Form 8-K
8-K — Ainos, Inc.
Accession: 0001493152-26-044454
Filed: 2026-09-28
Period: 2026-09-24
CIK: 0001014763
SIC: 3577 (COMPUTER PERIPHERAL EQUIPMENT, NEC)
Item: Entry into a Material Definitive Agreement
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — form8-k.htm (Primary)
EX-10.1 (ex10-1.htm)
EX-99.1 (ex99-1.htm)
XML — IDEA: XBRL DOCUMENT (R1.htm)
8-K
8-K (Primary)
Filename: form8-k.htm · Sequence: 1
false
0001014763
0001014763
2026-09-24
2026-09-24
0001014763
AIMD:CommonStockParValue0.01PerShareMember
2026-09-24
2026-09-24
0001014763
AIMD:WarrantsToPurchaseCommonStockMember
2026-09-24
2026-09-24
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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): September 24, 2026
AINOS,
INC.
(Exact
name of registrant as specified in its charter)
Texas
001-41461
75-1974352
(State
or other Jurisdiction
of
Incorporation)
(Commission
File
Number)
(IRS
Employer
Identification
No.)
3050
Post Oak Blvd, Suite 510-T80, Houston, TX 77056
(281)
898-6586
(Address
and telephone number, including area code, of registrant’s principal executive offices)
(Former
name or former address if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐
Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant
to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications
pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading
Symbol(s)
Name
of each exchange on which registered
Common Stock, par value
$0.01 per share
AIMD
The Nasdaq Stock Market
LLC
Warrants to purchase Common
Stock
AIMDW
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
September 24, 2026 (the “Effective Date”), Ainos, Inc. (the “Company”) entered into a Global Exclusive License
Agreement (the “License Agreement”) with BioPhoenix Co., Ltd., a company organized under the laws of the Republic of China
(Taiwan) (“BioPhoenix”). The License Agreement covers the Company’s VELDONA® low-dose oral interferon alpha technology
platform.
Under
the License Agreement, the Company granted BioPhoenix an exclusive, worldwide, irrevocable, transferable and sublicensable license under
certain of the Company’s intellectual property and related assets. The license allows BioPhoenix to research, develop, manufacture,
have manufactured, use, import, export, offer for sale, sell, commercialize and otherwise exploit VELDONA® for Sjögren’s
Disease and Thrombocytopenia (the “Licensed Indications”). The licensed territory covers all countries and territories worldwide.
During the term and for 10 years after it ends, the Company may not compete with the Licensed Indications anywhere in the world. The
Company also granted BioPhoenix a right of first refusal and a call option to license certain additional VELDONA® indications that
have progressed to Phase 2 clinical trials. BioPhoenix further has an option to license other non-licensed VELDONA® indications under
separate written agreements.
In
consideration for the license, BioPhoenix will pay the Company an upfront license fee of $600,000. The upfront fee is due after BioPhoenix
receives the complete data package and written confirmation that technology transfer is complete. BioPhoenix will also pay the Company
a one-time fee when it grants its first sublicense to a third party. If BioPhoenix licenses all of the additional VELDONA® indications
available under the License Agreement, the total license fees payable to the Company, including the upfront license fee and the first
sublicense fee, would be approximately $10.0 million. In addition, the Company will receive twenty-five percent (25%) of BioPhoenix’s
net sublicensing revenue for the Licensed Indications.
The
License Agreement continues on an indication-by-indication and country-by-country basis until the later of (a) the expiration of the
last-to-expire patent covering the applicable Licensed Indication or (b) 20 years after the Effective Date, unless terminated earlier.
Either party may terminate the License Agreement for the other party’s uncured material breach or insolvency. The License Agreement
contains customary representations, warranties, covenants, indemnification obligations and confidentiality provisions.
The
foregoing description of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the full
text of the License Agreement, a copy of which is filed with this current report on Form 8-K as Exhibit 10.1 and is hereby incorporated
herein by reference.
Item
7.01 Regulation FD Disclosure
On
September 28, 2026, the Company announced the execution of the License Agreement with BioPhoenix. A copy of the press release issued
by the Company in this connection is furnished herewith as Exhibit 99.1.
The
information furnished with this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended,
or the Exchange Act.
Item
9.01 Financial Statement and Exhibits
(d)
Exhibits.
Exhibit No.
Description
10.1#+
Global Exclusive License Agreement, dated September 24, 2026, by and between Ainos, Inc. and BioPhoenix Co., Ltd.
99.1
Press Release dated September 28, 2026, issued by the Ainos, Inc.
104
Cover Page Interactive
Data File (embedded within the Inline XBRL document).
#
Annexes, schedules and/or exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The registrant hereby undertakes to
furnish on a supplemental basis a copy of any omitted schedules and similar attachments to the Securities and Exchange Commission upon
request.
+
Certain portions of this Exhibit were redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company hereby agrees to furnish
a copy of any omitted portion to the Securities and Exchange Commission upon request.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
Ainos, Inc.
Date: September 28, 2026
By:
/s/ Chun-Hsien
Tsai
Name:
Chun-Hsien Tsai
Title:
Chief Executive Officer
EX-10.1
EX-10.1
Filename: ex10-1.htm · Sequence: 2
Exhibit 10.1
PURSUANT
TO ITEM 601(b)(10)(iv) OF REGULATION S-K, CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS NOT MATERIAL
AND IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
GLOBAL
EXCLUSIVE LICENSE AGREEMENT — VELDONA®
LICENSE
AGREEMENT
BY
AND BETWEEN
AINOS,
INC.
AS
“LICENSOR”
AND
BIOPHOENIX
CO., LTD.
AS
“LICENSEE”
Effective
Date: the date of the last signature below
Page 1 of 50
LICENSE
AGREEMENT
This
License Agreement (this “Agreement”) is entered into on the date of the last signature below (the “Effective
Date”), by and between Ainos, Inc. (“Licensor”), a corporation organized under the laws of the State of Texas,
United States, with its principal place of business at 3050 Post Oak Boulevard., Suite 510-T80, Houston, TX, 77056 U.S.A. and BioPhoenix
Co., Ltd. (“Licensee”), a company organized under the laws of the Republic of China (Taiwan), with its registered address
at 3F, No. 23, Chung Shan North Road, Section 2, Taipei, Taiwan 104404, R.O.C.
(Licensor
and Licensee each a “Party” and collectively the “Parties”)
This
Agreement grants Licensee an effective, unconditional, worldwide exclusive license under the Licensed IP and Licensed Assets for the
Licensed Indications, subject to the terms and conditions set forth herein.
RECITALS
(A) WHEREAS,
Licensor owns or controls the VELDONA® (Low-Dose Oral Interferon Alpha)
technology platform and related patents, patent applications, trademarks, trade secrets,
Know-How, manufacturing technology, formulations, clinical data, Regulatory Data, and other
Intellectual Property; and
(B) WHEREAS,
Licensor desires to grant, and Licensee desires to receive, a global, exclusive, sublicensable
license under the Licensed IP and Licensed Assets to research, develop, manufacture, commercialize,
and otherwise exploit VELDONA® for Sjögren’s Disease and Thrombocytopenia
throughout the Territory.
NOW,
THEREFORE, in consideration of the mutual covenants, agreements, representations, and warranties contained herein, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE
I
DEFINITIONS
As
used in this Agreement, the following terms shall have the meanings set forth below:
“Affiliate”
means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by, or is under common control
with that Person. “Control” means ownership of fifty percent (50%) or more of the voting securities or equivalent ownership
interest, or the power to direct management and policies.
Page 2 of 50
“Applicable
Law” means all Laws, regulations, rules, guidelines, orders, permits, and binding requirements applicable to a Party or to
the Licensed IP, Licensed Assets, Licensed Indications, or the activities contemplated by this Agreement.
“BPC-Developed
Indication” means any indication for VELDONA® or any derivative product thereof that is discovered, identified,
or developed by or for Licensee, its Affiliates, or its sublicensees after the Effective Date, where: (a) Licensor did not initiate,
fund, or conduct (whether independently or through a Third Party) clinical trials or regulatory activities directed to such indication
before the date of Licensee’s discovery or identification thereof; and (b) the discovery, development, or advancement of such indication
is funded and conducted solely by or for Licensee, its Affiliates, or its sublicensees. For the avoidance of doubt, (i) an indication
does not cease to be a BPC-Developed Indication merely because Licensee used Derivative IP, Licensed IP, or Licensed Assets in connection
with its discovery or development; and (ii) all Intellectual Property, data, regulatory materials, clinical results, and other rights
generated by or for Licensee in connection with any BPC-Developed Indication (collectively, “BPC-Developed Indication IP”)
shall be solely and exclusively owned by Licensee and shall not constitute Jointly Owned IP under Section 7.5.
“Background
IP” means any Intellectual Property that: (a) was owned or controlled by a Party before the Effective Date; or (b) is developed
or acquired by a Party after the Effective Date independently and without use of the other Party’s Confidential Information, Licensed
IP, Licensed Assets, Complete Data Package, or Trial Results. Background IP includes each Party’s pre-existing patents, patent
applications, trade secrets, Know-How, proprietary methods, and other Intellectual Property that does not constitute Derivative IP or
Jointly Owned IP.
“Business
Day” means any day other than a Saturday, Sunday, or day on which banks are authorized or required to be closed in Taipei,
Taiwan as well as in Houston, Texas.
“Change
of Control” means, with respect to a Party, a merger, consolidation, reorganization, sale of substantially all assets, or other
transaction resulting in a Person or group obtaining direct or indirect control of that Party. For the avoidance of doubt, capital increases,
equity financings, reorganizations, or corporate governance matters undertaken by Licensor in the ordinary course of its business (including
private placements, public offerings, stock splits, or changes to Licensor’s board composition) shall not constitute a Change of
Control unless they result in a Person or group obtaining control of Licensor as described in this definition.
“Complete
Data Package” means the complete set of clinical trial data for Sjögren’s Disease and Thrombocytopenia, CMC data,
regulatory filings and correspondence, patent and trademark documents, Know-How, manufacturing and formulation records, and other technical
materials listed in Schedule 7.
“Confidential
Information” has the meaning set forth in Article XV.
“Control”
means the possession, whether by ownership, license, or other lawful means, of the ability to grant the rights and licenses provided
under this Agreement without violating any Third Party agreement.
Page 3 of 50
“Derivative
IP” means any invention, improvement, modification, formulation, process, data set, regulatory material, work product, or other
Intellectual Property generated from or using the Licensed IP, Licensed Assets, Complete Data Package, or Trial Results after the Effective
Date.
“Effective
Date” means the date on which the last Party executes this Agreement.
“Encumbrance”
means any lien, pledge, mortgage, security interest, charge, claim, restriction, option, or other third-party right that would restrict
Licensor’s ability to grant the Licensed Rights.
“Force
Majeure Event” means an event beyond a Party’s reasonable control, including natural disaster, epidemic, war, terrorism,
civil unrest, governmental action, embargo, labor disruption, utility failure, or failure of transportation or communications systems.
“First
Sublicense Fee” means the one-time fee of USD [***] payable by Licensee to Licensor under Article III, Section 3.5 upon the
grant of the first sublicense to any Third Party under this Agreement. For the avoidance of doubt, the First Sublicense Fee is payable
only once, upon the very first sublicense under this Agreement, and subsequent sublicenses (whether to additional Third Parties or for
additional Licensed Indications) do not trigger any additional First Sublicense Fee.
“Governmental
Authority” means any government, ministry, agency, court, regulatory body, administrative authority, or other governmental
entity in any jurisdiction.
“Intellectual
Property” means patents, patent applications, trademarks, trade names, service marks, copyrights, trade secrets, Know-How,
inventions, data rights, regulatory rights, and other intellectual property rights recognized in any jurisdiction.
“Know-How”
means all non-public technical information, trade secrets, data, formulations, manufacturing processes, methods, techniques, specifications,
quality-control information, and other proprietary information relating to VELDONA® or the Licensed Indications.
“License
Fee” means the aggregate fee payable under Article III, Section 3.1.
“Licensed
Assets” means the clinical data, Regulatory Data, regulatory filings, regulatory approvals, CMC materials, formulations, manufacturing
materials, technical documents, and other tangible or intangible assets listed in Schedules 1 through 4 and Schedule 7.
“Licensed
Indications” means Sjögren’s Disease and Thrombocytopenia.
“Licensed
IP” means all Intellectual Property owned or controlled by Licensor that is necessary or useful to research, develop, manufacture,
commercialize, or sublicense VELDONA® for the Licensed Indications, including the patents, patent applications, trademarks,
Know-How, Regulatory Data, clinical data, and related rights listed in Schedules 1 through 4.
Page 4 of 50
“Licensed
Rights” means the exclusive, worldwide, sublicensable rights granted under Article II to research, develop, manufacture, have
manufactured, use, import, export, offer for sale, sell, commercialize, and otherwise exploit the Licensed IP and Licensed Assets for
the Licensed Indications, including, without limitation, the right to manufacture and have manufactured VELDONA® and any products
derived therefrom.
“Licensor”
means Ainos, Inc., together with any Affiliate through which Licensor controls any Licensed IP or Licensed Assets.
“Non-Licensed
Indications” means indications other than the Licensed Indications, including the ROFR Indications until Licensee exercises
the Right of First Refusal.
“Net
Sub-licensing Revenue” means all consideration received by Licensee from a Third Party for a sublicense or similar grant covering
a Licensed Indication, less documented Taxes, accounting fees, legal fees, and other reasonable, directly attributable costs permitted
under Schedule 8.
“Person”
means any individual, corporation, partnership, limited liability company, joint venture, association, trust, governmental authority,
or other entity.
“Regulatory
Authority” means any Governmental Authority responsible for issuing, maintaining, or enforcing regulatory approvals, licenses,
registrations, or standards relating to pharmaceutical research, development, manufacture, or commercialization.
