UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported):
(Exact name of registrant as specified in charter)
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
(Address of principal executive offices and zip code)
(
(Registrant’s telephone number including area code)
N/A
(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 registrant under any of the following provisions (see General Instruction A.2. below):
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| Soliciting material pursuant to Rule 14a-12(b) 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 | ||
| The (Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by checkmark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act.
Item 1.01. Entry into a Material Definitive Agreement.
On December 10, 2025, Cadrenal Therapeutics, Inc., a Delaware corporation (the “Company”) entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Veralox Therapeutics Inc., a Delaware corporation (“Seller”) pursuant to which Seller sold all or substantially all of its right title and interest in assets owned or otherwise used or held for use by Seller in connection with the compound known as VLX-1005 (“VLX-1005”), and all back-up and follow-on compounds, including the VLX-2000 series (the “Compounds”), including, without limitation, all intellectual property related to the Compounds, all inventory related to the Compounds, certain contracts including a license agreement, all Permits and other Governmental Authorizations and Books and Records (as such terms are defined in the Purchase Agreement), free and clear of any liens (collectively referred to as the “Assets”). The transactions contemplated by the Purchase Agreement were consummated on December 10, 2025 (the “Closing”).
The Purchase Price payable by the Company to the Seller for the Assets consists of (i) a cash payment of $200,000, (ii) the assumption of certain Assumed Liabilities (as such term is defined in the Purchase Agreement) by the Company; (iii) contingent milestone payments in an amount not to exceed $15 million, and (iv) royalty payments described below.
The contingent milestone payments, which are payable in cash, common stock, or in any combination thereof in the Company’s sole discretion, are payable upon the achievement of the following clinical and regulatory milestone events:
| (i) | $2,000,000 upon the occurrence of the dosing of the first patient enrolled in the first clinical trial initiated after Closing for VLX-1005; |
| (ii) | $8,000,000 upon approval of the first regulatory filing seeking approval to market a pharmaceutical product for human use containing a Compound that is covered by a patent owned or licensed by the Seller (the “Product”) in the United States; |
| (iii) | $2,000,000 upon approval of the first regulatory filing seeking approval to market a Product outside the United States; |
| (iv) | $2,000,000 upon approval of a regulatory filing seeking approval to market a Product for a subsequent indication in the United States; and |
| (v) | $1,000,000 upon approval of a regulatory filing seeking approval to market a Product for a subsequent indication outside the United States. |
The Company will pay the Seller royalties of 5% on the Annual Net Sales (as such term is defined in the Purchase Agreement) of each Product containing any of the Compounds that are the subject of the Purchase Agreement which are covered by a Valid Patent Claim (as such term is defined in the Purchase Agreement) in any country, such royalty to be payable from the first commercial sale of the Product in each country until the expiration of the last-to-expire Valid Patent Claim that would be infringed by the commercialization of such Product in that country, provided however that, on a Product-by-Product and country-by-country basis, in the event that, with respect to a Product in a country, Generic Competition (as such term is defined in the Purchase Agreement) exists with respect to such Product in such country in a calendar year, then the royalty rates in such country for such Product will thereafter be reduced by fifty percent (50%). The Purchase Agreement also provides that in the event that the Seller or its affiliates licenses or otherwise acquires rights from one or more third-parties in order to make, use, sell, import or otherwise exploit a Product in a country, then 50% of any amounts payable to the third-party in such country shall be deductible from the royalty amounts payable to Seller.
The Purchase Agreement contains customary representations, warranties and agreements by the Company and the Seller, customary conditions to closing, and other obligations of the parties. Subject to certain customary limitations, the Seller agreed to indemnify the Company, its affiliates and each of their respective successors, assigns, officers, directors, shareholders, partners, employees and agents against certain losses related to, among other things, breaches of the Seller’s representations, warranties and covenants contained in the Purchase Agreement, as well as any retained liabilities or excluded assets described therein. Subject to certain customary limitations, the Company also agreed to indemnify the Seller, its affiliates and each of their respective successors, assigns, officers, directors, shareholders, partners, employees and agents against certain losses related to, among other things, breaches of the Company’s representations, warranties and covenants as well as any assumed liabilities.
1
The Assets also include the assignment of an Amended and Restated Exclusive License Agreement by and between the Seller and Old Dominion University, as successor in interest to Eastern Virginia Medical School (“Licensor”), dated as of May 1, 2020, as amended on December 9, 2025 pursuant to a First Amendment to Amended and Restated Exclusive License Agreement (the “Amendment to License Agreement”) by and between Old Dominion University, as successor in interest to Eastern Virginia Medical School, and the Seller (as amended, collectively, the “License Agreement”), pursuant to which Licensor granted Seller an exclusive worldwide license under the EVMS Patent Rights (as such term is defined in the License Agreement) related to the development and commercialization of 4-((2-Hydroxy-3-MethoxyBenzyl)Amino) Benzenesulfonamide Derivatives as 12-Lipoxygenase Inhibitors (“12-LOX”). Pursuant to the License Agreement, the Seller agreed to pay Licensor certain royalties and certain milestone payments related to the first Licensed Product or Licensed Service developed, some of which will be assumed by the Company as part of the Assumed Liabilities. The term “Licensed Product” is defined in the License Agreement as any process or method, material, composition, drug or other product, the manufacture, use or sale of which by Seller, its affiliates or sublicensees would constitute, but for the license granted to Seller pursuant to the License Agreement, an infringement of any Valid Claim (as such term is defined in the License Agreement) of any of the EVMS Patent Rights . The term “Licensed Service” is defined in the License Agreement as the performance on behalf of a third-party by Seller, its affiliates or sublicensees of any method or the manufacture of any product or the use of any product or composition which would constitute, but for the license granted to Seller pursuant to the License Agreement, an infringement of a Valid Claim of the EVMS Patent Rights.
Pursuant to the License Agreement, the Company will pay Licensor milestone payments in the aggregate amount of $300,000 upon regulatory approval to market a Licensed Product in: (i) Japan or the European Union; and (ii) the United States, provided however that irrespective of whether such milestones are met, such milestone payments will be due in 2031 and 2032, respectively. Additionally, the Company will pay to Licensor royalties of 2% on worldwide net sales of a Licensed Product or Licensed Service less than or equal to $200,000,000 and royalties of 3% on worldwide sales greater than $200,000,000. Regardless of the commercialization status of any Licensed Product or Licensed Service, the License Agreement requires a minimum annual royalty payment to be paid to Licensor within (30) days of May 1st of each year beginning May 1, 2025, ranging between $10,000 and $50,000 per year. Such annual royalty payments have been waived by Licensor for fiscal years 2026, 2027 and 2028, with the first payment to be made by the Company due May 1, 2029.
The License Agreement may be terminated: (i) upon the failure of a party to perform any material obligation required of it to be performed under the License Agreement and thereafter such failure to perform is not timely cured, by the non-defaulting party upon written notice; (ii) by either party upon the bankruptcy or insolvency of the other party upon written notice: (iii) by the Company with or without Cause (as such term is defined in the License Agreement) upon 90 days’ written notice to Licensor; and (iv) by Licensor: (a) in the event the Company fails to meet any of the Milestone Deadlines (as such term is defined in the License Agreement) upon 90 days’ written notice; or (b) immediately in the event the Company or any of its affiliates brings, or assists others in bringing, a Patent Challenge (as such term is defined in the License Agreement) against Licensor or any co-owner of the EVMS Patent Rights. The foregoing descriptions of the Purchase Agreement and License Agreement do not purport to be complete and are qualified in their entirety by reference to the Purchase Agreement, License Agreement and Amendment to License Agreement, copies of which are filed as Exhibits 10.1, 10.2 and 10.3, respectively, to this Current Report on Form 8-K (“the Current Report”) hereto and incorporated by reference herein.
Item 7.01. Regulation FD Disclosure.
On December 11, 2025, the Company issued a press release announcing the acquisition and consummation of the transactions contemplated by the Purchase Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and is incorporated into this Item 7.01 by reference herein.
The information included under Item 7.01 of this Current Report (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise be subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended or the Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.
2
Caution Concerning Forward Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “expects,” “intends,” “projects,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning the development of the Compounds and the Company’s payment of milestone payments and royalties. Forward-looking statements are based on management’s current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding the Company’s business are described in detail in its filings with the Securities and Exchange Commission (the “SEC”), including in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on March 13, 2025, the Company’s Quarterly Report for the quarter ended March 31, 2025 filed with the SEC on May 8, 2025, the Company’s Quarterly Report for the quarter ended June 30, 2025 filed with the SEC on August 11, 2025, the Company’s Quarterly Report for the quarter ended September 30, 2025 filed with the SEC on November 10, 2025 and in the Company’s subsequent filings with the SEC, which are available on the SEC’s website at www.sec.gov. Additional information will be made available in other filings that the Company makes from time to time with the SEC. These forward-looking statements speak only as of the date hereof, and the Company disclaims any obligation to update these statements except as may be required by law.
Item 8.01. Other Events.
On December 11, 2025, the Company posted an updated corporate presentation on its website (the “Presentation”) for use in meetings with investors, analysts and others, which discusses the development of its anticoagulation pipeline. The Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are furnished with this Current Report on Form 8-K:
| Exhibit Number |
Exhibit Description | |
| 10.1* | Asset Purchase Agreement between Cadrenal Therapeutics, Inc. and Veralox Therapeutics, Inc., dated December 10, 2025 | |
| 10.2* | Amended and Restated Exclusive License Agreement by and between Eastern Virginia Medical School and Veralox Therapeutics, Inc., dated May 1, 2020 | |
| 10.3 | First Amendment to Amended and Restated Exclusive License Agreement by and between Old Dominion University, as successor in interest to Eastern Virgina Medical School, and Veralox Therapeutics, Inc., effective as of December 9, 2025 | |
| 99.1 | Press Release of Cadrenal Therapeutics, Inc. dated December 11, 2025 | |
| 99.2 | Corporate Presentation dated December 2025 | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
| * | Exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company agrees to furnish supplementally a copy of any omitted exhibit or schedule to the SEC upon request. |
3
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.
| Dated: December 11, 2025 | CADRENAL THERAPEUTICS, INC. | |
| By: | /s/ Quang X. Pham | |
| Name: | Quang X. Pham | |
| Title: | Chairman and Chief Executive Officer | |
4
Exhibit 10.1
ASSET PURCHASE AGREEMENT
THIS ASSET PURCHASE AGREEMENT (this “Agreement”) is made as of December 10, 2025 (the “Execution Date”) by and between Cadrenal Therapeutics, Inc., a Delaware corporation (“Purchaser”), and VERALOX THERAPEUTICS Inc., a Delaware corporation (“Seller”). Purchaser and Seller are referred to in this Agreement individually as a “Party” and together as the “Parties.” Capitalized terms in this Agreement have the respective meanings given to them in Section 1.1 or the other applicable provisions of this Agreement (including this preamble).
RECITALS
A. Seller owns certain compounds and assets related thereto, including but not limited to patents and intellectual property rights, rights under license agreements, non-clinical and clinical data and samples, CMC methods and data and materials including drug substance inventory, development and commercialization strategies, market research analyses and reports, business plans, financial models and projections, books and records, and regulatory communications, approvals and filings including investigational new drug applications, and any other item(s) that may be useful for the development, regulatory approval and commercialization of the Products that may be in the possession of the Seller and/or to which the Seller has the rights and Company Intellectual Property (defined below).
B. Subject to the terms and conditions set forth herein, Seller desires to sell, transfer, assign and deliver to Purchaser, and Purchaser desires to purchase and acquire from Seller, all or substantially all of Seller’s assets with respect to the Compounds, including, without limitation, all of Seller’s right, title and interest in and to the Compounds and the Company Intellectual Property, free and clear of any Liens (the “Acquisition”).
AGREEMENT
NOW, THEREFORE, in consideration of the premises and for other good and valuable consideration, the receipt and sufficiency of which are hereby expressly acknowledged, the Parties, intending to be legally bound, hereby agree as follows:
Article I. DEFINITIONS
1.1 Definitions. The following capitalized terms shall, for all purposes of the Agreement, have the following meanings:
“Accounting Standards” means the accounting standards used by a party for maintaining its records and books of accounts, which are in accordance with U.S. GAAP.
“Affiliate” with respect to any Person, any other Person directly or indirectly controlling, controlled by, or under common control with such Person provided that, for purposes of this definition, “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”), as used with respect to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities or by contract or otherwise.
“Annual Net Sales” means gross cash received by the Purchaser and its Affiliates and licensees for sales of any Product sold to unaffiliated Third Parties in an arms-length transaction after the deductions set forth below (the “Sales Deductions”), as determined in accordance with the Accounting Standards of Purchaser and/or its licensees, as applicable, as consistently applied (“Net Sales”), in a Calendar Year. The deductions actually booked on an accrual basis by Purchaser and its Affiliates and licensees to calculate the recorded Net Sales from gross sales shall be limited to the following:
| (i) | normal trade and cash and quantity discounts; |
| (ii) | amounts repaid or credited by reasons of defects, rejections, recalls or returns; |
| (iii) | retroactive price reductions, shelf stocking adjustments, credits or allowances actually granted or accrued upon claims or rejections or returns of Products, rebates and chargebacks to customers and Third Parties (including, without limitation, Medicare, Medicaid, Managed Healthcare and similar types of rebates) and related administrative fees; |
| (iv) | amounts provided or credited to customers through coupons and other discount programs; |
| (v) | amounts written off by reason of uncollected debt if and when actually written off or allowed, provided that such amounts shall be added back to Net Sales if and when collected; |
| (vi) | costs of freight, shipping, insurance, customs duties and other transportation and distribution charges directly related to the distribution of the Product; |
| (vii) | taxes, duties, tariffs or other governmental charges (including any tax such as a value added or similar tax, but excluding any taxes based on income) levied on or measured by the billing amount for the Product; |
| (viii) | other reductions or specifically identified amounts deducted for reasons similar to those set forth above in accordance with Accounting Standards of Purchaser and/or its licensees; and |
| (ix) | in respect of sales outside the United States, deductions in the applicable jurisdiction that are substantially similar to deductions otherwise set forth in clauses (i) through (viii), above, but because of local applicable law, practices and customs may not conform in terminology to the deductions set forth in the said clauses (i) through (viii). |
With respect to the calculation of Annual Net Sales:
| (i) | In the event that a Product is sold as a Combination Product, the Net Sales will be calculated by multiplying the net sales of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in the relevant country of the Product when sold separately in finished form, and B is the weighted average sale price (by sales volume) in that country of the other product(s) or systems that are part of the Combination Product sold separately in finished form. If the weighted average sale price cannot be determined for the Product or other product(s) or systems that are part of the Combination Product, the calculation of net sales for Combination Product will be agreed by the Parties based on the relative value contributed by each component (each Party’s agreement not to be unreasonably withheld or delayed). |
2
| (ii) | Net Sales shall not include revenue received by Purchaser (or any of its Affiliates) from transactions with an Affiliate, where the Product in question will be resold to an independent third-party distributor, agent or end user by the Affiliate (such revenue to be considered Net Sales at the time of receipt of revenue by such Affiliate or its sublicensee from an independent third party distributor, agent or end user). |
| (iii) | Net Sales shall not include units of Product disposed of by Purchaser for purposes directly related to pre-clinical or clinical studies, regulatory approval or clearance, that are reasonable or customary in the trade. |
“Books and Records” means all drawings, specifications, manuals, notes, logs, documents, papers, books, records, data, analyses, reports, labeling, operating and production records, manuals, files and information, all other works of authorship regarding or relating to the Compounds or the other Purchased Assets, including research, development, manufacturing, testing and non-clinical study, pre-clinical study, and clinical trial results and data related thereto, lab books, working papers, audit results, consultant reports, Regulatory Documentation, and any drug master files. Books and Records also includes all: (i) sales promotion materials, creative materials, art work, photographs, public relations and advertising material, studies, reports and records; (ii) all information regarding past, present and prospective clients and customers and all client, customer, prospect and supplier lists and schedules (and all related files and records) with respect to past, present or prospective clients, customers and suppliers and all goodwill and benefits associated therewith; (iii) copies of Assigned Contracts, and (iv) all financial records regarding the Compounds or other Purchased Assets and information relating to markets, business plans and strategies.
“Business Day” means any day other than a Saturday, Sunday or a day on which banks in New York, New York are authorized or obligated by applicable Law or executive Order to close or are otherwise generally closed.
“Calendar Year” means the period from January 1 until December 31.
“Claim” means suit, action, investigation, allegation, proceeding, inquiry or other claim or legal or administrative proceeding.
“Closing Date Payment” means $200,000.
“Common Stock” means the common stock, par value $0.001, of the Purchaser.
“Code” means the Internal Revenue Code of 1986, as it may be amended from time to time, and any successor thereto. Any reference herein to a specific section or sections of the Code shall be deemed to include a reference to any corresponding provision of future law.
3
“Combination Product” means a product in a finished dosage containing a Product in combination with one or more other products or as part of a bundled product or as part of a delivery system.
“Company Intellectual Property” means all U.S. and foreign (a) Patents, (b) Trademarks, (c) Copyrights, (d) confidential and proprietary and information, including Know-How or other proprietary rights in technical, scientific, manufacturing, regulatory and other information, inventions (whether or not patentable), discoveries, designs, results, techniques, database rights, data, databases, data collections and other know-how, including plans, improvements, processes, practices, methods, trade secrets, instructions, industrial models, algorithms, designs, technology, methodologies, formulae, formulations, recipes, compositions, specifications, protocols, analytical and quality control information and procedures, test data and results, reports, studies, and marketing, pricing, distribution, cost and sales information, (e) Internet domain names, and (f) any other proprietary rights relating to any of the foregoing and any registrations and applications for registration of the foregoing, in each case ((a) – (f)) related to, regarding, or used or held for use by Seller in connection with the Compounds. For avoidance of doubt, the Company Intellectual Property includes all Patents, Trademarks, and Copyrights set forth on Schedule 2.1(b)(i).
“Compounds” means the compound known as VLX-1005 (“VLX-1005”), and all back-up and follow-on compounds, including the VLX-2000 series.
“Confidential Information” means and includes all information of either Party that is disclosed by one Party to the other Party in connection with this Agreement, including all technical information, inventions, developments, discoveries, software, know-how, methods, techniques, formulae, animate and inanimate materials, data, processes, finances, business operations or affairs, and other proprietary ideas, whether or not patentable or copyrightable. The Parties acknowledge and agree that (i) the terms and conditions of this Agreement will be deemed the Confidential Information of both Parties, (ii) information that constitutes Confidential Information of a Party shall be treated as such regardless of whether such information is marked or identified as confidential, and (iii) after Closing, any Confidential Information of Seller that is included in the Purchased Assets will be considered the Confidential Information of Purchaser. Notwithstanding the foregoing, Confidential Information will not include the following, in each case, to the extent evidenced by competent written proof of the receiving Party: (i) information that was generally available to the public or otherwise part of the public domain at the time of its disclosure to the receiving Party; and (ii) information that became generally available to the public or otherwise part of the public domain after its disclosure, other than through any act or omission of the receiving Party in breach of this Agreement.
“Contract” means any agreement, lease, license, mortgage, indenture, note, debenture, credit agreement, security agreement or other contract or commitment, whether written or oral.
“Copyrights” means copyrights and all copyright and copyrighted works, including database rights, computer software, websites and firmware (existing in any form) (and all registrations, applications, renewals and extensions of any of the foregoing), together with all amendments, alterations, modifications, restorations and reversions of any of the foregoing.
4
“Covered” means that the use, manufacture, sale, offer for sale, research, development, commercialization, or importation of the subject matter in question would, absent a license thereto (or ownership thereof) infringe a granted Valid Patent Claim (or, in the case of a pending Valid Patent Claim that has not yet been granted, would infringe such Valid Patent Claim if it were to be granted in its then-current form) of a Patent.
“EVMS License Agreement” means that certain Amended and Restated Exclusive License Agreement by and between Seller and Eastern Virginia Medical School (“EVMS”), dated as of May 1, 2020.
“FDA” means the U.S. Food and Drug Administration.
“FFDCA” means the U.S. Federal Food, Drug and Cosmetic Act of 1938, as amended.
“First Patient In” means the dosing of the first patient enrolled in a clinical study.
“GAAP” means generally accepted accounting principles in the United States.
“Generic Competition” means the availability in the Territory of a therapeutic product, which is equivalent to and references the marketing authorization of the Product or a Combination Product.
“Governmental Authorities” means any government, any governmental or quasi-governmental entity or municipality or political or other subdivision thereof, department, commission, board, self-regulating authority, bureau, branch, authority, official, agency or instrumentality, and any court, tribunal, arbitrator or judicial body, in each case, whether federal, state, city, county, local, provincial, foreign or multi-national.
“Governmental Authorization” means any authorization, order, Permit, approval, grant, license, quota, consent, commitment, right, franchise, privilege, certificate, judgment, writ, injunction, award, determination, direction, decree or demand or the like, including any IND or Product Registration and any amendment or supplement thereto, which may be issued or granted by law or by rule or regulation of any Governmental Authorities and all pending applications for renewal of the foregoing, in each case related to the development, manufacture, import, export, or exploitation of the Compounds or the Products.
“Governmental Charges” means all Taxes, levies, assessments, reassessments and other charges together with all related penalties, interest and fines, due and payable to any Governmental Authorities.
“IND” means an Investigational New Drug Application, as defined in the FFDCA, as amended, and all regulations promulgated thereunder, or an analogous application, filing or submission to the analogous Governmental Authority in a regulatory jurisdiction outside the United States, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.
“IRS” means the United States Internal Revenue Service.
5
“Know-How” means trade secrets and all other confidential, technical or proprietary information and know-how of any kind (including, without limitation, ideas, inventions (whether or not patentable), discoveries, processes, techniques, methods, designs, processes, research and development information, source code, improvements, technology, data, specifications, proposals, financial, business and marketing plans, and customer and supplier lists).
“Knowledge of Seller” or “Seller’s Knowledge” means the actual knowledge following due inquiry of any director or officer of Seller and including the Persons set forth on Schedule 1.
“Law” or “Laws” means, at the applicable time, each provision of any then currently existing federal, state, regional, provincial, local or foreign laws, including any statute, standard, ordinance, act, code, order, rule, regulation, constitutional provision, decree, promulgation or common law of any Governmental Authority, the rules of any securities exchange, and each term of any order, judgment, award or decree then currently existing of any court, arbitrator or tribunal of any Governmental Authority (including the United States Patent and Trademark Office).
“Liability” means any direct or indirect indebtedness, liability, assessment, expense, claim, loss, damage, deficiency, obligation or responsibility, known or unknown, disputed or undisputed, joint or several, vested or unvested, executory or not, fixed or unfixed, choate or inchoate, liquidated or unliquidated, secured or unsecured, determinable or undeterminable, accrued or unaccrued, absolute or not, actual or potential, contingent or otherwise (including any liability under any guarantees, letters of credit, performance credits or with respect to insurance loss accruals).
“Lien” means any mortgage, lien (including mechanics, warehousemen, laborers and landlords liens), claim, pledge, charge, community property interest, equitable interest, right-of-way, easement, encroachment, security interest, preemptive right, right of first refusal or similar restriction or right, option, judgment (including any judgments arising from Proceedings instituted against Seller), title defect or encumbrance of any kind.
“Ordinary Course of Business” means the ordinary course of business of Seller, consistent with past practices.
“Patents” means all patents and patent applications (whether provisional or non-provisional), and any patent cooperation treaty (PCT) applications, continuations, divisionals, continuations-in-part, substitutions, restorations, renewals, reissues, revisions, extensions, and reexaminations (or any other patent resulting from a post-grant proceeding) thereof, and other Governmental Authority-issued indicia of invention ownership (including certificates of invention, petty patents, and patent utility models) as well as any patent and patent application, filed or issued in any foreign country or the United States, that claims priority to (directly or indirectly, in whole or in part) the foregoing patent, patent application, or PCT application (and any patents granted therefor).
“Permits” means all permits, licenses, franchises, approvals, authorizations, registrations, certificates, certifications, privileges, waivers, exemptions, variances and similar rights issued by, filed with, obtained from, or required to be obtained from, any Governmental Authority and any right of reference to any drug master file, in each case related to the development, manufacture, import, export, or exploitation of the Compounds or the Products.
6
“Permitted Lien” means (1) statutory Liens for current Taxes that are not yet due and payable as of the Closing Date or which are being contested in good faith; (2) Liens imposed by applicable law (such as materialmen’s, mechanic’s, workmen’s, carrier’s and repairmen’s Liens) (3) Liens arising under original purchase price conditional sales contracts and equipment leases with third parties entered into in the Ordinary Course of Business; and (4) other non-monetary Liens, in each case that arise or are incurred in the Ordinary Course of Business, are not material in amount and do not adversely affect the title of, materially detract from the value of or materially interfere with any present use of, the assets or properties affected by such Lien.
“Person” means an individual, corporation, partnership, limited partnership, limited liability company, limited liability partnership, syndicate, person (including a “person” as defined in Section 13(d)(3) of the Securities Exchange Act of 1934, as amended, together with the rules and regulations promulgated thereunder), trust, union, association, Governmental Authority, arbitrator or mediator.
“Proceeding” means any action, claim, counter-claim, arbitration, mediation, audit, hearing, investigation, litigation or suit (whether civil, criminal, administrative, investigative or informal) commenced, brought, conducted or heard by or before or otherwise involving any Governmental Authority, arbitrator or mediator.
“Product” or “Products” a pharmaceutical product for human use containing a Compound that is Covered by a Company Owned Patent or a Company Licensed Patent as an active pharmaceutical ingredient.
“Product Registrations” mean any current or future filing with any regulatory authority seeking approval to market the Products in any territory, including any associated regulatory authority approval to so market the Products, and any underlying drafts, paperwork, studies, drug master files, marketing authorization dossiers, and any correspondence related thereto.
“Purchased Marks” means any Trademarks included in the Purchased Assets.
“Purchased Patent” means any Patent included in the Purchased Assets, whether owned by Seller or licensed to Seller.
“Regulatory Authority” means any multinational, federal, national, state, provincial or local regulatory agency, department, bureau or other governmental authority with authority over the clinical development, manufacture, marketing or sale of a Product in a country.
“Regulatory Documentation” means any and all applications (including IND number IND146881) and any other IND related to the Compounds or any Product and any related orphan drug designations or priority review designations, registrations, licenses, authorizations and approvals (including all Governmental Authorizations), and non-clinical and clinical study authorization applications or notifications (including all supporting files, writings, data, correspondence, studies and reports) prepared for submission to a Regulatory Authority or research ethics committee with a view to the granting of any Regulatory Authority, and any correspondence to or with the FDA or any other Regulatory Authority (including minutes and official contact reports relating to any communications therewith), and all data contained in any of the foregoing, including ClinicalTrials.gov records, adverse event files, complaint files and manufacturing records.
7
“Representatives” means, with respect to any Party to this Agreement, such Party’s directors, officers, managers, Affiliates, employees, attorneys, accountants, representatives, lenders, consultants, independent contractors and other agents.
“Royalty” has the meaning given to such term in Section 2.5(d)(i) below.
“Royalty Term” means, with respect to a Product in a country in the Territory, the term commencing with the first commercial sale of the Product by the Purchaser or any of its Affiliates or licensees to a Third Party in such country following the approval of the Product Registration for such Product until the expiration of the last-to-expire Valid Patent Claim of the Purchased Patents that would be infringed by the commercialization of such Product in such country.
“Seller Fundamental Representations” means, collectively, the representations and warranties in Section 4.1 (Formation and Qualification), Section 4.2 (Authority Relative to this Agreement), Section 4.3 (No Conflict), Section 4.5 (Title to Purchased Assets), Section 4.10 (No Finder) and Section 4.14 (Tax).
“Solvent” means Seller: (a) is able to pay its debts and other liabilities, contingent obligations and other commitments as they mature in the Ordinary Course of Business; (b) does not intend to, and does not believe that it will, incur debts or liabilities beyond Seller’s ability to pay such debts and liabilities as they mature in the Ordinary Course of Business; (c) is not engaged in a business or a transaction, and is not about to engage in a business or a transaction, for which Seller’s property would constitute unreasonably small capital; (d) the fair value of the property of Seller is greater than the total amount of liabilities, including contingent liabilities, of Seller; and (e) the present fair salable value of the assets of Seller is not less than the amount that will be required to pay the probable liability of Seller on its debts as they become absolute and matured. The amount of contingent liabilities at any time shall be computed as the amount that, in the light of all the facts and circumstances existing at such time, represents the amount that can reasonably be expected to become an actual or matured liability.
“Tax Return” means any return, report, statement, form or other documentation (including any additional or supporting material and any amendments or supplements) filed or maintained, or required to be filed or maintained, with respect to or in connection with the calculation, determination, assessment or collection of any Taxes.
8
“Taxes” means: (i) any and all taxes, fees, levies, duties, tariffs, imposts and other charges in the nature of a tax, imposed by any Governmental Authority or taxing authority, including taxes or other charges in the nature of a tax on, measured by, or with respect to income, franchise, windfall or other profits, gross receipts, property, sales, use, capital stock, payroll, employment, social security, workers’ compensation, unemployment compensation or net worth; taxes or other charges in the nature of excise, withholding, ad valorem, stamp, transfer, value-added or gains taxes; license, registration and documentation fees; and customers’ duties, tariffs and similar charges in the nature of a tax; (ii) any Liability for the payment of any amounts of the type described in (i) as a result of being a member of an affiliated, combined, consolidated or unitary group for any taxable period; (iii) any Liability for the payment of amounts of the type described in (i) or (ii) as a result of being a transferee of, or a successor in interest to, any Person or as a result of an express or implied obligation to indemnify any Person; and (iv) any and all interest, penalties, additions to tax and additional amounts imposed in connection with or with respect to any amounts described in (i), (ii) or (iii).
“Territory” means worldwide.
“Third Party” or “Third Parties” means any entity other than the Purchaser, and its Affiliates.
“Trademarks” means all trademarks, service marks, trade names, trade dress, corporate names, brand names, symbols, logos, slogans, tag lines, account names, social media identifiers, domain names and other source indicators (and all registrations, applications, renewals and extensions of any of the foregoing), whether registered or based on common-law use, and all goodwill associated therewith or symbolized thereby.
“Transaction Documents” means, collectively, this Agreement and each of the other agreements and instruments to be executed and delivered by the Parties in connection with the consummation of the Acquisition.
“Valid Patent Claim” means (a) a claim of an issued patent that has not expired or been rejected, revoked, held invalid or unenforceable by a patent office, court or other governmental agency of competent jurisdiction in a final and non-appealable judgment (or judgment from which no appeal was taken within the allowable time period) or (b) a patent application that has not been pending for more than five (5) years from the effective filing date of such application.
Additional Definitions. In addition to the terms defined in Section 1.1, each of the following terms is defined in the Section of the Agreement set forth opposite such term:
| Term | Section | |
| Acquisition | Recitals | |
| Agreement | Preamble | |
| Assigned Contracts | 2.1(b)(iii) | |
| Assigned Inventory | 2.1(a)(ii) | |
| Assignment and Assumption Agreement | 3.2(a)(i) | |
| Assumed Liabilities | 2.3 | |
| Bankruptcy Exception | 4.2 | |
| Claim Notice | 7.4 | |
| Closing | 3.1 | |
| Closing Date | 3.1 | |
| Disclosure Schedules | Article IV | |
| Excluded Assets | 2.2 | |
| Excluded Contracts | 2.2(d) |
9
| Execution Date | Preamble | |
| Final Determination | 7.7 | |
| Losses | 7.1 | |
| Milestone 1 | 2.5(c)(i) | |
| Milestone 2 | 2.5(c)(ii) | |
| Milestone 3 | 2.5(c)(iii) | |
| Milestone 4 | 2.5(c)(iv) | |
| Milestone 5 | 2.5(c)(v) | |
| Milestone Payments | 2.5(c) | |
| Notice of Completion | 2.5(c) | |
| Order | 4.8(a) | |
| Parties | Preamble | |
| Party | Preamble | |
| Purchase Price | 2.5(a) | |
| Purchased Assets | 2.1(b) | |
| Purchaser | Preamble | |
| Purchaser Indemnitees | 7.1 | |
| Retained Liabilities | 2.4 | |
| Royalty | 2.5(d)(i) | |
| Royalty Report | 2.5(d)(ii) | |
| Seller | Preamble | |
| Seller Governmental Consents | 4.4(a) | |
| Seller Indemnitees | 7.2 | |
| Seller Third Party Consents | 4.4(b) | |
| Third-Party Claim | 7.5(a) | |
| Transfer Taxes | 2.6 | |
| Transactions | 3.3(a)(i) | |
| True-Up Adjustment | 2.5(d)(ii) |
1.2 Interpretation. Unless the context otherwise requires, the terms defined in Section 1.1 and elsewhere in this Agreement shall have the respective meanings herein specified for all purposes of this Agreement, applicable to both the singular and plural forms thereof.
Article II. PURCHASE & SALE OF PURCHASED ASSETS
2.1 Purchased Assets.
(a) Subject to the terms and conditions of this Agreement and in reliance upon the representations, warranties, covenants and agreements of Seller contained herein, at the Closing, Seller shall sell, convey, transfer, assign and deliver to Purchaser, free and clear of all Liens other than Permitted Liens, and Purchaser shall purchase from Seller, the Purchased Assets (as defined in Section 2.10) for an aggregate amount equal to the Purchase Price.
10
(b) For purposes of this Agreement, “Purchased Assets” shall mean all right, title and interest of Seller in all tangible and intangible assets owned or otherwise used or held for use by Seller in connection with the Compounds, in each case as of the Closing Date including, without limitation the assets set forth below, but excluding the Excluded Assets:
(i) The Company Intellectual Property, including the intellectual property set forth on Schedule 2.1(b)(i);
(ii) All inventory related to the Compounds, including all active pharmaceutical ingredients, excipients, or other raw materials, and works in process, wherever located included in transit set forth on Schedule 2.1(b)(ii) (the “Assigned Inventory”);
(iii) Those Contracts set forth in Schedule 2.1(b)(iii) but not including the “Excluded Contracts” referenced in Section 2.2(c) (collectively, the “Assigned Contracts”);
(iv) All Books and Records,
(v) All Permits and other Governmental Authorizations to the extent assignable, including, without limitation, those items more particularly described in Schedule 2.1(b)(v);
(vi) All claims existing or arising from the Purchased Assets (whether asserted or not) and whether arising in contract, tort or otherwise or related to any Assigned Contract, indemnity claim, refund claim, right of setoff, or otherwise including, without limitation, those items more particularly described in Schedule 2.1(b)(vi).
(vii) All goodwill relating to the Compounds and Company Intellectual Property; and
(viii) All other assets that are held or used by Seller primarily in connection with the Compounds, including the miscellaneous assets as set forth on Schedule 2.1(b)(viii).
2.2 Excluded Assets. Notwithstanding anything to the contrary contained in Section 2.1 or elsewhere in this Agreement, the following assets shall not be part of the sale and purchase contemplated hereunder, are excluded from the Purchased Assets, and shall remain the property of Seller after the Closing (collectively, the “Excluded Assets”):
(a) Insurance policies and proceeds and rights thereunder;
(b) All credit, deposits, rights to refund, claims for and rights to receive refunds of any nature arising in respect of Taxes relating to the Seller and any notes, worksheets, files or documents relating thereto;
(c) All Contracts, and rights and obligations thereunder, other than the Assigned Contracts (the “Excluded Contracts”);
11
(d) Seller’s rights under or pursuant to this Agreement and the other agreements between Purchaser and Seller contemplated hereby;
(e) All bank accounts of Seller, including all cash and cash equivalents;
(f) The outstanding equity interests issued by Seller;
(g) Seller’s corporate charter, qualifications to conduct business, arrangements with registered agents relating to foreign qualification, taxpayer and other identification numbers, seals, minute books, and similar organizational records of Seller; and
(h) All Contracts or any other liabilities related to real property, whether leased or owned; and
(i) Any other assets listed on Schedule 2.2(i), if any.
2.3 Assumed Liabilities.
(a) At Closing, Purchaser shall assume as of the Closing Date and shall pay, perform and discharge when due the following liabilities of Seller (referred to as the “Assumed Liabilities”):
