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): November 2, 2021
INVO BIOSCIENCE, INC.
(Exact name of registrant as specified in charter)
| Nevada | 001-39701 | 20-4036208 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
5582 Broadcast Court Sarasota, Florida |
34240 | |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s telephone number, including area code: (978) 878-9505
(Former name or former address, if changed since last report)
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 (see General Instruction A.2. below):
| ☐ | 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 | ||
| Common Stock, $0.0001 par value per share | INVO | The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities 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 1.02 Termination of a Material Definitive Agreement.
On November 2, 2021, Ferring International Center S.A. (“Ferring”), notified us of its intention to terminate that certain Distribution Agreement dated November 12, 2018 by and among Ferring, INVO Bioscience, Inc. (“INVO”), and Bio X Cell, Inc., (the “Agreement”). Ferring gave notice of termination for convenience under Section 14.2(b) of the Agreement which requires 90-days prior written notice. Accordingly, the Agreement will officially terminate on January 31, 2022. Capitalized terms used and not otherwise defined have the meanings set forth in the Agreement.
Pursuant to the terms of the Agreement, for ninety (90) days after the expiration or termination, Ferring shall use Commercially Reasonable Efforts to transition any customers for the Product in the Territory to INVO and otherwise facilitate the orderly transition of the distribution of the Product in the Territory from Ferring to INVO or its designee. In addition, Ferring shall provide INVO with a list of all then-existing customers, of the Product in the Territory.
INVO’s Supply Agreement with Ferring dated November 12, 2018 automatically terminates upon termination of the Agreement, pursuant to its terms. As such, the Supply Agreement will terminate on January 31, 2022.
Item 8.01 Other Events
On November 8, 2021, we issued a press release titled “INVO Bioscience Regains Full U.S. Commercialization Rights”. A copy of the press release is filed hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 10.1 | Termination Notice | |
| 99.1 | Press Release dated November 8, 2021 | |
| 104 | Cover Page Interactive Data File (formatted as Inline XBRL) | |
| -2- |
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 thereunto duly authorized.
| INVO BIOSCIENCE, INC. | ||
| By: | /s/ Steven Shum | |
| Name: | Steven Shum | |
| Title: | Chief Executive Officer | |
| Dated November 8, 2021 | ||
| -3- |
Exhibit 10.1
November 2, 2021
INVO Bioscience Inc.
407 R. Mystic Ave
Suite 34C
Medford, MA 02155
Attention: Mr. Steve Shum
Bio X Cell, Inc.
407 R. Mystic Ave
Suite 34C
Medford, MA 02155
Attention: Mr. Steve Shum
Re: Notice of Termination
Dear Mr. Shum,
Ferring International Center S.A. (“Ferring”), INVO Bioscience, Inc. (“Invo”), and Bio X Cell, Inc., are parties to a distribution agreement dated November 12, 2018 (the “Agreement”). Capitalized terms used in this letter but not defined have the meanings given to them in the Agreement.
As discussed with you and Bipin Dalmia and David Powley, this notice shall serve as our notice of termination for convenience pursuant to Section 14.2(b) of the Agreement. The effective date of termination/expiration of the Term shall be ninety (90) days from the date of this notice – January 31, 2022.
Bipin, David and potentially other members of our Ferring team will be in touch separately to coordinate further discussions and transition activities with you and your team.
Regards,
/s/ Curt McDaniel
Curt McDaniel
Chief Legal Officer
Ferring International Center S.A.
