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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): January 18, 2022

 

Petros Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

  

Delaware

(State or other
jurisdiction of
incorporation)

001-39752

(Commission
File Number)

85-1410058

(I.R.S. Employer

Identification No.)

 

1185 Avenue of the Americas, 3rd Floor

New York, New York 10036
(Address of principal executive offices)    (Zip code)

 

(973) 242-0005
(Registrant's telephone number, including area code)

 

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:

 

¨ 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 $0.0001 per share PTPI The Nasdaq Stock Market LLC

 

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 x

 

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.

 

Settlement Agreement

 

On January 18, 2022, Metuchen Pharmaceuticals LLC (“Metuchen”), a wholly owned subsidiary of Petros Pharmaceuticals, Inc. (the “Company”), and VIVUS LLC, a Delaware limited liability company and formerly VIVUS, Inc. (“VIVUS”) entered into a Settlement Agreement (the “Settlement Agreement”) relating to the settlement of certain previously disclosed disputes between VIVUS and Metuchen that arose in connection with the performance of the Commercial Supply Agreement, dated September 30, 2016 (the “Supply Agreement”), which was later terminated effective September 30, 2021, related to the minimum purchase requirements under the Supply Agreement in 2018, 2019 and 2020 and certain reimbursement rights asserted by a third-party retailer in connection with quantities of the Company’s Stendra® product that were delivered to the third-party retailer and later returned.

 

In connection with the Settlement Agreement, Metuchen retains approximately $7.3 million of active pharmaceutical ingredient (“API”) inventory (which represents the 2018 and 2019 minimum purchase requirements mentioned above) in conjunction with forgiveness of $9,622,430 of current liabilities relating to returned goods and minimum purchase commitments. The API retained is sole sourced from VIVUS and is estimated to provide adequate supply for the foreseeable future. In exchange for the API and reduction of current liabilities, Metuchen has agreed to execute an interest-bearing promissory note (the “Note”) in favor of VIVUS in the principal amount of $10,201,758.04. The parties have also agreed to enter into a Security Agreement (the “Security Agreement”) to secure the obligations of Metuchen under the Note.

 

Metuchen and VIVUS are parties to the License and Commercialization Agreement dated as of September 30, 2016 (the “Original License Agreement”). Pursuant to the Settlement Agreement, the parties also executed an Amendment No. 1 to the Original License Agreement (the “Amendment” and, together with the Original License Agreement, the “License Agreement”). The Amendment provides that VIVUS shall retain its co-exclusive right along with the Company to develop, manufacture, commercialize and otherwise exploit the Stendra® product in the territory covered by the License Agreement, provided that VIVUS shall not exercise such right unless an Event of Default occurs under the Settlement Agreement, the Note, or the Security Agreement. The Amendment further provides that, upon such an Event of Default, the License Agreement will terminate and VIVUS will have the right to use all regulatory documentation and submissions of Metuchen and other rights as may be necessary for VIVUS to exercise its right to exploit the Stendra® product. The Amendment also acknowledges that Metuchen has assigned its rights under the License Agreement to VIVUS as a “financing entity” and provides that such rights may be assigned in certain circumstances.

 

In addition to the payments to be made in accordance with the Note, Metuchen further agreed in the Settlement Agreement to (i) grant to VIVUS a right of first refusal to provide certain types of debt and convertible equity (but not preferred equity) financing issued by or to Metuchen (including any subsidiaries and intermediaries) until the Note is paid in full, and (ii) undertake to make certain regulatory submissions to effectuate VIVUS’ ability to exercise its rights under the License Agreement. Upon Metuchen’s satisfaction of certain regulatory submissions and making a prepayment of the obligations under the Note in the amount of $900,000 and a payment of $1,542,904 with respect to the purchase order made in 2021 to VIVUS, VIVUS agreed to release 50% of the quantity of bulk Stendra® tablets under Metuchen’s existing open purchase order (the “Open Purchase Order”) being held by VIVUS, which represents approximately a six month supply of inventory. VIVUS also agreed to release the remaining 50% of the quantity of bulk Stendra® tablets under the Open Purchase Order upon Metuchen’s satisfaction of the remaining regulatory submission requirements (not to exceed 180 days from the date of the Settlement Agreement). The Settlement Agreement stipulated that VIVUS is the sole owner of all active pharmaceutical ingredient (API) unless or until such time as certain quantities of API are shipped to Metuchen upon the fulfillment of the aforementioned payment conditions.

 

Promissory Note and the Security Agreement

 

Under the terms of the Note, the principal amount of $10,201,758.04 is payable in consecutive quarterly installments beginning on April 1, 2022 through January 1, 2027, on the dates and in the respective amounts set forth in Schedule A to the Note. Interest on the principal amount will accrue at a rate of 6% per year until the principal is repaid in full and is due and payable, in arrears, on the first day of each January, April, July, and October of each calendar year, commencing on April 1, 2022.

 

 

 

 

Under the terms of the Note, Metuchen may prepay the Note, in whole or in part, at any time, with no premium or penalty. In the event that Metuchen defaults under the Security Agreement, all principal outstanding under the Note at the time of the default will bear interest at a rate of 9% per year until the full and final payment of all principal and interest under the Note (regardless of whether any default is waived or cured). If the Note is placed in the hands of any attorney for collection, or if it is collected through any legal proceeding at law or in equity or in bankruptcy, receivership, or other court proceedings, Metuchen will also be required to pay all costs of collection including, but not limited to, court costs and attorneys’ fees.

 

Pursuant to the Security Agreement, dated January 18, 2022, Metuchen granted to VIVUS a continuing security interest in all of its Stendra® API and products and its rights under the License Agreement. The Security Agreement contains customary events of default.

 

The description of terms of the Settlement Agreement, the Note, the Security Agreement, and the Amendment set forth herein do not purport to be complete and are qualified in their entirety by the full text of the such documents, which are attached hereto as Exhibits 10.1, 10.2, 10.3 and 10.4, respectively, and incorporated herein by reference.

 

Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant.

 

The information contained in Item 1.01 of this Current Report on Form 8-K in relation to the entry into the Settlement Agreement, the Note, and the Security Agreement is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

See the Exhibit Index below, which is incorporated by reference herein.

 

EXHIBIT INDEX

 

Exhibit Description
10.1 *† Settlement Agreement, dated January 18, 2022, between Metuchen Pharmaceuticals LLC and VIVUS LLC, a Delaware limited liability company
10.2 * Promissory Note, dated January 18, 2022, by Metuchen Pharmaceuticals LLC in favor or VIVUS LLC, a Delaware limited liability company
10.3 Security Agreement, dated January 18, 2022, between Metuchen Pharmaceuticals LLC and VIVUS LLC, a Delaware limited liability company
10.4 † Amendment No. 1 to License and Commercialization Agreement, dated January 18, 2022, between Metuchen Pharmaceuticals LLC and VIVUS LLC, a Delaware limited liability company
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

* The exhibits to this Agreement have been omitted pursuant to Item 601(a)(5) of Regulation S-K. A copy of any omitted schedule and/or exhibit will be furnished to the SEC upon request.

 

† Certain portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The omitted information is (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed. The Company agrees to furnish supplementally an unredacted copy of the exhibit to the SEC upon its request.

 

 

 

 

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.

 

    PETROS PHARMACEUTICALS, INC.
     
Date: January 21, 2022 By: /s/ Fady Boctor
    Name: Fady Boctor
    Title: President and Chief Commercial Officer

 

 

 

Exhibit 10.1

 

PLEASE NOTE: CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

 

SETTLEMENT AGREEMENT

 

This SETTLEMENT AGREEMENT, dated as of January 18, 2022, (this “Agreement”) is entered into by and between METUCHEN PHARMACEUTICALS LLC, a Delaware limited liability company (the “Metuchen”) and VIVUS LLC, a Delaware limited liability company and formerly VIVUS, Inc. (“VIVUS”). Metuchen and VIVUS are collectively referred to as the “Parties” and each a “Party.”

 

WHEREAS, Metuchen and VIVUS are parties to that certain License and Commercialization Agreement, dated September 30, 2016 (as amended, restated, amended and restated, supplemental or otherwise modified, the “License Agreement”), pursuant to which VIVUS granted to Metuchen an exclusive license in the Territory (as defined below) for, among other things, the development and commercialization of the therapeutic drug known as STENDRA® (avanafil) (“STENDRA”);

 

WHEREAS, Metuchen and VIVUS were parties to that certain Commercial Supply Agreement, dated September 30, 2016 (as amended, restated, amended and restated, supplemental or otherwise modified, the “Supply Agreement”), pursuant to which, among other things, VIVUS supplied to Metuchen, and Metuchen agreed to purchase from VIVUS, the Product (as defined below) in quantities no less than the Minimum Purchase Obligation (as defined in the Supply Agreement);

 

WHEREAS, the Supply Agreement was terminated on September 30, 2021;

 

WHEREAS, Metuchen sells its finished product STENDRA tablets to, and VIVUS sells its finished product of a drug known as QSYMIA® (phentermine/topiramate) (“QSYMIA”) tablets to, the retail chain CVS Pharmacy (“CVS”);

 

WHEREAS, on or about February 2018 and thereafter, CVS [***] deducted monies [***] from its sale of VIVUS’s product QSYMIA in an amount equal to Six Million and Three Hundred Eighty Thousand Three Hundred Forty-Two Dollars and Four Cents ($6,380,342.04) to cover costs owed to CVS by Metuchen for the return of Metuchen’s product STENDRA (the “CVS Principal Amount”);

 

WHEREAS, on December 2, 2020, Metuchen consummated a merger with Neurotrope, Inc., a Nevada corporation, including its acquisition by a new publicly traded parent holding company, Petros Pharmaceuticals, Inc., a Delaware corporation (“Petros”);

 

WHEREAS, on March 3, 2021, Metuchen submitted to VIVUS that certain Purchase Order MT 2021-01 dated March 3, 2021 for the Product (the “2021 Purchase Order”) and has agreed to pay, concurrently with the execution and delivery of this Agreement, One Million Five Hundred Forty-Two Thousand Nine Hundred Four Dollars ($1,542,904), representing the full amount payable for the 2021 Purchase Order;

 

WHEREAS, Metuchen has acknowledged, and hereby reaffirms, that VIVUS is not responsible for the STENDRA products returned by CVS or any costs incurred by CVS in connection with the returned STENDRA products and that Metuchen is obligated to indemnify VIVUS for the total amount of the CVS Principal Amount pursuant to its indemnification obligations under Article 10 of the License Agreement;

 

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WHEREAS, Metuchen also has acknowledged, and hereby reaffirms, that VIVUS is not responsible for Metuchen’s failure to fulfil its Minimum Purchase Obligations under the Supply Agreement and that it owes VIVUS an amount equal to Nine Million Two Hundred Twenty-One Thousand Four Hundred and Sixteen Dollars ($9,221,416) less Two Hundred Fifty Thousand Dollars ($250,000) that Metuchen has paid VIVUS and One Million Dollars ($1,000,000) that VIVUS has reduced the indebtedness by (and in consideration for the execution and performance of this Agreement) (the “Vivus Debt Reduction”) with Seven Million Nine Hundred Seventy-One Thousand Four Hundred and Sixteen Dollars ($7,971,416) remaining payable to VIVUS for Metuchen’s failure to fulfil its Minimum Purchase Obligation under the Supply Agreement for the calendar years 2018 and 2019 (the “MPO Principal Amount” and, together with the CVS Principal Amount, the “Principal Amount”) in addition to (and not deductive of) the CVS Principal Amount;

 

WHEREAS, in order to repay the Principal Amount to VIVUS, the Parties desire to enter into this Agreement and document Metuchen’s obligation to pay such Principal Amount and interest thereon in the form of the promissory note attached hereto as Exhibit A (the “Promissory Note”), which Promissory Note will be secured by certain assets of Metuchen as described and in accordance with the terms of the security agreement attached hereto as Exhibit B (“Security Agreement”);

 

WHEREAS, in furtherance of the payment and security obligations set forth in the Promissory Note and Security Agreement and to ensure Metuchen’s full and prompt performance of its obligations hereunder and under such documents, the Parties desire to enter into the additional agreements set forth in this Agreement, including certain amendments to the License Agreement, agreements concerning regulatory matters relating to VIVUS’ ability to sell and commercialize STENDRA; and

 

WHEREAS, the Parties acknowledge and agree that the Vivus Debt Reduction granted and agreed by Vivus constitutes valid and sufficient consideration for the mutual agreements set forth herein and in the Promissory Note and Security Agreement and other documents attached hereto.

 

NOW THEREFORE, the Parties hereto agree as follows:

 

1.            Definitions.

 

(a)            Definitions of Certain Terms Used Herein. The following terms used herein shall have the following meanings:

 

Affiliate” means, with respect to a Person, any current or future person, firm, trust, corporation, company, partnership, or other entity or combination thereof that directly or indirectly controls, is controlled by or is under common control with such Person. For the purposes of this definition, the word “control” (including, with correlative meaning, the terms “controlled by” or “under the common control with”) means (a) ownership of fifty percent (50%) or more of the voting and equity rights of such person, firm, trust, corporation, company, partnership or other entity or combination thereof, or (b) the power to direct the management of such person, firm, trust, corporation, company, partnership, or other entity or combination thereof.