“Regulatory
Data” means all clinical, preclinical, CMC, safety, pharmacovigilance, regulatory, and submission data, filings, correspondence,
approvals, and reports relating to VELDONA® or the Licensed Indications.
“Representatives”
means a Party’s and its Affiliates’ directors, officers, employees, agents, advisors, consultants, accountants, attorneys,
and other representatives.
“ROFR
Indications” means the remaining VELDONA® indications identified in Schedule 5 that have progressed to Phase
2 clinical trials and are subject to the Right of First Refusal under Article IV.
“Sjögren’s
Disease” means the Sjögren’s Disease indication covered by the VELDONA® development and commercialization
programs, including any sub-indication agreed by the Parties in writing.
“Tax”
or “Taxes” means all taxes, duties, levies, imposts, assessments, withholdings, and governmental charges of any kind,
including related penalties, interest, and additions.
“Technology
Transfer” means Licensor’s transfer, disclosure, and explanation of the Complete Data Package and related technical materials
to Licensee under Article VI.
“Territory”
means all countries and territories worldwide.
“Third
Party” means any Person other than the Parties and their respective Affiliates.
“Thrombocytopenia”
means the thrombocytopenia indication covered by the VELDONA® development and commercialization programs, including any
sub-indication agreed by the Parties in writing.
Page 5 of 50
“Trial
Results” means all data, results, reports, analyses, regulatory submissions, documents, inventions, Derivative IP, and other
materials generated from or arising out of any trial of any Licensed Indications, ROFR indications or Non-Licensed Indications.
“VELDONA®”
means the low-dose oral interferon alpha product and technology platform, including its formulations, dosage forms, improvements, line
extensions and trademarks.
Other
terms used but not defined in this Article I shall have the meanings ascribed to them elsewhere in this Agreement.
ARTICLE
II
GRANT
OF LICENSE
Section
2.1 License Grant.
Subject
to the terms of this Agreement, Licensor hereby grants to Licensee, and Licensee accepts, an exclusive, worldwide, irrevocable, transferable,
sublicensable license under the Licensed IP and Licensed Assets to research, develop, manufacture, have manufactured, use, import, export,
offer for sale, sell, commercialize, and otherwise exploit VELDONA® for the Licensed Indications. For the avoidance of
doubt, the license grant under this Section 2.1 includes the right to manufacture and have manufactured VELDONA® and any products
derived therefrom, which manufacturing rights are included in the License Fee payable under Section 3.1. The license is exclusive as
to Licensor and its Affiliates and is effective and unconditional upon execution of this Agreement.
Section
2.2 Scope of Licensed Rights.
The
Licensed Rights include the following, to the extent controlled by Licensor:
(a) all
Patents and patent applications relating to VELDONA® or the Licensed Indications,
including the items listed in Schedule 1;
(b) all
trademarks, service marks, trade names, and branding rights relating to VELDONA®
or the Licensed Indications, including Schedule 2;
(c) all
clinical, preclinical, CMC, safety, pharmacovigilance, and other technical data, including
all data from Sjögren’s Disease and Thrombocytopenia studies;
(d) all
Know-How, trade secrets, manufacturing technology, formulations, processes, specifications,
quality systems, and technical information listed in Schedule 4;
(e) all
rights to manufacture and have manufactured VELDONA® and any products derived therefrom
for the Licensed Indications, which manufacturing rights are included in the License Fee;
(f) all
Regulatory Data, regulatory filings, regulatory approvals, correspondence, briefing documents,
IND materials, and other submissions listed in Schedule 3;
(g) all
rights to make, have made, use, sell, offer for sale, import, export, distribute, commercialize,
and sublicense products or services for the Licensed Indications;
Page 6 of 50
(h) all
rights to create, use, register, prosecute, maintain, enforce, and otherwise exploit Derivative
IP arising from the Licensed Rights, subject to the joint ownership provisions of Section
7.5 with respect to Jointly Owned IP, as further set forth in Article VII (Intellectual Property
Ownership); and
(i) all
other rights reasonably necessary or useful to exercise the foregoing rights for the Licensed
Indications throughout the Territory.
Section
2.3 Exclusivity.
During
the Term, Licensor shall not, and shall cause its Affiliates not to, directly or indirectly grant any right to, license, sublicense,
research, develop, manufacture, commercialize, or otherwise exploit the Licensed IP or Licensed Assets for any Licensed Indication in
the Territory other than through Licensee or Licensee’s permitted sublicensees.
Section
2.4 Sub-licensing Rights.
Licensee
may grant sublicenses, through multiple tiers, under any portion of the Licensed Rights to Affiliates and Third Parties without Licensor’s
prior consent; provided, however, that Licensee shall provide Licensor with prior written notice regarding the terms and conditions of
such sublicense before granting any sublicense. The content of any sublicense (including any sublicense agreement) shall not reduce or
diminish the interests of either Party under this Agreement. Licensee shall ensure that each sublicense is consistent with the scope
of this Agreement, confidentiality obligations, audit rights, and applicable compliance requirements.
(a) Licensee
remains responsible for its sublicensees’ material compliance with this Agreement,
but no sublicense shall impose any obligation on Licensor beyond the obligations expressly
stated herein.
(b) All
sublicense consideration received by Licensee is subject to the revenue-sharing provisions
of Article V, and Licensee shall retain the remaining portion for its own account.
Section
2.5 Retained Rights of Licensor.
Licensor
retains all rights not expressly granted under this Agreement, but only with respect to Non-Licensed Indications (excluding ROFR Indications,
which remain subject to Article IV) and only to the extent that Licensor’s exercise of those rights does not use the Licensed Rights
to compete with, substitute for, or materially impair the Licensed Indications or Licensee’s exclusive rights.
Licensor
may conduct research and development for Non-Licensed Indications (other than ROFR Indications), subject to Section 11.3, and may discuss
or grant rights for such Non-Licensed Indications; provided, however, that (a) no such activity is directed to, or competes with, substitutes
for, or materially impairs a Licensed Indication or Licensee’s exclusive rights therein, (b) with respect to ROFR Indications,
Licensor shall comply with the notice and exercise procedures of Article IV before granting any Third Party rights, and (c) Licensor
shall not use Licensed IP, Licensed Assets, Trial Results, or Confidential Information in connection with any Non-Licensed Indication
activity except as expressly permitted under a separate written agreement with Licensee.
Page 7 of 50
No
license, sublicense, or other right is granted by implication, estoppel, or otherwise except as expressly set forth in this Agreement.
Nothing in this Section 2.5 shall be construed to limit Licensee’s rights under Article IV or to permit Licensor to circumvent
the Right of First Refusal. The provisions of Section 7.6 (No Implied Licenses) apply.
(a) For
clarity, the Licensed Rights include all rights necessary to enable Licensee and its sublicensees
to research, develop, manufacture, commercialize, and sublicense products for the Licensed
Indications throughout the Territory, including full manufacturing rights.
(b) Licensor
shall not reserve or exercise any right that would materially frustrate Licensee’s
exercise of the Licensed Rights.
(c) The
Parties shall cooperate in good faith to correct any Schedule omission that would materially
impair Licensee’s exercise of the Licensed Rights.
(d) Any
correction under this Section shall be documented in writing and shall not reduce the scope
of the Licensed Rights.
(e) The
Parties acknowledge that the license grant in this Article is the principal subject matter
of this Agreement.
Section
2.6 Ownership.
Ownership
of the Licensed IP, Licensed Assets, Derivative IP is governed by Article VII (Intellectual Property Ownership). Except as expressly
provided in Article VII, Licensor retains ownership of the Licensed IP and Licensed Assets, subject to the exclusive Licensed Rights
granted to Licensee during the Term.
Section
2.7 BPC-Developed Indications.
Licensee
shall have the sole and exclusive right, without any obligation to Licensor, to research, develop, manufacture, commercialize, sublicense,
and otherwise exploit any BPC-Developed Indication.
No
BPC-Developed Indication shall be treated as, or deemed to be, a Licensed Indication, Non-Licensed Indication, or ROFR Indication under
this Agreement. The Right of First Refusal under Article IV does not apply to any BPC-Developed Indication, and Licensor shall not be
entitled to notice, an opportunity to make an offer, or any other right under Article IV with respect to any BPC-Developed Indication.
For
clarity, any Intellectual Property, data, regulatory materials, clinical results, inventions, improvements, processes, formulations,
and other rights (including any Derivative IP) created, generated, discovered, or developed solely by or for Licensee in connection with
a BPC-Developed Indication (collectively, “BPC-Developed Indication IP”) shall be solely and exclusively owned by Licensee
from creation, free and clear of any claim or interest by Licensor. BPC-Developed Indication IP shall not constitute Jointly Owned IP
under Section 7.5, and Section 7.5 shall not apply to any BPC-Developed Indication IP regardless of whether such IP was derived from
or generated using the Licensed IP, Licensed Assets, Complete Data Package, or Trial Results.
Page 8 of 50
Licensor
shall not include any BPC-Developed Indication in Schedule 5 or otherwise represent to any Third Party that a BPC-Developed Indication
or any BPC-Developed Indication IP is subject to Article IV, Section 7.5, or any other provision of this Agreement that would limit Licensee’s
sole ownership or exploitation rights. If a dispute arises as to whether an indication is a BPC-Developed Indication or whether Intellectual
Property constitutes BPC-Developed Indication IP, the Parties shall first attempt to resolve the matter under Section 13.1 (Senior Management
Negotiation).
This
Section 2.7 shall survive termination or expiration of this Agreement and shall not be affected by any exercise of the BPC Buy-Out Option
under Section 13.3 or any other provision of this Agreement. Licensee’s sole ownership of BPC-Developed Indication IP is absolute
and irrevocable and shall not be affected by any termination or expiration of this Agreement.
ARTICLE
III
LICENSE
FEE AND PAYMENT
Section
3.1 License Fee and Payment.
As
consideration for the Licensed Rights (including, without limitation, the manufacturing rights for the Licensed Indications), Licensee
shall pay Licensor a license fee of USD 600,000 (the “License Fee”) as set forth in this Article III. For the avoidance
of doubt, the License Fee includes full consideration for all rights to manufacture and have manufactured VELDONA® and any products
derived therefrom. The License Fee is payable in USD by wire transfer to an account designated by Licensor. Licensee shall pay Licensor
the License Fee within 15 Business Days after Licensee’s receipt of the Complete Data Package and written confirmation that the
Technology Transfer has been completed in accordance with Article VI and Schedule 7.
Completion
of the Technology Transfer and Licensee’s receipt of the Complete Data Package are conditions precedent to Licensee’s obligation
to pay the License Fee. Licensee may request supplementation under Section 6.2, and the License Fee shall not become due until both the
clinical data and Regulatory Data have been received by Licensee in complete form in all material respects.
Section
3.2 Non-Licensed Indications Licensing Option.
(a) The
Parties acknowledge that Licensee reserves the right to obtain a license for one or more
Non-Licensed Indications listed in Schedule 5 at any time during the Term, subject to this
Section 3.2 and Article IV.
(b) The
licensing fee for each individual Non-Licensed Indication listed in Schedule 5 shall be USD
[***] per indication (the “Indication License Fee”). The Indication License
Fee for each such indication shall be payable by Licensee to Licensor within 15 Business
Days after execution of a separate written licensing agreement between the Parties setting
forth the terms and conditions for licensing such indication.
Page 9 of 50
(c) Notwithstanding
the foregoing, the aggregate Indication License Fees payable by Licensee for the remaining
15 Non-Licensed Indications acquired under this Section 3.2 shall be USD [***] (the “Aggregate
Indication Cap”), unless otherwise agreed by the Parties in writing. Once Licensee
has paid Indication License Fees totaling the Aggregate Indication Cap, Licensee shall have
no further payment obligation for any additional Non-Licensed Indications acquired thereafter,
unless the Parties agree otherwise in writing.
(d) The
Parties agree to engage in good faith discussions regarding Licensee’s potential acquisition
of Non-Licensed Indications; provided, however, that nothing in this Section 3.2 shall constitute
a binding obligation on either Party to enter into any such license until a separate written
licensing agreement has been duly executed by both Parties. Licensor’s obligations
under Article IV (Right of First Refusal) shall remain in full force and effect with respect
to ROFR Indications.
Section
3.3 Currency, Taxes, and Payment Mechanics.
(a) All
payments under this Agreement shall be made in USD by wire transfer of immediately available
funds, without set-off or deduction except as required by Applicable Law.
(b) If
Licensee is required by Applicable Law to withhold or deduct any Taxes or other amounts from
any payment due to Licensor under this Agreement, Licensee shall increase the payment by
such additional amount (the “Gross-Up Amount”) as is necessary to ensure
that Licensor receives a net amount equal to the full amount it would have received had no
such withholding or deduction been imposed. Licensee shall remit the withheld or deducted
amount to the appropriate Governmental Authority and promptly furnish Licensor with official
receipts, certificates, or other evidence of such remittance.
(c) The
gross-up obligation under Section 3.3(b) applies to all forms of payment and consideration
payable by Licensee to Licensor under this Agreement, including the License Fee, Indication
License Fees, the First Sublicense Fee, the Sub-licensing Revenue Share under Article V,
and any other amounts due under this Agreement or any ancillary agreement.
(d) Licensor
shall cooperate in good faith with Licensee’s reasonable requests to provide documentation,
forms, or certifications (including IRS Form W-8BEN-E or any successor form) required to
claim treaty benefits, establish Licensor’s eligibility for exemptions, or reduce the
rate of withholding. Licensor shall notify Licensee promptly of any change in circumstances
that may affect the applicability of any treaty benefit or exemption.
