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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported) November 3, 2023
THARIMMUNE,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-41210 |
|
84-2642541 |
(State
or other jurisdiction |
|
(Commission |
|
(I.
R. S. Employer |
of
incorporation) |
|
File
Number) |
|
Identification
No.) |
1200
Route 22 East, Suite 2000
Bridgewater,
NJ 08807
(Address
of principal executive offices, including zip code)
(908)
955-3140
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
name or former address, if changed since last report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
stock, $0.0001 par value |
|
THAR |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
1.01 Entry into a Material Definitive Agreement.
On
November 3, 2023 (“Avior Effective Date”), Tharimmune, Inc. (the “Company”) entered into a patent license agreement
(the “Avior Patent License Agreement”) with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) pursuant to which the Company
received an exclusive sublicensable right and license to Licensed Patent Rights (as defined in the Avior Patent License Agreement) and
Licensed Technology (as defined in the Avior Patent License Agreement) to, among other things, Develop (as defined in the Avior Patent
License Agreement), have Developed, make, have made, use, sell, import, export and commercialize AV104 (to be renamed TH104) and AV103
(to be renamed TH103) and to practice the Licensed Technology in connection with the foregoing, throughout the world. Pursuant to the
Avior Patent License Agreement, the Company shall pay Avior a mid six digit up front license fee within ten days of the Avior
Effective Date and an additional mid six digit license fee which shall be paid in four equal installments within ten days of the end
of each fiscal quarter following the Avior Effective Date. In addition, the Company shall pay Avior a high single digit percentage of
any upfront payments received by it as a result of the grant of any sublicenses with respect to AV104. The Company shall also pay Avior
milestone payments in the aggregate amount of $24,250,000 upon the occurrence of various development milestones (the “Development
Milestone Payments”). Furthermore, the Company shall pay Avior certain fees based upon sales milestones. The payments for such
sales milestones range from the low seven digits to the low eight digits with higher sales being subject to higher fees. Finally, the
Company shall pay Avior royalties based on net sales. Such royalties range from low single digit percentages to mid single digit
percentages with higher sales being subject to lower percentages. The Avior Patent License Agreement shall expire upon the expiration
of the final payment obligation due to Avior as set forth in such agreement. Upon the expiration of the Avior Patent License Agreement,
the Company shall have a fully paid, irrevocable, freely transferable and sublicensable worldwide license to the Licensed Patent Rights
and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported,
export, have exported, commercialize or have commercialized any and all Licensed Products and to practice the Licensed Technology worldwide.
Pursuant to the Avior Patent License Agreement, the Company may terminate the agreement at any time without cause, upon 30 days’
prior written notice to Avior along with payment of the next unpaid Development Milestone Payment, if any. Furthermore, either the Company
or Avior may terminate the Avior Patent License Agreement (i) on written notice to the other party if the other party materially breaches
any provision of the Avior Patent License Agreement and fails to cure such breach within 30 days after the breaching party receives written
notice thereof or (ii) on written notice in the event that either party (A) becomes insolvent or admits its inability to pay its
debts generally as they become due; (B) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic or foreign
bankruptcy or insolvency law, which is not fully dismissed or vacated within 60 days; (C) is dissolved or liquidated or takes any corporate
action for such purpose; (D) makes a general assignment for the benefit of creditors; or (E) has a receiver, trustee, custodian or similar
agent appointed by order of any court of competent jurisdiction to take charge of or sell any material portion of its property or business.
Upon termination of the Avior Patent License Agreement, the license granted pursuant to such agreement shall terminate and all rights
in the Licensed Patent Rights and Licensed Products shall revert back Avior.
The
foregoing description of the Avior Patent License Agreement does not purport to be complete and is subject to, and qualified in its entirety
by reference to the full text of the Avior Patent License Agreement, a copy of which is attached hereto as Exhibit 10.1 and is incorporated
herein by reference.
Item
8.01 Other Events.
On
November 6, 2023, the Company issued a press release with respect to the Avior Patent License Agreement, a copy of which is attached
hereto as Exhibit 99.1 and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
#
Pursuant to Item 601(b)(10) of Regulation S-K, certain confidential portions of this exhibit were omitted by means of marking such portions
with an asterisk because such information is both not material and is the type that the Company treats as private or confidential.
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.
Date:
November 7, 2023 |
THARIMMUNE,
INC. |
|
|
|
/s/
Randy Milby |
|
Randy
Milby |
|
Chief
Executive Officer |
Exhibit
10.1
[*]
Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) is the type of information
that the company treats as private or confidential.
PATENT
LICENSE AGREEMENT
THIS
PATENT LICENSE AGREEMENT (this “Agreement”) is entered into as of the 3rd day of November, 2023, (the
“Effective Date”) by and between Avior Inc. dba Avior Bio, a North Carolina corporation (the “Licensor”)
and Tharimmune, Inc., a Delaware corporation (the “Licensee”). Licensor and Licensee may individually be referred
to as a “Party” and collectively as the “Parties.”
BACKGROUND
Licensor
is a clinical stage, pharmaceutical company advancing therapies in pruritus (itch) in chronic liver disease and atopic dermatitis.
Licensor
owns all right, title and interest in and to the Licensed Patent Rights and Licensed Technology (each as defined below).
Licensee
desires to license from Licensor, and Licensor desires to license to Licensee, the Licensed Patent Rights and Licensed Technology.
AGREEMENT
In
consideration of the foregoing and the representations, warranties and covenants contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE
I
DEFINITIONS
“API”
means the active pharmaceutical ingredient known as nalmefene.
“AV103”
means the buccal film known as AV103 containing the API, that is the subject matter of IND 151315 filed with the FDA.
“AV104”
means the buccal film known as AV104 containing the API, that is the subject matter of IND 152235 and IND 147007 filed with the FDA.
“Books
and Records” shall mean all books, files, papers, agreements, correspondence, databases, data, records, manuals and other documentation
information systems, programs, software, documents and records (regardless of medium, whether in physical or electronic format and stored
in computer memory or other storage device).
“Business
Day” means any day other than Saturday, Sunday and any day on which commercial banks in New York, NY are authorized by Law
to be closed.
“Development,”
with a correlative meaning for “Develop” and “Developing,” means with respect to a Licensed
Product, all activities conducted after the date hereof relating to (a ) research and development in connection with seeking,
obtaining or maintaining Regulatory Approval, (b) preclinical and clinical trials, toxicology testing, statistical analysis and
publication and presentation of study results with respect to Licensed Product (collectively, “Development
Activities”) and (b) obtaining, registering and maintaining Regulatory Approval of Licensed Products, including the
reporting, preparation and submission of applications for Regulatory Approval (collectively, “Regulatory
Activities”). “Drug Approval Application” shall mean any application for Regulatory Approval (including
pricing and reimbursement approvals) required prior to any commercial sale or use of a pharmaceutical product in any country or
jurisdiction in the Territory, including, without limitation, any NDA or MAA or any equivalent application filed with the FDA or any
Foreign Regulatory Authority for Regulatory Approval (including pricing and reimbursement approvals) required prior to any
commercial sale or use of a pharmaceutical product in any country or jurisdiction in the Territory.
“FDA”
means the U.S. Food and Drug Administration.
“FDA
Law” means the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. § 301 et seq.), the Public Health Service Act
(42 U.S.C. § 201 et seq.), as amended, and the regulations promulgated thereunder.
“Governmental
Entity” means any federal, foreign, state, county, municipal, provincial or local governmental authority, court, judicial body,
arbitration tribunal, government or self-regulatory organization, commission, tribunal or organization, or any regulatory, administrative
or other agency, or any political or other subdivision, department, commission, board, bureau, branch, division, ministry, or instrumentality
of any of the foregoing.
“Improvements”
means any enhancement, invention or discovery created, identified, conceived, made or reduced to practice by or on behalf of Licensee,
which constitutes an improvement to the subject matter of the Licensed Patent Rights or Licensed Technology.
“IND”
shall mean an investigational new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended
from time to time) filed or to be filed with the FDA.
“Intellectual
Property Rights” means any and all Patent Rights, copyrights, moral rights, rights in trademarks, trade secret and know-how
rights, and any other form of intellectual property rights recognized in any jurisdiction throughout the world, including without limitation
any applications and registrations for any of the foregoing.
“Knowledge”
means the actual knowledge of Licensor and Niraj Vasisht after reasonable inquiry, including of those personnel having oversight over
the relevant fact or matter.
“Law”
means any applicable local, county, state, federal, foreign or other law, statute, regulation, ordinance, rule, order, decree, judgment,
consent decree, settlement agreement or governmental requirement enacted, promulgated, entered into, agreed or imposed by any Governmental
Entity.
“Liability”
means, with respect to any Person, any debt, liability or obligation of such Person of any kind, character or description, whether known
or unknown, absolute or contingent, accrued or unaccrued, disputed or undisputed, liquidated or unliquidated, secured or unsecured, joint
or several, due or to become due, vested or unvested, executory, determined, determinable or otherwise, and whether or not the same is
required to be accrued on the financial statements of such Person.