(i) All obligations of Seller to be performed after the Closing in accordance with the terms of the EVMS License Agreement and those Assigned Contracts that are specifically set forth in Schedule 2.1(b)(iii), but only to the extent that (x) such obligations do not arise from any breach or default by Seller under the EVMS License Agreement or any such Assigned Contract on or before the Closing (including any breach or default triggered by the occurrence of the Closing), and (y) such obligations do not arise from any event, circumstance or condition occurring or existing on or prior to the Closing that, with or without notice or lapse of time, would constitute or result in a breach of the EVMS License Agreement or any of such Assigned Contract; and
(ii) all obligations specifically set forth in Schedule 2.3(a)(ii).
(b) Except for the Assumed Liabilities, Purchaser does not assume or agree to pay, satisfy, discharge, or perform any Liability, commitments, obligation, or indebtedness of Seller, whether primary or secondary, direct or indirect, liquidated, absolute or contingent, known or unknown and expressly disclaims any liability for Claims made against Purchaser by reason of successor liability or any other similar legal theory.
2.4 Retained Liabilities. All Liabilities of Seller, other than the Assumed Liabilities, shall be retained by Seller (the “Retained Liabilities”) and shall be performed and discharged by Seller when due, and Purchaser shall have no obligation of any kind with respect to the Retained Liabilities. For the avoidance of doubt, “Retained Liabilities” shall include, but not be limited to the following:
(a) Any obligation or Liability of Seller arising under any Assigned Contract to the extent attributable to the time period prior to Closing including, but not limited to, (i) with respect to Contracts with customers, any claims against Seller by any client asserting any counterclaim, refund claim, indemnity claim, breach of warranty claim, tort, negligence or other claim to the extent such claims relate to services performed or products provided prior to Closing or otherwise related to the period of time prior to Closing; and (ii) with respect to Contracts with vendors or other parties providing services or products to Seller, any claims against Seller by any such contracting party asserting any amount due, indemnity claim, tort, negligence or other claim of any kind to the extent such claims relate to services performed or products provided prior to Closing or otherwise related to the period of time prior to Closing;
12
(b) Any obligation or Liability of Seller arising before or after Closing with respect to any Contract that is not specifically referenced in Schedule 2.1(b)(iii), including the payment with respect to the Closing hereunder under Section 5 of the First Amendment to EVMS License Agreement;
(c) Any obligation or Liability of Seller arising before or after Closing with respect to the operation, discontinuation, and wind-down of the VLX-1005-003 Phase II clinical trial;
(d) All obligations and Liabilities (i) of Seller with respect to Taxes of any kind, whether relating to or attributable to the Seller or otherwise arising out of the transactions consummated pursuant to this Agreement, including, without limitation, the obligation to withhold and remit all Taxes of any kind that have been (or were required to have been) withheld from, assessed upon, or collected from employees, contractors or clients, but excluding any interest, penalties, or additions to Tax the imposition of which is directly caused by Purchaser’s failure to withhold pursuant to Section 2.7, (ii) for any Tax of Seller relating to the Purchased Assets or the Seller’s business involving the Purchased Assets (the “Business”) for any taxable period (or portion thereof) ending on or prior to the Closing Date, (iii) for any Tax related to the Excluded Assets, (iv) for any Transfer Taxes, (v) for Taxes of another Person as a transferee or successor, by contract, or otherwise, which relate to an event or transaction occurring before the Closing, or (vi) for any failure to comply with the provisions of any bulk sales, bulk transfer, or similar Laws of any jurisdiction that may otherwise be applicable with respect to the sale and transfer of any or all of the Purchased Assets to Purchaser;
(e) Any obligations or Liabilities of the Seller relating to laws, regulations, Permits or other Governmental Authorizations relating to the time period prior to the Closing including, without limitation, any fees, penalties, fines or other Governmental Charges;
(f) Any obligations or Liabilities of Seller to any employees (in all cases relating to the time period prior to the Closing) including obligations for salaries, compensation, benefits, sick pay, vacation pay, (including, but not limited to, any liability or penalties associated with any violation of any Laws regarding payment of vacation or paid time off upon termination or employment), bonuses, deferred compensation of any kind, severance or termination pay or remuneration of any kind any obligation or liability relating to the termination of any such employee including any termination relating to the consummation of the transactions set forth herein;
(g) Any obligation or Liabilities of Seller under any employee benefit plan;
13
(h) Any obligations or Liabilities of Seller under any indebtedness, including, without limitation, convertible debt;
(i) Any obligations or Liabilities of Seller for transaction expenses;
(j) Any obligations or Liabilities relating to or arising out of the Excluded Assets; and
(k) Any other indebtedness of any kind.
2.5 Purchase Price; Payment of Purchase Price.
(a) Purchase Price. The aggregate consideration for the Purchased Assets shall consist of: (i) the Closing Date Payment; (ii) the assumption of the Assumed Liabilities by Purchaser; (iii) any Milestone Payments paid in accordance with Section 2.5(c); and (iv) any Royalties paid in accordance with Section 2.5(d) (together, the “Purchase Price”).
(b) Closing Date Payment. Payment of the Closing Date Payment shall be made within twenty-four (24) hours following the Closing, payable in cash in United States Dollars by wire transfer(s) of immediately available funds to such bank account(s) as shall be designated in writing by Seller prior to Closing.
(c) Milestone Payments. In reliance upon the representations, warranties and covenants set forth herein and in consideration of the sale, assignment, transfer, and delivery of the Purchased Assets by Seller to Purchaser, Purchaser shall pay to Seller an amount not to exceed Fifteen Million Dollars ($15,000,000) in the aggregate for all Products if certain milestone events are achieved by the Purchaser or any of its Affiliates or licensees. Purchaser shall make the following milestone payments (each, a “Milestone Payment”) without duplication (for the avoidance of doubt, each milestone is payable only once and not with respect to each Product) after achievement of each of the following milestone events by the Purchaser or any of its Affiliates or licensees (each, a “Milestone Event”):
(i) $2,000,000 upon the occurrence of the First Patient In in the first clinical trial initiated after Closing for VLX-1005 (“Milestone 1”);
(ii) $8,000,000 upon approval of the first Product Registration for a Product in the United States (“Milestone 2”);
(iii) $2,000,000 upon approval of the first Product Registration for a Product outside the United States (“Milestone 3”);
(iv) $2,000,000 upon approval of a Product Registration for a subsequent indication of a Product in the United States (“Milestone 4”); and
(v) $1,000,000 upon approval of a Product Registration for a subsequent indication of a Product outside the United States (“Milestone 5”);
14
provided that, within thirty (30) days after completion of each Milestone Event, Purchaser shall deliver to Seller: (i) a written notice of completion that sets forth the element(s) of such Milestone Event and the corresponding date(s) of completion; and (ii) a statement reflecting the amount due for completion of such Milestone Event (together, a “Notice of Completion”). Each Milestone Payment may be made by Purchaser, in its sole discretion, (i) as a cash payment in U.S. Dollars to Seller via wire transfer of immediately available funds to the bank and account designated in writing by Seller, (ii) as an issuance of Common Stock based on the closing price of a share of the Common Stock on the date of the completion of the applicable Milestone Event, or (iii), a combination of (i) and (ii) hereof. Notwithstanding anything to the contrary contained herein, Purchaser shall not make payments of any Milestone Payments by issuing any shares of Common Stock (and, instead, shall make payment of such Milestone Payment in cash) if such issuance would require the recipient to become a reporting person or would require the Purchaser to obtain any Governmental Authorizations, including from any securities exchange or other regulatory body. Purchaser shall make payment to Seller within forty-five (45) days of receipt of the Notice of Completion.
Notwithstanding anything to the contrary set forth above, no Milestone Payment shall be paid by the Purchaser by the issuance of shares of Common Stock to Seller if such issuance (i) alone or together with all prior issuances made pursuant to this Agreement that were not approved by the stockholders will exceed 19.99% of the outstanding shares of Purchaser’s Common Stock on the date of this Agreement unless prior to such issuance the Purchaser obtains stockholder approval for the issuance of the number of shares of Common Stock that would exceed 19.99% of the outstanding shares of Purchaser’s Common Stock on the date of execution of this Agreement, all in compliance with the Nasdaq listing requirements, or the requirements of any exchange on which the Common Stock is trading at the time of such payment and (ii) if such issuance will cause Seller to beneficially own in excess of 19.99% of the outstanding shares of Purchaser’s Common Stock on the date of issuance unless, prior to such issuance, the Purchaser obtains stockholder approval of a change of control in compliance with the Nasdaq listing requirements, or the requirements of any exchange on which the Common Stock is trading at the time of such payment.
(d) Royalties.
(i) With respect to each Calendar Year during the Royalty Term, Purchaser shall pay Seller an amount equal to five percent (5%) of Annual Net Sales of each Product (each, a “Royalty”). For clarity, Royalties are due only on sales of a Product in a country in the Territory where a Product is covered by a Valid Patent Claim. The Parties agree that the use of Valid Patent Claim in calculating the duration of the Royalty Term and geographic scope of the Royalty obligation is the result of an arms-length negotiation on a reasonable length and scope of such Royalty payments with respect to the total Purchase Price payable hereunder, and not to imply that the Seller retains any rights or ownership interest in or to the Purchased Assets.
15
(ii) Within forty-five (45) days following the end of each Calendar Year following the first commercial sale of any Product in a country in the Territory, Purchaser shall provide Seller with a report (“Royalty Report”) showing with respect to such Calendar Year on a country-by-country basis the calculation of Annual Net Sales of the Product and the calculation of the Royalty amount due to Seller. Each Royalty Report and all Royalty payments will be subject to a true-up adjustment to take into account Sales Deductions under the definition of Annual Net Sales either (a) allowed during a Calendar Year but that were not accrued during such Calendar Year, or (b) accrued during a Calendar Year but not taken or later subject to reversal following the end of such Calendar Year (each of (a) and (b), a “True-Up Adjustment”). Each Royalty Report delivered by Purchaser shall set forth the amount of any True-Up Adjustment applicable to any prior Calendar Year and the Annual Net Sales calculation and resulting Royalty payments for the Calendar Year just ended shall be adjusted accordingly. All Royalty payments under this Agreement shall be made in US Dollars. Any sales incurred in a currency other than US Dollars shall be converted to the US Dollar equivalent using the standard exchange rate set forth in the Wall Street Journal for the last day of the Calendar Year to which the Royalty Report applies or as otherwise agreed by the Parties in writing.
(iii) Subject to Section 2.5(d)(v), on a Product- by- Product and country-by-country basis, in the event that, with respect to a Product in a country, Generic Competition exists with respect to such Product in such country in a calendar year, then the royalty rates in such country for such Product will thereafter be reduced to fifty percent (50%) of the amounts set forth in Section 2.5(d)(i).
(iv) Subject to Section 2.5(d)(v), in the event that Purchaser or its Affiliates licenses or otherwise acquires rights from one or more Third Parties in order to make, use, sell, import or otherwise exploit a Product in a country, then fifty percent (50%) of any amounts payable to the Third Party in such country shall be deductible from the amounts payable to Seller under Section 2.5(d)(i). For clarity, Purchaser shall not have the right to deduct any payments due under the EVMS License Agreement from the amounts payable to Seller under this Section 2.5.
(v) In no event shall the Royalties payable to Seller with respect to a country pursuant to Section 2.5(d)(i) be reduced pursuant to Section 2.5(d)(iii) or Section 2.5(d)(iv), either individually or in combination, by more than fifty percent (50%). Any reduction in the Royalties pursuant to Section 2.5(d)(iii) or Section 2.5(d)(iv), or portion thereof, that is rendered not usable pursuant to the foregoing limitation in this Section 2.5(d)(v) may be carried forward to future Calendar Years until the entire amount to which Purchaser is entitled to deduct has been so deducted.
2.6 Sales and Use Taxes. Purchaser shall be solely responsible for: (i) timely paying any sales, use, value added, documentary, stamp, registration, transfer, conveyance and other similar Taxes (“Transfer Taxes”) that may apply with respect to the purchase and sale of the Purchased Assets; and (ii) making any and all filings required in connection with the payment of the Transfer Taxes and/or claiming any exemption as is permitted under applicable Law and as it may assert is available to avoid or mitigate the Transfer Taxes.
2.7 Withholdings. Purchaser shall be entitled to deduct and withhold any amounts Purchaser is required to deduct and withhold under any applicable Law in connection with payments to be made by Purchaser pursuant to the terms of this Agreement. Such amounts deducted or withheld shall be treated as having been paid to the Person in respect of whom such deduction and withholding was made for all purposes under this Agreement.
16
2.8 Bulk Sales Laws. The Parties hereby waive compliance by Seller with requirements and provisions of any bulk sales, bulk transfer, or similar Laws of any jurisdiction that may otherwise be applicable with respect to the sale and transfer of any or all of the Purchased Assets to Purchaser.
Article III. CLOSING
3.1 Closing. The consummation of the purchase and sale of the Purchased Assets in accordance with this Agreement and the other transactions provided for herein (the “Closing”) shall take place concurrently with the execution of this Agreement remotely via the electronic exchange of documents and signatures between the Parties and shall be deemed effective at 11:59 P.M. Eastern Daylight Time on the Business Day upon which this Agreement is fully executed by the Parties (the “Closing Date”). All events which shall occur at the Closing shall be deemed to occur simultaneously.
3.2 Closing Deliveries of Purchaser. At or prior to Closing, Purchaser shall deliver, or cause to be delivered, the following to Seller:
(a) A Bill of Sale and Assignment and Assumption Agreement between Seller and Purchaser that assigns the Purchased Assets to Purchaser, substantially in the form attached hereto as Exhibit 3.2(a) (the “Bill of Sale and Assignment and Assumption Agreement”) executed by Purchaser.
3.3 Closing Deliveries of Seller. At or prior to Closing, Seller shall deliver, or cause to be delivered, the following to Purchaser:
(a) a certificate, dated as of the Closing Date, of the secretary (or similar officer) of Seller certifying, among other things, that attached to such certificate: (i) is a true and correct copy of the certificate of incorporation of Seller, and all amendments thereto; (ii) is a true copy of all corporate actions taken by Seller, including resolutions of its board of directors authorizing the consummation of the Acquisition and the execution, delivery and performance of this Agreement and each of the Transaction Documents to be delivered by Seller pursuant hereto; (iii) is a true copy of all actions taken by the shareholders of Seller authorizing the consummation of the Acquisition and the execution, delivery and performance of this Agreement and each of the Transaction Documents to be delivered by Seller pursuant hereto; and (iv) are the names and signatures of the duly elected or appointed officers of Seller who are authorized to execute and deliver this Agreement, the Transaction Documents to which Seller is a party and any certificate, document or other instrument in connection herewith, which certificate shall be deemed to be a representation and warranty made by Seller to Purchaser on the Closing Date for the purpose of inducing Purchaser to consummate the transactions contemplated by the Agreement (the “Transactions”) and with knowledge that Purchaser is relying on such certificate in determining to consummate the Transactions;
(b) a certificate of good standing from the Secretary of State of the State of Delaware, dated no earlier than five (5) Business Days prior to the Closing Date, certifying that Seller is in good standing in the State of Delaware;
17
(c) the Bill of Sale and Assignment and Assumption Agreement, duly executed by Seller;
(d) A copy of an amended and restated EVMS License Agreement, which has been amended to Purchaser’s satisfaction and executed by EVMS and Seller;
(e) evidence of release of any and all Liens against the Purchased Assets;
(f) a W-9 Form executed by Seller;
(g) all other instruments of conveyance and transfer executed by Seller, in form and substance reasonably acceptable to Purchaser, as may be necessary to convey the Purchased Assets to Purchaser free and clear of all Liens and Liabilities (other than Assumed Liabilities);
(h) possession and control of the Purchased Assets; and
(i) such other documents, instruments and certificates as Purchaser may reasonably request.
3.3 Post-Closing Obligations of Seller. Seller shall deliver all Books and Records to Purchaser within thirty (30) days following Closing. Without limiting the foregoing, Seller shall (i) cooperate with Purchaser to migrate all data included in the Books and Records to Purchaser within thirty (30) days following Closing in such format as reasonably requested by Seller, and (ii) retrieve any Books and Records related to the VLX-1005-003 Phase II study, including any data, reports, templates, source documents, and materials, from any third party, including any clinical trial site, and deliver such Books and Records to Purchaser within thirty (30) days after Closing. Within two (2) business days following Closing, Seller will deliver to Purchaser the worldwide assignment of patents agreement, in the form attached hereto as Exhibit 3.3, duly executed by Seller and notarized.
Article IV. REPRESENTATIONS AND WARRANTIES OF SELLER
As an inducement to Purchaser to enter into this Agreement and to consummate the Acquisition, Seller hereby represents and warrants to Purchaser that, except as expressly disclosed on a schedule corresponding with the appropriate Section numbers below (the “Disclosure Schedules”), each of the following representations and warranties is true and correct as of the Closing Date:
4.1 Formation and Qualification. Seller is a corporation, duly incorporated, validly existing and in good standing in Delaware. Seller has all corporate power and authority to own, lease and operate its properties and to carry on its business as it is now being conducted. Seller is duly qualified or licensed to do business, and is in good standing or its equivalent in the jurisdiction of its incorporation. Seller is qualified in each jurisdiction where the character of the properties owned, leased or operated by it or the nature of its business makes such qualification or licensing necessary except where the failure to be so qualified would not, individually or in the aggregate, reasonably be expected to have a material adverse effect.
18
4.2 Authority Relative to this Agreement. Seller has all corporate power and authority to execute and deliver this Agreement and the other Transaction Documents to which it is a party, to perform its obligations hereunder and to consummate the Acquisition. The execution and delivery of this Agreement and the other Transaction Documents by Seller and the consummation by such Seller of the Acquisition have been duly and validly authorized by all necessary corporate action, and no other proceedings on the part of Seller are necessary to authorize this Agreement or to consummate the Acquisition. This Agreement and the other Transaction Documents have been duly executed and delivered by Seller and each such agreement constitutes a legal, valid and binding obligation of Seller, enforceable against Seller in accordance with its terms, subject to the effect of any applicable bankruptcy, moratorium, insolvency, reorganization or other similar law affecting the enforceability of creditors’ rights generally and to the effect of general principles of equity which may limit the availability of remedies (whether in a Proceeding at Law or in equity) (the “Bankruptcy Exception”).
4.3 No Conflict. The execution and delivery of this Agreement and the other Transaction Documents by Seller do not, and the performance by Seller of its obligations hereunder and the consummation of the Acquisition will not: (a) conflict with or violate any provision of incorporation of Seller or any resolutions adopted by the board of directors of Seller; (b) conflict with or violate any Law or Order applicable to Seller or by which any of the Purchased Assets or Seller is bound or affected; or (c) result in any breach of or constitute a default (or an event which with the giving of notice or lapse of time or both could reasonably be expected to become a default) under, or give to others any right of termination, amendment, acceleration or cancellation of, or result in the creation of a Lien on any of the Purchased Assets or Seller pursuant to, any note, bond, mortgage, indenture, contract, agreement, lease, license, permit, franchise or other instrument, or other obligation.
4.4 Required Filings and Consents.
(a) Schedule 4.4(a) sets forth a complete and accurate list of all waivers, approvals, Permits, orders or authorizations of, or registrations, declarations or filings with, any Governmental Authority that are required in connection with (i) the execution and delivery of this Agreement by the Seller or the performance of its obligations hereunder, or (ii) the consummation by Seller of the transactions contemplated by this Agreement (collectively, the “Seller Governmental Consents”).
(b) Schedule 4.4(b) sets forth a complete and accurate list of all consents, waivers, approvals, or authorizations of, or notices to, any Third Party other than a Governmental Authority in connection with (i) the execution and delivery of this Agreement by the Seller or the performance of its obligations hereunder or thereunder, or (ii) the consummation of the transactions contemplated by this Agreement (collectively, the “Seller Third Party Consents”).
19
4.5 Title to Purchased Assets . Seller has good and valid title to all of the Purchased Assets and has all rights necessary to perform its obligations hereunder. As of the Closing Date, upon payment of the Purchase Price, the Purchased Assets will be free and clear of all Liens. Seller has not granted to any Person any right, title, or interest in or to any of the Purchased Assets and, except as set forth on Schedule 4.5, no Person has any right, title, or interest in or to the Purchased Assets.
4.6 Intellectual Property.
(a) Schedule 2.1(b)(i) sets forth a correct, current, and complete list of all of the following: (i) Patents owned or purported to be owned by Seller (“Company Owned Patents”) or exclusively licensed to Seller (“Company Licensed Patents”) included in the Purchased Patents; (ii) Trademark registrations and applications included in the Purchased Marks; (iii) Copyright registrations and applications included in the Company Intellectual Property; and (iv) all other material Company Intellectual Property included in the Purchased Assets, in each case including, as applicable: title, mark, or design; the issue, registration or filing date; the current status; the current owner; the patent, the registration or application number; and the jurisdiction in which the application has been filed or registration has been obtained. The Company Intellectual Property constitutes all intellectual property rights owned by or licensed to Seller that relate to, or are necessary or useful for, the research, development, manufacture, use, commercialization and/or exploitation of the Compounds. Except as otherwise set forth in Schedule 2.1(b)(i), Seller is the sole and exclusive beneficial and, with respect to registrations and applications therefor, record owner of all of the items of Company Intellectual Property listed on Schedule 2.1(b)(i). Except as set forth on Schedule 4.6(a), there are no actions that must be taken within four (4) months from the date hereof, including, without limitation, the payment of fees or filing of documents, to obtain, maintain or renew any applications or registrations for any Company Intellectual Property listed on such schedule. Effective written assignments and other instruments necessary to establish, record, and perfect a complete chain-of-title from the original owner to Seller with respect to all registered and applied-for Company Owned Patents listed on Schedule 2.1(b)(i) have been obtained and duly validly, executed, delivered, and filed with the appropriate Governmental Authorities and authorized registrars. All required filings and fees related to the Company Owned Patents set forth in Schedule 2.1(b)(i) have been timely filed with and paid to the relevant Governmental Authorities and authorized registrars. To the Knowledge of Seller, all required filings and fees related to the Company Licensed Patents set forth in Schedule 2.1(b)(i) have been timely filed with and paid to the relevant Governmental Authorities and authorized registrars. All Company Intellectual Property registrations set forth in Schedule 2.1(b)(i) are in good standing. Seller has provided Purchaser with true and complete copies of (and within thirty (30) days following Closing, all) file histories, material documents, certificates, office actions and any other material correspondence with the relevant Governmental Authorities related to all such Company Intellectual Property within Seller’s possession and control. All of the registered Company Intellectual Property set forth in Schedule 2.1(b)(i) are subsisting, unexpired, and valid and, to the Knowledge of Seller, enforceable and to the Knowledge of Seller, all of the applications for Company Intellectual Property set forth in Schedule 2.1(b)(i) are subsisting, unexpired and validly applied-for, and none of them have been abandoned (other than abandonment of Company Intellectual Property applications in the ordinary course of business), cancelled, or adjudicated invalid, or are subject to any outstanding agreement, Order, judgment, or decree restricting their use or adversely affecting Seller’s rights thereto.
20
(b) Seller owns or possesses the valid and enforceable right to use, free and clear of all Liens (except Permitted Liens), all of the Purchased Assets. Except as set forth on Schedule 4.6(b), the consummation of the Transactions will not result in the loss or impairment of any rights in, require the payment of any additional amounts with respect to, nor require the consent of any Person in respect of, any of the Purchased Assets, including, without limitation, the impairment of any enforcement or any continuations to filings of any Purchased Patents. Except as set forth in Schedule 4.6(b), no royalties, fees, commissions, and other amounts are payable by Seller to any other Person upon or for the manufacture, sale, or distribution of any Compound or the use of any Company Intellectual Property, and after Closing, no such amounts will become payable by Purchasers for the continued manufacture, sale, or distribution of any such Compound or use of any Company Intellectual Property. Schedule 4.6(b) sets forth all terminal disclaimers that have been filed in connection with or related to any Purchased Patents listed in Schedule 2.1(b)(i). Seller has transferred to Purchaser any Purchased Patents subject to or related to any terminal disclaimer of those Purchased Patents identified in Schedule 2.1(b)(i).
(c) With respect to Seller’s current and former use of the Purchased Assets, such Purchased Assets (including, without limitation, research, development, manufacture, use, and other exploitation of the Compounds by or on behalf of Seller), are not infringing, misappropriating, or otherwise violating any intellectual property rights of any Person, and have not infringed, misappropriated or otherwise violated the intellectual property rights of any Person. To Seller’s Knowledge, the Purchased Assets (including, without limitation, Buyer’s continuing research, development, manufacture, use, and other exploitation of the Compounds) will not infringe, misappropriate, or otherwise violate any intellectual property rights of any Person. Seller has not granted to any Person any license or right to use any of the Compounds or Company Intellectual Property.
(d) To Seller’s Knowledge, no Person is infringing or misappropriating any of the Company Intellectual Property.
(e) Seller has necessary rights and licenses to use, and to grant its customers the rights to use, all third party intellectual property incorporated into the Purchased Assets in the manner in which such third party content is and has been used, or authorized to be used, by Seller and its customers, as applicable, and has at all times used such third party content without: (i) infringing, misappropriating, or violating any intellectual property or other right of any third party; (ii) breaching any Contract; or (iii) any requirement of additional permissions, licenses, consents, or the payment of any fees.
(f) There are no decided, settled, pending or, to Seller’s Knowledge, previously or presently, threatened (including in the form of offers to obtain a license) Claims by any Person alleging infringement, misappropriation, or other violation by Seller of such Person’s intellectual property, or challenging the enforceability, registrability, patentability, ownership or validity of any of the Company Intellectual Property (including, without limitation, any cancellation, opposition, revocation, review, or other action or proceeding), and to Seller’s Knowledge, no valid basis exists for any such Claims. For Company Intellectual Property licensed by Seller, the owner or licensor thereof has not, and to Seller’s Knowledge has not threatened to, terminate any rights attached to the use of such Company Intellectual Property by Seller and to Seller’s Knowledge, no valid basis exists for any such action.
21
(g) Schedule 4.6(g) identifies all applicable Know-How or categories of Know-How included in the Purchased Assets. Seller has at all times taken commercially reasonable industry-standard measures designed to maintain and enforce its Know-How and to protect the confidentiality of such Know-How, including, without limitation, by entering into appropriate binding, written confidentiality agreements with any officers, directors, employees, consultants, and other Persons with access to such Know-How. To Seller’s Knowledge, no such Know-How have been disclosed or otherwise accessed by any unauthorized Person or used in any unauthorized manner. Seller has at all times complied with all applicable Laws in all material respects, including, without limitation, any use by or on behalf of Seller of any data and biological specimens.
(h) All current and former employees, founders, agents, consultants, and contractors of Seller that have contributed to the development of any Compound, and to Seller’s Knowledge, any other inventors of Purchased Patents, have been identified in any applicable filings with any applicable Governmental Authority and, with respect to Company Intellectual Property owned by Seller, have assigned to Seller, under valid, binding, written, and enforceable agreements, all Company Intellectual Property in its entirety without retained rights, including, without limitation, inventions and work product, they created, conceived, contributed to, or reduced to practice (1) with respect to employees, during the term of their employment or (2) with respect to non-employees, arising from their engagement with Seller, in each case pursuant to employee invention assignment agreements and consulting agreements.
(i) Schedule 4.6(i) sets forth a correct, current, and complete list of all domain names included in the Purchased Assets. Seller is the registrant of all such domain names, and all registrations of such domain names are in good standing until such dates as set forth on Schedule 4.6(i). No action has been taken or is pending to challenge rights to, suspend, cancel or disable any such domain name, registration therefore or the right of Seller to use such domain name. Seller has the rights to use on the Internet such domain names.
(j) Except to the extent set forth on Schedule 4.6(j), no government funding, facilities or resources of a university, college, other educational institution, multi-national, bi-national or international organization or research center was used in the development of any Purchased Assets in a manner that results in any such government, institution, organization or research center having any rights in or interests to such Purchased Assets. No current or former employee, consultant, independent contractor or director of Seller, who has been involved in the creation or development of any Purchased Assets or have had access to such Company Intellectual Property, has performed services for the government, university, college, or other educational institution or research center during a period of time during which such employee, consultant, independent contractor or director was also performing services for Seller in a manner that results in any such government, university, college, or other educational institution or research center having any rights in or interests to the Purchased Assets. Except to the extent set forth on Schedule 4.6(j), there are no current or contingent usage rights, march-in rights, manufacturing restrictions or other rights of any Governmental Authority in or to any Purchased Assets. Except to the extent set forth on Schedule 4.6(j), no public or private entity was or is involved in any innovation related to the subject matter covered by any Purchased Patents that are a part of the Purchased Assets in a manner that results in any such entity having any ownership rights in such Purchased Patents.
22
(k) To Seller’s Knowledge, the Purchased Patents disclose and/or claim patentable and enforceable subject matter. To Seller’s Knowledge, no third party public disclosures have occurred that have impaired or is expected to impair the prosecution of such Purchased Patents.
(l) Seller states that any representations, filings, and/or statements made by Seller regarding intellectual property to the United States Patent Trademark Office or any other Governmental Authorities have been truthful and correct and have made all necessary disclosures to such Governmental Authorities as required by Law and in good faith.
(m) To the extent that the Excluded Assets include any overlapping (in-part or whole) technology, written description, or otherwise with the Purchased Patents that are a part of the Purchased Assets, Seller agrees not to seek patent prosecution (in-part or whole) on such overlapping technology and further agrees that if in the future any ownership or other dispute arises because of such overlapping technology, Seller agrees to transfer it to Purchaser.
4.7 Contracts.
(a) Except as set forth in Schedule 4.7(a): (i) each of the Assigned Contracts is in full force and effect and constitutes a valid and binding obligation of Seller and of the counterparties thereto; (ii) each of the Assigned Contracts is fully assignable by Seller to Purchaser without obtaining the consent of any Person and, upon assignment to Purchaser in connection with the Closing, will remain at the time of assignment in full force and effect as a valid and binding obligation of the counterparties thereto; and (iii) the assignment of each of the Assigned Contracts by Seller to Purchaser will not give any other party to any such Contract the right to impose additional fees or charges of any kind under such Contract or terminate such Contract. Except as provided in Schedule 4.7(a) and during the three (3) year period immediately prior to the Closing (w) Seller has complied with all of its obligations under the Assigned Contracts, and Seller has not received written notice that it is in default or alleged to be in default under any of the Assigned Contracts; (x) to Seller’s knowledge, there exists no event or condition which, after notice or lapse of time, or both, would constitute a default under any Assigned Contract; (y) Seller has not received any written notice from any party to any Assigned Contract terminating or threatening to terminate any such Assigned Contract or asserting any dispute or disagreement regarding any such Assigned Contract or otherwise reduce the services obtained from Seller pursuant to such Contract; and (z) no amounts owed under any Assigned Contract are past due. To Seller’s knowledge, there are no defaults by any other party to any Assigned Contract.
(b) (i) Seller has provided notice to EVMS of Seller’s planned discontinuation of its operations and Seller’s discontinuation and winding down of the VLX-1005-003 Phase II trial, (ii) such discontinuation is not a breach of the EVMS License Agreement, (iii) all amounts owed by Seller under the EVMS License Agreement with respect to the period prior to Closing have been paid by Seller, and (iv) EVMS has provided no notice to Seller of any failure by Seller to comply with its obligations under the EVMS License Agreement.
(c) Except as set forth in Schedule 4.7(c), there are no Assigned Contracts in existence between the Seller and any Affiliate thereof and there are no Assigned Contracts in existence that impose “most favored nation” or similar requirements on Seller or otherwise impose competition, solicitation or other similar restrictions on Seller. Seller has provided Purchaser with true and complete copies of all Assigned Contracts referenced in Section 2.1(b)(iii) (including all amendments thereto).
23
4.8 Claims and Proceedings; Compliance with Laws.
(a) Except as disclosed on Schedule 4.8(a): (i) there are no Proceedings, Orders (defined below) or Claims pending or threatened against Seller or the Purchased Assets; (ii) there are no Proceedings, Orders, or Claims pending or threatened in writing by Seller against any third party, at law or in equity, or before or by any Governmental Authority (including any Proceedings with respect to the Transactions) relating to the Purchased Assets; and (iii) Seller and the Purchased Assets are not subject to any order, judgment, preliminary or permanent injunction, temporary restraining order, award, citation, decree, consent decree or writ (each, an “Order”) of any Governmental Authority.
(b) Seller is and has been in compliance with all Laws and Orders applicable to Seller. Except as set forth on Schedule 4.8(b), Seller has not received any written notice (whether formal or informal, including whistleblower or similar complaints) regarding any failure to comply with any Law or Order applicable to Seller or the Purchased Assets.
4.9 Business Activity Restriction. With respect to the Purchased Assets: (a) there is no non-competition or other similar agreement, commitment or Order to which Seller or any of its Affiliates is a party or subject to that has or could reasonably be expected to have the effect of prohibiting or impairing the Purchased Assets; (b) Seller has not entered into any agreement under which Seller is restricted from selling, licensing or otherwise distributing any of its technology or products to, or providing services to, customers or potential customers or any class of customers, in any geographic area, during any period of time or in any segment of the market or line of business; and (c) no Affiliate of Seller is a party to any agreement, which, by virtue of such person’s relationship with Seller, restricts Seller or any successor from, directly or indirectly, engaging in any business involving the Purchased Assets.
4.10 No Finder. Neither Seller nor any Person acting on behalf of Seller has agreed to pay to any broker, finder, investment banker or any other Person, a brokerage, finder’s or other fee or commission in connection with this Agreement or any matter related hereto, nor has any broker, finder, investment banker or any other Person taken any action on which a claim for any such payment could be based.
4.11 Solvency. Except as set forth on Schedule 4.11, Seller is Solvent, and the consummation of the transactions contemplated hereby will not render the Seller insolvent, and no solvency Proceedings have been initiated, or to Seller’s knowledge, threatened against Seller.
24
4.12 Financials; Undisclosed Liabilities. Complete copies of Seller’s financial statements (the “Financial Statements”) consisting of (i) Seller’s audited balance sheet as of December 31, 2023 and December 31, 2024 and the related statement of income for such period, and (ii) an unaudited interim balance sheet as of September 30, 2025 (the “Interim Balance Sheet Date”) and related statement of income for such period have been delivered to Purchaser. The Financial Statements have been prepared in accordance with GAAP applied on a consistent basis throughout the periods involved. The Financial Statements are based on the books and records of the Seller and fairly present the financial condition of the Seller as of the respective dates they were prepared and the results of the operations for the periods indicated. Except as set forth on Schedule 4.12, Seller has no Liabilities of a type required to be reflected on a balance sheet except (a) those which are adequately reflected or reserved against in the Financial Statements, and (b) those which have been incurred in the ordinary course of business consistent with past practice since the Interim Balance Sheet Date and which are not, individually or in the aggregate, material in amount.
4.13 Regulatory Matters.
(a) As of the Closing Date, Seller has not obtained approval of any Product Registration in the Territory or commercially sold any product containing any Compound.
(b) The pre-clinical studies and clinical trials conducted by or on behalf of or sponsored by Seller with respect to the Compounds, or in which Seller has participated with respect to the Compounds, were conducted in accordance with all applicable Laws and any applicable protocol therefor. Except as set forth on Schedule 4.13(b), no IND filed by or on behalf of the Seller with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any other Governmental Authority or institutional review board or ethics committee has commenced, or, to the Knowledge of Seller, threatened in writing to initiate, any action to place a clinical hold order on any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Seller. Seller has discontinued its Phase II clinical trial with respect to VLX-1005 and wound-down all related operations in compliance with its contractual obligations related to such trial. Except as set forth on Schedule 4.13(b), no orphan drug designation granted to the Seller by the FDA or the European Medicines Agency (EMA) has been terminated or suspended by the FDA or EMA, as applicable.
(c) Seller has not made an untrue statement of material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the time such disclosure was made or failure to disclose occurred, would provide a basis for the FDA or any other Governmental Authority to invoke the FDA Application Integrity Policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any similar policy.
(d) Neither Seller nor any officers, employees or, to the Knowledge of Seller, agents of Seller has been excluded, suspended or debarred from any government healthcare program or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (x) debarment under 21 U.S.C. Section 335a or any similar Law or (y) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law, and, to the Knowledge of Seller, no such Proceeding is currently contemplated, proposed or pending.
25
4.14 Inventory.
All items of inventory included in the Assigned Inventory conform to the specifications therefor, are fit for the purposes for which they were procured or manufactured, and consist of a quality usable in the ordinary course of business. The Assigned Inventory is set forth on Schedule 2.1(b)(ii), which schedule specifies the location of such Assigned Inventory.
4.15 Taxes.