Page 10 of 50
Section
3.4 No Additional Economics.
(a) Except
for the License Fee, the First Sublicense Fee under Section 3.5, and the Sub-licensing Revenue
Share under Article V, no additional upfront payment, royalty, or other consideration is
payable for the Licensed Rights unless agreed in a later written amendment signed by both
Parties. For the avoidance of doubt, (i) the License Fee includes full consideration for
all manufacturing rights relating to the Licensed Indications; (ii) the License Fee, the
First Sublicense Fee, and the Sub-licensing Revenue Share are each separate and independent
payment obligations that are independently owed and payable; and (iii) payment of one does
not satisfy, reduce, offset, or include any portion of another.
(b) Each
Party shall bear its own bank charges and internal costs relating to payments, except that
Licensor shall bear charges imposed by its receiving bank.
Section
3.5 First Sublicense Fee.
Upon
the grant of the first sublicense by Licensee to any Third Party under this Agreement (regardless of the Licensed Indication covered
by such sublicense), Licensee shall pay Licensor a one-time fee of USD [***] (the “First Sublicense Fee”). The First
Sublicense Fee shall be payable within 30 days after the effective date of such first sublicense, in USD by wire transfer of immediately
available funds to an account designated by Licensor.
For
the avoidance of doubt, the First Sublicense Fee is a one-time payment obligation that shall be triggered only once under this Agreement,
upon the grant of the very first sublicense to any Third Party. Subsequent sublicenses to additional Third Parties (whether for the same
Licensed Indication or different Licensed Indications) shall not trigger any additional First Sublicense Fee. Once the First Sublicense
Fee has been paid, no further First Sublicense Fee shall be due regardless of the number of sublicenses granted by Licensee or the Licensed
Indications covered thereby.
The
First Sublicense Fee is a separate and independent payment obligation from the Sub-licensing Revenue Share under Article V. Payment of
the First Sublicense Fee does not satisfy, reduce, offset, or include any portion of the Sub-licensing Revenue Share, and payment of
the Sub-licensing Revenue Share does not satisfy, reduce, offset, or include any portion of the First Sublicense Fee. For the avoidance
of doubt, the First Sublicense Fee is not included in Gross Consideration or Net Sub-licensing Revenue for purposes of calculating the
Sub-licensing Revenue Share.
ARTICLE
IV
RIGHT
OF FIRST REFUSAL
Section
4.1 ROFR Indications.
Licensor
shall provide Licensee a right of first refusal with respect to each ROFR Indication listed in Schedule 5. The ROFR Indications are presently
expected to comprise VELDONA® indications that have progressed to Phase 2 clinical trials.
Page 11 of 50
Section
4.2 Third-Party Offer Notice.
(a) If
Licensor receives a bona fide written offer from a Third Party to license, sublicense, or
otherwise commercialize a ROFR Indication, Licensor shall promptly give Licensee written
notice before accepting or entering into that offer.
(b) The
notice shall identify the ROFR Indication and include the material economic, territorial,
development, commercialization, exclusivity, term, and other terms of the bona fide Third
Party offer, together with a copy of the offer if available.
Section
4.3 Exercise Period and Price.
(a) Licensee
shall have 30 days after receipt of the notice to exercise the ROFR by written notice to
Licensor. The exercise price shall be the higher of (i) USD [***] per ROFR Indication or
(ii) the price set forth in the bona fide Third Party offer. If the Third Party offer includes
material non-price terms that are more favorable to Licensor than the terms of this Agreement,
the Parties shall negotiate in good faith to agree on comparable terms for the exercised
ROFR; provided, however, that Licensee’s failure to agree to any specific non-price
term shall not invalidate a timely exercise of the ROFR if Licensee pays the exercise price
determined under this Section 4.3(a).
(b) If
Licensee exercises the ROFR, the Parties shall negotiate and execute definitive license documents
for that ROFR Indication within 30 days, and Licensor shall not grant the ROFR Indication
to the Third Party during that period.
Section
4.4 Waiver and Third-Party Transaction.
(a) If
Licensee does not exercise the ROFR within the 30 day period, the ROFR shall be deemed waived
for that offer only, and Licensor may proceed with the Third Party.
(b) Licensor
shall not complete the Third Party transaction on terms more favorable to the Third Party
than those offered to Licensee. Any materially more favorable transaction shall be re-submitted
to Licensee under this Article IV.
Section
4.5 Scope and Non-Interference.
The
ROFR applies only to ROFR Indications and does not limit Licensee’s exclusive rights in the Licensed Indications, Licensee’s
sublicensing rights, or Licensor’s retained rights in Non-Licensed Indications.
Section
4.6 Information and Updates.
(a) Licensor
shall provide Licensee with reasonable updates regarding the development status of ROFR Indications
and shall update Schedule 5 in writing when a ROFR Indication is identified, materially reclassified,
or removed from the contemplated Phase 2 portfolio.
Page 12 of 50
(b) No
failure to update Schedule 5 shall expand the ROFR to an indication that is not a ROFR Indication,
but Licensor shall not intentionally omit an indication to avoid this Article IV. For the
avoidance of doubt, no BPC-Developed Indication (as defined in Article I) shall be included
in Schedule 5 or subject to this Article IV.
(c) The
Parties shall cooperate in good faith to document an exercised ROFR on terms consistent with
this Article IV and the Licensee’s existing rights under this Agreement.
Section
4.7 Assignability.
The
ROFR is personal to Licensee and its Affiliates and may be exercised by Licensee or an Affiliate designated in the exercise notice, subject
to Section 16.5.
Section
4.8 Licensee Call Option.
(a) In
addition to the Right of First Refusal under Sections 4.1 through 4.4, Licensee shall have
the right, exercisable at any time during the Term, to elect by written notice to Licensor
to acquire an exclusive license for any ROFR Indication then listed in Schedule 5, without
any requirement for a Third Party offer or other triggering event (the “Call Option”).
(b) The
exercise price for the Call Option shall be USD [***] per ROFR Indication. Payment shall
be due within thirty (30) days after Licensee’s exercise notice, unless the Parties
agree otherwise in writing.
(c) Upon
Licensee’s valid exercise of the Call Option and payment of the exercise price, the
Parties shall negotiate and execute definitive license documents for the applicable ROFR
Indication within sixty (60) days. The definitive license shall grant Licensee rights substantially
equivalent to the Licensed Rights, adapted as necessary for the applicable ROFR Indication.
(d) Licensee’s
exercise of the Call Option shall not affect or limit Licensee’s Right of First Refusal
under Sections 4.1 through 4.4 with respect to any other ROFR Indication. Licensee may exercise
the Call Option and the Right of First Refusal independently and in any sequence.
(e) Licensor
shall not, during the pendency of a Call Option exercise notice and until definitive license
documents are executed or the Parties agree to terminate the exercise process, grant any
Third Party rights in the applicable ROFR Indication.
Section
4.9 Survival.
The
rights and obligations under this Article IV survive any amendment or termination of this Agreement to the extent a Third Party offer
was notified before the effective date of that amendment or termination.
Page 13 of 50
ARTICLE
V
SUB-LICENSING
REVENUE SHARE
Section
5.1 Revenue Share.
If
Licensee or any Affiliate or sublicensee receives consideration from a Third Party for a sublicense or similar grant covering a Licensed
Indication, Licensee shall calculate Net Sub-licensing Revenue in accordance with this Article V and Schedule 8.
Net
Sub-licensing Revenue shall be shared seventy-five percent (75%) to Licensee and twenty-five percent (25%) to Licensor (the “Sub-licensing
Revenue Share”). For clarity, Licensee shall retain its 75% share and pay Licensor its 25% share in accordance with Section
5.3. The Sub-licensing Revenue Share is a separate and independent payment obligation from the First Sublicense Fee under Section 3.5.
Payment of the First Sublicense Fee does not satisfy, reduce, offset, or include any portion of the Sub-licensing Revenue Share, and
payment of the Sub-licensing Revenue Share does not satisfy, reduce, offset, or include any portion of the First Sublicense Fee. Both
payment obligations are independently owed and payable in full when due under their respective provisions. In addition to the Sub-licensing
Revenue Share stipulated under this Section 5.1, Licensor shall be entitled to the First Sublicensing Fee, subject to and in accordance
with Section 3.5.
Included
consideration includes upfront fees, option fees, milestone payments, royalties, minimum guarantees, equity or non-cash consideration
valued at fair market value, and other amounts received in connection with the sublicense (“Gross Consideration”).
Permitted
deductions are limited to documented Taxes, accounting fees, legal fees, and other reasonable, directly attributable costs incurred in
negotiating, administering, collecting, or enforcing the applicable sublicense, as further described in Schedule 8.
Section
5.2 Semi-Annual Reports.
(a) Within
15 days after the end of each half year, Licensee shall produce a written report in accordance
with the reporting schedule prescribed by the competent Regulatory Authorities having jurisdiction
over Licensee (including, without limitation, the Taiwan Financial Supervisory Commission
and the Taipei Exchange for OTC-listed companies). Each report shall show, for each sublicense
covering a Licensed Indication: (i) the consideration received during the applicable reporting
period; (ii) the permitted deductions; (iii) the resulting Net Sub-licensing Revenue; and
(iv) the amount payable to Licensor.
(b) Each
report shall additionally include: (i) reasonable supporting detail and copies or summaries
of applicable Third Party statements, invoices, and payment records, subject to redaction
of unrelated confidential information; and (ii) a summary of material developments relating
to the Licensed IP and Derivative IP during the applicable reporting period, including the
status of any patent prosecution, maintenance, or enforcement activities, material regulatory
filings or approvals, and the creation or registration of any new Derivative IP.
Page 14 of 50
Section
5.3 Payment.
(a) Licensee
shall pay Licensor the 25% share within 30 days after delivery of the applicable semi-annual
report, in USD or, for non-cash consideration, in the form received or at the agreed fair
market value.
(b) No
payment is due until Licensee or its applicable Affiliate has actually received the relevant
consideration from the Third Party, and any later refund, credit, or reversal shall be reflected
in the next semi-annual report.
Section
5.4 Records and Audit Rights.
(a) Licensee
shall maintain complete and accurate books and records supporting the revenue-share calculations
for at least 5 years after the applicable report.
(b) Licensor
may, at its expense and on at least 30 days’ notice, appoint an independent accountant
bound by confidentiality to audit the relevant records no more than once in any calendar
year, except following a material discrepancy.
(c) If
an audit identifies an underpayment of more than 5% for the audited period, Licensee shall
promptly pay the shortfall, reimburse reasonable audit costs, and correct the affected reports.
Section
5.5 Excluded Revenue.
The
revenue share does not apply to Licensee’s or its Affiliates’ direct sales, direct commercialization, internal transfers,
grants, research funding, or consideration relating solely to Non-Licensed Indications, unless the applicable agreement expressly covers
a Licensed Indication.
The
revenue share does not apply to any ROFR Indication unless and until Licensee exercises the ROFR and the Parties execute definitive license
documents for that indication.
Section
5.6 Taxes and Currency.
Payments
under this Article V shall be made in USD. The gross-up provisions of Section 3.3(b) through Section 3.3(d) apply to all payments under
this Article V. Licensee shall provide reasonable evidence of any tax remittance and shall cooperate with Licensor to claim applicable
treaty benefits or exemptions.
Section
5.7 Continuing Effect.
(a) Accrued
revenue-share payment and reporting obligations survive termination or expiration of this
Agreement for all consideration received before termination and for any payment received
under a sublicense entered into before termination, until fully reported and paid.
(b) The
Parties shall cooperate in good faith to resolve any calculation dispute, but Licensee shall
pay all undisputed amounts when due.
(c) Any
adjustment resulting from a calculation dispute shall be reflected in the next semi-annual
report or paid within 30 days after resolution.
Page 15 of 50
(d) Nothing
in this Article V grants Licensor any right to approve or control Licensee’s sublicense
terms, except as expressly stated in this Agreement.
(e) Licensee
shall use commercially reasonable efforts to ensure that sublicense agreements contain sufficient
reporting and payment provisions to enable Licensee to comply with this Article V.
Section
5.8 General Provisions.
Licensor
shall keep all sublicense information confidential in accordance with Article XV and shall use it only to administer this Article V and
exercise its audit rights.
The
Parties shall update Schedule 8 by written agreement if the reporting methodology changes materially.
(a) No
amendment to Schedule 8 may reduce Licensor’s 25% share without Licensor’s express
written consent.
(b) For
purposes of this Article V, a sublicense includes any license, option, covenant, collaboration,
distribution, or other arrangement that grants a Third Party rights substantially equivalent
to a sublicense for a Licensed Indication.
(c) The
Parties acknowledge that this Article V is a revenue-sharing arrangement and does not create
a partnership, joint venture, or agency relationship.
Section
5.9 Additional Terms.
Any
sublicensee’s failure to pay Licensee does not relieve Licensee of its reporting obligations, but Licensee is not required to pay
Licensor amounts it has not actually received.
If
a sublicense is terminated, any final payment, refund, or settlement relating to that sublicense shall be included in the next semi-annual
report.
(a) Licensee
shall notify Licensor of any material sublicense termination that materially affects the
revenue share.
(b) All
calculations under this Article V shall be made consistently from a half year to a half year
using the methodology in Schedule 8.
(c) Licensee
shall promptly correct any known error in a semi-annual report and shall notify Licensor
of the correction.
(d) The
obligations in this Article V are in addition to, and do not limit, Licensor’s audit
and information rights under Article XVII.
In
the event of a conflict between this Article V and Schedule 8, this Article V controls unless the Parties expressly agree otherwise in
writing.
Section
5.10 Post-Commercialization Royalty Negotiation.
If
Licensee or any sublicensee grants a sublicense under Section 2.4 for any Licensed Indication and the sublicensed product is subsequently
commercialized and generates royalties from sales to end users or other Third Parties (“Post-Commercialization Royalties”),
the Parties shall negotiate in good faith to reach a mutually acceptable agreement regarding the allocation and sharing of such Post-Commercialization
Royalties. Such negotiation shall take into account the nature of the sublicense, the respective contributions of each Party to the development
and commercialization of the sublicensed product, and prevailing industry practices.
