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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): December 23, 2024
Marinus
Pharmaceuticals, Inc.
(Exact name of registrant as specified
in its charter)
Delaware |
001-36576 |
20-0198082 |
(State
or other jurisdiction of
incorporation) |
(Commission File Number) |
(IRS
Employer Identification
No.) |
5 Radnor Corporate Center, Suite 500
100
Matsonford Rd, Radnor, PA |
19087 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s
telephone number, including area code: (484) 801-4670
__________________________________________________________________
(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:
¨ |
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 |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.001 |
MRNS |
Nasdaq Global Market |
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 check mark 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.
On December 23, 2024
(the “Termination Effective Date”), Marinus Pharmaceuticals, Inc. (the “Company”) and Orion Corporation (“Orion”)
entered into a Termination and Release Agreement (the “Termination Agreement”) to terminate, as of the Termination Effective
Date, (i) that certain Collaboration Agreement by and between Orion and the Company, dated as of July 30, 2021 (the “Collaboration
Agreement”); (ii) that certain Manufacturing and Supply Agreement by and between Orion and the Company, dated as of October 24,
2022 (the “Supply Agreement”); and (iii) a number of ancillary agreements related to the Collaboration Agreement and
the Supply Agreement. The Termination Agreement also provided a mutual release of claims. The Termination Agreement was entered into in
connection with the Company’s review of its strategic alternatives.
Under
the terms of the Termination Agreement, Orion is not required to pay to the Company the five hundred thousand Euros
(€500,000) development costs payment associated with the
Collaboration Agreement which would otherwise have been due for the fourth quarter of 2024 under the Collaboration Agreement. In
addition, the Company will pay to Orion one million five hundred thousand Euros (€1,500,000)
within ten (10) business days after the first to occur of (i) the closing of a transaction between the Company and a third
party transferring or selling all or substantially all of the Company’s assets or business that relate to a
biopharmaceutical product which incorporates ganaxolone as the sole active ingredient or in combination with one or more other
active ingredients (in the same formulation) for any of the indications for which Orion was granted commercialization rights
pursuant to the Collaboration Agreement; or (ii) the Company’s merger or consolidation or similar transaction
constituting a change of control of the Company; or (iii) June 30, 2025.
The
foregoing description of the Termination Agreement does not purport to be
complete and is qualified in its entirety by reference to the Termination Agreement, a copy of which is filed as Exhibit 10.1 to
this Current Report on Form 8-K and is incorporated by reference into this Item 1.01.
Item
1.02. Termination of a Material Definitive Agreement.
The information regarding the termination of the
Collaboration Agreement included under Item 1.01 of this Current Report on Form 8-K is incorporated by reference into this Item 1.02.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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.
|
MARINUS PHARMACEUTICALS, INC. |
|
|
Date: December 30, 2024 |
/s/ Steven Pfanstiel |
|
Steven Pfanstiel |
|
Chief Operating Officer, Chief Financial Officer and Treasurer |
Exhibit 10.1
EXECUTION
VERSION
TERMINATION AND RELEASE AGREEMENT
THIS
TERMINATION AND RELEASE AGREEMENT (“Agreement”) is made and entered into on this 23rd day of December, 2024 (the
“Termination Effective Date”) by and between Orion Corporation
("Orion"), a corporation incorporated and existing under the laws of Finland, business identity code 1999212-6 (“Licensee”),
having a principal place of business at Orionintie 1, 02200 Espoo, Finland,
and Marinus Pharmaceuticals, Inc. (“Marinus”), a Delaware corporation with an office address at 5 Radnor Corporate
Center, Suite 500, 100 Matsonford Road, Radnor, PA 19087 USA. Marinus and Licensee are referred to in this Agreement individually
as a “Party” and collectively as the “Parties”.
Background
A. Orion
and Marinus entered into a Collaboration Agreement entered into as of July 30, 2021 (the “Collaboration Agreement”),
a Manufacturing and Supply Agreement entered into as of October 24, 2022 (the Supply Agreement”), and a number of ancillary
agreements related to the Collaboration Agreement and the Supply Agreement, including without limitation a Data Protection Agreement
entered into as of January 26, 2022, a Cooperation and Support Agreement for Individual Patient Expanded Access of Investigational
Drug entered into as of July 12, 2022, a Safety Data Exchange Agreement, as amended, entered into as of September 14, 2023
and a Quality Agreement entered into as of April 25, 2023 (previous version July 13, 2022) (collectively, the “Ancillary
Agreements”). Capitalized terms used but not defined in this Agreement shall have the respective meaning assigned to them in the
Collaboration Agreement, the Supply Agreement or the Ancillary Agreements, as applicable.
B. The
Parties desire to terminate the Collaboration Agreement, the Supply Agreement and the Ancillary Agreements on the terms and conditions
set forth in this Agreement that is made in reference to the Collaboration Agreement.
NOW, THEREFORE, in consideration of the mutual
covenants and obligations set forth below, and intending to be legally bound, the Parties agree as follows:
1. Termination
1.1. Termination
of Agreements. Orion and Marinus (each for itself and all of its Affiliates) hereby agree that the Collaboration Agreement,
the Supply Agreement and each of the Ancillary Agreements is terminated effective as of the Termination Effective Date.
