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| EX-99.1 - PRESS RELEASE - PALATIN TECHNOLOGIES INC | ptn_ex991.htm |
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): January 8,
2017
Palatin Technologies, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-15543
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95-4078884
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(State or other jurisdiction
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(Commission
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(IRS employer
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of incorporation)
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File Number)
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identification number)
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4B Cedar Brook Drive, Cranbury, NJ
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08512
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (609) 495-2200
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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:
[ ] 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))
Item
1.01.
Entry into a Material Definitive Agreement
On January 8, 2017, Palatin Technologies, Inc.
(“Palatin” or the “Company”) entered into a license agreement (the
“License Agreement”)
with AMAG Pharmaceuticals, Inc. (“AMAG”). Under the terms of the License
Agreement, subject to the conditions set forth therein, the Company
will grant to AMAG (i) an exclusive license in all countries of
North America (the “Territory”), with the right to grant sub-licenses, to
research, develop and commercialize products containing
bremelanotide (each a “Product,” and collectively,
“Products”), an investigational product designed to
be an on-demand treatment for hypoactive sexual desire disorder
(“HSDD”) in pre-menopausal women, (ii) a
non-exclusive license in the Territory, with the right to grant
sub-licenses, to manufacture Products, and (iii) a non-exclusive
license in all countries outside the Territory, with the right to
grant sub-licenses, to research, develop and manufacture (but not
commercialize) the Products.
Pursuant to the terms of the License Agreement,
and subject to the conditions set forth therein, AMAG is required
to make the following payments to the Company: (i) $60 million as a
one-time initial research payment within five days following the
date of the closing of the transactions contemplated by the License
Agreement (the “Effective
Date”), and (ii) up to an
aggregate amount of $25 million to reimburse the Company for all
reasonable, documented, out-of-pocket expenses incurred by the
Company following the Effective Date, in connection with the
development and regulatory activities necessary to file a new drug
application (“NDA”) for a Product for HSDD in the United
States.
In
addition, pursuant to the terms of the License Agreement, Palatin
will be eligible to receive from AMAG: (i) up to $80 million
in specified regulatory and development payments upon achievement
of certain development and regulatory milestones, and (ii) up to
$300 million in sales milestone payments based on achievement of
annual net sales amounts for all Products in the
Territory.
AMAG is also obligated to pay Palatin tiered
royalties on annual net sales of Products on a product-by-product
basis, in the Territory ranging from the high-single digits to the
low double-digits. The royalties will expire on a
product-by-product and
country-by-country basis until the latest to occur of
(i) the earliest date
on which there are no valid claims of Palatin patent rights
covering such Product in such
country, (ii) the expiration of
the regulatory exclusivity period for such Product in
such country and (iii) ten years
following the first commercial sale of such Product in such
country. Such royalties are subject to reductions in the event
that: (a) AMAG must license additional third party
intellectual property in order to develop, manufacture or
commercialize a Product, or (b) generic competition occurs with
respect to a Product in a given country, subject to an aggregate
cap on such deductions of royalties otherwise payable to Palatin.
After the expiration of the applicable royalties for any Product in
a given country, the license for such product in such country shall
become a fully paid-up, royalty-free, perpetual and irrevocable
license.
The closing of the transactions contemplated by
the License Agreement is subject to customary conditions,
including, if required, Palatin’s delivery of the required
financial statements to be filed by AMAG with the U.S. Securities
and Exchange Commission (“SEC”) pursuant to Rule 3-05 of Regulation
S-X.
The
Company and AMAG have made customary representations and warranties
and have agreed to certain customary covenants, including
confidentiality and indemnification.
The License Agreement expires on the date of
expiration of all royalty obligations due thereunder unless earlier
terminated in accordance with the agreement. If any of the closing
conditions have not been met within 120 days of the date of signing
of the License Agreement AMAG has the right to terminate the
License Agreement upon ten days’ written notice to Palatin.
In addition, AMAG has the right to terminate the License Agreement
without cause, in its entirety or on a product-by-product and
country-by-country basis, upon at least 180 days’ prior
written notice to Palatin. Either party may terminate the License
Agreement for cause if the other party materially breaches or
defaults in the performance of its obligations, and, if
curable, such
material breach remains uncured for 90 days.
2
The
foregoing is only a summary of the material terms of the License
Agreement and does not purport to be a complete description of the
rights and obligations of the parties under such agreement. The
foregoing summary is qualified in its entirety by reference to the
available text of the License Agreement, a redacted copy of which
the Company expects to file as an exhibit to its Quarterly Report
on Form 10-Q for the quarter ended March 31, 2017.
On
January 9, 2017, the Company issued a press release relating to the
matters set forth above. A copy of the press release is filed with
this Form 8-K and is attached hereto as Exhibit 99.1.
Item 9.01. Financial Statements and Exhibits.
(d)
Exhibits
99.1
Press release, dated January 9, 2017.
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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 hereunto duly authorized.
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PALATIN TECHNOLOGIES, INC.
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Date: January 9, 2017
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By:
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/s/ Stephen T.
Wills
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Stephen T. Wills, CPA, MST
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Executive Vice President, Chief Financial
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Officer
and Chief Operating Officer
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4
EXHIBIT INDEX
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Exhibit No.
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Description
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99.1
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Press
release, dated January 9, 2017.
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