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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date of report (Date of earliest event
reported): October 29, 2024
Y-MABS THERAPEUTICS, INC.
(Exact name of registrant as specified
in its charter)
Delaware |
|
001-38650 |
|
47-4619612 |
(State or other jurisdiction of
incorporation or organization) |
|
(Commission
File Number) |
|
(I.R.S. Employer
Identification No.) |
230 Park Avenue
Suite 3350
New York, New York 10169
(Address of principal executive offices)
(Zip Code)
(646) 885-8505
(Registrant’s telephone number,
include area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K
filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see
General Instruction A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of
the Act:
Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange on which
registered |
Common Stock, $0.0001 par value |
|
YMAB |
|
Nasdaq Global Select Market |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 1.01 Entry into a Material Definitive
Agreement.
On October 29, 2024, Y-mAbs Therapeutics, Inc., (the “Company”)
entered into a license agreement (the “License Agreement”) with Nobelpharma Co., Ltd. (“Nobel”),
effective October 23, 2024, pursuant to which the Company granted Nobel an exclusive license to develop and commercialize DANYELZA®
(naxitamab-gqgk) or other formulations of naxitamab (the “Licensed Product”) for the treatment of patients with neuroblastoma
and, potentially, relapsed osteosarcoma in Japan (the “Territory”).
The Company also agreed to license certain patents, and know-how related
to the Licensed Product, including data and results and the Company’s regulatory materials and strategies, to the extent necessary
in connection with Nobel’s efforts to obtain regulatory approval for and commercialize the Licensed Product in the Territory.
Nobel has agreed to use its commercially reasonable efforts to carry
out development of the Licensed Product necessary to obtain regulatory approval for the Licensed Product in the Territory. The Company
has agreed to bear 50% of certain development costs spent by Nobel for a specified Phase 1 study required for the development of the Licensed
Product.
In connection with the execution of the License Agreement, Nobel will
make an upfront cash payment to the Company of $2.0 million. Nobel is obligated to make additional payments of up to $31.0 million to
the Company based on achievement of specified product milestones and commercial milestones relating to the Licensed Product. Nobel is
also required to make low double-digit royalty payments on net sales of the Licensed Product in the Territory.
The License Agreement continues in force until terminated by either
party, or until the later of (i) the expiration of the licensed patents, (ii) the date after which a biosimilar has garnered more than
a specified percentage of the market, or (iii) 10 years after the product is first launched. Each party may terminate the License Agreement
if the other party materially breaches the License Agreement and does not cure such breach within a specified period or if a party experiences
certain insolvency events. In addition, Nobel may terminate the License Agreement in the event any safety issues arise with respect to
Naxitamab and/or it is not economically or commercially reasonably to develop or commercialize the Licensed Product in the Territory.
The License Agreement contains representations, warranties, covenants,
and indemnification provisions, subject to certain limitations.
The foregoing description of the License Agreement is not complete
and is qualified in its entirety by reference to the text of the License Agreement, a copy of which is attached to this Current Report
on Form 8-K (“Form 8-K”) as Exhibit 10.1 and incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On November 4, 2024, the Company issued a press release with
respect to the License Agreement described in Item 1.01 of this Form 8-K. A copy of the Company’s press release
is furnished as Exhibit 99.1 to this Form 8-K and incorporated herein by reference.
The information furnished pursuant to Item 7.01 of this Form 8-K,
including Exhibit 99.1 furnished herewith, 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,
except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
+ Portions of this exhibit have been omitted because the information
omitted is both not material and the type that the Company treats as private or confidential.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|
Y-MABS THERAPEUTICS, INC. |
|
|
|
Date: November 4, 2024 |
By: |
/s/ Michael Rossi |
|
|
Michael Rossi |
|
|
President and Chief Executive Officer |
Exhibit 10.1
Certain information (marked as
[***]) has been excluded from this exhibit because it is both (i) not material and (ii) is the type that the registrant treats as private or confidential.
LICENSE AGREEMENT
This License Agreement (this “Agreement”)
is made and entered into as of October 23, 2024 (the “Effective Date”) by and between:
Y-mAbs Therapeutics, Inc.
(“Licensor”), a corporation incorporated and existing under the laws of Delaware, with its registered principal
place of business at 230 Park Avenue, Suite 3350, New York, NY 10169, USA; and
Nobelpharma Co., Ltd.
(“Licensee”), a corporation incorporated and existing under the laws of Japan, with its registered principal place
of business at NMF Kayabacho Building, 1-17-24, Shinkawa, Chuo-ku, Tokyo 104-0033, Japan.
Licensor and Licensee are hereinafter
collectively referred to as the “Parties” and individually as a “Party.”
Recitals
Whereas, Licensor is currently
developing the product candidate using the Compound (as defined below) which target tumors that express GD2;
Whereas, Licensor has been granted
world-wide rights to develop, market and commercialize the Compound as described in that certain License Agreement between Memorial Sloane
Kettering Cancer Center (“MSK”) and Licensor as of August 15, 2015;
Whereas, Licensor is the owner
of the beneficial rights in and to the intellectual property rights relating to the Compound; and
Whereas, Licensee has expressed
its interest in receiving a sub-license of such intellectual property rights from Licensor to engage in the development and commercialization
of the Compound and the Licensed Product (as defined below).
Now, therefore, for and in consideration
of the premises and covenants contained herein, the Parties hereby agree as follows:
Article 1 Definitions
| 1.1 | For
the purpose of this Agreement, the following capitalized terms (the singular may include
the plural and vice versa) shall have the meaning respectively in this Article. |
| (1) | “Affiliate”
means any corporation or other business entity controlling, controlled by, or under common
control with any party; and for such purpose control means direct or indirect ownership of
more than fifty percent (50%) of the voting interest in such corporation or other business
entity. |
| (2) | “Business
Day” means a day other than Saturday, Sunday or any day on which the Bank of Japan
or commercial banks located in New York, New York are authorized or obligated by applicable
Laws to close. |
| (3) | “Calendar
Quarter” means each respective period of three (3) consecutive calendar months
ending on March 31, June 30, September 30 and December 31. |
| (4) | “Calendar
Year” means each respective period of twelve (12) consecutive calendar months ending
on December 31. |
| (5) | “Commercialization”,
“Commercialize” or “Commercializing” means any and
all activities conducted to commercialize the Licensed Product or other pharmaceutical products,
including, without limitation, manufacturing for sale, having made, importing, exporting,
marketing, packaging, promoting, distributing, offering for sale, selling, and consigning
for sale of the Licensed Product or other pharmaceutical products and all attendant medical
affairs activities. |
| (6) | “Commercial
Milestone Event” has the meaning ascribed to it in Section 6.3. |
| (7) | “Commercially
Reasonable”, or “Commercially Reasonable Efforts” means, with
respect to a Party (directly or through Affiliates or sublicensees) performing activities
under this Agreement, such reasonable, diligent, and good faith efforts as such Party would
normally use to accomplish a similar objective under similar circumstances, but no less than
the efforts and resources commensurate with those efforts commonly used in the biopharmaceutical
industry by a company of comparable size in connection with the development, manufacture
or commercialization of biopharmaceutical products of similar market potential at a similar
stage of development or commercialization in its product lifecycle, but, with respect to
Licensee’s obligations under this Agreement, not taking into account any competitive
product researched, developed or commercialized by Licensee or in which Licensee will share
profits or revenues from the sale thereof. Commercially Reasonable Efforts requires, with
respect to an obligation under this Agreement, that a Party reasonably and in good faith:
(i) set and seek to achieve reasonable objectives for carrying out such obligation and
(ii) reasonably make and implement decisions and allocate resources designed to advance
progress with respect to such objectives, all taking into account the factors referred to
above. |
| (8) | “Compound”
means Naxitamab. |
| (9) | “Confidential
Information” has the meanings ascribed to it in Article 14. |
| (10) | “Development”,
“Develop” or “Developing” means any and all studies,
test, research, development or other activities necessary or useful to seek, obtain and maintain
the Regulatory Approval for the Licensed Product, including, but not limited to, non-clinical
studies, clinical trials and safety tests of the Licensed Product or other pharmaceutical
products, filing an NDA for the Licensed Product, and negotiation with the Regulatory Authority
for the registration of the Licensed Product in the Territory. |
| (11) | “Development
Plan” has the meaning ascribed to it in Section 3.3. |
| (12) | “Indication”
means neuroblastoma (“NB”) and an option of Osteosarcoma (“OS”). |
| (13) | “Infringement
Notice” has the meaning ascribed to it in Section 11.3. |
| (14) | “JSC”
has the meaning ascribed to it in Section 4.1. |
| (15) | “Launch”
means the first commercial sale of a Licensed Product to a Third Party in the Territory by
Licensee or any of their respective Affiliates after the Regulatory Approval has been obtained
for such Licensed Product. |
| (16) | “Law”
shall mean any law, ordinance, regulation, rule, code, order, constitution, treaty, common
law, judgment, decree, guidance, directive, permit (including any Regulatory Approval), or
other requirement of any governmental authorities including any regulatory authorities. |
| (17) | “Licensed
Patents” mean, any Licensor Patents in the Territory as of the Effective Date or
at any time during the Term, that covers the Compound or Licensed Products including those
listed in Exhibit A that, in the absence of the right thereunder, would be infringed
by the activities by Licensee under this Agreement. |
| (18) | “Licensed
Product” means any pharmaceutical formulations using the Compound as an active