1.2 Effect
of Termination. Orion and Marinus (each for itself and all of its Affiliates) hereby agree that the
termination of the Collaboration Agreement, the Supply Agreement and the Ancillary Agreements shall (i) not affect any rights or
obligations of either Party to the extent that such obligations or rights have accrued or matured prior to the Termination Effective
Date, (ii) post-termination obligations, including cooperation for wind down and transition activities shall be in accordance with
the applicable provisions as set forth in each of the terminated agreements, and (iii) survival of specific provisions of each terminated
agreement shall be governed by the terms set forth in that agreement.
1.3 Research
and Development Reimbursement. In consideration of entering into this Agreement, Marinus agrees that Orion shall not be required
to pay to Marinus the Development Costs for the fourth (4th) Calendar Quarter of 2024 that would otherwise be required pursuant
to Section 4.5 of the Collaboration Agreement.
EXECUTION VERSION
1.4 Termination
Payment. In consideration of the termination of the Collaboration Agreement, the Supply Agreement and the Ancillary Agreements, Marinus
shall pay to Orion, the amount of one million five hundred thousand Euros (€1,500,000 )
(“Termination Payment”), to be paid within ten Business Days after the first to occur of (i) closing of a transaction
between Marinus and a Third Party transferring or selling all or substantially all of Marinus’ assets or business that relate
to a biopharmaceutical product which incorporates Ganaxolone as sole Active Ingredient or in combination with one or more other Active
Ingredients (in the same formulation) for any of the Indications for which Orion is granted Commercialization rights pursuant to Article 4
of the Collaboration Agreement or (ii) Marinus’ merger or consolidation or similar transaction constituting a Change of Control
of Marinus or (iii) 30 June 2025.
1.5 Purchase
Orders of Licensed Product. The Parties agree that all purchase orders of Licensed Product placed by Orion prior to the Termination
Effective Date are hereby cancelled.
2. Mutual
Release.
2.1. Each
Party, for itself and its Affiliates, their respective successors and assigns, and the directors, officers, employees, shareholders,
members, partners and other equity owners and holders and representatives of each of the foregoing (collectively, the “Releasors”),
does hereby remise, release and forever discharge the other Party, the Affiliates of such other Party, their respective successors and
assigns, and the directors, officers, employees, shareholders, members, partners and other equity owners and holders and representatives
of each of the foregoing (collectively, the “Releasees”), of and from any and all causes of action, actions, suits, damages,
losses, liabilities, costs, expenses, fees, invoices, accounts receivable, interest, indebtedness, obligations, liens, claims and demands
of whatever kind, known or unknown, foreseeable or unforeseeable, liquidated or unliquidated, in law or in equity, which the Releasors
ever had, now have or hereafter can, shall or may have against the Releasees, for, by reason of, or arising out of, any performance,
breach or alleged breach of the Collaboration Agreement, the Supply Agreement or the Ancillary Agreements to and including the Termination
Effective Date; provided, however, that this release does not, and shall not be construed to, apply to any Surviving Claims (defined
below).
2.2. As
used herein, the term “Surviving Claims” means any causes of action, actions, suits, damages, losses, liabilities, costs,
expenses, fees, invoices, accounts receivable, interest, indebtedness, obligations, liens, claims and demands arising out of: any of
the provisions of the Collaboration Agreement, the Supply Agreement or any of the Ancillary Agreements which survive the termination
of the Collaboration Agreement, the Supply Agreement or any of the Ancillary Agreements and the execution of this Agreement, including,
without limitation, arising out of any breach of, or any other failure to observe or perform, any of such surviving provisions thereof,
but only with respect to such breaches or failures that occur after the Termination Effective Date of this Agreement.
EXECUTION VERSION
2.3. Each
Party, for itself and its other Releasors, represents and warrants that no Releasor has assigned or transferred, or purported to assign
or transfer, voluntarily, involuntarily, or by operation of law, any claim herein released or any part or portion thereof.
2.4. Each
Party, for itself and its other Releasors, covenants and agrees never to commence, prosecute, or cause, permit, or advise to be commenced
or prosecuted on behalf of any of the Releasors, any action, suit or proceeding based upon any claim or other matter herein released or
any part or portion thereof.
3. No
Disparagement. Each Party agrees, for itself, its Affiliates, and its and their respective successors and assigns, and the directors,
officers, employees, shareholders, members, partners and other equity owners and holders within such Party’s control and representatives
of each of the foregoing, not to make any statements or comments of a disparaging nature to Third Parties (including any of their customers)
regarding the other Party, any Affiliates of the other Party, any of their respective successors or assigns, any director, officer or
employee of any of the foregoing, any current or planned product or service of any of the foregoing, or any prospects, condition or conduct
of any of the foregoing.
4. General
Provisions.
4.1. Amendments.
This Agreement may only be amended by a writing specifically referencing this Agreement, which has been signed by authorized representatives
of each Party.
