United Therapeutics Corporation (NASDAQ:UTHR) Files An 8-K Entry into a Material Definitive Agreement

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United Therapeutics Corporation (NASDAQ:UTHR) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement

Settlement Agreement and Corporate Integrity Agreement

On December19, 2017, United Therapeutics Corporation (the “Company”) entered into a civil Settlement Agreement with the U.S. Department of Justice (“DOJ”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (collectively the “United States Government”). The Settlement Agreement relates to a May2016 subpoena from the DOJ requesting documents regarding the Company’s support of 501(c)(3)organizations that provide financial assistance to patients. Other companies received similar inquiries as part of a DOJ investigation regarding whether that support may violate the Federal Anti-Kickback Statute and the Federal False Claims Act. The Settlement Agreement is neither an admission of facts nor liability by the Company, nor a concession by the United States Government that its contentions are not well-founded. Under the Settlement Agreement, the Company is required to pay to the United States Government the sum of $210 million plus interest at a rate of 2.25% commencing from July27, 2017 through the day before full payment is made. During the second quarter of 2017, the Company recorded a $210 million accrual relating to this matter. In connection with the civil settlement, the Company also entered into a Corporate Integrity Agreement with the OIG, effective as of December18, 2017, which requires the Company to maintain its corporate compliance program and to undertake a set of defined corporate integrity obligations for a period of five years from the date the agreement was signed.

The foregoing description of certain material provisions of the Settlement Agreement and Corporate Integrity Agreement is not complete and is qualified in its entirety by reference to the full text of such agreements, which are filed herewith as Exhibit10.1 and 10.2, respectively, to this current report on Form8-K, and are incorporated herein by reference.

Agreements with Accredo and CuraScript

On December20, 2017, the Company entered into a Wholesale Product Purchase Agreement (the “Purchase Agreement”) with Priority Healthcare Distribution,Inc., doing business as CuraScript SD Specialty Distribution (“CuraScript”), a non-exclusive agreement under which CuraScript will be appointed as a distributor of the Company’s treprostinil-based products: Remodulin®, Orenitram® and Tyvaso®. Under the Purchase Agreement, CuraScript will purchase the Company’s products at a transfer price equal to the current wholesale acquisition cost for each product, which the Company may change from time-to-time upon notice to CuraScript. CuraScript will be permitted to distribute the products to hospitals, Veterans Administration and 340B entities, and Accredo Health Group,Inc. (“Accredo”). The Company will pay fees to CuraScript for certain ancillary services in connection with distributing the Company’s Products.

Concurrently with the Purchase Agreement, the Company also entered into a Specialty Pharmacy Network Agreement with Accredo, which is an affiliate of CuraScript (the “Network Agreement”). Under the Network Agreement, Accredo is permitted to purchase the Company’s products form CuraScript, and dispense them as part of the Company’s distribution network. Accredo will be obligated to maintain certain minimum and maximum inventory levels based on anticipated demand, to ensure adequate supply to avoid disruption of therapy for patients.

Both the Purchase Agreement and the Network Agreement will become effective January1, 2018, at which time the Company’s existing distribution agreements with Accredo will terminate. The new agreements contain, in the aggregate, substantially similar terms to the Company’s existing distribution agreements with Accredo. The Company will continue to compensate Accredo for certain ancillary services, including assistance with administering the Company’s patient assistance programs, under a separate services agreement. The Network Agreement has an initial term of one year, renewable automatically for successive one-year terms unless either party submits a termination notice at least 90 days prior to the end of the then-current term. The Purchase Agreement has an initial term of two years, renewable automatically for successive one-year terms unless either party submits a termination notice at least 60 days prior to the end of the then-current term. Either party may terminate one or both agreements upon 90 days written notice to the other party, for any reason.

The foregoing description of certain material provisions of the Purchase Agreement and Network Agreement is not complete and is qualified in its entirety by reference to the full text of such agreements, which the Company intends to file as exhibits to its Annual Report on Form10-K for the year ended December31, 2017.

Item 1.02. Termination of a Material Definitive Agreement

The information under the heading “Agreements with Accredo and CuraScript” in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.

Item 9.01. Exhibits

(d) Exhibits


UNITED THERAPEUTICS Corp Exhibit
EX-10.1 2 a17-28656_1ex10d1.htm EX-10.1 Exhibit 10.1   SETTLEMENT AGREEMENT   This Settlement Agreement (“Agreement”) is entered into among the United States of America,…
To view the full exhibit click here

About United Therapeutics Corporation (NASDAQ:UTHR)

United Therapeutics Corporation is a biotechnology company. The Company is focused on the development and commercialization of products for the treatment of chronic and life-threatening conditions. Its therapeutic products and product candidates include Prostacyclin Analogues, Phosphodiesterase Type 5 (PDE-5) Inhibitor and Monoclonal Antibody (MAb). Its Prostacyclin Analogues lead product is Remodulin (treprostinil) Injection. It also includes Tyvaso (treprostinil) Inhalation Solution and Orenitram (treprostinil) Extended-Release Tablets. Its subsidiary is developing another oral prostacyclin analogue for the treatment of pulmonary arterial hypertension (PAH) called esuberaprost. Its PDE-5 inhibitor is Adcirca (tadalafil) tablets are indicated for the treatment of PAH. Its Unituxin (dinutuximab) Injection in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2 and 13-cis-retinoic acid is indicated for the treatment of pediatric patients with neuroblastoma.