pharmaceutical ingredient for the Indication. |
| (19) | “Licensee
Indemnitees” has the meaning ascribed to it in Section 18.2. |
| (20) | “Licensee’s
Intellectual Property” has the meaning ascribed to it in Section 13.2. |
| (21) | “Licensor
Indemnitees” has the meaning ascribed to it in Section 18.1. |
| (22) | “Licensor
Know How” means all tangible and intangible techniques, technology, practices,
trade secrets, inventions (whether patentable or not), processes, formulations, media, designs,
formulas, ideas, programs, software models, algorithms, developments, experimental works,
protocols, methods, knowledge, know-how, skill, experience, data and results (including,
but not limited to pharmacological, toxicological and non-clinical and clinical data and
results), compilations of data, other works of analytical and quality control data, results,
descriptions, compositions of matter, regulatory materials and strategies related to or covering
a Compound or a Licensed Product which as of the Effective Date (i) is controlled by
or hereafter owned or controlled by Licensor or its Affiliates (ii) is not generally
known, (iii) is not covered by any Licensor Patent and (iv) is necessary for the
research, Development, manufacture, use, sale, distribution, importation, exportation or
Commercialization of the Licensed Products in the Territory. |
| (23) | “Licensor
Patents” means all patents and patent applications (whether provisional or non-provisional),
including continuations, continuations-in-part, divisions, renewals, counterparts, reissues,
reexaminations and extension of any of the foregoing, that (i) as of the Effective Date
and during the Term are owned or Controlled by Licensor or its Affiliates and (ii) claim,
cover, or would be practiced by, the research, Development, manufacture, use, sale, distribution,
importation, exportation or Commercialization of the Licensed Product. |
| (24) | “Licensor
Technology” means the Licensor Patents and the Licensor Know-How. |
| (25) | “Milestone
Payment” has the meaning ascribed to it in Section 6.4. |
| (26) | “NDA”
means a new drug application and all amendments and supplements thereto filed with regulatory
authorities, including all documents, data and other information concerning pharmaceutical
products which are necessary for gaining the Regulatory Approval to Commercialize such pharmaceutical
product within the Territory. |
| (27) | “Net
Sales” means gross amounts invoiced by the Licensee to a Third Party, in accordance
with generally accepted accounting principles in the Territory, for sales of the Licensed
Product, less the following, to the extent included in such gross invoiced sales or otherwise
directly paid or incurred by Licensee, sublicensee(s) or such Third Party: [***] The
Net Sales shall not include any transfer between Licensee and its sub-licensee(s) for
resale. |
| (28) | “Product
Milestone Event” has the meaning ascribed to it in Section 6.2. |
| (29) | “Regulatory
Approval” means the issuance or granting of all approvals necessary to Commercialize
the Licensed Product in the Territory. |
| (30) | “Regulatory
Authority” means a regulatory authority or governmental entity having responsibility,
jurisdiction, and authority to approve Commercializing of pharmaceutical products within
the Territory. |
| (31) | “Royalty”
has the meaning ascribed to it in Section 7.1. |
| (32) | “Term”
has the meaning ascribed to it in Section 15.1. |
| (33) | “Territory”
means Japan. |
| (34) | “Third
Party” means an entity other than Licensor, Licensee or the Affiliates of Licensor
or Licensee. |
| (35) | “Third
Party Compensation” has the meaning ascribed to it in Section 11.4. |
| (36) | “Trademark”
means a trademark used solely for the Licensed Product within the Territory as selected in
accordance with provisions in Article 10 whether registered or not. |
| (37) | “Valid
Licensed Patents” means issued patents within the Licensed Patent(s), with respect
to the Territory, that: (a) have not been revoked, declared unenforceable or unpatentable,
or held invalid by a court or other government agency of competent jurisdiction that is unappealable
or unappealed within the time allowed for the appeal; (b) have not been admitted to
be rendered invalid or unenforceable through reissue, disclaimer, or otherwise; and (c) have
not been finally cancelled, withdrawn, abandoned or rejected by any governmental agency of
competent jurisdiction. |
Article 2 License Grant
| 2.1 | Licensor
hereby grants to Licensee an exclusive royalty-bearing, non-transferable license in the Territory
under the Licensed Patents and the Licensor Know-How to Develop, research, use, obtain and
maintain the Regulatory Approval for, and to Commercialize the Licensed Product. |
| 2.2 | Subject
to the prior written consent of the Licensor, which consent shall not be unreasonably withheld,
Licensee shall have the right to grant sublicenses under the license granted pursuant to
Section 2.1 above in order to Develop and Commercialize the Licensed Product. Licensee
shall remain responsible for any and all sub-licensee(s)’ actions as if such actions
had been made by Licensee. |
Article 3 Development
| 3.1 | Licensor
shall disclose the Licensor Know-How to Licensee, solely as reasonably necessary and sufficient
to Develop, obtain and maintain the Regulatory Approval for, and Commercialize the Licensed
Product. Such disclosure of the Licensor Know-How will be made promptly after the execution
of this Agreement, and from time to time thereafter as Licensor acquires or generates additional
Licensor Know-How. It is agreed that without any required authorization, waiver of authorization,
or exemption under applicable privacy laws, no patient-specific information will be included
in the Licensor Know-How. It is further agreed that if Licensor discloses Licensee any patient-specific
information hereunder, Licensee shall only use or permit use of same for the purposes under
which Licensor received such information and for no other purpose without express patient
authorization. |
| 3.2 | Licensee
shall make and shall cause its sub-licensee(s) to make Commercially Reasonable Efforts
to carry out the Development of the Licensed Product necessary to obtain the Regulatory Approval
at its own expense and risk except as otherwise provided in this Agreement. Licensor shall
make reasonable efforts to support the Development and cooperate with Licensee to obtain
the Regulatory Approval. |
| 3.3 | Licensee
shall provide a reasonable development plan and timelines for the Development, which shall
include [***] (the “Development Plan”) of the Licensed Product(s) necessary
for obtaining the Regulatory Approval in the Territory. The Development Plan shall be an
integral part of this Agreement as Exhibit B hereto. In case Licensee intends to modify
the Development Plan substantially, Licensee shall notify Licensor of such intention as soon
as possible, and both Parties shall discuss in good faith the modification of the Development
Plan in the JSC (defined below). |
| 3.4 | Licensor
shall, at Licensee's reasonable request, cooperate with and provide all reasonable assistance
to Licensee's Development of the Licensed Products in accordance with the Development Plan,
including but without limiting the foregoing: |
| (a) | Licensor
shall provide Licensee with all reasonable assistance in obtaining Regulatory Approval for
the Licensed Products, including providing necessary documents or supporting data and materials
required by Regulatory Authority to obtain Regulatory Approval by Licensee; and/or |
| (b) | Licensor
shall keep Licensee reasonably informed in a timely manner of the status of the development
activities of Licensor, its Affiliates and its licensees relating to the Compound or any
Licensed Product outside the Territory including the safety and efficacy results generated
from such activities. |
| 3.5 | Licensee
will provide a copy or summary of material communication to and from the Regulatory Authority
in the Territory either in English or Japanese. Licensee will use Commercially Reasonable
Efforts to provide Licensor the important points of such communication in English and Licensor
will take care of the translation in case of Japanese. Licensor may give comments on any
communication from Licensee to the Regulatory Authority in the Territory, and Licensee shall
accept any of the comments which are reasonably acceptable. |
| 3.6 | In
accordance with, and as more specifically detailed the Development Plan, Licensor shall supply
Licensee the Compound and/or Licensed Product required and sufficient for Licensee in timely
manner to conduct Development free of charge together with written analytic data to verify
such Compound and/or Licensed Product. Licensee shall use the Compound and Licensed Product
provided exclusively by Licensor under this Article for Development purpose only. |
| 3.7 | Licensor
shall bear fifty percent (50%) of the Development costs spent by Licensee limited to Naxitamab
and [***] in the clinical trial required for the Development as described in the Developed
Plan attached hereto as Exhibit B. For avoidance of doubt, the Development costs under
this section include (a) fees for consultations with the Regulatory Authority related
to the Development, (b) Regulatory Approval application fee, (c) cost of concomitant
drugs used in combination with the Licensed Product in the clinical trial required for the
Development, (d) costs for any data and information acquired in the Development used
for the approval of the concomitant drug for the use in combination with Licensed Product,
Licensee will provide Licensor the information on the budgets for and costs actually incurred
in Development by Licensee. |
Article 4
Collaboration
| 4.1 | Within
[***] days after the Effective Date, the Parties shall establish a cross-functional, joint
steering committee (the “Joint Steering Committee” or the “JSC”),
to serve as a forum for information exchange, discussion and decisions with respect to Development
relating to the Licensed Products and the Compound in the Territory. |
| 4.2 | The
JSC shall be comprised of [***] named representatives of each Party (or such other number
as the Parties may agree in writing), each of whom will be an officer or employee of the
applicable Party having sufficient seniority within such Party to make decisions arising
within the scope of the JSC’s responsibilities. The JSC will be led by a chairperson
appointed by Licensee; provided that, if such chairperson is not reasonably acceptable to
Licensor and Licensor so informs Licensee (not more than once per Calendar Year), Licensee
shall appoint a replacement chairperson reasonably acceptable to Licensor. The role of the
chairperson shall be to convene and preside at the meeting of the JSC and to ensure the preparation
of meeting minutes, but the chairperson shall have no additional powers or rights beyond
those held by other JSC representatives. The JSC may change its size from time to time by
mutual consent of the Parties. Each Party may replace one or more of its representatives,
in its sole discretion, effective upon written notice to the other Party of such change.