 

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Applicable Law” means any and all laws, statutes, ordinances, regulations, permits, orders, decrees, judgments, directives, rulings or rules of any kind whatsoever that are promulgated by a federal, state, province, or other Governmental Authority, in each case pertaining to any of the activities contemplated by this Agreement, including any regulations promulgated by any Regulatory Authority in the Territory, all as amended from time to time.

 

Bankruptcy Code” means Title 11 of the United States Code entitled “Bankruptcy,” as amended from time to time, or any successor statute.

 

Business Day” means each day other than a Saturday, Sunday or other day on which commercial banks in New York City are authorized or required by law to remain closed.

 

CVS” has the meaning assigned to such term in the preamble.

 

CVS Principal Amount” has the meaning assigned to such term in the preamble.

 

Confidential Information” means all confidential and proprietary Information of VIVUS or a Group Member that is disclosed to or accessed without breach of the Settlement Documents.

 

Debtor Relief Laws” means the Bankruptcy Code, and all other liquidation, conservatorship, bankruptcy, assignment for the benefit of creditors, moratorium, rearrangement, receivership, insolvency, reorganization, or similar debtor relief laws of the United States or other applicable jurisdictions from time to time in effect.

 

Dollars” or “$” means the lawful money of the United States.

 

Event of Default” has the meaning assigned to such term in the Security Agreement.

 

FDA” means the United States Food and Drug Administration or its successor.

 

Fiscal Year” means the twelve-month period ending on December 31st.

 

Governmental Authority” means any transnational, domestic or foreign federal, provincial, state or local governmental, regulatory or administrative authority (including any Regulatory Authority), department, court, agency or official, including any political subdivision thereof.

 

Group Member” means Petros, and each of its current and future subsidiaries and affiliates, including Metuchen and Metuchen’s current and future subsidiaries and affiliates.

 

License Agreement” has the meaning assigned to such term in the preamble.

 

Settlement Documents” shall mean, collectively, this Agreement, the Promissory Note, the Security Agreement, the License Agreement, and all other documents, instruments, and agreements executed or delivered in connection with, or pursuant to, any of the foregoing, and all exhibits, schedules, annexes, appendices, and other attachments thereto, in each case, as the same may be amended, restated, supplemented, or otherwise modified from time to time.

 

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Material Adverse Effect” means (a) a material adverse effect upon the validity, performance, or enforceability of any of the Settlement Documents or any of the transactions contemplated by any of the Settlement Documents; (b) a material adverse effect upon the properties, operations, business, prospects, or condition (financial or otherwise) of Petros and its subsidiaries, taken as a whole, or on Metuchen or any of its subsidiaries, individually or taken as a whole; (c) a material adverse effect upon the ability of any Group Member to fulfill any obligation under any of the Settlement Documents; or (d) a material adverse effect on the Collateral (as defined in the Security Agreement).

 

Minimum Purchase Obligation” has the meaning assigned to such term in the Supply Agreement.

 

Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

 

Pricing Approval” means the approval, agreement, determination, or governmental decision establishing the price or level of reimbursement for the Product, as required in a given jurisdiction.

 

Product” means formulated tablets containing Compound (as defined in the License Agreement) in bulk form which, if appropriately packaged and labeled would constitute the pharmaceutical product STENDRA, as described in the FDA-approved New Drug Application (as defined in the United States Federal Food, Drug and Cosmetic Act) for such product (as such New Drug Application may be modified in the future in accordance with the Supply Agreement and/or the License Agreement).

 

Promissory Note” has the meaning assigned to such term in the preamble.

 

QSYMIA” has the meaning assigned to such term in the preamble.

 

Regulatory Approval” means all approvals necessary for the manufacture, marketing, importation and sale of the Product for one or more indications in a country or regulatory jurisdiction, which may include satisfaction of all applicable regulatory and notification requirements, but which shall exclude any Pricing Approval.

 

Regulatory Authority” means, in a particular country or regulatory jurisdiction, any applicable Governmental Authority involved in granting Regulatory Approval and/or, to the extent required in such country or regulatory jurisdiction, Pricing Approval, including the FDA in the case of the Territory.

 

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Responsible Officer” means, with respect to any Person, any of the president, chief executive officer, chief financial officer, treasurer, controller, managing director, managing member or general partner of such Person but, in any event, with respect to financial matters, any such officer that is responsible for preparing or reviewing the financial statements delivered hereunder.

 

STENDRA” has the meaning assigned to such term as defined in the preamble.

 

Supply Agreement” has the meaning assigned to such term as defined in the preamble.

 

Territory” means the United States and its territories and possessions, including Puerto Rico and U.S. military bases abroad, Canada, South America and India.

 

Third Party” means any legal person, entity or organization other than Metuchen, VIVUS or an Affiliate of either Party, including any Governmental Authority.

 

VIVUS Exploitation Rights” means VIVUS’ right to Develop, Manufacture, Commercialize (as such terms are defined in the License Agreement) and otherwise exploit STENDRA in the Licensee Territory (as defined in the License Agreement), as to each, without limitation.

 

2.            Promissory Note; Future Financings.

 

(a)            Payment. Metuchen shall repay the entire unpaid Principal Amount then outstanding to VIVUS, together with all accrued and unpaid interest thereon, at the times and in accordance with the terms of the Promissory Note.

 

(b)            Additional Payments. As a condition to the release and shipment of the Product specified in the 2021 Purchase Order, Metuchen shall immediately (i) make an initial payment with respect to the Promissory Note in the amount of Nine Hundred Thousand Dollars ($900,000) and (ii) make the payment with respect to the 2021 Purchase Order in the amount of One Million Five Hundred Forty-Two Thousand Nine Hundred Four Dollars ($1,542,904), which amount represents payment for the Product only and does not include the associated cost, freight and insurance which Metuchen is solely responsible to pay.

 

(c)            Future Financings. VIVUS is hereby granted a right of first refusal (including in respect of any financing proposal received from a Group Member or Third Party) to provide any debt financing, convertible debt or equity, or debt-linked instrument (e.g. common or preferred equity, or warrants, options or other agreements that act like, may be exercised for, or converted into debt) issued by or to Metuchen (including any subsidiaries and intermediaries) until the Promissory Note is irrevocably paid in full in cash.

 

3.            Withholding. If any Applicable Law requires the deduction or withholding of any tax from amounts otherwise payable pursuant to this Agreement, the Promissory Note or any other Settlement Document, then Metuchen shall be entitled to make such deduction or withholding and shall timely pay the full amount deducted or withheld to the relevant Governmental Authority in accordance with Applicable Law, and if such tax is imposed, then the sum payable by Metuchen shall be increased as necessary so that after such deduction or withholding has been made (including, such deductions and withholdings applicable to such additional sums payable under this Section 3), VIVUS (or the applicable transferee) receives an amount equal to the sum it would have received had no such deduction or withholding had been made.

 

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4.            Termination of Supply Agreement. The Parties hereby agree and acknowledge that the Supply Agreement terminated effective as of September 30, 2021, and except as set forth herein (a) Metuchen has no further obligation to make any further purchases or pay any further amounts to VIVUS under the Supply Agreement and (b) VIVUS has not further obligation to manufacture (or have manufactured) and supply Product or API to Metuchen. For the avoidance of doubt, Metuchen shall not have any Minimum Purchase Obligations under the Supply Agreement for calendar year 2020, 2021 or otherwise.

 

5.            Amendments to License Agreement. In order to ensure that, upon an Event of Default, VIVUS will already have all of the rights under the License Agreement to exercise the VIVUS Exploitation Rights (regardless of whether the termination of the license is stayed or deemed ipso facto by a bankruptcy court), the License Agreement will be amended in the form of Amendment No. 1 to License Agreement attached hereto as Exhibit C (“First License Amendment”), including to achieve the following:

 

(a)            VIVUS will retain co-exclusive rights to exercise the VIVUS Exploitation Rights in the Licensee Territory (and otherwise exclusively on a worldwide basis);

 

(b)            VIVUS will undertake a limited forbearance from exercising the VIVUS Exploitation Rights in the Licensee Territory unless or until an Event of Default occurs;

 

(c)            Upon an Event of Default, the License Agreement will terminate;

 

(d)            VIVUS will have such rights to use all Metuchen regulatory documentation, rights of reference to all regulatory submissions to Regulatory Authorities and other rights as may be necessary or appropriate in VIVUS’ discretion in order to enable VIVUS to immediately commence the exercise of the VIVUS Exploitation Rights; and

 

(e)            Metuchen will agree and stipulate that (i) VIVUS is the sole and exclusive owner of all of the API unless or until such time that certain quantities of API are shipped to Metuchen against payments made under the Promissory Note in accordance with Section 7 below, and (ii) VIVUS’ exercise of the VIVUS Exploitation Rights would not be subject to the automatic stay, any need for a court order (including that of a bankruptcy court) or in any way impact property of a Metuchen bankruptcy estate upon the occurrence of an Event of Default.

 

6.            Regulatory Matters. Metuchen agrees to the following and to take any and all further actions and to enter into or amend any agreement (including the License Agreement) in each case deemed necessary or appropriate by VIVUS in its sole discretion to effectuate and accomplish the following:

 

(a)            Labeler Code. VIVUS shall have the right to exercise the VIVUS Exploitation Rights under its own labeler code. VIVUS has the right to take all steps it deems necessary and appropriate to prepare for the immediate exercise of the VIVUS Exploitation Rights, including entering into any agreements with a third party in respect thereof, but will forbear from actually exercising the VIVUS Exploitation Rights only unless or until an Event of Default occurs (the “Limited Forbearance”).

 

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(b)            Regulatory Authorities. Metuchen agrees to perform in a timely manner all steps as may be required or as otherwise requested by VIVUS to effectuate VIVUS’ ability to engage in the VIVUS Exploitation Rights, including submitting an NDC Labeler code request SPL to FDA via ESG or CDER Direct Portal, indicating a new labeler and label addition (together, the “Labeler Addition”) and such other documentation as FDA, VIVUS and other third parties may require or request. The Parties acknowledge and agree that Metuchen’s regulatory advisor, OneSource Regulatory (“OneSource”), shall assist Metuchen and VIVUS with respect to the foregoing, and will submit the Labeler Addition documents in form and substance acceptable to VIVUS (estimated to be within 1 business day from the date of this Agreement), with confirmation of receipt estimated to be within three (3) days or less from submission. Any other steps in addition to those stated above deemed necessary or desired by VIVUS to exercise the VIVUS Exploitation Rights will be promptly performed by Metuchen upon request by VIVUS (collectively such requirements in addition to those stated in this Section 6, the “Regulatory Requirements”). The Regulatory Requirements may be performed by OneSource with the prior written consent of VIVUS. The Regulatory Requirements will be performed and completed (i) at Metuchen’s sole cost and expense, (ii)  in accordance with applicable laws, (iii) pursuant to the terms and conditions of the Settlement Documents as well as subject to the additional requirement of VIVUS’s reasonable satisfaction and (iv) in accordance with the time period and other requirements set forth in this Agreement and the other Settlement Documents. A failure to perform the Regulatory Requirements in accordance with this Agreement shall constitute a material breach of this Agreement and accordingly, and Event of Default.

 

7.            Transfer of Ownership to Active Pharmaceutical Ingredient.

 

(a)            Initial Transfer. Upon Metuchen’s (i) submission of the Labeler Addition (in accordance with Section 6(b)), and (ii) a nonrefundable payment of $2,442,904 to VIVUS (in accordance with Section 2(b)), VIVUS will agree to promptly (but in any event, within three (3) business days of satisfaction of conditions (i) and (ii) of this Section 7(a)) release to Metuchen 50% of quantity of bulk STENDRA tablets under Metuchen’s existing open purchase order being held by VIVUS (“Open Purchase Order”), which represents approximately a six (6) month supply of inventory. No shipment of STENDRA will occur unless and until the requirements of both Section 7(a)(i) and 7(a)(ii) are performed.

 

(b)            Upon the timely completion of the remaining Regulatory Requirements (estimated to be within a subsequent 30-60 days of all required submissions by Metuchen or OneSource, VIVUS, or Metuchen in connection therewith, but not to exceed 180 days from the date hereof), VIVUS will release the remaining 50% of the bulk STENDRA tablets covered by the Open Purchase Order to Metuchen. Time is of the essence in respect of the completion of the Regulatory Requirements, and Metuchen shall (and shall cause OneSource) to use its best efforts to do so as quickly as possible. Failure to use such best efforts, complete the Regulatory Requirements within the 180 day time period stated above or achieve the FDA validation of VIVUS’s rights to exercise the VIVUS Exploitation Rights (including specifically the right to manufacture, commercialize, or distribute STENDRA in the Licensed Territory) shall constitute an Event of Default under the Settlement Documents and shall trigger any and all of the rights and remedies available to VIVUS under the Settlement Documents or otherwise.

