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): September 29, 2020
Palatin Technologies, Inc.
(Exact
name of registrant as specified in its charter)
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
Not Applicable
(Former
name or former address, if changed since last report.)
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 (see General Instruction A.2.
below):
[ ]
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))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of Each Class
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Trading
Symbol
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Name of
Each Exchange
on
Which Registered
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Common Stock, par value $.01 per share
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PTN
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NYSE American
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Indicate
by check mark whether the registrant is an emerging growth company
as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of
1934 (§240.12b-2 of this chapter). Emerging growth
company ☐
If an
emerging growth company, indicate by checkmark if the registrant
has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act. ☐
Item
1.01
Entry
into a Material Definitive Agreement.
Entry into Catalent Agreement
As
previously disclosed, on June 20, 2016, Palatin Technologies, Inc.
(“Palatin”)
entered into a Commercial Supply Agreement (the “Catalent Agreement” or the
“Prior Catalent
Agreement”) with Catalent Belgium S.A.
(“Catalent”), a
subsidiary of Catalent Pharma Solutions, Inc., with an effective
date of June 10, 2016, pursuant to which Catalent agreed to
provide manufacturing and supply services to Palatin related to
production of Vyleesi® (the trade name for
bremelanotide).
AMAG License; Assignment of Catalent Agreement to AMAG
As
previously disclosed, the Catalent Agreement was subsequently
assigned to AMAG Pharmaceuticals, Inc. (“AMAG”) pursuant to a License
Agreement by and between Palatin and AMAG, dated January 8, 2017
(the “AMAG Licensee
Agreement”). Pursuant to the AMAG License Agreement,
AMAG acquired the exclusive rights to commercialize Vyleesi in
North America.
Termination of AMAG License; Assignment of Catalent Agreement to
Palatin
As
previously disclosed, effective July 24, 2020, Palatin entered into
a termination agreement (the “AMAG License Termination
Agreement”) with AMAG, thereby terminating the AMAG
License Agreement. In connection with the AMAG License Termination
Agreement, the Catalent Agreement was assigned to
Palatin.
Termination of Catalent Agreement
In
planning for Palatin’s future manufacturing needs, Palatin
and Catalent decided to terminate the Catalent Agreement and enter
into a replacement agreement with certain modified terms, including
a reduction in the minimum annual purchase requirements and
modification of other financial terms. In consideration for a
one-time payment of Six Million Euros (€6,000,000), Palatin
and Catalent have terminated the Catalent Agreement by mutual
agreement, in accordance with the terms and conditions set forth in
the Termination and Release Agreement, dated September 29, 2020
(the “Termination
Agreement”).
Entry into New Catalent Agreement
In
connection with the termination of the Prior Catalent Agreement,
Palatin entered into a new Commercial Supply Agreement, dated as of
September 29, 2020, between Palatin and Catalent (the
“New Catalent
Agreement” or the “Agreement”). Like the Prior
Catalent Agreement, the New Catalent Agreement provides that
Catalent will provide manufacturing and supply services to Palatin
related to production of Vyleesi, including that Catalent will
supply specified minimums of Palatin’s requirements for
Vyleesi during the term of the Agreement.
The
initial term of the Agreement will continue until August 20, 2025.
The initial term of the Agreement will be automatically extended
for one 24-month period unless either party notifies the other of
its desire to terminate as of the end of the initial term as
outlined in the Agreement.
The
Agreement also includes customary terms and conditions relating to
forecasting and minimum commitments, ordering, delivery, inspection
and acceptance, and termination, among other matters.
The
foregoing description of the terms of the Termination Agreement and
the New Catalent Agreement are qualified in their entirety by the
full text of the Termination Agreement and the New Catalent
Agreement, which Palatin expects to file as exhibits to a future
periodic report.
Item
1.02
Termination
of a Material Definitive Agreement.
The
description under the heading “Termination of Catalent
Agreement” set forth in Item 1.01 above is incorporated by
reference in this Item 1.02.
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:
October 2, 2020
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By:
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/s/
Stephen T. Wills
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Stephen
T. Wills, CPA, MST
Executive
Vice President, Chief Financial Officer and Chief Operating
Officer
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