Copy to:
Shulman Rogers
12505 Park Potomac Avenue
6th Floor
Potomac, MD 20854
Attn: Scott Museles
Exhibit 99.1
INVO Bioscience Regains Full U.S. Commercialization Rights
SARASOTA, Florida – November 8, 2021 — INVO Bioscience, Inc. (“INVO” or the “Company”) (NASDAQ: INVO), a medical device company focused on commercializing the world’s only in vivo culture system (IVC), today announced it will regain full U.S. commercialization rights for its patented INVOcell® device due to Ferring International Center S.A.’s termination for convenience of that certain Distribution Agreement dated November 12, 2018 with INVO, which termination will officially take effect on January 31, 2022. Over the past three years, INVO has been executing on a multi-faceted commercialization strategy which includes partnering to open dedicated “INVO Centers” focused on INVOcell and the IVC procedure, and establishing agreements with distributors in key markets. The terms of the U.S. Distribution Agreement had limited the number of INVO Centers that we were allowed to operate. INVO can now further support U.S. fertility clinicians directly as the exclusive provider of INVOcell® in pursuit of our mission to bring advanced fertility care to the millions of people that are without access to treatment.
“The patients are at the core of our strategy, and we believe that our partnerships and multi-channel business approach can most effectively deliver treatment where it is needed,” said Steve Shum, CEO of INVO. “We believe that direct access to the U.S. market enables us to aggressively pursue our mission to address and improve capacity constraints in the market, and to provide quality fertility care to the patients who need it. We have assembled a strong team of industry leaders who are highly experienced in commercializing advanced reproductive technologies. With the capital we have raised, we are well positioned to leverage their expertise and our infrastructure to accelerate adoption of INVOcell throughout all channels in the U.S. market. In our opinion, the clinical and commercial validation of INVOcell has grown tremendously over the past few years and we believe this provides a solid foundation for our strategy. Direct control of the U.S. market should now enable us to sell directly into the existing IVF clinics, expand the number of INVO Centers free of any limitations, and to aggressively pursue our market expansion to increase access to care.
“We thank Ferring for their valuable partnership and contributions toward the advancement of the INVOcell technology over the past three years,” stated Mike Campbell, COO and VP business development of INVO. “We are excited, and INVO is fully prepared to support and execute on the opportunities across our expanding customer base in the U.S.”
An Update on Recent Commercialization Milestones
| ● | Initial treatment cycles have commenced at the Company’s first U.S.-based INVO Center in Birmingham, Alabama following its opening in August 2021. | |
| ● | The second U.S.-based INVO Center opened in Atlanta, Georgia in September 2021. The practice has begun seeing patients and will perform initial treatment cycles this week. | |
| ● | The first international INVO Center opened in Monterrey, Mexico on November 1, 2021. The Monterrey INVO Center has begun seeing patients, with the first cycles scheduled to occur later this year. |
| ● | Signed a partnership agreement with Lyfe Medical, LLC to establish and operate a INVO Center in the San Francisco Bay area to offer the INVOcell. | |
| ● | Completed the acquisition of a Canadian-based entity formed to offer INVOcell in Canada. | |
| ● | Development efforts for new branding, logos and website are underway, as well as an expanded social media presence. Rollout is expected in the coming weeks. | |
| ● | International distribution and INVO Center developments continue across all continents. |
Additional information regarding the timing and transfer of the INVOcell U.S. commercialization rights can be found in the Company’s Form 8-K filed today with the Securities and Exchange Commission and available at www.sec.gov.
About INVO Bioscience
We are a medical device and fertility clinic development company focused on creating simplified, affordable treatments for patients diagnosed with infertility. Our solution, the INVO® Procedure, is a revolutionary in-vivo method of vaginal incubation that offers patients a more natural and intimate experience. Our lead product, the INVOcell®, is a patented medical device used in infertility treatment and is considered an “assisted reproductive technology.” The INVOcell® enables the first intra-vaginal culture (IVC) procedure in the world and is used for the natural, in-vivo incubation of eggs and sperm during fertilization and early embryo development. The INVOcell offers an alternative to traditional in-vitro fertilization (IVF) and intrauterine insemination (IUI). Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost and increase the availability of care. For more information, please visit invobio.com.
Safe Harbor Statement
This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at www.sec.gov. We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please contact:
INVO Bioscience
Steve Shum, CEO
978-878-9505
sshum@invobio.com
Investors
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com