 

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(c)            With respect to all of VIVUS’ inventory of API, the Parties agree that for so long as the Principal Amount remains outstanding, upon the tender of payment by Metuchen on each Payment Date under the Promissory Note, Metuchen shall accrue a Principal Credit Balance (as defined below) against which Metuchen may upon submission of a written API PO (as defined below) to VIVUS request VIVUS to transfer title to the API Quantity (as defined below) to Metuchen against the API Quantity Amount (as defined below) applicable to such API PO. In connection with each API PO submitted in accordance with this Section 7, VIVUS shall convey, assign and transfer to Metuchen title to the applicable API Quantity without any further documentation required to effectuate such transfer; provided that if any other actions are reasonably required in order to effectuate such transfer, VIVUS shall promptly perform any and all such actions. Metuchen shall be the rightful owner of the API Quantity that is the subject of an API PO following tender of payment by Metuchen and transfer of title, including all risks of loss of such API, subject in each case to the security interests granted to VIVUS under the Security Agreement to secure the prompt and full payment of the Principal Amount and all interest accrued in connection therewith under the Promissory Note and such other Obligations (as defined in the Promissory Note).

 

(d)            For purposes of this Agreement, an “API PO” means a purchase order conforming to the terms and conditions set forth in Exhibit D attached hereto. The Parties agree that any and all terms and conditions included in any API PO and not otherwise set forth in Exhibit D shall be disregarded and not of any force or effect hereunder or under such API PO unless expressly agreed by the Parties in writing and executed by an authorized representative of each Party.

 

(e)            ALL API TRANSFERRED BY VIVUS TO METUCHEN UNDER THIS SECTION 7 IS TRANSFERRED “AS-IS” AND VIVUS DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES CONCERNING THE API, INCLUDING REPRESENTATIONS AND WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

(f)            For purposes of this Agreement and this Section 7, the follow definitions shall apply:

 

(i)            The “Principal Credit Balance” means the aggregate amount of all payments of the Principal Balance received by VIVUS under and in accordance with the Promissory Note less the aggregate API Quantity Amount applied by Metuchen to acquire title to each transfer of API Quantity.

 

-8-

 

 

(ii)            The “API Quantity” means the quantity of API (as defined in the Supply Agreement) in weight equivalent to each API Quantity Amount requested to be applied by Metuchen and as determined using VIVUS’ then current pricing for API.

 

(iii)            The “API Quantity Amount” means the U.S. dollar amount of the Principal Credit Balance that Metuchen requests VIVUS to apply and release a corresponding API Quantity to Metuchen.

 

8.            No Duty to Mitigate. Metuchen agrees that VIVUS, its Affiliates and each of their representatives shall have no duty or other obligation to mitigate in respect of any breach, enforcement or action concerning the Settlement Documents, and waives any right, claim, or defense with respect thereto. The Settlement Documents are hereby amended by this Section 8, as applicable.

 

9.            Intentionally Omitted.

 

10.            Representations and Warranties. Metuchen represents and warrants the following:

 

(a)            Metuchen is duly organized, validly existing and in good standing under the laws of its jurisdiction of formation. Metuchen has all requisite power and authority to execute and deliver this Agreement and each of the Settlement Documents and to perform its obligations under this Agreement and each of the Settlement Documents. The execution, delivery and performance of this Agreement and each of the Settlement Documents by Metuchen has been duly authorized and approved by all necessary action in accordance with Applicable Law and no other action on the part of Metuchen is necessary to authorize the execution, delivery and performance of this Agreement and each of the Settlement Documents. This Agreement and each of the Settlement Documents has been duly executed and delivered by Metuchen and constitutes a valid and binding obligation of Metuchen. All documents and financial data (other than any projections or other forward-looking information) that have been or will be provided to VIVUS by Metuchen or any of its Affiliates are, when furnished, true, complete and correct in all material respects.

 

(b)            Each of the Group Members is solvent and able to pay its obligations as they become due, that this Agreement and the Settlement Documents provide fair consideration and reasonably equivalent value to it (quantitatively and/or qualitatively), and that by entering into and performing the Settlement Documents it is not actually hindering, delaying, or defrauding its creditors.

 

(c)            Metuchen’s exact legal name is correctly set forth on the signature page hereof. Metuchen will not change its name or identity without giving prior written notice to VIVUS. Metuchen has been duly organized as a Delaware limited liability company. Metuchen’s chief executive office is located at 200 US Hwy 9, Suite 500, Manalapan, NJ 07726. Metuchen will not change the location of its chief executive office, type of organization, business structure or place of incorporation or organization without giving not less than 30 days’ prior written notice to VIVUS.

 

-9-

 

 

(d)            Metuchen has no knowledge of any Lien held by any third party or other facts or circumstances that would prevent or adversely impact VIVUS obtaining a first priority Lien in and to the Collateral (as defined in the Security Agreement) upon execution of the Settlement Documents (and assuming VIVUS promptly and properly perfects its security interest in and to the Collateral).

 

11.            Covenants. Metuchen agrees that, from the date of execution of this Agreement until the obligations hereunder and the Obligations (as defined in the Security Agreement) have been fully paid and satisfied, Metuchen will not challenge its obligations to fulfill requirements set forth in the Settlement Documents and in addition to any and all covenants and obligations under the Promissory Note, the Security Agreement and the other Settlement Documents will perform the following:

 

(a)            Financing Statements and other Information. Metuchen shall deliver to VIVUS each of the following:

 

(i)            Annual Financial Statements. Upon the earlier of (A) fifteen (15) days following a filing of its annual reports (or the reports of Petros) with the U.S. Securities and Exchange Commission (“SEC”) or (B) one hundred twenty (120) days after the end of each Fiscal Year of Metuchen, Metuchen shall provide VIVUS with its audited consolidated balance sheet and related statements of operations, stockholders’ equity and cash flows as of the end of and for such year, setting forth in each case in comparative form the figures for the previous fiscal year, accompanied by an audit opinion from an accounting firm (that is not subject to qualification as to the scope of such audit, but that may contain a “going concern” statement) to the effect that such consolidated financial statements present fairly in all material respects the financial condition and results of operations of Metuchen and its subsidiaries on a consolidated basis in accordance with GAAP.

 

(ii)            Quarterly Financial Statements. Upon the earlier of (A) fifteen (15) days following a filing of its quarterly reports (or the reports of Petros) with the SEC or (B) seventy-five (75) days after the end of each fiscal quarter of Metuchen not corresponding with the fiscal year end, Metuchen shall provide VIVUS with its unaudited consolidated balance sheet and related statements of operations and cash flows as of the end of and for such fiscal quarter and the then elapsed portion of the fiscal year, setting forth in each case in comparative form the figures for the corresponding period or periods of (or, in the case of the balance sheet, as of the end of) the previous fiscal year, all certified by a Responsible Officer as presenting fairly in all material respects the financial condition and results of operations of Metuchen and its consolidated subsidiaries on a consolidated basis in accordance with GAAP, subject to normal year-end audit adjustments and the absence of footnotes.

 

(b)            VIVUS shall have the right to interview and obtain such additional information from Metuchen’s management concerning any financial or business information set forth or otherwise reflected in the annual and quarterly financial statements required to be delivered under Section 11(a) as may be reasonably requested from time to time.

 

-10-

 

 

(c)            Pay Indebtedness and other Liabilities. Each Group Member will pay and discharge when due all of its and its subsidiaries’ indebtedness and all of its and its subsidiaries’ taxes, assessments, charges, levies and other liabilities imposed upon such Person, such Person’s income, profits, property or business, except those which currently are being contested in good faith by appropriate proceedings and for which Metuchen shall have set aside adequate reserves with respect thereto.

 

(d)            Compliance with Laws, Etc. Metuchen and each Group Member will comply in all material respects with all Applicable Laws applicable to the Group Members and to the operation of their business (including without limitations any statute, rule or regulation relating to employment practices and pension benefits or to environmental, occupational and health standards and controls) and take all actions necessary to maintain, renew and keep in full force and effect all New Drug Applications, Regulatory Approvals, permits, governmental authorizations, patents, trademarks, copyrights or other rights related to the Product or otherwise necessary to enable it to continue its business.

 

12.            Acknowledgements; Release of Claims.

 

(a)            Acknowledgements. Metuchen hereby acknowledges and agrees to the following:

 

(i)            that VIVUS is not responsible for the STENDRA products returned by CVS or any costs incurred by CVS in connection with the returned STENDRA products and that Metuchen is obligated to indemnify and hold harmless VIVUS for the total amount of the CVS Principal Amount pursuant to its indemnification obligations under Article 10 of the License Agreement; and

 

(ii)            that VIVUS is not responsible for Metuchen’s failure to fulfil its Minimum Purchase Obligations under the Supply Agreement and that it owes VIVUS the MPO Principal Amount for failure to fulfil its Minimum Purchase Obligation under the Supply Agreement for the calendar years 2018 and 2019.

 

(b)            Release of Claims. Metuchen, on behalf of itself and each of its former and future subsidiaries, Affiliates and other Group Members and its and their former and future respective predecessors, managing agents, employees, officers, directors, stockholders, managers, representatives, agents, administrators, successors and assigns (each, the applicable Party’s “Releasees”), hereby absolutely and unconditionally, to the fullest extent permitted by Applicable Law, surrenders, relinquishes, releases, holds harmless and forever discharges VIVUS and its Releasees from and against any and all actions, causes of action, setoffs, claims, cross-claims, suits, debts, accounts, demands, proceedings, arbitrations, limitations, covenants, contracts, controversies, agreements, promises, damages, losses, demands, costs and expenses (including attorney’s fees and costs actually incurred), liabilities, obligations, defenses, orders, executions, claims for relief or judgments, of whatsoever kind or character, whether known or unknown, knowable or not knowable, foreseen or unforeseen, suspected or unsuspected, whether or not concealed or hidden, fixed or unfixed, direct or indirect, contingent or otherwise, at law or in equity, that have existed, may have existed, do exist as of the date of this Agreement or which may exist in the future and are based on any facts, events, matters, acts or omissions arising of out of or relating to the subject of the acknowledgments made in Section 12(a).

 

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13.            Amendment or Waiver.

 

(a)            Amendment or Waiver. No change, modification, or amendment of this Agreement shall be valid or binding unless such change, modification or amendment is in writing and shall have been consented to by Metuchen and VIVUS in writing.

 

(b)            Severability. If any provision of this Agreement, or the application of such provision to any Person or circumstance, shall be held invalid under the Applicable Law of any jurisdiction, the remainder of this Agreement or the application of such provision to other Persons or circumstances or in other jurisdictions shall not be affected thereby. Further, if any provision of this Agreement is invalid or unenforceable under any Applicable Law, then such provision shall be deemed inoperative to the extent that it may conflict therewith and shall be deemed modified to conform with such law. Any provision hereof that may prove invalid or unenforceable under any law shall not affect the validity or enforceability of any other provision hereof, and this Agreement shall be amended to give the Parties the benefit of their bargain to the maximum extent possible in that event..

 

14.            Governing Law; Jurisdiction; Venue; Consent to Service of Process.

 

(a)            Governing Law. Resolution of all disputes arising out of or related to this Agreement or the validity, construction, interpretation, enforcement, breach, performance, application or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

 

(b)            JURISDICTION. EACH OF the PartIES Hereto agreeS THAT DISPUTES MAY BE RESOLVED BY LITIGATION IN THE FIRST INSTANCE AND hereby unconditionally and irrevocably submits, for itself and its property, to the exclusive jurisdiction of THE New York state court sitting in the Borough of Manhattan, in the City of New York (or any appellate court therefrom) over any suit, action or proceeding arising out of or related to this AGREEMENT OR OTHER SETTLEMENT DOCUMENTS and agrees that all claims in respect of any such action or proceeding shall be heard and determined in such New York state court; PROVIDED, hOWEVER, THAT ANY SUIT BY VIVUS SEEKING ENFORCEMENT AGAINST ANY COLLATERAL OR OTHER PROPERTY MAY BE BROUGHT, AT VIVUS’S OPTION, IN THE COURTS OF ANY JURISDICTION WHERE VIVUS ELECTS TO BRING SUCH ACTION OR WHERE SUCH COLLATERAL OR OTHER PROPERTY MAY BE FOUND. The SETTLEMENT DOCUMENTS ARE hereby AMENDED BY THIS SECTION 14(b), as applicable.

 

-12-

 

 

(c)            VENUE. EACH OF the PartIES HEreto hereby unconditionally and irrevocably waiveS, to the fullest extent permitted by applicable law, any objection which IT may now or hereafter have to the laying of venue of any dispute, suit, action or proceeding arising out of or relating to this agreement OR ANY OTHER SETTLEMENT DOCUMENT brought in any court specified above, or any defense of inconvenient forum for the maintenance of such dispute, suit, action or proceeding.

 

(d)            CONSENT TO SERVICE OF PROCESS. each Party Hereto hereby irrevocably waives personal service of any and all process upon them WITH RESPECT TO THIS AGREEMENT AND THE OTHER SETTLEMENT DOCUMENTS and agrees that all such service of process may be made by registered mail (or any substantially similar form of mail) directed to it at its address for notices as provided in Section 19 of this AGREEMENT. each Party HEREto hereby waives any objection to such service of process and further irrevocably waives and agrees not to plead or claim in any action or proceeding commenced hereunder that SUCH service of process was invalid and ineffective. Nothing in this AGREEMENT will affect the right of any Party Hereto to serve process in any other manner permitted by law.