Each Party’s representatives on the JSC, and any replacement for any such representative,
shall be bound by the obligations of confidentiality set forth in Article 14. |
| 4.3 | The
JSC shall, consistent with the terms and conditions set forth in this Agreement: |
| (a) | coordinate
the Parties’ Development and Regulatory Approval activities under this Agreement; |
| (b) | discuss
the overall strategy for the Development and Regulatory Approval throughout the Territory; |
| (c) | facilitate
communications and discussion between the Parties with respect to the Development; |
| (d) | discuss
and approve any substantial amendments or revisions to the Development Plan; |
| (e) | keep
track of the implementation of the Development Plan and review and serve as an information-sharing
forum for Development, including discussion of the results of the activities being carried
out thereunder; |
| (f) | define
and coordinate regulatory strategy for the Licensed Product; |
| (g) | resolve
disputed matters that may arise in relation to the Development; and |
| (h) | perform
any and all tasks and responsibilities that are expressly attributed to the JSC under this
Agreement or that are otherwise agreed by the Parties in writing. |
| 4.4 | The
JSC shall meet, until the Regulatory Approval is obtained or the Development is discontinued
by any reason, [***] or more or less often as otherwise agreed by the Parties, by videoconference,
teleconference, or in person as agreed by the Parties. The chairperson of the JSC shall be
responsible for calling meetings on reasonable prior notice. Prior to any meeting of the
JSC, the chairperson of the JSC shall prepare and circulate an agenda for such meeting. The
JSC shall agree on the minutes of each meeting as promptly as practicable, but in any event
within [***] Business Days, following such meeting. |
| 4.5 | As
appropriate (subject to the discretion of the chairperson of the JSC, with approval not to
be unreasonably withheld, conditioned or delayed), and provided that a prior written
notice (preferably two (2) or more Business Days before the meeting) has been given
to the other Party, other employees of the Parties may attend JSC meetings as observers. |
| 4.6 | Each
Party may also call for special meetings of the JSC with reasonable prior written notice
to the other Party to resolve particular matters requested by such Party. |
| 4.7 | If
the JSC is unable to reach a consensus regarding any technical discussion pertaining to Development
matters or regulatory affairs, final decision shall be made by Licensee. |
| 4.8 | Each
Party shall be responsible for all of its own expenses incurred in connection with participating
in all meetings. |
Article 5 Approvals
| 5.1 | After
the completion of the Development activities necessary to file an NDA for the Licensed Product,
Licensee shall use Commercially Reasonable Efforts to file and/or shall cause its sub-licensee(s) file
the NDA of such Licensed Product without undue delay and Licensee shall make and/or shall
cause its sub-licensee(s) to make its sincere endeavors to obtain the Regulatory Approval
in the Territory. |
| 5.2 | Licensee
hereby grants to Licensor the right to use, cross-reference, file or incorporate by reference
any relevant regulatory filings pertaining to the Licensed Products submitted by or on behalf
of Licensee in the Territory. Licensor and permitted sublicensees may use such rights of
reference solely for the purpose of seeking, obtaining and maintaining Regulatory Approval
and Commercializing Licensed Products outside the Territory and in interactions with any
Regulatory Authority in connection with Development, manufacturing or Commercialization outside
the Territory, subject in each case to Licensor’s obligation to provide written notice
to Licensee reasonably in advance of any submissions made in connection with such right of
reference or such interactions or other communications, in each case in order for Licensee
to consult with Licensor and to propose including, adopting or incorporating any reasonable
recommendations or instructions in connection with the rights granted under this Section 5.2. |
| 5.3 | Prior
to Licensee’s and/or its sub-licensee(s)’ filings of such NDA, Licensee shall
give Licensor an advance notice of such filings. Licensee shall furnish Licensor with a copy
of the filing documents submitted by Licensee and/or its sub-licensee(s) to the Regulatory
Authority for such NDA. |
| 5.4 | If
any question or comment is raised by the Regulatory Authority to Licensee and/or its sub-licensee(s) in
regard to the NDA, Licensee shall give and/or shall cause its sub-licensee(s) to give
appropriate answer to the Regulatory Authority in response to such questions or comments.
