ENDV 8-K
Endonovo Therapeutics, Inc. (ENDV)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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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 | |