employee options with vesting are revalued at the end of each reporting period based upon the change in the fair value of the options and amortized to consulting expense over the related vesting period.

 

For the purpose of valuing options and warrants granted to our employees, non-employees and directors and officers during the nine months ended September 30, 2014 and 2013, we used the Binomial options pricing model. To determine the risk-free interest rate, we utilized the U.S. Treasury yield curve in effect at the time of grant with a term consistent with the expected term of our awards. We estimated the expected life of the options granted based on anticipated exercises in the future periods assuming the success of our business model as currently forecast. The expected dividend yield reflects our current and expected future policy for dividends on our common stock. The expected stock price volatility for our stock options was calculated by examining historical volatilities for publicly traded industry peers as we do not have sufficient trading history for our common stock. We will continue to analyze the expected stock price volatility and expected term assumptions as more historical data for our common stock becomes available. We currently estimate that we will experience 5%-8% forfeitures for those options currently outstanding.

 

ASU 2014-10 regarding development stage entities

 

In June 2014 the FASB issued ASU 2014-10 regarding development stage entities. The ASU removes the definition of development stage entity, as was previously defined under generally accepted accounting principles in the United States (U.S. GAAP), from the accounting standards codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP.

 

In addition, the ASU eliminates the requirements for development stage entities to (i) present inception-to-date information in the statement of income, cash flow and stockholders’ equity, (ii) label the financial statements as those of a development stage entity, (iii) disclose a description of the development stage activities in which the entity is engaged, and (iv) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage.

 

We have applied the ASU effective from the financial statements as of June 30, 2014.

 

24
 

  

Off-Balance Sheet Arrangements

 

In May 2014, we signed an agreement with the Board of Trustees of the Leland Stanford Junior University (Stanford). According to the agreement, Stanford granted us a non-exclusive license for a patent for commercial development, production and marketing of certain products based on its know-how. In consideration, we agreed to pay Stanford the following amounts:

 

i)  An issue royalty of $25,000 upon signing the agreement.

ii) License maintenance fees of:

1. $10,000 in May 2015 and May 2016
2. $20,000 in May 2017 and May 2018
3. $50,000 in May 2019 and each year thereafter

 iii) Royalties at a rate of 1.5% of net sales.

iv)  Milestone payments of: 

1. $50,000 upon dosing of the first patient with a licensed product
2. $150,000 upon the first approval in the U.S. of a licensed product
3. $150,000 upon the first approval in Europe or Japan of a licensed product

 

The license agreement with the University of Michigan was terminated effective August 13, 2014.

 

ITEM 3 — Quantitative and Qualitative Disclosures about Market Risk

 

There has been no significant change in our exposure to market risk during the nine months ended September 30, 2014. For a discussion of our exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in our Annual Report on Form 10-K for the year ended December 31, 2013.

 

ITEM 4 — Controls and Procedures

 

Evaluation of disclosure controls and procedures

 

As required by Exchange Act Rule 13a-15(b), in connection with the filing of this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of September 30, 2014, the end of the period covered by this report.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) during the quarter ended September 30, 2014 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

25
 

 

PART II — OTHER INFORMATION

 

ITEM 1 — Legal Proceedings

 

We are not currently a party, as plaintiff or defendant, to any legal proceedings which, individually or in the aggregate, are expected by us to have a material effect on our business, financial condition or results of operation if determined adversely to us.

 

ITEM 1A — Risk Factors

 

Following increased terrorist attacks, Israel launched Operation Protective Edge in July in the Gaza Strip. During this operation our activities were not affected; however, there is no assurance that they will not be significantly affected in the future.

 

ITEM 2 — Unregistered Sales of Equity Securities and Use of Proceeds

 

Recent Sales of Unregistered Securities

 

At the end of June 2014, an investor exercised warrants to purchase 3,750 shares of common stock at an exercise price of $4.54 per share using the cashless exercise method. Using this cashless exercise method, the investor was issued 1,674 shares of common stock in July 2014. The issuance of these shares was deemed exempt from registration under the Securities Act in reliance upon Section 4(2) of the Securities Act. There were no underwriters employed in connection with this transaction.

 

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

 

None.

 

ITEM 3 — Defaults Upon Senior Securities

 

None.

 

ITEM 4 — Mine Safety Disclosures

 

Not applicable.

 

ITEM 5 — Other Information

 

None.

 

26
 

 

ITEM 6 — Exhibits

  

Exhibit No.   Description
     
3.1   Amended and Restated Certificate of Incorporation (previously filed as Exhibit 3.1 to the Company’s Registration Statement on Form S-1 filed November 5, 2010 (File No. 333-170425) and incorporated herein by reference).
     
3.2   Certificate of Amendment to Amended and Restated Certificate of Incorporation (previously filed as Exhibit 3.2 to the Company’s Registration Statement on Form S-1 filed November 5, 2010 (File No. 333-170425) and incorporated herein by reference).
     
3.3   Certificate of Amendment to Amended and Restated Certificate of Incorporation dated as of February 14, 2011 (previously filed as Exhibit 4.3 to the Company’s Post-Effective Amendment No. 1 to Form S-1 on Form S-3 filed July 16, 2012 (File No. 333-170425) and incorporated herein by reference).
     
3.4   Second Amended and Restated By-Laws (previously filed as Exhibit 3.3 to the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 (File No. 001-35112) and incorporated herein by reference).
     
10.1   Employment Agreement, dated as of September 8, 2014, between Medgenics, Inc. and Scott Applebaum (filed herewith).
     
10.2   Addendum to Employment Agreement, dated as of July 15, 2014, among Medgenics, Inc., Medgenics Medical Israel, Ltd. and Phyllis Bellin (previously filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 18, 2014 (File No. 001-35112) and incorporated herein by reference).
     
10.3   First Amendment to Addendum to Employment Agreement, dated as of September 17, 2014, among Medgenics, Inc., Medgenics Medical Israel, Ltd. and Phyllis Bellin (filed herewith).
     
31.1   Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
     
31.2   Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
     
32.1   Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
     
101   Interactive Data File (furnished herewith).
     

   

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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 thereunto duly authorized.

 

MEDGENICS, INC.
     
Date: October 15, 2014 By: /s/ Michael F. Cola
    Michael F. Cola
    President and Chief Executive Officer
    (Principal Executive Officer)
     
Date: October 15, 2014 By: /s/ John H. Leaman
    John H. Leaman
    Chief Financial Officer
    (Principal Financial Officer)

 

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Exhibit 10.1

 

Employment Agreement

 

This Employment Agreement is made and entered into effective September 8, 2014 (the “ Effective Date ”), by and between Medgenics, Inc ., a Delaware corporation, and Scott Applebaum . As used in this Agreement, capitalized terms have the meanings set forth in Section 20 .

 

Recitals

 

A. The Company desires to employ Executive as Chief Legal Officer, and Executive desires to be so employed by the Company, on the terms and conditions set forth herein.

 

B. The Parties have made commitments to each other on a variety of important issues concerning Executive’s employment, including the performance that will be expected of Executive, the compensation Executive will be paid, how long and under what circumstances Executive will remain employed, and the financial details relating to any decision that either the Company or Executive may make to terminate this Agreement and Executive’s employment with the Company.

 

C. The Parties desire to enter into this Agreement as of the Effective Date and to have this Agreement supersede all agreements between the Parties, whether or not in writing, and to have any such prior agreements become null and void as of the Effective Date.

 

Agreement

 

In consideration of the foregoing and the mutual promises and covenants of the Parties set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, hereby expressly covenant and agree as follows:

 

1. Employment Period . The Company shall employ Executive during the Employment Period and Executive shall remain in the employ of the Company and provide services to the Company during the Employment Period in accordance with the terms of this Agreement. The “ Employment Period ” shall be the period beginning on the Effective Date and ending on the third anniversary of the Effective Date, unless sooner terminated as provided herein, provided that the Employment Period shall be extended automatically for one additional year beginning on the third anniversary of the Effective Date and on each anniversary thereafter unless either Party notifies the other Party, by written notice delivered no later than 90 days prior to such anniversary, that the Employment Period shall not be extended.

 

2. Duties .

 

(a) During the Employment Period, Executive shall devote Executive’s full business time, energy, and talent to serving as Chief Legal Officer of the Company, with legal responsibilities for all U.S. and Israeli operations, including:

 

 

  

o with Chief Financial Officer, responsibility for financial oversight/reporting for the Company;
o with Head of Research and Development, responsibility for the execution of patent strategy for Medgenics
o responsibility for oversight of all legal activities associated with business development.

Executive shall report to, and be under the direction, of the CEO.

 

(b) Executive shall have the duties that are commensurate with Executive’s positions and any other duties that may be assigned to Executive by the CEO, and Executive shall perform all such duties faithfully and efficiently in compliance with applicable law and Company policies, as may be in effect from time to time. Executive shall have such powers as are inherent to the undertakings applicable to Executive’s positions and necessary to carry out the duties required of Executive hereunder.

 

(c) Executive’s principal place of business shall be within 50 miles of Philadelphia, Pennsylvania; however, it is understood that Executive may be required to travel both domestically and internationally in fulfillment of Executive’s duties set forth herein.