“Licensed
Patent Rights” means all Patent Rights which are Controlled by Licensor as of the Effective Date or become Controlled by Licensor
during the Term, to the extent necessary for the Development, manufacture, use or sale of the Licensed Products. The Licensed Patent
Rights as of the Effective Date are listed in Exhibit A, attached hereto and made a part hereof. Exhibit A shall be updated
immediately following the discovery by either party that a patent or patent application was inadvertently not listed on Exhibit A,
and the exclusion of a patent or patent application from Exhibit A is not to be deemed a conclusive indication of whether that
patent or application should not be considered a “Licensed Patent Right” for purposes of this Agreement.
“Licensed
Product(s)” shall mean AV103 and/or AV104, as the context requires.
“Licensed
Technology” means and includes all Technology, tangible or intangible, whether or not patentable, that (a) is related to any
patent or patent application included in the Licensed Patent Rights, or (b) is necessary for Licensee to practice the licenses granted
hereunder.
“Losses”
means losses, liabilities, claims, fines, deficiencies, damages, penalties, taxes, payments and reasonable attorneys’ and accountants’
fees and disbursements.
“NDA”
shall mean a new drug application (as defined in Title 21 of the United States Code of Federal Regulations, as amended from time to time)
and all supplements filed with, and pursuant to the requirements of, the FDA, including all documents, data and other information concerning
the applicable drug which are necessary to seek Regulatory Approval to market and sell a pharmaceutical product in the United States.
“Net
Sales” shall mean the gross amounts actually received by Licensee, its Affiliates or Sublicensees for all AV104 sold by Licensee,
its Affiliates or Sublicensees to Third Parties throughout the Territory, less any deductions allowed under U.S. G.A.A.P. to the extent
not already taken, including, without limitation, the following amounts incurred or paid by Licensee, its Affiliates or Sublicensees
with respect to sales of AV104:
(a)
trade, cash and quantity discounts or rebates actually allowed or taken, including discounts or rebates to governmental or managed care
organizations;
(b)
reimbursements, credits or allowances actually given or made for rejection or return of previously sold AV104 (including Medicare and
similar types of rebates);
(c)
any charges for insurance, freight, and other transportation costs directly related to the delivery of AV104;
(d)
any tax, tariff, duty or governmental charge levied on the sales, transfer, transportation or delivery of AV104 (including any tax such
as a value added or similar tax or government charge) borne by the seller thereof, other than franchise or income tax of any kind whatsoever;
(e)
amounts paid as distribution fees to Third Parties;
(f)
any import or export duties or their equivalent borne by the seller;
(g)
any amounts received in connection with conducting clinical trials;
(h)
sales to government organizations, charitable non-governmental organizations, indigent programs and sales of AV104 at a loss or for materially
reduced profit margins; and
“Net
Sales” shall not include sales or transfers between Licensee and its Affiliates or Sublicensees, unless the AV104 is consumed
by the Affiliate or Sublicensee. For the avoidance of doubt, Net Sales does not include any sales or transfers of AV103.
“MAA”
shall mean an application filed with the relevant Foreign Regulatory Authorities in Europe seeking Regulatory Approval to market and
sell any pharmaceutical product in Europe or any country or territory therein.
“Patent
Rights” shall mean the rights and interests in and to issued patents and pending patent applications (including inventor’s
certificates and utility models) in any country or jurisdiction within the Territory, including all provisionals, substitutions, continuations,
continuations-in-part, divisionals, supplementary protection certificates, renewals, all letters patent granted thereon, and all reissues,
reexaminations, extensions, confirmations, revalidations, registrations, patents of addition thereof, PCTs and foreign counterparts.
“Person”
means any individual, corporation, partnership, joint venture, limited liability company, trust, unincorporated organization or governmental
entity.
“Regulatory
Approval” shall mean any and all filings and approvals (including pricing and reimbursement approvals only in those jurisdictions
requiring reimbursement approval required before marketing can commence), product and establishment licenses, registrations or authorizations
of any kind of the FDA or any Foreign Regulatory Authority necessary for the development, pre-clinical and/or human clinical testing,
manufacture, quality testing, supply, use, storage, importation, export, transport, marketing and sale of a pharmaceutical product (or
any component thereof) in any country or other jurisdiction in the Territory. “Regulatory Approval” shall include, without
limitation, any INDs, NDAs and drug master files.
“Regulatory
Documentation” shall mean all applications, registrations, licenses, authorization and approvals (including all Regulatory
Approvals), all correspondence submitted to or received from the FDA or any Foreign Regulatory Authority (including minutes and official
contact reports relating to any communications with the FDA or any Foreign Regulatory Authority) and all supporting documents and data
contained in any of the foregoing (including any INDs or foreign equivalents, any manufacturing facility validation and/or licensure,
any Drug Approval Applications, orphan drug applications, and any other documents related to Regulatory Approvals) in Licensor’s
possession or control.
“Sublicensee”
shall mean any Third Party to whom Licensee grants a license or sublicense of some or all of the rights granted to Licensee under this
Agreement.
“Technology”
means and includes any and all know-how, methods, technology, manufacturing and production or business processes, proprietary information,
protocols, schematics, specifications, techniques, Trade Secrets, discoveries, concepts, ideas, research and development, results, analysis,
studies, CMC data, drug master files, compositions, designs, drawings, business and marketing plans and proposals, works of authorship,
data collections, diagrams, formulae, graphs, inventions (whether or not patentable), algorithms, apparatuses, charts, databases, technical
information (including, without limitation, structural and functional information), pre-clinical information, clinical information, and
any and all proprietary chemical, pharmacological, toxicological, pre-clinical, clinical, assay, control and manufacturing data and materials,
and other forms of technology (whether or not embodied in any tangible form and including all tangible embodiments of the foregoing,
such as instruction manuals, laboratory notebooks, prototypes, samples, studies and summaries), whether patentable or not.
“Territory”
shall mean all countries and jurisdictions of the world.
“Third
Party” shall mean any Person other than Licensee, Licensor and their respective Affiliates.
“Trade
Secrets” means know-how, trade secrets and other confidential or proprietary information, including any inventions, invention
disclosures, discoveries, improvements, concepts, ideas, methods, processes, designs, plans, schematics, drawings, formulae, technical
information and data, business and financial information and data, customer lists, specifications, research and development information,
technology and product roadmaps and databases.
“Valid
Claim” shall mean a claim in an issued, unexpired patent or in a pending patent application within the Licensed Patent Rights
that (a) has not been finally cancelled, withdrawn, abandoned or rejected by any administrative agency or other body of competent jurisdiction,
(b) has not been revoked, held invalid, or declared unpatentable or unenforceable in a decision of a court or other body of competent
jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer
or otherwise, and (d) is not lost through an interference proceeding.
ARTICLE
II
LICENSE
Section
2.1 License. On the terms and subject to the conditions set forth in this Agreement, Licensor hereby grants to Licensee during
the Term an exclusive (including as to Licensor), sublicensable, transferable (in accordance with Section 11.5) right and license
under the Licensed Patent Rights and Licensed Technology to Develop, have Developed, make, have made, use, have used sell, offer for
sale, have sold, import, have imported, export, have exported, commercialize or have commercialized Licensed Products, and to practice
the Licensed Technology in connection with the foregoing, in the Territory.
Section
2.2 Right to Sublicense. Licensee shall have the right to grant sublicenses to any Sublicensee to all or any portion of its
rights under the license granted pursuant to Section 2.1 provided that the terms of the Sublicensee’s license agreement
shall not contradict the terms of this Agreement and shall include or otherwise substantively incorporate the following provisions of
this Agreement: Section 2.1, Section 3.7, Section 5.3, ARTICLE VII and Section 10.3.
ARTICLE
III
PAYMENTS
Section
3.1 License Fees.
(a)
In consideration of the licenses granted herein, Licensee will pay Licensor:
(i)
$[*] in cash (the “Upfront License Fee”), in immediately available funds by wire transfer to the wire instructions
of Licensor set forth on Exhibit B hereto, within ten (10) days following the date hereof; and
(ii)
$[*] in cash (the “Deferred License Fee”), by wire transfer to the wire instructions of Licensor set forth on Exhibit
B hereto, to be paid in four (4) equal installments of $[*] within ten (10) days of the end of each fiscal quarter following the
date hereof.
(b)
The Upfront License Fee, the Deferred License Fee and the Milestone Payments are subject to forfeiture and/or repayment pursuant to the
indemnification provisions set forth in ARTICLE IX below.
Section
3.2 Milestone Payments.
(a)
As a material inducement for Licensor to enter into this Agreement, Licensee shall pay the Development Milestone Payments, if any, pursuant
to Exhibit C hereto (the “Development Milestone Payments”).
(b)
As a material inducement for Licensor to enter into this Agreement, Licensee shall pay the Sales Milestone Payments, if any, pursuant
to Exhibit D hereto (the “Sales Milestone Payments”, and, together with the Development Milestone Payments,
the “Payments”) based on Net Sales of AV104.