4.2. Binding
Effect. This Agreement will be binding upon and inure to the benefit of the Parties hereto and their respective successors
and assigns.
4.3. Governing
Law and Dispute Resolution. This Agreement is made in reference to the Collaboration Agreement and therefore Section 14.4
(Governing Law; English Language) and Section 14.5 (Dispute Resolution) of the Collaboration Agreement shall apply to this Agreement.
4.4. Entire
Agreement. This Agreement, and the certain provisions of the Collaboration Agreement, the Supply Agreement and the Ancillary
Agreements that survive termination set forth the entire agreement and understandings between the Parties hereto with respect to the subject
matter hereof.
4.5. Further
Assurances. Orion and Marinus hereby covenant and agree, without the necessity of any further consideration, to execute, acknowledge
and deliver any and all documents and take any action as may be reasonably necessary to carry out the intent and purposes of this
Agreement. Orion acknowledges that Orion shall take all such actions as contemplated in the Collaboration Agreement, the Supply Agreement
and the Ancillary Agreements to effect an orderly termination of the foregoing agreements to effect the termination and transition of
the rights back to Marinus or to a third party as requested by Marinus.
4.6. Waivers.
An effective waiver under this Agreement must be in writing signed by the Party waiving its right. The failure of either Party to require
performance by the other Party of any provision hereof shall not affect the full right to require such performance at any time thereafter;
nor shall the waiver by either Party of a breach of any provision hereof be taken or held to be a waiver of subsequent breaches of that
or any other provision hereof.
EXECUTION VERSION
4.7. Severability.
If in any jurisdiction any one or more of the provisions of this Agreement should be for any reason be held by any court or
authority having jurisdiction over this Agreement or any of the Parties hereto to be invalid, illegal or unenforceable, such provision
or provisions shall be validly reformed so as to nearly approximate the intent of the Parties as possible and if not reformable, the Parties
shall meet to discuss what steps should be taken to remedy the situation; in other jurisdictions, this Agreement shall not be affected.
4.8. Notices.
All notices, consents or waivers under this Agreement shall be in writing and will be deemed to have been duly given when (a) scanned
and converted into a portable document format file (i.e., pdf file) and sent as an attachment to an e-mail message (and promptly confirmed
by registered letter or overnight courier by an internationally recognized overnight delivery service (receipt requested)), or (b) the
earlier of when received by the addressee or five (5) days after it was sent, if sent by registered letter or overnight courier by
an internationally recognized overnight delivery service (receipt requested), in each case to the appropriate addresses and e-mail addresses
set forth below (or to such other addresses and e-mail addresses as a Party may designate by notice):
If to Marinus: Marinus Pharmaceuticals, Inc.
5 Radnor Corporate Center,
100 Matsonford Road, Suite 500
Radnor, PA 19087
Attention: Martha Manning, Esq.
Tel: (610) 639-6174
with a copy to (which shall not constitute
notice):
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia, PA 19103
Attention: Steve J. Abrams
Tel: (267) 675-4642
If to Orion: Orion
Corporation
Orionintie 1,
02200 Espoo,
Finland
Attn: Senior Vice President, Branded
Products
Tel: +358 10 426
1
with a copy to (which shall not constitute notice):
Orion Corporation Legal Affairs
Orionintie 1,
02200 Espoo, Finland
Attn: Head of
Legal Affairs
Tel: +358 10 426
1
EXECUTION
VERSION
4.9. Counterparts.
This Agreement may be executed in one or more counterparts, including without limitation electronic or facsimile, each of which shall
be deemed an original and all of which together shall constitute one and the same instrument. This Agreement shall become binding when
any one or more counterparts hereof, individually or taken together, bear the signatures of both Parties hereto.
4.10. Headings.
The section headings appearing in this Agreement are inserted only as a matter of convenience and are to be of no force or effect in construing
and interpreting the provisions of this Agreement.
4.11. Relationship
of the Parties. The Parties are independent contractors under this Agreement. Nothing herein contained shall be deemed to create
or establish an employment, agency, joint venture, or partnership relationship between the Parties, or any other legal arrangement that
would impose liability upon one Party for the act or failure to act of the other Party. Neither Party shall have any express or implied
power to enter into any contracts, commitments or negotiations or to incur any liabilities in the name of, or on behalf of, the other
Party, or to bind the other Party in any respect whatsoever.
IN WITNESS WHEREOF, the Parties have caused this
Agreement to be duly executed and delivered by their proper and duly authorized officers as of the day and year first written above.
|
MARINUS PHARMACEUTICALS, INC. |
|
|
|
By: |
/s/ Steven Pfanstiel |
|
Name: |
Steven Pfanstiel |
|
Title: |
Chief Financial Officer |
|
|
|
ORION CORPORATION |
|
|
|
By: |
/s/ Liisa Hurme |
|
Name: |
Liisa Hurme |
|
Title: |
SVP Global Operations |
|
|
|
By: |
/s/ Outi Vaarala |
|
Name: |
Outi Vaarala |
|
Title: |
SVP R&D |
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