 

(d) Notwithstanding the foregoing provisions of this Section 2 , during the Employment Period, Executive may devote reasonable time to activities other than those required under this Agreement, including activities of a charitable, educational, religious, or similar nature to the extent such activities do not, in the judgment of the CEO, inhibit, prohibit, interfere with, or conflict with Executive’s duties under this Agreement or conflict in any material way with the business of the Company or any Affiliate; provided, however, that Executive shall not serve on the board of directors of any business (other than the Company or an Affiliate) or hold any other position with any business without receiving the prior written consent of the CEO.

 

3. Compensation and Benefits . During the Employment Period, while Executive is employed by the Company, the Company shall compensate Executive for Executive’s services as follows:

 

(a) Executive shall be paid a base salary at an annual rate of $350,000 (the “ Annual Base Salary ”), which shall be payable in accordance with the normal payroll practices of the Company then in effect (currently twice monthly). For fiscal year 2016 and each subsequent fiscal year during the Employment Period, Executive’s Annual Base Salary shall be reviewed by the Board for possible increase, but not decrease, with any such increase to be effective as of January 1 of the year of such adjustment. The Company retains the discretion to review Executive’s Annual Base Salary prior to January of 2016, though there is no intended inference or agreement to do so.

 

(b) Executive shall be eligible to receive performance-based annual incentive bonuses (each, the “ Incentive Bonus ”) from the Company for each fiscal year ending during the Employment Period. Incentive Bonuses shall be as determined in the discretion of the Board, or as may be pursuant to a new annual incentive plan as may be adopted and in effect from time to time, with any applicable performance metrics and goals to be established by the Board after consultations with Executive. Executive’s initial target bonus shall be 40% of Annual Base Salary (“ Target Bonus ”), but may be greater or less based upon actual performance and Board determination. Any Incentive Bonus shall be paid to Executive no later than 60 days after the close of the fiscal year in which it is earned, provided that any Incentive Bonus shall not be considered earned until the Board has made all determinations and taken all actions necessary to establish such Incentive Bonus. Executive’s Incentive Bonus for fiscal year 2014 shall be prorated on a per diem basis for the number of days employed during such fiscal year, divided by 365, and shall be determined in the discretion of the Board based upon performance criteria to be mutually agreed upon by Executive and the CEO within the first 45 days following the Effective Date.

 

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(c) Effective on the Effective Date, Executive shall receive an initial stock option award with respect to 450,000 shares of the Company’s common stock, granted under the Company’s Stock Incentive Plan, as amended. The form of the award agreement shall be in the form attached hereto as Exhibit B , which provides for, (i) three-year vesting (1/3 vesting on the first anniversary of grant and the balance vesting in equal increments on a monthly basis thereafter), (ii) exercisability through the 10th anniversary of grant, subject to expiration following termination as provided herein, (iii) exercisability on a net basis, and (iv) an exercise price based upon the closing price of the Company’s common stock on the date of grant.

 

(d) Executive shall be eligible to participate, subject to the terms thereof, in all incentive plans of the Company as may be in effect from time to time with respect to senior executives employed by the Company in the United States, on as favorable a basis as other similarly situated and performing executives.

 

(e) Executive and Executive’s dependents, as the case may be, shall be eligible to participate, subject to the terms thereof, in all pension and similar benefit plans and all medical, dental, disability, group and executive life, accidental death and travel accident insurance, and other similar welfare benefit plans of the Company as may be in effect from time to time with respect to senior executives employed by the Company in the United States, on as favorable a basis as other similarly situated and performing executives. If the Company does not have in place a medical (including eye) and dental insurance program, the Company shall pay to Executive a monthly amount up to $3,560 to continue COBRA continuation coverage (including any spousal or family coverage, as may be applicable) through Executive’s prior employer, provided Executive remains eligible for and elects such continuation coverage.

 

(f) Executive shall be entitled to accrue paid time off and holidays in accordance with and subject to the Company’s paid time off programs and policies relating to its employees in the United States as may be in effect from time to time, provided that Executive shall be entitled to a minimum of 20 days of paid time off per fiscal year, accrued pro rata throughout the year. Paid time off not taken in the fiscal year accrued shall not cumulate or be useable in any subsequent fiscal year, unless so provided in the Company’s paid time off programs and policies relating to its employees in the United States as may be in effect from time to time.

 

(g) Executive shall be eligible to be reimbursed by the Company, on terms that are substantially similar to those that apply to other similarly situated and performing executives employed by the Company, for reasonable out-of-pocket expenses for entertainment, travel, meals, lodging, and similar items that are consistent with the Company’s expense reimbursement policy and that are actually incurred by Executive in the promotion of the Company’s business.

 

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4. Termination . This Agreement and Executive’s employment under this Agreement may be terminated for any of the reasons described in this Section 4 . Executive’s right to benefits, if any, for periods after the Termination Date shall be determined in accordance with this Section 4 :

 

(a) Minimum Benefits upon Termination . If the Termination Date occurs during the Employment Period for any reason, Executive shall be entitled, in addition to any other benefits to which Executive may be entitled under the following provisions of this Section 4 or the express terms of any employee benefit plan or as required by law, to the following:

 

(i) Executive’s earned but unpaid Annual Base Salary for the period ending on the Termination Date;

 

(ii) Executive’s earned but unpaid Incentive Bonus, if any, for any completed fiscal year preceding the Termination Date; provided , however , that Executive shall not be entitled to any Incentive Bonus in the event of a Termination for Cause if the events giving rise to the Termination for Cause occurred in such prior fiscal year;

 

(iii) Executive’s accrued but unpaid paid time off for the fiscal year during which the Termination Date occurs;

 

(iv) Executive’s unreimbursed business expenses through and including the Termination Date, provided that all required submissions for expense reimbursement are made in accordance with the Company’s expense reimbursement policy and within 45 days following the Termination Date; and

 

(v) The benefits, incentives, and awards described in Section (g)(i) .

 

Any benefits to be provided to Executive pursuant to this Section 4(a) shall be provided within 30 days after the Termination Date (except that payments under Section 4(a)(iv) shall be made within 30 days following submission for reimbursement); provided , however , that any benefits, incentives, or awards payable as described in Section 4(g)(i) shall be provided in accordance with the terms of the applicable plan, program, or arrangement. Except as may expressly be provided to the contrary in this Agreement, nothing in this Agreement shall be construed as requiring Executive to be treated as employed by the Company or any Affiliate following the Termination Date for purposes of any plan, program, or arrangement.

 

(b) Termination for Death or Disability . The Company shall be entitled to terminate the employment of Executive upon Executive’s death or Disability, by giving written notice to Executive, in which event the date that the Company gives such notice shall be deemed the Termination Date. Upon a Termination due to Executive’s death or Disability, Executive (or Executive’s estate, if applicable) shall be entitled to the following:

 

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(i) The benefits described in Section 4(a) ;

 

(ii) A payment, payable on the 45 th day following the Termination Date, equal to the Target Bonus for the fiscal year in which the Termination Date occurs, prorated on a per diem basis for the number of days employed during such fiscal year prior to the Termination Date, divided by 365 (a “ Pro-Rated Bonus ”);

 

(iii) A lump sum payment, payable on the 45 th day following the Termination Date, in an amount equal to the sum of (x) 100% of Executive’s Annual Base Salary in effect on the Termination Date, and (y) 100% of the Target Bonus for the fiscal year in which the Termination Date occurs;

 

(iv) All unvested stock options then held by Executive that are scheduled to vest within 12 months after the Termination Date shall immediately vest and all vested stock options shall remain exercisable through the earlier of the 24-month anniversary of the Termination Date or the original expiration date of the applicable stock option; and

 

(v) The continuation of benefits as provided in Section 4(f) , provided such benefit shall only be for a maximum period of 12 months.

 

(c) Termination With Good Reason or Without Cause . Executive shall be entitled to terminate his employment for Good Reason by giving at least 10 days’, but not more than 30 days’, prior written notice of termination to the Company, in which event the date specified in the notice of termination shall be deemed the Termination Date; provided , however , that (A) prior to giving such notice of Termination for Good Reason, Executive must give the Company written notice of the existence of any condition giving rise to Good Reason within 30 days of its initial existence and the Company shall have 30 days from the date of such notice in which to cure the condition giving rise to Good Reason, if curable, and if, during such 30-day period, the Company cures the condition giving rise to Good Reason, such condition shall not constitute Good Reason and (B) any Termination for Good Reason must occur within six months of the initial existence of the condition constituting Good Reason. The Company shall be entitled to terminate Executive’s employment for any reason that does not constitute Cause, or for no reason, by giving at least 10 days’ prior written notice to Executive, in which event the date specified in the notice of termination shall be deemed the Termination Date. Upon a Termination by Executive for Good Reason or a Termination by the Company without Cause, Executive shall be entitled to the following:

 

(i) The benefits described in Section 4(a) ;

 

(ii) A Pro-Rated Bonus, payable on the 45 th day following the Termination Date;

 

(iii) A lump sum payment, payable on the 45 th day following the Termination Date, in an amount equal to the sum of (x) 150% of Executive’s Annual Base Salary in effect on the Termination Date, and (y) 150% of the Target Bonus for the fiscal year in which the Termination Date occurs;

 

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(iv) All unvested stock options then held by Executive shall immediately vest and all vested stock options shall remain exercisable through the earlier of the 24-month anniversary of the Termination Date or the original expiration date of the applicable stock option; and

 

(v) The continuation of benefits as provided in Section 4(f)f) .