Section
3.3 Royalties. As a material inducement for Licensor to enter into this Agreement, Licensee shall pay the Royalties, if any,
pursuant to Exhibit E hereto (the “Royalties”) based on Net Sales of AV104.
Section
3.4 License or Sale Revenue. As a material inducement for Licensor to enter into this Agreement, Licensee shall pay to Licensor
[*]% of any upfront payments (“Upfront Payments”) received by Licensee from the grant by Licensee of a sublicense
of the Licensed Patent Rights to Develop, have Developed, make, have made, use, have used sell, offer for sale, have sold import, have
imported, export, have exported, commercialize or have commercialized AV104. Notwithstanding the foregoing, Upfront Payments shall not
include (i) purchases of Licensee’s equity or debt securities (to the extent not in excess of the fair market value thereof), (ii)
advances for the post-license execution performance of research, development, or commercialization activities or patent prosecution or
maintenance (to the extent such amount does not exceed the actual cost or amount thereof), (iii) issuances of a licensee’s equity
securities (to the extent Licensee pays fair market monetary consideration therefor), or (iv) amounts paid for purchases of tangible
goods or other assets.
Section
3.5 Payment Terms. Unless otherwise expressly provided in an Exhibit hereto, Licensee shall make any milestone and royalty
payments owed to Licensor hereunder in arrears, within forty-five (45) days from the end of each calendar year in which the Net Sales
giving rise to such payments are received by Licensee, or with respect to milestones, within forty-five (45) days of the date when such
milestone was achieved. Each royalty payment shall be accompanied by a report specifying: Net Sales in each country’s currency;
the royalties payable, including an accounting of deductions taken in the calculation of Net Sales; if any proceeds on Net Sales were
received in currencies other than United States Dollars, the applicable exchange rate to convert from each country’s currency to
United States Dollars under this Section 3.5; and the royalties payable in United States Dollars.
Section
3.6 Accounting. All payments hereunder shall be made in the United States in United States Dollars. Conversion of foreign
currency to United States Dollars shall be made at the conversion rate existing in the United States (as reported in The Wall Street
Journal) on the last Business Day of the quarter immediately preceding the applicable calendar quarter. If The Wall Street Journal
ceases to be published, then the rate of exchange to be used shall be that reported in such other business publication of national
circulation in the United States as the Parties reasonably agree.
Section
3.7 Tax Withholding; Restrictions on Payment. All payments of royalties hereunder shall be made free and clear of any taxes,
duties, levies, fees or charges, except for withholding taxes (to the extent applicable). Licensee shall make any applicable withholding
payments due on behalf of Licensor and shall provide Licensor upon request with such written documentation regarding any such payment
as available to Licensee relating to an application by Licensor for a foreign tax credit for such payment with the United States Internal
Revenue Service. If by law, regulations or fiscal policy of a particular country in the Territory, remittance of royalties in United
States Dollars is restricted or forbidden, written notice thereof shall promptly be given to Licensor, and payment of the royalty shall
be made by the deposit thereof in local currency to the credit of Licensor in a recognized banking institution reasonably designated
by Licensor by written notice to Licensee. When in any country in the Territory the law or regulations prohibit both the transmittal
and the deposit of royalties on sales in such country, royalty payments shall be suspended for as long as such prohibition is in effect
and as soon as such prohibition ceases to be in effect, all royalties that Licensee would have been under an obligation to transmit or
deposit but for the prohibition shall forthwith be deposited or transmitted, to the extent allowable.
ARTICLE
IV
DEVELOPMENT
AND COMMERCIALIZATION; REGULATORY ACTIVITIES
Section
4.1 Development and Commercialization. Licensee shall have full control and authority over the Development and commercialization
of Licensed Products, including without limitation, (a) all pre-clinical Development Activities (including any pharmaceutical development
work on formulations or process development relating to any Licensed Product), (b) all activities related to clinical trials (including
all clinical studies), (c) all activities relating to manufacture and supply of all Licensed Products (including all required process
development and scale up work with respect thereto), (d) all commercialization, marketing, promotion, sales, distribution, import and
export activities relating to any Licensed Product, and (e) all activities relating to any regulatory filings, registrations, applications
and Regulatory Approvals relating to any of the foregoing (including any INDs or foreign equivalents, any manufacturing facility validation
and/or licensure, any Drug Approval Applications and any other Regulatory Approvals). Licensee shall own all data, results and all other
information arising from any such activities under this Agreement, including without limitation, all regulatory filings, registrations,
applications and Regulatory Approvals relating to Licensed Products (including any INDs or foreign equivalents, any Drug Approval Applications
and any other Regulatory Approvals), and all of the foregoing information, documentation and materials shall be considered Confidential
Information and Technology solely owned by Licensee (collectively, “Development IP”); provided that Licensee shall
keep Licensor reasonably apprised of any Development IP. Licensee will keep Licensor reasonably informed of any actions or events related
to the Development and commercialization of the Licensed Products that would reasonably be expected to give rise to a prospective claim
by a Third Party or Governmental Entity.
Section
4.2 Regulatory Activities; FDA Communications. Licensee shall have the right to direct and control all Regulatory Activities
following the Effective Date. Without limiting the foregoing, Licensee shall be responsible for communicating with the FDA regarding
the Licensed Products and Licensor shall not initiate contact with the FDA regarding the Licensed Products without Licensee’s prior
written consent, and shall not respond to any FDA inquiries regarding the Licensed Products without the prior written consent of Licensee.
Licensor shall cooperate with and provide assistance to Licensee with respect to communications with the FDA and with responding to all
requests for information from, and with making all required filings with, the FDA in respect of the Licensed Products, including the
Licensed Product IND (as defined below).
ARTICLE
V
FILING,
PROSECUTION AND MAINTENANCE
Section
5.1 Rights to IND and IND Maintenance. Licensor hereby transfers and assigns to Licensee all right, title and interest in
and to: (a) any IND and foreign equivalents related to the Licensed Products and (b) all data and information underlying such IND and
foreign equivalents (including without limitation pre-clinical data, stability data and process data) (collectively, the “Licensed
Product IND”). In connection with such transfer, Licensor shall: (i) submit or file all documents and information required
to be submitted by Licensor, as the current owner of the Licensed Product IND; (ii) promptly after the Effective Date, provide to Licensee
a complete copy of the Licensed Product IND, including all supplements, amendments thereto and reports and records that are required
to be submitted or kept under applicable Law and all communications with FDA regarding the Licensed Product IND; and (iii) take all other
actions imposed upon a current owner of an IND to transfer the Licensed Product IND to Licensee. In addition, Licensor shall provide
to Licensee all data and information necessary for Licensee to comply with all requirements and obligations to the FDA with respect to
the maintenance of the Licensed Product IND. Without limiting the generality of the foregoing, Licensor shall: (x) promptly communicate
and deliver to Licensee all information that is necessary or reasonably useful in Licensee’s reasonable discretion for the maintenance
of the Licensed Product IND; (y) provide such technical assistance as may be reasonably requested by Licensee from time to time, including
without limitation relating to test methods, specifications, and impurity/degradation product identification; and (z) execute and/or
deliver such documents, reports, and certificates (including, without limitation, any certificates of analysis) and take such action,
as Licensee may reasonably request, to assist Licensee with the maintenance of the Licensed Product IND.
Section
5.2 Patent Filing, Prosecution and Maintenance. Licensee shall be responsible for preparing, filing, prosecuting, obtaining
and maintaining, at its sole cost, expense and discretion, and using patent counsel selected by Licensee, all Licensed Patent
Rights. Licensee will keep Licensor reasonably informed of the status of such filing, prosecution and maintenance.
Section
5.3 Notice of Infringement. If either Party learns of any actual, alleged or threatened infringement by a Third Party of any
Licensed Patent Rights under this Agreement, such Party shall promptly notify the other Party and shall provide such other Party with
available evidence of such infringement.
Section
5.4 Infringement of Patent Rights. Licensee shall have the first right (but not the obligation), at its own expense and with
legal counsel of its own choice, to bring suit (or take other appropriate legal action) against any actual, alleged or threatened infringement
of the Licensed Patent Rights. Licensor shall have the right, at its own expense, to be represented in any such action by Licensee by
counsel of Licensor’s own choice; provided, however, that under no circumstances shall the foregoing affect the right
of Licensee to control the suit as described in the first sentence of this Section 5.4. If Licensee does not file any action or
proceeding against a material infringement within six (6) months after the later of (a) Licensor’s notice to Licensee under Section
5.3 above or (b) Licensee’s notice to Licensor under Section 5.3 above, then Licensor shall have the right (but not
the obligation), at its own expense, to bring suit (or take other appropriate legal action) against such actual, alleged or threatened
infringement, with legal counsel of its own choice, but shall not be permitted to settle any such suit without the prior consent of Licensee,
which consent shall not be unreasonably withheld. Any damages, monetary awards or other amounts recovered, whether by judgment or settlement,
pursuant to any suit, proceeding or other legal action taken under this Section 5.4, shall applied as follows:
(a)
First, to reimburse the Parties for their respective costs and expenses (including reasonable attorneys’ fees and costs) incurred
in prosecuting such enforcement action;
(b)
Second, to Licensee in reimbursement for lost sales (net of royalties) associated with Licensed Products and to Licensor in reimbursement
for lost royalties owing hereunder based on such lost sales;
(c)
Third, any amounts remaining shall be allocated as follows: (i) if Licensee is the Party bringing such suit or proceeding or taking such
other legal action, one hundred percent (100%) to Licensee, (ii) if Licensor is the Party bringing such suit or proceeding or taking
such other legal action, one hundred percent (100%) to Licensor, or (iii) if the suit or proceeding is brought jointly, fifty percent
(50%) to each Party.