(a) All income and other material Tax Returns with respect to the Purchased Assets or the Business have been timely filed, and all such Tax Returns were true, correct, and complete in all material respects.
(b) All income and other material Taxes due and payable (whether or not shown on any Tax Return) relating to the Purchased Assets or the Business have been timely paid.
(c) There is no unpaid Tax: (A) which constitutes or could reasonably be expected to constitute a Lien upon any of the Purchased Assets; or (B) for which Purchaser would be liable under applicable Law by reason of having acquired the Purchased Assets.
(d) There are no Proceedings in progress, pending or, to Seller’s knowledge, threatened in writing against Seller in respect of any Taxes and, in particular, there are no currently outstanding assessments, reassessments or written inquiries which have been issued to, or raised in respect of, Seller by any Governmental Authority relating to any Taxes.
(e) There are no Liens for Taxes (other than Liens for Taxes not yet due and payable) upon, pending against or, to the Seller’s knowledge, threatened in writing against any Purchased Assets.
(f) Seller has collected and/or withheld from employees, contractors, clients, and any other Person all Taxes of any kind required to be collected and/or withheld, including with regard to employment periods up to and including the Closing Date, services received from contractors up to and including the Closing Date and services provided to clients up to and including the Closing Date and has remitted such Taxes to the applicable taxing or regulatory authority.
(g) No claim has been made in writing or to the Seller’s Knowledge, orally, by a Governmental Authority (i) in a jurisdiction in which the Seller does not file Tax Returns, that Seller is or may be subject to taxation in that jurisdiction with respect to the Purchased Assets or the Business or (ii) in a jurisdiction in which the Seller has previously filed any Tax Return, that Seller is or may be subject to additional Taxes with respect to the Purchased Assets or the Business.
(h) There are no outstanding agreements extending or waiving the statutory period of limitations applicable to any claim for, or the period for the collection or assessment or reassessment of, Taxes due from the Seller relating to the Purchased Assets or the Business for any taxable period (and no request for any such waiver or extension is currently pending), and there are no outstanding waivers or agreements extending the due date for filing any Tax Return or paying any Taxes with respect to the Purchased Assets or the Business.
(i) There is no Tax allocation, Tax sharing or similar agreement applicable to the Business or the Purchased Assets other than such agreements entered into by the Seller in the Ordinary Course of Business, the primary purpose of which does not relate to Taxes.
26
(j) The Seller does not have any Liability for Taxes of any Person relating to the Purchased Assets or the Business, including as a transferee or successor, by Contract or otherwise.
(k) The Seller has (i) collected and remitted all applicable sales and/or use Taxes to the appropriate Governmental Authority, and (ii) has obtained, in good faith, any applicable sales and/or use Tax exemption certificates.
(l) With respect to the Business or the Purchased Assets, there is no power of attorney relating to any Tax matters granted to any Person that remains in effect.
4.16 Legal. None of Seller or any officer of Seller has previously been convicted of or pleaded guilty or nolo contendere to (i) a felony or (ii) any crime (whether or not a felony) involving moral turpitude, including theft, fraud, embezzlement, forgery, misappropriation or willful misappropriation. Neither the Seller nor (to the Seller’s knowledge) any of its “Covered Persons” is a “bad actor,” as each such term is defined or used under Rule 506(d) of Regulation D of the Securities Act of 1933.
4.17 Nasdaq Representation. Seller does not hold 5% or greater of the Common Stock of Purchaser, and following the transactions, will not hold 5% or greater of the Common Stock of Purchaser.
4.18 No Other Representations or Warranties. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS ARTICLE 4 AND THE RELATED DOCUMENTS, SELLER DOES NOT, NOR DO ANY OTHER PERSONS ON BEHALF OF SELLER, MAKE ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO ITSELF, THE BUSINESS, THE PURCHASED ASSETS OR THE ASSUMED LIABILITIES, OR WITH RESPECT TO ANY OTHER INFORMATION PROVIDED TO PURCHASER OR ITS REPRESENTATIVES, AND SELLER DISCLAIMS ANY OTHER REPRESENTATIONS OR WARRANTIES, WHETHER MADE BY OR ON BEHALF OF SELLER OR ANY OTHER PERSON.
Article V. REPRESENTATIONS AND WARRANTIES OF PURCHASER
As an inducement to Seller to enter into this Agreement and to consummate the Acquisition, Purchaser represents and warrants to Seller, that each of the following representations and warranties is true and correct as of the Closing Date:
5.1 Organization. Purchaser is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation. Purchaser has all requisite corporate or equivalent power and authority to enter into and perform its obligations under this Agreement and the Transaction Documents to which Purchaser is a party.
27
5.2 Authorization and Validity. The execution and delivery of this Agreement and the other Transaction Documents by Purchaser and the consummation by Purchaser of the Acquisition have been duly and validly authorized by all necessary corporate or equivalent action. This Agreement and the other Transaction Documents have been duly executed and delivered by Purchaser and, assuming the due authorization, execution and delivery by the other Parties thereto, each such agreement constitutes a legal, valid and binding obligation of Purchaser, enforceable against Purchaser in accordance with its terms, subject to the Bankruptcy Exception.
5.3 No Conflict. The execution and delivery of this Agreement and the other Transaction Documents by Purchaser do not, and the performance by Purchaser of its obligations hereunder and the consummation of the Acquisition do not and will not: (a) conflict with or violate any provision of the charter documents of Purchaser; (b) conflict with or violate any Law or Order applicable to Purchaser or by which Purchaser is bound or affected, or (c) any contract, agreement, or other instrument to which Purchaser is a party. No consent or approval is required to be obtained by Purchaser from any Third Party in connection with the execution and delivery of this Agreement or the consummation of the transactions contemplated hereby.
5.4 No Finder. Purchaser has not agreed to pay to any broker, finder, investment banker or any other Person, a brokerage, finder’s or other fee or commission in connection with this Agreement or any matter related hereto.
5.5 No Other Representations or Warranties. EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES CONTAINED IN THIS ARTICLE 5 AND THE RELATED DOCUMENTS, PURCHASER DOES NOT, NOR DO ANY OTHER PERSONS ON BEHALF OF PURCHASER, MAKE ANY OTHER EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WITH RESPECT TO ITSELF OR ANY OTHER INFORMATION PROVIDED TO SELLER OR ITS REPRESENTATIVES, AND PURCHASER DISCLAIMS ANY OTHER REPRESENTATIONS OR WARRANTIES, WHETHER MADE BY OR ON BEHALF OF PURCHASER OR ANY OTHER PERSON.
Article VI. POST-CLOSING COVENANTS
6.1 Funds Received in Respect of Purchased Assets or Excluded Assets. From and after the Closing Date: (a) Seller shall promptly transfer and deliver to Purchaser without set-off, deduction, or offset, any cash or other property, if any, that Seller may receive related to the Purchased Assets; and (b) Purchaser shall promptly transfer and deliver to Seller without set-off, deduction, or offset, any cash or other property, if any, that Purchaser may receive related to the Excluded Assets owned by Seller.
28
6.2 Further Assurances and Registration of Company Intellectual Property. Seller hereby agrees, without further consideration but at no cost to Seller, to promptly execute and deliver following the Closing such other instruments of transfer or assignment and to take such other actions as Purchaser or its counsel may reasonably request in order to put Purchaser in possession of, and to vest in Purchaser, all of Seller’s right, title and interest in and to the Purchased Assets in accordance with this Agreement and otherwise to consummate the Acquisition. Seller will cooperate with and reasonably assist Purchaser in relation to Purchaser’s registration as the new owner of the Purchased Assets at no cost to Seller. Seller will cooperate with and reasonably assist Purchaser to complete, execute, and submit such forms as are required by the FDA or EMA to transfer ownership of the IND146881 and orphan drug designations for VLX-1005 to Purchaser. Seller will execute and deliver, or cause to be executed and delivered, at no cost to Purchaser but at no cost to Seller, any and all documents reasonably requested by Purchaser that may be necessary, in accordance with the rules and regulations of the applicable Governmental Authorities, to transfer to Purchaser or its Affiliates or successors, Seller’s right, title and interest in and to the Purchased Assets and to register the transfer at the Patent and Trademark Office of the United States, and patent offices in all other territories where patent rights have been granted or are pending. For clarity, and notwithstanding anything express or implied in the foregoing provisions of this Section 6.2 or elsewhere in this Agreement to the contrary, but without limiting Seller’s obligations with respect to the Retained Liabilities, Purchaser shall be responsible, at its sole cost and expense, to prepare any and all documents to be executed and delivered by Seller pursuant to the foregoing provisions of this Section 6.2 and to file and register the transfer of all patents, trademarks, copyrights and other intellectual property included in the Purchased Assets with the Patent and Trademark Office of the United States, other foreign patent and trademark offices and with any other entities or organizations where such filings and registrations are required or advisable to be made, and to pay for all filing, registration, recordation and transfer fees, taxes and charges in connection therewith. If Purchaser elects to record this Agreement or any other documents with the appropriate United States or foreign Governmental Authorities or registries, Purchaser will bear the costs and fees associated with recording, but Seller will provide timely cooperation to Purchaser as reasonably requested at no cost to Purchaser but at no cost to Seller.
6.3 Confidentiality. Following Closing, Seller shall, and shall direct, instruct and cause its Affiliates and each of their respective officers, directors, managers, trustees, beneficiaries, advisors, agents, representatives or other intermediaries to, keep all Confidential Information confidential, and shall not, and shall direct, instruct and cause its Affiliates and each of their respective officers, directors, managers, trustees, advisors, agents, representatives or other intermediaries not to, use Confidential Information, except to the extent that (a) it is legally required to disclose such information to a government authority having jurisdiction over Seller or any of its Affiliates, officers, directors, managers, trustees, beneficiaries, advisors, agents, representatives or other intermediaries from whom disclosure is sought, (b) any requirement of Law requires otherwise, (c) or such use is solely in connection with the performance or enforcement of this Agreement, and, then only to the extent such Confidential Information is required or in good faith believed to be necessary to be disclosed in connection therewith; provided that, with respect to subclauses (a) and (b), if Seller is requested or required (by oral question or request for information or documents in any Proceeding, interrogatory, subpoena, civil investigative demand, or similar process) to disclose any Confidential Information, then Seller will notify Purchaser promptly of the request or requirement in writing so that Purchaser may seek an appropriate protective order or waive compliance with the provisions of this Section 6.3 in that limited instance. If, in the absence of a protective order or the receipt of a waiver from Purchaser hereunder, Seller is, based on advice of outside counsel, compelled to disclose any Confidential Information to any tribunal or else stand liable for contempt, Seller may disclose only that Confidential Information legally required to be disclosed to the applicable government authority. In any event, Seller shall mark, or cause to be marked, any Confidential Information that is disclosed in accordance with this Section 6.3 as confidential and use best efforts to accord such information confidential treatment.
29
Notwithstanding the foregoing, Seller, its Affiliates and each of their respective officers, directors, managers, trustees, beneficiaries, advisors, agents, representatives or other intermediaries may disclose non-public Confidential Information concerning this Agreement and the other Transaction Documents to Persons to whom Seller assigns pursuant to Section 8.4 Seller’s right to receive payment under this Agreement and the representatives, advisors and agents of such Persons, provided that such recipients (i) are contractually bound by confidentiality obligations no less stringent than those set forth herein, and (ii) to the extent such Person would receive scientific or technical Confidential Information of Purchaser or Confidential Information of Purchaser that is unrelated to the payment obligation assigned to the assignee, such recipients do not, directly or indirectly, themselves or through any Person, engage in the development, manufacture or commercialization of any drug product that targets the 12-Lipoxygenase. Purchaser may disclose the terms of this Agreement as necessary to comply with the rules of the U.S. Securities and Exchange Commission and any stock exchange.
6.4 Rights under Contracts. Seller shall use its commercially reasonable efforts to obtain the written consent of any third party required in connection with the transfer of any Assigned Contracts to Purchaser. Notwithstanding anything in this Agreement to the contrary, to the extent that any Assigned Contract is not assignable without the consent of another party whose consent has not been obtained, neither this Agreement nor any related assignment or assumption agreement or instrument shall constitute an assignment or attempted assignment of such Assigned Contract if such assignment or attempted assignment would constitute a breach thereof or materially detract from the rights transferred to Purchaser. Instead, if any such required consent is not obtained, then Seller shall provide and extend the full benefit of such Assigned Contract to Purchaser and shall enter into any other reasonable arrangement requested by Purchaser that is designed to give Purchaser the full benefit of such Assigned Contract accruing on or after the Closing and that does not violate applicable law.
6.5 Tail Policy. Prior to the expiration of the current Clinical Trial Liability policy maintained by Seller through Berkley Life Sciences with a limit of $5,000,000, Seller shall purchase and maintain in effect for a period of three (3) years after the expiration of the current policy a claims made tail policy (the “Tail Policy”) with respect to Claims arising from facts or events that occurred on or before the Closing Date, which Tail Policy will contain substantially the same coverage and amounts as the current policy.
Article VII. INDEMNIFICATION
7.1 Indemnification by Seller. Subject to the terms, conditions and limitations of this ARTICLE VII, following the Closing, Seller shall indemnify Purchaser, its affiliates and each of their respective successors, assigns, officers, directors, shareholders, partners, employees and agents (collectively, the “Purchaser Indemnitees”) from and against, and hold them harmless from, any Liability, indebtedness, claim, loss, damage, Lien, deficiency, obligation, judgment, penalty, responsibility or other costs or expenses (including reasonable attorneys’ fees and expenses paid in connection with any of the foregoing) (collectively, “Losses”) suffered or incurred by any such Purchaser Indemnitee (whether involving direct claims by Purchaser against Seller or third party claims) arising out of or resulting from (a) any breach of any representation or warranty of Seller contained in this Agreement, (b) the breach of any covenant of Seller contained in this Agreement, (c) the Retained Liabilities or the Excluded Assets, (d) the operation by the Seller of the Purchased Assets prior to the Closing, and (e) any claims, demands, or causes of action asserted against any Purchaser Indemnitee by any creditor of Seller under any successor theories, including without limitation any claims under successor in interest or de facto merger theories, under applicable state law for the receipt of any fraudulent transfers including claims under the Uniform Voidable Transactions Act, and/or any claims or causes of action asserted under Sections 544, 547 and 548 of the United States Bankruptcy Code.
30
7.2 Indemnification by Purchaser. Subject to the terms, conditions and limitations of this ARTICLE VII, following the Closing, Purchaser and its subsidiaries shall indemnify Seller, its affiliates and each of their respective successors, assigns, officers, directors, shareholders, partners, employees and agents (collectively, the “Seller Indemnitees”) from and against, and hold them harmless from, any Losses suffered or incurred by any such Seller Indemnitee (whether involving direct claims by Seller against Purchaser or third party claims) arising out of or resulting from (a) any breach of any representation or warranty of Purchaser contained in this Agreement, (b) the breach of any covenant of Purchaser contained in this Agreement, (c) the Assumed Liabilities, and (d) the operations by Purchaser of the Purchased Assets following the Closing (except to the extent such claim is within the scope of Seller’s indemnification obligations under Section 7.1 above).
7.3 No Third Party Beneficiaries. The indemnities herein are intended solely for the benefit of the Persons expressly identified in this ARTICLE VII (and their successors and permitted assigns) and are in no way intended to, nor shall they, constitute an agreement for the benefit of, or be enforceable by, any other Person.
7.4 Termination of Indemnification. The obligations to indemnify and hold harmless an indemnified party hereunder pursuant to Section 7.1 and Section 7.2 shall terminate when the applicable representation, warranty or covenant terminates pursuant to Section 7.6 of this Agreement; provided that such obligations to indemnify and hold harmless shall not terminate with respect to any specific matter as to which the person to be indemnified shall have, before the expiration of the applicable period, previously made a claim by delivering a written notice thereof (stating in reasonable detail the basis of such claim and the provisions of this Agreement applicable to such claim) (a “Claim Notice”) to the indemnified party hereunder.
7.5 Indemnification Procedures.
(a) In order for an indemnified party hereunder to be entitled to any indemnification provided for under this Agreement in respect of, arising out of or involving a claim or demand made by any Person against such indemnified party (a “Third-Party Claim”), such indemnified party must provide the indemnifying party hereunder with a Claim Notice regarding the Third-Party Claim promptly and in any event within ten (10) Business Days after receipt by such indemnified party of written notice of the Third-Party Claim; provided that failure to give such notification shall not affect the indemnification provided hereunder except to the extent the indemnifying party shall have been actually prejudiced as a result of such failure (except that the indemnifying party shall not be liable for any expense incurred during the period in which the indemnified party failed to give such notice). Thereafter, the indemnified party shall deliver to the indemnifying party, within five (5) Business Days after the indemnified party’s receipt thereof, copies of all notices and documents (including court papers) received by the indemnified party relating to the Third-Party Claim.
31
(b) If a Third-Party Claim is made against an indemnified party hereunder, the indemnifying party hereunder will be entitled to participate in the defense thereof and, if it so chooses and such Third-Party Claim does not relate to Taxes, to assume the defense thereof with counsel selected by the indemnifying party hereunder. If the Third-Party Claim includes allegations for which the indemnifying party hereunder both would and would not be obligated to indemnify the indemnified party hereunder, the indemnifying party hereunder and the indemnified party shall in that case jointly assume the defense thereof. Should the indemnifying party hereunder be permitted to and so elect to assume the defense of a Third-Party Claim, the indemnifying party will not be liable to the indemnified party hereunder for legal fees and expenses subsequently incurred by the indemnified party hereunder in connection with the defense thereof. If the indemnifying party hereunder assumes such defense, the indemnified party hereunder shall have the right, at its own expense, to participate in the defense thereof and, at its own expense, to employ counsel reasonably acceptable to the indemnifying party hereunder, separate from the counsel employed by the indemnifying party hereunder, it being understood that the indemnifying party shall control such defense. The indemnifying party hereunder shall be liable for the fees and expenses of counsel employed by the indemnified party hereunder for any period during which the indemnifying party has not assumed the defense thereof (other than during any period in which the indemnified party shall have failed to give notice of the Third-Party Claim as provided above). If the indemnifying party chooses to defend or prosecute any Third-Party Claim, all the parties hereto shall cooperate in the defense or prosecution thereof. Such cooperation shall include the retention and (upon the indemnifying party’s request) the provision to the indemnifying party of records and information which are reasonably relevant to such Third-Party Claim, and making officers, directors, employees and agents of the indemnified party hereunder available on a mutually convenient basis to provide information, testimony at depositions, hearings or trials, and such other assistance as may be reasonably requested by the indemnifying party hereunder. Whether or not the indemnifying party hereunder shall have assumed the defense of a Third-Party Claim, the indemnified party hereunder shall not admit any Liability with respect to, or settle, compromise or discharge, such Third-Party Claim without the indemnifying party’s prior written consent (which consent shall not be unreasonably withheld or delayed). The indemnifying party hereunder shall not admit any Liability with respect to, or settle, compromise or discharge any Third-Party Claim without the indemnified party’s prior written consent (which consent shall not be unreasonably withheld or delayed); provided that, unless the Third-Party Claim relates to Taxes, the indemnified party shall agree to any admission of Liability, settlement, compromise or discharge of a Third-Party Claim that the indemnifying party may recommend and that by its terms obligates the indemnifying party to pay the full amount of the Liability in connection with such Third-Party Claim and which releases the indemnified party completely in connection with such Third-Party Claim.
(c) All amounts owed by an indemnifying party to the indemnified party (if any) shall be paid in full within five (5) business days after a final judgment (without further right of appeal) determining the amount owed is rendered, or after a final settlement or agreement as to the amount owed is executed.
32
7.6 Survival of Representations and Warranties. All representations and warranties contained in this Agreement shall survive until the date which is three (3) years after the Closing, other than the Seller Fundamental Representations, which shall survive for a period of six (6) months following the applicable statute of limitations for the applicable underlying claim, including any extensions or waivers thereof. All covenants and agreements contained in this Agreement shall survive until the last date on which such covenant or agreement is to be performed. Notwithstanding the foregoing, if, prior to the close of business on the applicable survival period expiration date, an indemnifying party shall have been properly notified of a claim for indemnity hereunder and such claim shall not have been finally resolved or disposed of at such date, such claim shall continue to survive and shall remain a basis for indemnity hereunder until such claim is finally resolved or disposed of in accordance with the terms hereof.
7.7 Tax Treatment of Indemnification Payments. Any indemnification payments made to Purchaser pursuant to this Agreement shall be treated as an adjustment to the final Purchase Price, unless a Final Determination with respect to the indemnified party hereunder causes any such payment not to be treated as an adjustment to the Purchase Price. For purposes of this agreement, “Final Determination” means (i) with respect to federal income taxes, a “determination” as defined in Section 1313(a) of the Internal Revenue Code of 1986, as amended, or execution of an Internal Revenue Service Form 870 AD, and (ii) with respect to taxes other than federal income taxes, any final determination of Liability in respect of a tax that, under applicable law, rule or regulation is not subject to further appeal, review or modification through proceedings or otherwise (including the expiration of a statute of limitations or a period for the filing of claims for refunds, amended returns or appeals from adverse determinations).
7.8 Liability Limits; Exclusive Remedy; Set Off Right.
(a) The indemnities provided for herein shall constitute the sole and exclusive remedy of Purchaser, Seller, or any indemnified party for any Losses arising out of, resulting from or incurred in connection with any claims related to the negotiation, execution, delivery, performance or nonperformance of this Agreement; provided, however, that (i) this exclusive remedy shall not preclude a Party from bringing an action for specific performance or other equitable remedy to require a party to perform its obligations under this Agreement, and (ii) no limitation set forth in this Agreement, including the limitations set forth in this Article 7, shall limit any remedy that may be available to Purchaser or Seller against any other Party on account of fraud.
(b) Other than claims for Losses arising out of, or caused by or relating to (i) inaccuracy in or breach of the Seller Fundamental Representations, or (ii) fraud, in no event shall Seller be liable to provide indemnification pursuant to Article 7 for Losses arising from or in connection with Section 7.1(a), in the aggregate in excess of an amount equal to the Purchase Price actually paid to Seller hereunder.
(c) Notwithstanding anything to the contrary set forth herein, in no event shall Purchaser have any liability to the Seller Indemnitees for Losses arising out of, resulting from, or incurred in connection with any claims related to the negotiation, execution, delivery, performance, or nonperformance of this Agreement in excess of the Purchase Price actually paid to Seller hereunder.
33
(d) In addition to all other rights and remedies that the Purchaser may have, Purchaser shall have the right to setoff against amounts owed to the Seller under this Agreement any Losses for which the Purchaser is entitled to indemnification under this Article 7 (including the amounts owed, if any, pursuant to Section 2.5(c) and Section (d)). Purchaser’s rights to indemnification under this Article 7 shall not be in any manner limited by or to this right of setoff. If on the date that any amount is due to Seller pursuant to this Agreement, Purchaser has a claim against Seller hereunder for indemnification under this Article 7 and such claim has been disputed and such disputed claim has not, by such date, been resolved, Purchaser shall retain the amount in dispute until the date of resolution. If the amount in dispute is less than the amount due to be paid on such date, Purchaser shall pay the balance of any such payment. The “amount in dispute” shall mean the amount stated in good faith in the notice most recently given by Purchaser to the Seller related to such claim. No such statement as to the amount of such claim shall limit the liability of the Seller under this Article 7 if it is later determined that the amount which Purchaser would otherwise be entitled to indemnification is higher than initially believed or so stated by Purchaser.
(e) All references in this Agreement to “material,” “material respects,” “material adverse effect,” “material adverse change” and similar qualifications are to be excluded with regard to determining the amount of indemnifiable Losses.
Article VIII. GENERAL
8.1 Notices. All notices, requests, claims, demands or other communications that are required or may be given pursuant to the terms of this Agreement shall be in writing and shall be deemed to have been duly given: (a) when delivered, if delivered by hand; (b) one (1) Business Day after transmitted, if transmitted by a nationally recognized overnight courier service; (c) when sent by electronic mail (with copy by mail or courier) or confirmed facsimile during regular business hours on a regular Business Day; or (d) five (5) Business Days after mailing, if mailed by registered or certified mail (return receipt requested), to the Parties at the following addresses (or at such other address for a Party as shall be specified in a notice given in accordance with this Section 8.1):
If to Purchaser:
CADRENAL THERAPEUTICS, INC.
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
| Telephone: | (904) 300-0701 |
| Attention: | Quang X. Pham, CEO |
| Email: | [_______] |
With a copy to (which shall not constitute notice or such other communication):
Blank Rome LLP
1271 Sixth Avenue
New York, NY 10020
| Attn: | Leslie Marlow |
| Email: | [_______] |
34
If to Seller:
VERALOX THERAPEUTICS INC.
[_______]
[_______]
[_______]
| Attn: | [_______] |
| Email: | [__________] |
With a copy to:
[____________]
[____________]
[____________]
| Attn: | [_______] |
| Email: | [______] |
8.2 Severability. If any provision of this Agreement for any reason shall be held to be illegal, invalid or unenforceable, such illegality shall not affect any other provision of this Agreement, but this Agreement shall be construed as if such illegal, invalid or unenforceable provision had never been included herein.
8.3 Assignment; Binding Effect. Except as otherwise provided in Section8.3, neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned by Seller (whether by operation of Law or otherwise) without the prior written consent of the Purchaser. Any purported assignment, unless so consented to or permitted as provided herein, shall be void and without effect. Subject to the foregoing, this Agreement shall be binding upon and shall inure to the benefit of the Parties and their respective successors and permitted assigns. Except to the extent otherwise provided in Section 8.4, nothing in this Agreement, expressed or implied, is intended to confer on any Person other than the Parties or their respective successors and permitted assigns any rights or remedies under or by reason of this Agreement.
8.4 Assignment of Right to Payment.
(a) Notwithstanding Section 8.3, Seller may assign its right to payment of any Milestone Payment or Royalty payment due hereunder, in whole or in part, to any party (each an “Authorized Individual”) upon written notice to Purchaser. Each Authorized Individual (the “Transferring Assignee”) shall have the right to further assign and transfer to any of such Authorized Individual’s Affiliates, successors, heirs, family members and/or estate planning trusts, as applicable (each, a “Receiving Assignee”), such Transferring Assignee’s right, in whole or in part, to receive a portion of any Milestone Payment or Royalty payment payable pursuant to this Agreement at any time and from time to time following the effective date of the applicable assignment made by such Transferring Assignee pursuant to this Section 8.4(a) to any such Receiving Assignees. For clarity, the term “Authorized Individuals” shall mean, collectively, any and all Persons that are, directly or indirectly, assignees pursuant to, and in accordance with, the provisions of this Section 8.4 of Seller’s right to receive payment of any Milestone Payment or any Royalty payment payable pursuant to this Agreement.
35
(b) Upon such assignment by a Transferring Assignee to a Receiving Assignee, such Receiving Assignee shall become an Authorized Individual with the right to receive payment of any Milestone Payment or Royalty of the applicable Transferring Assignee (to the extent of the interest transferred by such applicable Transferring Assignee to such Receiving Assignee), and the right to assign and transfer such Receiving Assignee’s right to receive payment of any Milestone Payment or Royalty payment payable pursuant to this Agreement in accordance with this Section 8.4.
(c) Certain capitalized terms used in this Section 8.4(c) are defined in Exhibit 8.4(c) hereto. Prior to any Milestone Payment or Royalty payment becoming due and payable under this Agreement to an Authorized Individual, such Authorized Individual shall (i) make a representation to the Purchaser that (i) such Authorized Individual is a “Permitted Assignee” (as defined in Exhibit 8.4(c)) and (ii) such Authorized Individual shall deliver to Purchaser documentation and information reasonably necessary to establish that such Authorized Individual is a Permitted Assignee as reasonably requested by Purchaser, banking institution, paying agent or other third party. In the event that a Milestone Payment or Royalty Payment or portion thereof is due to a particular Authorized Individual who has not yet been determined to be a Permitted Assignee, Purchaser shall be entitled to hold such payment until such time as such Authorized Individual satisfies the requirements to be a Permitted Assignee pursuant to the previous sentence or directs in writing that such payment be made to a Person who satisfies the requirements that such Authorized Individual would have to satisfy in order to be a Permitted Assignee.
(d) In the event that Purchaser chooses, at its option, to pay any Milestone Payment or Royalty due hereunder by the issuance of shares of Common Stock, the Seller or the Authorized Individual, as applicable, shall provide, upon request, such representations, warranties, and information as may be reasonably necessary to ensure that the issuance of any shares pursuant to this Agreement qualifies for an exemption from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”) and any applicable state securities laws (the “Securities Representations”). Without limiting the foregoing, each Authorized Individual shall execute and deliver any certificates, agreements, or other documents, and shall make such Securities Representations, as may be reasonably requested by the Purchaser or its counsel to establish that the issuance of shares is exempt from registration under the Securities Act and applicable state securities laws. The Purchaser shall not be obligated to issue any shares of Common Stock without receipt of the Securities Representations.
(e) Each Authorized Individual’s right to receive payment of their applicable portion of each Milestone Payment and each Royalty payment made or required to be made pursuant to this Agreement at any time and from time to time following the effective date of the assignment applicable to such Authorized Individual shall be subject to and upon all of the terms and conditions of this Agreement that would be applicable to the payment of such Milestone Payment or such Royalty payment, as the case may be, by Purchaser to Seller if Seller had not assigned its rights to receive payment of such Milestone Payment or such Royalty payment, as the case may be, pursuant to this Section 8.4.
36
(f) Notwithstanding anything express or implied in this Agreement to the contrary, notwithstanding the assignment by Seller of any right to payment hereunder to an Authorized Individual (or the subsequent assignment of such right to a downstream Authorized Individual), all other rights and decisions of Seller under this Agreement shall be exercised by Seller.
(g) Any assignment by any Authorized Individual pursuant to, and in accordance with, the foregoing provisions of this Section 8.4 of such Authorized Individual’s right, in whole or in part, to receive a portion of each Milestone Payment and each Royalty payment payable pursuant to this Agreement shall be made and effected in writing, and the Transferring Assignee and Receiving Assignee must provide to Purchaser a written notice of the assignment that is signed by both the Transferring Assignee and the Receiving Assignee and specifies the percentage interest of each Milestone Payment or Royalty payment applicable to such Receiving Assignee (the “Percentage”) and the wire instructions applicable to the payment to such Receiving Assignee (the “Assignment Notice”). Upon receipt by Purchaser of a fully executed Assignment Notice, Purchaser shall be entitled to rely on such Assignment Notice without conducting any investigation and may make payment to the Receiving Assignee identified in such Assignment Notice of the Percentage identified in such Assignment Notice of any Milestone Payment and Royalty payment payable pursuant to this Agreement at any time after the date that Purchaser receives such fully executed Assignment Notice and after the Receiving Assignee is determined to be a Permitted Assignee in accordance herewith. Payment by Purchaser to the Receiving Assignee identified in such Assignment Notice of the Percentage identified in such Assignment Notice of any Milestone Payment and Royalty payment payable pursuant to this Agreement at any time after the date that Purchaser receives such fully executed Assignment Notice and after the Receiving Assignee is determined to be a Permitted Assignee in accordance herewith shall be deemed to satisfy Purchaser’s obligation to make the payment of such amount hereunder.
8.5 Governing Law; Jurisdiction. THIS AGREEMENT SHALL BE GOVERNED BY, AND CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF DELAWARE OTHER THAN CONFLICT OF LAWS PRINCIPLES THEREOF DIRECTING THE APPLICATION OF ANY LAW OTHER THAN THAT OF DELAWARE. COURTS WITHIN THE STATE OF DELAWARE WILL HAVE EXCLUSIVE JURISDICTION OVER ALL DISPUTES BETWEEN THE PARTIES HERETO ARISING OUT OF OR RELATING TO THIS AGREEMENT AND THE AGREEMENTS, INSTRUMENTS AND DOCUMENTS CONTEMPLATED HEREBY. THE PARTIES HEREBY KNOWINGLY AND WILLING CONSENT TO AND AGREE TO SUBMIT TO THE EXCLUSIVE JURISDICTION OF SUCH COURTS, TO THE EXCLUSION OF ANY OTHER COURTS. TO THAT END, EACH OF THE PARTIES HERETO: (A) WAIVES, AND AGREES NOT TO ASSERT IN ANY SUCH DISPUTE, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY CLAIM THAT (I) SUCH PARTY IS NOT PERSONALLY SUBJECT TO THE JURISDICTION OF SUCH COURTS, (II) SUCH PARTY AND SUCH PARTY’S PROPERTY IS IMMUNE FROM ANY LEGAL PROCESS ISSUED BY SUCH COURTS OR (III) ANY LITIGATION COMMENCED IN SUCH COURTS IS BROUGHT IN AN INCONVENIENT FORUM; AND (B) AGREES THAT SERVICE OF PROCESS TO ITS ADDRESS AS IN EFFECT FROM TIME TO TIME PURSUANT TO SECTION 8.1 SHALL BE AND CONSTITUTE GOOD, VALID, AND SUFFICIENT SERVICE OF PROCESS ON SUCH PARTY AND HIS OR ITS AFFILIATES.
37
8.6 Waiver of Jury Trial. EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY PROCEEDING (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY TRANSACTION OR AGREEMENT CONTEMPLATED HEREBY OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE OR ENFORCEMENT HEREOF.
8.7 Headings. The descriptive headings contained in this Agreement are included for convenience of reference only and shall not affect in any way the meaning or interpretation of this Agreement.
8.8 Counterparts. This Agreement may be executed and delivered in one or more counterparts (including facsimile, PDF, or other electronic counterparts), each of which when executed and delivered shall be deemed to be an original but all of which taken together shall constitute one and the same agreement.
8.9 Entire Agreement. This Agreement (including the Disclosure Schedules attached hereto) and the Transaction Documents executed in connection with the consummation of the Acquisition contain the entire agreement between the Parties with respect to the subject matter hereof and related transactions and supersede all prior agreements, written or oral, with respect thereto.
8.10 Waivers and Amendments. This Agreement may be amended, superseded, canceled, renewed or extended only by a written instrument signed by each of the Parties. The provisions hereof may be waived only in writing signed by the Party making such waiver or sought to be bound thereby. No delay on the part of any Party in exercising any right, power or privilege hereunder shall operate as a waiver thereof, nor shall any waiver on the part of any Party of any such right, power or privilege, nor any single or partial exercise of any such right, power or privilege, preclude any further exercise thereof or the exercise of any other such right, power or privilege.
8.11 Preservation of Remedies. Except as otherwise provided herein, the rights and remedies provided for in this Agreement are cumulative and are not exclusive of any rights or remedies that any Party may otherwise have at Law or in equity. The Parties agree and acknowledge that irreparable damage would occur to the other Party in the event that any provision of this Agreement was not performed in accordance with the terms hereof or in the event of any breach or threatened breach of any provision of this Agreement by the other Party and that, therefore, each Party shall be entitled to seek expedited and immediate: (a) specific performance of the terms hereof; (b) injunctive relief to enjoin any breach or threatened breach of any of the terms hereof; or (c) other appropriate equitable relief, in each case in addition to any other remedy at Law, in equity, by contract, or otherwise and that in connection therewith such Party shall not be required or compelled to post any bond or security in connection with any application or petition for any such equitable remedy or relief it or may seek.
38
8.12 Expenses. Except as otherwise specifically provided in this Agreement, each of the Parties shall bear its own fees, costs, and expenses incurred in connection with the preparation, execution and performance of this Agreement and the Acquisition.
8.13 Public Announcements. No party shall make any public announcement or communication or issue any circular in connection with the existence or the subject matter of this Agreement without the prior written approval of the other party. The restriction in this Section 8.13 shall not apply to the extent that the public announcement, communication or circular is required by Law, by any stock exchange or any regulatory or supervisory body or authority of competent jurisdiction to which a Party is subject or submits, whether or not the requirement has the force of Law. If this exception applies, the Party making the public announcement or communication or issuing the circular shall use its commercially reasonable efforts to consult with the other Party in advance as to its form, content and timing.
8.14 Construction. The Parties agree that any rule of construction to the effect that ambiguities are to be resolved against the drafting Party shall not be applied in the construction or interpretation of this Agreement as each Party participated in the drafting of this Agreement and the Parties have agreed that no provision or provisions of this Agreement can, may, or should be attributed to any particular Party.
8.15 Specific Performance. Each of the Parties acknowledges and agrees that the other Party would be damaged irreparably in the event any of the provisions of this Agreement are not performed in accordance with their specific terms or otherwise are breached. Accordingly, each of the Parties agrees that the other Party will be entitled to an injunction or injunctions to prevent breaches of the provisions of this Agreement and to enforce specifically this Agreement and the terms and provisions of this Agreement in any action instituted in any court having jurisdiction over the Parties and the matter, in addition to any other remedy to which they may be entitled, at Law or in equity. Each Party agrees to waive the defense that a remedy at law would be adequate in any action for specific performance under this Section 8.15.
[Signatures appear on next page]
39
IN WITNESS WHEREOF, intending to be legally bound hereby, the Parties have executed this Asset Purchase Agreement by their duly authorized representatives as of the Execution Date.
| PURCHASER: | ||
| CADRENAL THERAPEUTICS, INC. | ||
| By: | /s/ Quang X. Pham | |
| Name: | Quang X. Pham | |
| Title: | Chief Executive Officer | |
[Signatures continue on next page.]
IN WITNESS WHEREOF, intending to be legally bound hereby, the Parties have executed this Asset Purchase Agreement by their duly authorized representatives as of the Execution Date.
| SELLER: | ||
| VERALOX THERAPEUTICS INC. | ||