 

(e)            WAIVER OF JURY TRIAL. EACH PARTY HERETO IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED ON CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OF THE SETTLEMENT DOCUMENTS OR THE ACTIONS OR OMISSIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE OR ENFORCEMENT THEREOF.

 

15.            Headings. The section headings in this Agreement are for convenience of reference only and shall not be deemed to alter or affect the meaning or interpretation of any provision hereof.

 

16.            Other Terms. Whenever in this Agreement the singular number is used, the same shall include the plural where appropriate (and vice versa), and words of any gender shall include each other gender where appropriate. As used in this Agreement, the following words or phrases shall have the meanings indicated: (a) “day” means a calendar day; (b) “include,” “including,” or their derivatives means “including without limitation”; and (c) “laws” means statutes, regulations, rules, judicial orders, and other legal pronouncements having the effect of law. To the extent that the License Agreement (for the avoidance of doubt, including Amendment No. 1 thereto) is in any way inconsistent with the terms of this Agreement, this Agreement shall control and such inconsistent provisions shall be revised to fulfill the agreements set forth in this Agreement.

 

17.            Counterparts; Electronic Mail Execution. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when executed and delivered, shall be deemed to be an original, and all of which, when taken together, shall constitute but one and the same Agreement. Delivery of an executed counterpart of this Agreement by electronic mail shall be equally as effective as delivery of an original executed counterpart of this Agreement. Any party delivering an executed counterpart of this Agreement by electronic mail also shall deliver an original executed counterpart of this Agreement but the failure to deliver an original executed counterpart shall not affect the validity, enforceability, and binding effect of this Agreement.

 

-13-

 

 

18.            Set Off. Metuchen shall not be entitled to set off, offset or net amounts owed to VIVUS against or in respect of any claim against VIVUS under this Agreement or under any of the Settlement Documents.

 

19.            Notices. All notices and other communications required or permitted hereunder shall be effective if in writing and (a) delivered personally, (b) sent by electronic mail, (c) sent by nationally recognized overnight courier, or (d) sent by registered or certified mail, postage prepaid, in each case, addressed as follows:

 

(i)            if to VIVUS, to it at the following address:

 

VIVUS LLC

900 E. Hamilton Avenue, Suite 550

Campbell, CA 95008

Attention: Chief Financial Officer and General Counsel
Email: CFO@vivus.com and GeneralCounsel@vivus.com

 

With a copy (which shall not constitute notice) to:

 

Greenberg Traurig, LLP

MetLife Building

200 Park Avenue

New York, NY 10166

Attention: Oscar N. Pinkas

Email: pinkaso@gtlaw.com

 

-14-

 

 

(ii)            If to Metuchen, to:

 

Metuchen Pharmaceuticals LLC

200 US Hwy 9

Suite 500

Manalapan, NJ 07726

Attention: Fady Boctor

Email: fboctor@metuchenpharma.com

 

With a copy to:

 

Morgan, Lewis & Bockius LLP

1111 Pennsylvania Avenue, NW

Washington, DC 20004

Attention: Andrew M. Ray, Esq.

Fax: (202) 373-6001

Email: andrew.ray@morganlewis.com

 

Unless otherwise specified herein, such notices or other communications shall be deemed effective, (a) on the date received, if personally delivered or sent by electronic mail during normal business hours on a Business Day, or (b) if delivered by registered or certified mail or by overnight courier, on the date delivered as established by return receipt or courier service confirmation or the date on which the return receipt or courier service confirms that acceptance of delivery was returned by the addressee. Each of the parties hereto shall be entitled to specify a different address by giving notice as aforesaid to each of the other parties hereto.

 

20.            Expenses and Indemnification. In addition to VIVUS’s indemnification and other rights under the Security Agreement and other Settlement Documents:

 

(a)            Metuchen shall reimburse VIVUS on demand for all reasonable and documented out-of-pocket costs, expenses and fees (including reasonable expenses and fees of its external counsel) incurred by VIVUS in connection with the enforcement of VIVUS’s rights hereunder and under the Loan Documents or in any bankruptcy case or insolvency proceeding. Failure by Metuchen to pay VIVUS any amounts due under this Section 20(a) within ten (10) days of demand for payment shall result in such amount being added to the Principal Amount under the Promissory Note.

 

(b)            Metuchen shall indemnify, defend, protect and hold harmless VIVUS and each of VIVUS’s Affiliates, and their respective officers, directors, members, managers, employees, attorneys, consultants, and agents from and against any and all losses, damages, liabilities, obligations, penalties, fines, fees, costs, and expenses (including, without limitation, attorneys’ and paralegals’ fees, costs and expenses, and fees, costs and expenses for investigations and experts) (collectively “Losses”) incurred by such indemnitees, whether before or from and after the date hereof, arising from or relating to any suit, investigation, action, or proceeding by any Person, whether threatened or initiated, asserting a claim for any legal or equitable remedy against any Person under any statute, regulation, or common law principle, arising from or in connection with the Excluded Liabilities. The obligations of Metuchen under this paragraph shall survive the payment in full of this Agreement. Failure by Metuchen to pay VIVUS any amounts due under this Section 20(b) within ten (10) days of demand for payment shall result in such amount being added to the Principal Amount under the Promissory Note.

 

-15-

 

 

21.            Confidentiality. Each Party will maintain the Confidential Information in accordance with Article 11 of the License Agreement. The Parties agree not to disclose any financial or otherwise commercially sensitive terms or conditions of this Agreement to any Third Party without the prior written consent of the other Party, except as required by Applicable Law or to the extent necessary in a dispute between the Parties (including between VIVUS and any Group Member). If either Party is required to disclose any financial term or condition of this Agreement due to the reporting obligations under the Securities and Exchange Act of 1934, as amended or other legal obligation, then the Party seeking disclosure shall notify the other Party of such fact prior to any such disclosure and proceed to redact such provisions as the non-disclosing Party reasonably requests pursuant to a confidential treatment request order.

 

22.            Cleansing. Notwithstanding anything, under any of the Settlement Documents or otherwise, the receipt of Confidential Information shall not in any way limit or restrict VIVUS or any of its affiliates, and does not constitute, and shall not be construed to create, a standstill or any other restriction whatsoever on the ability of VIVUS or any of its affiliates to (i) purchase or sell securities or other instruments, including those of a Group Member, (ii) purchase or sell any such companies substantially in their entirety (whether by merger, asset sale or otherwise), (iii) provide financing to any such companies or (iv) conduct similar activities in the ordinary course of VIVUS or any of its affiliates’ businesses in the same manner as they are presently conducted. In the event that any Confidential Information disclosed to VIVUS constitutes material nonpublic information about Metuchen or any Group Member, within 5 days following the end of each quarterly fiscal period or any material breach or default or a Settlement Document, Petros shall file a document (the “Cleansing Document”) containing such Confidential Information (or an appropriate summary thereof) (the “Disclosure Information”) with the SEC, including appropriate exceptions for information disclosed to VIVUS’s outside advisors and specifically designated as “non-cleansing” or “advisors’ eyes only” information (or other similar designation) with VIVUS’ prior written consent. As promptly as practicable, but in no event less than 48 hours before the filing of the Cleansing Document, Petros will provide VIVUS with a draft of the Cleansing Document and will consider in good faith any timely comments VIVUS has with respect to the Cleansing Document. In the event that Petros fails to timely file the required Cleansing Document or such Cleansing Document does not contain all of the Disclosure Information as determined by VIVUS based on the advice of its legal counsel, then Petros, on behalf of itself and any Group Member, agrees that VIVUS or its representatives (each an “Authorized Cleansing Party”) shall be authorized to make available to the public at any time more than two (2) business days thereafter (and notwithstanding if this Agreement has been terminated) all the Disclosure Information not so disclosed by Petros in a single disclosure; provided that before any such disclosure such Authorized Cleansing Party shall (i) so long as (but only if) the Cleansing Document is delivered by Petros, notify Petros of its intent to disclose any such Disclosure Information within 48 hours after its receipt of the Cleansing Document and (ii) provide Petros with a draft of the documents VIVUS intends to use to publicly disclose such Disclosure Information at least 48 hours prior to any such disclosure. During such periods, such Authorized Cleansing Party and its legal counsel will make a reasonable effort to consult with Petros and its legal counsel regarding the content of any such disclosure and to consider in good faith any comments that Petros has with respect thereto (including, without limitation, as to whether Petros has previously disclosed all Disclosure Information). Petros agrees, on behalf of itself and each Group Member, that none of VIVUS or its affiliates, or any of their representatives, shall have any liability to any Group Member, or any of their representatives in connection with the disclosure of the Disclosure Information in accordance with the foregoing except in the case of an intentional misrepresentation. Petros shall agree to and acknowledge this section on behalf of itself and all of its present and future subsidiaries and affiliates.

 

23.            Entire Agreement. This Agreement (including its Exhibits) and the other Settlement Documents represent the entire agreement of Metuchen and VIVUS with respect to the subject matter hereof, and there are no promises, undertakings, representations or warranties by VIVUS related to the subject matter hereof not expressly set forth or referred to herein or in the other Settlement Documents.

 

[signature pages follow]

 

-16-

 

 

IN WITNESS WHEREOF, the undersigned have executed and delivered this Agreement on the date first above written.

 

  METUCHEN:
   
  Metuchen Pharmaceuticals LLC
   
  By: /s/ Fady Boctor
    Name: Fady Boctor
    Title: Authorized Person

 

[Signature Page to Settlement Agreement]

 

 

 

  VIVUS:
   
  VIVUS LLC
   
  By: /s/ John Amos
    Name: John Amos
    Title: Chief Executive Officer

 

[Signature Page to Settlement Agreement]

 

 

 

  AGREED AND ACKNOWLEDGED AS TO SECTION 22:
   
  Petros, on behalf of itself and its present and future subsidiaries and affiliates
   
  By: /s/ Fady Boctor
    Name: Fady Boctor
    Title: President

 

 

 

Exhibit A

 

Promissory Note

 

[***]

 

 

 

Exhibit B

 

Security Agreement

 

[***]

 

 

 

EXHIBIT C

 

Amendment No. 1 to License Agreement

 

[***]

 

 

 

EXHIBIT D

 

API PO

 

The following shall constitute the terms of each API PO submitted by Metuchen for API in accordance with Section 5 of the Agreement:

 

[***]

 

 

Exhibit 10.2

 

PROMISSORY NOTE

 

$10,201,758.04   January 18, 2022

 

FOR VALUE RECEIVED, the undersigned, METUCHEN PHARMACEUTICALS LLC, a Delaware limited liability company (“Maker”), hereby executes this Promissory Note (this “Note”) and hereby unconditionally promises to pay to the order of VIVUS LLC, a Delaware limited liability company (“VIVUS”; VIVUS, together with its successors and assigns, “Payee”), in accordance with the payment instructions set forth below, the principal sum of TEN MILLION TWO HUNDRED ONE THOUSAND SEVEN HUNDRED FIFTY-EIGHT AND 4/100 DOLLARS ($10,201,758.04), plus interest thereon on the terms provided below.

 

Capitalized terms which are used, but not defined, herein shall have the meanings given such terms in that certain Settlement Agreement dated as of the date hereof by and among Maker and Vivus (as the same may be amended, restated, supplemented, or otherwise modified from time to time, the “Settlement Agreement”).

 

1.             Payment of Principal. Maker shall pay the principal amount of this Note in consecutive quarterly installments, each of which shall be due and payable on the “Installment Due Dates” set forth in Schedule A, attached hereto and made a part hereof, in the “Principal Amount” set forth each of such dates in Schedule A (each such installment due on an applicable date in an applicable amount, an “Installment”), with the first Installment due on the first date set forth in Schedule A. In any event, the outstanding principal amount of this Note shall be due and payable in full on January 1, 2027.

 

2.             Interest. Interest shall accrue on the outstanding principal under this Note from the date hereof until all principal under shall have been repaid. Interest shall be calculated on the basis of a year of 365/6 days based on the actual number of days elapsed. The interest rate under this Note is 6.00% per annum; provided, however, that, upon and at all times after the occurrence of any Event of Default (as defined below), the interest rate otherwise payable under this Note shall be increased by 3.00% per annum, automatically and without notice to any person or entity, to a total rate of 9.00% per annum, and such increased rate shall remain effective until the full and final payment of all principal and interest under this Note (regardless of whether any such Event of Default is waived or cured). All accrued and unpaid interest under this Note shall be due and payable, in arrears, on the first day of each January, April, July, and October of each calendar year, commencing with the first of such dates to occur after the date hereof.

 

3.             Payments. If any day on which any payment is otherwise due and payable under this Note (whether principal, interest, or otherwise) is not a business day, then such payment shall be made on the immediately following business day (and interest shall accrue for each such day). All payments on this Note shall be applied, first, to all accrued and unpaid interest, next to all costs, fees, and expenses which are, at the time of such payment, due and payable, and, then, to principal. All payments on account of this Note (whether principal, interest, or otherwise) shall be payable in U.S. dollars, in immediately available funds, and in accordance with the following instructions (or such other instructions provided by Payee to Maker in a writing from time to time):

 

[***]

 

 

 

 

4.             Occurrence of Event of Default. During the existence of any Event of Default, Payee may (in addition to all rights and remedies of Payee under applicable law or otherwise, all such rights and remedies being cumulative, not exclusive and enforceable alternatively, successively and concurrently), at its option, declare any or all amounts owing under this Note (whether principal, interest, or otherwise), to be due and payable, whereupon the same shall become immediately due and payable; provided, however, that upon the occurrence of any Event of Default of the kind described in Sections 9(e) or 9(f) of the Security Agreement (as defined below), the obligations of Maker hereunder shall automatically become and be due and payable in full, without notice of any kind.