Page 16 of 50
Section
5.11 Installment Payments.
If
Licensee receives Gross Consideration from a sublicensee in two or more installments under the applicable sublicense agreement, Licensee
shall pay Licensor the corresponding Sub-licensing Revenue Share in the same number of installments, with each installment to Licensor
calculated as Licensor’s 25% share of the Net Sub-licensing Revenue attributable to the installment received by Licensee from the
sublicensee. Each such installment payment to Licensor shall be due within 30 days after Licensee’s actual receipt of the corresponding
installment from the sublicensee.
If
the sublicense agreement provides for irregular installments (i.e., installments of unequal amounts or at irregular intervals), Licensee
shall calculate and pay Licensor’s share of each installment on a pro rata basis in proportion to the amount of that installment
relative to the total Gross Consideration payable under the sublicense agreement. For the avoidance of doubt, Section 5.3(b) applies
to installment payments, and no payment is due to Licensor with respect to any installment until Licensee has actually received such
installment from the sublicensee.
ARTICLE
VI
TECHNOLOGY
TRANSFER AND ONGOING SUPPORT
Section
6.1 Technology Transfer.
Licensor
shall complete the Technology Transfer and make the Complete Data Package available to Licensee within 30 days after the Effective Date,
through secure electronic delivery and, where reasonably requested, physical delivery of original or certified records.
The
Complete Data Package shall include all clinical trial data for Sjögren’s Disease and Thrombocytopenia, CMC and manufacturing
data, INDs and other regulatory filings, briefing documents, regulatory correspondence, patent and trademark documents, Know-How, formulations,
specifications, quality records, and other technical documents identified in Schedule 7.
Licensor
shall provide a completed deliverables index and reasonable explanations necessary for Licensee to use and evaluate the Complete Data
Package.
Section
6.2 Review and Supplementation.
Licensee
shall have 30 days after receipt of the Complete Data Package to review it for completeness against Schedule 7 and notify Licensor of
any material omission or deficiency.
Licensor
shall promptly supplement or correct any incomplete or deficient item identified by Licensee. If Licensor fails to supplement or correct
any materially incomplete or deficient item within 15 Business Days after receiving Licensee’s written notice specifying the deficiency
in reasonable detail, such failure shall constitute a material breach of this Agreement.
Page 17 of 50
Section
6.3 Reserved.
Section
6.4 Ongoing Technical Consultation.
For
5 years after the Effective Date, or until the milestone agreed by the Parties in writing, Licensor shall provide reasonable technical
consultation and support relating to Phase 3 planning, regulatory submissions to the FDA, TFDA, and other Regulatory Authorities, CMC
and manufacturing matters, and reasonable technical inquiries concerning the Licensed Indications.
Support
shall include up to 8 hours per month at no additional charge. Additional support shall be provided at USD [***] per hour, or another
rate agreed in writing, and shall be requested and approved through the designated contacts.
Licensor
shall respond to routine technical inquiries within 3 Business Days and to urgent regulatory or safety inquiries within 1 Business Day,
subject to reasonable availability of the designated personnel.
Licensor
shall designate key personnel for the support period. Licensor shall not replace any designated key person with a person lacking substantially
equivalent qualifications without prior notice to Licensee and reasonable consultation.
Section
6.5 Derivative IP.
Ownership
of Derivative IP generated in connection with the Technology Transfer or ongoing support is governed by Section 7.2 (Derivative IP Ownership)
and Section 7.5 (Joint Ownership of Certain Derived IP) of Article VII. Licensor shall protect Licensee’s Confidential Information
received during the Technology Transfer and ongoing support in accordance with Article XV and shall use it only to perform its obligations
under this Agreement.
ARTICLE
VII
INTELLECTUAL
PROPERTY OWNERSHIP
Section
7.1 Pre-Existing Intellectual Property.
(a) Licensor
is and shall remain the owner of the Licensed IP and Licensed Assets, subject to the exclusive
Licensed Rights granted to Licensee under this Agreement.
(b) Licensee
acknowledges that, except for the Derivative IP expressly owned by Licensee under this Article
VII and Licensee’s interest in Jointly Owned IP under Section 7.5, it acquires no ownership
interest in the Licensed IP or Licensed Assets.
(c) Nothing
in this Agreement shall be construed as an assignment or transfer of ownership of the Licensed
IP or Licensed Assets from Licensor to Licensee.
Page 18 of 50
Section
7.2 Derivative IP Ownership.
(a) Except
for Jointly Owned IP (as defined in Section 7.5) and BPC-Developed Indication IP (as defined
in Section 2.7), all Derivative IP generated by or for Licensee in connection with the Licensed
Rights, Complete Data Package, Technology Transfer, or ongoing support shall be owned exclusively
by Licensee from creation. For the avoidance of doubt, (i) Jointly Owned IP shall be owned
jointly by Licensor and Licensee in accordance with Section 7.5; and (ii) BPC-Developed Indication
IP shall be solely and exclusively owned by Licensee in accordance with Section 2.7 and shall
not be subject to joint ownership under Section 7.5.
(b) To
the extent any Derivative IP (other than Jointly Owned IP) does not vest automatically in
Licensee under Applicable Law, Licensor hereby assigns and agrees to assign all right, title,
and interest in such Derivative IP to Licensee. With respect to Jointly Owned IP, each Party
shall execute such documents as may be reasonably requested by the other Party to evidence,
perfect, or register the joint ownership contemplated by Section 7.5.
(c) Licensor
shall promptly disclose to Licensee any Derivative IP of which it becomes aware and shall
execute such documents and take such actions as Licensee may reasonably request to evidence,
perfect, maintain, or enforce Licensee’s ownership of Derivative IP (other than Jointly
Owned IP) and the joint ownership of Jointly Owned IP.
(d) Licensor
shall ensure that its employees, contractors, and agents assign or are deemed to have assigned
all Derivative IP (other than Jointly Owned IP) to Licensee, and shall include appropriate
assignment provisions in its agreements with such persons. With respect to Jointly Owned
IP, Licensor shall ensure that its employees, contractors, and agents assign their interests
to Licensor and Licensee jointly in accordance with Section 7.5.
Section
7.3 Work Made for Hire.
To
the extent permitted by Applicable Law, all Derivative IP (other than Jointly Owned IP) created by or for Licensee shall be deemed “work
made for hire” for Licensee. To the extent any such work is not deemed a work made for hire under Applicable Law, Licensor hereby
irrevocably assigns and agrees to assign to Licensee all right, title, and interest therein. This Section 7.3 does not apply to Jointly
Owned IP, which shall be owned jointly by Licensor and Licensee in accordance with Section 7.5.
Section
7.4 Further Assurances for IP Ownership.
(a) Each
Party shall execute and deliver such documents and take such actions as the other Party may
reasonably request to evidence, perfect, maintain, register, record, or enforce the ownership
and other intellectual property rights contemplated by this Article VII.
Page 19 of 50
(b) Licensor
hereby appoints Licensee as its attorney-in-fact, with full power of substitution, to execute
and deliver any document and to take any action that Licensor is obligated to take under
this Section 7.4 solely with respect to the Licensed Indications, if Licensor fails to do
so within 15 days after Licensee’s written request. This power of attorney is coupled
with an interest and is irrevocable.
Section
7.5 Joint Ownership of Certain Derived IP.
(a) Notwithstanding
Section 7.2, but subject always to Section 2.7 (BPC-Developed Indications), any Intellectual
Property that is (i) developed by or for Licensee after the Effective Date, (ii) derived
from or generated using the Licensed IP, Licensed Assets, Complete Data Package, or Trial
Results transferred by Licensor to Licensee under this Agreement, (iii) not Background IP
of either Party, and (iv) not BPC-Developed Indication IP (such Intellectual Property, “Jointly
Owned IP”), shall be owned jointly by Licensor and Licensee in equal, undivided
shares (50% each). For the avoidance of doubt, BPC-Developed Indication IP (as defined in
Section 2.7) shall be solely and exclusively owned by Licensee and shall not constitute Jointly
Owned IP regardless of whether such IP was derived from or generated using the Licensed IP,
Licensed Assets, Complete Data Package, or Trial Results.
(b) For
the avoidance of doubt, Background IP shall not be subject to joint ownership under this
Section 7.5, and each Party shall retain sole ownership of its respective Background IP.
Nothing in this Section 7.5 shall be construed to transfer, assign, or grant any ownership
interest in a Party’s Background IP to the other Party.
(c) Licensee
shall have the right, without the consent of Licensor and without any obligation to account
to or compensate Licensor (other than pursuant to Article V), to use, practice, license,
sublicense, commercialize, and otherwise exploit all Jointly Owned IP for any purpose relating
to the Licensed Indications throughout the Territory. Such right includes the right to grant
sublicenses through multiple tiers, consistent with Section 2.4, and to create derivative
works from the Jointly Owned IP for the Licensed Indications.
(d) Neither
Party may assign, transfer, encumber, or grant an exclusive license to a Third Party with
respect to its share of the Jointly Owned IP without the prior written consent of the other
Party, which consent shall not be unreasonably withheld, conditioned, or delayed. Each Party
shall promptly notify the other Party of any invention, improvement, or other Intellectual
Property that may constitute Jointly Owned IP and shall cooperate in good faith to document
and, if applicable, register or protect such Jointly Owned IP.
Section
7.6 No Implied Licenses.
No
license, sublicense, or other right is granted by implication, estoppel, or otherwise except as expressly set forth in this Agreement.
All rights not expressly granted are reserved to the granting Party.
Page 20 of 50
Section
7.7 IP Ownership Representations.
(a) Licensor
represents and warrants that it is the lawful owner or controller of the Licensed IP and
Licensed Assets and has the unrestricted right to grant the Licensed Rights to Licensee and
its permitted sublicensees.
(b) Licensor
represents and warrants that no undisclosed lien, license, covenant, security interest, option,
or other third-party right limits the grant or exercise of the Licensed Rights.
(c) The
representations in this Section 7.7 are in addition to, and do not limit, the representations
and warranties in Article IX.
Section
7.8 Survival of IP Ownership.
Licensee’s
ownership of Derivative IP (other than Jointly Owned IP) under this Article VII is absolute and irrevocable, and shall not be affected
by any termination or expiration of this Agreement. The Parties’ joint ownership of Jointly Owned IP under Section 7.5 is likewise
absolute and irrevocable, and shall not be affected by any termination or expiration of this Agreement. Licensee’s sole ownership
of BPC-Developed Indication IP under Section 2.7 is absolute and irrevocable, and shall not be affected by any termination or expiration
of this Agreement. Termination or expiration shall not require either Party to assign, transfer, return, or destroy any Derivative IP,
Jointly Owned IP, or BPC-Developed Indication IP in which it holds an ownership interest.
ARTICLE
VIII
CONDITIONS
PRECEDENT
Section
8.1 Conditions to Effectiveness.
This
Agreement becomes effective on the Effective Date, subject to satisfaction or written waiver of the conditions set forth in this Article
VIII. The license grant in Article II shall become effective and unconditional upon mutual execution of this Agreement by both Parties,
provided that the payment obligations in Article III are conditioned as set forth in Section 8.2.
Section
8.2 Conditions Precedent to License Fee.
The
License Fee is conditioned on satisfaction of each of the following, any of which (other than clause (iii)) may be waived by Licensee
in its sole discretion by written notice to Licensor: (i) completion of the Technology Transfer in accordance with Sections 6.1 and 6.2;
(ii) Licensee’s receipt of the materially complete Complete Data Package as described in Schedule 7; (iii) satisfaction of the
mutual conditions precedent set forth in Section 8.3; and (iv) satisfaction of the additional conditions to Licensee’s obligations
set forth in Section 8.4, including delivery of good standing certificates, execution of regulatory and patent recordation instruments,
and absence of a Material Adverse Effect.
Page 21 of 50
Section
8.3 Mutual Conditions Precedent.
Each
Party’s performance obligations under this Agreement are subject to the following conditions:
(a) the
representations and warranties of the other Party set forth in Article IX (for Licensor)
or Article X (for Licensee) shall be true and correct in all material respects as of the
Effective Date;
(b) the
other Party shall have obtained all corporate authorizations and board approvals required
to execute and perform this Agreement;
(c) no
Governmental Authority shall have enacted, issued, promulgated, enforced, or entered any
order, injunction, or judgment that would prohibit or materially impair the consummation
of the transactions contemplated by this Agreement; and,
(d) the
other Party shall have delivered all documents and executed all ancillary agreements required
to be delivered or executed on or before the Effective Date.
Section
8.4 Additional Conditions to Licensee’s Obligations.
Licensee’s
obligation to pay the License Fee is further subject to the following conditions, each of which may be waived, in whole or in part, by
Licensee in its sole discretion by written notice to Licensor:
(a) Licensor
shall have delivered to Licensee certificates of good standing or equivalent documentation
for Licensor in its jurisdiction of organization;
(b) Licensor
shall have executed and delivered such regulatory documents, patent recordation instruments,
or trademark assignments as reasonably requested by Licensee to evidence or protect the Licensed
Rights with respect to the Licensed Indications; and,
(c) no
Material Adverse Effect shall have occurred with respect to the Licensed IP or Licensed Assets
between the Effective Date and the date on which the applicable payment is due.
Section
8.5 Satisfaction and Waiver of Conditions.
(a) A
condition precedent set forth in this Article VIII may be waived only by a written instrument
signed by the Party entitled to the benefit of such condition. No waiver shall be effective
unless it expressly refers to this Article VIII and the specific condition being waived.
(b) Waiver
of any condition shall not operate as a waiver of any other condition, and no waiver shall
constitute a continuing waiver unless expressly stated. No course of dealing or delay in
exercising any right under this Article VIII shall operate as a waiver thereof.
(c) Each
Party shall use commercially reasonable efforts to cause the conditions set forth in this
Article VIII to be satisfied promptly after the Effective Date and shall keep the other Party
reasonably informed of progress toward satisfaction.