| By: | /s/ Matthew Boxer | |
| Name: | Matthew Boxer | |
| Title: | Chief Operating Officer | |
Exhibit 10.2
AMENDED AND RESTATED
EXCLUSIVE LICENSE AGREEMENT
This Amended and Restated Exclusive License Agreement (“Agreement”) is entered into as of the 1st day of May, 2020 (“Effective Date”), by and between EASTERN VIRGINIA MEDICAL SCHOOL (“EVMS”) located at P.O. Box 1980 Norfolk, VA 23501-1980, U.S.A., and Veralox Therapeutics, Inc. 4539 Metropolitan Court, Frederick, MD 21704 (“LICENSEE”), with respect to the facts set forth below.
RECITALS
A. EVMS is engaged in fundamental scientific research including research relating to 4-((2- Hydroxy-3-MethoxyBenzyl)Amino) Benzenesulfonamide Derivatives as 12-Lipoxygenase Inhibitors and uses thereof.
B. LICENSEE is engaged in the business of researching, developing, manufacturing and selling products and processes related to modulation of lipoxygenase including the 12-LOX inhibitor ML355 (aka VLX-105) and derivatives thereof.
C. EVMS owns the EVMS Patent Rights (as hereinafter defined) along with co-owners the National Institutes of Health, within the Department of Health and Human Services (“HHS”) through the Office of Technology Transfer (“NIH”), the Regents of the University of California, Santa Cruz (“UCSC”), and Thomas Jefferson University (“TJU”) (collectively “Co-Owners”) and has the exclusive right to grant licenses thereunder.
D. EVMS desires to grant to LICENSEE, and LICENSEE wishes to acquire, an exclusive worldwide license, under the EVMS Patent Rights, to develop, to make, to have made, to use, to import, to export, to sell and/or to offer for sale the Licensed Product (as hereinafter defined).
E. The parties have previously entered into an exclusive license agreement on June 1, 2018 (the “Original Agreement”) regarding the subject matter of this Agreement and now wish to clarify, amend, replace and supersede the Original Agreement in its entirety with this Agreement.
AGREEMENT
NOW, THEREFORE, in consideration of the mutual covenants and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, EVMS and LICENSEE (collectively “parties”, individually “party”) hereby agree as follows:
1. Definitions. The following capitalized terms shall have the meaning set forth below. The plural form of the defined terms shall be included within the definitions of the corresponding singular form and vice versa.
1.1 Affiliate. The term “Affiliate” shall mean any corporation, company, partnership, joint venture or other entity, which directly or indirectly controls, is controlled by or is under common control with LICENSEE. The term “control” (including, with correlative meanings, the terms “controlling”, “controlled by” and “under common control with”) as used herein shall mean, without limitation, direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the securities or other ownership interests representing the equity, voting stock, general partnership or membership interest of such entity.
1 of 21
1.2 Change in Control. The term “Change in Control” shall mean the (1) consolidation or merger of LICENSEE with or into any person or entity as a result of which the beneficial owners of the outstanding voting securities or other ownership interests of LICENSEE immediately prior to such transaction have beneficial ownership of less than fifty percent (50%) of the outstanding voting securities or other ownership interests of such surviving person or entity immediately following such transaction, or (2) sale, transfer or other disposition of all or substantially all of the assets of LICENSEE related to this Agreement; or (3) acquisition by any person or entity, or group of persons or entities acting in concert, of beneficial ownership of fifty percent (50%) percent or more (or such lesser percentage that constitutes control) of the outstanding voting securities or other ownership interests of LICENSEE other than through a Financing.
1.3 Combination Product. The term “Combination Product” means a combination or bundle of two or more products or services, at least one of which products or services is a Licensed Product or Licensed Service that has been assigned its own separate stock keeping unit number or reasonable equivalent thereof (used to track such product or service for sales purposes) (a “SKU”) by Licensee, an Affiliate of Licensee or a Sublicensee and at least one of which products or services has been assigned its own and separate SKU but is not a Licensed Product or License Service, which combination or bundle is sold by Licensee, an Affiliate of Licensee or a Sublicensee for a single price under its own separate SKU.
1.4 Confidential Information. The term “Confidential Information” shall mean all non-public or proprietary information disclosed by or on behalf of a party or any of its Affiliates to the other party or any of its Affiliates under this Agreement, without regard to whether such information is marked “confidential” or “proprietary”, or disclosed in oral, written, graphic or electronic form; provided that any non-public or proprietary information disclosed under this Agreement shall not be deemed to be “Confidential Information” if the receiving party can show that such information:
(a) is or was disclosed to the receiving party or any of its Affiliates on a non-confidential basis by a third party that, to the receiving party’s knowledge, is not bound by an obligation of confidentiality to the disclosing party with respect to such information;
(b) is now, or hereafter becomes, through no breach of this Agreement on the part of the receiving party or any of its Affiliates, generally known or available to the public, either before or after it is disclosed to the receiving party by the disclosing party; or
(c) is independently discovered or developed by or on behalf of the receiving party or any of its Affiliates without the use of or reference to any Confidential Information of the disclosing party, as evidenced by contemporaneous written records.
The parties hereby acknowledge that this Agreement and all of the terms and conditions of this Agreement shall be deemed to be the Confidential Information of each party.
1.4 EVMS Patent Rights. The term “EVMS Patent Rights” shall mean patents and patent applications set forth in Exhibit A, and all divisionals and continuations thereof, any corresponding foreign patent applications and any patents, or other equivalent foreign patent rights issuing, granted or registered thereon.
1.5 Field. The term “Field” shall mean all uses.
1.6 Financing. The term “Financing” shall mean a purchase of preferred shares of equity issued by LICENSEE in a bona fide financing transaction in which direct or indirect beneficial ownership of at least fifty percent (50%) of the outstanding voting securities or other ownership interest of LICENSEE.
2 of 21
1.7 Licensed Product. The term “Licensed Product” shall mean any process or method, material, composition, drug or other product, the manufacture, use or sale of which by LICENSEE or any Affiliate of LICENSEE or Sublicensee would constitute, but for the license granted to LICENSEE herein, an infringement of any claim of any of the EVMS Patent Rights, or unauthorized use of know-how related to the EVMS Patent Rights. (Infringement includes direct, contributory, or inducement to infringe).
1.8 Licensed Service. The term “Licensed Service” shall mean the performance on behalf of a third party by LICENSEE or any Affiliate of LICENSEE or Sublicensee of any method or the manufacture of any product or the use of any product or composition which would constitute, but for the license granted to LICENSEE herein, an infringement of a claim of EVMS Patent Rights or unauthorized use of know-how related to the EVMS Patent Rights. (Infringement includes direct, contributory or inducement to infringe).
1.9 Net Sales. The term “Net Sales” shall mean gross sales revenues invoiced (or if no amount is invoiced, the amount actually charged) by LICENSEE or any Affiliate of LICENSEE or Sublicensee from the sale of Licensed Products or Licensed Services to any unrelated third party less (i) normal and customary returns, rebates, chargebacks and allowances for damaged or missing goods, in each case actually allowed, (ii) normal and customary outbound packing, transportation, freight, handling, postage charges or other charges relating to such shipping charges, such as insurance and (iii) sales, excise, value added, turnover, use and other like taxes or customs duties paid or any other governmental charges imposed upon the sale of Licensed Products or Licensed Services. In the event that LICENSEE or any Affiliate of LICENSEE or Sublicensee sells a Licensed Product or Licensed Services as a Combination Product, the Net Sales for purposes of royalty payments shall be determined in accordance with the following paragraph. In the event that consideration in addition to or in lieu of money is received for the sale of any Licensed Product in an arms-length transaction, the fair market value of such consideration (as of the date it is received by LICENSEE) shall be included in the determination of Net Sales Revenue for such sale. To the extent that any Licensed Product is sold in other than an arms-length transaction, Net Sales Revenue for such sale shall be the average sales price of such Licensed Product if sold in an arms-length transaction during the applicable calendar quarter in the jurisdiction in which the non-arms-length transaction occurred. Calculations and determination of royalties payable hereunder shall be made using U.S. generally accepted accounting principles (“GAAP”), consistently applied.
In the event that Licensee undergoes a Change in Control and inventory of Licensed Products is sold as an asset sale as part of such Change in Control, the amount received by Licensee for such sale of inventory of Licensed Products in such Change in Control shall not be deemed to be Net Sales.
For purposes of calculating Net Sales, in the case of Net Sales attributable to a Licensed Product or Licensed Service in any Combination Product that is sold in a particular country, Net Sales thereof shall be determined by multiplying the actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the weighted average sale price of such Licensed Product or Licensed Service in such country if sold separately in such country during the applicable calendar quarter and B is the sum of the weighted average sale prices in such country of the other product/services included in such Combination Product in each case if sold separately in such country during the applicable calendar quarter. In the event that that a Licensed Product, Licensed Service, or any other product/service included in such Combination Product was not sold separately in such country during the applicable calendar quarter, LICENSEE shall propose to EVMS LICENSEE’s best estimate of what the weighted average sales price of such Licensed Product, Licensed Service or any other product/service included in such Combination Product would have been, and LICENSEE shall also provide to EVMS the method of calculating such best estimate, within five (5) days after the end of the applicable calendar quarter. EVMS and LICENSEE shall negotiate in good faith regarding the amount of such weighted average sales price.
3 of 21
Except as set forth in this paragraph, in no event shall the calculations set forth in the previous paragraph reduce the Net Sales of a Combination Product below fifty percent (50%) of what the Net Sales of each Licensed Product or Licensed Service included in such Combination Product would have been (the “Floor”). In the event that LICENSEE can demonstrate to EVMS’s reasonable satisfaction that the calculation set forth in the previous paragraph would result in the sum of the value of the Net Sales of the Licensed Products or Licensed Services included in a Combination Product being equal to or less than twenty percent (20%) of the Net Sales of such Combination Product (calculated in accordance with previous paragraph) in a country during a calendar quarter, than the Floor shall not apply to such Combination Product in such country during such calendar quarter.
1.10 Patent Challenge. The term “Patent Challenge” shall mean a legal action filed in a court of competent jurisdiction or with the United States Patent Office (or a foreign equivalent) to challenge to the validity, patentability, or enforceability of any EVMS Patent Right or otherwise opposing any EVMS Patent Right during the Term. However, a Patent Challenge will not include any counterclaim, defense or other assertion by LICENSEE, its Affiliates or any Sublicensee in connection with an action filed by EVMS or any Co-Owner against LICENSEE, its Affiliates or any Sublicensee.
1.11 Phase I Clinical Trial. The term “Phase I Clinical Trial” shall mean any human clinical trial (whether including a phase 1a or a phase 1b trial) in any country, the principal purpose of which is a preliminary determination of safety in individuals or patients, that would satisfy the requirements of 21 C.F.R. 312.21(a) or the corresponding regulation in any jurisdiction other than the United States.
1.12 Phase II Clinical Trial. The term “Phase II Clinical Trial” shall mean a clinical trial of a product conducted in humans that would satisfy the requirements of 21 C.F.R. 312.21(b) or the corresponding regulation in any jurisdiction other than the United States.
1.13 Phase III Clinical Trial. The term “Phase III Clinical Trial” shall mean a clinical trial of a product conducted in humans which is performed with the intent to gain evidence, alone or along with other clinical trials, with statistical significance of the efficacy of such product in a target population to form the basis for the filing for approval of a new drug application, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in any jurisdiction other than the United States.
1.14 Reseller. The term “Reseller” shall mean an Affiliate of LICENSEE acting as a representative of LICENSEE for the purpose of selling any Licensed Product and/or Licensed Service. The term “Reseller” may also include a third party reseller acting as a representative of LICENSEE for the purpose of selling any Licensed Product and or Licensed Service on behalf of LICENSEE.
1.15 Sublicensee. The term “Sublicensee” shall mean any person or entity to which LICENSEE has granted a sublicense of the EVMS Patent Rights, and that is not an Affiliate of LICENSEE.
1.16 Sublicense Income. The term “Sublicense Income” shall mean any consideration received by or on behalf of LICENSEE or any of its Affiliates from a Sublicensee in consideration of the grant of (a) a sublicense under any EVMS Patent Right, (b) option to license any EVMS Patent Right or (c) a Change in Control of LICENSEE, other than an asset sale of all or substantially all of the assets of LICENSEE, in which this Agreement or rights to any EVMS Patent Right are obtained by a party other than LICENSEE (in each case, (a), (b) or (c), a “Burdened Transaction”) (including license fees, option fees, distribution fees, fees to maintain license rights, milestone payments, contingent payments or other fees) but excluding from such consideration (w) amounts received as running royalties or other revenue for which EVMS receives a running royalty in accordance with Section 2.3.2, (x) amounts received for the purchase of debt or equity securities of LICENSEE or any of its Affiliates at fair market value; (y) amounts serving as reimbursement for fees due to EVMS pursuant to Section 2.2, for Future Patent Costs, or Past Patent Costs; or (z) amounts paid and used exclusively for research and development of Licensed Products or Licensed Services by LICENSEE or any of its Affiliates whether through research and development agreements, joint ventures, partnerships or collaboration agreements.
4 of 21
In the event that LICENSEE receives consideration in addition to or in lieu of money in connection with a Burdened Transaction, whether in the form of money, equipment, property, equity, debt financing or any other noncash consideration, other than sales-generating royalty payments due to EVMS as a running royalty on Net Sales, the parties will negotiate in good faith to determine the fair market value of such noncash consideration within ninety (90) days after receipt, and LICENSEE will pay EVMS such amount by the end of such ninety (90) day period, provided that such valuation is amicably reached. Otherwise, the parties will submit the matter to an impartial third party arbitrator for a final and non-appealable decision regarding such valuation.
1.17 Territory. The term “Territory” shall mean worldwide.
1.18 Valid Claim. The term “Valid Claim” shall mean a claim of any (i) issued and unexpired letters patent, or (ii) pending patent application included in any EVMS Patent Right, that (a) has not been pending for more than seven (7) years and (b) has not been revoked, abandoned or held invalid, unallowable, unpatentable or unenforceable by final decision of a court or other governmental agency of competent jurisdiction, unappealed or unappealable within the time allowed for appeal, and that is not specifically disclaimed, denied or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.
2. License Terms and Conditions.
2.1 Grant of License. Subject to the terms of this Agreement, EVMS hereby grants to LICENSEE an exclusive license (with the right to sublicense to LICENSEE Affiliates and Resellers pursuant to Section 2.7) under the EVMS Patent Rights to make, have made, use, import, offer for sale and/or sell Licensed Products and/or to provide Licensed Services in the Territory.
2.1.1 The EVMS Patent Rights are governed by an Inter-Institutional Agreement signed on or about October 29, 2014 (“IIA”), a copy of which is attached as Exhibit B. Accordingly, the rights and obligations of this Agreement, as applied to EVMS Patent Rights shall be governed by and subject to the terms of the IIA. EVMS may share all confidential information submitted by LICENSEE with the Co-Owners on a confidential basis to enable the Co-Owners to verify compliance. In addition, the grant set forth in Section 2.1 is subject to (a) rights retained by the United States Government in accordance with 35 U.S.C. 200-205 and P.L. 96-517, as amended by P.L. 98-620, (b) the retained right of EVMS to make, have made, provide and use for non-commercial purposes any Licensed Product or Licensed Service, including the ability to distribute any biological material covered under EVMS Patent Rights for nonprofit academic research use to non-profit entities as is customary in the scientific community with prior notice to LICENSEE and (c) the rights retained by Co-Owners set forth in this Agreement.
2.1.2 In the event that EVMS develops any improvement to know-how claimed by an EVMS Patent Right in the Field, such improved invention shall be disclosed to LICENSEE but shall remain the property of EVMS. LICENSEE may elect, by written notice, within sixty (60) days after receiving notification from EVMS, to negotiate, at its option, a license to such know-how at such time.
5 of 21
2.1.3 In addition, should there exist, as of the Effective Date, patent applications and/or patents owned exclusively by EVMS and known to the Director of Technology Transfer of EVMS, other than those set forth in Exhibit A, to cover the developing, making, using, importing, exporting and/or selling of any Licensed Product or Licensed Service, LICENSEE may elect to acquire, at its option, a license to such patent applications or patents, such license to be consistent with the terms hereof. EVMS shall provide written notice of such patent applications and/or patents and such option must be exercised by written notice within ninety (90) days after LICENSEE receives notification from EVMS.
2.2 License Fees.
2.2.1 License Fee. LICENSEE shall pay to EVMS a nonrefundable, non-creditable license fee in the sum of fifty thousand U.S. Dollars ($50,000) according to the following schedule:
| (a) | One thousand U.S. Dollars ($1,000) within thirty (30) days following the Effective Date; |
| (b) | Ten thousand U.S. Dollars ($10,000) within five (5) days of the date LICENSEE raises one million dollars ($1,000,000) in the form of equity or the second (2nd) anniversary of the Effective Date, whichever comes first; and |
| (c) | Thirty-Nine thousand U.S. Dollars ($39,000) within five (5) days of the date LICENSEE raises two million U.S. Dollars ($2,000,000) in the form of equity or the third (3rd) anniversary of the Effective Date, whichever comes first. |
2.2.2 Milestone Payment Fees. LICENSEE shall pay to EVMS milestone payments as set forth below for the first Licensed Product or Licensed Service developed by LICENSEE or any Affiliate of Licensee or Sublicensee within thirty (30) days of achieving each of the following milestones:
| (a) | Twenty-five thousand U.S. Dollars ($25,000) upon first dosing of the first patient in a Phase I Clinical Trial at a site other than EVMS (“Phase 1 First Dose”); and |
| (b) | Fifty thousand U.S. Dollars ($50,000) upon first dosing of the first patient in a Phase II Clinical Trial at a site other than EVMS (“Phase 2 First Dose”); and |
| (c) | Seventy-Five thousand U.S. Dollars ($75,000) upon first dosing of the first patient in a Phase III Clinical Trial at a site other than EVMS (“Phase III First Dose”); and |
| (d) | One hundred thousand U.S. Dollars ($100,000) upon receipt of regulatory approval to market a Licensed Product in Japan or the European Union (“Regulatory Approval – JP or EUR”); and |
| (e) | Two hundred thousand U.S. Dollars ($200,000) upon receipt of regulatory approval to market a Licensed Product in the United States (“Regulatory Approval – US”). |
6 of 21
2.2.3 Milestone Payment Deadlines. In the event that LICENSEE has not achieved a milestone set forth in Section 2.2.2 prior to the date set forth below, such milestone shall automatically become payable on the beginning date of each quarter as set forth below for such milestone.
| Milestone | Payment (from Section 2.2.2) | Due Date | ||||
| Phase 1 First Dose | $ | 25,000.00 | Second quarter of the year 2020 | |||
| Phase 2 First Dose | $ | 50,000.00 | Third quarter of the year 2021 | |||
| Phase 3 First Dose | $ | 75,000.00 | Fourth quarter of the year 2023 | |||
| Regulatory Approval – JP or EUR | $ | 100,000.00 | 2027 | |||
| Regulatory Approval – US | $ | 200,000.00 | 2028 | |||
2.3 Royalties.
2.3.1 Royalty. LICENSEE shall pay to EVMS a running royalty for each Licensed Product sold, and for each Licensed Service provided, by LICENSEE or any Affiliate or Sublicensee, based on the royalty set forth below on Net Sales.
| Aggregate Net Sales for each Licensed Product or Licensed Service | Royalty rate | |||
| On the portion of worldwide Net Sales less than or equal to two hundred million U.S. Dollars ($200,000,000). | 2 | % | ||
| On the portion of worldwide Net Sales greater than two hundred million U.S. Dollars ($200,000,000). | 3 | % | ||
2.3.2 Minimum Annual Royalty. Regardless of the commercialization status of any Licensed Product or Licensed Service, in order to maintain the license granted hereunder in force, LICENSEE shall pay to EVMS each year a minimum annual royalty within thirty (30) days of each anniversary of the Effective Date of this Agreement, beginning with the fifth (5th) anniversary (running royalties accrued and paid to EVMS during the one year period preceding an anniversary of the Effective Date shall be credited against the minimum annual royalties due on that anniversary date). Any percentage royalties earned and paid to EVMS pursuant to Section 2.3.1 for any one (1) year period shall be credited against the minimum royalty payable for such period, and the payment of any shortfall between actual royalties paid and the minimum annual royalty applicable to such one (1) year period shall be payable to EVMS within ninety (90) days after the last day of such one (1) year period.
| Anniversary of the Effective Date | Minimum Annual Royalty owed | |||
| 5 | $ | 10,000 | ||
| 6 | $ | 20,000 | ||
| 7 | $ | 30,000 | ||
| 8 | $ | 40,000 | ||
| 9+ | $ | 50,000 | ||
7 of 21
2.3.3 Consequences of a Patent Challenge. In the event that (a)(i) LICENSEE or any of its Affiliates brings a Patent Challenge against EVMS or any Co-Owner; or (ii) LICENSEE or any of its Affiliates assists another party in bringing a Patent Challenge against EVMS or any Co-Owner (except as required by court order or subpoena) and (b) EVMS does not exercise its right to terminate this Agreement, then the running royalties due hereunder shall be doubled for the remainder of the term of the Agreement, except as set forth in Section 8.6.3. In the event that such a Patent Challenge is successful, LICENSEE will have no right to recoup any royalties paid during the period of challenge. In the event that a Patent Challenge is unsuccessful, LICENSEE shall reimburse EVMS and each Co-Owner for all reasonable legal fees and expenses incurred in its defense against such Patent Challenge.
2.4 Quarterly Payments. With regard to Net Sales made by LICENSEE, any of its Affiliates or any of its or their Resellers, royalties shall be payable by LICENSEE quarterly, within thirty (30) days after the end of each quarter ending on March 31, June 30, September 30 and December 31, based on the Net Sales during such quarter, commencing with the quarter in which the first commercial sale of any Licensed Product or Licensed Service is made in any country.
2.5 Royalty Obligations. LICENSEE shall be solely responsible for payment of royalties incurred by LICENSEE, any of its Affiliates or any of its or their Resellers. All payments hereunder shall be made by check or wire transfer to such bank and account as EVMS may from time to time designate in writing to LICENSEE. All payments shall be made in U.S. Dollars. Whenever any payment hereunder shall be stated to be due on a day which is not a Business Day (defined as a day on which banks are not required or permitted to be closed for business in Gaithersburg, Maryland and Norfolk, Virginia, USA), then such payment shall be made on the immediately succeeding Business Day. Payments hereunder shall be considered to be made as of the day on which they are received at EVMS’ designated bank.
2.6 One Royalty. Only one earned royalty shall be paid on a given Licensed Product and/or Licensed Service even if such Licensed Product and/or Licensed Service is sold by LICENSEE, any of its Affiliates or any of its or their Resellers and sold to a third party. Where a resale has actually occurred by LICENSEE, its Affiliate, or their Reseller, the subsequent sale of such Licensed Product and/or Licensed Service shall be deemed Net Sales.
2.7 Sublicense. Subject to the terms of this Agreement, LICENSEE may grant sublicenses during the Term in the Field of use to Sublicensees within the Territory by entering into a written sublicense agreement that is signed by and binding on the Sublicensee. LICENSEE shall pay to EVMS the percentage set forth below multiplied by Sublicense Income.
| Percentage | Sublicense | ||
| 10% | In respect of any Burdened Transaction entered into by LICENSEE with any Sublicensee prior to the first commercial sale of any Licensed Product or Licensed Service for which Net Sales are calculated. | ||
| 5% | Sublicenses granted by LICENSEE to any Sublicensee after first commercial sale of any Licensed Product or Licensed Service for which Net Sales are calculated. |
8 of 21
LICENSEE may also grant sublicenses during the Term in the Field to any of its Affiliates or any of its or their Resellers without the prior authorization of EVMS, with respect to the development, manufacture, importation, exportation, sale or offer for sale of any Licensed Product or any Licensed Service. In order to meet its Commercial Development Obligations under Section 4.1, LICENSEE may also grant non-royalty bearing sublicenses without prior authorization of EVMS during the Term in the Field to research collaborators, contract research organizations, and contractors with respect to the development and manufacture for any Licensed Product or Licensed Service (“Development Sublicenses”). LICENSEE shall not pay any additional royalty or other payment to EVMS with respect to Development Sublicenses. Any such sublicense shall be in writing, and a copy such sublicense shall be provided to EVMS within thirty (30) days of its execution by LICENSEE. Such sublicense shall make express reference to this Agreement and shall incorporate by reference, in all respects, all the restrictions, exceptions, obligations, reports, termination provisions and other provisions of this Agreement, including provisions regarding Patent Challenges and disclosure of any such sublicense agreement to EVMS and each Co-Owner. LICENSEE shall pay EVMS fees on all Net Sales of such Sublicensees in accordance with this Section 2, the same as if such Net Sales had been made by LICENSEE by itself.
2.8 Duration of Royalty Obligations. The royalty obligations of LICENSEE as to Licensed Product and/or Licensed Service shall terminate on a country-by-country basis concurrently with the expiration of the last to expire Valid Claim of the EVMS Patent Rights which covers the making, use, import, export and/or sale of Licensed Product or Licensed Service, thereafter LICENSEE shall have no obligation to make any payment to EVMS, including the fees and royalties set forth in Section 2.
2.9 Change in Control Payments. In the event of a Change in Control, LICENSEE shall pay to EVMS one percent (1%) of the consideration received by LICENSEE within ten (10) days after the closing of such Change in Control; provided that if any such consideration is deemed to be Sublicense Income, no payment pursuant to this Section 2.9 will be due on such Sublicense Income. To the extent possible, such consideration shall be in the form in which LICENSEE receives such consideration from the person or entity that acquired control of LICENSEE through such Change in Control. For example, but without limitation, in the event that LICENSEE receives stock of an acquirer in connection with a Change in Control, LICENSEE shall assign one percent (1%) of the stock of such acquirer to EVMS. However, in the event that applicable law would not permit the transfer of such consideration to EVMS (for example, but without limitation, if the acquirer is a private company with unregistered securities that cannot be lawfully transferred to EVMS and such unregistered securities form a portion of the consideration paid to LICENSEE in connection with the applicable Change in Control), LICENSEE shall (a) calculate the value of such consideration; (b) provide information used by LICENSEE to calculate such valuation to EVMS; and (c) pay one percent (1%) of the value of such consideration in U.S. Dollars to EVMS. In the event that EVMS does not agree with the calculation provided by LICENSEE in such an instance, the Parties shall promptly meet and discuss LICENSEE’s basis for such calculation.
9 of 21
2.10 Reports. LICENSEE shall furnish to EVMS at the same time as each royalty payment is made by LICENSEE under Section 2.3, a written report, in English, of calculated Net Sales and the royalty due and payable thereon, in sufficient detail to permit EVMS to determine how Net Sales have been calculated as permitted under Section 1.7, on a product-by-product and country-by-country basis, for the quarter upon which the royalty payment is based.
2.11 Records. LICENSEE shall keep, and cause its Affiliates, Resellers and Sublicensees to keep, full, complete and accurate records and accounts of all sales of any Licensed Product and/or the Licensed Service in sufficient detail to enable the royalties payable on the Net Sales of each Licensed Product and/or each Licensed Service to be determined. EVMS shall have the right to appoint an independent certified public accounting firm to audit, on reasonable advance notice and during regular business hours of LICENSEE, its Affiliates, their Resellers or Sublicensees, the records of LICENSEE, its Affiliates, their Resellers or Sublicensees as EVMS may deem necessary to verify the royalties paid and/or payable pursuant to this Agreement. LICENSEE shall pay to EVMS an amount equal to any additional royalties to which EVMS is entitled as disclosed by the audit, plus interest thereon at the rate of one percent (1 %) per month, or the maximum rate allowed by applicable law, if lower. Such interest shall accrue on the balance of unpaid or underpaid amounts outstanding from the date on which portions of such amounts become due and owing until payment thereof in full. Such audit shall be at EVMS’ expense; provided, however, that if the audit discloses that EVMS was (1) not paid any royalties with respect to any Licensed Product and/or any Licensed Service in respect of which LICENSEE made Net Sales in a calendar quarter, or (2) underpaid royalties with respect to any Licensed Product and/or any Licensed Service by at least five percent (5%) for any quarter, then LICENSEE shall reimburse EVMS for any such audit costs. The accounting firm shall disclose to EVMS only information relating to the accuracy of the royalty payments. LICENSEE, its Affiliates, their Resellers and Sublicensees shall preserve and maintain, and shall cause its Affiliates, Resellers and Sublicensees to preserve and maintain, all such records required for audit for a period of seven (7) years after the year to which the records apply, provided that if a dispute arises respecting royalty obligations in any year period under this Agreement, LICENSEE shall continue to preserve and maintain, and shall cause its Affiliates and Resellers to preserve and maintain, all such records until such time as such dispute is resolved. Absent a dispute between the parties, EVMS’ right to audit previously unaudited records with respect to a particular year shall terminate seven (7) years after the end of any such year.
No part of any amount payable to EVMS hereunder may be reduced due to any counterclaim, set-off, adjustment or other right which LICENSEE might have against EVMS, any other party, or otherwise.
2.12 Foreign Sales. The remittance of royalties payable on sales outside the United States shall be payable to EVMS in United States Dollar equivalents at the official rate of exchange of the currency of the country from which the royalties are payable, as quoted in the Wall Street Journal (International Edition) for the last business day of the quarter in which the royalties are payable. LICENSEE shall pay any fees or costs associated with such currency conversion.
2.13 Foreign Taxes. Unless otherwise set forth in this Agreement, taxes now or hereafter imposed with respect to the transactions contemplated under this Agreement shall be the responsibility of the party upon which such taxes are imposed or levied. Any tax required to be withheld by LICENSEE under the laws of any foreign country for the accounts of EVMS shall be promptly paid by LICENSEE for and on behalf of EVMS to the appropriate governmental authority, and LICENSEE shall furnish EVMS with proof of payment of such tax, together with official or other appropriate evidence issued by the applicable governmental authority. Any such tax actually paid by LICENSEE for or on behalf of EVMS shall be deducted from the fees and royalty payments due hereunder.
10 of 21
2.14 Suspension of the Payment of Running Royalties. If and so far as an issued and unexpired letter patent of any EVMS Patent Rights over any Licensed Product or Licensed Service are ruled invalid by a court of competent jurisdiction and an appeal therefrom is taken by EVMS, and provided that no other Valid Claim of any EVMS Patent Rights covers such Licensed Product or Licensed Service in any country, LICENSEE may, in the country concerned, suspend the payment of the running royalty set forth in Section 2.3; provided, however, that LICENSEE shall pay such running royalty retroactively (together with interest at the rate of the prime rate according to Citibank, Manhattan, with the interest accruing from the moment that such payment is suspended) if and when such ruling of invalidity is successfully appealed by EVMS.
2.15 Total Consideration. The fees described in this Section 2 are the total consideration for the grant and continuation of the license hereunder, and EVMS shall have no obligation to return any portion of such fees notwithstanding any failure by LICENSEE to develop any Licensed Product and/or any Licensed Service or market any Licensed Product and/or any Licensed Service commercially.
3. Patent Matters.
3.1 Patent Prosecution and Maintenance.
| (a) | EVMS and LICENSEE agree that commencing on May 1, 2020 (the “Transition Date”), EVMS shall transfer to LICENSEE, and LICENSEE shall have the sole and exclusive right to direct and control the preparation, filing, prosecution and maintenance of any United States and foreign patents, patent applications, and all divisionals, continuations, reissues and/or reexaminations thereof, arising from the EVMS Patent Rights (including any Post Grant Reviews, Inter Parte Reviews, interferences, foreign oppositions, nullification actions and the same nature of any action in the Territory) (collectively, the “Prosecution and Maintenance Rights”). LICENSEE shall exercise the Prosecution and Maintenance Rights at its sole cost and expense using reasonable care and skill. |
| (b) | LICENSEE shall provide EVMS with a copy of all patent application filings, amendments thereto, and other related correspondence to and from patent offices. |
| (c) | EVMS and LICENSEE covenant and agree to cooperate with each other and provide, execute and deliver any and all information, documents and other instruments as shall be necessary, proper or convenient to direct and control the Prosecution and Maintenance rights, including, without limitation, any powers of attorney from EVMS to LICENSEE and its agents and attorneys to allow LICENSEE to exercise the Prosecution and Maintenance Rights as well as provide any documents, data, signatures or other information needed for accomplishing such Prosecution and Maintenance hereinafter. As EVMS retains ownership of the EVMS Patent Rights, EVMS shall promptly inform LICENSEE in the event EVMS is notified of any event involving the EVMS Patent Rights, but in any event within 30 days. |
| (d) | LICENSEE shall provide EVMS notice of its intention to allow any patents or patent applications to go abandoned whether passively or intentionally at least sixty (60) days in advance of any final deadlines in such cases. In the event that LICENSEE informs EVMS that it no longer desires to direct and control the Prosecution and Maintenance Rights, then the Prosecution and Maintenance Rights shall revert to EVMS. LICENSEE covenants and agrees to cooperate with EVMS and provide, execute and deliver any and all information, documents and other instruments as shall be necessary, proper or convenient to effectuate such reversion, including, without limitation, any powers of attorney from LICENSEE to EVMS to allow EVMS to again exercise the Prosecution and Maintenance Rights. Any cases that LICENSEE cedes control of the Prosecution and Maintenance Rights to EVMS shall no longer be included as part of the EVMS Patent Rights licensed herein. |
11 of 21
| (e) | Without limiting any other provision in this Section 3.1, for so long as LICENSEE controls the Prosecution and Maintenance Rights, EVMS shall not incur Future Patent Costs (as defined in Section 3.3) after the Transition Date and LICENSEE shall have no liability for any costs and expenses incurred by EVMS after the Transition Date. |
3.2 Information to LICENSEE. EVMS shall keep LICENSEE informed of any development with regard to the EVMS Patent Rights that affects LICENSEE’s obligation to pay consideration under this Agreement without delay but in any event within at least thirty (30) days of such development. In the event that EVMS’ notice of such development occurs after LICENSEE pays consideration under this Agreement, EVMS will refund any overpayment to LICENSEE within sixty (60) days of written notification by LICENSEE upon EVMS’ review and agreement with LICENSEE’s recalculations.
3.3 Patent Costs. LICENSEE acknowledges and agrees that EVMS does not have independent funding to cover patent costs, and that the license granted hereunder is in part in consideration for LICENSEE’s assumption of patent costs and expenses as described herein. LICENSEE shall pay for all costs associated with the preparation, filing, maintenance and prosecution of EVMS Patent Rights after February 28, 2018 (“Future Patent Costs”). Future Patent Costs shall be due within thirty (30) days of LICENSEE raising a total of one million dollars ($1,000,000) in equity financing, and shall continue to be due within thirty (30) days after each month in which Future Patent Costs are incurred. LICENSEE shall reimburse EVMS the amount of two hundred fifty five thousand eight hundred ninety four dollars and eighty four cents ($255,894.84) for the reasonable costs associated with preparing, filing, maintaining and prosecuting EVMS Patent Rights prior to the Effective Date (“Past Patent Costs”). Payment of Past Patent Costs shall be due within thirty (30) days of LICENSEE raising a total of two million dollars ($2,000,000) in equity financing or three (3) years after the Effective Date, whichever comes first, at which time LICENSEE shall pay ten thousand dollars ($10,000) per calendar quarter until all Past Patent Costs have been paid. In the event that LICENSEE elects to discontinue filing, prosecution and/or maintenance of any patent application and/or patent within EVMS Patent Rights, any such patent application or patent shall be excluded from the definition of EVMS Patent Rights and from the scope of the license granted under this Agreement, and all rights relating thereto shall revert to EVMS and may be freely licensed by EVMS. LICENSEE shall give EVMS at least sixty (60) days prior written notice of such election. No such notice shall have any effect on Licensee’s obligations to pay expenses incurred up to the effective date of such election.
3.4 Ownership. The EVMS Patent Rights shall be owned by EVMS (and any Co-Owner). LICENSEE shall have no right under, or interest in or to, any patents or patent applications within the EVMS Patent Rights not expressly granted under this Agreement, by implication or otherwise. EVMS shall be responsible for compensating Co-Owners for their co-ownership interests in the EVMS Patent Rights.
12 of 21
3.5 Patent Enforcement and Prosecution and Defense of Infringement.
3.5.1 In the event that LICENSEE shall learn of any infringement of any EVMS Patent Rights, LICENSEE shall notify EVMS in writing and shall provide EVMS with all available evidence of such infringement. If LICENSEE elects to seek to eliminate such infringement prior to any litigation, LICENSEE will use commercially reasonable efforts to eliminate the infringement without litigation. If LICENSEE’s efforts to eliminate the infringement without litigation are not successful in eliminating the infringement within ninety (90) days of the infringing party having been formally notified of the infringement by LICENSEE, LICENSEE shall have the first right to enforce any patent within the EVMS Patent Rights and the Field against such infringement. If LICENSEE elects not to eliminate such infringement prior to litigation, within sixty (60) days after becoming aware of such infringement, LICENSEE shall notify EVMS and EVMS shall have the first right to enforce against such infringement until the date that is one hundred twenty (120) days after EVMS’s receipt of such notice. If, within one hundred twenty (120) days after EVMS’s receipt of such notice, EVMS has not successfully eliminated the infringement or commenced litigation seeking to eliminate the infringement, LICENSEE and EVMS will discuss the appropriate manner in which to address such infringement.
3.5.2 Each Co-Owner retains the right to join any such suit brought by LICENSEE. LICENSEE shall reimburse each Co-Owner and EVMS for reasonable costs, expenses or fees that such party incurs in connection with any such suit, including reasonable costs incurred in opposing any joinder action. EVMS shall reasonably cooperate in any such litigation at LICENSEE’s expense. If at any time during the term of this Agreement, LICENSEE’s rights with respect to the EVMS Patent Rights are terminated, EVMS shall have the right to take whatever action EVMS deems appropriate to obtain or maintain the corresponding patent protection at its own expense. LICENSEE may enter into settlements, stipulated judgments or other arrangements respecting such infringement, at its own expense, but only with the prior written consent of EVMS, which consent shall not be unreasonably withheld. EVMS shall permit any action to be brought in its name if required by law to institute or maintain such action and shall use reasonable efforts to request Co-Owners to join such action, and LICENSEE shall hold EVMS and each Co-Owner harmless from any costs or expenses or liability respecting any such infringement or charge of infringement. Except as set forth herein, LICENSEE shall not join any Co-Owner or EVMS in any action by LICENSEE absent such Co-Owner’s or EVMS’ written consent, such consent not to be unreasonably withheld. EVMS agrees to provide reasonable assistance of a technical nature which LICENSEE may require in any litigation arising in accordance with the provisions of this Section 3.5 for which LICENSEE shall pay to EVMS a reasonable hourly rate of compensation. In the event that LICENSEE fails to prosecute any such infringement, LICENSEE shall promptly notify EVMS in writing and EVMS shall have the right to prosecute such infringement on its own behalf.