 

As used herein, “Event of Default” has the meaning given such term in the Security Agreement.

 

5.             Prepayments. Maker shall have a right to prepay all or any part of the principal of this Note before it is due and any such prepayment shall be without penalty or premium. All prepayments under this Note shall be applied, first, to any accrued and unpaid interest and, secondly, to the then-remaining principal Installments in the inverse order of the maturities thereof.

 

6.             Security for Payment. The indebtedness evidenced by this Note is secured by that certain Security Agreement dated as of the date hereof, by Maker in favor of Payee (as the same may be amended, restated, supplemented, or otherwise modified from time to time, the “Security Agreement”), which creates legal and valid encumbrances on and an assignment of all of the Collateral (as defined in the Security Agreement).

 

7.             Legal Fees. If this Note is placed in the hands of any attorney for collection, or if it is collected through any legal proceeding at law or in equity or in bankruptcy, receivership, or other court proceedings, Maker agrees to pay all costs of collection including, but not limited to, court costs and attorneys’ fees.

 

8.             Waivers. Maker, for itself, its successors and assigns, hereby waives diligence, presentment, protest and demand and notice of protest, demand, dishonor and non-payment of this Note. No waiver by Payee of any of its rights or remedies hereunder or under any other document evidencing or securing this Note or otherwise shall be considered a waiver of any other subsequent right or remedy of Payee; no delay or omission in the exercise or enforcement by Payee of any rights or remedies shall ever be construed as a waiver of any right or remedy of Payee; and no exercise or enforcement of any such rights or remedies shall ever be held to exhaust any right or remedy of Payee.

 

9.             Choice of Law; Waiver of Jury Trial. This Note shall be governed by and construed in accordance with the laws of the State of New York. MAKER, BY EXECUTION HEREOF, AND PAYEE, BY ACCEPTANCE HEREOF, MUTUALLY AND WILLINGLY WAIVE THE RIGHT TO A TRIAL BY JURY OF ANY AND ALL CLAIMS MADE BETWEEN THEM WHETHER NOW EXISTING OR ARISING IN THE FUTURE, INCLUDING, WITHOUT LIMITATION, ANY AND ALL CLAIMS, DEFENSES, COUNTERCLAIMS, CROSS CLAIMS, THIRD PARTY CLAIMS AND INTERVENOR’S CLAIMS WHETHER ARISING FROM OR RELATED TO THE NEGOTIATION, EXECUTION AND PERFORMANCE OF THE TRANSACTIONS TO WHICH THIS NOTE RELATES.

 

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10.           Amendments. This Note may be amended only by an instrument in writing signed by Payee and Maker.

 

11.           Severability. The unenforceability of any provision of this Note will not affect the enforceability or validity of any other provision herein.

 

12.           Continuing Obligations. The obligations and liabilities of Maker under this Note shall be binding upon and enforceable against Maker and its successors and assigns. The representations, undertakings, and covenants made by the undersigned under this Note are, and shall be deemed to be, of continuing force and effect until all indebtedness and obligations of the undersigned under this Note have been fully and finally paid and performed.

 

13.           Authority. Maker hereby represents and warrants to Payee that, by its execution below, Maker has the full power, authority, and legal right to execute and deliver this Note and that the indebtedness evidenced hereby constitutes a valid and binding obligation of Maker without exception or limitation.

 

14.           Successors-in-Interest; Assignment. This Note binds and may be enforced against the successors-in-interest of Maker, except as otherwise provided. This Note shall inure to the benefit of and may be enforced by Payee and its successors and assigns. This Note may not be assigned by Maker without the prior written consent of Payee.

 

15.           Time is of the Essence. Time is of the essence to all terms and provisions set forth herein.

 

[Continued on following page.]

 

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IN WITNESS HEREOF, the undersigned has caused this Promissory Note to be duly executed and delivered on the date first given above.

 

  METUCHEN PHARMACEUTICALS LLC, as Maker
   
  By: /s/ Fady Boctor                
  Name: Fady Boctor
  Title: Authorized Person

 

 

VIVUS—METUCHEN PROMISSORY NOTE

 

 

 

SCHEDULE A

 

PAYMENT SCHEDULE

 

Installment Installment Due Date Principal Amount
1 4/1/2022 $176,973.63
2 7/1/2022 $179,628.23
3 10/1/2022 $182,322.66
4 1/1/2023 $185,057.50
5 4/1/2023 $357,833.36
6 7/1/2023 $363,200.86
7 10/1/2023 $368,648.87
8 1/1/2024 $374,178.61
9 4/1/2024 $379,791.29
10 7/1/2024 $385,488.15
11 10/1/2024 $391,270.48
12 1/1/2025 $397,139.53
13 4/1/2025 $763,096.63
14 7/1/2025 $774,543.08
15 10/1/2025 $786,161.22
16 1/1/2026 $797,953.64
17 4/1/2026 $809,922.95
18 7/1/2026 $822,071.79
19 10/1/2026 $834,402.87
20 1/1/2027 $872,072.71

 

 

Exhibit 10.3

  

SECURITY AGREEMENT

 

THIS SECURITY AGREEMENT (this “Agreement”) is entered into as of January 18, 2022, by and between METUCHEN PHARMACEUTICALS LLC, a Delaware limited liability company (“Grantor”), and VIVUS LLC, a Delaware limited liability company (“Secured Party”).

 

WHEREAS, reference is made to that certain Settlement Agreement dated the date hereof by and among Grantor and Secured Party (as the same may be amended, restated, supplemented, or otherwise modified from time to time, the “Settlement Agreement”), pursuant to which, among other things, Grantor has acknowledged that it is indebted to Secured Party in the amount set forth therein.

 

WHEREAS, reference is made to the Settlement Documents (as defined in the Settlement Agreement).

 

WHEREAS, as part of the Settlement Agreement, Grantor agreed to execute and deliver this Agreement to secure its obligations under the Settlement Documents.

 

WHEREAS, Secured Party would not have entered into the Settlement Agreement without, among other things, Grantor’s execution and delivery of this Agreement.

 

NOW, THEREFORE, the parties hereto agree as follows:

 

1.             DEFINITIONS.

 

(a) All capitalized terms used, but not otherwise defined, herein shall have the meanings given to such terms in the Settlement Agreement.

 

(b) Unless otherwise defined herein, terms used herein which are defined in the Code shall have the meanings given such terms in the Code.

 

(c) All terms defined in the recitals to this Agreement have the meanings given such terms in the recitals. The recitals to this Agreement are incorporated herein by this reference.

 

(d) As used herein, the following terms have the following meanings:

 

Approved Location” means, with respect to any Collateral, (a) any location owned or leased by Grantor; (b) any Person providing third-party warehousing or logistics services to Grantor so long as such Person has executed and delivered to Secured Party a written agreement in form and substance satisfactory to Secured Party with respect to the Collateral in such Person’s possession or control; (c) any location of a customer to which any of such Collateral has been consigned by Grantor, so long as such consignment has been approved in writing by Secured Party; (d) any location of any Person acting in the ordinary course of business as an inventory processor with respect to the Collateral pursuant to a written agreement between Grantor and such Person, so long as such Person has executed and delivered to Secured Party an inventory processor agreement or similar instrument in form and substance satisfactory to Secured Party; and (e) any location at which any of such Collateral is located while in transit from one of the foregoing locations to another of the foregoing locations.

 

 

 

Change of Control” means the occurrence of (a) a third party who owns or has a license or other right, either directly or through its Affiliates, to any product that operates as a phosphodiesterase type-5 inhibitor other than the Product (i.e., a “Competing Product” as defined in the License Agreement) either (i) becoming an Affiliate of Grantor or (ii) becoming Grantor’s successor under this Agreement; (b) for whatever reason, Petros ceases to own and control (with full power to vote), directly or indirectly, all classes of equity interests issued from time to time by Grantor; or (c) any person or “group” (within the meaning of Rules 13d-3 and 13d-5 under the Exchange Act (as amended from time to time), other than JCP III SM AIV, L.P., METP Holdings, LLC and their existing subsidiaries (collectively, “Juggernaut”), shall have acquired beneficial ownership of 35% or more on a fully diluted basis of the voting equity interests issued by Petros.

 

Code” means the Uniform Commercial Code as in effect in the State of New York.

 

Lien” means any mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance, lien (statutory or other), charge, or preference, priority or other security interest or preferential arrangement of any kind or nature whatsoever (including any conditional sale or other title retention agreement, any easement, right of way or other encumbrance on title to real property.

 

Obligations” means all of Grantor’s obligations and liabilities of every kind and character to Secured Party under, pursuant to, or in connection with the Settlement Documents, whether now existing or hereafter arising, including, without limitation, all amounts now owed or hereafter from time to time owed under the terms of this Agreement or the other Settlement Documents, or arising out of the transactions described herein or therein, including, without limitation, principal, interest, fees (including, without limitation, reasonable attorneys’ fees), charges, costs, the costs of preparing Collateral for sale (including, without limitation, the costs of storing and warehousing, transporting, producing, manufacturing, and selling STENDRA Product), expenses, and all amounts due or from time to time becoming due under the indemnification and reimbursement provisions of this Agreement and the other Settlement Documents, together, in each of the foregoing cases in this definition, with all interest accruing thereon, including any interest on pre-petition Obligations accruing after bankruptcy (whether or not allowable in such bankruptcy), and whether any of the foregoing amounts are now due or from time to time hereafter become due, are direct or indirect, or are certain or contingent, and whether such amounts due are from time to time reduced or entirely extinguished and thereafter re-incurred.

 

Permitted Liens” means (a) the Liens granted by Grantor to Secured Party pursuant to this Agreement or any other Settlement Document; (b) any Liens of warehousemen, inventory processors, and other third-parties arising in the ordinary course of business by operation of law (and not by contract) and the obligations or liabilities secured thereby are not past due (unless the subject of a bona fide dispute); and (c) Liens arising as a matter of law which secure the payment of taxes which are not yet due and payable (or are the subject of a bona fide dispute with the applicable taxing authority which is being diligently pursued).

 

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Person” means any natural person, corporation, limited liability company, trust, joint venture, association, company, partnership, governmental authority, or other entity or authority.

 

Specified License Agreement” means that certain License and Commercialization Agreement dated as of September 30, 2016, by and between Grantor and Secured Party, as amended by that certain Amendment No. 1 to License and Commercialization Agreement dated as of the date hereof and as the same may be further amended, restated, supplemented, or otherwise modified from time to time, and all of Grantor’s rights therein.

 

STENDRA API” means the active pharmaceutical ingredient in STENDRA based products, in whatever form it exists, whether solid, liquid, or otherwise, and however packaged.

 

STENDRA Associated Components” means any and all materials (including, without limitation, inert ingredients, mixtures, or compounds) which have been combined, mixed, or commingled in any way with any STENDRA API.

 

STENDRA Packaging” means any bottles, cases, boxes, sleeves, drums, blister wrap, or other containers in which any other STENDRA Product is, or is intended to be, stored or packaged (whether for manufacturing, transportation, storage, or sale purposes), and all labeling, marketing materials, and supplies of any kind or character bearing the name or mark STENDRA.

 

STENDRA Product” means any and all of the following, whether now existing or hereafter arising or existing: (a) all STENDRA API; (b) all STENDRA Tablets; (c) all STENDRA Associated Components; and (d) all STENDRA Packaging.

 

STENDRA Tablets” means all pills, tablets, and other dose configurations which contain any amount of STENDRA API, as such items exist in their completely manufactured state or as work in process.

 

2.             GRANT OF SECURITY INTEREST. Grantor grants to Secured Party a continuing security interest (the “Security Interest”) in all of the following property of Grantor or in which Grantor has rights, whether presently existing or acquired after the date of this Agreement (collectively, together with all Proceeds, the “Collateral”):

 

(a)            all STENDRA Product;

 

(b)           the Specified License Agreement; and

 

all books and records relating to the foregoing and all proceeds (as such term is defined in the Code) and products, whether tangible or intangible of any of the above property, all proceeds of insurance covering or relating to any or all of the above property, and all rebates and returns relating to any of the above property (all such proceeds, collectively, “Proceeds”).

 

3.             OBLIGATIONS SECURED. The obligations secured by the Security Interest are the full and final payment in cash and performance of all of the Obligations.

 

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4.             AUTHORIZATION TO FILE FINANCING STATEMENTS. Grantor authorizes Secured Party to file financing statements describing the Collateral to perfect Secured Party’s Security Interest in the Collateral. All financing statements filed before the date of this Agreement to perfect the Security Interest were authorized by Grantor and are ratified.

 

5.             REPRESENTATIONS AND WARRANTIES OF GRANTOR. Grantor represents and warrants to Secured Party that:

 

(a)            Grantor (i) is duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization, (ii) has all requisite power and authority to (A) own or lease its assets and carry on its business and (B) execute, deliver and perform its obligations under the Settlement Documents, (iii) is duly qualified and in good standing under the laws of each jurisdiction where its ownership, lease, or operation of properties or the conduct of its business requires such qualification, (iv) is in material compliance with all laws, orders, writs, injunctions, and orders, and (v) has all requisite governmental licenses, authorizations, consents, and approvals to operate its business as currently conducted.

 

(b)           Grantor’s execution, delivery, and performance of the Settlement Documents, and the consummation of the transactions contemplated therein, are within Grantor’s limited liability company powers, have been duly authorized by all necessary organizational action, and do not and will not (i) contravene the terms of any of Grantor’s organizational or charter documents, (ii) conflict with or result in any breach or contravention of, or the creation of any Lien under (other than Permitted Liens), or require any payment to be made under (A) any document, instrument, or agreement to which Grantor is a party or affecting Grantor’s properties or any of its subsidiaries or (B) any material order, injunction, writ, or decree of any governmental authority or any arbitral award to which Grantor or its property is subject; or (iii) violate any law in any material respect.

 

(c)            No material approval, consent, exemption, authorization, or other action by, or notice to, or filing with, any governmental authority or any other Person is necessary or required in connection with (i) the execution, delivery or performance by, or enforcement against, Grantor of this Agreement or any other Settlement Document, or for the consummation of the transactions contemplated herein or therein, (ii) the grant by Grantor of the security interests granted by it pursuant to this Agreement and the other Settlement Documents, (iii) the perfection or maintenance of the Lien created under this Agreement or any of the other Settlement Documents (including the priority thereof), or (iv) the exercise by Secured Party of its rights under the Settlement Documents or the remedies in respect of the Collateral pursuant to this Agreement and the other Settlement Documents, except for (A) filings necessary to perfect the security interest in the Collateral granted by Grantor in favor of Secured Party and (B) the approvals, consents, exemptions, authorizations, actions, notices, and filings which have been duly obtained, taken, given or made and are in full force and effect.

 

(d)           This Agreement and each other Settlement Document has been duly executed and delivered by Grantor. This Agreement and each other Settlement Document constitutes a legal, valid, and binding obligation of Grantor, enforceable against Grantor in accordance with its terms, except as such enforceability may be limited by bankruptcy and insolvency laws and general principles of equity.

 

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(e)            Grantor’s legal name is exactly as set forth on the first page of this Agreement. Grantor’s chief executive office and principal place of business are accurately set forth on Schedule A, attached hereto and made a part hereof. All of Grantor’s organizational documents or agreements delivered to Secured Party are complete and accurate in every respect.

 

(f)            Grantor has legal title to and has possession or control of the Collateral. None of Grantor’s Affiliates owns, or has any rights in and to, or is in possession of any STENDRA Product.

 

(g)           Grantor has the exclusive right to grant a security interest in the Collateral.

 

(h)           All Collateral is genuine, free from Liens, adverse claims, setoffs, default, prepayment, defenses and conditions precedent of any kind or character, except for Permitted Liens.

 

(i)             No financing statement covering any of the Collateral, and naming any secured party other than Secured Party and holders of Permitted Liens, is on file in any public office.

 

(j)             None of the Collateral is stored at any location other than an Approved Location.

 

6.             COVENANTS OF GRANTOR.

 

(a)            Grantor covenants and agrees:

 

(i)            to permit Secured Party to exercise its rights, remedies, and powers under this Agreement and the other Settlement Documents and under law;

 

(ii)           not to change its name, or, as applicable, its chief executive office, its principal residence or the jurisdiction in which it is organized without giving Secured Party 30 days’ prior written notice;

 

(iii)          to keep the Collateral only at an Approved Location;

 

(iv)          to provide information concerning the Collateral (including, without limitation, its location, quantities, its position in the manufacturing process, the name and address of each Person in possession of any Collateral and the nature of such possession, and otherwise) and sales of the Collateral to Secured Party promptly upon Secured Party’s request from time to time and in such form and of such substance as Secured Party may request from time to time; and

 

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(iv)          to cooperate with Secured Party in perfecting all security interests granted by this Agreement and in obtaining such agreements from third parties as Secured Party deems necessary, proper or convenient in connection with the preservation, perfection or enforcement of any of its rights with regard to Collateral or access to Collateral.

 

(b)           Grantor agrees with regard to the Collateral, unless Secured Party agrees otherwise in writing:

 

(i)            not to use any Collateral for any unlawful purpose or in any way that would void any insurance required to be carried on such Collateral;

 

(ii)           to insure the Collateral, with Secured Party named as lender’s loss payee and additional insured, in form, substance and amounts, under agreements, against risks and liabilities, and with insurance companies satisfactory to Secured Party and to provide to Secured Party, promptly upon Secured Party’s request therefor from time to time, certificates of insurance and copies of applicable policies and related endorsements demonstrating Grantor’s compliance with this section;

 

(iii)          to keep, in accordance with GAAP, complete and accurate records regarding all Collateral, and to permit Secured Party to inspect the same and make copies thereof at any reasonable time;

 

(iv)          not to sell, pledge or dispose of, nor permit the transfer by operation of law of, any of the Collateral or any interest in the Collateral, except sales of Inventory to buyers in the ordinary course of Grantor’s business at fair market value;

 

(v)           not to permit any Lien on the Collateral, including without limitation, Liens arising from the storage of Inventory, except for Permitted Liens;

 

(xii)          if and to the extent any of the Collateral is subject to a Document, to provide all originals of such Document to Secured Party promptly upon Secured Party’s request, together with any indorsement thereof requested by Secured Party;

 

(xiii)         to provide any service and do any other acts which may be necessary to maintain, preserve and protect all Collateral and, as appropriate and applicable, to keep all Collateral in good and saleable condition, to deal with the Collateral in accordance with the standards and practices adhered to generally by users and manufacturers of like property, and to keep all Collateral free and clear of all defenses, rights of offset and counterclaims; and

 

(xiv)         not to consign any of Grantor’s Inventory unless such consignment has been approved in writing by Secured Party or sell any of its Inventory on bill and hold, sale or return, sale on approval, or other conditional terms of sale, unless such arrangements have been approved in writing by Secured Party.

 

7.             POWERS OF SECURED PARTY. Grantor appoints Secured Party its attorney in fact to perform any of the following powers, which are coupled with an interest, are irrevocable until termination of this Agreement and may be exercised from time to time by Secured Party’s officers and employees, or any of them, whether or not an Event of Default has occurred:

 

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(a)           to perform any obligation of Grantor to Secured Party hereunder in Grantor’s name or otherwise;

 

(b)           to give notice to others of Secured Party’s rights in the Collateral, to enforce or forebear from enforcing the same and to make extension or modification agreements;

 

(c)           to release Persons liable on Collateral and to give receipts and compromise disputes;

 

(d)           to release or substitute security;

 

(e)           to resort to security in any order;

 

(f)            to prepare, execute, file, record or deliver notes, assignments, schedules, designation statements, initial financing statements and amendments, continuation statements, termination statements, statements of assignment, applications for registration or like papers to perfect, preserve or release Secured Party’s interest in the Collateral;

 

(g)           to verify facts concerning the Collateral by inquiry of obligors thereon, or otherwise, in its own name or a fictitious name;

 

(h)           to endorse, collect, deliver and receive payment under instruments for the payment of money constituting or relating to Collateral;

 

(i)            to prepare, adjust, execute, deliver and receive payment under insurance claims, and to collect and receive payment of and endorse any instrument in payment of loss or returned premiums or any other insurance refund or return, and to apply such amounts received by Secured Party, at Secured Party’s sole option, toward repayment of the Obligations or replacement of the Collateral;

 

(j)            to exercise all rights, powers and remedies which Grantor would have, but for this Agreement, with respect to all Collateral;

 

(k)           to enter onto Grantor’s premises to inspect the Collateral; and

 

(l)            to do all acts and things and execute all documents in the name of Grantor or otherwise, deemed by Secured Party as necessary, proper and convenient in connection with the preservation, perfection, priority or enforcement of Secured Party’s rights.

 

8.             PAYMENT OF PREMIUMS, TAXES, CHARGES, LIENS AND ASSESSMENTS. Grantor agrees to pay, prior to delinquency, all insurance premiums, taxes, charges, liens and assessments against the Collateral, and upon the failure of Grantor to do so, Secured Party at its option may pay any of them and shall be the sole judge of the legality or validity and the amount necessary to discharge the same. Any such payments made by Secured Party shall be a part of the Obligations and secured by the Collateral and shall be due and payable immediately upon demand, together with interest at a rate equivalent to the then applicable rate per annum of interest in the Note.

 

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9.             EVENTS OF DEFAULT. Each of the following shall constitute an “Event of Default”:

 

(a)           Grantor shall fail to pay when due any principal of or interest on the Note, any fee or other amounts due to Secured Party hereunder or any other Settlement Document, or any other Obligations; or

 

(b)           Grantor shall default on the performance of any agreement, covenant, or obligation contained in this Agreement or any other Settlement Document;

 

(c)           Any representation or warranty made by Grantor in this Agreement or any other Settlement Document, or in any certificate or report furnished in connection with this Agreement or any other Settlement Document, shall prove to have been untrue or incorrect in any material respect when made; or

 

(d)           Grantor or any other Group Member shall fail to make any payment in respect of outstanding indebtedness (other than the Obligations) having an aggregate outstanding principal amount in excess of $25,000 or more when due after the expiration of any applicable grace period, or any event or condition shall occur which results in the acceleration of the maturity of such indebtedness (including, without limitation, any required mandatory prepayment or “put” of such indebtedness to any such Person) or enables (or, with the giving of notice or passing of time or both, would enable) the holders of such indebtedness or a commitment related to such indebtedness (or any Person acting on such holders’ behalf) to accelerate the maturity thereof or terminate any such commitment before its normal expiration (including, without limitation, any required mandatory prepayment or “put” of such indebtedness to such Person); or

 

(e)           Grantor or any other Group Member shall (i) voluntarily dissolve, liquidate, or terminate operations or apply for or consent to the appointment of, or the taking of possession by, a receiver, custodian, trustee, or liquidator or of all or of a substantial part of its assets, (ii) admit in writing its inability, or be generally unable, to pay its debts as the debts become due, (iii) make a general assignment for the benefit of its creditors, (iv) commence a voluntary case under the any insolvency or bankruptcy law (as now or hereafter in effect), (v) file a petition seeking to take advantage of any other law relating to bankruptcy, insolvency, reorganization, winding-up, or composition, or adjustment of debts, (vi) fail to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against it in an involuntary case under any insolvency or bankruptcy law, or (vii) take any limited liability action for the purpose of effecting any of the foregoing; or

 

(f)            An involuntary petition or complaint shall be filed against Grantor or any other Group Member seeking bankruptcy relief or reorganization or the appointment of a receiver, custodian, trustee, intervenor, or liquidator of Grantor or any other Group Member, or all or substantially all of its assets, and such petition or complaint shall not have been dismissed within 30 days after the filing thereof; or an order, order for relief, judgment, or decree shall be entered by any competent governmental entity approving or ordering any of the foregoing actions; or

 

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(g)           A judgment of more than $25,000 in excess of insurance coverage therefor (as provided by an underwriter acceptable to Secured Party, where such underwriter has agreed in writing to pay such judgment, and for which the deductible does not exceed $10,000) shall be rendered against Grantor or any other Group Member and shall remain undischarged, undismissed, and unstayed for more than 10 days or there shall occur any levy upon, or attachment, garnishment, or other seizure of, any portion of the Collateral or other assets of Grantor or any other Group Member in excess of $25,000 by reason of the issuance of any tax levy, judicial attachment, garnishment, or levy of execution; or

 

(h)           There occurs a loss, theft, damage, or destruction of any material portion of the Collateral for which there is either no insurance coverage or for which, in Secured Party’s reasonable opinion, there is insufficient insurance coverage; or

 

(i)            There shall occur any change in the condition (financial or otherwise) of Grantor or any other Group Member which, in Secured Party’s reasonable opinion, could have a Material Adverse Effect; or

 

(j)            A Change of Control occurs; or

 

(k)           Grantor or any other Person shall repudiate or revoke, or attempt to repudiate or revoke, its obligations (whether monetary or otherwise) under this Agreement or any other Settlement Document, whether in whole or in part.

 

 

10.           REMEDIES. Upon the occurrence and during the continuation of any Event of Default, Secured Party shall have the right to declare immediately due and payable all or any Obligations secured by this Agreement; provided, however, that all Obligations shall immediately become due and payable, automatically and without notice, upon the occurrence of an Event of Default under Section 9(e) or Section 9(f). Secured Party shall have all other rights, powers, privileges and remedies granted to a secured party upon default under the Code or otherwise provided by law, including without limitation, the right to:

 

(a)            contact all Persons obligated to Grantor on any Collateral and to instruct such Persons to deliver all Collateral directly to Secured Party;

 

(b)           contact any Person in possession of any Collateral and provide instructions to such Persons with respect to the disposition of such Collateral;

 

(c)           manufacture or complete the manufacture of STENDRA Product, and to hire or engage third parties to do the same for and on behalf of Secured Party, and to sell, lease, license or otherwise dispose of any or all Collateral;

 

(d)           without notice to or consent by Grantor, and without the obligation to pay rent or other compensation, to take exclusive possession of all locations where Grantor conducts its business or has any rights of possession and use the locations to store, process, manufacture, sell, use and liquidate or otherwise dispose of Collateral;

 

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(e)           without regard to the occurrence of waste or the adequacy of security, apply for the appointment of a receiver for Grantor or for the assets of Grantor and Grantor waives any objection to such appointment or to the right to have a bond or security posted by Secured Party. Grantor hereby waives any objection or defense to the appointment of any such receiver and any right that Grantor has or may have to seek the posting of a bond or other security by Secured Party.