 

(d) Termination for Cause . The Company shall be entitled to terminate Executive’s employment for Cause by giving written notice of termination to Executive, in which event the date that the Company gives such notice shall be deemed the Termination Date; provided , however , that (A) with respect to clauses (iii) or (iv) of the definition of “Cause” set forth in Section 20 (e) , to the extent curable, Executive shall be entitled to at least 30 days’ prior written notice of the Company’s intention to terminate Executive’s employment for Cause, which notice shall specify the grounds for Cause; and Executive shall be provided a reasonable opportunity to cure any conduct or act, if curable, alleged as grounds for Cause, and a reasonable opportunity to present to the Board Executive’s position regarding any dispute relating to the existence of any grounds for Cause. Further, all rights Executive has or may have under this Agreement shall be suspended automatically during (A) the pendency of any investigation by the Board or its designee, or (B) any negotiations between the Board or its designee and Executive regarding any actual or alleged act or omission by Executive of the type that would warrant a Termination for Cause and any such suspension shall not give rise to a claim of Good Reason by Executive. Upon a Termination for Cause, Executive shall only be entitled to the benefits described in Section 4(a) and all unvested stock options then held by Executive shall immediately expire on the Termination Date and all vested stock options shall immediately terminate on the Termination Date and shall no longer be exercisable. Notwithstanding anything to the contrary contained herein, a Termination for Cause shall be deemed to have occurred if, within 12 months following the Termination, facts and circumstances arising during the course of such employment are discovered that would have warranted a Termination for Cause.

 

(e) Termination due to Voluntary Resignation or Executive’s Notice of Non-Renewal . Executive shall be entitled to terminate his employment without Good Reason by giving at least 60 days’ prior written notice to the Company, in which event the date that is 60 days after the date that Executive gives such notice shall be deemed to be the Termination Date. Upon a Termination by Executive without Good Reason or in the event that Executive gives a notice of his desire not to extend the Employment Period as provided in Section 1 (in which event the Termination Date shall be deemed to be the expiration of the Employment Period), Executive shall only be entitled to the benefits described in Section 4(a) and all unvested stock options then held by Executive shall immediately expire on the Termination Date and all vested stock options shall remain exercisable for a period of 90 days after the Termination Date.

 

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(f) Medical and Dental Benefits . If Executive’s employment is terminated pursuant to Section 4(b) or 4(c) , then, to the extent that Executive or any of Executive’s dependents may be covered under the terms of any medical or dental plans of the Company (or an Affiliate) for active employees immediately prior to the Termination Date and provided Executive is eligible for and elects to continue coverage (under the health care continuation rules of COBRA, provided that if, on the Termination Date, the Company is not subject to COBRA, the Company shall provide for continuation coverage as if it were subject to COBRA for the entire period to which COBRA would have applied if the Company had been subject to COBRA (collectively for purposes of this Agreement, “COBRA”)), the Company shall provide Executive and those dependents with coverage equivalent to the coverage in effect immediately prior to the applicable Termination Date for a period of up to 18-months following the Termination Date, such that Executive shall be required to pay, on a monthly basis, the same amount as Executive would pay if Executive continued in employment with the Company during such period (“ Subsidized Coverage ”) and thereafter Executive shall be responsible for the full cost of such continued coverage; provided , however , that Subsidized Coverage shall be provided as described above unless the Company determines, based on a written legal opinion of counsel, that the Company’s provision of Subsidized Coverage results in the violation of non-discrimination provisions of applicable law, as may be applicable to the Company (the enforcement of which is not suspended by legislation, regulation or administrative action), the imposition of a material additional tax or other material penalty being imposed on the Company (or an Affiliate) or any employee participating in such plans. If the Company makes such a determination, then the Company shall pay Executive an additional severance benefit equal to the cost to the Company of the Subsidized Coverage (had such Subsidized Coverage been provided) to assist Executive with the cost of COBRA or, if not available, to assist Executive with the cost of comparable coverage for Executive and his eligible dependents. The coverages under this Section 4(f) are first intended to provide coverage under the Company plans to the maximum extent permitted by law, subject to the foregoing exceptions, and if such coverage is not so provided due to such exceptions, only then coverage may be procured directly by the Company (or an Affiliate, if appropriate) apart from, and outside of the terms of the respective plans, provided that Executive and Executive’s dependents comply with all of the terms of the substitute medical or dental plans. In the event Executive or any of Executive’s dependents is or becomes eligible for coverage under the terms of any other medical and/or dental plan of a subsequent employer with plan benefits that are comparable to Company (or Affiliate) plan benefits, the Company’s and its Affiliates’ obligations under this Section 4(f) shall cease with respect to the eligible Executive and/or dependent. Executive and Executive’s dependents must notify the Company of any subsequent employment and provide information regarding medical and/or dental coverage available.

 

(g) Other Benefits .

 

(i) Executive’s rights following a Termination with respect to any benefits, incentives, or awards provided to Executive pursuant to the terms of any plan, program, or arrangement sponsored or maintained by the Company or its Affiliates, whether tax-qualified or not, which are not specifically addressed herein, shall be subject to the terms of such plan, program, or arrangement and this Agreement shall have no effect upon such terms except as specifically provided herein.

 

(ii) Except as specifically provided in this Agreement, the Company and its Affiliates shall have no further obligations to Executive under this Agreement following a Termination.

 

(h) Removal from any Boards and Positions . Unless otherwise agreed to in writing by the Parties at the time of Termination, upon a Termination, Executive shall be deemed to resign (i) if a member, from the Board and the board of directors of any Affiliate and any other board to which Executive has been appointed or nominated by or on behalf of the Company or an Affiliate, (ii) from each position with the Company and any Affiliate, including as an officer of the Company or an Affiliate and (iii) as a fiduciary of any employee benefit plan of the Company and any Affiliate.

 

7
 

  

(i) Claw-back . Any compensation or benefits received under this Agreement shall be subject to potential cancellation, recoupment, rescission, payback or other similar action as may be required by law, and, if the Company implements a claw-back policy during the Employment Period, Executive shall acknowledge and consent to the Company’s application, implementation and enforcement of such policy with respect to any compensation or benefits received under this Agreement.

 

5. Release . Notwithstanding any provision of this Agreement to the contrary, Executive shall not be entitled to any benefits under Section 4(b), 4(c) or 4(f) (other than the benefits set forth in Section 4(a) ), and shall repay to the Company any such benefits received, unless Executive (or Executive’s estate, if applicable) executes (without subsequent revocation) and delivers to the Company a Release within 21 days (or such longer period to the extent required by applicable law) following the Termination Date.

 

6. Restrictive Covenants . Executive acknowledges that Executive has been and will continue to be provided intimate knowledge of the business practices, trade secrets, and other confidential and proprietary information of the Company (including the Confidential Information), which, if exploited by Executive, would seriously, adversely, and irreparably affect the interests of the Company and the ability of the Company to continue its business. Executive further acknowledges that, during the course of Executive’s employment with the Company, Executive may produce and have access to Confidential Information.

 

(a) Confidential Information . During the course of Executive’s employment and following a Termination:

 

(i) Executive shall not directly or indirectly use, disclose, copy, or make lists of Confidential Information for the benefit of anyone other than the Company, except to the extent that such information is or thereafter becomes lawfully available from public sources, or such disclosure is authorized in writing by the Company, required by law, or otherwise as reasonably necessary or appropriate in connection with the performance by Executive of Executive’s duties to the Company.

 

(ii) If Executive receives a subpoena or other court order or is otherwise required by law to provide information to a governmental authority or other person concerning the activities of the Company or its Affiliates, or Executive’s activities in connection with the business of the Company or its Affiliates, Executive shall immediately notify the Company of such subpoena, court order, or other requirement and deliver forthwith to the Company a copy thereof and any attachments and non-privileged correspondence related thereto.

 

(iii) Executive shall take reasonable precautions to protect against the inadvertent disclosure of Confidential Information.

 

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(iv) Executive shall abide by the Company’s policies, as in effect from time to time, respecting avoidance of interests conflicting with those of the Company and its Affiliates. In this regard, Executive shall not directly or indirectly render services to any person or Entity where Executive’s service would involve the use or disclosure of Confidential Information.

 

(v) Executive shall not use any Confidential Information to guide Executive in searching publications or other publicly available information, selecting a series of items of knowledge from unconnected sources, and fitting them together to claim that Executive did not violate any terms set forth in this Agreement.

 

(b) Documents and Property .

 

(i) All records, files, documents, and other materials or copies thereof relating to the business of the Company or its Affiliates that Executive prepares, receives, or uses, shall be and remain the sole property of the Company and, other than in connection with the performance by Executive of Executive’s duties to the Company, shall not be removed from the premises of the Company or its Affiliates without the Company’s prior written consent, and shall be immediately returned to the Company upon a Termination, together with all copies (including copies or recordings in electronic form), abstracts, notes, or reproductions of any kind made from or about the records, files, documents, or other materials.

