Attached files
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| EX-99.1 - PRESS RELEASE - PALATIN TECHNOLOGIES INC | ptn_ex991.htm |
| EX-10.1 - TERMINATION AGREEMENT - PALATIN TECHNOLOGIES INC | ptn_ex101.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): July 24, 2020
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
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:
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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.
As
disclosed in Item 1.02, incorporated into this Item 1.01, effective
July 24, 2020, Palatin Technologies, Inc. (“Palatin”)
entered into a Termination Agreement (the “Termination
Agreement”) with AMAG Pharmaceuticals, Inc.
(“AMAG”). Pursuant to the Termination Agreement,
Palatin will assume Vyleesi® (bremelanotide injection)
manufacturing contracts with Catalent Belgium S.A.
(“Catalent”), a subsidiary of Catalent Pharma
Solutions, Inc., to manufacture drug product and prefilled syringes
and assemble prefilled syringes into an auto-injector device (the
“Catalent Agreement”), Ypsomed AG
(“Ypsomed”), to manufacture the auto-injector device
(the “Ypsomed Agreement”), and Lonza Ltd.
(“Lonza”), to manufacture the active pharmaceutical
ingredient peptide (the “Lonza
Agreement”).
Palatin
originally entered into the Catalent Agreement on June 20, 2016,
and subsequently assigned the Catalent Agreement to AMAG pursuant
to a License Agreement by and between Palatin and AMAG, dated
January 8, 2017. Upon entering into the Termination Agreement, the
Catalent Agreement is being assigned to Palatin. The initial term
of the Catalent Agreement is for five years after August 21, 2019,
the date that is 60 days from the date on which the Food and Drug
Administration gave market regulatory approval to Vyleesi, unless
earlier terminated in accordance with the terms of the Catalent
Agreement. The initial term of the Catalent 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 Catalent Agreement. The Catalent
Agreement may be terminated immediately by either party if the
other party files a petition in bankruptcy, enters into an
agreement with its creditors or takes similar action, or if the
other party materially breaches any of the provisions of the
Catalent Agreement and such breach is not cured within the period
outlined in the Catalent Agreement. Palatin may terminate the
Catalent Agreement if Catalent fails to supply products in
accordance with the Catalent Agreement, or if Palatin provides
notice and pays a termination penalty. There are specified minimum
purchase requirements under the Catalent Agreement, and under
specified circumstances, termination fees may be payable upon
termination of the Catalent Agreement by Palatin.
AMAG
entered into the Lonza Agreement on June 1, 2018, and upon Palatin
and AMAG entering into the Termination Agreement, the Lonza
Agreement is being assigned to Palatin. The term of the Lonza
Agreement is through December 31, 2022. The Lonza Agreement may be
terminated if the other party materially breaches any provisions of
the Lonza Agreement and such breach is not cured within the period
outlined in the Lonza Agreement, by Palatin if Palatin is required
to withdraw the defined product from the market, or by either
party, if the other party becomes insolvent, is dissolved, files a
petition in bankruptcy or takes similar action. There are specified
minimum purchase requirements under the Lonza Agreement, and under
specified circumstances, termination fees may be payable upon
termination of the Lonza Agreement by Palatin.
AMAG
entered into the Ypsomed Agreement on December 20, 2018, and upon
Palatin and AMAG entering into the Termination Agreement, the
Ypsomed Agreement is being assigned to Palatin. The initial term of
the Ypsomed Agreement is through December 31, 2025, with automatic
renewal for successive one-year periods unless either party
terminates the Ypsomed Agreement by ten months’ written
notice prior to the expiration of the Ypsomed Agreement or any
automatic renewal period. The Ypsomed Agreement may be terminated
if the other party materially breaches any provisions of the
Ypsomed Agreement and such breach is not cured within the period
outlined in the Ypsomed Agreement, by Palatin if Palatin is
required to withdraw the defined product from the market, or by
either party, if there is a change of control of the other party or
the other party becomes insolvent, is dissolved, files a petition
in bankruptcy or takes similar action. There are specified minimum
purchase requirements under the Ypsomed Agreement, and under
specified circumstances, termination fees may be payable upon
termination of the Lonza Agreement by Palatin.