Page 22 of 50
Section
8.6 Consequences of Non-Satisfaction.
(a) If
any condition precedent in Section 8.2, Section 8.3, or Section 8.4 is not satisfied or waived
within 60 days after the Effective Date (or such longer period as the Parties may agree in
writing), the Party entitled to the benefit of such condition may, by written notice to the
other Party:
(i)
extend the period for satisfaction of such condition by a further period specified in the notice; (ii) waive such condition in writing
and proceed with the affected transaction; or (iii) if the non-satisfaction results from the other Party’s breach or failure to
perform, terminate this Agreement (in whole or with respect to the affected obligation) upon written notice, without prejudice to any
claim for damages or other remedies available under Article XII or Applicable Law.
(c) Termination
under this Section 8.6 shall not affect: (i) accrued rights and obligations arising before
the effective termination date; (ii) obligations that by their nature survive termination,
including confidentiality, indemnification, and dispute resolution; or (iii) Licensee’s
ownership of any Trial Results, Derivative IP (other than Jointly Owned IP), or BPC-Developed
Indication IP, and the Parties’ joint ownership of Jointly Owned IP, under Article
VII (Intellectual Property Ownership) and Section 2.7 (BPC-Developed Indications).
Section
8.7 Further Assurances.
Each
Party shall execute documents and take actions reasonably necessary to implement the Licensed Rights, evidence the satisfaction of conditions,
maintain regulatory continuity, and complete the Technology Transfer. Neither Party shall be required to take any action that would convert
this Agreement into an ownership transfer or materially alter the allocation of rights and obligations set forth herein.
ARTICLE
IX
REPRESENTATIONS
AND WARRANTIES OF LICENSOR
Licensor
represents and warrants to Licensee as of the Effective Date and throughout the Term, except where a representation expressly speaks
as of another date, as follows:
Section
9.1 Organization and Good Standing.
Licensor
is duly organized, validly existing, and in good standing under the laws of its jurisdiction of organization and has the corporate power
and authority to own or control the Licensed IP and Licensed Assets and perform this Agreement.
Section
9.2 Authority and Enforceability.
Licensor
has full corporate power and authority to execute, deliver, and perform this Agreement. All required corporate approvals have been obtained,
and this Agreement is a legal, valid, and binding obligation of Licensor, enforceable subject to applicable insolvency laws and equitable
principles.
Page 23 of 50
Section
9.3 No Conflicts.
The
execution, delivery, and performance of this Agreement by Licensor do not and will not:
(a) violate
or conflict with Licensor’s organizational documents;
(b) violate
any Applicable Law applicable to Licensor, the Licensed IP, or the Licensed Assets;
(c) breach
or result in a default under any agreement binding on Licensor or the Licensed IP; or
(d) create
or permit any Encumbrance or third-party right that would restrict or impair the Licensed
Rights.
Section
9.4 Ownership and Right to Grant.
The
representations and warranties in Section 7.7 (IP Ownership Representations) of Article VII are incorporated by reference. In addition,
Licensor represents and warrants that it is the lawful owner or controller of the Licensed IP and Licensed Assets and has the unrestricted
right to grant the Licensed Rights to Licensee and its permitted sublicensees. No undisclosed lien, license, covenant, security interest,
option, or other third-party right limits the grant or exercise of the Licensed Rights.
Section
9.5 Patents and Patent Maintenance.
(a) Schedule
1 lists all material Patents and patent applications controlled by Licensor that are necessary
or useful for the Licensed Indications.
(b) To
Licensor’s knowledge, the Patents listed in Schedule 1 are subsisting and have not
been intentionally abandoned, and all material maintenance fees due as of the Effective Date
have been paid or arrangements for payment are in place.
(c) No
Patent listed in Schedule 1 is subject to an order, judgment, decree, or agreement that materially
restricts the Licensed Rights, except as disclosed in Schedule 6.
Section
9.6 Trademarks and Branding.
Schedule
2 lists the material trademarks and branding rights controlled by Licensor for VELDONA®. To Licensor’s knowledge,
those rights are subsisting and have not been abandoned or materially impaired.
Section
9.7 Non-Infringement.
Licensor
represents and warrants that the grant and exercise of the Licensed Rights, and the use of the Licensed IP and Licensed Assets for the
Licensed Indications as contemplated by this Agreement, do not infringe, misappropriate, or otherwise violate any Third Party Intellectual
Property right, except as disclosed in Schedule 6.
(a) Licensor
has not received written notice of any unresolved Third Party claim alleging that the Licensed
Rights or Licensed Assets infringe, misappropriate, or violate a Third Party right; and,
Page 24 of 50
(b) to
Licensor’s knowledge, no Third Party is materially infringing the Licensed IP in a
manner that would materially impair Licensee’s Licensed Rights.
Section
9.8 No Undisclosed Encumbrances or Rights.
Schedules
1 through 4 and Schedule 7 identify all material Licensed IP, Licensed Assets, Regulatory Data, clinical data, Know-How, and technical
deliverables known to Licensor to be necessary or useful for the Licensed Indications. Licensor has not intentionally omitted a material
item that would materially impair Licensee’s exercise of the Licensed Rights.
Section
9.9 Regulatory Filings and Data.
The
Regulatory Data and regulatory filings included in the Complete Data Package have been prepared and submitted in material compliance
with Applicable Law and are complete and accurate in all material respects to Licensor’s knowledge. Licensor has not received written
notice of any threatened revocation, suspension, or material limitation of a material regulatory approval, except as disclosed in Schedule
3.
Section
9.10 Material Agreements.
Licensor
has disclosed to Licensee the material agreements and Third Party rights affecting the Licensed IP or Licensed Assets, and no such disclosed
agreement is, to Licensor’s knowledge, in material default.
Section
9.11 Litigation.
There
is no pending or, to Licensor’s knowledge, threatened action, investigation, claim, or proceeding that would materially impair
Licensor’s ability to grant the Licensed Rights or Licensee’s exercise of them, except as disclosed in Schedule 6.
Section
9.12 Compliance with Law and Taxes.
Licensor
has conducted its activities relating to the Licensed IP and Licensed Indications in material compliance with Applicable Law and has
paid or adequately reserved for Taxes attributable to periods before the Effective Date.
Section
9.13 No Broker’s Fees.
Licensor
has not incurred any obligation for a finder’s, broker’s, or agent’s fee or commission in connection with this Agreement
for which Licensee would be liable.
Section
9.14 Full Disclosure.
No
representation or warranty of Licensor in this Agreement or Schedule contains an untrue statement of material fact or omits a material
fact necessary to make the statement not misleading in light of the circumstances in which it was made.
Page 25 of 50
Section
9.15 Sufficiency of Licensed Rights.
The
Licensed IP, Licensed Assets, Complete Data Package, and Regulatory Data together include the material rights and materials necessary
for Licensee to research, develop, manufacture, commercialize, and sublicense VELDONA® for the Licensed Indications in
the Territory, subject to third-party rights expressly disclosed in Schedule 6. For the avoidance of doubt, the Licensed Rights include
the right to manufacture and have manufactured VELDONA® and any products derived therefrom, which manufacturing rights are included
in the License Fee payable under Section 3.1.
Section
9.16 No Conflicting Grants.
(a) Licensor
has not granted and is not obligated to grant any license, covenant not to sue, option, or
other right that conflicts with or materially impairs the Licensed Rights, including the
manufacturing rights included therein;
(b) Licensor
has disclosed all known Third Party technology, consent, or approval requirements material
to Licensee’s exercise of the Licensed Rights;
(c) Licensor
shall not knowingly take any action after the Effective Date that would create a conflict
with the Licensed Rights; and
(d) any
permitted disclosure or exception is limited to the scope expressly stated in this Agreement
or Schedule 6.
ARTICLE
X
REPRESENTATIONS
AND WARRANTIES OF LICENSEE
Licensee
represents and warrants to Licensor as of the Effective Date as follows:
Section
10.1 Organization and Good Standing.
Licensee
is duly organized, validly existing, and in good standing under the laws of the Republic of China (Taiwan).
Section
10.2 Authority and Enforceability.
Licensee
has full corporate power and authority to execute, deliver, and perform this Agreement. All required approvals have been obtained, and
this Agreement is a legal, valid, and binding obligation of Licensee, enforceable subject to applicable insolvency laws and equitable
principles.
Section
10.3 No Conflicts.
The
execution, delivery, and performance of this Agreement by Licensee do not and will not violate Licensee’s organizational documents,
Applicable Law, or any material agreement binding on Licensee.
Page 26 of 50
Section
10.4 Sufficient Funds.
Licensee
has, and when due will have, sufficient immediately available funds to pay the License Fee and perform its financial obligations under
this Agreement.
Section
10.5 Compliance and Anti-Corruption.
Licensee
shall comply, and represents that it has complied, with Applicable Law, the U.S. Foreign Corrupt Practices Act, the UK Bribery Act 2010,
and other applicable anti-corruption and anti-money-laundering laws in connection with this Agreement. Licensee has not incurred any
broker or finder fee for which Licensor would be liable.
ARTICLE
XI
COVENANTS
Section
11.1 IP Maintenance and Protection.
Licensor
shall, at its cost, maintain the Patents in Schedule 1, pay applicable maintenance and renewal fees, prosecute pending applications,
and take commercially reasonable steps to preserve the validity and enforceability of the Licensed IP.
(a) Licensor
shall provide Licensee with reasonable periodic updates on filing, prosecution, maintenance,
renewal, and regulatory status and shall consult Licensee before abandoning or materially
narrowing a Patent relevant to a Licensed Indication.
(b) With
Licensee’s prior written consent, Licensor may transfer responsibility for particular
Patent maintenance or prosecution activities to Licensee. The Parties shall agree the cost
allocation and transition mechanics in writing before the transfer.
Section
11.2 Patent Infringement.
(a) Each
Party shall promptly notify the other of any actual, suspected, or threatened infringement
of the Licensed IP or any Third Party claim that the Licensed Rights infringe a Third Party
right, and shall provide reasonably available information and assistance.
(b) Licensee
shall have the first right, but not the obligation, to bring, control, and settle enforcement
proceedings against infringement relating to the Licensed Indications in the Territory, in
Licensee’s name or Licensor’s name as legally required.
(c) Licensor
shall cooperate in any enforcement action, including joining as a party if necessary, providing
documents and witnesses, and executing reasonable authorizations. If Licensee declines to
proceed, Licensor may pursue the matter after consulting with Licensee.
(d) The
enforcing Party shall bear the documented out-of-pocket costs of an enforcement action. After
reimbursement of those costs, any monetary recovery relating to a Licensed Indication shall
be payable to Licensee, unless the Parties agree otherwise in writing.
Page 27 of 50
Section
11.3 Non-Compete.
During
the Term and for 10 years after termination or expiration of this Agreement, Licensor shall not, and shall cause its Affiliates and their
respective directors, officers, employees, agents, and consultants not to, anywhere in the world, directly or indirectly compete with
the Licensed Indications.
(a) Competing
activities include researching, developing, manufacturing, commercializing, licensing, sublicensing,
marketing, promoting, or otherwise exploiting a product or technology directed to Sjögren’s
Disease or Thrombocytopenia that competes with the Licensed Rights.
(b) Licensor
and its Affiliates shall not use Licensed IP, Licensed Assets, Trial Results, or Confidential
Information to support a competing activity or assist a Third Party in doing so.
(c) The
restriction does not prohibit Licensor’s performance of technical consultation or other
support services expressly provided to Licensee under this Agreement or another written technical
consultation arrangement with Licensee.
(d) The
restriction also does not prohibit research and development directed solely to Non-Licensed
Indications, provided that the activity does not use Licensed Rights to compete with, substitute
for, or materially impair the Licensed Indications.
For
clarity, the exceptions in this Section are limited to the express technical-consultation and Non-Licensed Indications research exceptions
stated above.
Licensor
shall take reasonable steps to ensure compliance by each Restricted Party and shall notify Licensee promptly upon becoming aware of an
actual or threatened breach.
Licensee
may seek temporary, preliminary, and permanent injunctive relief, specific performance, and damages for any breach or threatened breach
of this Section, in addition to any other remedy available at law or in equity.
The
Parties acknowledge that the scope, duration, and territory of this Section are reasonable and necessary to protect Licensee’s
legitimate interests in the Licensed Rights.
If
a court finds any restriction unenforceable, it shall be modified to the minimum extent necessary to make it enforceable while preserving
the Parties’ intent.
If
a Restricted Party breaches this Section, the restricted period shall be extended for the duration of the breach to the extent permitted
by Applicable Law.
Section
11.4 Regulatory Change.
If
a change in Applicable Law, regulatory guidance, or regulatory practice materially impedes development, manufacture, or commercialization
of a Licensed Indication, the Parties shall promptly meet and negotiate in good faith on mitigation measures, revised timelines, and
allocation of incremental costs.
Page 28 of 50
The
Parties shall continue performing unaffected obligations during those discussions and shall document any agreed mitigation or cost-sharing
arrangement in writing.
Section
11.5 Public Announcements.
Neither
Party shall issue a press release or public announcement regarding this Agreement or the transaction without the other Party’s
prior written consent, except as required by Applicable Law, securities rules, or a Governmental Authority.
A
Party required to disclose shall, where legally permitted, provide reasonable advance notice and an opportunity to review the proposed
disclosure.
Nothing
in this Section prevents Licensor from making disclosures reasonably for US SEC and Licensee from making disclosures reasonably necessary
for Taiwan OTC or other securities-market, investor, regulatory, or financing purposes, subject to Applicable Law and reasonable confidentiality
protections.
Each
Party shall reasonably cooperate with the other in preparing accurate disclosures that describe the global exclusive license, the Licensed
Indications, and the principal economic terms without mischaracterizing the transaction.