 

(ii) Executive acknowledges that Executive’s access to and permission to use the Company’s and its Affiliates’ computer systems, networks, and equipment, and all the Company and Affiliate information contained therein, is restricted to legitimate business purposes on behalf of the Company and reasonable personal use in accordance with the Company’s applicable policies and procedures. Any other access to or use of such systems, networks, equipment, and information is without authorization and is prohibited. The restrictions contained in this Section 6(b) extend to any personal computers or other electronic devices of Executive that are used for business purposes relating to the Company or its Affiliates. Executive shall not transfer any Company or Affiliate information to any personal computer or other electronic device that is not otherwise used for any business purpose relating to the Company or an Affiliate. Upon a Termination, Executive’s authorization to access and permission to use the Company’s and its Affiliates’ computer systems, networks, and equipment, and any Company and Affiliate information contained therein, shall cease, and Executive shall delete any Company and Affiliate information from Executive’s personal computer or other electronic device.

 

(c) Non-Competition and Non-Solicitation . The primary service area of the Company’s business in which Executive will actively participate extends separately to the Restricted Area. Therefore, as an essential ingredient of and in consideration of the compensation and benefits (including the initial stock option award and the severance benefits) provided herein, this Agreement and Executive’s employment with the Company, Executive shall not, during Executive’s employment with the Company or during the Restricted Period, directly or indirectly do any of the following (all of which are collectively referred to in this Agreement as the “ Restrictive Covenant ”):

 

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(i) Engage or invest in, own, manage, operate, finance, control, participate in the ownership, management, operation, or control of, be employed by, associated with, or in any manner connected with, serve as a director, officer, or consultant to, lend Executive’s name or any similar name to, lend Executive’s credit to or render services or advice to, in each case in the capacity (or any substantially similar capacity) that Executive provided services to the Company, any person, firm, partnership, corporation, other Entity, or trust that owns, operates, or is in the process of forming, a Competitor doing or planning to do business in the Restricted Area (as may be evidenced by being identified in a filing with any regulatory authority, if applicable); provided , however , that the following activities shall not violate this Section 6(c)(i): (x) the ownership by Executive of shares of the capital stock of any Entity, which shares are listed on a securities exchange and that do not represent more than 2% of the Entity’s outstanding capital stock, and (y) Executive’s private practice of law provided that Executive shall not provide legal services to any Competitor during the Restricted Period.

 

(ii) (A) Induce or attempt to induce any employee of the Company or its Affiliates to leave the employ of the Company or its Affiliates; (B) interfere with the relationship between the Company or its Affiliates and any employee of the Company or its Affiliates; or (C) induce or attempt to induce any customer, supplier, licensee, advisor, consultant, or other business relation of the Company or its Affiliates with whom Executive or any reporting employee had a business relationship to cease doing business with the Company or its Affiliates or interfere with the relationship between the Company or its Affiliates and their respective customers, suppliers, licensees, advisors, consultants or other business relations with whom Executive or any reporting employee had a business relationship.

 

(iii) Serve as the agent, broker, or representative of, or otherwise assist, any person or Entity in obtaining services or products from any Competitor within the Restricted Area, with respect to products, activities, or services that Executive or any reporting employee devoted time to on behalf of the Company or any Affiliate (or any substantially similar products, activities, or services) and that compete in whole or in part with the products, activities, or services of the Company or its Affiliates.

 

(iv) Accept employment with, provide services to, or act in any other such capacity for or with any Competitor, if in such employment or capacity Executive would inevitably use or disclose the Company’s Confidential Information in Executive’s work or service for such Competitor.

 

(d) Works Made for Hire; Ownership of Company Work Product.

 

(i) The Parties understand and agree that all work prepared by Executive for the Company or for its Affiliates shall be a Work Made For Hire as such phrase is defined under the U.S. Copyright laws, 17 U.S.C. Sec. 101 et seq. , and if such work does not qualify as a Work Made For Hire, Executive shall, and does, assign to the Company all of Executive’s right, title, and interest in and to the work, including all patent, copyright, trademark, and other proprietary rights thereto.  Executive waives and releases all moral rights in any of the works as Executive may possess by virtue of the Visual Artist’s Moral Rights Act of 1990 and various country or state laws of attribution, authorship, and integrity commonly referred to as Moral Rights Law.  Executive shall not assert any claim based upon such moral rights against the Company, the Affiliates, or any of their respective successors in interest or assigns.  Executive shall have no right, title, or interest in any of the work and shall not be entitled to any royalties or other proceeds received by the Company or its Affiliates from the commercialization in any manner of the work.

 

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(ii) Executive hereby assigns to the Company any right, title, and interest in and to all Company Work Product that Executive may have, by law or equity, without additional consideration of any kind whatsoever from the Company or its Affiliates.

 

(iii) Executive shall execute and deliver any instruments or documents and do all further acts (including the giving of testimony and executing any applications, oaths, and assignments) requested by the Company (both before and after a Termination) in order to vest more fully in the Company or its Affiliates all ownership rights in the Company Work Product (including obtaining patent, copyright, trademark, or other intellectual property protection therefore in the United States and foreign countries). 

 

(iv) The Company or its Affiliates shall at all times own and have exclusive right, title, and interest in and to all Confidential Information and Company Work Product, and the Company or its Affiliates shall retain the exclusive right to use, license, sell, transfer, and otherwise exploit and dispose of the same.  Executive acknowledges the Company’s or its Affiliates’ exclusive right, title, and interest in and to the Confidential Information and Company Work Product, and shall not contest, challenge or make any claim adverse to the Company’s or its Affiliates’ ownership of or the validity of the Confidential Information and Company Work Product, any future application for registration or registration thereof, or any rights of the Company or its Affiliates therein, or which, directly or indirectly, may impair any part of the Company’s or its Affiliates’ right, title, and interest therein.

 

(v) To the extent required by applicable state statute, this Section 6(d) shall not apply to an invention for which no equipment, supplies, facility, or trade secret information of the Company or its Affiliates was used and that was developed entirely on Executive’s own time, unless the invention (i) relates to the business of the Company or an Affiliate or to the Company’s or an Affiliate’s actual or demonstrably anticipated research or development or (ii) results from any work performed by Executive for the Company or an Affiliate. 

 

(e) Consent and Release . From time to time, the Company’s business locations may be the subject of a Promotional Work.  Executive acknowledges that Executive is aware that Executive’s name, image, and likeness may be captured in such Promotional Work, and hereby consents and agrees that the Company may use Executive’s name, image, and likeness as captured in the Promotional Work in any manner, in connection with the Company’s products and services, and, at all times, the Company, its Affiliates, and, without limitation, their respective customers, successors, licensees, and assigns, may continue to use the Promotional Work that includes Executive’s name, image, or likeness.  Executive, Executive’s heirs, predecessors, successors, assigns, and all affiliated entities hereby fully and finally release, remise, and forever discharge the Company, its Affiliates, their respective predecessors, successors, assigns, and all affiliated entities, and each of their respective directors, officers, members, shareholders, partners, employees, customers, agents, and attorneys, to the extent that such apply, of and from any and all manner of actions, causes of action, losses, claims, demands, liabilities, obligations, suits, debts, sums of money, accounts, reckonings, bonds, bills, specialties, covenants, controversies, agreements, promises, variances, trespasses, damages, judgments, and executions, in law or in equity, that arise out of or are related to the Company’s or its Affiliates’ use of a Promotional Work that includes Executive’s name, image, or likeness.

 

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(f) Company Proprietary and Intellectual Property . The Company or its Affiliates shall at all times own and have exclusive right, title, and interest in and to all Company Proprietary and Intellectual Property, and the Company or its Affiliates shall retain the exclusive right to use, license, sell, transfer, and otherwise exploit and dispose of the same.  Executive acknowledges the Company’s or its Affiliates’ exclusive right, title, and interest in and to Company Proprietary and Intellectual Property, and shall not contest, challenge, or make any claim adverse to the Company’s or its Affiliates’ ownership of or the validity of Company Proprietary and Intellectual Property, any future application for registration or registration thereof, or any rights of the Company or its Affiliates therein, or which, directly or indirectly, may impair any part of the Company’s or its Affiliates’ right, title, and interest therein.  Executive shall not use or otherwise exploit any of Company Proprietary and Intellectual Property in any manner not authorized by the Company.

 

(g) Remedies for Breach of Restrictive Covenant .

 

(i) Executive has reviewed the provisions of this Agreement with legal counsel, or has been given adequate opportunity to seek such counsel, and Executive acknowledges that the covenants contained in this Section 6 are reasonable with respect to their duration, geographical area, and scope.

 

(ii) Executive acknowledges that (A) the restrictions contained in this Section 6 are reasonable and necessary for the protection of the legitimate business interests of the Company, (B) such restrictions create no undue hardships, (C) any violation of these restrictions would seriously, adversely, and irreparably injure the Company and such interests, and (D) such restrictions were a material inducement to the Company to employ Executive and to enter into this Agreement and to provide the compensation, benefits and opportunities hereunder.

