Current Report Filing (8-k)
January 17 2019 - 04:07PM
Edgar (US Regulatory)
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):
January 1 4, 2019
INVO BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
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Nevada
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333-147330
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20-4036208
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(State or other jurisdiction of
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(Commission
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(I.R.S. Employer
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Incorporation)
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File Number)
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Identification No.)
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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:
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c)
under the Exchange Act (17 FR 240.13e-4(c))
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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 ☐.
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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.
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Item 1.01. Entry into a Material Definitive Agreement.
On January 14, 2019, INVO Bioscience, Inc (the “Company”)
consummated the transactions contemplated by its previously
reported Distribution Agreement with Ferring International Center
S.A. (“Ferring”), dated November 12, 2018.
At the closing, the Company received its initial $5,000,000 license
fee. Pursuant to the Distribution Agreement, 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 completed
its obligation to make an initial payment to the Company of
$5,000,000 upon completion of the required closing conditions,
including executed agreements 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. 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 January 14, 2019, INVO Bioscience, Inc. issued a press release
announcing its closing of 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
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.
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INVO Bioscience, Inc.
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Date: January 17, 2019
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By:
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/s/ Kathleen T. Karloff
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Kathleen T. Karloff
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Chief Executive Officer and Chairman of the Board of Directors
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INVO BioScience (QB) (USOTC:IVOB)
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