Section
11.6 Records and Compliance Cooperation.
(a) Each
Party shall maintain records reasonably sufficient to demonstrate compliance with this Agreement
and shall provide reasonable cooperation in responding to regulatory or governmental inquiries
concerning the Licensed Indications.
(b) Each
Party shall promptly notify the other of a material regulatory inquiry, warning letter, investigation,
or enforcement action relating to a Licensed Indication or the Licensed Rights.
Licensor
shall not knowingly use Licensee’s data, information, or Derivative IP for any purpose outside this Agreement or disclose it to
a competitor of Licensee.
The
covenants in this Article XI supplement the express rights and obligations in Articles II, VI, XII, and XV.
Section
11.7 Development Consultation and Planning.
Within
60 days after Licensee’s receipt of the Complete Data Package pursuant to Section 6.1 and written confirmation that the Technology
Transfer has been completed in accordance with Article VI and Schedule 7 (such date, the “Development Consultation Trigger Date”),
Licensee shall use commercially reasonable efforts to initiate discussions with Licensor regarding the clinical trial and development
plans for the Licensed Indications.
Page 29 of 50
For
purposes of this Section 11.7, “commercially reasonable efforts” means, with respect to Licensee’s development consultation
and planning obligations, the level of effort and resources typically devoted by a similarly situated pharmaceutical or biotechnology
company to the development of a product at a similar stage of development with similar commercial potential, taking into account relevant
market conditions, regulatory requirements, competitive landscape, safety and efficacy considerations, manufacturing feasibility, and
available financial and personnel resources. Nothing in this Section 11.7 shall require Licensee to undertake any development activity
that is not commercially justified or that conflicts with sound scientific, medical, or business judgment.
Upon
initiation of development consultation discussions, the Parties shall negotiate in good faith to establish a development framework for
the Licensed Indications, which may include (i) an overview of the proposed clinical trial design and study endpoints, (ii) the anticipated
timeline for trial commencement and key milestones, (iii) the estimated budget and resource allocation, (iv) the regulatory strategy
for FDA, TFDA, and other relevant Regulatory Authorities, and (v) any anticipated collaboration or support from Licensor under Section
6.4 (collectively, the “Development Framework”).
The
Parties shall use good faith efforts to agree on a Development Framework within 180 days after the Development Consultation Trigger Date.
If the Parties are unable to reach agreement on any material element of the Development Framework within such period, either Party may
refer the matter to senior management negotiation under Section 13.1. The Parties acknowledge that failure to agree on a Development
Framework shall not constitute a material breach of this Agreement, and Licensee shall retain full discretion over all development decisions
for the Licensed Indications.
ARTICLE
XII
INDEMNIFICATION
Section
12.1 Indemnification by Licensor.
Subject
to Section 12.4, Licensor shall indemnify, defend, and hold harmless Licensee and its Affiliates, and their respective directors, officers,
employees, agents, and successors (each, a “Licensee Indemnified Party”), from and against all losses, damages, liabilities,
costs, and expenses, including reasonable attorneys’ fees, arising out of or resulting from:
(a) any
breach or inaccuracy of Licensor’s representations or warranties;
(b) any
breach of Licensor’s covenants or obligations;
(c) any
claim that the Licensed IP, Licensed Assets, or Licensed Rights infringe, misappropriate,
or violate a Third Party Intellectual Property right;
(d) any
negligent, reckless, fraudulent, or willful act or omission of Licensor, its Affiliates,
or their personnel in performing this Agreement.
Page 30 of 50
Section
12.2 Indemnification by Licensee.
Subject
to Section 12.4, Licensee shall indemnify, defend, and hold harmless Licensor and its Affiliates, and their respective directors, officers,
employees, agents, and successors (each, a “Licensor Indemnified Party”), from and against all losses, damages, liabilities,
costs, and expenses, including reasonable attorneys’ fees, arising out of or resulting from:
(a) any
breach or inaccuracy of Licensee’s representations or warranties;
(b) any
breach of Licensee’s covenants or obligations;
(c) claims
arising from Licensee’s or its sublicensees’ commercialization or use of the
Licensed Rights after the Effective Date, except to the extent caused by Licensor’s
breach, negligence, or misconduct;
(d) any
fraud or willful misconduct of Licensee.
Section
12.3 Indemnification Procedures.
(a) The
indemnified Party shall provide prompt written notice of a claim, describing in reasonable
detail the nature and amount of the Loss.
(b) Failure
to provide timely notice shall not relieve the indemnifying Party except to the extent it
is materially prejudiced.
(c) The
indemnifying Party may assume the defense of a Third Party claim with counsel reasonably
satisfactory to the indemnified Party and at the indemnifying Party’s expense.
(d) The
indemnified Party shall reasonably cooperate in the defense at the indemnifying Party’s
expense and may participate with separate counsel at its own expense.
(e) The
indemnifying Party shall not settle a claim without the indemnified Party’s prior written
consent if the settlement imposes non-monetary obligations, admits fault, or does not provide
a complete release.
(f) The
indemnified Party may assume the defense if the indemnifying Party fails to do so promptly
or if a conflict of interest makes separate control appropriate.
Section
12.4 Limitations.
(a) A
Party shall not be liable for Losses until the aggregate amount exceeds USD [***] (the “Basket”),
after which liability shall be from the first dollar.
(b) The
aggregate liability of an indemnifying Party shall not exceed USD [***] (the “Cap”),
except as provided below.
(c) The
Basket and Cap shall not apply to fraud, willful misconduct, breach of Section 9.4 or Section
9.7, breach of confidentiality, or IP infringement claims.
(d) Indemnity
claims properly asserted before expiration of the applicable survival period shall survive
until final resolution.
(e) Each
indemnified Party shall use commercially reasonable efforts to mitigate Losses, but no mitigation
obligation requires it to compromise a material right.
Page 31 of 50
(f) Losses
shall be reduced by insurance proceeds actually received and Tax benefits actually realized,
but not by amounts for which the indemnified Party remains liable to repay.
(g) There
shall be no double recovery, and punitive, speculative, or consequential damages are excluded
except to the extent payable to a Third Party.
Section
12.5 Exclusive Remedy.
Except
for fraud, willful misconduct, payment obligations, equitable remedies, and remedies expressly provided in Articles II, XI, XIII, XIV,
and XV, this Article XII provides the Parties’ exclusive monetary remedy for breach of this Agreement.
Section
12.6 Survival.
The
following provisions survive termination or expiration for the period applicable to the underlying representation, warranty, covenant,
claim, or liability: Article I (Definitions), Section 2.7 (BPC-Developed Indications), Article VII (Intellectual Property Ownership),
Article III (Payment Obligations, to the extent accrued), Article V (Revenue Sharing, to the extent accrued), this Article XII (Indemnification
and Limitation of Liability), Article XIII (Deadlock Resolution), Article XV (Confidentiality), Article XVI (Governing Law and Dispute
Resolution), Article XVII (Miscellaneous), and any other provision that by its nature should survive.
ARTICLE
XIII
DEADLOCK
RESOLUTION
Section
13.1 Deadlock.
A
“Deadlock” occurs when the Parties cannot resolve a material dispute concerning the Licensed Rights, development, regulatory
strategy, sublicensing, or performance of this Agreement after good-faith discussions.
Upon
written notice of a Deadlock, the matter shall be escalated to senior management representatives of each Party, who shall meet and negotiate
in good faith for 15 days.
Section
13.2 Standstill.
During
the Deadlock and until the matter is resolved or the BPC Buy-Out Option is completed, Licensor shall not license, sublicense, sell, or
otherwise grant rights in the disputed Licensed Indications to a Third Party and shall not take action intended to circumvent Licensee’s
rights.
Section
13.3 BPC Buy-Out Option.
If
the senior-management negotiation period expires without resolution, Licensee may elect to purchase all of Licensor’s right, title,
and interest in the Licensed IP and Licensed Assets solely for the Licensed Indications, converting the exclusive license into full ownership
for those indications.
Page 32 of 50
Licensee
shall exercise the BPC Buy-Out Option by written notice within 30 days after the end of the negotiation period. The transfer shall be
documented through instruments reasonably necessary to confirm ownership of the Licensed IP for the Licensed Indications. The purchase
price shall be determined by agreement of the Parties.
Section
13.4 ROFR Unaffected.
The
ROFR for ROFR Indications under Article IV remains in effect and is not reduced, waived, or impaired by a Deadlock or exercise of the
BPC Buy-Out Option.
Section
13.5 Continuing Performance.
During
a Deadlock, each Party shall continue performing undisputed obligations, and the Deadlock shall not excuse payment, confidentiality,
compliance, safety, or regulatory obligations.
ARTICLE
XIV
TERM
AND TERMINATION
Section
14.1 Term.
This
Agreement begins on the Effective Date and continues, on an indication-by-indication and country-by-country basis, until the later of
(a) expiration of the last-to-expire Patent covering the applicable Licensed Indication or (b) 20 years after the Effective Date, unless
terminated earlier under this Article XIV.
Section
14.2 Termination for Material Breach.
Either
Party may terminate this Agreement, in whole or in part, for the other Party’s material breach if the breach is not cured within
30 days after written notice.
Notwithstanding
the foregoing, a payment breach shall have a cure period of 10 Business Days after written notice. A breach involving confidentiality,
anti-corruption, non-compete, safety, or regulatory integrity may be subject to immediate equitable relief and termination if not promptly
cured.
Section
14.3 Insolvency.
Either
Party may terminate this Agreement upon written notice if the other Party becomes insolvent, enters liquidation, makes an assignment
for creditors, or becomes subject to an insolvency proceeding that is not dismissed within 15 days, to the extent permitted by Applicable
Law.
Section
14.4 Licensor Change of Control.
Licensor
shall notify Licensee promptly, and in any event within 30 days, of any proposed or pending Change of Control. For the avoidance of doubt,
Licensor’s capital increases, equity financings, reorganizations, and corporate governance matters (including private placements,
public offerings, stock splits, board composition changes, and similar transactions) are within Licensor’s sole discretion.
Page 33 of 50
Notwithstanding
any Change of Control of Licensor, the Licensed Rights granted to Licensee under this Agreement shall remain in full force and effect
and shall not be impaired, diminished, or otherwise affected by such Change of Control. Any successor or assignee of Licensor resulting
from a Change of Control shall be bound by all of Licensor’s obligations under this Agreement and shall not have the right to modify,
terminate, or adversely affect the Licensed Rights without Licensee’s prior written consent.
For
the avoidance of doubt, a Change of Control of Licensor shall not: (a) terminate, reduce, or modify the Licensed Rights or any other
rights of Licensee under this Agreement; (b) give rise to any termination right in favor of Licensor or its successor; (c) accelerate,
increase, or otherwise modify any payment obligation of Licensee; (d) impose any new obligation, restriction, or condition on Licensee;
or (e) affect Licensee’s ownership of any Derivative IP, BPC-Developed Indication IP, Trial Results, or other Intellectual Property
owned by Licensee under this Agreement.
Section
14.5 Force Majeure.
A
Party may suspend performance of an obligation affected by a Force Majeure Event, provided it promptly notifies the other Party, uses
reasonable mitigation efforts, and resumes performance as soon as practicable.
If
a Force Majeure Event continues for more than 3 consecutive months and materially prevents performance of a material obligation, either
Party may terminate the affected portion of this Agreement on written notice, subject to accrued rights and continuing confidentiality
and payment obligations.
Section
14.6 Effect of Termination.
Termination
does not affect accrued rights, obligations, or liabilities arising before the effective termination date.
(a) Except
for a permitted sell-off or transition expressly provided below, the Licensed Rights for
the terminated Licensed Indication shall cease on the effective termination date. Licensee
shall have 6 months to sell existing finished inventory and fulfill binding customer commitments.
(b) Licensee
shall handle remaining inventory in a commercially reasonable manner and shall comply with
applicable quality, safety, pharmacovigilance, and regulatory requirements during the sell-off
period.
(c) Each
Party shall return or destroy the other Party’s Confidential Information on request,
except that Licensee may retain Trial Results, Derivative IP (including Licensee’s
interest in Jointly Owned IP), BPC-Developed Indication IP, regulatory records, audit records,
and one archival copy required by law or internal compliance policy.
Page 34 of 50
Article
V, Article VII (Intellectual Property Ownership), Article XI, Article XII, Article XIII, Article XV, Article XVI, and Article XVII, together
with accrued payment obligations and any provision that by its nature should survive, survive termination or expiration.
Termination
or expiration shall not impair Licensee’s ownership of Trial Results, Derivative IP (other than Jointly Owned IP), or BPC-Developed
Indication IP, or the Parties’ joint ownership of Jointly Owned IP, under Article VII and Section 2.7, and shall not eliminate
payment, audit, confidentiality, indemnity, or other accrued rights.
ARTICLE
XV
CONFIDENTIALITY
Section
15.1 Definition.
“Confidential
Information” means non-public information disclosed by or on behalf of a Party to the other Party in connection with this Agreement,
including technical information, Know-How, clinical and regulatory data, Trial Results, Derivative IP, business plans, financial information,
sublicense terms, and the terms of this Agreement.
Section
15.2 Confidentiality Obligations.
The
Receiving Party shall protect the Disclosing Party’s Confidential Information using at least reasonable care and no less care than
it uses for its own information of similar sensitivity.
(a) The
Receiving Party shall use Confidential Information solely to exercise rights or perform obligations
under this Agreement and shall not disclose it to a Third Party except as permitted below.
(b) The
Receiving Party shall limit access to Representatives who need to know the information and
are bound by confidentiality obligations no less protective than this Article XV.
(c) The
Receiving Party shall promptly notify the Disclosing Party of any unauthorized use or disclosure
and reasonably cooperate in mitigating the resulting harm.
Neither
Party may use the other Party’s Confidential Information to compete with the other Party or to circumvent the Licensed Rights,
the ROFR, or the revenue-sharing provisions.