If
a Party brings any such action or proceeding hereunder, the other Party agrees to be joined as party plaintiff if necessary to prosecute
such action or proceeding, and to give the Party bringing such action or proceeding reasonable assistance and authority to file and prosecute
the suit; provided, however, that neither Party shall be required to transfer any right, title or interest in or to any property to the
other Party or any Third Party to confer standing on a Party hereunder.
ARTICLE
VI
REPRESENTATIONS AND WARRANTIES
Licensor
hereby represents, warrants and covenants to Licensee that:
Section
6.1 Organization. Licensor is a corporation duly organized and validly existing under the Laws of the State of North
Carolina.
Section
6.2 Authorization and Validity of Agreement. Licensor has all requisite organizational power and authority to enter into this
Agreement and to perform its obligations hereunder. The execution and delivery of this Agreement by Licensor and the performance by it
of its obligations hereunder has been duly authorized by all necessary organizational action of Licensor, and no other proceedings on
the part of Licensor are necessary to authorize the execution, delivery or performance by Licensor of this Agreement. This Agreement
has been duly executed and delivered by Licensor and constitutes Licensor’s valid and binding obligation, enforceable against Licensor
in accordance with its terms.
Section
6.3 No Conflict or Violation. The execution, delivery, consummation and performance of this Agreement by Licensor does not
and shall not: (a) violate any provision of Law applicable to Licensor, (b) violate or result in a breach of or constitute (with or without
due notice or the passage of time, or both) a default under any agreement, instrument or understanding to which Licensor is a party or
by which it is bound, or (c) require the consent, approval or authorization of any governmental or regulatory authority or other Third
Party. Licensor has not granted and will not grant any licenses or other contingent or non-contingent right, title or interest under
or relating to Licensed Patent Rights.
Section
6.4 Rights and Authority. Licensor is the sole and exclusive legal and beneficial owner of the entire right, title, and interest
in and to the Licensed Patent Rights and Licensed Technology, and is the record owner of all patent applications and issued patents that
are Licensed Patents Rights. Licensor has the full right and legal capacity to grant the rights granted to Licensee hereunder without
the necessity of obtaining any consent or approval that has not already been obtained or otherwise violating the rights of any Third
Party.
Section
6.5 Compliance with Law; FDA Regulatory.
(a)
To the Knowledge of the Licensor, Licensor is, and has been, in compliance in all material respects with all applicable Laws in the jurisdictions
in which Licensor conducts business including, as applicable (i) the requirement for and the terms of all necessary regulatory permits,
(ii) establishment registration, (iii) payment of all establishment fees, (iv) Good Clinical Practices, (v) Good Manufacturing Practices,
and (vi) recordkeeping and reporting requirements. Licensor is not in default with respect to any order, writ, judgment, award, injunction
or decree of any Governmental Entity or arbitrator applicable to it, or any of Licensed Patent Rights, Licensed Technology or Licensed
Products. Licensor has not received, at any time during the prior five (5) years from the date of this Agreement, any written notice
from any Governmental Entity regarding any actual, alleged, or potential violation of, or failure to comply with, any Law applicable
to Licensor in any material respect that in any way relates or may have an effect on any of Licensed Patent Rights, Licensed Technology
or Licensed Products.
(b)
To the Knowledge of the Licensor, Licensor holds all material registrations, reports, documents, permits or notices required to be filed,
maintained or furnished under FDA Law and all other applicable local, state and federal laws and regulations of the relevant Governmental
Entity in the jurisdictions in which Licensor performed any clinical trials involving the Licensed Products (“FDA Permits”).
All FDA Permits are in full force and effect in all material respects and no suspension, revocation, cancellation or withdrawal of such
FDA Permits is threatened and there is no reasonable basis for believing that such FDA Permits will not be renewable upon expiration
or will be suspended, revoked, cancelled or withdrawn.
(c)
Licensor has not received any written notice or communication from any Governmental Entity of any actual or threatened investigation,
inquiry, or administrative, judicial or regulatory action, hearing, or enforcement proceeding against Licensor regarding any violation
of applicable FDA Law. Licensor has no knowledge of any material obligation arising under an investigation, inquiry, or administrative,
judicial or regulatory action, hearing, or enforcement proceeding by or on behalf of the FDA.
(d)
In the last five (5) years, Licensor has not been party to any corporate integrity agreement, monitoring agreement, consent decree, settlement
order or other similar written agreement, in each case, entered into with or imposed by the FDA. Neither Licensor nor, to the Knowledge
of the Licensor, any of its officers, employees or agents, or any manufacturer, distributor, or other entity in Licensor’s supply
chain, has been or is currently disqualified or debarred, suspended, proposed for debarment or suspension, deemed non-responsible, or
otherwise excluded from the award of contracts or from participating in any Federal healthcare programs by any Federal agency. Neither
Licensor nor, to the Knowledge of the Licensor, any of its officers, employees, or agents has made an untrue statement of a material
fact or a fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, in each of the foregoing
cases on behalf of the Licensor.
(e)
To the Knowledge of the Licensor, no officer, employee or agent of the Licensor is or has been, or has been threatened to be: (i) debarred
under FDA proceedings under 21 U.S.C. § 335a; (ii) disqualified under FDA investigator disqualification proceedings; (iii) subject
to FDA’s Application Integrity Policy; or (iv) subject to any enforcement proceeding arising from material false statements to
FDA pursuant to 18 U.S.C. § 1001. Licensor will provide written notice to Licensee immediately upon becoming aware that any officer,
employee or agent of the Licensor is or has been, or has been threatened to be: (i) debarred under FDA proceedings under 21 U.S.C. §
335a; (ii) disqualified under FDA investigator disqualification proceedings; (iii) subject to FDA’s Application Integrity Policy;
or (iv) subject to any enforcement proceeding arising from material false statements to FDA pursuant to 18 U.S.C. § 1001.
Section
6.6 Neither Licensor nor any of its managers, directors, officers, agents and employees have: (a) used any corporate funds of Licensor
for unlawful contributions, gifts, entertainment or other unlawful expenses related to political activity, (b) made any unlawful payments
to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns from corporate funds
or violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any other U.S. or foreign Laws concerning
corrupt payments applicable to its business or (c) made or received any other payment, contribution, gift, bribe, rebate, payoff or kick-back
prohibited under any applicable Law. Neither Licensor nor to the Knowledge of the Licensor, any of its managers, directors, officers,
stockholders, agents and employees is or has been the subject of any investigation, inquiry or enforcement proceeding by any Governmental
Entity regarding any offense or alleged offense under anti-bribery, anti-corruption or anti-fraud Law in any jurisdiction and, no such
investigation, inquiry or proceedings have been threatened. Licensor will provide written notice to Licensee immediately upon becoming
aware that any of its managers, directors, officers, stockholders, agents and employees has become the subject of any such investigation,
inquiry or proceeding.
Section
6.7 Intellectual Property.
(a)
To the best of Licensor’s Knowledge, the Licensed Patent Rights have been properly filed and prosecuted and Licensor is not aware
of any Third Party patent, patent application or other Intellectual Property Rights that would be infringed (i) by practicing any process
or method or by making, using or selling any composition which is claimed or disclosed in, or which constitutes, the Licensed Patent
Rights or Licensed Technology, or (ii) by making, using, offering for sale, selling or importing Products. To the best of Licensor’s
Knowledge, Licensor is not aware of any infringement or misappropriation by a Third Party of the Licensed Patent Rights or Licensed Technology.
(b)
No proceedings (including for opposition, cancelation, revocation or rectification) are pending or, to the Knowledge of Licensor, threatened
against Licensor or its Affiliates by any Person with respect to the ownership, validity, enforceability, scope, infringement, registration
or use of the Licensed Patent Rights or Licensed Technology and all such intellectual property is subsisting, valid and enforceable and
constitutes all of the intellectual property used or held for use by Licensor necessary to Develop, manufacture, commercialize, distribute,
and sell, and otherwise commercialize and exploit Licensed Products in the Territory. The Licensed Patent Rights and Licensed Technology
have not been infringed, nor are being infringed. To the extent that any Licensed Patent Rights or Licensed Technology has been developed,
created, conceived or reduced to practice by any Third Parties, Licensor has obtained ownership of all such intellectual property. Licensor
is not obligated to pay to any Person any royalties, licensing fees, commissions or other amounts in connection with the Licensed Patent
Rights or Licensed Technology.
