SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 18, 2021
HARROW HEALTH, INC.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction
|102 Woodmont Blvd., Suite 610|
|(Address of principal executive offices)||(Zip Code)|
Registrant’s telephone number, including area code: (615) 733-4730
|(Former Name or Former Address, if Changed Since Last Report)|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name on exchange on which registered|
|8.625% Senior Notes due 2026||HROWL||The NASDAQ Global Market|
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))|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Act of 1934: Emerging growth company ☐
If any 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 August 18, 2021, Harrow Health, Inc. (the “Company”) entered into a License Agreement and a Basic Sale and Purchase Agreement (together, the “Agreements”) with Wakamoto Pharmaceutical Co., Ltd. (“Wakamoto”), pursuant to which Wakamoto granted the Company the exclusive license and marketing rights to its ophthalmic drug candidate (“MAQ-100”) in the United States of America (“U.S.”) and Canada.
Pursuant to the Agreements, Wakamoto will supply MAQ-100 to the Company, and the Company will pay Wakamoto a per unit transfer price to supply MAQ-100. In addition, the Company is required to pay Wakamoto various one-time milestone payments totaling up to two million dollars ($2,000,000) upon the achievement of certain regulatory milestones and up to six million two hundred thousand dollars ($6,200,000) upon the achievement of certain commercial milestones. Under the terms of the Agreements, the Company will be responsible for regulatory filings and fees for MAQ-100 in the U.S. and Canada
Subject to certain limitations, the term of the Agreements is for five years from the date of the U.S. Food and Drug Administration’s (or FDA’s) market approval of MAQ-100 and allows for a five-year extension if certain unit sales thresholds are met.
The foregoing is a summary description of certain terms of the Agreements, is not complete and is qualified in its entirety by reference to the text of the Agreements, which the Company expects to file as an exhibit to the Company’s Quarterly Report on Form 10-Q for the quarter ending September 30, 2021.
Item 8.01 Other Events.
On August 18, 2021, the Company issued a press release announcing its exclusive arrangement to MAQ-100. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
|99.1||Harrow Health and Wakamoto Press Release dated August 18, 2021|
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.
|HARROW HEALTH, INC.|
|Dated: August 18, 2021||By:||/s/ Andrew R. Boll|
|Name:||Andrew R. Boll|
|Title:||Chief Financial Officer|