Licensee will provide a copy or summary of material communications regarding such questions
or comments either in English or Japanese as soon as practically possible. Licensor may give
comments on those communications and Licensee shall accept any of the comments which are
reasonably acceptable. Licensor will help Licensee at Licensee’s request respond to
said questions or comments as Licensor is reasonably able to do so. |
| 5.5 | Licensee
shall hold and control all Regulatory Approval and applications, amendments or supplements
underlying any such Regulatory Approval for the benefit of the Licensor. |
| 5.6 | After
obtaining Regulatory Approval for the Licensed Product, Licensee will aim to achieve an NHI
drug price of [***] yen per treatment course per patient (base on a USD/Yen exchange rate
of 1:138) or [***] USD, while the number of vials to be used in a treatment course will depend
on the judgment of the Regulatory Authority in the Territory. Licensee shall make a strategic
plan for the NHI drug price negotiations with the Regulatory Authority to achieve no less
than the aforementioned targeted NHI drug price or over and Licensor shall provide reasonable
assistance to such effort by Licensee. In cases of inquiries from Regulatory Authority regarding
the COGs of the Licensed Product, Licensor, in its commercially reasonable discretion, shall
have the ability, but not the obligation,, directly or indirectly through Licensee, to provide
reasonable answers to such inquiries. |
Article 6 Initial Payment and
Milestone Payments
| 6.1 | Subject
to the terms and conditions of this Agreement, Licensee shall pay Licensor the non-refundable,
one-time initial payment of two million US dollars (USD 2,000,000) to Licensor within
[***] days of the Effective Date. |
| 6.2 | Subject
to the terms and conditions of this Agreement, promptly following the first occurrence of
each of the events set forth below (each, a “Product Milestone Event”),
whether such Product Milestone Event is achieved by Licensee or its sub-licensee(s), Licensee
shall notify Licensor of the occurrence of such Product Milestone Event.: |
Product
Milestone Events
| 6.3 | Subject
to the terms and conditions of this Agreement, within thirty (30) days from the end of the
Calendar Quarter in which any commercial milestone event set forth below (each, a “Commercial
Milestone Event”) is achieved, whether by Licensee or its sub-licensee(s), Licensee
shall notify Licensor of the occurrence of such Commercial Milestone Event: |
Commercial
Milestone Events
| (1) | Exceeding
Cumulative Total Net Sales of USD [***]: |
USD [***] |
| (2) | Exceeding
Cumulative Total Net Sales of USD [***]: |
USD [***] |
| (3) | Exceeding
Cumulative Total Net Sales of USD [***]: |
USD [***] |
| (4) | Exceeding
Cumulative Total Net Sales of USD [***]: |
USD [***] |
| (5) | Exceeding
Cumulative Total Net Sales of USD [***]: |
USD [***] |
| 6.4 | Licensee
shall pay to Licensor the milestone payment set forth in Section 6.2 corresponding to
such Product Milestone Event within [***] days after an occurrence of such Product Milestone
Event; and the milestone payment set forth in Section 6.3 corresponding to such Commercial
Milestone Event by the end of the second month after the end of the Calendar Quarter with
the occurrence of such Commercial Milestone Event (each, a “Milestone Payment”). |
Article 7 Royalty Payments
| 7.1 | In
addition to the foregoing payments, during the Term of this Agreement, Licensee shall pay
to Licensor a quarterly royalty (“Royalty”) equal to [***] percent ([***]%)
of the Net Sales in a certain Calendar Year. |
| 7.2 | With
respect to any Calendar Year, [***] for Licensed Product held by Licensee [***] previously
paid by Licensee when the [***] (determined on [***] basis as defined by US GAAP) [***] imposed
by the Ministry of Health, Labor and Welfare. The [***] will be used to [***]. |
| 7.3 | Notwithstanding
the foregoing, after the last Valid Licensed Patents, are expired, and then only if generic/biosimilar
products are launched which capture [***] percent ([***]%) of the market for the Licensed
Product, the Royalty shall be [***] percent ([***]%) of the Net Sales commencing with the
next month. Notwithstanding the foregoing, the Parties will discuss Royalty rate adjustments
in case the NHI drug price is not achieved as aimed under Section 5.6. |
| 7.4 | Within
[***] Business Days from the end of each Calendar Quarter, Licensee shall deliver to Licensor
a written report showing its computation of the Royalty during such Calendar Quarter including
any inventory of Licensed Product subject to the credit memo under Section 7.2 above,
if any. Such report shall state the gross sales of the Licensed Product(s), the amount deducted
and the Net Sales for the relevant Calendar Quarter. |
| 7.5 | Licensor
shall issue and send Licensee an invoice for the Royalty for each of the Calendar Quarter
after receiving the report under Section 7.4. Licensee shall pay such Royalty within
[***] days of the invoice date, payable in US Dollars. |
| 7.6 | Licensee
shall keep and cause its sub-licensee(s) to keep complete, true and accurate books and
records with respect to the Net Sales, the Royalty payable by Licensee to Licensor under
Article 7 and the calculation thereof in sufficient detail to enable the determination
of such Royalty. |
| 7.7 | Licensor
shall have the right during the Term of this Agreement and for a period of [***] thereafter,
to have an independent certified public accounting firm, either mutually acceptable to Licensee
and Licensor or nominated by Licensor among the large international accounting firms examine
the relevant books and records of the accounts of Licensee, and/or its sub-licensee(s) to
determine whether the Royalty has been accurately reported by Licensee for the preceding
three (3) years period. Such examination shall not take place more often than one (1) time
during each Calendar Year. All expenses for such examination shall be borne by Licensor;
provided, however, that Licensee shall reimburse Licensor for all of such expenses if an
underpayment of more than [***] percent ([***]%) is discovered in Licensee’s reports
of the Royalty for the audit period. Licensor shall cause its accounting firm to retain all
financial information subject to review under this paragraph in strict confidence, and Licensee
shall have the right to require that such accounting firm, prior to conducting such audit,
enter into an appropriate non-disclosure agreement with Licensee regarding such financial
information. The accounting firm shall disclose to Licensor only whether the Royalty reports
are correct or not and the amount of any discrepancy, if any. Licensor shall treat all such
financial information as Licensee’s Confidential Information. |
Article 8 Payments
| 8.1 | All
payments due to Licensor hereunder shall be remitted by wire transfer to the following bank
account of Licensor: |
Bank
Name: |
[***] |
Bank
Address: |
[***] |
Bank
SWIFT CODE: |
[***] |
Banking
Routing Number: |
[***] |
Account
Number: |
[***] |
Account
Name: |
[***] |
When conversion
of payments from any foreign currency to US dollars is required, such conversion shall be at an exchange rate equal to the telegraphic
transfer middle rate published [***]
| 8.2 | In
the event of any withholding taxes being levied on payments under Articles 6 and 7 due to
Licensor under any applicable Laws or treaties, such taxes shall be withheld by Licensee
from the said payment. Licensee shall pay such taxes on behalf of Licensor to the appropriate
tax authorities and promptly furnish Licensor with official certificate of payment of such
taxes to permit Licensor to claim a tax credit therefor. If Licensor is entitled under any
applicable tax treaty to reduction or exemption of applicable withholding tax and intends
to benefit from such reduction or exemption under treaty, Licensor shall submit the required
forms and documentation to the appropriate tax authorities through Licensee before the payments
are made. Licensor shall provide any such required
forms and documentation to Licensee at
least fifteen (15) Business Days prior to the time that the payments are due. |
| 8.3 | In
the event that any payment due under this Agreement is not made when due, the payment shall
accrue interest from the date due at a rate per annum that is [***] percentage points ([***]%)
above the U.S. Prime Rate of interest as reported by Bloomberg on the date such payment is
due; provided, however, that in no event shall such rate exceed the maximum legal annual
interest rate. |
Article 9
Forecast, Delivery and Orders Forecast
| 9.1 | Subject
to the terms and conditions of this Agreement, for the purpose of Commercialization of the
Licensed Product in the Territory, Licensor shall be the exclusive supplier to Licensee of
the Licensed Products in unlabeled vials and shall supply the Licensed Products sufficient
for Commercialization in timely manner to Licensee on [***]. To avoidance of doubt, Licensee
has the right to furnish final package of Licensed Product for the Commercialization in the
Territory. |
| 9.2 | In
consideration for the supply of the Licensed Product in Section 9.1 above, Licensee
shall pay to Licensor a price (“Supply Price”) equal to the cost of goods sold
(“COGS”) plus [***]% per vial, where COGS means the actual manufacturing
and packaging costs as calculated under US GAAP. |
| 9.3 | Licensee
shall have the right during the Term of this Agreement and for a period of [***] thereafter,
to have an independent certified public accounting firm, either mutually acceptable to Licensor
and Licensee or nominated by Licensee among the large international accounting firms examine
the relevant books and records of the accounts of Licensor to determine whether the COGs
have been accurately calculated and reflected by Licensor to the Supply Price. |
| 9.4 | In
case of the marked increase in COGS (in yen terms) due to economic changes such as currency
exchange fluctuation and/or rising raw material costs placing Licensee in an economically
and commercially difficult situation to continue the Development, Commercialization and other
activities under this Agreement, the Parties will discuss in good faith to review and amend
the provisions of this Agreement. |
| 9.5 | Licensor
and Licensee shall conclude a supply and quality agreement based on mutual agreement that
defines detailed terms and conditions regarding supply and quality of the Licensed Products
respectively. |
Article 10 Trademark
| 10.1 | The
Trademark to be used by Licensee on the Licensed Product(s) shall be selected by Licensee
and shall be owned by Licensee. Licensee shall be responsible for the registration and maintenance
of such selected Trademark at its expense and risk. |
| 10.2 | Notwithstanding
the foregoing, if Licensee desires to use any trademark owned by Licensor by itself or through
its sub-licensee(s) in connection with the Commercialization of the Licensed Product(s) in
the Territory, Licensor, after reviewing and approving Licensee’s written proposal
for the use of the trademark, may in its sole discretion, grant Licensee a limited, royalty-free
license to use such trademark in connection with the Commercialization of the Licensed Product.