Section
6.8 Litigation. (a) There are no proceedings pending or, to the Knowledge of Licensor, threatened against Licensor or any
of its assets related to the Licensed Patent Rights or Licensed Technology, (b) there are no unsatisfied judgments of any kind against
Licensor or any of its assets related to the Licensed Patent Rights or Licensed Technology, and (c) Licensor is not subject to any outstanding
judgment, order, or decree of any court or Governmental Entity related to the Licensed Patent Rights or Licensed Technology.
Section
6.9 Title. Licensor has good and marketable title to all of the Transferred Materials, free and clear of all liens and encumbrances.
Section
6.10 Condition and Sufficiency of Assets.
6.10.1
The Licensed Patent Rights and Licensed Technology together with the Transferred Materials (defined in Section 8.1 below) constitute
all of the assets (including all Intellectual Property Rights), taken as a whole, as are sufficient or necessary or reasonably useful
to make, have made, use, have used, sell, offer for sale, have sold, import, have imported, Develop, have Developed, commercialize, and
have commercialized the Licensed Products.
6.10.2
Exhibit F contains a complete and accurate list of all finished product inventories of Licensed Products, together with all expiration
dates (“Finished Product”). All inventory of Finished Products comply with all applicable Laws (including cGMPs) and
quality agreements), are free from defects in material and workmanship, and meet all Finished Product specifications and certificates
of analysis. The Finished Products are not, and at the time of delivery to Licensee, the Finished Products shall not be adulterated or
misbranded within the meaning of the FDA Law, or equivalent regulations promulgated by the applicable Governmental Entity, as amended
and in effect at the time of shipment. In the event of any breach of the foregoing warranty, Licensor shall at its own cost and expense,
immediately replace any defective Finished Product with conforming Licensed Product, and in any event no later than sixty (60) days after
notice to Licensor of such defect.
ARTICLE
VII
CONFIDENTIAL INFORMATION
Section
7.1 Confidential Information. For purposes of this Agreement, “Confidential Information” means the Trade
Secrets, other Technology and other information, whether written or oral and whether merely remembered or embodied in a tangible or intangible
form, of a Party (the “Disclosing Party”), which the other Party (the “Receiving Party”) is provided
or otherwise has access to and which is marked as, or that by its nature or circumstances of disclosure should reasonably understood
to be confidential, proprietary, and/or trade secret information. The Receiving Party shall use the same standard of care in protecting
Confidential Information as it would use to protect its own Confidential Information, but shall in no event use less than a reasonable
standard of care. The Receiving Party shall not use the Disclosing Party’s Confidential Information for any purpose other than
for the performance of its obligations or exercise of its rights under this Agreement and shall not disclose the Confidential Information
to any Third Party except as permitted herein. The Receiving Party may disclose Confidential Information only to its affiliates, employees,
consultants, contractors and suppliers (“Authorized Persons”) who have a need to know, provided that such Authorized
Persons are bound by confidentiality obligations with respect to such information that are at least as stringent as those provided under
this Section. The Receiving Party shall be responsible for any breach of this Section by its Authorized Persons.
Section
7.2 Exceptions. For purposes hereof, “Confidential Information” does not include information that: (a) was rightfully
in the Receiving Party’s possession without restriction before disclosure hereunder; (b) was or becomes public knowledge through
no fault of the Receiving Party; (c) was rightfully disclosed to the Receiving Party without restriction by a third party not bound by
a confidentiality restriction; or (d) was independently developed by the Receiving Party without use of or reference to the Disclosing
Party’s Confidential Information.
Section
7.3 Legal Disclosure. Neither Party may publicly disclose the existence or terms or any other matter of fact regarding this
Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed; provided,
however, that either Party may make such a disclosure (a) to the extent required by applicable Law or by the requirements of any
nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed
or traded, or (b) to any investors, prospective investors, lenders and other potential financing sources who are obligated to keep such
information confidential. In the event that such disclosure is required as aforesaid, the disclosing Party shall provide the other Party
with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure.
Section
7.4 Equitable Relief. Each Party acknowledges that remedies at law may be inadequate to protect the other Party and his, her
or its affiliates against any actual or threatened breach of this ARTICLE VII by such party. Without limiting any other rights
or remedies available to such party, each Party will, in addition to any and all other rights and remedies that may be available to it
in respect of such breach, be entitled to obtain equitable relief from an actual or threatened violation of this ARTICLE VII,
including specific performance and temporary or permanent injunctive relief. To obtain any such equitable relief, no Party will be required
to post a bond or other security or prove actual damages.
ARTICLE
VIII
TECHNOLOGY
AND MATERIAL TRANSFER; INTELLECTUAL PROPERTY
Section
8.1 Material Transfer. As of the Effective Date, Licensor hereby irrevocably transfers and assigns to Licensee, free and clear
of all liens and encumbrances, all of its right, title and interest in and to (a) any and all Finished Product inventories; (b) the Licensed
Product IND and all Regulatory Documentation and correspondence with the FDA or other Regulatory Authority in the Territory and in the
possession or control of Licensor and its Affiliates with respect to the Licensed Products, including tracking files, meeting minutes
and strategy materials; and (c) all of Licensor’s Books and Records that embody or relate to the Licensed Products, including studies,
reports, publications, correspondence and other similar documents and records, whether in electronic form or otherwise (collectively,
the “Transferred Materials”). Promptly following the Effective Date, Licensor will deliver to Licensee (i) the Transferred
Materials and (ii) all pre-clinical and clinical data and information and other tangible Licensed Technology.
Section
8.2 Technology Transfer. Without limiting Section 8.1, in order to enable Licensee to exercise its rights in the Licensed
Patent Rights and Licensed Technology, Licensor will promptly provide to Licensee all necessary cooperation and assistance reasonably
requested by Licensee in connection with transferring any Licensed Patent Rights, Licensed Technology and the Licensed Product IND. The
foregoing may include providing Licensee access to Niraj Vasisht in order for Licensee to ask questions and causing its employees to
furnish to Licensee such information as Licensee may reasonably request from time to time. In any event, the technology transfer shall
be completed within sixty (60) days after the Effective Date hereof.
Section
8.3 Intellectual Property. Subject to the terms of this Agreement, Licensee shall be the sole and exclusive owner of (a) the
Licensed Product IND; (b) the Development IP and (c) any and all Improvements or other derivatives of the Licensed Patent Rights or Licensed
Technology, and all Patent Rights or other Intellectual Property Rights therein.
Section
8.4 Retained Rights. Subject to the other terms of this Agreement, Licensor retains the right to use the Licensed Technology
and practice the Licensed Patent Rights to Develop, have Developed, make, have made, use, have used, sell have sold, offer for sale,
import, have imported, export and have exported any product that does not contain the API. For clarity, Licensor, its Affiliates and
sublicensees shall not during the Term Develop, have Developed, make, have made, use, have used, sell have sold, offer for sale, import,
have imported, export and have exported any product containing the API.
Section
8.5 Transfer Taxes. All transfer, documentary, sales, use, stamp, registration, value added and other such taxes and fees
(including any penalties and interest) (collectively, “Transfer Taxes”) incurred in connection with the sale of the
Transferred Material under this Agreement shall be borne and paid by the Licensor.
ARTICLE
IX
INDEMNIFICATION
Section
9.1 Indemnification by Licensor. Subject to the applicable provisions of this ARTICLE IX, Licensor shall indemnify
and hold harmless Licensee and its successors, assigns and affiliates, and their respective shareholders, partners, employees, managers,
officers, directors representatives and agents (collectively, the “Licensee Indemnified Parties”) from and against
any Losses incurred by or imposed upon such Licensee Indemnified Parties, or any of them, in connection with any Third Party claims,
suits, actions, demands or judgments, including, without limitation, personal injury and product liability matters (but excluding any
patent infringement matters, which are governed by ARTICLE V above) (“Claims”), directly or indirectly arising
from or relating to:
(a)
The breach of any of the representations or warranties of Licensor contained in this Agreement.
(b)
The breach or failure to perform by Licensor of any of its respective covenants or obligations contained in this Agreement.
(c)
A claim that any manufacture, use, sale, offer for sale or importation of any Licensed Product in the Territory, or the exercise of any
rights or privileges by Licensee granted to it under this Agreement, infringes any patent or other Intellectual Property Right of any
Third Party.
Section
9.2 Indemnification by Licensee. Licensee shall indemnify and hold harmless Licensor and its successors, assigns, heirs and
affiliates, and their respective shareholders, partners, employees, managers, officers, directors, representatives and agents (collectively,
the “Licensor Indemnified Parties”) from and against any Losses incurred by or imposed upon such Licensor Indemnified
Parties, or any of them, in connection with any Claim directly or indirectly arising from or relating to a breach by Licensee of any
of its respective covenants or obligations contained in this Agreement and against any claim that any manufacture, use, sale, offer for
sale or importation of any Licensed Product in the Territory, infringes any patent or other Intellectual Property Right of any Third
Party to the extent that such claim is based on the Improvements.