 

Grantor acknowledges and agrees that the nature of Collateral is such that only a limited market may exist for the disposition of some or all of the Collateral, that Secured Party may be unable to dispose of the Collateral to a third party in a commercially reasonable manner; and that, in such cases, it is not commercially unreasonable for the Secured Party to commence the manufacture and sale of STENDRA Product over an extended period (even a period of years).

 

While an Event of Default exists:

 

(1)           Grantor will not dispose of any Collateral except on terms approved by Secured Party;

 

(2)           At Secured Party’s request, Grantor will, at its sole cost and expense and subject to applicable law, assemble and deliver all Collateral, and books and records pertaining thereto, to Secured Party at a place designated by Secured Party; and

 

(3)           Secured Party may, without notice to Grantor, enter onto Grantor’s premises and take possession of the Collateral.

 

11.           INDEMNIFICATION. In addition to all other Obligations, the obligations and liabilities described in this section shall constitute Obligations and shall be in addition to, and cumulative of, any other indemnification provisions set forth in any other Settlement Document. Grantor agrees to defend, protect, indemnify, and hold harmless Secured Party and its Affiliates and their respective officers, directors, members, managers, employees, attorneys, consultants, and agents from and against any and all losses, damages, liabilities, obligations, penalties, fines, fees, costs, and expenses (including, without limitation, attorneys’ and paralegals’ fees, costs and expenses, and fees, costs and expenses for investigations and experts) incurred by such indemnitees, whether before or from and after the date hereof, as a result of or arising from or relating to (a) any suit, investigation, action, or proceeding by any Person, whether threatened or initiated, asserting a claim for any legal or equitable remedy against any Person under any statute, regulation, or common law principle, arising from or in connection with Secured Party’s execution and delivery of this Agreement or any other Settlement Document; (b) Secured Party’s preservation, administration, and enforcement of its rights under the Settlement Documents and applicable law, including, without limitation, (i) all fees, costs of collection, attorneys’ fees and expenses of, or advances by, Secured Party which Secured Party pays or incurs (A) in discharge of obligations of Grantor, (B) to inspect, repossess, remove, transport, deliver, protect, store, preserve, complete, collect, store, sell or otherwise dispose of any Collateral, or (C) in connection with the appointment and administration of any receiver and (ii) the administration of and actions relating to any Collateral, this Agreement or the other Settlement Documents and the transactions contemplated hereby and thereby, including any actions taken to perfect or maintain priority of Secured Party’s Liens on any Collateral, to maintain any insurance required hereunder or to verify Collateral; and (c) the reasonable fees and disbursements of counsel for Secured Party in connection therewith, whether any suit is brought or not and whether incurred at trial or on appeal; (d) any civil penalty or fine assessed by and governmental authority against Secured Party and all reasonable costs and expense (including, without limitation, reasonable attorneys’ fees) incurred in connection with defense thereof by Secured Party, as a result of Secured Party’s entering into this Agreement or the other Settlement Documents, the acceptance of payments due under the Note or any other Settlement Documents, or the acceptance of any Collateral; (e) any matter relating to the transactions contemplated by this Agreement or the other Settlement Documents or by any other document executed in connection with the transactions contemplated hereby or thereby, other than for such loss, damage, liability, obligation, penalty, fee, cost or expense arising from such indemnitee’s gross negligence or willful misconduct; (f) any liability for payment of any state documentary stamp taxes, intangible taxes, or similar taxes (including interest or penalties, if any) which may now or hereafter be determined to be payable in respect to the execution, delivery, or recording of any Settlement Document, whether originally thought to be due or not, and regardless of any mistake of fact or law on the part of Secured Party (or its counsel) or Grantor with respect to the applicability of such tax; and (g) any payment made by Secured Party with respect to any taxes or other amount payable by Grantor required to be paid by the terms of this Agreement or any other Settlement Document and which may be reasonably necessary to protect or preserve any Collateral or Grantor’s or Secured Party’s interests therein. Grantor’s obligation for indemnification and reimbursement for all of the foregoing losses, damages, liabilities, obligations, penalties, fees, costs, and expenses of Secured Party shall be part of the Obligations, shall be secured by the Collateral, shall be due and payable by Grantor ON DEMAND, and shall survive termination of this Agreement.

 

10

 

 

12.           CUMULATIVE RIGHTS. All rights, powers, privileges and remedies of Secured Party shall be cumulative. No delay, failure or discontinuance of Secured Party in exercising any right, power, privilege or remedy hereunder shall affect or operate as a waiver of such right, power, privilege or remedy; nor shall any single or partial exercise of any such right, power, privilege or remedy preclude, waive or otherwise affect any other or further exercise or the exercise of any other right, power, privilege or remedy.

 

13.           WAIVERS AND CONSENTS OF SECURED PARTY. Any waiver, permit, consent or approval of any kind by Secured Party of any default, or any such waiver of any provisions or conditions, must be in writing and shall be effective only to the extent set forth in writing.

 

14.           DISPOSITION OF COLLATERAL AND PROCEEDS; TRANSFER OF INDEBTEDNESS. In disposing of Collateral, Secured Party may disclaim all warranties of title, possession, quiet enjoyment and the like. Any proceeds of any disposition of any Collateral, may be applied by Secured Party to the payment of expenses incurred by Secured Party, including reasonable attorneys’ fees, and the balance of such proceeds may be applied by Secured Party toward the payment of the Obligations in such order of application as Secured Party may from time to time elect. Upon the transfer of all or any part of the Obligations, Secured Party may transfer all or any part of the Collateral and shall be fully discharged from all liability and responsibility with respect to such transferred Collateral, and the transferee shall be vested with all rights and powers of Secured Party hereunder; but with respect to any Collateral not so transferred, Secured Party shall retain all rights, powers, privileges and remedies. It is agreed that public or private sales or other dispositions, for cash or on credit, to a wholesaler or retailer or investor, or user of property of the types subject to this Agreement, or public auctions, are all commercially reasonable since differences in the prices generally realized in the different kinds of dispositions are ordinarily offset by the differences in the costs and credit risks of such dispositions. Grantor agrees that, to the extent notice of sale shall be required by law, at least 10 days’ notice to Grantor of the time and place of any public sale or the time after which any private sale is to be made shall constitute reasonable notification and such notice shall constitute a reasonable “authenticated notification of disposition” within the meaning of Section 9-611 of the Code. Secured Party shall not be obligated to make any sale of Collateral regardless of notice of sale having been given. Secured Party may adjourn any public or private sale from time to time, and such sale may be made at the time and place to which it was so adjourned. Grantor agrees that the internet shall constitute a “place” for purposes of Section 9-610(b) of the Code. Grantor agrees that any sale of Collateral to a licensor pursuant to the terms of a license agreement between such licensor and Grantor is sufficient to constitute a commercially reasonable sale (including as to method, terms, manner, and time) within the meaning of Section 9-610 of the Code. Grantor grants to Secured Party a non-exclusive, worldwide and royalty-free license to use or otherwise exploit all intellectual property rights of Grantor for the purpose of: (a) completing the manufacture of any in-process materials following any Event of Default so that such materials become saleable Inventory, all in accordance with the same quality standards previously adopted by Grantor for its own manufacturing; and (b) selling, leasing or otherwise disposing of any or all Collateral following any Event of Default.

 

11

 

 

15.           STATUTE OF LIMITATIONS. Until all Obligations shall have been fully and finally paid in cash and performed, the power of sale or other disposition and all other rights, powers, privileges, and remedies granted to Secured Party shall continue to exist and may be exercised by Secured Party at any time and from time to time irrespective of the fact that the Obligations or any part thereof may have become barred by any statute of limitations or that the personal liability of Grantor may have ceased, unless such liability shall have ceased due to the payment in full in cash of all of the Obligations.

 

16.           WAIVERS OF GRANTOR. Grantor waives any right to require Secured Party to (a) proceed against Grantor or any other Person, (b) marshal assets or proceed against or exhaust any security from Grantor or any other Person, (c) perform any obligation of Grantor with respect to any Collateral; and (d) make any presentment or demand, or give any notice of nonpayment or nonperformance, protest, notice of protest or notice of dishonor hereunder or in connection with any Collateral or Proceeds.

 

17.           FURTHER ASSURANCES. At any time upon the request of Secured Party, Grantor will execute or deliver to Secured Party any and all financing statements, fixture filings, security agreements, assignments, endorsements, and all other documents (the “Additional Documents”) that Secured Party may request and in form and substance satisfactory to Secured Party, to create, perfect, and continue perfection or to better perfect Secured Party’s Liens in the Collateral (whether now owned or subsequently arising of acquired, tangible or intangible, real or personal), and in order to fully consummate all of the transactions contemplated under this Agreement and under the other Settlement Documents. If Grantor refuses or fails to execute or deliver any requested Additional Documents, Grantor authorizes Secured Party to execute such Additional Documents in Grantor’s name and authorizes Secured Party to file such executed Additional Documents in any appropriate filing office.

 

12

 

 

18.           NOTICES. Any notice or other communication hereunder to any party hereto or thereto shall be given in accordance with Section 18 of the Settlement Agreement, the provisions of which (as the same may be amended, restated, supplemented, or otherwise modified from time to time) are incorporated herein, mutatis mutandis.

 

19.           COSTS, EXPENSES AND ATTORNEYS’ FEES. Grantor shall pay to Secured Party immediately upon demand the full amount of all payments, advances, charges, costs and expenses, including reasonable attorneys’ fees, expended or incurred by Secured Party in connection with or related to this Agreement. Further, Grantor indemnifies Secured Party against all losses, claims, demands, liabilities, and expenses of every kind caused by property subject to this Agreement.

 

20.           SUCCESSORS; ASSIGNS; AMENDMENT. This Agreement will be binding upon and inure to the benefit of the heirs, executors, administrators, legal representatives, successors and assigns of the parties; provided that Grantor may not assign or transfer its interests, rights, or obligations under this Agreement without Secured Party’s prior written consent. Secured Party may sell, assign, transfer, negotiate, or grant participations in all or any part of, or any interest in, Secured Party’s rights and benefits under this Agreement and the other Settlement Documents. This Agreement may be amended or modified only in writing signed by Secured Party and Grantor.

 

21.           SEVERABILITY OF PROVISIONS. If any provision of this Agreement shall be held to be prohibited by or invalid under applicable law, such provision shall be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of such provision or any remaining provisions of this Agreement (and, in any such case, this Agreement shall be deemed amended to provide the parties hereto the benefit of their bargain as expressed herein to the maximum extent possible).

 

22.           GOVERNING LAW. Resolution of all disputes arising out of or related to this Agreement or the validity, construction, interpretation, enforcement, breach, performance, application or termination of this Agreement and any remedies relating thereto, shall be governed by and construed under the substantive laws of the State of New York, excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

 

23.           JURISDICTION; VENUE; CONSENT TO SERVICE OF PROCESS; AND WAIVER OF JURY TRIAL. THE PROVISIONS OF SECTIONS 14(b), 14(c), 14(d), AND 14(e) OF THE SETTLEMENT AGREEMENT ARE INCORPORATED INTO THIS AGREEMENT, MUTATIS MUTANDIS.

 

[Continued on following page.]

 

13

 

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed as of the day and year first above written.

 

  GRANTOR:
   
  METUCHEN PHARMACEUTICALS LLC
   
   
  By: /s/ Fady Boctor            
  Name: Fady Boctor
  Title: Authorized Person

 

 

 

  SECURED PARTY:
   
  VIVUS LLC
   
   
  By: /s/ John Amos            
  Name: John Amos
  Title: Chief Executive Officer

 

 

 

SCHEDULE A

 

CHIEF EXECUTIVE OFFICE AND PRINCIPAL PLACE OF BUSINESS

 

200 Route 9 North

Suite 500

Manalapan, NJ 07726

 

 

Exhibit 10.4

 

PLEASE NOTE: CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

  

AMENDMENT No. 1 TO

LICENSE AND COMMERCIALIZATION AGREEMENT

 

This Amendment No. 1 (this “Amendment”) to the License and Commercialization Agreement dated as of September 30, 2016, is hereby entered into and effective as of January 18, 2022 (the “Amendment Effective Date”) by and between VIVUS LLC, a Delaware limited liability company, (“VIVUS”), and Metuchen Pharmaceuticals LLC, a Delaware limited liability company (“Metuchen”). VIVUS and Metuchen are sometimes referred to in this Amendment collectively as the “Parties” and individually as a “Party”.

 

WHEREAS, VIVUS and Metuchen entered into the License and Commercialization Agreement dated September 30, 2016 (as amended, restated, amended and restated, supplemental or otherwise modified, the “License Agreement”), pursuant to which, among other things, in Section 2.1 of the License Agreement VIVUS granted to Metuchen an exclusive, royalty-bearing license to “(i) to use, distribute, import, Promote, market, sell, offer for sale, and otherwise Commercialize Products in the Field in the Licensee Territory; (ii) make and have made Products in the Manufacturing Territory, where such Product is solely for use or sale in the Field in the Licensee Territory (subject to Section 2.2), and (iii) to conduct certain Development activities on the Product in the Field pursuant to ARTICLE 4 solely in support of Regulatory Approval in the Licensee Territory”;

 

WHEREAS, in connection with the settlement of certain amounts that Metuchen has agreed are due and payable by Metuchen to VIVUS under that certain Commercial Supply Agreement dated September 30, 2016 (as amended, restated, amended and restated, supplemental or otherwise modified, the “Supply Agreement”), by and between Metuchen and VIVUS and in connection with amounts [***] deducted by CVS Pharmacy (“CVS”) of amounts owed to VIVUS from sale of VIVUS’s product QSYMIA, (i) Metuchen and VIVUS have entered into a Settlement Agreement dated as of even date herewith (“Settlement Agreement”), (ii) Metuchen has executed a promissory note payable to the order of VIVUS, dated as of even date herewith (the “Promissory Note”) and (iii) Metuchen has executed a security agreement to secure the obligations under the Promissory Note, dated as of even date herewith (“Security Agreement”);

 

WHEREAS the Supply Agreement was terminated on September 30, 2021;

 

WHEREAS, under the Settlement Agreement, Metuchen has expressly agreed (among other things) that (i) VIVUS will retain co-exclusive rights to exercise the VIVUS Exploitation Rights (as defined in the Settlement Agreement) in the Licensee Territory, (ii) upon an Event of Default (as defined in the Security Agreement), the License Agreement will terminate, (iii)  VIVUS will have and maintain such rights to use all Metuchen regulatory documentation, rights of reference to all regulatory submissions to Regulatory Authorities and other rights as may be necessary or appropriate in VIVUS’ discretion in order to enable VIVUS to immediately commence the exercise of the VIVUS Exploitation Rights; and (iv) Metuchen will agree and stipulate (A) that VIVUS is the sole and exclusive owner of all of the API unless or until such time that certain quantities of API are shipped to Metuchen against payments made under the Promissory Note in accordance with Section 7 of the Settlement Agreement, and (B) VIVUS’ exercise of the VIVUS Exploitation Rights will not be subject to the automatic stay, any need for a court order (including that of a bankruptcy court) or in any way impact property of a Metuchen bankruptcy estate upon the occurrence of an Event of Default;

 

 

 

WHEREAS, as a condition to acceptance of the Settlement Agreement, the Promissory Note and Security Agreement by VIVUS, the Parties have agreed to amend the License Agreement as set forth herein.

 

NOW, THEREFORE, in consideration of the foregoing and the agreements contained herein, Metuchen and VIVUS hereby agree as follows:

 

1.            Capitalized terms used but not defined in this Amendment shall have the meanings ascribed to them in the License Agreement.

 

2.            The Article 1 of the License Agreement is hereby amended to add the following definition:

 

VIVUS Exploitation Rights” means VIVUS’ right to Develop, Commercialize (as such terms are defined in the License Agreement), make and have made and otherwise exploit the Product in the Licensee Territory (as such terms are defined in the License Agreement), as to each, without limitation.

 

The Article 1 of the License Agreement is hereby amended as follows:

 

The last sentence of the defined term “Financing Entity” shall be amended to insert (x) the underlined text that follows “(i) … are not Financing Entities” and “(ii) … are not Financing Documents” as the Hercules Loan Agreements and the “Agent” and “Lenders” have been irrevocably satisfied in full and the Hercules Loan Agreements (including the letter agreement dated September 30, 2016 between VIVUS and Hercules Capital, Inc.) have been terminated without further obligation or liability, and (y) just prior to the last sentence, the following: “The Parties acknowledge that the note, security agreement and ancillary or related documents entered into on January 18, 2022 by Metuchen and VIVUS (and as amended from time to time) constitute Financing Documents and that VIVUS is a Financing Entity in its capacity as countersignatory to those documents.

 

3.            The License Agreement is hereby amended to delete Section 2.1 and replace it with a new Section 2.1 as follows:

 

2.1            License to Licensee. Subject to the terms and conditions of this Agreement (including VIVUS’ retained rights as set forth in Section 2.4), VIVUS hereby grants to Licensee a co-exclusive, royalty-bearing (subject in all respects to Section 7.2), sublicensable (subject to ARTICLE 6) license under the VIVUS Technology, (i) to use, distribute, import, Promote, market, sell, offer for sale, and otherwise Commercialize Products in the Field in the Licensee Territory; (ii) make and have made Products in the Manufacturing Territory, where such Product is solely for use or sale in the Field in the Licensee Territory (subject to Section 2.2), and (iii) to conduct certain Development activities on the Product in the Field pursuant to ARTICLE 4 solely in support of Regulatory Approval in the Licensee Territory and solely in accordance with the terms of this Agreement (collectively, the “License”).

 

 

 

4.            The License Agreement is hereby amended to delete Section 2.3 and replace it with a new Section 2.3 as follows:

  

2.3            License to VIVUS. Subject to the terms and conditions of this Agreement, Licensee hereby grants to VIVUS (a) a non-exclusive, royalty-free, sublicensable (subject to ARTICLE 6) license under the Licensee Technology, Regulatory Materials (including rights of reference to all of Licensee’s submissions to Regulatory Authorities) and Promotional Materials (i) to the extent necessary or desirable to fulfill obligations under this Agreement, including manufacturing and supply obligations under ARTICLE 6 and (ii) to conduct research, Development, Commercialization and manufacturing activities in the Licensee Territory; (b) an exclusive, royalty-free, sublicensable (subject to ARTICLE 6) license under the Licensee Technology, Regulatory Materials (including rights of reference to all of Licensee’s submissions to Regulatory Authorities) and Promotional Materials to conduct research, Development, Commercialization and manufacturing activities of Products in the VIVUS Territory; and (c) a non-exclusive, royalty-free, sublicensable (subject to ARTICLE 6) license under the Licensee Technology, Regulatory Materials (including rights of reference to all of Licensee’s submissions to Regulatory Authorities) and Promotional Materials to otherwise exercise the VIVUS Exploitation Rights (collectively, the “VIVUS License”).

 

5.            The License Agreement is hereby amended to delete Section 2.4 and replace it with a new Section 2.4 as follows:

 

2.4            VIVUS Retained Rights.

 

(a)            Notwithstanding the rights granted to Licensee under the License, VIVUS retains its rights under the VIVUS Technology within the Field in the Licensee Territory, and retains all rights to conduct Development, Commercialization, manufacturing and all other activities associated with exercise of the VIVUS Exploitation Rights within the Licensee Territory, including all rights as may be necessary or desirable to exercise in connection with the Regulatory Approval, Pricing Approval, or Commercialization of the Product in the Licensee Territory and in the VIVUS Territory (including the right to grant licenses to Affiliates or Third Parties with respect to such activities). VIVUS retains all rights to the VIVUS Technology outside the Field.

 

(b)            Licensee acknowledges and agrees that VIVUS’ co-exclusive rights as stated in Section 2.1 and its retained rights as set forth in Section 2.4(a) above enable VIVUS, at any time, to exercise the VIVUS Exploitation Rights, without restriction within the Licensee Territory; provided however, that unless or until an Event of Default occurs, VIVUS agrees to forbear from exercising the VIVUS Exploitation Rights in the Licensee Territory; provided further however, that upon the occurrence of an Event of Default, Metuchen shall not have, and waives, any and all rights and defenses under the License Agreement, the Settlement Agreement, the Promissory Note, the Security Agreement or otherwise at law or in equity to challenge, delay, restrict, impede, or otherwise interfere with VIVUS’ immediate and automatic right to exercise any or all of the VIVUS Exploitation Rights and any other rights retained by VIVUS. Neither Licensee nor any of its sublicensees shall (or seek to) challenge, delay, restrict, impede, or otherwise interfere with VIVUS’s retained rights and any such action by Licensee or any of its sublicensees shall constitute a material breach of this Agreement and VIVUS may immediately terminate this Agreement.

 

 

 

6.            The License Agreement is hereby amended to delete Section 12.2(a) and replace it with a new Section 12.2(a) as follows:

 

(a)            Material Breach. Metuchen shall have the right to terminate this Agreement, upon written notice to VIVUS if VIVUS, after receiving written notice from Metuchen identifying a material breach by VIVUS of its obligations under this Agreement, fails to cure (or if not curable within such time period, adopt a plan for cure during such time period) such material breach within [***] from the date of such notice (or, in the case of payment obligations, [***] from the date of such notice); provided, however, that in the event the VIVUS contests any such asserted breach in good faith and diligently pursues the dispute resolution procedures set forth in ARTICLE 13, such [***] cure period shall be tolled or suspended until the final resolution of such dispute pursuant to the terms of, and in accordance with, the terms and provisions of ARTICLE 13, subject to any exercise by MTPC of its right of termination of the MTPC Agreement due to any material breach of the provisions or conditions of the MTPC Agreement by VIVUS arising from the facts or circumstances that resulted in the material breach by VIVUS hereunder. For the avoidance of doubt (and without limiting VIVUS’ remedies for any other breaches by Licensee), Licensee’s failure to pay the amounts set forth in Section 7.1 by the deadlines set forth therein shall each be deemed to be a material breach of this Agreement.

 

7.            The License Agreement is hereby amended to add a new Section 12.2(e) as follows:

 

(e)            VIVUS Termination of License Upon Event of Default. Licensee is the maker of that certain Promissory Note dated as of January 18, 2022, payable to the order of VIVUS (the “Promissory Note”), which Promissory Note is secured under the terms of that certain Security Agreement by and between Licensee and VIVUS dated January 18, 2022 (the “Security Agreement”). VIVUS and Licensee agree that, in the event of (i) any Event of Default (as defined in the Security Agreement) or (ii) material breach of this Agreement by Metuchen, this Agreement shall terminate.

 

8.            Section 14.5 of the License Agreement is amended to insert the following underlined text in the second line thereof: “… except that, subject in each instance to the terms of the Financing Documents entered into with VIVUS as Financing Party and compliance therewith, (a) …”

 

9.            Section 14.8 of the License agreement is amended to replace the words “Hercules Capital, Inc.” with “VIVUS as Financing Party.”

 

10.            Further Assurances and Inconsistencies. Licensee acknowledges and agrees that this Amendment is intended to fully vest in VIVUS all of the necessary rights and privileges to practice and exploit the VIVUS Technology and to Develop, manufacture, have manufactured and otherwise Commercialize the Product in the Licensee Territory at such time and in such manner as VIVUS may determine. To the extent that VIVUS deems the execution of any agreement, further amendment to the License Agreement or such other document or any action (including with respect to FDA or any other Regulatory Authority), omission or otherwise as VIVUS may determine as necessary or appropriate in its sole discretion, Metuchen will and will cause any sublicensee or subcontractor to execute such document or perform such action, omission or otherwise in a prompt and timely manner. Any failure of Metuchen or any sublicensee or subcontractor to execute such documents or perform such further action, omission or otherwise in a prompt and timely manner as requested by VIVUS shall constitute a material breach of the License Agreement and VIVUS may immediately terminate the License Agreement.

 

 

 

11.            The License Agreement is amended as set forth in this Amendment as of the Amendment Effective Date. To the extent that the License Agreement is in any way inconsistent with the terms of this Amendment, this Amendment shall control and such inconsistent provisions shall be revised to fulfill the agreements set forth in this Amendment. To the extent that the License Agreement, as amended by this Amendment, is in any way inconsistent with the terms of the Financing Documents entered into with VIVUS as Financing Party, such Financing Documents shall control and such inconsistent provisions shall be revised to fulfill the agreements set forth in the Financing Documents entered into with VIVUS as Financing Party.

 

12.            The defined terms “VIVUS” and “Party” or “Parties” in the License Agreement or this Amendment shall not include VIVUS in its capacity as Financing Party unless expressly provided for therein absent notice from VIVUS provided after the Amendment Effective Date.

 

13.            Except as specifically provided for in this Amendment (including the resolution of any conflicts between this Amendment and the terms of the License Agreement in favor of the terms of this Amendment), all of the terms and conditions of the License Agreement shall remain in full force and effect as legally binding obligations of the Parties enforceable in accordance with their terms. Metuchen and VIVUS hereby ratify and confirm their respective obligations under the Agreement, as modified pursuant to this Amendment.

 

14.            This Amendment may be executed in counterparts, each of which shall be deemed an original, but all of which shall constitute one and the same instrument. All signatures need not be on the same counterpart.

 

[signature page follows]

 

 

 

IN WITNESS WHEREOF, the Parties have executed or caused this Amendment to be executed as of the Amendment Effective Date.

 

 

VIVUS, LLC     METUCHEN PHARMACEUTICALS LLC
     
     
BY: /s/ John Amos    BY: /s/ Fady Boctor
         
NAME: John Amos     NAME: Fady Boctor  
     
TITLE: Chief Executive Officer     TITLE: Authorized Person  

 

[Amendment to License and Commercialization Agreement]