 

(iii) Executive must, and the Company may, communicate the existence and terms of this Agreement to any third party with whom Executive may seek or obtain future employment or other similar arrangement.

 

(iv) In the event of any violation or threatened violation of the restrictions contained in this Section 6 , the Company, in addition to and not in limitation of, any other rights, remedies, or damages available to the Company under this Agreement or otherwise at law or in equity, shall not be required to provide any amounts or benefits under this Agreement and shall be entitled to preliminary and permanent injunctive relief to prevent or restrain any such violation by Executive and all persons directly or indirectly acting for or with Executive, as the case may be, without any requirement that the Company post bond.

 

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(v) If Executive violates the Restrictive Covenant and the Company brings legal action for injunctive or other relief, the Company shall not, as a result of the time involved in obtaining such relief, be deprived of the benefit of the full period of the Restrictive Covenant; accordingly, the Restrictive Covenant shall be deemed to have the duration specified herein computed from the date the relief is granted but reduced by the time between the period when the Restricted Period began to run and the date of the first violation of the Restrictive Covenant by Executive.

 

7. No Set-Off; No Mitigation . Except as provided herein, the Company’s obligation to provide benefits under this Agreement and otherwise to perform its obligations hereunder shall not be affected by any circumstances, including any set-off, counterclaim, recoupment, defense, or other right the Company may have against Executive or others. In no event shall Executive be obligated to seek other employment or take any other action by way of mitigation of the amounts payable to Executive under any of the provisions of this Agreement, and such amounts shall not be reduced whether or not Executive obtains other employment.

 

8. Notices . Notices and all other communications under this Agreement shall be in writing and shall be deemed given when mailed by United States registered or certified mail, return receipt requested, postage prepaid, addressed as follows: if to the Company, to the principal headquarters of the Company, attention: Chief Executive Officer; and if to Executive, to Executive’s most recent address in the Company’s records; or, in each respective case, to such other address as either Party may furnish to the other in writing, except that notices of changes of address shall be effective only upon receipt.

 

9. Governing Law . This Agreement shall be governed by and construed under the laws of the Commonwealth of Pennsylvania, without regard to principles of conflict of laws (whether in the Commonwealth of Pennsylvania or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the Commonwealth of Pennsylvania.

 

10. Choice of Venue and Consent to Jurisdiction . Each Party hereby irrevocably submits to the exclusive jurisdiction of the courts located in the City of Philadelphia, Pennsylvania, if such courts have or can acquire jurisdiction, and if such jurisdiction does not exist and cannot be acquired, to the exclusive jurisdiction of the United States District Court serving the City of Philadelphia, Pennsylvania, for the purpose of any suit, action, or other proceeding arising out of or based on this Agreement or any other agreement contemplated hereby or any subject matter hereof, whether in tort, contract, or otherwise. Each Party may be served with process in any manner permitted under Pennsylvania law, or by United States registered or certified mail, return receipt requested.

 

11. Entire Agreement . This Agreement constitutes the entire agreement between the Parties concerning the subject matter hereof, and supersedes all prior negotiations, undertakings, agreements, and arrangements with respect thereto, whether written or oral.

 

12. Withholding of Taxes . The Company may withhold from any benefits payable under this Agreement all federal, state, city and other taxes as may be required pursuant to any law, governmental regulation, or ruling.

 

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13. No Assignment . Executive’s right to receive benefits under this Agreement shall not be assignable or transferable whether by pledge, creation of a security interest, or otherwise, other than a transfer by will or by the laws of descent or distribution. In the event of any attempted assignment or transfer contrary to this Section 13 , the Company and its Affiliates shall have no liability to pay any amount so attempted to be assigned or transferred. This Agreement shall inure to the benefit of and be enforceable by Executive’s personal and legal representatives, executors, administrators, successors, heirs, distributees, devisees, and legatees.

 

14. Successors . This Agreement shall be binding upon and inure to the benefit of the Company, its successors, and assigns.

 

15. Legal Fees . In the event that either Party commences mediation, arbitration, litigation, or any similar action to enforce or protect such Party’s rights in accordance with and under this Agreement, the prevailing Party in any such action shall be entitled to recover reasonable attorneys’ fees and costs (including the costs of experts, evidence, and counsel) and other costs relating to such action, in addition to all other entitled relief, including damages and injunctive relief.

 

16. Amendment . This Agreement may not be amended or modified except by written agreement signed by the Parties.

 

17. Executive Acknowledgement . Executive hereby represents that from and after the Effective Date the performance of Executive’s duties hereunder will not breach any other agreement to which Executive is a party. Executive acknowledges that Executive has read and understands this Agreement, is fully aware of its legal effect, has not acted in reliance upon any representations or promises made by the Company other than those contained in writing herein, and has entered into this Agreement freely based on Executive’s own judgment.

 

18. Code Section 409A .

 

(a) To the extent any provision of this Agreement or action by the Company would subject Executive to liability for interest or additional taxes under Code Section 409A, it shall be deemed null and void, to the extent permitted by law and deemed advisable by the Company. It is intended that this Agreement will comply with Code Section 409A, and this Agreement shall be administered accordingly and interpreted and construed on a basis consistent with such intent. Notwithstanding any provision of this Agreement to the contrary, no termination or similar payments or benefits shall be payable hereunder on account of a Termination unless such Termination constitutes a “separation from service” within the meaning of Code Section 409A. For purposes of Code Section 409A, all installment payments of deferred compensation made hereunder, or pursuant to another plan or arrangement, shall be deemed to be separate payments. To the extent any reimbursements or in-kind benefit payments under this Agreement are subject to Code Section 409A, such reimbursements and in-kind benefit payments shall be made in accordance with Treasury Regulation Section 1.409A-3(i)(1)(iv). This Agreement may be amended to the extent necessary (including retroactively) by the Company to avoid the application of taxes or interest under Code Section 409A, while maintaining to the maximum extent practicable the original intent of this Agreement. This Section 18 shall not be construed as a guarantee of any particular tax effect for Executive’s benefits under this Agreement and the Company does not guarantee that any such benefits will satisfy the provisions of Code Section 409A or any other provision of the Code.

 

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(b) Notwithstanding any provision of this Agreement to the contrary, if Executive is determined to be a Specified Employee as of the Termination Date, then, to the extent required pursuant to Code Section 409A, payments due under this Agreement that are deemed to be deferred compensation shall be subject to a six-month delay following the Termination Date; and all delayed payments shall be accumulated and paid in a lump-sum payment as of the first day of the seventh month following the Termination Date (or, if earlier, as of Executive’s death), with all such delayed payments being credited with interest (compounded monthly) for this period of delay equal to the prime rate in effect on the first day of such six-month period. Any portion of the benefits hereunder that were not otherwise due to be paid during the six-month period following the Termination Date shall be paid to Executive in accordance with the payment schedule established herein.

 

19. Construction .

 

(a) In this Agreement, unless otherwise stated, the following uses apply: (i) references to a statute refer to the statute and any amendments and any successor statutes, and to all regulations promulgated under or implementing the statute, as amended, or its successors, as in effect at the relevant time; (ii) in computing periods from a specified date to a later specified date, the words “from” and “commencing on” (and the like) mean “from and including,” and the words “to,” “until,” and “ending on” (and the like) mean “to, and including”; (iii) references to a governmental or quasi-governmental agency, authority, or instrumentality also refer to a regulatory body that succeeds to the functions of the agency, authority, or instrumentality; (iv) the words “include,” “includes,” and “including” (and the like) mean “include, without limitation,” “includes, without limitation,” and “including, without limitation,” (and the like) respectively; (v) all references to preambles, recitals, sections, and exhibits are to preambles, recitals, sections, and exhibits in or to this Agreement; (vi) the words “hereof,” “herein,” “hereto,” “hereby,” “hereunder,” (and the like) refer to this Agreement as a whole (including exhibits); (vii) any reference to a document or set of documents, and the rights and obligations of the Parties under any such documents, means such document or documents as amended from time to time, and all modifications, extensions, renewals, substitutions, or replacements thereof; (viii) all words used shall be construed to be of such gender or number as the circumstances and context require; (ix) the captions and headings of preambles, recitals, sections, and exhibits appearing in or attached to this Agreement have been inserted solely for convenience of reference and shall not be considered a part of this Agreement, nor shall any of them affect the meaning or interpretation of this Agreement or any of its provisions; and (x) all accounting terms not specifically defined herein shall be construed in accordance with GAAP.

 

(b) If a court of competent jurisdiction determines that any provision of this Agreement is invalid or unenforceable, then the invalidity or unenforceability of that provision shall not affect the validity or enforceability of any other provision of this Agreement and all other provisions shall remain in full force and effect.

 

(c) The various covenants and provisions of this Agreement are intended to be severable and to constitute independent and distinct binding obligations.

 

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(d) Without limiting the generality of the foregoing, if the scope of any covenant contained in this Agreement is too broad to permit enforcement to its full extent, such covenant shall be enforced to the maximum extent permitted by law, and such scope may be judicially modified accordingly.

 

(e) This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same Agreement.

