Windtree Therapeutics, Inc. (NASDAQ:WINT) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01
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Entry into a Material Definitive |
Effective June 12, 2017 (the Effective Date),
Windtree Therapeutics, Inc. (the Company)
entered into a License, Development and Commercialization
Agreement (License Agreement) with Lees
Pharmaceutical (HK) Ltd., a company organized under the laws of
Hong Kong (Lees). Under the License Agreement,
the Company has granted to Lees an exclusive license with a right
to sublicense, (i) to develop and commercialize the Companys KL4
surfactant products, including SURFAXIN, which was approved by
the U.S. Food and Drug Administration (FDA) in
2012 for the prevention of respiratory distress syndrome
(RDS) in premature infants, SURFAXIN LS, the
lyophilized dosage form of SURFAXIN; and AEROSURF, the Companys
investigative combination drug/device product that is designed to
deliver aerosolized KL4surfactant noninvasively, and (ii) to
register and manufacture SURFAXIN and SURFAXIN LS for use in the
Licensed Territory, which includes the Peoples Republic of China
(PRC), Hong Kong, Thailand, Taiwan and 12 other
countries (the Licensed Territory). In addition,
the Company has granted Lees options to potentially add Japan to
the Licensed Territory and to manufacture the Companys aerosol
delivery device in the Licensed Territory, in each case subject
to conditions set forth in the License Agreement.
Under the License Agreement, Lees will make an upfront payment to
the Company of $1million on or before July 5, 2017. (Lees also
invested $2million in the Companys recent private placement of
Convertible Preferred Stock units that was effective February 13,
2017.) The Company also may receive up to $37.5 million in
potentialclinical, regulatory and commercial milestone payments.
The Company also will share in any sublicense income Lees may
receive at a rate equal to low double digits. In addition, Lees
will be responsible for all costs and expenses in and for the
Licensed Territory related to development activities, including a
planned AEROSURF phase 3 clinical trial, regulatory activities,
and commercialization activities.
The Company also will be eligible to receive tiered royalties
based on a percent of Net Sales, depending on the product,in the
range of high single to low-to-mid double digit percentages.
Royalties are payable on a country-by-country basis until the
latest of (A) the expiration of the last valid patent claim
covering the product in the country of sale, (B) the expiration
or revocation of any applicable regulatory exclusivity in the
country of sale, and (C) ten (10) years after the first
commercial sale in the country of sale. Thereafter, in
consideration of licensed rights other than patent rights,
royalties shall continue for the commercial life of each product
and, for the initial three years, shall be in the range of
low-to-mid single digits. In addition, in the event that one or
more generic products are introduced, the royalty rates will be
reduced, subject to certain minimums if the Company has
continuing obligations at the time to pay royalties under its
in-license agreements.
Under the License Agreement, Lees will be responsible for all
activities related to development, regulatory approval and
commercialization of the Companys KL4 surfactant and combination
drug / device products in the Licensed Territory. Lees will hold
the product licenses for all non-aerosolized products in the
Licensed Territory and will seek regulatory approval initially
for SURFAXIN and SURFAXIN LS for RDS. The Company will hold the
product license in the Licensed Territory (except where
prohibited by law) for all aerosolized products and will
designate Lees its exclusive agent and representative to develop
and register AEROSURF and other aerosolized products in the name
of and on behalf of the Company. Lees also has agreed that,
except as provided in the License Agreement, for a period of ten
(10)years beginning with the later of the first commercial sale
of the first aerosolized product and the first commercial sale of
the first non-aerosolized product in the PRC, it will not
develop, register, manufacture, or commercialize any product for
the prevention and/or treatment of RDS in premature infants or
other diseases and conditions in humans, in either case that
administers, utilizes or contains pulmonary surfactant without
the Companys prior written consent.
Under the License Agreement, the Company and Lees will establish
a Joint Steering Committee (JSC) to oversee the development,
registration and commercialization of the products in the
Licensed Territory. In addition, the Company and Lees will
establish a Joint Development Committee to prepare and oversee
the development plan for the Licensed Territory, and at the
appropriate time, a Joint Commercialization Committee to
implement a commercialization plan and oversee the
commercialization of approved products in the Licensed Territory.
Lees may sublicense certain activities under the License
Agreement to an affiliate of Lees, but may not grant sublicenses
to unaffiliated third parties without the prior consent of the
Company. A sublicensee and a subcontractor may not be a
competitor identified by the Company. Sublicenses under the
License Agreement do not include the right to further sublicense.
In addition, the Company and Lees plan to negotiate (i)a
technology transfer agreement under which the Company will
transfer to Lees the manufacturing processes for SURFAXIN and
SURFAXIN LS; (ii) a manufacturing agreement providing for the
manufacture of SURFAXIN and SURFAXINLS by Lees and giving the
Company access to such products outside the Licensed Territory;
(iii) a manufacturing and supply agreement providing for the
manufacture and supply of AEROSURF drug and medical device
components by the Company to Lees; and (iv) such other agreements
and amendments as may be necessary for the parties to perform
their obligations under the License Agreement.
