Form 8-K - Current report

 

 

 

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, 15^th Floor

Woodland Hills, CA 91367

(Address of principal executive office)(Zip Code)

 

Registrant’s telephone number, including area code: [phone]

 

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 1^st, 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 1^st, 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

 

Cover	Dec. 29, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Dec. 29, 2023
Entity File Number	000-55453
Entity Registrant Name	ENDONOVO THERAPEUTICS, INC.
Entity Central Index Key	0001528172
Entity Tax Identification Number	45-2552528
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	6320 Canoga Avenue
Entity Address, Address Line Two	15th Floor
Entity Address, City or Town	Woodland Hills
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	91367
City Area Code	(800)
Local Phone Number	489-4774
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Entity Emerging Growth Company	false

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