3.6 Allocation of Recovery. Any damages or other recovery from an infringement action undertaken by Licensee pursuant to Section 3.5 shall first be used to reimburse EVMS, the Co-Owners and LICENSEE for the costs and expenses incurred in such action, and any remainder will be allocated between EVMS and LICENSEE as follows: fifteen percent (15%) to EVMS and eighty five percent (85%) to LICENSEE. If LICENSEE fails to prosecute any such action to completion, then any damages or other recovery, net of the parties’ costs and expenses incurred in such infringement action, shall be the sole property of EVMS.
13 of 21
4. Obligations Related to Commercialization.
4.1 Commercial Development Obligation. In order to maintain the license granted hereunder in force, LICENSEE shall use commercially reasonable and diligent efforts to develop and to introduce Licensed Product(s) and Licensed Service(s) into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration or termination of this Agreement, LICENSEE shall use commercially reasonable efforts to keep Licensed Product(s) and Licensed Service(s) reasonably available to the public. LICENSEE shall also exercise commercially reasonable efforts to develop Licensed Product(s) suitable for different indications within the Field, so that EVMS Patent Rights can be commercialized as broadly and as speedily as good scientific and business judgment would deem possible, unless unreasonable. In addition, LICENSEE shall provide to EVMS within two (2) months after the Effective Date a confidential written development plan setting forth LICENSEE’s initial development strategy. Such development plan is subject to EVMS’ approval, such approval not to be unreasonably withheld. LICENSEE shall keep EVMS generally informed as to LICENSEE’s progress in such development, production and sale, including its efforts, if any, to sublicense EVMS Patent Rights, and LICENSEE shall deliver to EVMS a quarterly written report and such other reports as EVMS may reasonably request. The parties acknowledge and agree that achievement of the milestones set forth in the table set forth immediately below on or before the dates set forth therein shall be evidence of compliance by LICENSEE with its commercial development obligations hereunder for the time periods set forth in such table. In the event that EVMS has a reasonable basis to believe that LICENSEE is not using reasonable efforts and due diligence as required hereunder, upon notice by EVMS to LICENSEE which specifies the basis for such belief, EVMS and LICENSEE shall negotiate in good faith to attempt to mutually resolve the issue. In the event that EVMS and LICENSEE cannot agree upon any matter related to LICENSEE’s commercial development obligations, the parties agree to utilize mediation pursuant to Section 10.2 hereof in order to resolve the matter. If in mediation it is determined that LICENSEE has not complied with its obligations hereunder, and such default is not fully cured within sixty (60) days after the mediation decision, EVMS may terminate LICENSEE’s rights set forth in this Agreement.
| Event | Date | |
| Equity or financing event (e.g., Series A financing) | The second quarter of 2019 | |
| Initiation of IND enabling studies | The second quarter of 2019 | |
| Submission of investigational new drug application | The fourth quarter of 2020 | |
| Initiation of clinical study for safety or efficacy | The first quarter of 2021 |
EVMS agrees that LICENSEE will be deemed to be using reasonable efforts and due diligence as required hereunder unless LICENSEE fails to invest at least $750,000 per twelve month period (measured on a rolling twelve month basis) towards the research, development and commercialization of the Licensed Product(s) (the “Funding Condition”). Starting with the fourth quarter of 2020 and for every calendar quarter thereafter, LICENSEE shall provide EVMS with evidence to demonstrate that it is complying with the Funding Condition.
4.2 Governmental Approvals and Marketing of Licensed Products. LICENSEE shall be responsible for obtaining all necessary governmental approvals, authorizations and/or licenses for the development, production, distribution, import, re-import, export, re-export, sale and use of any Licensed Product and/or any Licensed Service, at LICENSEE’s expense, including any safety studies. LICENSEE shall have sole responsibility for any warning labels, packaging and instructions as to the use of the Licensed Product and/or the Licensed Service and for the quality control for any Licensed Product and/or any Licensed Service.
4.3 Indemnity. LICENSEE hereby agrees to indemnify, defend and hold harmless EVMS, each Co-Owner and any parent, subsidiary or other affiliated entity thereof, and the respective trustees, officers, employees, scientists and agents of any of them from and against any liability or expense arising from any product liability claim as to development, manufacture, use, import, export and sale of any Licensed Product and/or any Licensed Service or any claims arising from the use of any EVMS Patent Right by LICENSEE, its Affiliates and/or their Resellers or Sublicensees pursuant to this Agreement. Prior to any sale or use by LICENSEE in humans of a Licensed Product or Licensed Service (including use for a clinical trial), LICENSEE at its sole cost shall obtain and thereafter until six (6) years after such Licensed Product or Licensed Service is last sold by LICENSEE, maintain reasonable general commercial and product liability coverage for each Licensed Product and Licensed Service in an amount not less than five million U.S. Dollars ($5,000,000) naming EVMS as an additional insured. LICENSEE shall deliver to EVMS a certificate of insurance evidencing such coverage.
14 of 21
4.4 Patent Marking. To the extent required by applicable law(s) or regulation(s), LICENSEE shall mark all Licensed Products or their containers in accordance with applicable patent marking law(s) and regulation(s).
4.5 No Use of Name. The use of the name “EASTERN VIRGINIA MEDICAL SCHOOL”, “EVMS”, or any variation thereof, or of the name of any parent, subsidiary or other affiliated entity of EVMS, or of the name of any trustees, officers, employees, scientists or agents of EVMS, in connection with the advertising or sale of the Licensed Product and/or the Licensed Combination Service by LICENSEE, its Affiliates or their Resellers or Sublicensees is expressly prohibited; provided, however, that LICENSEE, its Affiliates or their Resellers or Sublicensees may use the name “EASTERN VIRGINIA MEDICAL SCHOOL” or “EVMS” in connection with the advertising or sale of Licensed Product in a particular country(ies) to the extent such use of the EVMS name is required by the applicable law(s) or regulation(s) in such country(ies) of the Territory.
4.6 U.S. Manufacture. To the extent required by applicable United States laws, LICENSEE agrees that Licensed Products will be substantially manufactured in the United States or its territories, subject to such waivers as may be obtained from the National Institutes of Health.
4.7 Foreign Registration. LICENSEE agrees to register this Agreement with any foreign governmental agency that requires such registration, if any, and LICENSEE shall pay all costs and legal fees in connection therewith. In this case, EVMS shall reasonably cooperate with LICENSEE to effect any such registration, at LICENSEE’s cost.
4.8 Packaging. LICENSEE agrees to provide EVMS four (4) inert samples of each Licensed Product, as covered by EVMS Patent Rights, or their packaging, for educational and display purposes.
5. Representation and Warranty. EVMS hereby represents and warrants to LICENSEE that:
| (a) | EVMS has full right and power to enter into this Agreement; and |
| (b) | to the best knowledge of EVMS, EVMS is not in a possession of any information which would render any Valid Claim of any EVMS Patent Rights invalid and/or unenforceable; and to the knowledge of EVMS with no duty of inquiry, EVMS and the Co-Owners own all right, title and interest in and to the EVMS Patent Rights. The maximum liability of EVMS for any breach of this Section 5 is equal to amounts actually received by EVMS from LICENSEE in accordance with Section 2 during the first seven (7) years after the Effective Date multiplied by twenty five percent (25%), except in the case of fraud by EVMS. |
| (c) | EVMS MAKES NO OTHER WARRANTIES CONCERNING THE EVMS PATENT RIGHTS, INCLUDING WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AS TO EVMS PATENTS, ANY LICENSED PRODUCT OR ANY LICENSED SERVICE. EVMS MAKES NO WARRANTY OR REPRESENTATION THAT ANY LICENSED PRODUCT WILL BE FREE FROM AN INFRINGEMENT OF PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES, OR THAT NO THIRD PARTIES ARE IN ANY WAY INFRINGING EVMS PATENT RIGHTS COVERED BY THIS AGREEMENT. |
6. Interests in Intellectual Property Rights.
6.1 Preservation of Title. EVMS, together with the Co-Owners, shall retain full ownership and title to EVMS Patent Rights licensed hereunder. This Section 6.1 shall not be understood to obligate the Co-Owners.
15 of 21
6.2 Royalty-free License to Improvements. LICENSEE hereby grants to EVMS an non-exclusive, royalty-free license to any improvement to any EVMS Patent Rights developed by LICENSEE or on behalf of LICENSEE, to use for its own non-commercial research purposes or grant to other nonprofit institutions for their non-commercial research purposes. This Section 6.2 will not require LICENSEE, and LICENSEE has no obligation, to disclose any improvement or otherwise provide any data or other information to EVMS about or related to any such improvement.
6.3 Governmental Interest. LICENSEE and EVMS acknowledge that EVMS has received, and expects to continue to receive, funding from the United States Government in support of EVMS’ research activities. LICENSEE and EVMS acknowledge and agree that their respective rights and obligations pursuant to this Agreement shall be subject to EVMS’ obligations to and the rights of the United States Government, which arise or result from EVMS’ receipt of research support from the United States Government, including the grant by EVMS to the United States Government of a non-exclusive, irrevocable, royalty-free license to EVMS Patent Rights licensed hereunder by or on behalf of the United States Government or any foreign government or international organization pursuant to any existing or future treaty or agreement to which the United States Government is a signatory, including when necessary to fulfill health or safety needs or when necessary to meet requirements for public use specified by Federal regulations.
6.4 Reservation of Rights. EVMS, on behalf of itself and each Co-Owner, reserves the right to use for any non-commercial research purposes and the right to allow other nonprofit institutions to use for any noncommercial research purposes any EVMS Patent Rights licensed hereunder, without EVMS, a Co-Owner or such other institutions being obligated to pay LICENSEE any royalties or other compensation.
7. Confidentiality and Publication.
7.1 Treatment of Confidential Information. The parties agree that during the term of this Agreement, and for a period of three (3) years after this Agreement terminates, a party receiving Confidential Information of the other party will (i) maintain in confidence such Confidential Information to the same extent such party maintains its own proprietary industrial information, (ii) not disclose such Confidential Information to any third party without prior written consent of the other party and (iii) not use such Confidential Information for any purpose except those permitted by this Agreement. However, EVMS may disclose this Agreement to each of the Co-Owners.
7.2 Publications. LICENSEE agrees that EVMS shall have a right to publish in accordance with its general policies. However, prior to such publication, EVMS shall submit to LICENSEE copies of proposed publications which contain subject matter relating to intellectual property licensed hereunder or to a Licensed Product, and afford LICENSEE thirty (30) days to review the publication(s). Upon timely written request by LICENSEE, EVMS shall further delay any such publication until the preparation and filing of a patent application pursuant to Section 3.1, which delay shall not exceed sixty (60) days.
7.3 Publicity. Except as otherwise provided herein or required by law, no party shall originate any publication, news release or other public announcement, written or oral, whether in the public press, stockholders’ reports, or otherwise, relating to this Agreement or to any sublicense hereunder, or to the performance hereunder or any such agreements, without the prior written approval of the other party, which approval shall not be unreasonably withheld. Scientific publications published in accordance with Section 7.2 of this Agreement shall not be construed as publicity governed by this Section 7.3.
8. Term and Termination.
8.1 Term. Unless terminated sooner in accordance with the terms set forth herein, this Agreement, and the license granted and obligations incurred hereunder, shall come into force as from the Effective Date and continue to be effective until the expiration date of the last to expire of the EVMS Patent Rights, on a country-by-country basis, after which the licenses granted hereunder shall be fully paid, perpetual and irrevocable.
16 of 21
8.2 Termination Upon Default. The following event shall constitute an event of default hereunder the failure of a party to perform any material obligation required of it to be performed hereunder, where such party fails to cure such failure to the satisfaction of the other party within sixty (60) days (or in the case of non-payment within fifteen (15) days) after receipt of written notice from the other party specifying in reasonable detail the nature of such failure; provided that if LICENSEE makes more than three (3) payments during any two (2) year period, or a total of fifteen (15) payments hereunder, more than five (5) business days late, EVMS will not be obligated to permit LICENSEE to cure such failure. Upon the occurrence of any event of default, the non-defaulting party may deliver to the defaulting party written notice of termination, such termination to be effective upon the date set forth in such notice.
Such termination rights shall be in addition to and not in substitution for any other remedy that may be available to the non-defaulting party. Termination pursuant to this Section 8.2 shall not relieve the defaulting party from liability and damages to the other party for breach of this Agreement including liability for any payments owed by either party. Waiver by either party of a single default or a succession of defaults shall not deprive such party of any right to terminate this Agreement arising by reason of any subsequent default.
8.3 Termination Upon Bankruptcy or Insolvency. This Agreement may be terminated by either party giving written notice of termination to the other party upon the filing of bankruptcy or bankruptcy of the other party or the appointment of a receiver of any of the other party’s assets, or the making by the other party of any assignment for the benefit of creditors, or the institution of any proceedings against the other party under any bankruptcy law. Termination shall be effective upon the date specified in such notice.
8.4 License Status in Bankruptcy. This Agreement shall constitute an executory contract under Section 365 of the United States Bankruptcy Code, 11 U.S.C. §101 et seq. (the “Bankruptcy Code”). All rights and licenses granted pursuant to this Agreement are, and shall be deemed to be, licenses of and rights to “intellectual property” as that term is defined in Section 101(35A), and used in Section 365, of the Bankruptcy Code. The parties agree that (i) LICENSEE, as licensee under this Agreement, shall possess and may fully exercise all of its rights, remedies and elections afforded by and under the Bankruptcy Code, and (ii) EVMS, as licensor under this Agreement, shall possess and may fully exercise all of its rights, remedies and elections afforded by and under the Bankruptcy Code. The parties further agree that, in the event of the commencement of a bankruptcy case by or against EVMS under the Bankruptcy Code, LICENSEE shall be entitled to all applicable rights under Section 365 of the Bankruptcy Code, including a complete duplicate of (or complete access to, as appropriate) any such intellectual property referred to above in subsection (a) and all embodiments of such intellectual property upon written request therefor by LICENSEE.
8.5 Termination by LICENSEE.
8.5.1 Termination by LICENSEE with Cause. In case LICENSEE discontinues or suspends the development, manufacture, import, export, use and/or sale of any Licensed Product or any Licensed Service for any reason, including the reason that LICENSEE cannot obtain a license under reasonable terms and conditions for any patents or other intellectual property rights of a third party or parties which is necessary for LICENSEE to develop, make, use, import, export and/or sell such Licensed Product and/or such Licensed Service, or, the reason that it is, in LICENSEE’s judgment, no longer a profitable business for LICENSEE to develop, manufacture, import, export, use and/or sell the Licensed Product and/or the Licensed Service, LICENSEE may, without paying any compensation or indemnification whatsoever to EVMS, forthwith terminate this Agreement with at least ninety (90) days’ prior written notice to EVMS describing the termination date; provided that termination by LICENSEE under this Section shall not relieve LICENSEE of its obligation to pay to EVMS any monies accrued prior to the date of termination, which shall be payable to EVMS within thirty (30) days after the termination date. In the event that LICENSEE terminates under this Section 8.5.1, LICENSEE shall send a written report providing the same information required in accordance with Section 2.9 together with the above- mentioned payment.
17 of 21
8.5.2 Termination by LICENSEE Without Cause. In the event that LICENSEE determines for or without any reason that the license granted hereunder is no longer necessary (except for the cases pursuant to Section 8.5.1), LICENSEE may terminate this Agreement with at least ninety (90) days’ prior written notice to EVMS setting forth the termination date. LICENSEE’s termination under this Section 8.5.2 shall require that LICENSEE pay any monies accrued prior to the date of termination by the date of termination and LICENSEE shall send a written report providing the same information required in accordance with Section 2.9 together with the above-mentioned payment. Any payments not paid by the date of termination under this Section shall be subject to interest at the rate of one and a half percent (1.5%) per month or the maximum rate allowed under applicable law, if lower.
8.6 Termination by EVMS.
8.6.1 In the event that LICENSEE fails to meet any of the Milestone Deadlines, then EVMS and LICENSEE shall follow the procedures described in Section 4.1 above and after conclusion of the mediation described therein, if it is determined in such mediation that LICENSEE has not complied with its obligations under Section 4.1 and has thereafter failed to fully cure a default within the period of time described therein, the n EVMS may terminate this Agreement upon giving LICENSEE ninety (90) days’ written notice.
8.6.2 In the event that LICENSEE or any of its Affiliates brings a Patent Challenge against EVMS or any Co-Owner, or assists others in bringing a Patent Challenge against EVMS or any Co-Owner (except as required by court order or subpoena), then EVMS may immediately terminate this Agreement. In the event that a Sublicensee brings a Patent Challenge against EVMS or any Co-Owner or assists another party in bringing a Patent Challenge EVMS or any Co- Owner (except as required by court order or subpoena), then EVMS may require LICENSEE to terminate the sublicense to such Sublicensee, and if LICENSEE does not terminate such sublicense within thirty (30) days after EVMS’s demand, EVMS may terminate this Agreement.
8.6.3 Notwithstanding Section 8.6.2, in the event that LICENSEE brings a Patent Challenge against EVMS regarding an individual product not infringing EVMS Patent Rights (and not based on a challenge to the validity, patentability or enforceability of any EVMS Patent Rights or an opposite to any EVMS Patent Rights), then EVMS shall not terminate this Agreement with respect to Licensed Products in respect of which LICENSEE has complied with its obligations hereunder, and royalties for Licensed Products shall not be doubled in accordance with Section 2.3.3. For clarity, EVMS may dispute LICENSEE’s allegation of non-infringement.
8.7 Rights Upon Expiration. Neither party shall have any further rights or obligations upon the expiration of this Agreement upon its regularly scheduled expiration date with respect to this Agreement, other than the obligation of LICENSEE to make any and all reports and payments then due to EVMS under this Agreement.
8.8 Rights Upon Termination. Notwithstanding any other provision of this Agreement, upon any termination of this Agreement prior to the regularly scheduled expiration date of this Agreement, the license granted hereunder shall terminate. Except as otherwise provided for in this Agreement to the contrary, upon such termination, LICENSEE shall have no further right to practice under any EVMS Patent Rights or to develop, to make, to have made, to use, to import, to export, to sell and to offer for sale any Licensed Product or Licensed Service. Any such termination shall not relieve either party from any obligations accrued up to and including the effective date of such termination. For the avoidance of doubt, LICENSEE is not obligated to make any payments hereunder which have not yet accrued at the time of such termination of this Agreement.
18 of 21
8.9 Work-in-Progress. Upon any termination of this Agreement by EVMS in accordance with this Agreement, except termination by EVMS in accordance with Sections 8.2, 8.3 or 8.6, LICENSEE shall be entitled to finish any work-in-progress and to sell any completed inventory of any Licensed Product or any Licensed Service covered by the Valid Claim of EVMS Patent Rights which remains on hand as of the date of the termination, within six (6) months after the date of termination, so long as LICENSEE pays to EVMS the royalties applicable to such sales in accordance with this Agreement and any other accrued fees or payments owed.
8.10 Survival. In addition to accrued obligations, the following Sections shall survive any termination or expiration of this Agreement: 1, 2.10, 2.11, 4.3, 4.5, 5(d), 6, 7.1, 7.3, 8.8, 8.9, this 8.10, 9 and 10.
9. Assignment; Successors.
9.1 Assignment. LICENSEE may assign this Agreement only (1) with the prior written consent of EVMS; or (2) to an Affiliate of LICENSEE or to the acquirer of all or substantially all of the capital stock or assets of LICENSEE related to this Agreement, through purchase, merger, consolidation or otherwise, without the prior written consent of EVMS, provided that LICENSEE provides prior written notice thereof to EVMS confirming that the assignee has agreed in writing to be bound by the terms hereof.
9.2 Binding Upon Successors and Assigns. Subject to the limitations on assignment herein, this Agreement shall be binding upon and inure to the benefit of any successors in interest and assigns of EVMS and LICENSEE. Any such successor or assignee of either party’s interest shall expressly assume in writing the performance of all the terms and conditions of this Agreement to be performed by such party.
10. General Provisions.
10.1 Independent Contractors. The relationship between EVMS and LICENSEE is that of independent contractors. EVMS and LICENSEE are not joint ventures, partners, principal and agent, master and servant, employer or employee, and have no other relationship other than independent contracting parties. EVMS and LICENSEE shall have no power to bind or obligate each other in any manner, other than as is expressly set forth in this Agreement.
10.2 Dispute Resolution. All disputes arising in connection with this Agreement which cannot be settled in an amicable way between EVMS and LICENSEE within sixty (60) days shall be mediated in good faith. The party raising such dispute shall promptly advise the other party of such claim, dispute or controversy in a writing which describes in reasonable detail the nature of such dispute. By no later than fifteen (15) business days after the recipient has received such notice of dispute, each party shall have selected for itself a representative who shall have the authority to bind such party, and shall additionally have advised the other party in writing of the name and title of such representative. By no later than fifteen (15) business days after the date of such notice of dispute, the party against whom the dispute shall be raised shall select a mediation firm in Norfolk, Virginia, U.S.A. if it is initiated by LICENSEE and in Gaithersburg, Maryland, U.S.A. if it is initiated by EVMS. Such representatives shall schedule a date with such firm for a mediation hearing. The parties shall enter into a good faith mediation, which mediation shall be held in English. Neither party will be obligated to continue with mediation for more than thirty (30) days after the appointment of a mediator. Any agreement reached by the parties during mediation shall constitute a binding and final resolution only to the extent reduced to writing in an agreement signed by the parties.
19 of 21
10.3 Entire Agreement; Modification. This Agreement sets forth the entire agreement and understanding between the parties as to the subject matter hereof. There shall be no amendments or modifications to this Agreement, except by a written document which is signed by both parties.
10.4 Applicable Law. This Agreement shall be construed and enforced in accordance with the laws of the Commonwealth of Virginia, U.S.A., excluding its conflicts of laws principles, provided that questions of patent law shall be construed and enforced in accordance with the patent laws of the country which granted the pertinent patent or in which the pertinent patent application is pending.
10.5 Sovereign Immunity. Nothing in this Agreement shall be construed to waive the sovereign immunity of Eastern Virginia Medical School or of any Co-Owner.
10.6 Name. Whenever there has been an assignment by either party as permitted by this Agreement, the term “EVMS” as used in this Agreement shall also include and refer to, if appropriate, its assignee and the term “LICENSEE” as used in this Agreement shall also include and refer to, if appropriate, its assignee.
10.7 Notices. Any notices required by this Agreement shall be in writing, shall specifically refer to this Agreement and shall be sent by prepaid, first class, registered or certified airmail or by prepaid express/overnight delivery service provided by a commercial carrier, properly addressed to the respective addresses set forth below unless subsequently changed by written notice to the other party:
| For EVMS: | Eastern Virginia Medical School |
[ ]
[ ]
Attention: Director. Office of Technology Transfer
| For LICENSEE: | Veralox Therapeutics |
[ ]
[ ]
Attention: Jeff Strovel, CEO
Notice shall be deemed delivered upon the earlier of (i) when received, (ii) ten (10) business days after deposit into the mail marked for “Air Mail”, or (iii) two (2) business days immediately following delivery to overnight courier (except Sunday and holidays).
10.8 Compliance with Applicable Laws. Nothing contained in this Agreement shall require or permit EVMS or LICENSEE to do any act inconsistent with the requirements of any applicable law, regulation or executive order as the same may be in effect from time to time.
10.9 Severability. If any provision of this Agreement is held to be invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is taken, the provision shall be considered severed from this Agreement and shall not serve to invalidate any remaining provisions hereof. The parties shall make a good faith effort to replace any invalid or unenforceable provision with a valid and enforceable one such that the objectives contemplated by the parties when entering this Agreement may be realized.
20 of 21
10.10 No Third Party Beneficiary. Except for indemnitees, each party agrees that this Agreement shall not benefit, or create any right or cause of action in or on behalf of, any person or entity other than the parties.
10.11 Headings. The headings of each Section and the attached exhibit have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in a particular Section or exhibit.
10.12 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement may be executed by .pdf or other electronically transmitted signatures or by digital signatures and such signatures shall be deemed to bind each party as if they were the original signatures.
10.13 Interpretation. The parties agree that (a) the terms and conditions of this Agreement are the result of negotiations between the parties and (b) this Agreement shall not be construed in favor of or against any party by reason of the extent to which any party or its professional advisors participated in the preparation of this Agreement. As used in this Agreement, “including” and its grammatical variations shall be deemed to be followed by “without limitation”.
IN WITNESS WHEREOF, the parties have executed this Agreement by their duly authorized representatives effective as of the Effective Date.
| Eastern Virginia Medical School | Veralox Therapeutics | |||
| /s/ Mark Babasin | /s/ Matthew Boxer | |||
| By: | Mark Babashanian | By: | Matthew Boxer | |
| Title: | Vice President for Administration and Finance | Title: | Chief Operating Officer | |
21 of 21
Exhibit 10.3
FIRST AMENDMENT TO
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT
THIS FIRST AMENDMENT TO AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT (the “First Amendment”) is entered into effective as of December 9, 2025 (the “First Amendment Effective Date”), by and between OLD DOMINION UNIVERSITY, as successor in interest to EASTERN VIRGINIA MEDICAL SCHOOL (“EVMS”) at P.O. Box 1980, Norfolk, Virginia 23501-1980, and VERALOX THERAPEUTICS, INC. (“Licensee”) located at 4539 Metropolitan Court, Frederick, Maryland 21704.
WHEREAS, EVMS and Licensee are parties to that certain Amended and Restated Exclusive License Agreement dated as of May 1, 2020 (the “Original Agreement” and, together with this First Amendment, the “Agreement”);
WHEREAS, Licensee and Cadrenal Therapeutics, Inc., a Delaware corporation (“Cadrenal”), are entering into an Asset Purchase Agreement pursuant to which, among other things, Licensee will sell, assign, transfer, convey and deliver to Cadrenal, and Cadrenal will purchase and acquire from Licensee, all or substantially all of the assets of Licensee, including the Original Agreement as amended by this First Amendment (such transaction, the “Proposed Transaction”);
WHEREAS, consistent with Section 9.2 of the Original Agreement, Cadrenal has agreed in writing to be bound by the terms of the Original Agreement, subject to the amendment of certain terms in the Original Agreement, as set forth herein; and
WHEREAS, capitalized terms used but not otherwise defined herein shall have the meanings provided in the Original Agreement.
NOW, THEREFORE, in consideration of good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, EVMS and Licensee agree as follows:
1. Licensed Product. Section 1.7 of the Agreement is deleted in its entirety and replaced with the following:
“1.7 Licensed Product. The term “Licensed Product” shall mean any process or method, material, composition, drug or other product, the manufacture, use or sale of which by Licensee or any Affiliate of Licensee or Sublicensee would constitute, but for the license granted to Licensee herein, an infringement of any Valid Claim of any of the EVMS Patent Rights. (Infringement includes direct, contributory, or inducement to infringe).”
2. Licensed Service. Section 1.8 of the Agreement is deleted in its entirety and replaced with the following:
“1.8 Licensed Service. The term “Licensed Service” shall mean the performance on behalf of a third party by Licensee or any Affiliate of Licensee or Sublicensee of any method or the manufacture of any product or the use of any product or composition which would constitute, but for the license granted to Licensee herein, an infringement of a Valid Claim of EVMS Patent Rights. (Infringement includes direct, contributory or inducement to infringe).”
3. Milestone Payment Deadlines. EVMS acknowledges and agrees that, as of the First Amendment Effective Date, each of the Phase 1 First Dose, Phase 2 First Dose and Phase 3 First Dose milestones set forth in Section 2.2.3 of the Agreement have been timely satisfied by the Licensee, and the parties agree that Section 2.2.3 of the Agreement is deleted in its entirety and replaced with the following:
“2.2.3 Milestone Payment Deadlines. In the event that Licensee has not achieved a milestone set forth in Section 2.2.2 prior to the date set forth below, such milestone shall automatically become payable on the beginning date of each quarter as set forth below for such milestone.
| Milestone | Payment (from Section 2.2.2) | Due Date | ||||
| Phase 1 First Dose | $ | 25,000.00 | PAID | |||
| Phase 2 First Dose | $ | 50,000.00 | PAID | |||
| Phase 3 First Dose | $ | 75,000.00 | PAID | |||
| Regulatory Approval – JP or EUR | $ | 100,000.00 | 2031 | |||
| Regulatory Approval – US | $ | 200,000.00 | 2032 | |||
4. Minimum Annual Royalty. Section 2.3.2 of the Agreement is deleted in its entirety and replaced with the following:
“2.3.2 Minimum Annual Royalty. Regardless of the commercialization status of any Licensed Product or Licensed Service, in order to maintain the license granted hereunder in force, Licensee shall pay to EVMS each year a minimum annual royalty within thirty (30) days of each anniversary of the Effective Date of this Agreement, beginning with the fifth (5th) anniversary (running royalties accrued and paid to EVMS during the one year period preceding an anniversary of the Effective Date shall be credited against the minimum annual royalties due on that anniversary date). Any percentage royalties earned and paid to EVMS pursuant to Section 2.3.1 for any one (1) year period shall be credited against the minimum royalty payable for such period, and the payment of any shortfall between actual royalties paid and the minimum annual royalty applicable to such one (1) year period shall be payable to EVMS within ninety (90) days after the last day of such one (1) year period.
| Anniversary of the Effective Date | Minimum Annual Royalty owed | |||
| 5 | PAID | |||
| 6 | WAIVED | |||
| 7 | WAIVED | |||
| 8 | WAIVED | |||
| 9 | $ | 10,000 | ||
| 10 | $ | 20,000 | ||
| 11 | $ | 30,000 | ||
| 12 | $ | 40,000 | ||
| 13+ | $ | 50,000 | ||
2
5. Change in Control Payments. The parties acknowledge and agree that the Proposed Transaction constitutes a Change in Control and, subject to Licensee’s payment of the amounts owed to EVMS under Section 2.9 of the Agreement (which payment shall be based upon the cash payment received by Licensee from Cadrenal at the closing of the Proposed Transaction), Section 2.9 of the Agreement is deleted in its entirety as of the First Amendment Effective Date and no further amounts shall become payable by Licensee or Cadrenal under Section 2.9 of the Agreement.
6. Assignment Fee. A new Section 2.16 is hereby added to the Agreement, which will read as follows:
“2.16 Assignment Fee. In the event of Licensee’s assignment of this Agreement in connection with a Change in Control undertaken after the closing of the Proposed Transaction, within ten (10) days after the closing of such Change in Control, Licensee shall pay to EVMS a one-time payment of twenty thousand dollars ($20,000).”
7. Patent Costs. Section 3.3 of the Agreement is deleted in its entirety and replaced with the following:
“3.3 Patent Costs. Licensee acknowledges and agrees that EVMS does not have independent funding to cover patent costs, and that the license granted hereunder is in part in consideration for Licensee’s assumption of patent costs and expenses associated with the preparation, filing, maintenance and prosecution of the EVMS Patent Rights after February 28, 2018 (“Past Patent Costs”). Commencing in the calendar quarter ending March 31, 2026, Licensee shall pay EVMS ten thousand dollars ($10,000) per calendar quarter until all Past Patent Costs have been paid. In the event that Licensee elects to discontinue filing, prosecution and/or maintenance of any patent application and/or patent within EVMS Patent Rights, any such patent application or patent shall be excluded from the definition of EVMS Patent Rights and from the scope of the license granted under this Agreement, and all rights relating thereto shall revert to EVMS and may be freely licensed by EVMS. Licensee shall give EVMS at least sixty (60) days prior written notice of such election. No such notice shall have any effect on Licensee’s obligations to pay expenses incurred up to the effective date of such election.”
3
8. Past Patent Cost Balance. The parties acknowledge and agree that, as of the First Amendment Effective Date, EVMS is owed Past Patent Costs, as defined in Section 3.3, in the amount of ninety-eight thousand, one hundred and sixty-nine dollars and seventy-four cents ($98,169.74), which amount will be paid by Licensee in accordance with Section 3.3.
9. Commercial Development Obligation. EVMS acknowledges and agrees that, as of the First Amendment Effective Date, all of the milestone events set forth in Section 4.1 of the Agreement have been timely satisfied by the Licensee, and the parties further agree that the last two sentences of Section 4.1 of the Agreement concerning the Funding Condition are deleted in their entirety.
10. Confidentiality and Publication. Section 7.3 of the Agreement is deleted in its entirety and replaced with the following:
“7.3 Publicity. Except as otherwise provided herein or required by law, regulation, rule or legal process (including the rules of the U.S. Securities and Exchange Commission and any stock exchange) no party shall originate any publication, news release or other public announcement, written or oral, whether in the public press, stockholders’ reports, or otherwise, relating to this Agreement or to any sublicense hereunder, or to the performance hereunder or any such agreements, without the prior written approval of the other party, which approval shall not be unreasonably withheld. Scientific publications published in accordance with Section 7.2 of this Agreement shall not be construed as publicity governed by this Section 7.3. In addition, publication, news releases or other public announcements that contain a disclosure that is the same as a previously approved disclosure is deemed approved and shall not require a new approval”
11. Counterparts. This First Amendment may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.
12. Entire Agreement. The Original Agreement, as amended by this First Amendment, constitutes the entire understanding between the parties relating to the subject matter hereof and is hereby ratified and confirmed by the parties. Except as expressly amended by this First Amendment, the Original Agreement shall remain unchanged and shall be in full force and effect.
Remainder of page intentionally left blank; signature page follows.
4
IN WITNESS WHEREOF, the parties hereto have duly executed this First Amendment as of the First Amendment Effective Date set forth above.
| OLD DOMINION UNIVERISTY | ||
| By: | /s/ Kenneth J. Fridley | |
| Name: | Kenneth J. Fridley | |
| Title: | Vice President for Research and Economic Development | |
| VERALOX THERAPEUTICS, INC. | ||
| By: | /s/ Matthew Boxer | |
| Name: | Matthew Boxer | |
| Title: | Chief Operating Officer | |
5
Exhibit 99.1
FOR IMMEDIATE RELEASE
Cadrenal Therapeutics Acquires VLX-1005, a First-in-Class Phase 2 12-LOX Inhibitor for Patients with Heparin-Induced Thrombocytopenia (HIT)
| ● | Novel first-in-class therapeutic targeting a key immune signaling pathway and the underlying cause of HIT |
| ● | It is the first and only potent, highly selective inhibitor of human 12-LOX in clinical testing, distinguishing it from related compounds. |
| ● | Orphan Drug and Fast Track designations from the FDA |
PONTE VEDRA, FL, December 11, 2025 – Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing transformative therapeutics to overcome the limitations of current anticoagulation therapy, today announced the acquisition of VLX-1005 and related 12-lipoxygenase (12-LOX) assets from Veralox Therapeutics (“Veralox”). The acquisition immediately strengthens Cadrenal’s pipeline with a late-stage, first-in-class drug candidate targeting a critical immune signaling pathway. This acquisition addresses yet another underserved therapeutic opportunity in the $40 billion global anticoagulation market.
VLX-1005 is a novel, potent, selective small-molecule inhibitor of 12-LOX, a key pathway driving immune platelet-mediated inflammation and a contributor to the pathogenesis of HIT. This potentially life-threatening complication can occur in up to 5% of patients exposed to heparin – the most commonly used parenteral anticoagulant - regardless of dose, schedule, or route of administration. HIT antibodies can cause catastrophic and life-threatening arterial and venous thrombosis. Approximately 300,000 patients in the United States are evaluated each year for suspected HIT, and an estimated 56,000 confirmed diagnoses occur each year. Mortality and thromboembolic event (TE) rates remain high despite currently available therapies.
Two Phase 1 studies of VLX-1005 in healthy participants have demonstrated that VLX-1005 was well tolerated, with no deaths, no serious adverse events, and no trend in adverse event reporting with increasing doses. A recent Phase 2 study (VLX-1005-003) evaluated VLX-1005 in individuals with suspected HIT, and interim results demonstrated encouraging reductions in thromboembolic events. These events have become a preferred, clinically meaningful endpoint for regulators, clinicians, and payers, given the rising rates observed in current HIT populations.
VLX-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency. Second-generation therapeutics targeting 12-LOX are also under development for type 1 diabetes and other immune-mediated and inflammatory diseases.
“We are pleased the advancement of VLX-1005 for the treatment of HIT will continue under the leadership of Cadrenal,” said Matthew Boxer, Co-Founder of Veralox Therapeutics. “The program has found a home in Cadrenal, where it aligns with a shared vision and excitement regarding the promise 12-LOX technology may offer patients.”
“With the acquisition of VLX-1005, Cadrenal continues to advance novel therapeutics to treat or prevent thrombosis in high-risk patients,” said Quang X. Pham, Chairman and CEO of Cadrenal Therapeutics. “HIT remains a dangerous condition without a therapy that addresses its immune-driven biology. The emerging data from VLX-1005 suggest meaningful potential to improve patient outcomes while maintaining favorable tolerability. We believe this is a compelling strategic addition to our pipeline, with the market size for HIT reaching $1 billion in the US and EU.”
Under the terms of the acquisition agreement, Veralox is eligible to receive upfront and milestone payments contingent on the achievement of specified future clinical and regulatory milestones. Additionally, Veralox will be entitled to royalties on global sales of the acquired assets upon future commercialization. The structure and terms of the agreement enable Cadrenal to allocate capital to advancing the clinical development of VLX-1005.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is developing differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high-risk patient populations. It currently has three clinical-stage assets: VLX-1005, a first-in-class Phase 2 12-LOX Inhibitor for patients with HIT, tecarfarin, an oral vitamin K antagonist (VKA) for chronic use in patients with kidney dysfunction or left ventricular assist devices (LVADs), and frunexian, a parenteral small-molecule Factor XIa antagonist for use in acute hospital settings. For more information, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.
Safe Harbor
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding advancing VLX-1005 for the treatment of HIT; continuing to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the emerging data from VLX-1005 suggesting meaningful potential to improve patient outcomes while maintaining a favorable safety profile; VLX-1005 being a compelling strategic addition to Cadrenal’s pipeline; the payment to Veralox of milestone payments contingent upon the achievement of certain future clinical and regulatory milestones as well as royalties on global sales of the acquired assets upon future commercialization; the structure and terms of the agreement enabling Cadrenal to allocate capital to advancing the clinical development of VLX-1005; and developing transformative therapeutics to overcome the limitations of current anticoagulation therapy. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to advance the clinical development of VLX-1005 for the treatment of HIT; the ability to continue to advance novel therapeutics to treat or prevent thrombosis in high-risk patients; the ability to successfully complete clinical trials on time and achieve desired results and benefits as expected; the ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact:
Cadrenal Therapeutics:
Matthew Szot, CFO
Investors:
Lytham Partners, LLC
Robert Blum, Managing Partner
602-889-9700
Exhibit 99.2