The term of the License Agreement commenced on the Effective Date
and will continue on a country-by-country basis for the
commercial life of the products. Either party may terminate the
License Agreement in the event of bankruptcy or a material breach
of the License Agreement by the other party that remains uncured
for a period of sixty (60)days. In addition, either party may
terminate the License Agreement in its entirety or with respect
to any individual product or country if a regulatory authority
terminates, suspends or discontinues development of a product and
such termination, suspension or discontinuance persists for a
period in excess of eighteen (18) months. Upon termination of the
License Agreement in its entirety or with respect to a particular
product or country, generally all related rights and licenses
granted to Lees will terminate, all rights under the Companys
technology will revert to the Company, and Lees will cease all
use of the Companys technology.
The foregoing description of the License Agreement does not
purport to be complete and is qualified in its entirety by
reference to the License Agreement which is expected to be filed
with the Securities and Exchange Commission (SEC) as an exhibit
to the Quarterly Report on Form 10-Q for the quarter ended June
30, 2017. The License Agreement will be filed to provide
investors and the Companys stockholders with information
regarding the terms thereof and in accordance with applicable
rules and regulations of the SEC. to the License Agreement, each
of the Company and Lees made customary representations,
warranties and covenants and agreed to indemnify each other for
certain losses arising out of breaches of such representations,
warranties, covenants and other specified matters. The
representations, warranties and covenants were made by the
parties to and solely for the benefit of each other and any
expressly intended third party beneficiaries in the context of
all of the terms and conditions of the agreements and in the
context of the specific relationship between the parties.
Accordingly, investors and stockholders should not rely on the
representations, warranties and covenants. Furthermore, investors
and stockholders should not rely on the representations,
warranties and covenants as characterizations of the actual state
of facts or continuing intentions of the parties, since they were
only made as of the date of the agreements. Information
concerning the subject matter of such representations, warranties
and covenants may change after the date of the agreements, which
subsequent information may or may not be fully reflected in the
Companys reports or other filings with the Commission.
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Item .01. |
Other Events. |
Reference is made to Item 1.01. On June 12, 2017, the Company
issued a press release and announced the execution and delivery
of the License Agreement described above. The press release is
attached as Exhibit 99.1 to this Current Report on Form 8-K.
In addition, the Company will host a conference call and webcast
(including a slide presentation) at 8:00 a.m. EDT on Tuesday,
June 13, 2017 to discuss the License Agreement and answer
questions. The live webcast, including a slide presentation, can
be accessed at http://windtreetx.investorroom.com/events . To
participate in the live call and take part in the question and
answer session, dial (844) 802-2436 (domestic) or (412) 317-5129
(international).
A replay of the conference call will be accessible one hour after
completion through June 20, 2017 by dialing (877) 344-7529
(domestic) or (412) 317-0088 (international) and referencing
conference number 10108999. An archive of the webcast can be
accessed on the Companys website at
http://windtreetx.investorroom.com/events.
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Item 9.01. |
Financial Statements and Exhibits. |
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(d) |
Exhibits |
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99.1 |
Press release dated June 12, 2017 |
Cautionary Note Regarding Forward-looking
Statements:
To the extent that statements in this Current Report on Form 8-K
are not strictly historical, including statements as to business
strategy, outlook, objectives, future milestones, plans,
intentions, goals, future financial conditions, future
collaboration agreements, the success of the Companys product
development or otherwise as to future events, such statements are
forward-looking, and are made to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. The
forward-looking statements contained in this Current Report are
subject to certain risks and uncertainties that could cause
actual results to differ materially from the statements made.
Such risks and others are further described in the Companys
filings with the Securities and Exchange Commission including the
most recent reports on Forms 10-K, 10-Q and 8-K, and any
amendments thereto.
About Windtree Therapeutics, Inc. (NASDAQ:WINT)
Windtree Therapeutics, Inc., formerly Discovery Laboratories, Inc., is a biotechnology company. The Company is focused on developing KL4 surfactant therapies for respiratory diseases and other potential applications. The Company operates through the research and development of products focused on surfactant therapies for respiratory disorders and diseases, and the manufacture and commercial sales of approved products segment. The Company’s technology platform includes a synthetic, peptide-containing surfactant (KL4 surfactant) that is structurally similar to endogenous pulmonary surfactant, and drug delivery technologies being developed to enable non-invasive administration of aerosolized KL4 surfactant. The Company’s core development program, AEROSURF (lucinactant for inhalation), is focused on improving the management of respiratory distress syndrome (RDS) in premature infants, a respiratory condition that can result in long-term respiratory problems, developmental delay and death.