Section
15.3 Permitted Disclosures.
(a) A
Party may disclose Confidential Information to its Representatives, professional advisers,
actual or potential financing sources, insurers, auditors, and permitted sublicensees or
Affiliates, in each case subject to confidentiality obligations.
(b) A
Party may disclose Confidential Information as required by Applicable Law, court order, securities
rule, or Governmental Authority, provided that, where legally permitted, it gives prior notice
and reasonably cooperates in seeking confidential treatment.
Page 35 of 50
(c) Licensee
may disclose Confidential Information to Regulatory Authorities and securities markets as
reasonably necessary for development, regulatory submissions, financing, OTC review, investor
communications, or commercialization, subject to appropriate protections.
(d) Licensor
may disclose Confidential Information to Regulatory Authorities to perform Sponsor obligations
or support the Licensed Rights, but may not disclose Licensee’s Confidential Information
to a competitor except as required by law.
Section
15.4 Exclusions.
Confidential
Information does not include: (a) information that is or becomes publicly available through no breach of this Agreement; (b) was lawfully
known to the Receiving Party without restriction before disclosure; (c) is independently developed without use of the Disclosing Party’s
Confidential Information; or (d) is lawfully received from a Third Party without breach of a confidentiality obligation.
Section
15.5 Duration.
The
obligations under this Article XV continue during the Term and for 5 years after termination or expiration. Obligations relating to trade
secrets, Know-How, non-public regulatory data, and other information protected as a trade secret continue for so long as the information
remains legally protectable and non-public.
Section
15.6 Return and Retention.
Upon
written request after termination or expiration, the Receiving Party shall return or destroy the Disclosing Party’s Confidential
Information, subject to legal, regulatory, archival, and automatic-backup retention requirements.
Licensee
may retain Trial Results, Derivative IP (including Licensee’s interest in Jointly Owned IP), BPC-Developed Indication IP, regulatory
records, audit materials, and one archival copy of other Confidential Information to the extent necessary to exercise retained rights,
comply with law, or defend a claim.
Section
15.7 Licensee Information and Derivative IP.
Licensor
shall not use Licensee’s Confidential Information, Derivative IP (other than Jointly Owned IP, which Licensor may use in accordance
with Section 7.5), or BPC-Developed Indication IP except to perform this Agreement and shall not disclose it to a competitor of Licensee.
Section
15.8 Remedies.
A
breach of this Article XV may cause irreparable harm for which monetary damages are inadequate. The non-breaching Party may seek injunctive
relief, specific performance, and other equitable remedies, in addition to any other available remedy.
Page 36 of 50
Section
15.9 Publicity and OTC/SEC Reviews.
The
Parties may disclose the existence and principal terms of this Agreement as reasonably necessary for Taiwan OTC and US SEC reviews, securities
filings, investor communications, financing, regulatory submissions, and compliance with Applicable Law, subject to redaction of competitively
sensitive information where permitted.
A
Party making a permitted public disclosure shall, where practicable, provide the other Party a reasonable opportunity to review the disclosure
for accuracy and confidentiality concerns.
The
obligations in this Article XV apply to all Confidential Information exchanged before or after the Effective Date and survive in accordance
with Section 15.5.
ARTICLE
XVI
GOVERNING
LAW AND DISPUTE RESOLUTION
Section
16.1 Governing Law.
This
Agreement shall be governed by and construed in accordance with the Laws of the Republic of China (Taiwan), without regard to conflict-of-laws
principles that would require application of another jurisdiction’s laws.
Section
16.2 Good-Faith Negotiation.
A
Party shall give written notice of a dispute, and the Parties shall first attempt in good faith to resolve it through negotiation for
30 days after receipt of the notice.
Section
16.3 Jurisdiction.
If
the dispute is not resolved through negotiation, the Taipei District Court shall have exclusive jurisdiction as the court of first instance
over any dispute arising out of or relating to this Agreement, including its validity, interpretation, performance, breach, or termination.
Section
16.4 Continuing Performance.
During
any dispute, each Party shall continue performing all undisputed obligations, including payment, confidentiality, safety, regulatory,
trial, technology-transfer, and compliance obligations.
Nothing
in this Article XVI prevents either Party from seeking urgent injunctive or other interim relief from a court of competent jurisdiction
to protect Confidential Information, Licensed Rights, safety, or regulatory continuity.
Section
16.5 Language.
The
language of court proceedings shall be Chinese, provided that the English version of this Agreement shall govern its interpretation and
the Parties may submit English-language evidence with a Chinese translation if required.
The
Parties shall reasonably cooperate in translating documents and evidence required for dispute resolution.
Page 37 of 50
Each
Party shall bear its own legal costs unless the court orders otherwise, and the prevailing Party may seek recoverable costs to the extent
permitted by Applicable Law.
A
Party’s failure to enforce a right immediately shall not waive that right or any later enforcement of the same or another right.
Section
16.6 Scope of Relief.
A
court may grant any remedy available under Applicable Law, including damages, specific performance, injunctive relief, declaratory relief,
and enforcement of the Licensed Rights.
Any
settlement of a dispute must be in writing and signed by authorized representatives of both Parties to be binding.
This
Article XVI survives termination or expiration to the extent necessary to resolve a dispute arising before termination or expiration.
Section
16.7 Regulatory Continuity.
The
Parties shall cooperate to prevent a dispute from interrupting subject safety, pharmacovigilance, regulatory reporting, or other legally
required activities relating to a Licensed Indication.
A
Party may seek emergency relief to protect patients, maintain regulatory status, preserve evidence, or prevent misuse of Licensed IP
or Confidential Information.
The
remedies in this Article XVI are cumulative and do not exclude any remedy available under Applicable Law.
ARTICLE
XVII
MISCELLANEOUS
Section
17.1 Entire Agreement.
This
Agreement, including its Schedules, constitutes the entire agreement between the Parties concerning the Licensed Rights and supersedes
all prior negotiations, proposals, term sheets, understandings, and communications concerning that subject matter.
Section
17.2 Amendments.
This
Agreement may be amended, modified, or supplemented only by a written instrument signed by both Parties.
Section
17.3 Waiver.
No
waiver is effective unless in writing and signed by the waiving Party. A waiver of one breach is not a waiver of another or later breach.
Section
17.4 Severability.
If
a provision is invalid or unenforceable, the remaining provisions remain in effect and the Parties shall negotiate a valid replacement
that most closely preserves the original commercial intent.
Page 38 of 50
Section
17.5 Assignment.
Licensee
may assign this Agreement, in whole or in part, to an Affiliate with prior written notice to Licensor, provided Licensee remains responsible
for its obligations unless the assignee assumes them in writing.
Licensor
may not assign, transfer, delegate, or otherwise dispose of this Agreement or any Licensed IP affecting the Licensed Rights without Licensee’s
prior written consent, except in connection with a Change of Control of Licensor, in which case the successor or assignee shall be bound
by all of Licensor’s obligations under this Agreement and the Licensed Rights shall continue in full force and effect. For the
avoidance of doubt, Licensor’s capital increases, equity financings, reorganizations, and corporate governance matters do not require
Licensee’s consent and are within Licensor’s sole discretion, provided that such transactions do not constitute a Change
of Control.
Any
purported assignment in violation of this Section is void, except that a permitted successor in a Licensor Change of Control remains
bound by this Agreement.
Section
17.6 Notices.
All
notices must be in writing and delivered by personal delivery, internationally recognized courier, registered or certified mail, or email
to the designated contacts below.
A
notice is effective on delivery if delivered personally, on confirmed receipt if sent by courier or registered mail, and on confirmed
transmission if sent by email before 5:00 p.m. Taipei time on a Business Day; otherwise, it is effective on the next Business Day.
Each
Party shall designate a contact person, mailing address, courier address, and email address for notices and shall notify the other Party
of any change in writing.
Licensor
notice contact:
Ainos,
Inc.,
Attn:
[***]
address:
[***]
email:
[***].
Licensee
notice contact:
BioPhoenix
Co., Ltd.
Attn:
[***]
address:
[***]
email:
[***]
Page 39 of 50
Section
17.7 Force Majeure.
A
Force Majeure Event includes natural disaster, epidemic, pandemic, war, terrorism, civil unrest, governmental action, embargo, labor
disruption, utility failure, transportation failure, or communications failure beyond a Party’s reasonable control.
The
affected Party shall notify the other Party promptly, describe the expected impact, use commercially reasonable mitigation efforts, and
resume performance as soon as practicable.
Force
majeure does not excuse payment obligations accrued before the event or obligations relating to confidentiality, patient safety, pharmacovigilance,
regulatory reporting, or protection of Licensed IP.
Section
17.8 Anti-Corruption and Compliance.
Each
Party represents and covenants that it and its Affiliates will comply with the U.S. Foreign Corrupt Practices Act, the United Nations
Convention against Corruption (UNCAC), applicable anti-corruption, anti-bribery, anti-money-laundering, sanctions, export-control, and
healthcare laws in performing this Agreement.
Neither
Party shall offer, promise, authorize, request, or accept an improper payment or benefit in connection with the Licensed Rights, clinical
activities, regulatory submissions, or sublicensing.
A
Party shall promptly notify the other of a material compliance investigation, violation, or governmental inquiry relating to this Agreement
and shall reasonably cooperate in remediation.
Section
17.9 Counterparts and Electronic Signatures.
This
Agreement may be executed in counterparts, each deemed an original, and signatures delivered electronically or by PDF shall be effective
as original signatures.
Section
17.10 No Third-Party Beneficiaries.
Except
for indemnified parties expressly protected under Article XII, this Agreement benefits only the Parties and their permitted successors
and assigns and creates no rights in other Persons.
Section
17.11 Expenses.
Except
as expressly provided in this Agreement, each Party shall bear its own costs and expenses in negotiating, executing, and performing this
Agreement.
Section
17.12 Further Assurances.
Each
Party shall execute documents and take actions reasonably necessary to carry out this Agreement, protect the Licensed Rights, complete
the Technology Transfer, and maintain regulatory continuity.
Section
17.13 Language.
This
Agreement is executed in English. If translated, the English version controls in the event of any inconsistency.
Page 40 of 50
Section
17.14 Interpretation.
Headings
are for convenience only and do not affect interpretation.
“Including”
means “including without limitation.” References to Articles, Sections, and Schedules refer to this Agreement unless otherwise
specified.
Words
in the singular include the plural and vice versa; “or” is not exclusive; and “shall” and “will”
are mandatory while “may” is permissive.
Section
17.15 Order of Precedence.
If
a Schedule conflicts with the body of this Agreement, the body controls unless the Schedule expressly states that it overrides a specified
provision.
No
provision of this Agreement shall be interpreted to expand the Licensed Indications beyond Sjögren’s Disease and Thrombocytopenia
except through a written amendment or an exercised ROFR.
This
Section 17.15 and the other miscellaneous provisions survive termination to the extent necessary to interpret or enforce accrued rights.
Section
17.16 Binding Effect.
This
Agreement binds and benefits the Parties and their permitted successors and assigns.
The
Parties have caused this Agreement to be executed by their duly authorized representatives as of the date first written above.
Page 41 of 50
IN
WITNESS WHEREOF, the Parties have caused this License Agreement to be executed by their duly authorized representatives as of the date
first written above.
LICENSOR:
Ainos,
Inc.
By:
/s/
Eddy Tsai
Name:
Eddy
Tsai
Title:
Chairman
Date:
September
24, 2026
LICENSEE:
BioPhoenix
Co., Ltd.
By:
/s/
Hsin-Hung Wu
Name:
Hsin-Hung
Wu
Title:
Chairman
Date:
September
24, 2026
Page 42 of 50
SCHEDULE
1
Licensed
Patents and Patent Applications
Page 43 of 50
SCHEDULE
2
Licensed
Trademarks
Page 44 of 50
SCHEDULE
3
Clinical
Data and Regulatory Data
Page 45 of 50
SCHEDULE
4
Know-How,
CMC, Formulations, Manufacturing Technology, and Processes
Page 46 of 50
SCHEDULE
5
Licensed
Indications and ROFR Indications
Page 47 of 50
SCHEDULE
6
Third-Party
Rights, Existing Agreements, and Required Consents
Page 48 of 50
SCHEDULE
7
Complete
Data Package Deliverables List
Page 49 of 50
SCHEDULE
8
Sub-licensing
Revenue Share Calculation Methodology
Page 50 of 50
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 3
Exhibit 99.1
Ainos
Details Partner-Funded VELDONA Development and Revenue Opportunities, Reinforcing Focus on Chemical Intelligence
Initial
license payment tied to near-term contractual delivery; additional payment opportunities may arise during development, before drug approval
Partner
assumes assigned clinical and regulatory funding and execution, reducing Ainos’ independent capital and staffing requirements
Ainos
retains existing platform ownership and 25% of applicable net sublicensing revenue; potential economic participation extends beyond the
$10 million licensing framework
HOUSTON,
TX / September 28, 2026 / Ainos, Inc. (NASDAQ: AIMD, AIMDW) (“Ainos” or the “Company”) today detailed the financial
and strategic benefits of the VELDONA® License Agreement announced on September 24, 2026 (the “Agreement”). Ainos expects
to complete the agreed contractual delivery shortly, with an initial license fee of $600,000 payable within 15 business days after
the applicable payment conditions are satisfied. This payment does not depend on completion of future clinical trials or receipt of marketing
approval.
The
pharmaceutical development partner identified in the September 24 announcement (the “licensee”) will fund and execute the
clinical and regulatory activities assigned to it for the two initial globally licensed indications, Sjögren’s disease and
thrombocytopenia. This structure reduces Ainos’ need to independently finance subsequent development, expand specialist teams and
devote additional management resources to pharmaceutical execution, supporting the Company’s priority investment in Chemical Intelligence.
Ainos
is also entitled to 25% of applicable net sublicensing revenue. Qualifying transactions may generate upfront payments, option
fees and development or regulatory milestones during clinical development, creating opportunities for payments to Ainos before a product
reaches the market.