Bridging Important Gaps in Anticoagulation Management for High - Risk Patients December 2025 Corporate Presentation NASDAQ: CVKD

2 Forward - looking Statements This document contains forward - looking statements . In addition, from time to time, we or our representatives may make forward - looking statements orally or in writing . We base these forward - looking statements on our expectations and projections about future events, which we derive from the information currently available to us . Such forward - looking statements relate to future events or our future performance, including : our financial performance and projections ; our growth in revenue and earnings ; and our business prospects and opportunities . You can identify forward - looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms . In evaluating these forward - looking statements, you should consider various factors, including : our ability to successfully develop and commercialize product candidates, our ability to raise capital when needed, and the competitive environment of our business . These and other factors may cause our actual results to differ materially from any forward - looking statement, including those risk factors disclosed in our Annual Report on Form 10 - K for the year ended December 31 , 2024 , filed with the Securities and Exchange Commission on March 13 , 2025 , and our Quarterly Reports for the periods ended March 31 , 2025 , June 30 , 2025 , and September 30 , 2025 . Forward - looking statements are only predictions . The forward - looking events discussed in this document and other statements made from time to time by us or our representatives may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us . We are not obligated to publicly update or revise any forward - looking statement, whether as a result of uncertainties and assumptions, the forward - looking events discussed in this document, and other statements made from time to time by us or our representatives might not occur .