Licensee shall have right to use such Licensor’s trademark without any additional payment
other than Milestone Payments and Royalty defined in Articles 6 and 7. Licensee will indemnify
and hold harmless Licensor for any commercial liabilities growing out of such use. |
Article 11 Infringement
| 11.1 | Whenever
either Party becomes aware of any possible infringement of the Licensed Patents by a Third
Party, such Party shall promptly notify the other Party of any such infringement and shall
provide the other Party with any available evidence of such infringement. |
| 11.2 | Licensor
shall bring any action including lawsuit for infringement of the Licensed Patents. Any infringement
action brought by Licensor shall be solely at Licensor’s expense, and Licensee or its
sub-licensee(s) shall provide reasonable assistance at Licensor’s expense in the
prosecution of such action. Licensor shall not prosecute or settle such action in any manner
that affects Licensee’s rights in the Licensed Patents without the prior written consent
of Licensee. In the event that monetary damages are awarded or obtained by Licensor whether
by judgment, award, decree, settlement or otherwise, as a result of any infringement action
brought by Licensor, the money actually received shall be divided appropriately between Licensor
and Licensee with reference to the relative monetary injury suffered by the Party by reason
of the infringement, after first deducting the expenses incurred by Licensor in filing, prosecuting,
and maintaining such action. |
| 11.3 | In
the event a Third Party commences or threatens to commence any action including lawsuit against
Licensee, alleging infringement of such Third Party’s intellectual property rights
by Licensee’s or its sub-licensee(s)’ conducts or behavior of Development, Commercialization
or use of the Licensed Product, Licensee shall give prompt notice (“Infringement
Notice”) thereof to Licensor. Licensee shall have the right, but not the obligation,
to control the defense and settlement of any such action. If Licensee fails to exercise such
right within [***] days from the Infringement Notice, Licensor shall have the right, but
not the obligation, to control the defense and settlement of any such action solely on its
own behalf. Either Party shall not have the right to settle any such action in any manner
that could have any adverse effect on the other Party without the prior written consent of
such other Party. |
| 11.4 | Licensee
shall be entitled to deduct from any
amounts payable to Licensor under this Agreement (a) any amounts required to be
paid to a Third Party by Licensee or its sub-licensee(s) pursuant to 11.3 in order to
satisfy an award of damages or comply with a settlement agreement arising out of any claims
that Development, Commercialization, or use of the Licensed
Products by Licensee or its sub-licensee(s) independently of any Licensee Intellectual
Property infringes any intellectual property rights of such Third Party and (b) any
costs and expenses (including without limitation reasonable attorney’s fees) incurred
in connection with defending and/or settling any such claims and/or any invalidity, infringement
or other actions associated with (a). Further,
if the Parties agree that Licensee or
its sub-licensee(s) is required to obtain a license from any Third Party in order
to exercise its rights hereunder to Develop, Commercialize or use any Licensed Product, and
is required to pay to such Third Party a royalty, milestone payments or other fees in consideration
for the grant or maintenance of such license (“Third Party Compensation”)
it shall seek to enter such an agreement. Prior to finalizing such agreement, Licensee shall
give Licensor an opportunity to review and approve any proposal. Licensor will not unreasonably
withhold its approval. If any such agreement is approved by Licensor, the Licensee
shall be entitled to deduct an amount equal to [***]
percent ([***]%) of such Third Party Compensation paid by or
on behalf of Licensee to such Third Party during a Calendar Quarter, from the amounts of
Licensee’s Milestone Payment or Royalty otherwise due to Licensor in accordance with
Article 6 and Article 7 in a next Calendar Quarter. For clarity,
Licensee may carry over and apply any amount of aforementioned reductions, which are incurred
or accrued in a Calendar Quarter and are not deducted in such Calendar Quarter, to any subsequent
Calendar Quarter(s) in which Royalty or Milestone Payment are due. |
Article 12 Adverse Event
| 12.1 | Subject
to the restrictions of any applicable Laws, each Party shall disclose to the other Party
all reports and information received or obtained from any sources whether inside or outside
the Territory with respect to any adverse events of the Compound and/or a product containing
the Compound. |
| 12.2 | Licensee
shall be responsible for the collection, review, assessment, tracking and filing of information
related to adverse events associated with the Licensed Products in the Territory. |
| 12.3 | In
addition to the obligations set forth in Section 12.1 above, Licensee shall conduct
relevant post marketing surveillance activities to comply with the regulations in the Territory
at its sole expense and responsibility. |
| 12.4 | Detailed
terms and conditions regarding the exchange of drug safety information of Licensed Products
shall be concluded separately in Pharmacovigilance Agreement between both Parties. |
Article 13 Intellectual Property
and Intellectual Property Prosecution
| 13.1 | Except
as expressly provided herein, Licensor shall solely and exclusively own and hereby reserves
all rights, title, and interest in and to any Licensor Technology and all data, inventions,
discoveries and improvements including, but not limited to, formulation method, preparation
method, administration method and clinical application relating to the Compound and/or the
Licensed Product, whether patentable or not, developed by Licensor, its Affiliates, or in
conjunction with Licensee or on behalf of Licensee upon receiving Licensee’s written
consent hereto, and no rights, title or interest in and to the Licensor Technology or any
other intellectual property right is granted or otherwise conveyed by Licensor to Licensee,
whether by implication, estoppel, or otherwise. |
| 13.2 | Licensee
shall own and reserve all rights to any data, inventions, discoveries and improvements including,
but not limited to, formulation method, preparation method, administration method and clinical
application relating to the Compound and/or the Licensed Product, whether patentable or not,
developed hereunder only by Licensee or on behalf of only Licensee without using Licensor
Know-How (collectively, “Licensee’s Intellectual Property”). |
| 13.3 | Licensor
shall have an exclusive royalty-free license to use the Licensee’s Intellectual Property
outside the Territory. Licensee shall provide Licensor with the appropriate documentation
as may be needed to evidence such license. |
| 13.4 | Licensor
shall have responsibility for the preparation, filing, prosecution (including any interferences,
reissue proceedings and re-examinations) and maintenance of the Licensed Patents reasonably
needed to grant license stipulated in Section 2.1. In case of any patent application
within the Licensed Patents is filed by Licensor in the Territory, Licensor shall give Licensee
an advance notice of its filing date and serial number with a copy of such patent application
to be filed. |
| 13.5 | If
Licensor, in its sole discretion, decides to abandon the preparation, filing, prosecution
or maintenance of any patent or patent application in the Licensed Patents, then Licensor
shall notify Licensee in writing thereof, and following the date of such notice, Licensee
shall have the right to assume control, at its sole cost, for the preparation, filing, prosecution
and maintenance of such patents and patent applications, and shall have the right to offset
the cost thereof against amounts owing to Licensor hereunder. If Licensee fails to make such
an election, Licensor shall retain the right in its sole discretion to continue prosecution
and maintenance of such Licensed Patent or discontinue such work. |
| 13.6 | Licensee
shall have the sole right but not the obligation at its own expense to control the preparation,
filing, prosecution (including any interferences, reissue proceedings and re-examinations)
and maintenance of the Licensee’s Intellectual Property worldwide. Licensee shall keep
Licensor informed of progress with regard to the prosecution and maintenance of Licensee’s
Intellectual Property in the Territory, Licensee will consult with, and consider in good
faith the results and suggestions of, Licensor with respect to strategies for the filing
and prosecuting Licensee’s Intellectual Property in the Territory. |
| 13.7 | If
Licensee, in its sole discretion, decides to abandon the preparation, filing, prosecution
or maintenance of any patent or patent application in the Licensee’s Intellectual Property,
then Licensee shall notify Licensor in writing thereof, and following the date of such notice,
Licensor shall have the right to assume control, at its sole cost, for the preparation, filing,
prosecution and maintenance of such patents and patent applications, and shall have the right
to offset the cost thereof against amounts owing to Licensee hereunder. If Licensor fails
to make such an election, Licensee shall retain the right in its sole discretion to continue
prosecution and maintenance of such Licensee’s Intellectual Property or discontinue
such work. |
| 13.8 | It
is hereby acknowledged by the Parties that Licensor [***]. The Licensee shall make Commercially
Reasonable Efforts to timely provide any requested information and documentation [***]. |
Article 14 Confidential Information
| 14.1 | Either
Party shall treat all information (whether technical or non-technical) obtained from the
other Party (“Confidential Information”) as secret and confidential if
designated as such, and shall not supply or disclose to any Third Party any Confidential
Information during the Term of this Agreement and for a period of [***] years thereafter.
