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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of earliest event reported): December 29, 2023

 

ENDONOVO THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   000-55453   45-2552528
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

6320 Canoga Avenue, 15th Floor

Woodland Hills, CA 91367

(Address of principal executive office)(Zip Code)

 

Registrant’s telephone number, including area code: (800) 489-4774

 

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

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
None        

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 
 

 

Item 1.01 Entry into a Material Definitive Agreement.

 

On December 29, 2023, Endonovo Therapeutics, Inc. (“we”, “us” or the “Company”) entered into an amendment (the “Amendment”) to its May 2020 agreement with Evermed Medical Enterprise Ltd (“Evermed”) regarding the marketing of the Company’s SofPulse® device in Taiwan. The Amendment, among other things, establishes performance thresholds which Evermed must meet to maintain its exclusive rights in Taiwan under the Agreement. The Amendment sets forth quarterly sales thresholds for a six-year period beginning April 1, 2024. The thresholds increase during the six-year period from $8,400 in the first quarter of the first year to $2,856,000 in the last quarter of the sixth year and total $21,688,632 for the full six years. As reported in October 2023, the Taiwan Food and Drug Administration (“TFDA”), the regulatory division of the Ministry of Health and Welfare (“MOHW”) has approved the SofPulse® device for adjunctive treatment of pain and swelling (inflammation) after soft tissue surgery. We cannot guarantee that the payments provided for in the Amendment will actually be received by us.

 

The foregoing is only a summary of the terms of the Amendment which is included as an exhibit to this report.

 

Item 9.01 Financial Statements and Exhibits.

 

  (a) Financial Statements
     
  None
   
  (b) Exhibits
     
    10.1 The Amendment.
  104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 
 

 

SIGNATURES

 

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

 

Dated: January 3, 2024

 

  ENDONOVO THERAPEUTICS, INC.
   
  By: /s/ Alan Collier
    Alan Collier
    Chief Executive Officer

 

 

 

Exhibit 10.1

 

AMENDMENT TO AGREEMENT

 

THIS AMENDMENT AGREEMENT, dated as of December 29, 2023 (this “Amendment”), by and between Evermed Medical Enterprise Ltd (the “EVERMED”) and Endonovo Therapeutics, Inc. (“ENDONOVO”), amends the Sales and Strategic Partnership Agreement (the “Agreement”)

dated May 18, 2020.

 

WTNESSETH:

 

WHEREAS, the parties entered into the Agreement dated May 18, 2020 whereby EVERMED has the exclusive rights to market and sell the product within Taiwan (the “Territory”) in the area of post-surgery pain control and recovery;

 

WHEREAS, EVERMED shall be required to achieve the performance thresholds in order to maintain its exclusive rights as listed in EXHIBIT A;

 

WHEREAS, the parties desire to amend the Agreement as set forth below;

 

NOW THEREFORE, in consideration of the mutual benefits and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties hereto do hereby agree as follows.

 

AMENDMENT TO THE AGREEMENT:

 

ROLES AND RESPONSIBILITIES

Section A.

 

Add the following clauses:

 

9. EVERMED shall either publish (or have published) the results of the observational/demonstration trials in recognized surgical/medical publications or present (or have them presented) at recognized surgical/medical conferences

 

10. By no later than January 15 of each year during the term of the Agreement, EVERMED will provide ENDONOVO with:

 

  a) An annual sales forecast for SofPulse
  b) An annual sales and marketing plan for SofPulse, including the sales and marketing budgets.

 

11. EVERMED will provide ENDONOVO with Quarterly Reports within fourteen (14) days following the end of the most recent quarter. These reports will include the following:

 

:

a. Sales - Update on end of quarter sales and year-to-date sales

b. Update on marketing programs

c. Marketing spends (actual)

d. Number of hospitals purchasing SofPulse®

e. Number of new hospital accounts opened and total number of hospital accounts opened. in the past quarter as well as year-to-date

f. Number of new surgeons/physicians using SofPulse® and total number of surgeons/physicians using SofPulse® in the past quarter as well as year-to-date

 

 
 

 

g. Results of all observational/demonstration trials

h. Sales and marketing plans for the next quarter

i. Management narrative summarizing the quarterly results.

j. Sales and marketing plans for the next quarter

 

12. Evermed and Endonovo shall schedule a monthly meeting to discuss the contents in Section A. Clause# 11

 

13. Evermed will provide annually financial statement according to International Financial Reporting Standards (IFRS).

 

SHIPPING, PRICE, DISCOUNT AND PAYMENT

Section B(2) of the Agreement is amended as follows:

 

Each single ring Product is priced at a Sales Price to EVERMED is USD$168 per unit plus shipping cost at the point of ordering.

 

INITIAL TERM

Section D of the Agreement is amended as follows:

 

Unless earlier terminated as hereinafter provided, this Agreement shall continue in full force and effect for a period of six (6) years from the effective date of the initial marketing launch (no later than April 1st, 2024.

 

EXHIBIT A

Replace the performance Thresholds for the First Year (“Gross Revenue”) with a Thresholds for First Six-Years as follows.

 

Performance Thresholds for First Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   1st Year 
Medical Center   10    50    150    300    510 
Regional Hospital   40    100    150    200    490 
Total   50    150    300    500    1,000 
*Gross Revenue  $8,400    S25,200   $50,400   $84,000   $168,000 

 

Performance Thresholds for Second Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   2nd Year 
Medical Center   500    650    1000    1000    3150 
Regional Hospital   299    350    500    800    1949 
Total   799    1,000    1,500    1,800    5,099 
*Gross Revenue  $134,232   $168,000   $252,000   $302,400   $856,632 

 

 
 

 

Performance Thresholds for Third Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   3rd Year 
Medical Center   1300    1600    1900    2200    7000 
Regional Hospital   900    1000    1300    1800    5000 
Total   2200    2600    3200    4000    12,000 
*Gross Revenue  $369,600   $436,800   $537,600   $672,000   $2,016,000 

 

Performance Thresholds for Fourth, Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   4rd Year 
Medical Center   2,300    2,500    2,800    3,100    10,700 
Regional Hospital   2,200    2,700    3,200    3,200    11,300 
Total   4,500    5,200    6,000    6,300    22,000 
*Gross Revenue  $756,000   $873,600   $1,008,000   $1,058,400   $3,696,000 

 

Performance Thresholds for Fifth, Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   5rd Year 
Medical Center   3,200    3,300    3,400    3,600    13,500 
Regional Hospital   3,800    4,700    5,600    6,400    20,500 
Total   7,000    8,000    9,000    10,000    34,000 
*Gross Revenue  $1,176,000   $1,344,000   $1,512,000   $1,680,000   $5,712,000 

 

Performance Thresholds for Sixth, Year (“Gross Revenues”):

   Q1   Q2   Q3   Q4   6rd Year 
Medical Center   4,000    4,500    5,200    6,000    19,700 
Regional Hospital   7,000    8,000    9,300    11,000    35,300 
Total   11,000    12,500    14,500    17,000    55,000 
*Gross Revenue  $1,848,000   $2,100,000   $2,436,000   $2,856,000   $9,240,000 

 

*The gross revenue is calculated in $168 unit price in USD.

 

All currency is in US dollars. The Performance Threshold will start upon the initial marketing launch (no later than April 1st, 2024.

 

 
 

 

IN WITNESS WHEREOF, Evermed and Endonovo have caused their respective signature page to this Agreement to be duly executed as of the date first written above.

 

  EVERMED MEDICAL ENTERPRISE LTD (“EVERMED”).
     
  By:  
  Name: George Wang
  Title: CEO
     
     
  ENDONOVO THERAPEUTICS, INC. “ENDONOVO”)
     
  By:  
  Name: Alan Collier
  Title: CEO           

 

 

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