The
foregoing is only a summary of the material terms of the Catalent
Agreement, the Ypsomed Agreement and the Lonza Agreement, does not
purport to be a complete description of the rights and obligations
of the parties under the agreements, and is qualified in its
entirety by reference to each agreement. Palatin expects to file
the Catalent Agreement, the Ypsomed Agreement and the Lonza
Agreement as exhibits to its Annual Report on Form 10-K for the
fiscal year ending June 30, 2020.
Item 1.02 Termination of a Material Definitive
Agreement.
Palatin
previously disclosed that AMAG planned to divest certain of its
women’s healthcare products, including Vyleesi®, which it exclusively licensed from
Palatin for North America. In connection with AMAG’s
divestiture, to protect its rights as the Vyleesi licensor and the
value of the Vyleesi program, Palatin entered into the Termination
Agreement with AMAG.
The
Termination Agreement terminates, effective July 24, 2020, the
License Agreement by and between Palatin and AMAG, dated January 8,
2017, relating to North American marketing of Vyleesi
(bremelanotide injection) for the treatment of hypoactive sexual
desire disorder in premenopausal women.
Under
the Termination Agreement, Palatin regains all North American
development and commercialization rights for Vyleesi. AMAG will
make a $12 million payment to Palatin at closing and a $4.3 million
payment to Palatin on March 31, 2021. Palatin will assume all
Vyleesi manufacturing agreements, and AMAG will transfer to Palatin
all information, data, and assets related exclusively to Vyleesi,
including existing inventory. AMAG will provide certain
transitional services to Palatin for a period of time to ensure
continued patient access to Vyleesi during the transition to
Palatin. Palatin will reimburse AMAG for the costs of the
transition services.
The
foregoing summary is qualified in its entirety by the full text of
the License Agreement by and between Palatin and AMAG, which was
filed as Exhibit 10.1 to Palatin’s Quarterly Report on Form
10-Q filed on February 10, 1017, and to the Termination Agreement,
which is filed as Exhibit 10.1 to this Report on Form 8-K, and both
are incorporated by reference herein.
Item 8.01 Other Events.
On July
27, 2020, Palatin issued a press release disclosing the mutual
termination of the license agreement with AMAG for Vyleesi and
announcing a teleconference and webcast to be held July 27, 2020 at
8:30 a.m. Eastern time, which will include a discussion on
Palatin’s Vyleesi program. We have attached a copy of the
press release as Exhibit 99.1 to this report and it is incorporated
by reference herein.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits:
10.1*
Termination
Agreement between Palatin Technologies, Inc. and AMAG
Pharmaceuticals, Inc., dated July 24, 2020
99.1 Press Release, dated July 27,
2020
*
Confidential
portions of this exhibit were redacted pursuant to Item 601(b)(10)
of Regulation S-K and Palatin Technologies, Inc. agrees to furnish
supplementally to the U.S. Securities and Exchange Commission a
copy of any omitted schedule and/or exhibit upon request. The
confidential portions of this exhibit were omitted by means of
marking such portions with asterisks because the identified
confidential portions (i) are not material and (ii) would be
competitively harmful if publicly disclosed.
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:
July 27, 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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EXHIBIT INDEX
10.1*
Termination
Agreement between Palatin Technologies, Inc. and AMAG
Pharmaceuticals, Inc., dated July 24, 2020
Press Release,
dated July 27, 2020
*
Confidential
portions of this exhibit were redacted pursuant to Item 601(b)(10)
of Regulation S-K and Palatin Technologies, Inc. agrees to furnish
supplementally to the U.S. Securities and Exchange Commission a
copy of any omitted schedule and/or exhibit upon request. The
confidential portions of this exhibit were omitted by means of
marking such portions with asterisks because the identified
confidential portions (i) are not material and (ii) would be
competitively harmful if publicly disclosed.