The foregoing obligations of confidentiality and non-use shall not apply to: |
| (a) | information
which at the time of disclosure is publicly known; |
| (b) | information
which thereafter lawfully becomes publicly known other than through disclosure by the receiving
Party; |
| (c) | information
which, as evidenced in the receiving Party’s written records, was known by it prior
to the disclosure thereof by the disclosing Party; |
| (d) | information
which is disclosed to the receiving Party by a Third Party not under obligation of confidentiality
to the disclosing Party with respect to said disclosure; or |
| (e) | information
which, as evidenced in the receiving Party’s written records, the receiving Party establishes
or is subsequently developed by an employee of the receiving Party without actual knowledge
of the Confidential Information. |
For
the avoidance of doubt, the Confidential Information includes the ‘Information’ as defined in and disclosed to the other
Party under the CONFIDENTIALITY AGREEMENT dated September 22, 2022 between the Parties.
| 14.2 | Notwithstanding
the foregoing, both Parties shall be entitled to use, supply or disclose the Confidential
Information for the purpose of implementing this Agreement to any of the following: |
| (a) | either
Party’s Affiliates, directors, officers, employees and representatives who have a need
to know, provided that the recipients have been informed of this Agreement and such Party
shall be responsible for such recipients’ use, supply or disclosure of the Confidential
Information as if such use, supply or disclosure had been made by such Party; |
| (b) | either
Party’s contract manufacturers, contract research organizations, professional service
providers, distributors, sub-licensees, attorneys, accountants, tax advisors, or other professional
advisors or consultants who have a need to know, provided that the recipients have been informed
of and are bound to secrecy obligations substantially similar to those in this Agreement; |
| (c) | Licensee’s
shareholders; |
| (d) | investors
and financial institutions to whom either party is necessary to provide Confidential Information
for the purpose of its financing, provided that the recipients have been informed of and
are bound to secrecy obligations substantially similar to those in this Agreement; or |
| (e) | the
Regulatory Authorities which have been advised of the confidential status of the Confidential
Information. |
| 14.3 | In
the event the receiving Party is required by a valid legal order of any governmental, regulatory,
or supervisory authority to disclose any Confidential Information received under this Agreement,
the receiving Party may disclose such Confidential Information to the extent necessary to
comply with such requirement; provided that receiving Party gives the disclosing Party reasonable
notice of its intent to disclose such information. |
Article 15 Duration and Termination
| 15.1 | This
Agreement shall become effective on the Effective Date and shall, unless otherwise terminated
sooner as provided hereunder, remain in effect until the later of (i) the date of the
Licensed Patents expiration including any granted PTE, (ii) the date after which biosimilar
market entry have garnered more than [***]% of the Product market, or (iii) ten (10) years
from the first Launch (“Term”). |
| 15.2 | In
the event of any material breach of this Agreement by either Party, the Party not in breach
shall have the option to terminate this Agreement if such breach is not cured by the other
Party within the period stipulated for such cure (not to be less than [***] days) in the
written notice sent by the non-breaching Party relating to the material breach. |
| 15.3 | Licensee
shall have the right and option to terminate this Agreement immediately at any time in case
any safety issues arise with Compound or any product using Compound, and/or it is not economically
or commercially reasonable to Develop or Commercialize Licensed Product in the Territory,
by [***] days prior written notice to Licensor without any liability. Neither Party shall
disclaim any rights or make any claims to the other Party except for those legally required
for terminating this Agreement and for those duly obtained under this Agreement prior to
the effective date of termination. |
| 15.4 | Either
Party shall have the right and option to terminate this Agreement immediately at any time,
by notice in writing to the other Party, in the event that such other Party: |
| (a) | is
unable to pay, or admits its general inability to pay to any creditor, or takes any step
inconsistent with an ability to pay its debts as they fall due and payable; |
| (b) | files
for voluntary, or any Third Party files against such other Party, a petition of liquidation,
bankruptcy, reorganization, compulsory composition, dissolution or similar proceedings; |
| (c) | passes
any resolution for or permits any proceedings for its dissolution; or |
| (d) | abolishes
its business. |
Article 16 Effect of Expiration
or Termination
| 16.1 | Upon
the expiration of this Agreement in the Territory, Licensee shall thereafter have an irrevocable,
fully paid-up, non-exclusive license under the Licensed Patents and Licensor Know-How to
Develop and Commercialize the Licensed Product in the Territory and, in order thereto, to
use and exploit the Licensed Patents and Licensor Know-How. |
| 16.2 | The
License and Licensor’s Trademark (if used under Section 10.2) granted under this
Agreement shall become irrevocable, fully paid-up, non-exclusive license and Licensee may
continue to Commercialize the Licensed Product under the Regulatory Approval, if: |
| (a) | this
Agreement expires pursuant to Section 15.1; |
| (b) | this
Agreement is terminated by Licensee due to material breach of Licensor pursuant to Section 15.2;
or |
| (c) | this
Agreement is terminated by Licensee pursuant to Section 15.4. |
| 16.3 | The
Regulatory Approval of Licensed Product shall be transferred to Licensor at no cost to Licensor,
if: |
| (a) | this
Agreement is terminated by Licensor due to material breach of Licensee pursuant to Section 15.2;
or |
| (b) | this
Agreement is terminated by Licensor pursuant to Section 15.4. |
| 16.4 | Upon
the expiration or termination of this Agreement in its entirety, except in the case of Sections
16.1 and 16.2, each Party shall without undue delay return to the other Party, delete or
destroy all Confidential Information including all copies thereof, except that each Party
(a) may retain one complete copy of the same for the purpose of determining its obligations
hereunder and (b) shall not be required to erase electronic files created in the ordinary
course of business during automatic system back-up procedures pursuant to its electronic
record retention and destruction practices that apply to its own general electronic files
and information. |
| 16.5 | Any
expiration or termination of this Agreement shall not relieve either Party’s obligations
set forth in Sections 13.2, 21.7 and 21.8, and Articles 12, 16, and 18 hereof, and the confidential
obligations in Article 14 shall survive for the period ascribed therein. |
Article 17 Warranty
| 17.1 | Each
Party hereby represents, warrants and covenants that, as of the Effective Date, such Party
is duly organized, validly existing under the Laws of its state or country of incorporation
and has full corporate power and authority to enter into this Agreement and carry out the
provisions hereof. |
| 17.2 | Each
Party hereby represents and warrants that, as of the Effective Date, such Party is duly authorized
to execute and deliver this Agreement and to perform its obligations hereunder. |
| 17.3 | Each
Party hereby represents, warrants and covenants that, as of the Effective Date: (a) this
Agreement is legally valid and enforceable in accordance with its terms, except as such enforceability
may be limited by applicable bankruptcy, insolvency, moratorium, reorganization or similar
Laws, from time to time in effect, affecting creditors’ rights generally; and (b) the
execution, delivery and performance of this Agreement by such Party does not, and will not
during the Term of this Agreement, conflict with any agreement, instrument or understanding
to which it is a party or by which it is bound, nor to the best knowledge of each Party as
of the Effective Date will such execution, delivery and performance violate any applicable
Laws. |
| 17.4 | Licensor
represents and warrants that, as of the Effective Date: |
| (a) | it
has sufficient legal and/or beneficial title to the Licensed Patents and the Know-How, with
the right to grant (sub)licenses, necessary to grant to Licensee the rights it purports to
grant to Licensee as provided under this Agreement; |
| (b) | to
the best of Licensor’s knowledge, there are no claims or demands of any person, firm,
or corporation pertaining to the Licensed Patents and to the best of its knowledge, no proceedings
have been instituted or are pending or threatened, which challenge the rights of Licensor
under the Licensed Patents; |
| (c) | to
the best of its knowledge, there are no matters which would be reasonably expected to affect
the validity of the Licensed Patents; |
| (d) | to
the best of its knowledge, there are no patents owned by Third Party, or other proprietary
rights of Third Party, that would be infringed or misappropriated by Developing or Commercializing
the Licensed Product in the Territory; |
| (e) | it
has received no notice from any Third Party that Developing, manufacturing or Commercializing
the Licensed Product infringe the proprietary rights of such Third Party; |
| (f) | Exhibit A
is a true, complete and current listing of the patents owned or controlled by Licensor that
relate to the Compound and the Licensed Product; |
| (g) | there
is no pending or, to the best of its knowledge, overtly threatened action by relevant Regulatory
Authorities that will have a material adverse effect on Licensee’s ability to conduct
the Development of the Compound and Licensed Product in the Territory; |
| (h) | Licensor
has disclosed or made available to Licensee for review all Licensor development data, Regulatory
materials, and other material information relating to the safety and efficacy of the Compound
and the Licensed Product, and all such information is complete and accurate in all material
respects; |
| (i) | it
has not engaged in any conduct or activity which could lead to any debarment action, and,
to the best of its knowledge, none of the entities, laboratories or clinical sites, or their
employees, representatives or agents participating in any pre-clinical or clinical studies
prior to the Effective Date has been debarred; |
| (j) | Licensor
and its officers, directors, employees, and Affiliates shall perform all obligations under
