INVO Bioscience & Ferring Pharmaceuticals Close Exclusive U.S. Licensing Agreement to Commercialize INVOcell™ For Treatment of Infertility

By John Heerdink LinkedIn
INVO Bioscience (IVOB) is a medical device company focused on creating simplified treatments for patients diagnosed with infertility. Their solution, the INVO Procedure, is a disruptive new technology & is a revolutionary in vivo method of vaginal incubation that offers patients a more natural and intimate experience.
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. 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 order to receive FDA clearance, two clinical studies were conducted. These studies provided clinical effectiveness outcome data to support FDA clearance. According to Fertility Dynamics, an independent data analytics, research, and strategic advisory firm based in Washington, DC, 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. For more information, please visit https://invobioscience.com.
Ferring Pharmaceuticals is a research-driven biopharmaceutical company with approximately 6500 employees in 56 countries and is devoted to identifying, developing and marketing innovative products in the fields of reproductive health, women’s health, urology, gastroenterology, endocrinology, and orthopedics. For nearly two decades, Ferring has provided a range of therapies to help women along every step of the fertility journey. For more information visit www.FerringUSA.com.
Recently INVO Bioscience, Inc. (IVOB) and Ferring Pharmaceuticals announced the closing of the previously announced 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 the INVOcell devices to Ferring for commercial sales as well as performing a clinical study for label enhancement. 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.
Katie Karloff, Chief Executive Officer of INVO Bioscience stated, “We are extremely pleased to have finalized our agreement with Ferring to commercialize INVOcell in the U.S., With Ferring applying its extensive resources and expertise in the field of assisted reproductive technologies (ART) to market and supply the INVOcell across the U.S., INVO Bioscience will now focus our efforts on the international markets and the expansion of INVO clinics throughout the U.S. while at the same time ensuring we meet the goals to obtain label enhancement.”
Paul Navarre, CEO, Ferring Pharmaceuticals (US) stated, “Helping people to build families is at the heart of what we do at Ferring and as the leader in reproductive medicine, we will help shape the future of fertility in the U.S. With INVOcell, we will further expand treatment options 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.
Lori Kahler, VP of Global Operations for INVO Bioscience stated, “We are proud to have Ferring Pharmaceuticals as our exclusive partner in the US,” stated Lori Kahler, VP of Global Operations for INVO Bioscience. We look forward to working with the strong management team at Ferring as we further develop intravaginal culture technology to meet important fertility treatment needs. It is both exciting and gratifying to see that Ferring immediately recognized the value of the INVOcell Culture System in the treatment of infertility.”
According to an 8k filed by INVO Bioscience on 01-17-2019, an initial $5,000,000 license fee was paid to INVO Bioscience along with the balance of terms (See 8k agreement language below):

At the closing, the Company (INVO Bioscience) 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.”

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

MEDFORD, Mass., Jan. 14, 2019 /PRNewswire/ — INVO Bioscience, Inc. (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..

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