Section
9.3 Indemnification Procedure. In the event that a Party (as the “Indemnified Party”) is seeking indemnification
under this ARTICLE IX from a Party (the “Indemnifying Party”), the Indemnified Party shall promptly notify
the Indemnifying Party of such claim upon the Indemnified Party receiving notice of the Claim; provided, any failure to so notify the
Indemnifying Party shall not release the Indemnifying Party of its obligation to indemnify the Indemnified Party hereunder, except to
the extent the Indemnifying Party is materially prejudiced by such failure. The Indemnified Party shall permit the Indemnifying Party
to assume direction and control of the defense of the Claim and shall reasonably cooperate as requested (at the expense of the Indemnifying
Party) in the defense of the Claim; provided, the Indemnifying Party may not settle any Claim without the prior written consent of the
Indemnified Party, which consent shall not be withheld or delayed unreasonably, unless such settlement involves only the payment of monetary
damages, contains a release in favor of the Indemnified Party, and does not admit any fault or wrongdoing on the part of the Indemnified
Party. The Indemnified Party shall have the right to participate in the defense of any Claim with counsel of its own choosing, at its
expense.
Section
9.4 Offset Rights. Licensee shall have the right to reduce any amount due and payable to Licensor by Licensee or any of its
affiliates hereunder, including with respect to any deferred payments, milestones, royalties or license fees, by any or all amounts owed
by Licensor hereunder, including as Licensor Indemnifying Party (each such amount, an “Offset Amount”), without limitation
to any of Licensee’s other rights pursuant to this Agreement or Law.
ARTICLE
X
Limitations
on liability
In
no event shall either Party’s liability to the other Party, in the aggregate, exceed $[*]; provided, however, that
the foregoing limitation shall not apply in the case of a Party’s fraud, willful misconduct or gross negligence, or a Party’s
breach of its confidentiality obligations under ARTICLE VII.
ARTICLE
XI
TERM;
TERMINATION
Section
11.1 Term. The term of this Agreement (“Term”) shall expire upon the expiration of the final payment obligation
under ARTICLE III above. Upon the expiration of the Term of this Agreement, Licensee shall have a fully paid-up, irrevocable,
freely transferable and sublicensable license in the Territory under the Licensed Patent Rights and Licensed Technology, to Develop,
have Developed, make, have made, use, have used sell, offer for sale, have sold, import, have imported, export, have exported, commercialize
or have commercialized any and all Licensed Products and to practice the Licensed Technology in the Territory.
Section
11.2 Termination.
(a)
Licensee may terminate this Agreement at any time without cause, upon thirty (30) days’ prior written notice to Licensor along
with payment of the next unpaid Development Milestone Payment (if any).
(b)
Either Party may terminate this Agreement on written notice to the other Party if the other Party materially breaches any provision of
this Agreement and fails to cure such breach within thirty (30) days after the breaching Party receives written notice thereof.
(c)
Either Party may terminate this Agreement on written notice in the event that either Party (i) becomes insolvent or admits inability
to pay its debts generally as they become due; (ii) becomes subject, voluntarily or involuntarily, to any proceeding under any domestic
or foreign bankruptcy or insolvency law, which is not fully dismissed or vacated within sixty (60) days; (iii) is dissolved or liquidated
or takes any corporate action for such purpose; (iv) makes a general assignment for the benefit of creditors; or (v) has a receiver,
trustee, custodian or similar agent appointed by order of any court of competent jurisdiction to take charge of or sell any material
portion of its property or business.
Section
11.3 Effect of Termination. On termination of this Agreement by Licensee pursuant to Section 11.2(a) or by Licensor
pursuant to Section 11.2(b), the license granted pursuant to Section 2.1 shall terminate and all rights in the Licensed
Patent Rights and Licensed Products shall revert back to Licensor. Licensee shall cooperate with and provide reasonable assistance to
Licensor, at Licensor’s expense, with respect to transfer of all Licensed Patent Rights and the Licensed Product IND to Licensor.
Section
11.4 Survival. Any provision of this Agreement which, by its express terms or nature and context, is intended to survive termination
or expiration of this Agreement, will survive any such termination or expiration, including, without limitation: ARTICLE I, ARTICLE
II, ARTICLE V, ARTICLE VII, ARTICLE IX, ARTICLE X, Section 11.3, Section 11.4 and ARTICLE
XII.
ARTICLE
XII
MISCELLANEOUS PROVISIONS
Section
12.1 Bankruptcy. All licenses granted under this Agreement are deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy
Code, licenses of right to “intellectual property” as defined in Section 101 of such Code. The Parties agree that Licensee
may fully exercise all of its rights and elections under the U.S. Bankruptcy Code, regardless of whether either Party files for bankruptcy
in the United States or other jurisdiction subject to Licensee agreeing to perform its obligations under the Agreement in case of Licensee’s
bankruptcy filing. The Parties further agree that, in the event Licensee elects to retain its rights as a licensee under such Code, Licensee
shall be entitled to complete access to any technology licensed to it hereunder and all embodiments of such technology. Such embodiments
of the technology shall be delivered to Licensee not later than the commencement of bankruptcy proceedings against Licensor, upon written
request, unless Licensor elects to perform its obligations under the Agreement.
Section
12.2 Relationship of the Parties. For the purposes of this Agreement, the Parties are operating as independent contractors,
and nothing in this Agreement will be construed as creating a partnership, franchise, joint venture, employer-employee or agency relationship.
Section
12.3 Expenses. Each Party will bear its respective expenses and legal fees incurred with respect to this Agreement, and the
transactions contemplated hereby.
Section
12.4 Equitable Remedies. In the event of any actual or threatened breach by Licensor of this Agreement, Licensee will, without
limiting its other rights or remedies available to it, be entitled to immediate injunctive and other equitable relief, without posting
bond or other security and without the necessity of showing actual monetary damages.
Section
12.5 Assignment. Neither this Agreement nor any interest hereunder is assignable in part or whole by any Party hereto without
the prior written consent of the other Party, provided, however, that Licensee may assign this Agreement to an affiliate or to a successor
by merger, consolidation or sale of all or substantially all of its assets. Subject to the foregoing, this Agreement will be binding
upon the successors and permitted assigns of the Parties. Any assignment which is not in accordance with this Section 11.5 will
be void and without effect.
Section
12.6 Governing Law; Venue. This Agreement is made in accordance with and will be governed and construed in accordance with
the laws of the State of Delaware, without regard to conflicts of laws rules. Any disputes relating to this Agreement will be brought
solely in the state or federal courts in New York, New York, and the Parties hereby expressly consent to the exclusive jurisdiction,
venue and convenience of such courts.
Section
12.7 Notices. All notices and other communications hereunder will be in writing unless otherwise noted and will be deemed
given if delivered personally, sent by facsimile transmission (only if receipt is verified by the receiving Party), sent by electronic
mail transmission (only if receipt is verified by the receiving Party), or sent by express courier service. Such notices and communications
shall be made to the addresses provided by each Party.
Section
12.8 Amendment. No amendment, modification or supplement of any provision of this Agreement will be valid or effective unless
made in writing with signatures certified by a notary public and signed by (i) a duly authorized representative of Licensee and (ii)
a duly authorized representative of Licensor.
Section
12.9 Waiver. No provision of this Agreement will be waived by any act, omission or knowledge of a Party or its agents or employees
except by an instrument in writing expressly waiving such provision and signed by the waiving Party or a duly authorized officer thereof.
Section
12.10 Severability. Whenever possible, each provision of the Agreement will be interpreted in such manner as to be effective
and valid under applicable law, but if any provision of this Agreement is held to be prohibited by or invalid under applicable law, such
provision will be ineffective only to the extent of such prohibition or invalidity, without invalidating the remainder of this Agreement.
Section
12.11 Headings/Governing Language. The section headings appearing in this Agreement are inserted only as a matter of convenience
and in no way define, limit, construe or describe the scope or intent of any such section nor in any way affect this Agreement. The governing
language for the interpretation of this Agreement will be the English language.
Section
12.12 Waiver of Jury. LICENSEE AND LICENSOR KNOWINGLY AND VOLUNTARILY WAIVE ANY AND ALL RIGHT TO A TRIAL BY JURY IN ANY ACTION
OR PROCEEDING ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT, OR THE RELATIONSHIP BETWEEN THE PARTIES HERETO.
Section
12.13 Voluntary Execution. Each Party acknowledges and agrees that such Party has carefully read all of the provisions of
this Agreement, that such Party understands and has voluntarily accepted such provisions, and that such Party will fully and faithfully
comply with such provisions.
Section
12.14 Advice of Counsel. EACH PARTY ACKNOWLEDGES THAT, IN EXECUTING THIS AGREEMENT, SUCH PARTY HAS HAD THE OPPORTUNITY TO
SEEK THE ADVICE OF INDEPENDENT LEGAL COUNSEL, AND SUCH PARTY HAS READ AND UNDERSTOOD ALL OF THE TERMS AND PROVISIONS OF THIS AGREEMENT.