this Agreement in compliance with applicable Laws; |
| (k) | Licensor
will not engage in deceptive, misleading, illegal or unethical practices, representations,
statements or conduct that are or might be detrimental to Licensee, the Licensed products,
patients or the public; |
| (l) | to
the best of its knowledge, Licensor has no actual or perceived conflict of interest which
would adversely affect the performance of its obligations under this Agreement; |
| (m) | Licensor
will comply with all applicable national and international anticorruption laws (including
the US FCPA which prohibit bribery, offering, promising or giving any financial or other
advantage and the payment of money or anything of value to government officials, political
parties, candidates and any other person for the purpose of corruptly obtaining or retaining
business; and |
| (n) | Licensor
is not aware of any fact, act or omission that would constitute an inappropriate inducement
under applicable anti-bribery or anti-corruption laws. |
| 17.5 | Licensee
represents and warrants that, as of the Effective Date: |
| (a) | it
has not engaged in any conduct or activity which could lead to any debarment action, and,
to the best of its knowledge, neither any of its officers nor directors, employees, Affiliates,
and sub-licensees are debarred or disqualified by any Regulatory Authority in the Territory
in connection with any of their activities relating to the Compound or Licensed Products; |
| (b) | Licensee
and its officers, directors, employees, and Affiliates shall perform all obligations under
this Agreement in compliance with applicable Laws; |
| (c) | Licensee
will not engage in deceptive, misleading, illegal or unethical practices, representations,
statements or conduct that are or might be detrimental to Licensor, the Licensed Products,
patients or the public; |
| (d) | to
the best of its knowledge, Licensee has no actual or perceived conflict of interest which
would adversely affect the performance of its obligations under this Agreement; |
| (e) | Licensee
has and will maintain the necessary expertise to perform its obligations under this Agreement; |
| (f) | Licensee
will promote the Licensed Products in accordance with all applicable laws, regulations, this
Agreement and its self-regulatory codes; and |
| (g) | Licensee
will comply with all applicable national and international anticorruption laws (including
the US FCPA which prohibit bribery, offering, promising or giving any financial or other
advantage and the payment of money or anything of value to government officials, political
parties, candidates and any other person for the purpose of corruptly obtaining or retaining
business. |
| 17.6 | During
the Term of this Agreement, neither Party shall knowingly use any employee, representative,
agent, assistant or associate who has been debarred by any regulatory authority in connection
with any of the activities to be carried out under this Agreement. |
Article 18 Indemnifications;
Hold Harmless
| 18.1 | Licensee
shall indemnify, defend and hold Licensor and Licensor’s Affiliates and their respective
officers, directors, employees, partners and agents (“Licensor Indemnitees”)
harmless from and against any and all liability, damages, cost or expenses (including reasonable
attorneys’ fees and disbursements) incurred as a result of any claim made or suit brought
by a Third Party against Licensor Indemnitees arising out of the Development and Commercialization
of the Licensed Product by Licensee or Licensee’s breach of any warranties, representations
or covenants contemplated in this Agreement, except to the extent that such liability, damages,
costs or expenses are caused by the negligence or intentional misconduct or breach of covenant
in this Agreement by the Licensor Indemnitees. Upon receipt of any such claim or suit by
any of the Licensor Indemnitees, Licensor or such Licensor Indemnitees shall promptly notify
Licensee in writing of such claim or suit and shall permit Licensee to defend against and
control the defense of such claim or suit, provided that Licensee shall not compromise or
settle such claim or suit without the prior written approval of Licensor. Licensor or any
Licensor Indemnitees shall have the right to participate in the defense of such claim or
suit at its own expense; provided that Licensor or such Licensor Indemnitees shall not compromise
or settle such claim or suit without the prior written approval of Licensee. |
| 18.2 | Licensor
shall indemnify, defend and hold Licensee, Licensee’s Affiliates and its sub-licensee(s) and
their respective officers, directors, employees, partners and agents (“Licensee
Indemnitees”) harmless from and against any and all liability, damages, costs or
expenses (including reasonable attorney’s fees and disbursements) incurred as a result
of any claim made or suit brought by a Third Party against Licensee Indemnitees arising out
of Licensor’s manufacture and/or sale of the Compound or Licensed Product supplied
to Licensee that does not conform to its specifications or is not made in compliance with
GMP or Licensor’s breach of any warranties, representations or covenants contemplated
in this Agreement, except to the extent that such liability, damages, costs or expenses are
caused by the negligence or intentional misconduct or breach of covenant in this Agreement
by the Licensee Indemnitees. Upon receipt of any such claim or suit by any of the Licensee
Indemnitees, Licensee or such Licensee Indemnitees shall promptly notify Licensor in writing
of such claim or suit and shall permit Licensor to defend against and control the defense
of such claim or suit, provided that Licensor shall not compromise or settle such claim or
suit without the written approval of Licensee. Licensee or any Licensee Indemnitees shall
have the right to participate in the defense of such claim or suit at its own expense; provided
that Licensee or any Licensee Indemnitee shall not compromise or settle such claim or suit
without the prior written approval of Licensor. |
Article 19 Remedies
| 19.1 | The
Parties acknowledge that any breach of this Agreement may cause irreparable harm to the other
Party and agree that Licensor’s or Licensee’s remedies for any breach by the
other Party may include, in addition to damages and other available remedies, injunctive
relief against such breach. |
| 19.2 | It
is expressly understood that, except with regard to each Party’s obligation to indemnify
the other Party for indemnification liability to a Third Party under Article 18, neither
Party will be liable for any special, consequential, indirect, incidental or punitive damages,
under any cause of action, whether under any contract, negligence, strict liability or other
legal or equitable theory, with respect to any subject matter of this Agreement and whether
or not such Party or its agents have been advised of the possibility of such damage. This
limitation shall apply notwithstanding any failure of essential purpose of any limited remedy
provided herein. |
Article 20 Successors and Assigns.
| 20.1 | Neither
this Agreement nor any of the rights or obligations created herein may be assigned by either
Party, in whole or in part, without the prior written consent of the other Party, not to
be unreasonably withheld, conditioned or delayed, except that either Party shall be free
to assign this Agreement (a) to an Affiliate of such Party (for so long as such Affiliate
remains an Affiliate); provided that such Party shall remain liable and responsible to the
other Party for the performance and observance of all such duties and obligations by such
Affiliate, or (b) in connection with any sale of all or substantially all of the assets
of the Party that relate to this Agreement to a Third Party, whether by merger, consolidation,
divestiture, restructure, sale of stock, sale of assets or otherwise (a “Sale Transaction”;
such Third Party a “Third Party Acquirer”); provided that the party to which
this Agreement is assigned expressly agrees in writing to assume and be bound by all obligations
of the assigning Party under this Agreement. |
Article 21 Miscellaneous
| 21.1 | Disclaimer.
Except as otherwise expressly set forth in this Agreement, neither Party makes any representations
or extends any warranties of any kind, either express or implied, including, but not limited
to, warranties of merchantability, fitness for a particular purpose or non-infringement. |
| 21.2 | Force
Majeure. Any delay in the performance of any of the duties or obligations of either Party
shall not be considered a breach of this Agreement and the time required for performance
shall be extended for a period equal to the period of such delay, provided that such delay
caused by or is the result of any acts of God, acts of the public enemy, wars, terrorism,
insurrections, riots, embargoes, fires, explosions, floods, earthquakes, shortages of energy,
breach or failure on the part of any Third Party, or other unforeseeable causes beyond the
control and without the fault or negligence of the Party so affected. The Party so affected
shall give prompt notice to the other Party of such cause, and shall take whatever reasonable
steps are necessary to relieve the effect of such cause as rapidly as possible. |
| 21.3 | Severability.
In the event that any one or more of the provisions of this Agreement should for any reason
be held by a court or other governmental authority of competent jurisdiction to be invalid,
illegal or unenforceable, to the extent practicable such provision or provisions shall be
reformed or renegotiated to as nearly approximate the original reasonable intent of the Parties
as possible and the validity, legality or enforceability of the remaining provisions shall
in no way be affected or impaired thereby. |
| 21.4 | Non-waiver.
A Party’s failure to exercise or delay in exercising any right, remedy, power or privilege
hereunder shall not operate as a waiver thereof; nor shall any single or partial exercise
of any right, remedy, power or privilege hereunder preclude any other or further exercise
thereof, or the exercise of any other right, remedy, power or privilege. |
| 21.5 | Accrued
obligation. Expiration or termination of this Agreement for any reason shall not release
any Party from any liability which at the time of such expiration or termination has already
accrued to the other Party or which is attributable to a period prior to such expiration
or termination, nor preclude either Party from pursuing all rights and remedies it may have
hereunder or at law or in equity with respect to any breach of this Agreement. |
| 21.6 | Independent
contractor. The relationship between Licensor and Licensee is that of independent contractors.