3 Our Mission Develop novel, differentiated products that bridge critical gaps in current acute and chronic anticoagulation management for rare and high - risk patient populations.

4 A ddressing gaps in the $40B anticoagulation market VLX - 1005 expands our portfolio with a novel immune - targeted approach - 12 - LOX inhibition • A parenteral (intravenous) 12 - Lipoxygenase (12 - LOX) inhibitor designed to block key pathways in immune - mediated platelet activation • Blocks platelet activation and inhibits thrombus formation • Orphan Drug Designation (ODD) for patients with heparin induced thrombocytopenia (HIT) • Acquired December 2025 Recent Acquisition VLX - 1005 Tecarfarin • An oral Vitamin K antagonist (VKA) with a proven mechanism of action (MoA) – same as warfarin • Completely different – and desirable – metabolic pathway than warfarin • ODD for end - stage kidney disease (ESKD) patients with atrial fibrillation (AFib) • ODD for LVAD patients : collaboration with Abbott Frunexian • An acute parenteral Factor XIa (FXIa) inhibitor • Only parenteral FXIa with fast - on / fast - off profile for acute care use • For complex cardiac surgery (CABG) and continuous renal replacement therapy (CRRT) patients • Acquired September 2025 Existing Programs

5 Our development pipeline is focused on rare and high - risk indications Pivotal Phase II Phase I Preclinical Regulatory Form Indication MOA Program • FDA Orphan Drug Designation • EMA Orphan Drug Designation • FDA Fast Track Designation IV HIT 12 - LOX Inhibitor VLX - 1005 • FDA Orphan Drug Designation • FDA Fast Track Designation Oral ESKD+AFib Vitamin K Antagonist Tecarfarin • FDA Orphan Drug Designation Oral LVAD • Phase 2 ready IV CABG Factor XIa Inhibitor Frunexian The indications targeted in our pipeline represent a $3 billion+ peak annual revenue potential