 

20. Definitions . As used in this Agreement, the terms defined in this Section 20 have the meanings set forth below.

 

(a) Affiliate ” means each Entity that, directly or indirectly, is controlled by, controls, or is under common control with, the Company, where “control” means (i) the ownership of more than 50% of the Voting Securities or other voting or equity interests of any Entity, or (ii) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Entity.

 

(b) Agreement ” means this employment agreement, made and entered into as of the Effective Date, by and between the Parties.

 

(c) Annual Base Salary ” has the meaning set forth in Section 3(a) .

 

(d) Board ” means the Board of Directors of the Company.

 

(e) Cause ” means any of the following (in each case as determined by the Board):

 

(i) Executive’s conviction of, or plea of nolo contendere to, a crime of embezzlement or fraud or any felony under the laws of the United States or any state thereof;

 

(ii) An act of fraud, gross negligence, willful misconduct or dishonesty by Executive that could reasonably be expected to be materially injurious to the Company or an Affiliate;

 

(iii) A material breach by Executive of any of the provisions of this Agreement;

 

(iv) An act of moral turpitude by Executive that could reasonably be expected to lead to a material harm (financial or reputational) to the Company or an Affiliate; or

 

(v) Executive’s alcoholism or illegal drug use or drug abuse.

 

(f) CEO ” means the Chief Executive Officer of the Company.

 

(g) Code ” means the Internal Revenue Code of 1986.

 

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(h) Company ” means Medgenics, Inc.

 

(i) Company Proprietary and Intellectual Property ” means all products, systems, methods, procedures, techniques, manuals, databases, plans, lists, inventions, discoveries, innovations, improvements, enhancements, concepts, ideas, and software conceived, created, compiled, or otherwise developed by the Company or its Affiliates and/or comprised, in whole or part, of Confidential Information, together with all patent rights, copyrights, trademarks, service marks, trade name rights and other source identifiers, trade secrets, and other intellectual property and property rights therein, if any.

 

(j) Company Work Product ” means all products, systems, methods, procedures, techniques, manuals, databases, plans, lists, inventions, discoveries, innovations, improvements, enhancements, concepts, ideas, and software conceived, created, compiled, or otherwise developed by Executive in the course of Executive’s employment with the Company or its Affiliates and/or comprised, in whole or part, of Confidential Information, together with all patent rights, copyrights, trademarks, service marks, trade name rights, trade secrets, and other intellectual property and propriety rights therein, if any. Notwithstanding the foregoing sentence, to the extent required by applicable state statute, Company Work Product shall not include (i) any inventions independently developed by Executive and not derived, in whole or part, from any Confidential Information or (ii) any invention made by Executive prior to Executive’s exposure to any Confidential Information.

 

(k) Competitor ” means any Entity engaged, or proposing to engage, in any activities competing with products or services offered or reasonably anticipated to be offered or under active research and development by the Company or an Affiliate.

 

(l) Confidential Information ” means confidential or proprietary non-public information concerning the Company or its Affiliates, including research, development, designs, formulae, processes, specifications, technologies, marketing materials, financial and other information concerning customers and prospective customers, customer lists, records, data, computer programs, source codes, object codes, database structures, trade secrets, proprietary business information, pricing and profitability information, policies, strategic planning, commitments, plans, procedures, litigation, pending litigation, and other information not generally available to the public.

 

(m) Disability ” means that (i) Executive is unable to engage in any substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than 12 months, or (ii) Executive is, by reason of any medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than 12 months, receiving income replacement benefits for a period of not less than three months under an accident or health plan covering employees of the Company. In the event of a dispute regarding whether Executive has incurred a Disability, each of Executive and the Company shall choose a physician who together shall choose a third physician to make a final determination regarding whether Executive has incurred a Disability.

 

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(n) Effective Date ” has the meaning set forth in the first paragraph of this Agreement.

 

(o) Employment Period ” has the meaning set forth in Section 1 .

 

(p) Entity ” means any corporation, partnership, limited liability company, joint venture, association, partnership, business trust or other business entity.

 

(q) Executive ” means Scott Applebaum.

 

(r) Good Reason ” means the occurrence of any one of the following events, unless Executive agrees in writing that such event shall not constitute Good Reason:

 

(i) A material and adverse change in the nature, scope, or status of Executive’s position, authorities, or duties from those in effect in accordance with Section 2 ; provided , however , that a change in title as a result of a merger or reorganization of the Company or an Affiliate, where Executive maintains a similar level of responsibility or oversight (including, where applicable, duties with respect to a public company officer or director), shall not constitute Good Reason or a breach of this Agreement;

 

(ii) A material reduction in Executive’s then-current Annual Base Salary, or a material reduction in Executive’s aggregate benefits or other compensation plans in effect immediately following the Effective Date;

 

(iii) A permanent relocation of Executive’s primary place of employment of more than 25 miles from the initially-agreed place of employment, which relocation also causes Executive’s primary place of employment to be located further from Executive’s primary residence;

 

(iv) The Company gives Executive notice of its desire not to extend the Employment Period as provided in Section 1; or

 

(v) A material breach by the Company of this Agreement.

 

(s) Incentive Bonus ” has the meaning set forth in Section 3(b) .

 

(t) Parties ” means the Company and Executive.

 

(u) Promotional Work ” means, without limitation, photographs, films, clips, sketches, segments, and other media and promotional works.

 

(v) Pro-Rated Bonus ” has the meaning set forth in Section 4(b)(ii) .

 

(w) Release ” means a general release and waiver substantially in the form attached hereto as Exhibit A .

 

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(x) Restricted Area ” means each state in the United States and each country in which the Company or its Affiliates are actively engaged in or pursuing business at the time of Executive’s termination of employment.

 

(y) Restricted Period ” means a period of 12 months immediately following the applicable Termination Date.

 

(z) Restrictive Covenant ” has the meaning set forth in Section 6(c) .

 

(aa) Specified Employee ” means any person who is a “key employee” (as defined in Code Section 416(i) without regard to paragraph (5) thereof), as determined by the Company based upon the 12-month period ending on each December 31st (such 12-month period is referred to below as the “identification period”). If Executive is determined to be a key employee, Executive shall be treated as a Specified Employee for purposes of this Agreement during the 12-month period that begins on the April 1 following the close of the identification period. For purposes of determining whether Executive is a key employee, “compensation” means Executive’s W-2 compensation as reported by the Company for a particular calendar year.

 

(bb) Target Bonus ” means Executive’s target Incentive Bonus for the applicable fiscal year, if one is used, and if not, the Target Bonus shall be determined based upon the mid-point between the maximum Incentive Bonus and the threshold Incentive Bonus for the applicable fiscal year, with the threshold bonus based upon the first level of performance for which some amount of Incentive Bonus would be payable. For fiscal years 2014, 2015 and 2016, the Target Bonus shall be 40% of Annual Base Salary.

 

(cc) Termination ” means termination of Executive’s employment with the Company and all Affiliates for any reason or no reason.

 

(dd) Termination Date ” means the date of Termination.

 

(ee) Voting Securities ” means any securities that ordinarily possess the power to vote in the election of directors without the happening of any precondition or contingency.

 

21. Survival . The provisions of Section 6 shall survive the termination of this Agreement.

 

[Signature page follows.]

 

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IN WITNESS WHEREOF , the Company has caused this Agreement to be executed in its name and on its behalf, and Executive acknowledges understanding and acceptance of, and agrees to, the terms of this Agreement, all as of the Effective Date.

 

    Medgenics, Inc.
   
    B y: /s/ John H. Leaman
     
    Print Name: John H. Leaman, MD
     
    Title: CFO
     
     
    SCOTT APPLEBAUM
     
    B y: /s/ Scott Applebaum
     

 

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EXHIBIT A

 

Agreement and Release and Waiver

 

This Agreement and Release (“ Agreement ”) is made and entered into by and between Medgenics, Inc. (the “ Company ”) and [_______________] (“ Executive ”).

 

Whereas , Executive and the Company desire to settle fully and amicably all issues between them, including any issues arising out of Executive’s employment with the Company and the termination of that employment; and

 

Whereas , Executive and the Company are parties to that certain Employment Agreement, made and entered into as of [_______________] , as amended (the “ Employment Agreement ”).

 

Now, therefore , for and in consideration of the mutual promises contained herein, and for other good and sufficient consideration, receipt of which is hereby acknowledged, Executive and the Company (collectively, the “ Parties ” and, individually, each a “ Party ”), intending to be legally bound, hereby agree as follows:

 

1. Termination of Employment. Executive’s employment with the Company shall terminate effective as of the close of business on [_______________] (the “ Termination Date ”).

 

2. Compensation and Benefits. Subject to the terms of this Agreement, the Company shall compensate Executive under this Agreement as follows (collectively, the “ Severance Payments ”):

 

(a) Severance Payments . [_______________] .

 

(b) Accrued Salary and Vacation . Executive shall be entitled to a lump sum payment in an amount equal to Executive’s earned but unpaid annual base salary and vacation pay for the period ending on the Termination Date, with such payment to be made on the first payroll date following the Termination Date.