Licensor and Licensee are not joint venturers, partners, principal and agent, employer and
employee, and have no other relationship other than independent contracting parties. Neither
Party shall have the authority to make any statements, representations or commitments of
any kind, or to take any action, which shall be binding on the other Party, without the prior
written consent of the other Party. |
| 21.7 | Governing
law. This Agreement shall be governed by the laws of England and Wales without regard
to principles of conflicts of law thereof. |
| 21.8 | Dispute
resolution. All disputes arising out of or in connection with this Agreement shall be
subject to the exclusive jurisdiction of the courts of England. |
| 21.9 | Captions.
The captions of paragraphs in this Agreement are for convenience only, and this Agreement
shall not be construed or interpreted by reference to such captions. |
| 21.10 | Notice.
All notices, given by one Party hereto to the other Party hereunder shall be in writing and
made by registered or certified air mail, facsimile, express overnight courier or delivered
personally to the following addresses of the respective Parties: |
|
If to Licensor: |
Y-mAbs therapeutics, Inc. |
|
|
230 Park Avenue, Suite 3350, |
|
|
New York, NY 10169, USA |
|
|
Attention: [***] |
|
|
E-mail: [***] |
|
|
|
|
with a copy to (which will not constitute
notice) |
|
|
Attention:
[***] |
|
|
Email: [***] |
|
|
|
If to Licensee: |
Nobelpharma Co., Ltd. |
|
|
NMF Kayabacho Building, 1-17-24, Shinkawa, |
|
|
Chuo-ku, Tokyo 104-0033, Japan |
|
|
Attention: [***] |
|
|
Email: |
[***] |
|
|
|
[***] |
The notice
under the preceding paragraph, unless otherwise provided, shall be deemed to be effective: (a) upon receipt if personally delivered
or e-mailed, or upon transmitted by facsimile with evidence of transmission; (b) on the tenth (10th) business day following
the date of mailing if sent by registered or certified air mail; or (c) on the third (3rd) business day following the
date of transmission if sent by express overnight courier. Either Party may change its address listed above by sending notice to the
other Party.
| 21.11 | Publicity.
Neither Party shall originate any publicity, news release, publication or public announcement,
written or oral, whether to the public press, stockholders or otherwise, concerning this
Agreement or the subject matter hereof without the prior written consent of the other Party.
The foregoing restriction shall not apply to information which, in the opinion of legal counsel
of the Party intending to make disclosure, is legally required to be disclosed by law, regulation
or court order, including responding to subpoena or other legal process, or fulfilling the
obligations of either Party (or any successor thereto) as a publicly traded corporation under
any applicable laws and regulations. |
| 21.12 | Execution
in counterparts. This Agreement may be executed in any number of counterparts, each of
which shall be deemed an original but all of which together shall constitute one and the
same instrument. |
| 21.13 | Entire
agreement. This Agreement constitutes the entire agreement between the Parties relating
to the subject matter hereof. This Agreement shall supersede any prior agreement between
the Parties hereof. No term or provision of this Agreement shall be varied or modified by
any prior or subsequent statement, conduct or act of either of the Parties, except that the
Parties may amend this Agreement by a written instrument specifically referring to this Agreement. |
[remainder of this
page intentionally left blank]
IN WITNESS WHEREOF, the Parties
have executed the Agreement as of the date first above written.
On behalf of Y-mAbs Therapeutics, Inc.
as Licensor:
By: | /s/
Mike Rossi |
|
Name: | Mike
Rossi |
|
Title: | CEO |
|
By: | /s/
Thomas Gadd |
|
Name: | Thomas
Gad |
|
Title: | Founder,
Vice-Chair, CBO |
|
On behalf of Nobelpharma Co., Ltd.
as Licensee:
By: | /s/
Jin Shiomura |
|
Name: | Jin
Shiomura |
|
Title: | Managing
Director & CEO |
|
Exhibit 99.1
Y-mAbs
and Nobelpharma Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) in Japan
New
York, NY and Japan, November 4, 2024 – Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization
of novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, and Nobelpharma Co., Ltd.
today announced that they have entered into an exclusive license and distribution agreement for the development and commercialization
in Japan of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and, upon agreement by the parties,
potentially relapsed osteosarcoma.
Under the terms of the
agreement, Nobelpharma will employ its regulatory, marketing, sales and access expertise to carry out development work and to submit DANYELZA
for approval by Japanese regulatory authorities, and to market, sell, and distribute DANYELZA in Japan, if approved. Pursuant to the agreement,
Y-mAbs will receive an upfront payment of $2.0 million from Nobelpharma in connection with entering into the agreement and is entitled
to receive up to $31.0 million in product and commercial milestone payments in addition to royalties in the low double digits on commercial
sales on DANYELZA, if successfully approved and commercialized in Japan.
“Our exclusive
license and distribution agreement with Nobelpharma in Japan is an important step in our continued global expansion efforts of DANYELZA,”
said Michael Rossi, President and Chief Executive Officer of Y-mAbs. “If approved in the region, we believe DANYELZA can deliver
a meaningful impact to patients in Japan fighting relapsed/refractory high-risk neuroblastoma and improve long-term quality of life for
these children.”
“We believe that
Nobelpharma is the right partner for Y-mAbs in Japan, and we are excited to work with Nobelpharma towards the potential approval and commercial
launch of DANYELZA in the region,” said Thomas Gad, Founder and Chief Business Officer of Y-mAbs. “DANYELZA, if approved in
Japan for relapsed/refractory high-risk neuroblastoma, will provide a new out-patient anti-GD2 therapeutic option for physicians in the
treatment of children facing this advanced form of pediatric cancer. We remain steadfast in our commitment to provide access to DANYELZA
and improve the lives of children and families around the globe facing advanced cancers.”
Researchers at Memorial Sloan Kettering Cancer
Center (“MSK”) developed DANYELZA® (naxitamab-gqgk), which is exclusively licensed by MSK to Y-mAbs. MSK has institutional
financial interests in the compound and Y-mAbs.
About DANYELZA® (naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in
combination with granulocyte-macrophage colony-stimulating factor ("GM-CSF"), for the treatment of pediatric patients 1 year
of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated
a partial response, minor response, or stable disease to prior therapy. This indication was approved under accelerated approval based
on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description
of clinical benefits in a confirmatory trial. DANYELZA® includes a Boxed Warning for serious infusion-related reactions, such as cardiac
arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for
complete Boxed Warning and other important safety information.
DANYELZA is currently not approved for the treatment
of osteosarcoma in any jurisdiction.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel, radioimmunotherapy and antibody-based therapeutic cancer products.
The Company’s technologies include its investigational Self-Assembly DisAssembly (“SADA”) ​Pretargeted
Radioimmunotherapy Platform (“PRIT”)​ and bispecific antibodies generated using the Y-BiClone
platform. The Company’s broad and advanced product pipeline includes the anti-GD2 therapy DANYELZA® (naxitamab-gqgk), the first
FDA-approved treatment for patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow after a partial response,
minor response, or stable disease to prior therapy.
Forward-Looking
Statements
Statements in this press release about
future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934. Such statements include, but are not limited to, statements about expectations relating to the Company’s
partnership with Nobelpharma, including the development process and regulatory submissions with respect to the potential approval and
commercialization of DANYELZA in Japan and the potential indications thereof; the receipt by the Company of any payments or royalties
from Nobelpharma; and other statements that are not historical facts. Words such as ‘‘anticipate,’’ ‘‘believe,’’
“contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’
‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’
‘‘plan,’’ ‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’
‘‘should,’’ ‘‘target,’’ “will,” ‘‘would’,’ “guidance,”
“goal,” “objective,” and similar expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. Our product candidates and related technologies are novel approaches to
cancer treatment that present significant challenges. Actual results may differ materially from those indicated by such forward-looking
statements as a result of various factors, including but not limited to: risks associated with the Company’s reliance on a third-party
for development work associated with the regulatory process with respect to and potential commercialization of DANYELZA in Japan; cost
and success of the Company’s and Nobelpharma’s product development activities and clinical trials; the risks of delay in the
timing of the Company’s and Nobelpharma’s regulatory submissions or failure to receive approval of DANYELZA in Japan; and
the risks related to commercializing any approved pharmaceutical product in a territory, including with respect to the rate and degree
of market acceptance. All statements are subject to the risks described in the “Risk Factors” section included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and the Company’s Quarterly Reports on Form 10-Q
for the quarterly periods ended March 31, 2024 and June 30, 2024, and future filings and reports by the Company. Any forward-looking
statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update any forward-looking
statement, whether as a result of new information, future events or otherwise.
DANYELZA® and Y-mAbs® are registered trademarks
of Y-mAbs Therapeutics, Inc.
Investor Contact:
Courtney Dugan
VP, Head of Investor Relations
cdu@ymabs.com
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