Target: Immune - mediated Platelet Activation VLX - 1005

7 Dire Outcomes of HIT Require a New Approach to Treatment Epidemiology (US): ~300,000 suspected patients/year ~50,000 confirmed acute diagnoses/year Adapted from May J, Westbrook B, Cuker A. Heparin - induced thrombocytopenia: An illustrated review. Res Pract Thromb Haemost. 2023 Jun 22;7(5):100283. doi: 10.1016/j.rpth.2023.100283. PMID: 37601013; PMCID: PMC10439402.

8 Heparin Induced Thrombocytopenia (HIT) A Rare but Serious Immune Reaction to Heparin CVD Interventions Use Heparin • Cardiovascular disease (CVD) is on the rise across the world due to aging populations • Complications from CVD also expected to increase Heparin Usage Leads to HIT • SoC for CVD interventions is heparin • HIT results in platelet activation, causing thrombocytopenia and results in thrombosis Current Treatments • SoC does not treat disease pathogenesis and can cause severe bleeding HIT has High Morbidity & Mortality • HIT patients have dire outcomes including death, pulmonary embolism, stroke Our Solution VLX - 1005 has a unique MoA that directly addresses the pathogenesis of HIT at its source Current therapies only treat the thrombotic complications of HIT and convey additional bleeding risk

9 VLX - 1005: The only clinical stage 12 - LOX inhibitor • ~150K – 300K patients Epidemiology • $800M+ Est. Peak Sales 1 • Limited set of commercial non - heparin anticoagulants, led by argatroban • No other products in clinical development Competitive Outlook • Potential to demonstrate clear value in an orphan indication with high unmet need • Monotherapy and combination possibilities to integrate with current treatment paradigm Key Opportunity VLX - 1005 is uniquely positioned to address an underserved indication with a unique mechanism of action (MoA) and expected meaningful impact on thrombotic events beyond that achievable with current anticoagulant therapy Heparin - Induced Thrombocytopenia (HIT) 12 - LOX Inhibition • Validated with human ex vivo and animal in vivo data supporting role in platelet activity Validation • No other 12 - LOX inhibitors have successfully progressed to in - human clinical trials Competitive Outlook • First - in - class (FIC) molecule with Phase 2 PoC secondary endpoint data validating impact on key thrombotic event rate • ODD and Fast Track Designation from the FDA Key Opportunity VLX - 1005 is a first - in - class asset with a unique MoA progressing in an indication ripe for a new therapy 1 LEK Consulting Analysis, 2022.

10 VLX - 1005 – A Unique Mechanism of Action 12 - LOX inhibition treats both platelet activation and thrombus formation in HIT VLX - 1005 1 2 3 • HIT is a rare, potentially life - threatening reaction to heparin driven by an immune response to heparin - PF4 complexes • 12 - LOX is a key immune signaling enzyme, essential for the activation of multiple steps in platelet activation after immune complex binding to the Fc RIIa receptor • Platelet activation drives thrombus formation and the subsequent clinical manifestations of HIT - thrombocytopenia and thrombosis • VLX - 1005 inhibits 12 - LOX and blocks associated downstream pathways to reduce the stimuli driving both thrombus formation and thrombocytopenia • The current standard of care (anticoagulants) only attenuate thrombus formation, without any effect on the underlying cause of HIT - immune complex platelet activation

11 High Unmet Need in HIT HIT patients face significant risk of severe complications and death; legacy anticoagulation pharmacotherapy is marginally effective in this population and pose further major bleeding risks While heparin use is declining, it is still a key cornerstone of care, particularly for cardiovascular surgeries Patients with HIT still have high unmet need, with critical complications of thrombosis, limb gangrene, and death Current anticoagulation treatment for HIT causes or exacerbates bleeding, and can even result in fatal hemorrhage Population dynamics (e.g., aging population, increasing prevalence of comorbidities) point to a growing risk of HIT 48K 48K 240K 106K 0K 50K 100K 150K 200K 250K 300K HIT Patient Population Total Addressable Population HIT Epidemiology 1 Suspected Acute Only ~44% of suspected HIT patients expected to be treated with pharmacotherapy 1 All acute HIT patients are expected to be addressable 1 Notes: LEK Analysis, 2022. Sources: Chong. Blood. 2025; Company Materials.

12 Vehicle Control VLX - 1005 (7.5 mg/kg, PO) 2 1 Arterioscl Throm Vasc Biol . 2017 ;37:1828 All images are mouse data 2 VLX - 1005 was dosed 15h prior to imaging Inhibition of platelet aggregation without increasing bleeding is an important leap forward in safety over existing therapies 0 Sec 30 sec 4 min Control VLX - 1005 Heparin VLX - 1005 shows dose dependent prevention of platelet aggregation in a murine thrombosis model 1 Bleeding Time (sec) Time VLX - 1005 Inhibits Thrombus Formation without Altering Normal Hemostasis – Unlike Conventional Anticoagulants VLX - 1005 does not inhibit hemostatic plug formation VLX - 1005 does not increase bleeding times, in contrast to argatroban

13 VLX - 1005 Effective in an Animal Model of HIT Renna SA et al. Arterioscler Thromb Vasc Biol . 2023;43:1808 – 1817 DOI: 10.1161/ATVBAHA.123.319434 1500 1000 500 0 2000 Thromosis Score ns Thrombosis (30 mg/kg IP) Pulmonary Embolism Standard of Care (argatroban) has no impact on: • Prevention of pulmonary embolism • Thrombosis VLX - 1005 Vehicle VLX - 1005 Pulmonary Embolism • Lung images from mice • VLX - 1005 treatment significantly inhibits PE

14 Phase 1 Studies Demonstrate VLX - 1005 Well - Tolerated VLX - 1005 well - tolerated in Phase 1 SAD/MAD and DDI studies • Over 100 subjects dosed • Adverse events were uncommon and mild in severity • Orphan Drug Designation in US and EMA • Fast Track Designation in US Composite SAD/MAD results: • No treatment - based discontinuations • 69 treatment emergent adverse events were observed - 30% in VLX - 1005 treated subjects vs. 36% in placebo • No SAEs reported, no dose limiting toxicities • PK well behaved & dose proportional • No drug - drug interaction between VLX - 1005 & argatroban

15 VLX - 1005 Phase 2 PoC Study (ALATHEA) Primary Endpoint: Time to Platelet Count Recovery Secondary Endpoint: Composite Thromboembolic Events At – risk pts screened for suspected HIT • 4T Score > 4 (HIT likely) • Immunoassay positive • Serotonin assay sent Randomized VLX - 1005 + SOC* Placebo + SOC* *SOC (bivalirudin or argatroban) per clinician Treatment 7 – 14 Days (until plt count > 150,000) 30 Days Safety Follow - up Interim analysis complete. Database analysis 1Q26. Primary Study Goals Identify a clinically meaningful endpoint to demonstrate efficacy over SoC Evaluate safety in the indicated population

16 Near - Term Plan and Estimated Timeline for VLX - 1005 2027 2026 MILESTONES Q1 Q4 Q3 Q2 Q1 Database lock Data Analysis Publication Manuscript Pivotal Protocol Design FDA EOP2 Meeting CMC Readiness Study Start - up Pivotal Study Initiation

Target: Coagulation Tecarfarin and Frunexian

Opportunity • Only new VKA in the last 70 years • Targeting areas where DOACS are contra - indicated, unapproved, or not recommended Path Forward • Extensive safety data (n=1,000+) • CMC ready • Potential Phase 2 study in LVAD patients and/or ESKD+AFib patients Differentiation • Only VKA in late - stage development worldwide • Not metabolized by CYP450; not affected by renal impairment • ODD and Fast Track Approval in ESKD patients with AFib • ODD in LVAD patients Tecarfarin Overview A Novel VKA with Multiple Orphan Drug Designations by FDA Unmet Need • Poor warfarin control • Thrombosis • Bleeding • DOAC failures • ~30% of people can have genetic variants adversely impacting warfarin metabolism Tecarfarin A novel VKA • Addresses important limitations of warfarin • Predictable metabolism, fewer interactions • Suitable for patients with complex medication regimens • Positive safety and efficacy data • Consistent anticoagulation control • Levels not affected in patients with poor kidney function • Fills critical gaps unaddressed by DOACs

• Acute - care settings where there are opportunities to address treatment gaps with heparin Path Forward • Solidify CMC • Phase 2 dosing in preparation for potential Phase 3 program(s) • Complex cardiac surgery • Continuous Renal Replacement Therapy Differentiation • Fast - on / fast - off potent, dose - proportionate parenteral FXIa inhibition • Only acute - care parenteral XIa in development Frunexian Overview An Acute Parenteral Factor XIa inhibitor • Breakthrough Factor XIa asset(s) • Bridging opportunity (IV to Oral) Frunexian Acute parenteral FXIa inhibitor • Potent (> 95%) XIa inhibition • Effective blockade of contact activation • Predictable PK/PD • Parenteral administration • Rapid onset, short half - life • Phase 2 ready Unmet Need Opportunity

Leadership & Financial Summary

21 Experienced Leadership Across clinical to commercial drug development John R. Murphy Board Member Steven Zelenkofske, DO Board Member Glynn Wilson, PhD Board Member Quang X. Pham CEO & Founder, Chairman Matthew Szot, CPA Chief Financial Officer Jeff Cole Chief Operating Officer James Ferguson, MD, FACC, FAHA Chief Medical Officer Lee Golden, MD Board Member

22 Financials, Capitalization & Insider Alignment Cap Table $3.9 million Cash (at 9/30/2025) NONE Debt 2,075,845 Common Shares Outstanding (at 11/20/2025) 615,940 Warrants – Investors (avg. $17.82) 426,333 Stock Options Outstanding (avg. $17.61) Market Capitalization $23 million As of 12/11/2025 Insider Ownership (Common Stock) 22% Insider Ownership as Percent of Shares Outstanding 2025 Financial Results – Nine Months Ended Sept. 30 $8.8 million Operating Expenses (excluding non - cash items) $10.0 million Cash used in operating activities

23 Quang X. Pham CEO & Founder [email protected] Matthew Szot CFO [email protected] Contact Us: