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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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