 

(c) Executive Acknowledgement . Executive acknowledges that, subject to fulfillment of all obligations provided for herein, Executive has been fully compensated by the Company, including under all applicable laws, and that nothing further is owed to Executive with respect to wages, bonuses, severance, other compensation, or benefits. Executive further acknowledges that the Severance Payments (other than (b) above) are consideration for Executive’s promises contained in this Agreement, and that the Severance Payments are above and beyond any wages, bonuses, severance, other compensation, or benefits to which Executive is entitled from the Company under the terms of Executive’s employment or under any other contract or law that Executive would be entitled to absent execution of this Agreement.

 

(d) Withholding . The Severance Payments shall be treated as wages and subject to all taxes and other payroll deductions required by law.

 

3. Termination of Benefits. Except as provided in Section 2 above or as may be required by law, Executive’s participation in all employee benefit (pension and welfare) and compensation plans of the Company shall cease as of the Termination Date. Nothing contained herein shall limit or otherwise impair Executive’s right to receive pension or similar benefit payments that are vested as of the Termination Date under any applicable tax-qualified pension or other plans, pursuant to the terms of the applicable plan.

 

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4. Release of Claims and Waiver of Rights. Executive, on Executive’s own behalf and that of Executive’s heirs, executors, attorneys, administrators, successors, and assigns, fully releases and discharges the Company, its predecessors, successors, parents, subsidiaries, affiliates, and assigns, and its and their directors, officers, trustees, employees, and agents, both in their individual and official capacities, and the current and former trustees and administrators of each retirement and other benefit plan applicable to the employees and former employees of the Company, both in their official and individual capacities (the “ Releasees ”) from all liability, claims, demands, and actions Executive now has, may have had, or may ever have, whether currently known or unknown, as of or prior to Executive’s execution of this Agreement (the “ Release ”), including liability claims, demands, and actions:

 

(a) Arising from or relating to Executive’s employment or other association with the Company, or the termination of such employment,

 

(b) Relating to wages, bonuses, other compensation, or benefits,

 

(c) Relating to any employment or change in control contract,

 

(d) Relating to any employment law, including

 

(i) The United States and States of Pennsylvania, New Jersey or New York,

 

(ii) The Civil Rights Act of 1964,

 

(iii) The Civil Rights Act of 1991,

 

(iv) The Equal Pay Act,

 

(v) The Employee Retirement Income Security Act of 1974,

 

(vi) The Age Discrimination in Employment Act (the “ ADEA ”),

 

(vii) The Americans with Disabilities Act,

 

(viii) Executive Order 11246, and

 

(ix) Any other federal, state, or local statute, ordinance, or regulation relating to employment,

 

(e) Relating to any right of payment for disability,

 

(f) Relating to any statutory or contractual right of payment, and

 

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(g) For relief on the basis of any alleged tort or breach of contract under the common law of the States of Pennsylvania, New Jersey or New York, or any other state, including defamation, intentional or negligent infliction of emotional distress, breach of the covenant of good faith and fair dealing, promissory estoppel, and negligence.

 

Executive acknowledges that Executive is aware that statutes exist that render null and void releases and discharges of any claims, rights, demands, liabilities, actions, and causes of action that are unknown to the releasing or discharging party at the time of execution of the release and discharge. Executive waives, surrenders, and shall forego any protection to which Executive would otherwise be entitled by virtue of the existence of any such statutes in any jurisdiction, including the States of Pennsylvania, New Jersey or New York.

 

5. Exclusions from General Release. Excluded from the Release are any claims or rights that cannot be waived by law, as well as Executive’s right to file a charge with an administrative agency or participate in any agency investigation. Executive is, however, waiving the right to recover any money in connection with a charge or investigation. Executive is also waiving the right to recover any money in connection with a charge filed by any other individual or by the Equal Employment Opportunity Commission or any other federal or state agency.

 

6. Covenant Not to Sue.

 

(a) A “covenant not to sue” is a legal term that means Executive promises not to file a lawsuit in court. It is different from the release of claims and waiver of rights contained in Section 4 above. Besides waiving and releasing the claims covered by Section 4 above, Executive shall never sue the Releasees in any forum for any reason covered by the Release. Notwithstanding this covenant not to sue, Executive may bring a claim against the Company to enforce this Agreement, to challenge the validity of this Agreement under the ADEA or for any claim that arises after execution of this Agreement. If Executive sues any of the Releasees in violation of this Agreement, Executive shall be liable to them for their reasonable attorneys’ fees and costs (including the costs of experts, evidence, and counsel) and other litigation costs incurred in defending against Executive’s suit. In addition, if Executive sues any of the Releasees in violation of this Agreement, the Company can require Executive to return all but a sum of $100 of the Severance Payments, which sum is, by itself, adequate consideration for the promises and covenants in this Agreement. In that event, the Company shall have no obligation to make any further Severance Payments.

 

(b) If Executive has previously filed any lawsuit against any of the Releasees, Executive shall immediately take all necessary steps and execute all necessary documents to withdraw or dismiss such lawsuit to the extent Executive’s agreement to withdraw, dismiss, or not file a lawsuit would not be a violation of any applicable law or regulation.

 

7. Representations by Executive. Executive warrants that Executive is legally competent to execute this Agreement and that Executive has not relied on any statements or explanations made by the Company or its attorneys. Executive acknowledges that Executive has been afforded the opportunity to be advised by legal counsel regarding the terms of this Agreement, including the Release. Executive acknowledges that Executive has been offered at least 21 days to consider this Agreement. After being so advised, and without coercion of any kind, Executive freely, knowingly, and voluntarily enters into this Agreement. Executive acknowledges that Executive may revoke this Agreement within seven days after Executive has signed this Agreement and acknowledges understanding that this Agreement shall not become effective or enforceable until seven days after Executive has signed this Agreement (the “Effective Date”), as evidenced by the date set forth below Executive’s signature on the signature page hereto. Any revocation must be in writing and directed to [_______________] . If sent by mail, any revocation must be postmarked within the seven-day period described above and sent by certified mail, return receipt requested.

 

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8. Restrictive Covenants. Section 6 of the Employment Agreement (entitled “Restrictive Covenants”) shall continue in full force and effect as if fully restated herein.

 

9. Non-Disparagement. Executive shall not engage in any disparagement or vilification of the Releasees, and shall refrain from making any false, negative, critical, or disparaging statements, implied or expressed, concerning the Releasees, including regarding management style, methods of doing business, the quality of products and services, role in the community, or treatment of employees. Executive shall do nothing that would damage the Company’s business reputation or goodwill.

 

10. Company Property.

 

(a) Executive shall return to the Company all information, property, and supplies belonging to the Company or any of its affiliates, including any confidential or proprietary information, Company autos, keys (for equipment or facilities), laptop computers and related equipment, cellular phones, smart phones or PDAs (including SIM cards), security cards, corporate credit cards, and the originals and all copies of all files, materials, and documents (whether in tangible or electronic form) containing confidential or proprietary information or relating to the business of the Company or any of its affiliates.

 

(b) Executive shall not, at any time on or after the Termination Date, directly or indirectly use, access, or in any way alter or modify any of the databases, e-mail systems, software, computer systems, or hardware or other electronic, computerized, or technological systems of the Company or any of its affiliates. Executive acknowledges that any such conduct by Executive would be illegal and would subject Executive to legal action by the Company, including claims for damages and/or appropriate injunctive relief.

 

11. No Admissions. The Company denies that the Company or any of its affiliates, or any of their employees or agents, has taken any improper action against Executive, and this Agreement shall not be admissible in any proceeding as evidence of improper action by the Company or any of its affiliates or any of their employees or agents.

 

12. Confidentiality of Agreement. Executive shall keep the existence and the terms of this Agreement confidential, except for Executive’s immediate family members and Executive’s legal and tax advisors in connection with services related hereto and except as may be required by law or in connection with the preparation of tax returns.

 

13. Non-Waiver. The Company’s waiver of a breach of this Agreement by Executive shall not be construed or operate as a waiver of any subsequent breach by Executive of the same or of any other provision of this Agreement.

 

14. Governing Law. This Agreement shall be governed by and construed under the laws of the Commonwealth of Pennsylvania, without regard to principles of conflict of laws (whether in the Commonwealth of Pennsylvania or any other jurisdiction) that would cause the application of the laws of any jurisdiction other than the Commonwealth of Pennsylvania.

 

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15. Legal Fees. In the event that either Party commences mediation, arbitration, litigation, or any similar action to enforce or protect such Party’s rights in accordance with and under this Agreement, the prevailing Party in any such action shall be entitled to recover reasonable attorneys’ fees and costs (including the costs of experts, evidence, and counsel) and other costs relating to such action, in addition to all other entitled relief, including damages and injunctive relief.

 

16. Entire Agreement. This Agreement sets forth the entire agreement of the Parties regarding the subject matter hereof, and shall be final and binding as to all claims that have been or could have been advanced on behalf of Executive pursuant to any claim arising out of or related in any way to Executive’s employment with the Company and the termination of that employment.

 

17. Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same Agreement.

 

18. Successors. This Agreement shall be binding upon and inure to the benefit of the Company, its successors and assigns.

 

19. Enforcement. The provisions of this Agreement shall be regarded as divisible and separable and if any provision should be declared invalid or unenforceable by a court of competent jurisdiction, the validity and enforceability of the remaining provisions shall not be affected thereby. If the scope of any restriction or requirement contained in this Agreement is too broad to permit enforcement of such restriction or requirement to its full extent, then such restriction or requirement shall be enforced to the maximum extent permitted by law, and Executive hereby consents that any court of competent jurisdiction may so modify such scope in any proceeding brought to enforce such restriction or requirement. In addition, Executive stipulates that breach by Executive of restrictions and requirements under this Agreement will cause irreparable damage to the Releasees in the case of Executive’s breach and that the Company would not have entered into this Agreement without Executive binding Executive to these restrictions and requirements. In the event of Executive’s breach of this Agreement, in addition to any other remedies the Company may have, and without bond and without prejudice to any other rights and remedies that the Company may have for Executive’s breach of this Agreement, the Company shall be relieved of any obligation to provide Severance Payments and shall be entitled to an injunction to prevent or restrain any such violation by Executive and all persons directly or indirectly acting for or with Executive. Executive stipulates that the restrictive period for which the Company is entitled to an injunction shall be extended in for a period that equals the time period during which Executive is or has been in violation of the restrictions contained herein.

 

20. Construction. In this Agreement, unless otherwise stated, the following uses apply: (a) references to a statute refer to the statute and any amendments and any successor statutes, and to all regulations promulgated under or implementing the statute, as amended, or its successors, as in effect at the relevant time; (b) in computing periods from a specified date to a later specified date, the words “from” and “commencing on” (and the like) mean “from and including, “ and the words “to,” “until,” and “ending on” (and the like) mean “to, and including”; (c) references to a governmental or quasi-governmental agency, authority, or instrumentality also refer to a regulatory body that succeeds to the functions of the agency, authority, or instrumentality; (d) the words “include,” “includes,” and “including” (and the like) mean “include, without limitation,” “includes, without limitation,” and “including, without limitation,” (and the like) respectively; (e) all references to preambles, recitals, sections, and exhibits are to preambles, recitals, sections, and exhibits in or to this Agreement; (f) the words “hereof,” “herein,” “hereto,” “hereby,” “hereunder,” (and the like) refer to this Agreement as a whole (including exhibits); (g) any reference to a document or set of documents, and the rights and obligations of the parties under any such documents, means such document or documents as amended from time to time, and all modifications, extensions, renewals, substitutions, or replacements thereof; (h) all words used shall be construed to be of such gender or number as the circumstances and context require; (i) the captions and headings of preambles, recitals, sections, and exhibits appearing in or attached to this Agreement have been inserted solely for convenience of reference and shall not be considered a part of this Agreement, nor shall any of them affect the meaning or interpretation of this Agreement or any of its provisions; and (j) all accounting terms not specifically defined herein shall be construed in accordance with GAAP.

 

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21. Future Cooperation. In connection with any and all claims, disputes, negotiations, governmental, internal or other investigations, lawsuits, or administrative proceedings (the “ Legal Matters ”) involving the Company or any affiliate, or any of their current or former officers, employees or board members (collectively, the “ Disputing Parties ” and, individually, each a “ Disputing Party ”), Executive shall make himself reasonably available, upon reasonable notice from the Company and without the necessity of subpoena, to provide information and documents, provide declarations and statements regarding a Disputing Party, meet with attorneys and other representatives of a Disputing Party, prepare for and give depositions and testimony, and otherwise cooperate in the investigation, defense, and prosecution of any and all such Legal Matters, as may, in the good faith and judgment of the Company, be reasonably requested. The Company shall consult with Executive and make reasonable efforts to schedule such assistance so as not to materially disrupt Executive’s business and personal affairs. The Company shall reimburse all reasonable expenses incurred by Executive in connection with such assistance, including travel, meals, rental car, and hotel expenses, if any; provided such expenses are approved in advance by the Company and are documented in a manner consistent with expense reporting policies of the Company as may be in effect from time to time.

 

In witness whereof , the Parties have duly executed this Agreement as of the dates set forth belo w their respective signatures below.

 

    Medgenics, Inc.
   
    B y:  
     
    Print Name:  
     
    Title:  
       
    Date:  
     
     
    SCOTT APPLEBAUM
     
       
     Date:  

  

A- 5

Exhibit 10.3

 

First Amendment to Addendum to Employment Agreement

 

This First Amendment to Addendum to Employment Agreement (this “ Amendment ”) is entered into between Medgenics, Inc. (“ Medgenics ”), its wholly owned subsidiary, Medgenics Medical Israel, Ltd. (the “ Company ”) and Phyllis Bellin (the “ Employee ”) as of September 17, 2014.

 

WHEREAS as of November 1, 2005 the Employee has been employed by the Company;

 

WHEREAS , the Employee, the Company and Medgenics are parties to that certain Employment Agreement dated July 1, 2007 (the “ Employment Agreement ”), which Employment Agreement was amended by that certain Addendum to Employment Agreement dated as of July 15, 2014 (the “ Addendum ”) (the Employment Agreement as modified by the Addendum shall be referred to as the “ Amended Agreement ”);

 

WHEREAS , the parties have determined that an inadvertent error was made in the Addendum, and desire to amend the Addendum to correct such error and to make an additional change to the Employment Agreement. Capitalized terms in this Amendment have the same meaning attributed to them in the Amended Agreement, unless otherwise stated; and

 

WHEREAS , pursuant to Section 14.8 of the Employment Agreement, the Employment Agreement may be amended by written agreement of the Employee and the CEO, with the approval of the Board;

 

NOW THEREFORE, in consideration of the foregoing and the mutual promises and covenants of the parties set forth in this Amendment, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledge, the parties, intending to be legally bound, hereby expressly covenant, consent, and agree as follows:

 

1. The recitals to this Amendment constitute an integral part hereof and are hereby incorporated into the body of this Amendment as if fully restated herein.

 

2. The parties agree that the Accrued Vacation Amount as of the Determining Date was $46,556, not $33,780 as originally set forth in Section 2.7 of the Addendum. According, the parties agree that the first sentence of Section 2.7 of the Addendum shall be deleted in its entirety and replaced with the following: “The parties agree and acknowledge that as of the Determining Date the Employee has accrued 77.06 days of paid vacation, representing $46,556 in benefits based on her past salary (the “ Accrued Vacation Amount ”), the Accrued Vacation Amount shall be paid to the Employee upon the termination of the Employment Agreement, unless the Employment Agreement is terminated for cause as provided in Section 7.3 of the Employment Agreement.”

 

 
 

  

3. Amendment to Section 14.8 of the Employment Agreement . Section 14.8 of the Employment Agreement shall be deleted in its entirety and replaced with the following:

“This Agreement sets forth the entire agreement of the parties hereto in respect of the subject matter contained herein and supersedes all negotiations, undertakings, agreements, representations or warranties, whether oral or written, by any officer, employee or representative of Medgenics or the Company or any party thereto; and any prior agreement of the parties hereto or of the Employee and Medgenics and/or the Company in respect of the subject matter contained herein is hereby terminated and cancelled. Any modification to the Agreement can only be made in writing, signed by each of the parties hereto.”

 

4. Except as specifically amended hereby, the Amended Agreement remains in full force and effect and is hereby ratified by the parties thereto. In the event that any of the terms or conditions of the Amended Agreement conflict with this Amendment, the terms and conditions of this Amendment shall control.

 

[Signature page follows]

 

 
 

 

IN WITNESS WHEREOF the parties have duly executed this Amendment effective as of the date first wr itten above:

 

/s/ Phyllis Bellin   October 14, 2014  

Phyllis Bellin

  Dated  
       
Medgenics Medical Israel Ltd.      
       
By: /s/ Michael Cola   October 14, 2014  
  Its: Director   Dated  

   
       
Medgenics, Inc.      
       
By: /s/ John Leaman   October 14, 2014  
  Its:  CFO   Dated  
       

 

 

 

 

 

   

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Michael F. Cola, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of Medgenics, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: October 15, 2014 /s/  Michael F. Cola
  Michael F. Cola
  President and Chief Executive Officer
  (Principal Executive Officer)

 

 

 

 

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, John H. Leaman, certify that:

  

  1. I have reviewed this Quarterly Report on Form 10-Q of Medgenics, Inc.;

 

  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: October 15, 2014 /s/  John H. Leaman
  John H. Leaman
  Chief Financial Officer
  (Principal Financial Officer)

 

 

 

Exhibit 32.1

 

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED

PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (Chapter 63, Title 18 U.S.C. § 1350(a) and (b)), each of the undersigned hereby certifies that, to his knowledge, the Quarterly Report on Form 10-Q for the period ended September 30, 2014 of Medgenics, Inc. (the “Company”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 and that the information contained in such Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date:  October 15, 2014 /s/  Michael F. Cola
  Michael F. Cola
  President and Chief Executive Officer
  (Principal Executive Officer)
   
Date:  October 15, 2014 /s/  John H. Leaman
  John H. Leaman
  Chief Financial Officer
  (Principal Financial Officer)

 

A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request. The information contained in this written statement shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by specific reference in such a filing.