INVO Fertility, Inc 8-K, filed Mar 8, 2021
INVO Fertility, Inc. (IVF)
About this 8-K
INVO Fertility, Inc filed this 8-K on March 8, 2021, reporting on events of March 2, 2021.
Items reported
- Item 1.01: Entered into a material agreement
- Item 8.01: Other events
- Item 9.01: Financial statements and exhibits
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): March 2, 2021
INVO BIOSCIENCE, INC.
(Exact name of registrant as specified in charter)
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Nevada |
001-39701 |
20-4036208 |
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(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer |
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5582 Broadcast Court Sarasota, Florida (Address of principal executive offices) |
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34240 (Zip Code) |
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Registrant’s telephone number, including area code: (978) 878-9505 |
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(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:
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Title of each class |
Trading symbol(s) |
Name of each exchange on which registered |
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Common Stock, $0.0001 par value per share |
INVO |
The Nasdaq Stock Market LLC |
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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. ☐ |
Item 1.01. Entry into a Material Definitive Agreement.
On March 2, 2021, we entered into Amendment No. 1 to Distribution Agreement (the “Amendment”) with Ferring International Center S.A. (“Ferring”), which Amendment amended to terms of our November 12, 2018 Distribution Agreement with Ferring (the “Distribution Agreement”). Pursuant to the Amendment, Ferring agreed to purchase a 2,004 count of Product (i.e. 334 units of 6) for $501,000 pursuant to the Supply Agreement in March 2021, at which point the Minimum Annual Target for Calendar Year 2020 set forth in Section 2.4 of the Distribution Agreement will be deemed to be satisfied in full as a result of the purchase of such additional units of Product. Capitalized terms used and not otherwise defined have the meanings set forth in the Distribution Agreement.
In addition, the parties agreed to amend and restate Section 4.3 of the original Distribution Agreement as follows:
“Section 4.3 INVO Clinics. As a limited exception to the exclusive Product License, and subject to the terms and conditions of this Agreement, INVO shall be entitled, at its sole cost to establish INVO clinics that exclusively Commercialize INVO Cycles in the Territory in order to Commercialize the Product during the Term (the “INVO Clinics”) as follows: INVO may establish seven (7) INVO Clinics, upon not less than ninety (90) days’ advance written notice to Ferring of its intent to establish such an INVO Clinic, in locations where such INVO Clinic is under oversight, directorship, ownership, and/or control of a reproductive endocrinologist (REI); provided that, subject to the last sentence of Section 2.4(b), Ferring’s prior written consent shall be required for INVO to establish more than seven (7) INVO Clinics. For purposes of up to seven (7) INVO Clinics as contemplated immediately above, and otherwise subject to obtaining Ferring’s prior written consent, INVO shall be entitled to order and purchase Product solely from Ferring (the “Repurchased Product”) on the following terms: (a) INVO may not submit an order to purchase (when aggregated with all other orders to purchase during the immediately preceding 90 days) in the aggregate for more than ten percent (10%) of Ferring’s then-current inventory of the Product and (b) upon placing a purchase order with Ferring, INVO shall pay Ferring within thirty (30) days in immediately available funds the amount equal to One Hundred U.S. Dollars (US$100) more than the then-current purchase price of the Product per Product ordered pursuant to the Supply Agreement. Any Product revenue received by INVO from INVO Clinics shall be considered as INVO Revenue and counted towards Ferring’s satisfaction of the Minimum Annual Targets contemplated by Section 2.4(b). INVO, on behalf of itself and its Affiliates, hereby covenants and agrees to (i) exclusively require and promote use of the Ferring pharmaceutical product Menopur and, to the extent INVO determines it is reasonable and appropriate under Applicable Law, all of the Ferring Fertility Products (as and to the extent any pharmaceutical products intended for the Field are involved) in connection with the Product for all INVO Cycles performed in all INVO Clinics during the Term and (ii) provide Ferring with the opportunity to review, and reasonably comment on, and approve in a reasonable timeframe of all marketing materials to be used in connection with the INVO Clinics. Beginning on the Closing Date, INVO shall provide Ferring with annual reports summarizing its Commercialization activities for the Product at INVO Clinics in the Territory including a reasonably detailed report of revenue generated from INVO Clinics.”
The parties further agreed to amend and restate Section 7.2(b) of the Distribution Agreement to read as follow:
“(b) Product Label Enhancement. Ferring shall pay to INVO a one-time, non-refundable and non-creditable additional payment of Three Million U.S. Dollars (US$3,000,000) within ten (10) Business Days following the date that the FDA approves the Product Label Enhancement pursuant to Section 3.1 at least three (3) years prior to the expiration of the Term; provided that, following any conversion of the Product License to the Non-Exclusive Territory License, such additional payment shall not be payable.”
The foregoing summary of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the Agreement, a copy of which is filed as Exhibit 10.1 hereto and incorporated herein by reference.
Item 8.01 Other Events
On March 8, 2021, we issued a press release titled “INVO Bioscience Expands Clinic Opportunity [Addressable Market] Under Amended U.S. Commercialization Agreement.” 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.
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Exhibit No. |
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Description |
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10.1 |
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99.1 |
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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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By: |
/s/ Steven Shum |
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Name: |
Steven Shum |
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Title: |
Chief Executive Officer |
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Dated March 8, 2021 |
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Exhibit 10.1
AMENDMENT NO. 1
TO
DISTRIBUTION AGREEMENT
This AMENDMENT NO. 1 (this “Amendment”) to the Distribution Agreement, dated as of November 12, 2018 (the “Distribution Agreement”) is entered into as of March 02, 2021 (the “Effective Date”), by and among Ferring International Center S.A., a Société Anonyme organized and existing under the laws of Switzerland (“Ferring”), INVO Bioscience, Inc., a corporation organized and existing under the laws of Nevada (“INVO”), and Bio X Cell, Inc., a corporation organized and existing under the laws of Massachusetts (“Bio X Cell”). Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Distribution Agreement.
W I T N E S S E T H:
WHEREAS, the Parties desire to make certain amendments to the Distribution Agreement as described below.
NOW, THEREFORE, in consideration of the mutual promises set forth in this Amendment, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto, intending to be legally bound hereby, agree as follows:
1. Purchase of Additional Product and Satisfaction of Calendar Year 2020 Minimum Annual Target. The Parties acknowledge and agree that (i) Ferring shall purchase an additional 2,004 count of Product (i.e. 334 units of 6) for $501,000 pursuant to the Supply Agreement in March 2021, and (ii) the Minimum Annual Target for Calendar Year 2020 set forth in Section 2.4 of the Distribution Agreement is hereby deemed to be satisfied in full as a result of the purchase of such additional units of Product as defined in (i) of this section.
2. Section 4.3INVO Clinics. The Parties agree that (i) Schedule 4.3(a) of the Agreement is deleted in its entirety and (ii) Section 4.3 of the Agreement is deleted in its entirety and hereby amended and restated as follows:
“Section 4.3 INVO Clinics. As a limited exception to the exclusive Product License, and subject to the terms and conditions of this Agreement, INVO shall be entitled, at its sole cost to establish INVO clinics that exclusively Commercialize INVO Cycles in the Territory in order to Commercialize the Product during the Term (the “INVO Clinics”) as follows: INVO may establish seven (7) INVO Clinics, upon not less than ninety (90) days’ advance written notice to Ferring of its intent to establish such an INVO Clinic, in locations where such INVO Clinic is under oversight, directorship, ownership, and/or control of a reproductive endocrinologist (REI); provided that, subject to the last sentence of Section 2.4(b), Ferring’s prior written consent shall be required for INVO to establish more than seven (7) INVO Clinics. For purposes of up to seven (7) INVO Clinics as contemplated immediately above, and otherwise subject to obtaining Ferring’s prior written consent, INVO shall be entitled to order and purchase
Product solely from Ferring (the “Repurchased Product”) on the following terms: (a) INVO may not submit an order to purchase (when aggregated with all other orders to purchase during the immediately preceding 90 days) in the aggregate for more than ten percent (10%) of Ferring’s then-current inventory of the Product and (b) upon placing a purchase order with Ferring, INVO shall pay Ferring within thirty (30) days in immediately available funds the amount equal to One Hundred U.S. Dollars (US$100) more than the then-current purchase price of the Product per Product ordered pursuant to the Supply Agreement. Any Product revenue received by INVO from INVO Clinics shall be considered as INVO Revenue and counted towards Ferring’s satisfaction of the Minimum Annual Targets contemplated by Section 2.4(b). INVO, on behalf of itself and its Affiliates, hereby covenants and agrees to (i) exclusively require and promote use of the Ferring pharmaceutical product Menopur and, to the extent INVO determines it is reasonable and appropriate under Applicable Law, all of the Ferring Fertility Products (as and to the extent any pharmaceutical products intended for the Field are involved) in connection with the Product for all INVO Cycles performed in all INVO Clinics during the Term and (ii) provide Ferring with the opportunity to review, and reasonably comment on, and approve in a reasonable timeframe of all marketing materials to be used in connection with the INVO Clinics. Beginning on the Closing Date, INVO shall provide Ferring with annual reports summarizing its Commercialization activities for the Product at INVO Clinics in the Territory including a reasonably detailed report of revenue generated from INVO Clinics.”
3. Section 7.2(b) Product Label Enhancement. The Parties agree that Section 7.2(b) of the Agreement is deleted in its entirety and hereby amended and restated as follows:
“(b) Product Label Enhancement. Ferring shall pay to INVO a one-time, non-refundable and non-creditable additional payment of Three Million U.S. Dollars (US$3,000,000) within ten (10) Business Days following the date that the FDA approves the Product Label Enhancement pursuant to Section 3.1 at least three (3) years prior to the expiration of the Term; provided that, following any conversion of the Product License to the Non-Exclusive Territory License, such additional payment shall not be payable.”
4. Reference to and Effect on the Agreement. Each reference in the Agreement to “this Agreement”, “hereunder”, “hereof”, “herein”, or words of like import shall mean and be a reference to the Agreement as amended hereby. No reference to this Amendment need be made in any instrument or document at any time referring to the Agreement, a reference to the Agreement in any of such to be deemed to be a reference to the Agreement as amended hereby. Except as expressly amended by this Amendment, the Agreement shall remain unchanged and in full force and effect in all respects. In case of any conflict between this Amendment and the Distribution Agreement, the terms and conditions of this Amendment shall supersede the terms and conditions of the Distribution Agreement to the extent of such conflict.
5. Counterparts. This Amendment may be executed in one or more counterparts, each of which will be deemed an original, but all of which together will constitute a single instrument. A signed copy of this Amendment delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Amendment.
[Signature page follows]
IN WITNESS WHEREOF, and intending to be legally bound hereby, the parties hereto have caused this Amendment to be executed and delivered as of the Effective Date.
FERRING INTERNATIONAL CENTER S.A.
By: /s/ Jan Peutzfeldt
Name: Jan Peutzfeldt
Title: Senior Vice President, Global Marketing and Business Development
By: /s/ Curt McDaniel
Name: Curt McDaniel
Title: Chief Legal Officer
INVO BIOSCIENCE, INC.
By: /s/ Steve Shum
Name: Steve Shum
Title: CEO
BIO X CELL, INC.
By: /s/ Steve Shum
Name: Steve Shum
Title: CEO
[Signature Page to Amendment No. 1 to Distribution Agreement]
Exhibit 99.1
INVO Bioscience Expands Company-Owned Clinic Opportunity Under Amended U.S. Commercialization Agreement
SARASOTA, Florida – March 08, 2021 -- INVO Bioscience, Inc. (NASDAQ: INVO), a medical device company focused on commercializing the world's only in vivo Intravaginal Culture System (IVC), INVOcell®, an effective and affordable treatment for patients diagnosed with infertility, today announced an amendment under its exclusive U.S. commercialization agreement with Ferring Pharmaceuticals. The amendment provides for an increase in the number of INVO company-owned clinics initially allowable under the agreement and removes certain geographical restrictions.
Steve Shum, CEO of INVO Bioscience, commented, “We are pleased to have successfully completed this amendment with our U.S. partner, Ferring. We believe it reflects the strength of our ongoing collaboration and shared commitment to expand the use of INVOcell in the U.S. We also believe our dedicated clinic approach is an important complementary channel to accelerate awareness and market adoption of INVOcell and in our opinion will allow us to capture additional per-procedure income. In our view, this strategy will increase industry capacity, affordability and facilitate greater access for patients. We expect to report on our initial U.S. activities in the near future.”
The amendment also adjusted the remaining annual 2020 minimum contractual product purchase requirement, whereby Ferring will place a $501,000 order, which will be recognized as revenue by INVO Bioscience in the first quarter of 2021.
About INVO Bioscience
We are a medical device company focused on creating simplified, lower-cost 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 (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, as 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 of care and increase the availability of care. For more information, please visit http://invobioscience.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
steveshum@invobioscience.com
Investors
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com