THIS AGREEMENT WILL NOT BE CONSTRUED AGAINST ANY PARTY BY REASON OF THE DRAFTING OR PREPARATION HEREOF.
Section
12.15 Counterparts. This Agreement may be executed in counterparts with signatures certified by a notary public, each of which
shall be deemed an original, but all of which taken together shall constitute one and the same instrument.
Section
12.16 Entire Agreement of the Parties. This Agreement and all schedules and exhibits attached hereto constitute and contain
the complete, final and exclusive understanding and agreement of the Parties with respect to the subject matter hereof. This Agreement
cancels and supersedes any and all prior negotiations, correspondence, understandings and agreements, whether oral or written, between
the Parties respecting the subject matter thereof.
[Signature
Page Follows]
IN
WITNESS WHEREOF, the Parties have duly executed this Agreement as of the Effective Date.
LICENSOR: |
|
LICENSEE: |
AVIOR
BIO, LLC |
|
THARIMMUNE,
INC. |
|
|
|
By: |
/s/
Niraj Vasisht |
|
By: |
/s/
Randy Milby |
Name: |
Niraj
Vasisht |
|
Name: |
Randy
Milby |
Title: |
President
and Chairman of the Board |
|
Title: |
CEO |
Exhibit
A
Licensed
Patent Rights
METHOD
AND DEVICE OF TREATING CHRONIC KIDNEY
DISEASE-ASSOCIATED PRURITUS |
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[*] |
|
[*] |
[*] |
|
[*] |
|
[*] |
[*] |
|
[*] |
|
[*] |
[*] |
|
[*] |
|
[*]
|
PHARMACEUTICAL
ACTIVE-CONTAINING FILM
DELIVERY DEVICE FOR ORAL TRANSMUCOSAL ADMINISTRATION |
Country |
|
Application
No. /
Patent No. |
|
Filing
Date |
[*] |
|
[*] |
|
[*] |
[*] |
|
[*] |
|
[*] |
Licensor
may extend to Licensee a limited license, for use solely with the Licensed Products, process-related Patent Rights not listed in this
Exhibit A that are reasonably necessary for the Development, manufacture, use, or sale of the Licensed Products.
Exhibit
B
Licensor
Wire Instructions
Avior
Inc.
221
James Jackson Avenue
Cary,
NC 27513
c/o
[*]
[*][*][*]
Routing
Number:
Paper
and Electronic: [*]
Wire:
[*]
Account:
[*]
Exhibit
C
Development
Milestone Payments
Upon
the completion of each applicable event set forth below (each, a “Development Milestone Event”, and together, the
“Development Milestone Events”), Licensee shall pay to Licensor the payment amount and in the manner as set forth
opposite each such Development Milestone Event (each, a “Development Milestone Payment”, and together, the “Development
Milestone Payments”).
|
|
Development
Milestone Event |
|
Development
Milestone Payment |
|
|
|
|
|
1.
|
|
[*]
|
|
$[*],
in the form of cash or in the form of unregistered common stock of Licensee (valued using a 30-day VWAP of Licensee’s common
stock traded on Nasdaq beginning on the date the milestone is publicly announced). For the avoidance of doubt, Licensor will have
10 days to elect whether to accept the payment in cash or stock. Notwithstanding the foregoing, if Licensee undergoes a Change in
Control, any payment owed pursuant to this Development Milestone Event will be made in cash and not in stock. |
|
|
|
|
|
2.
|
|
[*] |
|
$[*],
in the form of cash or in the form of unregistered common stock of Licensee (valued using a 30-day VWAP of Licensee’s common
stock traded on Nasdaq beginning on the date the milestone is publicly announced). For the avoidance of doubt, Licensor will have
10 days to elect whether to accept the payment in cash or stock. Notwithstanding the foregoing, if Licensee undergoes a Change in
Control, any payment owed pursuant to this Development Milestone Event will be made in cash and not in stock. |
|
|
Development
Milestone Event |
|
Development
Milestone Payment |
|
|
|
|
|
3.
|
|
[*] |
|
$[*],
in the form of cash or in the form of unregistered common stock of Licensee (valued using a 30-day VWAP of Licensee’s common
stock traded on Nasdaq beginning on the date the milestone is publicly announced). For the avoidance of doubt, Licensor will have
10 days to elect whether to accept the payment in cash or stock. Notwithstanding the foregoing, if Licensee undergoes a Change in
Control, any payment owed pursuant to this Development Milestone Event will be made in cash and not in stock. |
|
|
|
|
|
4.
|
|
[*] |
|
$[*]
* |
|
|
|
|
|
5.
|
|
[*] |
|
$[*]
* |
|
|
|
|
|
6.
|
|
[*]
|
|
$[*]
per indication, for up to two indications* |
|
|
|
|
|
7.
|
|
[*] |
|
$[*]
* |
For
purposes for this Exhibit C, the term below shall have the following meaning:
“Change
in Control” shall mean (a) any consolidation or merger of Licensee with or into any other corporation or entity, or any other
corporate reorganization or similar transaction, in which the holders of outstanding voting securities of Licensee immediately prior
to such consolidation, merger, reorganization or similar transaction hold, directly or indirectly, less than fifty percent (50%) of the
outstanding voting securities of Licensee or of the surviving or resulting entity (or the power to direct or cause the direction of the
management and policies of the surviving or resulting entity) immediately after such consolidation, merger, reorganization or similar
transaction; or (b) any transaction or series of related transactions as a result of which the holders of outstanding voting securities
of Licensee immediately prior to such transaction or transactions hold, directly or indirectly, less than fifty percent (50%) of the
outstanding voting securities of Licensee (or the power to direct or cause the direction of the management and policies of Licensee)
immediately after such transaction or transactions.
If,
at any time, Licensee reasonably believes that a particular development milestone will not be met, Licensee shall provide Licensor with
notice of such belief, and Licensee and Licensor shall work together to update the development milestone deadlines as mutually acceptable
to both parties (the “Development Milestone Extension”). For avoidance of doubt, if the Parties cannot in good faith
come to a mutually acceptable extension date, the original milestone date shall remain in place.
*
In the event of a Development Milestone Extension of Development Milestones 1, 2, or 3, or failure of Licensee to meet the milestone
deadline, Licensee shall pay to Licensor [*] % of the Development Milestone Payment within five (5) Business Days of the date of such
original milestone, which shall offset future Development Milestone Payments for that milestone (if any). In the event of a Development
Milestone Extension of Development Milestones 4, 5, 6 or 7, or failure of Licensee to meet the milestone deadline, Licensee shall pay
to Licensor [*]% of the Development Milestone Payment within five (5) Business Days of the date of such original milestone, which shall
offset future Development Milestone Payments for that milestone (if any).
Exhibit
D
Sales
Milestone Payments
Upon
the completion of each event set forth below (each, a “Sales Milestone Event”, and together, the “Sales Milestone
Events”), Licensee shall pay to Licensor the payment amount set forth opposite such Sales Milestone Event.
Sales
Milestone Event |
|
Payment |
Annual
worldwide Net Sales greater than $[*] in any calendar year |
|
$[*] |
Annual
worldwide Net Sales greater than $[*] in any calendar year |
|
$[*] |
Annual
worldwide Net Sales greater than $[*] in any calendar year |
|
$[*] |
Annual
worldwide Net Sales greater than $[*] in any calendar year |
|
$[*] |
For
the avoidance of doubt, the Payments set forth above shall only be earned and paid in the first year in which the Sales Milestone Event
is achieved. For illustrative purposes only, if Annual worldwide Net Sales are $[*] in 2024, Licensee shall pay to Licensor $[*] . If
Annual worldwide Net Sales are $[*] in 2025, Licensor shall not be entitled to an additional $[*] . If, however, Annual worldwide Net
Sales are $[*] in 2025, Licensee shall pay to Licensor $[*].
Exhibit
E
Royalties
Licensee
shall pay to Licensor, at the end of each calendar year during the Royalty Term, the following Royalties based on the Net Sales of Licensee
in such calendar year:
Net
Sales |
|
Royalty
Rate |
Annual
worldwide Net Sales is less than or equal to $[*] |
|
[*]
% of the Net Sales |
Annual
worldwide Net Sales is between $[*] and $[*] |
|
[*]
% of the Net Sales |
Annual
worldwide Net Sales is between $[*] and $[*] |
|
[*]
% of the Net Sales |
Annual
worldwide Net Sales is greater than $[*] |
|
[*]
% of the Net Sales |
“Royalty
Term” shall mean the period starting on the date hereof and ending, on a country-by-country basis, on the date which the last
Valid Claim of an issued patent included in the Licensed Patent Rights covering AV104 expires in such country.
