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

Item 1.01. Entry into a Material Definitive Agreement.

On May17, 2017, United Therapeutics Corporation (the
Company) entered
into the First Amendment (the Amendment) to the
License Agreement, dated November14, 2008 (the Agreement), with
Eli Lilly and Company (Lilly). Under the
Agreement, Lilly granted the Company an exclusive license for the
right to develop, market, promote and commercialize Adcirca
(tadalafil) for the treatment of pulmonary hypertension in the
United States. Under the Agreement, the Company is obligated to
pay Lilly royalties equal to five percent of the Companys net
product sales of Adcirca. The purpose of the Amendment is to
clarify and extend the term of the Agreement and to amend the
economic terms of the Agreement following a patent expiry in
November2017.

The Agreement originally provided that it would terminate upon
the later of: (1)expiration, lapse, cancellation, abandonment or
invalidation of the last claim to expire within a Lilly patent
covering the commercialization of Adcirca for the treatment of
pulmonary hypertension in the United States; or (2)expiration of
any government-conferred exclusivity rights to use Adcirca for
the treatment of pulmonary hypertension in the United States.

A U.S. patent for Adcirca for the treatment of pulmonary
hypertension will expire in November2017. Lilly has two
additional patents expiring in Apriland November2020,
respectively, covering Adcirca and claiming pharmaceutical
compositions and free drug particulate forms (the
2020
Patents). The Patent Trial and Appeal Board
(PTAB) of the U.S.
Patent and Trademark Office issued a final written decision
finding these patents invalid as the result of aninter
partesreview proceeding initiated by Actelion
PharmaceuticalsLtd. Lillys appeal of the PTABs decision is
pending before the United States Court of Appeals for the Federal
Circuit.

The Company has previously disclosed that it is likely to face
generic competition for Adcirca following the expiration of the
November2017 patent. FDA has already tentatively approved ANDAs
filed by at least two generic companies to market generic
versions of Adcirca.

Under the Amendment, the term of the agreement has been amended
and extended so that the Agreement will now expire on the latest
to occur of (1)expiration, lapse, cancellation, abandonment or
invalidation of the last claim to expire within a Lilly patent
covering the commercialization of Adcirca for the treatment of
pulmonary hypertension in the United States; (2)expiration of any
government-conferred exclusivity rights to use Adcirca for the
treatment of pulmonary hypertension in the United States; or
(3)December31, 2020. As a result, even if generic competition
begins in November2017, the Company will continue to market and
sell branded Adcirca. As amended, the Agreement may be terminated
by either party upon six months written notice to the other
party.

Under the terms of the Amendment, beginning on December1, 2017,
the Company will pay Lilly (a)a ten percent royalty on net
product sales of Adcirca; and (b)milestone payments equal to
$325,000 for each $1,000,000 in net product sales. In the event
that Lilly prevails in one or both of the appeals noted above:
(a)the previous five percent royalty rate will apply and the
effective date of the new payment structure will be deferred
until the expiration, lapse, abandonment or invalidation of the
last claim of the 2020 Patents covering commercialization of
Adcirca for pulmonary hypertension; and (b)to the extent the
Company had previously paid amounts in excess of five percent,
those amounts will be refunded by Lilly.

This summary is qualified in its entirety by reference to the
copy of the Amendment filed herewith as Exhibit10.1.

Forward-Looking Statements

Statements included in this Current Report on Form8-K that are
not historical in nature are forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include, among others,
statements regarding the outlook of the Companys Adcirca business
and its agreements with Lilly. These forward-looking statements
are subject to certain risks and uncertainties, such as those
described in the Companys periodic and other reports filed with
the Securities and Exchange Commission that could cause actual
results to differ materially from anticipated results, and are
qualified by the cautionary statements, cautionary language and
risk factors set forth in the Companys periodic reports and
documents filed with the Securities and Exchange Commission,
including the Companys most recent Annual Report on Form10-K,
Quarterly Reports on Form10-Q and Current Reports on Form8-K. The
Company claims claim the protection of the safe harbor contained
in the Private Securities Litigation Reform Act of 1995 for
forward-looking statements. The Company is

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.

United Therapeutics Corporation (NASDAQ:UTHR) Recent Trading Information

United Therapeutics Corporation (NASDAQ:UTHR) closed its last trading session down -1.92 at 120.90 with 357,873 shares trading hands.