8-K

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 13, 2018

INVO BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Nevada	333-147330	20-4036208
(State or other jurisdiction of	(Commission	(I.R.S. Employer
Incorporation)	File Number)	Identification No.)

407R Mystic Avenue, Suite 34C, Medford, MA   02155

(Address of principal executive offices)          (Zip Code)

(978) 878-9505

(Registrant’s telephone number, including area code)

Not Applicable

(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:

☐	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 FR 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 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 November 12, 2018, INVO Bioscience, Inc (the “Company”) entered into a Distribution Agreement with Ferring International Center S.A. (“Ferring”), pursuant to which, among other things, the Company granted to Ferring an exclusive license in the United States (the “Territory”) with rights to sublicense under patents related to the Company’s proprietary intravaginal culture device known as INVOcell™, together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans (the “Field”). Ferring is responsible, at its own cost, for all commercialization activities for the Licensed Product in the Field in the Territory. The Company does retain a limited exception to the exclusive license granted to Ferring allowing the Company, subject to certain restrictions, to establish up to five clinics that will commercialize INVO cycles in the Territory. The Company retains all commercialization rights for the Licensed Product outside of the United States.

Under the terms of the Distribution Agreement, Ferring is obligated to make an initial payment to the Company of $5,000,000 upon satisfaction of certain closing conditions, including an agreement from all current manufacturers of the Licensed Product that upon a material supply default by the Company, Ferring can assume a direct purchase relationship with such manufacturers. The Closing under the Distribution Agreement will not occur prior to January 14, 2019 without consent of the Company and Ferring. Ferring is obligated to make a second payment to the Company of $3,000,000 provided that the Company is successful in obtaining a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product and provided further that Ferring has not previously exercised its right to terminate the Distribution Agreement for convenience. In addition, under the terms of a separate Supply Agreement, attached as an exhibit to the Distribution Agreement, Ferring is obligated to pay the Company a specified supply price for each Licensed Product purchased by Ferring for distribution.

The Distribution Agreement has an initial term expiring on December 31, 2025 and at the end of the initial term it may be terminated by the Company if Ferring fails to generate specified minimum revenues to the Company from the sale of the Licensed Product during the final two years of the initial term. Provided that no such termination occurs at the end of the initial term, thereafter the term of the Distribution Agreement shall automatically be renewed for successive three (3) years terms unless terminated by mutual consent. The Distribution Agreement is subject to termination upon a material breach by either party, or by Ferring for convenience. In addition, if the closing under the Distribution Agreement does not occur within seventy five (75) days, a non-breaching party may elect to terminate the Distribution Agreement.

The foregoing summary of the terms of the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the Distribution Agreement, copies of which will be filed with the Securities and Exchange Commission by the Company with its Annual Report on Form 10-K for the fiscal year ending December 31, 2018, requesting confidential treatment for certain portions.

Item 8.01     Other Events.

On November 13, 2018, INVO Bioscience, Inc. issued a press release announcing its entry into the Distribution Agreement with Ferring. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01     Financial Statements and Exhibits.

(d)          Exhibits

Exhibit No.	Description
99.1	Press Release Announcement on November 13, 2018 of Ferring U.S. Distribution Agreement

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.
Date: November 14, 2018	By:	/s/ Kathleen T. Karloff
		Kathleen T. Karloff
		Chief Executive Officer and Chairman of the Board of Directors

EX-99.1

Exhibit 99.1

INVO Bioscience Enters Exclusive U.S. Licensing Agreement with Ferring Pharmaceuticals to Commercialize the Novel INVOcell™ System for Use in the Treatment of Infertility

Medford, MA, November 13, 2018 -- INVO Bioscience, Inc. (OTCQB: IVOB), developers of the INVOcell intravaginal culture (IVC) system, and Ferring Pharmaceuticals, a specialty biopharmaceutical group committed to helping people around the world build families and live better lives, announced today that the companies have entered into an exclusive U.S. commercialization rights agreement for INVOcell. Ferring will be responsible for all U.S. commercial activities for INVOcell. INVO Bioscience will be responsible for manufacturing and supplying INVOcell to Ferring for commercial sales and to obtain a five (5) day label enhancement from the FDA for the current incubation period for the product. INVO Bioscience also retains certain limited rights to establish INVO clinics that exclusively commercialize INVO cycles and will retain commercialization rights outside the U.S.

The agreement is expected to close in January 2019, subject to customary closing conditions.

“We are pleased to have reached this agreement with Ferring to commercialize INVOcell in the U.S.,” said Katie Karloff, Chief Executive Officer of INVO Bioscience. “Ferring has commercial strength and market presence within the pharmaceutical fertility market and understands the unique opportunity that INVOcell provides to revolutionize fertility treatment. Our joint mission at INVO Bioscience and Ferring is to increase access to care and expand fertility treatment across the U.S., and with Ferring we’ve found a natural partner to accomplish this goal.”

“As a leader in reproductive medicine, Ferring understands that women seeking to start or expand a family want options that suit their individual circumstances,” said Paul Navarre, CEO, Ferring Pharmaceuticals (US). “With this agreement, Ferring aims to make INVOcell, a novel technology used in the treatment of infertility, widely available as an option for women and their healthcare providers.”

INVOcell is a novel fertility treatment that uses a woman’s own body as a natural incubator for the incubation of eggs and sperm during fertilization and early embryo development. In 2015, INVOcell received US Food & Drug Administration clearance. INVOcell is the first intravaginal culture (IVC) device and is a small polystyrene capsule used for egg fertilization and embryo development using vaginal incubation. In clinical studies supporting the FDA clearance, INVOcell has shown results comparable to traditional assisted reproductive techniques.

“In my practice, an increasing number of women and couples are choosing INVOcell with favorable results," said Amber R. Cooper MD, MSCI, FACOG, Medical and IVF Practice Director of VIOS Fertility Institute St. Louis, MO. "There is a growing consensus around the need for personalized medicine in reproductive health. That Ferring and INVO Bioscience are moving to make INVOcell an available option for infertility patients across the country is very welcome news.”

In the United States, statistics show that over 1.4 million women may benefit from advanced fertility treatment. However, only approximately 130,000 people begin such treatment.¹

Additional details pertaining to the agreement will be filed by INVO Bioscience with the SEC.

¹ Fertility Dynamics, an independent data analytics, research and strategic advisory firm based in Washington, DC; data on file

About INVO Bioscience

INVO Bioscience is a medical device company focused on creating simplified treatments for patients diagnosed with infertility. Our solution, the INVO Procedure, is a disruptive new technology. 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 (ART). The INVOcell is the first Intravaginal Culture (IVC) system in the world used for the natural in vivo incubation of eggs and sperm during fertilization and early embryo development. Our mission is to increase access to care and expand fertility treatment across the globe with a goal to lower the cost of care and increase availability of care. For more information, please visit https://invobioscience.com.

For Safety and Efficacy information:  
https://invobioscience.com/wp-content/uploads/2016/03/INVO_IFU_Instructions_for_use.pdf

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

Kathleen Karloff, CEO

978-878-9505 ext. 504

kkarloff@invobio.com