Notwithstanding
the foregoing, upon the introduction of a generic agent of AV-104 to the marketplace, Licensee shall pay to Licensor [*]% of all Net
Sales of AV-104 in lieu of the Royalties set forth above for a period of seven (7) years from the date of first introduction of such
generic agent to the marketplace. If no generic is approved or brought to market, Licensor will continue to receive above (full) royalty
payments for the Royalty Term.
|
● |
One
Royalty. Only one royalty, calculated at the highest applicable royalty rate under this Exhibit E, shall be payable to Licensor
hereunder for each sale of AV104. |
|
|
|
|
● |
Reports.
Each royalty payment shall be accompanied by a report specifying: Net Sales in each country’s currency; the royalties payable,
including an accounting of deductions taken in the calculation of Net Sales; if any proceeds on Net Sales were received in currencies
other than United States Dollars, the applicable exchange rate to convert from each country’s currency to United States Dollars;
and the royalties payable in United States Dollars. |
|
|
|
|
● |
Anti-Stacking.
In the event that in any royalty period, Licensee or any Affiliate or Licensee, in order to exploit AV104 in any country, actually
makes royalty payments to one or more Third Parties (“Third Party Payments”) as consideration for a license to
an issued patent or patents, in the absence of which AV104 could not legally be used or sold in such country, then Licensee shall
have the right to reduce the royalties otherwise due to Licensor for AV104 in such country by [*] ([*] %) of such Third Party Payments.
Notwithstanding the foregoing, such reductions shall in no event reduce such royalty for AV104 in any such country to less than [*]
([*]%) of the rates otherwise specified above. |
|
● |
Combination
Products. In the event that AV104 under this Agreement is sold in combination with another active ingredient or component having
independent therapeutic effect or diagnostic utility, then “Net Sales,” for purposes of determining royalty payments
on the combination, shall be calculated using one of the following methods: |
|
○ |
By
multiplying the Net Sales of the combination by the fraction A/A+B, where A is the gross selling price, during the royalty paying
period in question, of AV104 sold separately, and B is the gross selling price, during the royalty period in question, of the other
active ingredients or components sold separately; or |
|
|
|
|
○ |
In
the event that no such separate sales are made of AV104 or any of the active ingredients or components in such combination package
during the royalty paying period in question, Net Sales, for the purposes of determining royalty payments shall be calculated using
the above formula where A is the reasonably estimated commercial value of AV104 sold separately and B is the reasonably estimated
commercial value of the other active ingredients or components sold separately. Any such estimates shall be determined using criteria
to be mutually agreed upon by the parties. Such estimates shall be reported to Licensee with the reports to be provided with any
royalties. |
Exhibit
F
Finished
Product Inventories
The
follow AV104 materials are considered as part of Avior inventory.
POTENTIAL
CLINICAL SUPPLIES FOR AV104-105 (US IND) *
PRODUCT:
AV104 [*] MG FILM, PH [*]
BATCH:
[*]
LOT:
[*]
DOM:
[*]
QUANTITY:
[*] FILMS
POTENTIAL
CLINICAL SUPPLIES FOR AV104-104 ([*]) *
PRODUCT:
AV104 [*] MG FILM, PH [*]
BATCH:
[*]
LOT:
[*]
DOM:
[*]
QUANTITY:
[*] FILMS
PRODUCT:
AV104 [*] MG FILM, PH [*]
BATCH:
[*]
LOT:
[*]
DOM:
[*]
QUANTITY:
[*] FILMS
PRODUCT:
AV104 [*] MG FILM, PH [*]
BATCH:
[*]
LOT:
[*]
DOM:
[*]
QUANTITY:
[*]FILMS
CRT
STABILITY LOTS:
STRENGTH
|
|
BATCH
|
|
LOT
|
|
DOM |
|
QUANTITIES |
[*]
MG FILMS, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG FILMS, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG FILMS, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG FILMS, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG FILMS, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
R&D
LOTS:
STRENGTH
|
|
BATCH
|
|
LOT
|
|
DOM |
|
APPROX.
QNTY |
[*]
MG, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
[*]
MG, PH [*] |
|
[*] |
|
[*] |
|
[*] |
|
[*] |
AV104-106
RETAINS:
PRODUCT:
AV104 [*] MG FILM, PH [*]
BATCH:
[*]
LOT:
[*]
DOM:
[*]
QUANTITY:
[*] FILMS
*SUBJECT
TO RETEST MEETING SPECIFICATIONS
Exhibit
99.1
Tharimmune
Executes Exclusive Global Licensing Agreement for Innovative Clinical Stage Asset for Chronic Pruritis
Expects
completion and topline data of a Phase 2 clinical trial in chronic pruritis over approximately 12 months after aligning with FDA on trial
design
Seeking
first approval in an orphan disease, PBC, for the treatment of chronic pruritis in which more than 70% of patients suffer from debilitating
symptoms
BRIDGEWATER,
N.J., November 6, 2023 (GLOBE NEWSWIRE) –Tharimmune, Inc. (Nasdaq: THAR) (“Tharimmune” or the “Company”),
a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic conditions
announces the execution of an exclusive worldwide licensing agreement with Avior Inc. d/b/a Avior Bio, LLC (“Avior”) to develop,
market and commercialize a clinical-stage asset, AV104 (to be renamed TH104 and hereinafter referred to as TH104). TH104 has a dual mechanism
of action affecting receptors known to suppress chronic, debilitating pruritis or “uncontrollable itching”. The Company intends
to first seek approval in an orphan disease for the treatment of moderate-to-severe cholestatic pruritis in patients with primary biliary
cholangitis (“PBC”), an orphan liver disease with no known cure in which more than 70% of patients suffer from debilitating
symptoms.
TH104
is embedded with the active pharmaceutical ingredient onto a proprietary transdermal buccal film which easily adheres to the inside of
the mouth. This endows TH104 with key features making it an ideal product candidate for multiple liver-related and other pruritogenic
inflammatory conditions. The active molecule has a dual mechanism of action affecting both the µ -opioid receptor and the kappa
opioid receptor as well as inhibiting IL-17 inflammatory cytokine expression. These opioid receptors when stimulated and/or inhibited
by the body’s natural ligands have been known to be involved in the body’s itch circuitry.
When
the itch circuitry is imbalanced in diseased conditions, pharmacological intervention can help suppress this phenomenon which occurs
in patients suffering from chronic pruritis. TH104’s active compound crosses into the circulation via a proprietary buccal delivery
by adhering the drug-coated film inside the cheek, biodegrading in minutes and allowing the active compound to be absorbed. Buccal delivery
bypasses the liver’s first-pass metabolism creating higher drug concentrations in the skin, an added benefit for treating conditions
such as PBC in which the liver is impaired. Tharimmune expects to complete a phase 1 pharmacokinetic trial and a phase 2 proof-of-concept
efficacy study in PBC patients suffering from chronic pruritis over approximately 12 months after aligning with FDA on trial design.
Tharimmune
believes TH104 may also be used for treating chronic pruritogenic conditions associated with cholestatic liver disease as well as other
liver-related and non liver-related conditions including fatty and alcoholic diseases, non-alcoholic liver diseases and certain types
of hepatitis. Chronic pruritis is significant in liver diseases as well as chronic kidney diseases, hemodialysis as well as atopic dermatitis.
“The
past year has been a period of transformational change for our company,” said Randy Milby, CEO of Tharimmune. “This license
agreement allows the company to bring a clinical-stage asset into the organization as we shift into a business model focused on clinical
development signifying our next step as we grow into a patient-focused biotechnology organization.”
About
Tharimmune, Inc.
Tharimmune,
Inc. is a clinical-stage biotechnology company developing a portfolio of therapeutic candidates for rare, inflammatory, and oncologic
diseases. The Company has acquired an exclusive worldwide license for a clinical-stage asset, known to suppress chronic, debilitating
pruritis or “uncontrollable itching” in PBC, a rare and orphan liver disease with no known cure. The Company’s early-stage
immuno-oncology pipeline includes novel multi-specific antibodies targeting unique epitopes with novel mechanisms of action against well-known,
validated targets in multiple solid tumors. Tharimmune has a license agreement with OmniAb, Inc. to access the company’s antibody
discovery technology platform against specified targets. For more information please visit: www.tharimmune.com.
Forward
Looking Statements
Certain
statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All
statements, other than statements of historical facts, contained in this press release, including statements regarding Tharimmune’s
strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking
statements. The words “anticipate,” “believe,” “continue,” “could,” “depends,”
“estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,”
“predict,” “project,” “target,” “should,” “will,” “would,” and
similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying
words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and
you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans,
intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are
not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K/A for the year ended December 31, 2022
and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking
statements included in this press release represent the Company’s views as of the date of this release. Subsequent events and developments
may cause the Company’s views to change; however, the Company does not undertake and specifically disclaims any obligation to update
or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of
unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing
the Company’s views as of any date subsequent to the date of this release.
Investor
Relations Contact
ir@tharimmune.com
www.tharimmune.com
v3.23.3
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Tharimmune (NASDAQ:THAR)
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부터 5월(5) 2024 으로 6월(6) 2024
Tharimmune (NASDAQ:THAR)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024