Multiple
Payment Opportunities Beyond the Initial License
The
Agreement provides distinct sources of potential consideration:
● Initial
license fee: $600,000 payable under the contractual delivery and payment provisions.
● Sublicensing
participation: 25% of applicable net sublicensing revenue, which may include upfront
payments, option fees, milestones, royalties and other consideration covered by the Agreement.
● First-sublicense
fee: A separate, one-time fee payable within 30 days after the first third-party sublicense
takes effect, without reducing or offsetting Ainos’ applicable revenue share.
● Additional
indication licenses: A pathway for 15 additional VELDONA indications, subject to applicable
contractual rights, separate definitive agreements and payment.
● Product
supply: Opportunities under separately negotiated agreements and accepted purchase orders.
The
potential $10 million framework comprises the initial license fee, conditional additional-indication consideration and the first-sublicense
fee. Partner-funded development expenditures, applicable sublicensing revenue participation and potential product supply revenue are
additional to that framework. Where additional indication licenses carry forward the 25% net sublicensing participation, that share would
be additional to the corresponding license fees.
Accordingly,
$10 million is not a ceiling on Ainos’ total economic participation. Further value will depend on completed licenses, qualifying
sublicensing transactions and supply arrangements. Neither party is obligated to complete all 15 additional licenses, and the framework
represents neither guaranteed revenue nor a platform valuation.
The
25% share applies to the defined net sublicensing revenue base, subject to permitted deductions and other applicable terms. Payments
depend on qualifying transactions, receipt of consideration and contractual payment provisions; clinical activity alone does not trigger
a payment. License fees, the first-sublicense fee and separate supply payments are independent of that percentage calculation.
Ainos
may also negotiate direct licenses for available indications with other third parties, subject to the licensee’s applicable contractual
priority rights. Consideration contemplated under this Agreement does not set a ceiling on those separately negotiated transactions.
Established
Clinical and Intellectual Property Foundations
VELDONA
is a low-dose oral interferon alpha platform administered as a lozenge through the oral mucosa. Its clinical records, relevant patents,
regulatory history and manufacturing knowledge provide an established base for further development.
Sjögren’s
disease: Historical Phase II and Phase III programs include approximately 497 patients across two Phase III studies, providing human
exposure and clinical information to inform future trial design and regulatory discussions. This is historical development experience;
it does not indicate that a new registration trial is underway or that approval is assured.
Thrombocytopenia:
Assets addressing this blood disorder—characterized by low platelet counts and increased bleeding risk—include relevant patent
protection and human research examining platelet recovery. Historical evidence includes findings in patients with thrombocytopenia from
a randomized, double-blind, placebo-controlled study involving 169 participants. These records support further investigation and patient-population
selection, rather than establishing approval or clinical benefit for every cause of low platelet counts.
Across
the broader platform, Ainos’ previously disclosed history spans approximately four decades and 68 studies—three Phase I,
63 Phase II and two Phase III—covering 16 disease indications and healthy volunteers. Nearly 6,000 participants were enrolled,
approximately 4,600 received oral interferon alpha, and treatment extended up to five years in certain studies. This history provides
safety, tolerability and exposure information, while further clinical, manufacturing and regulatory evidence remains necessary under
current standards.
Complementary
Expertise, Defined Responsibilities and Lower Independent Resource Requirements
Ainos
contributes its existing VELDONA assets and agreed technical support. The licensee funds and executes its assigned development activities,
including clinical studies, CRO services, trial sites and investigators, investigational drug procurement, testing, data management,
statistical analysis and safety reporting. Regulatory responsibilities include specialist consultants, applications, supplemental studies
and responses to agency questions.
The
parties intend to advance the programs toward applicable marketing authorizations, including activities required to seek U.S. FDA approval
and TFDA activities specified in the agreed development plan. Ainos retains its contractual responsibilities; chemistry, manufacturing
and controls work, intellectual property maintenance and other costs remain subject to the agreed allocation.
This
division of work reduces the need for Ainos to independently build and finance a larger pharmaceutical development organization. Existing
records can also inform planning and reduce duplication of certain preparatory work. Actual time and cost benefits will depend on development
requirements and execution. Near-term priorities are contractual delivery, satisfaction of the initial payment conditions and development
planning.
Industry
research illustrates the scale of late-stage development. A 2025 study covering 631 projects across 22 Japanese pharmaceutical companies
reported separate Phase II and Phase III median costs that together equated to approximately $54 million; for projects targeting U.S.
or European approval, the Phase III median alone was approximately $74 million.[1] These figures are industry context, not
a VELDONA budget, a fixed partner funding commitment or an estimate of Ainos’ savings.
Preserving
VELDONA Ownership and Prioritizing Chemical Intelligence
Ainos
retains ownership of its existing VELDONA platform and background intellectual property, subject to the rights granted under the Agreement.
The initial license includes manufacturing rights for the agreed indications and does not transfer ownership of the existing platform.
Eddy
Tsai, Chairman, President and Chief Executive Officer of Ainos, commented:
“As
we continue to make progress in AI Nose and Chemical Intelligence, the importance of focused execution is increasing. Chemical Intelligence
is our first strategic priority, and we want our capital, talent and management attention concentrated on advancing customer adoption
and the chemical sensing, real-world data and AI capabilities behind it. Bringing in a pharmaceutical development partner for VELDONA
supports that focus while providing a path forward for the clinical knowledge, intellectual property and manufacturing expertise we have
already built. We contribute our existing assets and technical knowledge; the partner funds and executes its assigned clinical and regulatory
work.
“We
retain ownership of our existing platform, subject to the licensed rights, and participate through contractual payments, applicable sublicensing
proceeds and potential supply opportunities. This creates opportunities to receive value before drug approval while reducing our need
to independently finance development or expand a pharmaceutical organization. For shareholders, the objective is to advance VELDONA through
complementary expertise and keep Ainos focused on Chemical Intelligence. We will measure progress through delivery, payments received,
development milestones and execution in our core AI business.”
About
Ainos
Ainos,
Inc. (NASDAQ: AIMD, AIMDW) develops AI Nose and Chemical Intelligence technologies that convert real-world chemical and scent signals
into actionable information. The Company also holds the VELDONA low-dose oral interferon alpha platform, which it seeks to advance through
pharmaceutical licensing and development collaborations.
Forward-Looking
Statements
This
release contains forward-looking statements within the meaning of applicable U.S. securities laws, including statements concerning delivery
and payment timing; partner funding and execution; sublicensing, additional licenses and product supply; clinical and regulatory plans;
resource efficiencies; and future commercial value. These statements reflect current expectations and are subject to risks and uncertainties,
including satisfaction of contractual conditions, counterparty performance and financial resources, completion of qualifying transactions,
clinical results, regulatory requirements, manufacturing readiness and execution of the Company’s strategy. Actual results may
differ materially.
Historical
clinical experience does not guarantee future safety, efficacy, approval or commercial success. No guaranteed commercialization timetable
or quantified savings have been established. Potential receipts are not equivalent to recognized revenue; recognition depends on applicable
accounting requirements and satisfaction of relevant performance obligations. Additional risks are described in Ainos’ SEC filings.
The Company undertakes no obligation to update forward-looking statements except as required by law.
Reference
[1]
Okada, N. and Takahashi, Y. “Cost and Duration of Clinical Trials in Drug Development by Japanese Pharmaceutical Companies.”
Pharmaceutical Medicine 39, 199–207 (2025). Dollar equivalents use the study’s reference exchange rate of JPY 109
per U.S. dollar. The approximately $54 million figure adds separate phase-specific medians; it is not an observed median total development
cost. Source.
Forward-Looking
Statements
Certain
statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking
statements. Forward-looking statements are based on management’s current assumptions and expectations of future events and trends,
which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other
events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of
important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated
by the forward-looking statements in this press release. These factors include, among other things, the uncertainty of the contemplated
collaboration framework and the expected receipt of license fees, manufacturing license fees and other consideration thereunder; our
expectation that we will incur net losses for the foreseeable future; our ability to become profitable; our ability to raise additional
capital to continue our product development; our ability to accurately predict our future operating results; our ability to advance our
current or future product candidates through clinical trials, obtain marketing approval and ultimately commercialize any product candidates
we develop; the ability to obtain and maintain regulatory approval of our licensed indications and product candidates; delays in completing
the development and commercialization of our current and future product candidates; developing and commercializing additional products,
including diagnostic testing devices; our ability to compete in the marketplace; compliance with applicable laws, regulations and tariffs,
and factors described in the Risk Factors section of our public filings with the Securities and Exchange Commission (SEC). Because forward-looking
statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions
of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required
by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information,
future events and developments or otherwise.
Investor
Relations
ir@ainos.com
XML — IDEA: XBRL DOCUMENT
XML
Filename: R1.htm · Sequence: 9
v3.26.3
Cover
Sep. 24, 2026
Document Type
8-K
Amendment Flag
false
Document Period End Date
Sep. 24, 2026
Entity File Number
001-41461
Entity Registrant Name
AINOS,
INC.
Entity Central Index Key
0001014763
Entity Tax Identification Number
75-1974352
Entity Incorporation, State or Country Code
TX
Entity Address, Address Line One
3050
Post Oak Blvd
Entity Address, Address Line Two
Suite 510-T80
Entity Address, City or Town
Houston
Entity Address, State or Province
TX
Entity Address, Postal Zip Code
77056
City Area Code
281
Local Phone Number
898-6586
Written Communications
false
Soliciting Material
false
Pre-commencement Tender Offer
false
Pre-commencement Issuer Tender Offer
false
Entity Emerging Growth Company
false
Common Stock, par value $0.01 per share
Title of 12(b) Security
Common Stock, par value
$0.01 per share
Trading Symbol
AIMD
Security Exchange Name
NASDAQ
Warrants to purchase Common Stock
Title of 12(b) Security
Warrants to purchase Common
Stock
Trading Symbol
AIMDW
Security Exchange Name
NASDAQ
X
- Definition
Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.
+ References
No definition available.
+ Details
Name:
dei_AmendmentFlag
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Area code of city
+ References
No definition available.
+ Details
Name:
dei_CityAreaCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.
+ References
No definition available.
+ Details
Name:
dei_DocumentPeriodEndDate
Namespace Prefix:
dei_
Data Type:
xbrli:dateItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.
+ References
No definition available.
+ Details
Name:
dei_DocumentType
Namespace Prefix:
dei_
Data Type:
dei:submissionTypeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Address Line 1 such as Attn, Building Name, Street Name
+ References
No definition available.
+ Details
Name:
dei_EntityAddressAddressLine1
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Address Line 2 such as Street or Suite number
+ References
No definition available.
+ Details
Name:
dei_EntityAddressAddressLine2
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the City or Town
+ References
No definition available.
+ Details
Name:
dei_EntityAddressCityOrTown
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Code for the postal or zip code
+ References
No definition available.
+ Details
Name:
dei_EntityAddressPostalZipCode
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the state or province.
+ References
No definition available.
+ Details
Name:
dei_EntityAddressStateOrProvince
Namespace Prefix:
dei_
Data Type:
dei:stateOrProvinceItemType
Balance Type:
na
Period Type:
duration
X
- Definition
A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityCentralIndexKey
Namespace Prefix:
dei_
Data Type:
dei:centralIndexKeyItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Indicate if registrant meets the emerging growth company criteria.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityEmergingGrowthCompany
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.
+ References
No definition available.
+ Details
Name:
dei_EntityFileNumber
Namespace Prefix:
dei_
Data Type:
dei:fileNumberItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Two-character EDGAR code representing the state or country of incorporation.
+ References
No definition available.
+ Details
Name:
dei_EntityIncorporationStateCountryCode
Namespace Prefix:
dei_
Data Type:
dei:edgarStateCountryItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityRegistrantName
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b-2
+ Details
Name:
dei_EntityTaxIdentificationNumber
Namespace Prefix:
dei_
Data Type:
dei:employerIdItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Local phone number for entity.
+ References
No definition available.
+ Details
Name:
dei_LocalPhoneNumber
Namespace Prefix:
dei_
Data Type:
xbrli:normalizedStringItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 13e
-Subsection 4c
+ Details
Name:
dei_PreCommencementIssuerTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14d
-Subsection 2b
+ Details
Name:
dei_PreCommencementTenderOffer
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Title of a 12(b) registered security.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection b
+ Details
Name:
dei_Security12bTitle
Namespace Prefix:
dei_
Data Type:
dei:securityTitleItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Name of the Exchange on which a security is registered.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 12
-Subsection d1-1
+ Details
Name:
dei_SecurityExchangeName
Namespace Prefix:
dei_
Data Type:
dei:edgarExchangeCodeItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Exchange Act
-Number 240
-Section 14a
-Subsection 12
+ Details
Name:
dei_SolicitingMaterial
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Trading symbol of an instrument as listed on an exchange.
+ References
No definition available.
+ Details
Name:
dei_TradingSymbol
Namespace Prefix:
dei_
Data Type:
dei:tradingSymbolItemType
Balance Type:
na
Period Type:
duration
X
- Definition
Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.
+ References
Reference 1: http://www.xbrl.org/2003/role/presentationRef
-Publisher SEC
-Name Securities Act
-Number 230
-Section 425
+ Details
Name:
dei_WrittenCommunications
Namespace Prefix:
dei_
Data Type:
xbrli:booleanItemType
Balance Type:
na
Period Type:
duration
X
- Details
Name:
us-gaap_StatementClassOfStockAxis=AIMD_CommonStockParValue0.01PerShareMember
Namespace Prefix:
Data Type:
na
Balance Type:
Period Type:
X
- Details
Name:
us-gaap_StatementClassOfStockAxis=AIMD_WarrantsToPurchaseCommonStockMember
Namespace Prefix:
Data Type:
na
Balance Type:
Period Type: