Document:

Exhibit 10.1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

TECHNICAL KNOWHOW LICENSE

AND SERVICING AGREEMENT

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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THIS Technical
Knowhow License and Servicing Agreement (this “Agreement”) is made on the 8th of November 2022
(“Effective Date”)

 

BETWEEN:

 

		(1)	Coinllectibles LIMITED (BVI
company number: 2067445), a company incorporated in the British Virgin Islands, with registered address at Mandar House, 3rd
Floor, Johnson’s Ghut, Tortola, British Virgin Islands (hereinafter the “Customer”); and

 

		(2)	DATACUBE RESEARCH CENTRE LIMITED (HK
company number: 2258257), a company incorporated in Hong Kong, with a registered address at Unit 1717-1718, 17/F., Star House, 3 Salisbury
Road, Tsim Sha Tsui, Kowloon (hereinafter the “Service Provider”).

 

(the Service Provider and the Customer
are hereinafter collectively referred to as the “Parties” and individually as a “Party”).

 

WHEREAS :

 

		(A)	The Customer has engaged the Service Provider to develop the Deliverables (to be defined hereinbelow)
for the Customer.

 

		(B)	The Service Provider and the Customer desire to enter into a transfer of Technical Knowhow and in which
the Service Provider will provide description of services to the Customer.

 

NOW, THEREFORE, in consideration of the
mutual promises and undertakings herein contained, the Parties, intending to be legally bound, do hereby agree as follows:

 

		1.	Definitions

 

		1.1	For purposes of this Agreement, the following terms shall have the following meanings:

 

		i.	“Deliverables” means any tangible property with the implementation of the Technical
Knowhow, including software media, delivered to the Customer under this Agreement, as specified in the Clause 7;

 

		ii.	“Project” means the combination of Services and Deliverables to be provided under this
Agreement;

 

		iii.	“Services” means any and all services specified in the Statement of Work (as defined
in Clause 3);

 

		iv.	“Technical Knowhow” means the technical knowhow as fully described in Clause 2; and

 

		v.	“USD” means the legal tender of the United States of America.

 

		1.2	In this Agreement, unless the context otherwise requires, words denoting the singular number only shall
include the plural and vice versa. Save as otherwise indicated, references to "Clauses" and the "Schedule"
are to be construed as references to clauses of, and the schedule to, this Agreement.

 

 

 

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		1.3	Words importing the masculine gender, feminine gender or neuter shall include the others. All capitalised
words and phrases used in the agreement shall bear the meanings ascribed to them as set out in the definitions of such capitalised words
and phrases in the Schedule. The Service Provider shall have final authority to interpret this Agreement and to make any and all determinations
under them, and its decision shall be binding and conclusive upon the Parties in respect of any questions arising under this Agreement.
The words ‘include’ and ‘including’ shall be deemed to be qualified by a reference to ‘without limitation’.

 

		1.4	The Recitals set forth hereinabove are incorporated into and made part of this Agreement.

 

		2.	Technical Knowhow

 

		2.1	Visual Intelligence Engine; Speech Recognition Engine; Text Analytics Engine; Emotion Recognition Engine;
Motion Recognition Engine; AI Agent Creation Engine; NFT Generation and Loading Engine for the Customer.

 

		i.	Description of Technical Knowhow

 

		(A)	Visual Intelligence Engine (Price: USD 5M)

 

		a.	Feature Extraction: This module is to extract the features from given images. (Price: USD 1M)

 

		b.	Training: This module is to train a DNN model with the extracted features in order to generate
a fingerprint model. (Price: USD2M)

 

		c.	Classification: This module is to classify artwork using the trained model. (Price: USD 2M)

 

		(B)	Speech Recognition Engine (Price: USD 5M)

 

		a.	Speech to Text: This module is used for identifying and transcribing voice into text. The voice
is captured in sound frequencies that can be analysed in order to associate each phoneme with a word or a group of words to constitute
a text. (Price: USD 1M)

 

		b.	Natural Language Processing: This module is used for translating human language into machine language.
It can analyse the sentence, extract a maximum of linguistic data and finally can generate the reply in text format to the user. (Price:
USD 2M)

 

		c.	Text to Speech: This module is to convert text into voice and inform the user by the conversational
interface. It corresponds to the feedback of the system which is expressed through a synthetic voice. (Price: USD 2M)

 

		(C)	Text Analytics Engine (Price: USD 10M)

 

		a.	Tokenization: This module refers to the process of breaking out long-form text into sentences and
words called “tokens”. These are, then, used in the models, like bag-of-words, for information retrieval tasks. (Price:
USD 2M)

 

		b.	Stemming: This module refers to the process of separating the prefixes and suffixes from words
to derive the root word form and meaning. (Price: USD 2M)

 

 

 

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		c.	Summarization: This module provides a synopsis of long pieces of text to create a concise, coherent
summary of a document’s main points. (Price: USD 1.5M)

 

		d.	Part-of-Speech Tagging: This module assigns a tag to every token in a document based on its part
of speech. (Price: USD 1.5M)

 

		e.	Feature Selection: This module refers to the process of selecting the important features (dimensions)
to contribute the most to output of a predictive analytics model. (Price: USD 1.5M)

 

		f.	Feature Extraction: This module refers to the process of selecting a subset of features to improve
the overall performance by dimensionality reduction. (Price: USD 1.5M)

 

		(D)	Emotion Recognition Engine (Price: USD 5M)

 

		a.	Image: This module is to classify the expressions on face images into various categories such as
anger, fear, surprise, sadness, happiness and so on. (Price: USD 1.5M)

 

		b.	Voice: This module is to recognize a speaker's emotion using tone and tempo information of a voice
signal. (Price: USD 2M)

 

		c.	Text: This module is to detect and recognize types of feelings through the expression of texts,
such as anger, disgust, fear, happiness, sadness, and surprise. (Price: USD 1.5M)

 

		(E)	Motion Recognition Engine (Price: USD 7M)

 

		a.	Detection: This module detects hand or body movements and segments the image to find hand edges
and positions with deep learning. (Price: USD 2M)

 

		b.	Tracking. This module monitors movements frame by frame to capture every movement and provide accurate
input for data analysis. (Price: USD 2.5M)

 

		c.	Recognition. This module tries to find patterns based on the gathered data. When it finds a match
and interprets a gesture, it performs the action associated with this gesture. (Price: USD 2.5M)

 

		(F)	AI Agent Creation Engine (Price: USD 7M)

 

		a.	Dialog: This module is to get agents talking. (Price: USD 1.5M)

 

		b.	Event: This module is to trigger different actions based on event sequences. (Price: USD 1M)

 

		c.	Path: This module is to let agents moving to destinations with the shortest path approach. (Price:
USD 1M)

 

		d.	Behaviour: This module is to assign behaviours to agents so that they can interact with others.
(Price: USD 1.5M)

 

		e.	Emotion: This module is to allow for agents to have emotions that can change due to different reasons
and at various rates. (Price: USD 2M)

 

 

 

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		(G)	NFT Generation and Loading Engine (Price: USD 6M)

 

		a.	Smart Contract: This module is to send objects to outside the Roblox metaverse in order to facilitate
the creation of smart contracts for NFT products. (Price: USD 2M)

 

		b.	Metadata: This module is to facilitate uploading metadata of objects to a file system for storage.
(Price: USD 2M)

 

		c.	NFT Loading: This module is to facilitate loading objects from outside and port them into the Roblox
metaverse. (Price: USD 2M)

 

		3.	Statement of Work 

 

		3.1	Implementation the Technical Knowhow

 

		i.	The work which the Service Provider shall perform is specified as below:

 

		(A)	The Service Provider shall perform and deliver to the Customer the implementation the Technical Knowhow
as set forth in Clause 2 to the tangible items as instructed from time to time by the Customer against and subject to the terms and conditions
of this Agreement.

 

		(B)	The Service Provider performs production for each Deliverables and deliver to the Customer within ninety
(90) days upon commencement of production. The Customer deserves rights to examine progress during production period.

 

		4.	Development Fee

 

		4.1	In consideration of the Service Provider delivering the Deliverables to the Customer, the Customer shall
pay the Service Provider USD 45 million, amortized as follows:

 

		(A)	Visual Intelligence Engine (Price: USD 5M)

 

		(B)	Speech Recognition Engine (Price: USD 5M)

 

		(C)	Text Analytics Engine (Price: USD 10M)

 

		(D)	Emotion Recognition Engine (Price: USD 5M)

 

		(E)	Motion Recognition Engine (Price: USD 7M)

 

		(F)	AI Agent Creation Engine (Price: USD 7M)

 

		(G)	Metaverse Development on Roblox (Price: USD 6M)

 

 

 

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		5.	Term

 

		5.1	The term of the service shall be for 3 years, commencing from the Effective Date or until the exercise
of Clause 13 or as provided in Clause 12.

 

		6.	Terms of payment

 

		6.1	Payment channel

 

		i.	By bank transfer whereby the Service Provider specify a bank account to the Customer over the Term.

 

		ii.	By digital currencies, unless otherwise agreed between the parties in writing, in the form of stable-coins
(“Digital Currencies”) whereby the Service Provider specify a wallet address to the Customer over the Term.

 

		6.2	Payment details

 

		i.	The Customer hereby agrees to pay the Service Provider a deposit in the sum equivalent to the Development
Fee amortized pursuant to each module as amortized in Clause 4.1 (A-G) hereinabove, within thirty (30) days from the pre-paid invoice
being issued for each amortized module, after the Customer has given notice to the Service Provider to start certain scope(s) of the Technical
Knowhow describes above.

 

		ii.	The Customer will receive pre-paid and completion invoices based upon the billing/payment schedule contained
in the applicable Statement of Work. Invoices will contain a description of the Services or Deliverables provided. The Customer shall
arrange for payment within thirty (30) days to the Service Provider. If any invoice is not paid when due, the Service Provider may not
start the provision of Services and/or Deliverables without liability or penalty until final resolution of the matter.

 

		iii.	If the Customer chooses to pay the Service Provider via Digital Currencies, the Customer agrees that a
5% handling fee based on the deposit sum will be levied in accordance with clause 6.2.i hereinabove (“Handling Fee”)
and the Customer undertakes to pay for such Handling Fee (if any).

 

		7.	Deliverables

 

		7.1	Except for commercial off-the-shelf type products where the license for such products is contained in
the applicable Statement of Work, the Customer shall have the perpetual nonexclusive license to use for commercial purposes, all Deliverables
under this Agreement with the Service Provider.

 

		7.2	All of the foregoing shall be deemed to be work made for hire, except as hereafter specified, and belong
to the Customer, with the Customer having the sole right to obtain, hold, and renew, in its own name or for its own benefit, patents,
copyrights, registrations, or other appropriate protection.

 

		7.3	The Customer acknowledges that the Service Provider uses, or may develop hereunder, methods, concepts,
code sequences, format, sequence structure, organization, menu command hierarchy, templates, masks, user interface, techniques, program
organization, database structuring techniques, and the like (“Service Provider Proprietary Items”) that are proprietary
to the Service Provider.

 

 

 

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		7.4	It is agreed that these Service Provider Proprietary Items shall remain the sole and exclusive property
of the Service Provider. The Service Provider grants the Customer a perpetual, non-exclusive, paid-up license to use the Service Provider
proprietary items subject to the following:

 

		i.	The Customer may use the Service Provider proprietary items solely in connection with the products purchased
hereunder, for the purpose for which those products were originally purchased.

 

		ii.	The Customer may not transfer, sell, or otherwise dispose of any Service Provider Proprietary Items without
the prior written consent of the Service Provider.

 

		iii.	This license gives no title or ownership rights in the Service Provider proprietary items or related intellectual
property to the Customer.

 

		iv.	The Customer agrees to retain or reproduce on all copies of any the Service Provider proprietary items
all copyright notices and other proprietary legends and all trademarks or service marks of the Service Provider or any third party.

 

		v.	The Customer will have no rights to assign or sell the license granted herein to others.

 

		vi.	The Customer grants the Service Provider a perpetual non-exclusive, paid-up license to use all portions
of the Deliverables first developed by the Service Provider during the performance of this Agreement, not to include content or any material
provided to the Service Provider by the Customer.

 

		8.	Acceptance

 

		8.1	The Deliverables, if any, shall be deemed accepted by the Customer upon completion of the following acceptance
test:

 

		i.	Immediately upon receipt of said Deliverables, the Customer shall promptly perform testing of the Deliverables
to confirm that the Deliverables perform in accordance with the documentation or other standards applicable thereto as set forth in the
Statement of Work.

 

		ii.	The Customer shall either promptly provide the Service Provider with written acceptance of the Deliverables,
or deliver to the Service Provider a detailed written statement of nonconformities to be corrected prior to the Customer’s acceptance
of the Deliverables. Unless otherwise agreed to in writing by the parties, the Service Provider will redeliver corrected Deliverables
to the Customer within a reasonable amount of time after receipt of such statement of nonconformities.

 

		iii.	Following redelivery of corrected Deliverables, a new acceptance test shall be immediately commenced by
the Customer. Any such written statement of nonconformities shall provide sufficient detail to enable the Service Provider to remedy the
failure to conform to the completion criteria.

 

		8.2	If the Customer fails to provide a written acceptance or a written statement of nonconformities within
five (5) days of initial receipt of said Deliverables or such other mutually acceptable period as defined in the applicable Statement
of Work, or within five (5) days of re-delivery of said corrected Deliverables or such other mutually acceptable period, the Deliverables
shall be deemed immediately accepted by the Customer.

 

 

 

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		9.	Warranties and Remedies

 

Warranties

 

		9.1	The Service Provider warrants Deliverable functionality substantially as defined in the Statement of Work
for a period of seven (7) days following final delivery.

 

		9.2	The Service Provider warrants that with respect to any Deliverable assigned by the Service Provider to
the Customer that the Service Provider has the right to transfer title to the Customer.

 

		9.3	The Service Provider further warrants that to its knowledge the Deliverables do not infringe any intellectual
property right held by a third party.

 

		9.4	The Customer’s sole and exclusive remedy and the Service Provider’s only obligation for breach
of the warranty hereunder will be, at the Service Provider’s option, to correct any material errors in provision of Services or
to replace or repair Deliverables which do not conform to the warranty.

 

Remedies

 

		9.5	In order for the Customer to exercise its remedy under this provision, the Customer must give the Service
Provider written notice of such nonconformity within the warranty period, and the Service Provider must determine that any nonconformity
did not arise due to any cause specified below.

 

		9.6	The Service Provider shall be given free and full access to deliverables to make corrections, and the
Customer shall promptly inform the Service Provider of any changes in the location of Deliverables during the warranty period. If this
remedy is adjudged to have failed of its essential purpose, the Service Provider’s total liability will be to refund the price paid
to the Service Provider by the Customer for the nonconforming Deliverables.

 

		9.7	The remedy provided by the Service Provider for breach of warranty does not include the following, which
may be provided, at the Service Provider’s sole option, at the Service Provider’s then-current time and materials rates:

 

		i.	Repair of damage caused by events beyond the Service Provider’s reasonable control.

 

		ii.	Repair of damage caused by the Customer’s improper installation, relocation, or rearrangement of
Deliverables.

 

		9.8	Except for the warranties stated in this clause, the Service Provider DISCLAIMS ALL OTHER WARRANTIES WITH
RESPECT TO THE SERVICES AND DELIVERABLES, EXPRESS OR IMPLIED, ARISING BY OPERATION OF LAW, COURSE OF DEALING, USAGE OF TRADE OR OTHERWISE,
INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND WARRANTIES AGAINST NON-INFRINGEMENT.

 

		9.9	The Service Provider expressly does not warrant that the operation of Deliverables which are software
shall be uninterrupted or error-free; or that Deliverables will operate on any system, or with any software, other than the system with
which the Service Provider tested such Deliverables. The Service Provider does not warrant any third-party software development tools.
The Service Provider specifically does not warrant the accuracy of any technical or subject matter content of the courseware or software
that is based upon information or direction provided by the Customer.

 

 

 

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		10.	Limitation of liability

 

		10.1	The total liability of the Service Provider to the Customer from any cause whatsoever, will be limited
to the lesser of the Customer’s actual damages or the Service Fee paid to the Service Provider for those Services and Deliverables
that are the subject of the Customer’s claim.

 

		10.2	In no event will either party be liable for SPECIAL, INDIRECT, CONSEQUENTIAL, OR INCIDENTAL DAMAGES, including
but not limited to loss of profits, revenues, data or power, damage to or loss of the use of products, damage to property, claims of third
parties, including personal injury or death, suffered as a result of provision of Services or use of Deliverables.

 

		10.3	Time for Claims: All claims against the Service Provider must be brought within one (1) year after the
cause of action arises and the Customer waives any statute of limitations which might apply by operation of law or otherwise.

 

		11.	Indemnification

 

		11.1	The Customer shall defend, indemnify, and save the Service Provider harmless, at the Customer’s
own expense, against any action or suit brought for any loss, damage, expense or liability that may result by reason of an infringement
of any patent, trademark, copyright, or trade secret based upon the normal and intended use of the Deliverables furnished to the Service
Provider hereunder.

 

		11.2	Should any of the Deliverables furnished to the Service Provider hereunder become the subject of a claim
of any infringement of a patent, trademark, copyright, or trade secret, the Customer shall, at its option and expense, deliver non-infringing
material, modify the material so that it becomes non-infringing, or procure for the Service Provider the right to continue using the Customer’s
infringing material.

 

		11.3	The Customer agrees to indemnify and hold the Service Provider harmless against all claims, liabilities,
demands, damages, or expenses (including attorneys’ fees and expenses) arising out of or in connection with the Customer’s
use of the Deliverables.

 

		12.	Force majeure

 

		12.1	Neither party shall be liable for failure to perform, nor be deemed to be in default, under this Agreement
for any delay or failure in performance resulting from causes beyond its reasonable control, including but not limited to failure of performance
by the other party, acts of state or governmental authorities, acts of terrorism, natural catastrophe, fire, storm, flood, earthquake,
riot, insurrection, civil disturbance, sabotage, embargo, blockade, acts of war, or power failure. In the event of such delay, the date
of delivery or time of completion will be extended by a period of time reasonably necessary to overcome the effect of any such delay.

 

		13.	Termination

 

		13.1	The Customer reserves the right to terminate a Service in whole or in part, upon 7 days written notice
to the Service Provider. In the event the Project is terminated by the Customer prior to completion, the Service Provider shall use its
best efforts to conclude or transfer the Project, as directed by the Customer, as expeditiously as possible.

 

 

 

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		13.2	The Service Provider shall not undertake further work, incur additional expenses, or enter into further
commitments with regard to the Project after receiving such notice of termination from the Customer, except as mutually agreed upon by
the parties. In the event of termination of a Project as described above, the Service Provider shall be entitled to compensation as follows:

 

		i.	All payments due and owing under this Agreement at the time of the Service Provider’s receipt of
the written notice of termination for work completed and in progress;

 

		ii.	Reimbursement for any non-cancellable services and commitments entered into by the Service Provider, in
connection with the Project being terminated, provided the Service Provider provides the Customer with documentation of completion of
work or expenses incurred.

 

		13.3	Termination of the Project shall not affect either party’s obligations in connection with any other
ongoing Projects and the rights and obligations of all non-terminating parties to the Agreement shall remain in full force and effect.

 

		13.4	Failure by either party to comply in any material respect with any of its obligations in this Agreement
shall entitle the other party to give notice to the party in default requiring it to cure such default. If such default is not cured within
seven (7) days after receipt of such notice, the notifying party shall be entitled to terminate this Agreement by giving notice of such
termination to take effect immediately.

 

		13.5	The right of either party to terminate this Service Contract, as herein provided, shall not be affected
in any way by its waiver of, or failure to take action with respect to, any previous default.

 

		14.	Delay or suspension of work

 

		14.1	If the Customer’s acts or failure to act causes the Service Provider to delay or suspend performance
of Services, the Service Provider and the Customer will mutually agree to one of the following remedies:

 

		i.	The Service Provider will use reasonable efforts to continue performance as practicable under the circumstances
and the Customer will continue to make all scheduled payments; or

 

		ii.	The Service Provider will re-assign personnel to extend the Service Provider’s work schedule without
liability, and the Customer will pay all additional costs, if any.

 

		14.2	Notwithstanding the above, the Service Provider shall have the right to invoice the Customer for any work
performed to date of suspension.

 

		15.	Confidentiality

 

		15.1	The Service Provider and the Customer acknowledge that during the course of the performance of a Project,
information of a confidential nature may be disclosed between the parties. Such information, excluding the Deliverables and any other
information incident to the Deliverables that a party could reasonably be expected to be provided to the other party as contemplated hereunder,
shall be considered confidential information (“Confidential Information”).

 

 

 

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		15.2	Neither party has the right to disclose the Confidential Information of the other, in whole or in part,
to any third party, and neither party will make use of the Confidential Information of the other for its own or a third party’s
benefit or in any way use such Confidential Information other than for the purposes of performance of this Agreement without the prior
written consent of the disclosing party. Each party agrees to take all steps reasonable to protect the other’s Confidential Information
from unauthorized use and/or disclosure.

 

		15.3	The parties agree not to copy in whole or in part, any Confidential Information nor modify the same in
any way without prior written consent from the other party. Neither party will be liable to the other for the disclosure of Confidential
Information if, as shown by clear and convincing evidence, the Confidential Information: (a) is generally known to the public at the time
of disclosure by the disclosing party; or (b) becomes generally known to the public through no fault of the receiving party; or (c) was
lawfully in the possession of the receiving party prior to signing this Agreement; or (d) is subject to applicable United States laws
or a valid court order requiring disclosure of such Confidential Information.

 

		15.4	In any judicial proceeding, it will be presumed that the Confidential Information in question constitutes
protectable trade secrets of the disclosing party, and the receiving party shall bear the burden of proving that the Confidential Information
was publicly or rightfully known or disclosed.

 

		16.	Publicity

 

		16.1	The Service Provider may use the Customer’s name or mark and identify as a client of the Service
Provider, on the Service Provider’s website and/or marketing materials. The Service Provider may issue a press release, containing
the Customer’s name, related to any award under this Agreement.

 

		16.2	Neither party will use the other party’s name or marks, refer to or identify the other party for
any other reason, except as established in this clause, without such other party’s written approval. Any approval required under
this clause shall not be unreasonably withheld or delayed by either party.

 

		17.	General terms

 

		17.1	This Service Contract shall be deemed to have been made, executed and delivered in state of the Republic
of Singapore and shall be construed in accordance with the laws of the Republic of Singapore.

 

		17.2	Notice to be given by either party under this Agreement shall be sent by certified mail, express
overnight delivery, or telecopy to the attention of the other party at the addresses of the parties as first set forth above.

 

		17.3	Severability and assignment: The invalidity or unenforceability, in whole or in part, of any provision
in this Agreement shall not affect in any way the remainder of the provisions herein. This Agreement may not be assigned by the Customer
without the Service Provider’s consent.

 

		17.4	Entire agreement: This Agreement, together with any other materials referenced in or expressly
made a part of the Agreement, constitutes the final and entire Agreement between the Service Provider and the Customer and supersedes
all prior and contemporary agreements, oral or written.

 

		17.5	Counterparts: The Parties hereto agree that digital signatures shall be as effective as if originals.
This Agreement may be executed via email in any number of counterparts, all of which taken together shall constitute one and the same
agreement.

 

 

 

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		18.	Dispute Resolution

 

		18.1	Any dispute or difference, whether contractual or non-contractual, arising out of or in connection with
this Agreement, including any question regarding its existence, validity or termination shall first be referred to mediation under the
Mediation Rules of The Law Society of Hong Kong. If the mediation is terminated (as defined in the Mediation Rules of The Law Society
of Hong Kong), without the dispute or difference having been resolved, within 21 days after such termination, any party may refer the
dispute or difference to arbitration for final resolution.

 

		18.2	Where following mediation in accordance with Clause 18.1 above, the parties are unable to reach a mutually
satisfactory resolution of the Disputes, except insofar as the parties elect to enforce this Agreement by judicial process or injunction
as provided in the preceding Articles hereof, the Disputes must be submitted to be finally resolved by arbitration in Hong Kong in accordance
with UNICITRAL Arbitration Rules for the time being in force. The arbitration shall be administered by Hong Kong International Arbitration
Centre (“HKIAC”) in accordance with its Practice Note on UNICITRAL cases. The appointing authority shall be the President
or Vice President of HKIAC Court of Arbitration. The language to be used in the arbitral proceedings shall be English.

 

		18.3	This Agreement shall be governed by, and construed in accordance with, the laws of Hong Kong (without
giving effect to principles of conflicts or choices of law).

 

		18.4	A person who is not a party to this Agreement has no right under the Contracts (Rights of Third Parties)
Ordinance (Chapter 623) of Hong Kong (or any similar law, regulation or rule in any jurisdiction) of Hong Kong to enforce any term of
this Agreement.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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IN WITNESS WHEREOF, the undersigned have executed this Agreement
as of the date first above written.

 

	CUSTOMER	 
	
    SIGNED, SEALED and DELIVERED

    CHAN MAN CHUNG

     

    its director(s) or authorised signature(s) (duly
    authorised by resolution of the board of directors) for and on behalf of

    COINLLECTIBLES LIMITED
	
    )

    )

    )

    )

    )

    )

    )

    )
	 
	 	 	 	 

 

	Service Provider	 
	
    SIGNED, SEALED and DELIVERED

    wong king shiu daniel

     

    its director(s) or authorised signature(s) (duly
    authorised by resolution of the board of directors) for and on behalf of

    DATACUBE RESEARCH CENTRE
    LIMITED
	
    )

    )

    )

    )

    )

    )

    )

    )
	 
	 	 	 	 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	 	13Document

Exhibit 10.4

Execution Copy

SETTLEMENT AND LICENSE AGREEMENT

This SETTLEMENT AND LICENSE AGREEMENT (this “Agreement”) is hereby entered into and made effective on April 18, 2022 (the “Effective Date”) by and among, on the one hand, Teva Pharmaceuticals International GmbH (“Teva GmbH”) and Cephalon, Inc. (“Cephalon,” together with Teva GmbH, “Teva”), and Eagle Pharmaceuticals, Inc., (“Eagle,” together with Teva, “Plaintiffs”), and on the other hand, Hospira, Inc. (“Hospira” or “Defendant”). Plaintiffs and Hospira (and Defendant) are referred to herein individually as a “Party” and collectively, as the “Parties.”

WHEREAS, Eagle owns United States Patent Nos. 9,034,908 (“the ’908 patent”); 9,144,568 (“the ’568 patent”); 9,572,887 (“the ’887 patent”); 9,597,397 (“the ’397 patent”); 9,597,398 (“the ’398 patent”); 9,597,399 (“the ’399 patent”); 9,000,021 (“the ’021 patent”); 9,579,384 (“the ’384 patent”); 10,010,533 (“the ’533 patent”); and 11,103,483 (“the ’483 patent”) (collectively, the “Asserted Patents”);

WHEREAS, Eagle also owns United States Patent Nos. 8,609,707 (“the ’707 patent”); 9,265,831 (“the ’831 patent”); 9,572,796 (“the ’796 patent”); 9,572,797 (“the ’797 patent”); 10,052,385 (“the ’385 patent”) (collectively, with the Asserted Patents, the “Eagle Patents”);

WHEREAS, Teva owns United States Patent No. 8,791,270 (“the ’270 patent”) (collectively, with the Eagle Patents, the “Orange Book Patents”);

WHEREAS, Eagle is the holder of New Drug Application No. 208194, which is approved by the Food and Drug Administration (“FDA”) for the manufacture and sale of bendamustine hydrochloride injection solution in a 100 mg/4 mL (25 mg/mL) dosage strength for intravenous infusion over ten (10) minutes from a 50 mL infusion bag and used for the treatment of chronic lymphocytic leukemia (“CLL”) and non-Hodgkin’s lymphoma (“NHL”) which Teva and its Affiliates market in the Territory under the brand name BENDEKA®;

WHEREAS, Eagle and Cephalon entered into an Exclusive License Agreement on February 13, 2015, as amended (the “Exclusive License Agreement”), pursuant to which Eagle granted Cephalon an exclusive license under certain patents, including the Eagle Patents, for the commercialization of the Bendeka® NDA Product (as defined below) in the Territory (as defined below), including the right to sue for patent infringement;

WHEREAS, on or around October 14, 2015, Cephalon assigned its rights in the Exclusive License Agreement to Teva GmbH;

WHEREAS, Hospira is the holder of New Drug Application No. 211530, which was submitted to the FDA pursuant to 21 U.S.C. § 355(b)(2) seeking approval to market in the United States a generic bendamustine hydrochloride injection solution in a 25 mg/1 mL, 100 mg/4 mL, and 200 mg/8 mL (25 mg/mL) dosage strength
containing a certification pursuant to 21 U.S.C.
§ 355(b)(2)(A)(iv), alleging that the Orange Book Patents are not infringed or invalid;
			
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Exhibit 10.4

WHEREAS, Plaintiffs have contended that the Asserted Patents are valid and enforceable and that, but for the license granted to Hospira under this Agreement, the commercial manufacture, use, sale, offering for sale, or importation of Hospira Product (as defined below) in or for the Territory would infringe the Patents-In-Suit;

WHEREAS, Hospira has contended that the product described in the Hospira NDA (as defined below) does not infringe the Asserted Patents and/or that those patents are invalid;

WHEREAS, Plaintiffs and Defendant are involved in two (2) litigations in the United States District Court for the District of Delaware (the “District Court”), namely (i) Civil Action No. 18-cv-01704 (CFC) and (ii) Civil Action No. 21-cv-01619 (CFC) (collectively, the “Lawsuits”), concerning, inter alia, the validity of the Asserted Patents, as well as the alleged infringement by Defendant of the Asserted Patents resulting from the filing by Defendant of the Hospira NDA and related certification pursuant to 21 U.S.C. § 355(b)(2)(A)(iv);

WHEREAS, on December 16, 2019, the District Court denied Hospira’s motion to dismiss with respect to the ’887 patent and granted Hospira’s motion to dismiss with respect to all other patents asserted in Civil Action No. 18-cv-01704 (CFC), as a result of which the ’887 patent and the ’483 patent asserted in the second of the two (2) Lawsuits referenced in the immediately foregoing recital are the remaining asserted patents in the Lawsuits (the “Patents-In- Suit”);

WHEREAS, Plaintiffs have previously sued other defendant ANDA filers Apotex Inc. and Apotex Corp. (collectively, “Apotex”), Fresenius Kabi USA, LLC (“Fresenius Kabi”), Mylan Laboratories Ltd. (“Mylan”), and Slayback Pharma LLC (“Slayback”) for infringement of certain of the Orange Book Patents;

WHEREAS, on July 6, 2020, the district court entered judgment for Plaintiffs and against Apotex, Fresenius Kabi, Mylan, and Slayback for infringement and non-invalidity of one or more of the Orange Book Patents in Civil Action No. 15-cv-01154 (CFC);

WHEREAS, Apotex, Fresenius Kabi, and Mylan appealed this Court’s judgment of non- invalidity to the United States Court of Appeals for the Federal Circuit, which affirmed the district court’s judgement in Case No. 20-2134 on August 13, 2021, and denied Apotex and Mylan’s Petition for Rehearing En Banc on October 15, 2021;

WHEREAS, Apotex filed a petition for a writ of certiorari with the United States Supreme Court in Case No. 21-893 on December 14, 2021, which the Supreme Court denied on February 22, 2022;

WHEREAS, Plaintiffs are involved in litigations in the District Court for infringement of the Patents-In-Suit, pursuant to which Plaintiffs have sued (i) Accord Healthcare Inc. in Civil Action No. 21-952-952 (CFC) (the “Accord Litigation”) and (ii) Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. in Civil Action No. 21-cv-00695 (CFC) (the “DRL Litigation”);

WHEREAS, the Parties desire and agree to enter into this Agreement to avoid the costs, uncertainty, and risk associated with continued litigation of this matter, including the pending
			
	2

			
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Exhibit 10.4

Lawsuits, and to pennit entiy of generic competition prior to the expiration of the Patents-In-Suit upon the tenns and subject to the conditions set fo1th herein, and Defendant agrees not to make, have made, use, sell, offer for sale or impo1i the Hospira Product in the Te1Tito1y before the License Effective Date (as defined below) except as expressly pennitted by the tenns and conditions of this Agreement;

WHEREAS, other than the stipulation dismissing Hospira from the Lawsuits, this Agreement is the only agreement between the Paiiies related to the settlement of the Lawsuits with respect to the Hospira NDA and the Hospira Product; and

WHEREAS, no Paiiy has received any consideration from any other Pa1iy for its entiy into this Agreement other than that which is described in this Agreement.

NOW, THEREFORE, in consideration of the mutual promises and covenants herein contained and the consideration described herein, the sufficiency and receipt of which ai·e hereby acknowledged, the Paiiies hereto, intending to be legally bound hereby, agree as follows:

1.DEFINITIONS

1.1"Affiliates" means, with respect to a Pa1iy, any entity that, directly or indirectly, through one or more inte1mediai·ies, conu-ols, is conti·olled by, or is under common conu-ol with, such Paiiy. For purposes of this definition, "conti·ol" (including the tenns "conu-olled by" and "under common conti·ol with") of a business entity means the direct or indirect ownership of more than fifty percent (50%) of the voting stock or other ownership interest in such entity; or the direct or indirect ownership of the power to direct the management and policies of the other entity by any means whatsoever. For clai·ity, legal counsel for a Party ai·e not Affiliates.
1.2"ANDA" means an abbreviated new diug application filed pursuant to 21 U.S.C.
§ 355(j).

1.3"ANDA Product" means a phaimaceutical product that (a)(i) is a bendamustine hydi·ochloride solution, and (ii) is therapeutically equivalent to the Bendeka®
NDA Product, as manufactured or sold for use in the Te1Tito1y in a 100 mg/4 mL
			
	3

			
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Exhibit 10.4

25 m /mL

•• ••

.    !   I    • •    •• •

·    • •

•• • • •    ••

for the u-eatment of CLL and NHL    -

and (b) is sold, offered for sale or disu-ibuted under an ANDA that references the Bendeka®NDA Product as the reference-listed diug and is filed or othe1wise conu-olled by a person or entity other than Plaintiffs or their Affiliates. For the avoidance of doubt, the Hos ira Product is not an ANDA
			
	4

			
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Exhibit 10.4

1.1"Bendeka®NDA" means NDA No. 208194, and any amendments or supplements thereto, including additional indications, additional dosage strengths, or additional infusion bag volumes between 25 to 100 mL that are added to NDA No. 208194 after the Effective Date.

1.2"Bendeka®NDA Product" means the bendamustine hydrochloride solution product that is the subject of the Bendeka®NDA and marketed in the Tenito1y under the BENDEKA® trademark or any successor trademark thereto in a 100 mg/4 mL (25 mg/mL) dosage strength for intravenous infusion over ten (10) minutes from a 50 mL infusion ba and used for the treatment of CLL and NHL,

1.3"Controlled" means, with respect to any patent right granted to Defendant, and/or regulato1y exclusivity waived by the relevant Plaintiff, under this Agreement, the ownership of, or exclusive license rights to, such patent right and/or regulato1y exclusivity by the relevant Plaintiff or its Affiliates that pennits such Plaintiff or its Affiliates to grant such patent right or waive such regulato1y exclusivity to Defendant without violating the tenns of any agreement or other aiTangement
with any Third Paiiy or being obligated to pay any royalties or other consideration therefor. Notwithstanding the foregoing, with respect to any patent right and/or regulato1y exclusivity Controlled by an Affiliate of a Plaintiff, such patent right and/or regulato1y exclusivity will only be treated as "Controlled" under this Agreement for so long as such Affiliate remains an Affiliate of such Plaintiff.
1.4"Final Comi Decision" means a decision by a comi on the merits (e.g., after a trial or summaiy judgment motion) whereby such court enters final judgment from which no appeal (other than a petition to the United States Supreme Comi for a writ of ce1iiorai·i) has been or can be taken.

			
	5

			
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Exhibit 10.4

1.5
			
	6

			
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Exhibit 10.4

1.4"Hospira Product" means the NDA Product that is the subject of the Hospira NDA.
1.5"License Effective Date" means the earliest to occur of the following:

(a)Januaiy 17, 2028; (b)

provided, however, that a License Effective Date under this clause (b) shall (i) occur only if the Third Pa1ty against whom the Licensed Patents or a subset thereof were asserted in connection with such Final Court Decision included in its NDA or ANDA for its NDA Product or ANDA Product, respectively, a ce1tification pursuant to 21 U.S.C.

(c)the date of a decision by the United States Patent Trial and Appeal Boai·d ("PTAB") from which no appeal (other than a petition to the United States Supreme Comt for a writ of ce1tiorari) has been or can be taken, that all of the adjudicated and unexpired claims of the Licensed Patents ai·e unpatentable;

			
	7

			
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Exhibit 10.4

(d)the date on which all of the Patents-In-Suit have expired, become pennanently abandoned or disclaimed, withdrawn, or delisted from the Orange Book.

1.6"Licensed Patents" means the Patents-In-Suit, any conections, extensions (including pediatric exclusivities), reissues, or reexaminations of such patents, and any amended claims of such patents arising out of an inter partes review, post grant review, or other patent proceeding.
1.7"NDA" means a new drng application filed pursuant to 21 U.S.C. § 355(b)(2).

1.8"NDA Product" means a phannaceutical product that (a)(i) is a bendamustine hydrochloride solution, (ii) is therapeutically equivalent to the Bendeka®NDA Product, as manufactured or sold for use in the Tenito1y in a 100 mg/4 mL (25
Ill

and (b) is sold, offered for sale or distributed under an NDA that references the Bendeka®NDA Product as the reference-listed drng and is filed or othe1wise controlled by a person or entity other than Plaintiffs or their Affiliates. For the avoidance of doubt an NDA Product does not include 1

1.9"Orange Book" means FDA's publication entitled Approved Drng Products with Therapeutic Equivalence Evaluations.
1.10"Other Patents" means, other than the Licensed Patents, any other patent, including but not limited to Orange Book Patents that are not Patents-In-Suit, or patent application, and any conections, extensions (including pediatric exclusivities), 
			
	8

			
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Exhibit 10.4

reissues, or reexaminations of such other patents or amended claims of such other patents arising out of an inter partes review, post-grant review, or other patent proceeding Controlled now or in the future by a Plaintiff or any of its Affiliates that claim or cover the making, using, selling, offering for sale or impo1iation of the Hospira Product in the Tenito1y.
1.11
			
	9

			
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Exhibit 10.4

1.1“Third Party” means any entity or person that is not a Party or an Affiliate of a Party.

2.SETTLEMENT; DISMISSAL; RELEASE

2.1All of the terms and conditions set forth in this Agreement shall be binding on the Parties and their Affiliates as of the Effective Date.

2.2Dismissal. In consideration of the mutual benefits of entering into this Agreement, the Parties shall enter into and cause to be filed with the District Court, within five (5) days of the Effective Date, a joint motion to dismiss with prejudice all claims, defenses, and counterclaims as between Plaintiffs and Defendant in the Lawsuits, substantially in the forms attached hereto as Exhibit A.

2.3Release. In settlement of the disputed claims in the Lawsuits, and in consideration of the mutual execution of this Agreement and the mutual agreement to be legally bound by the terms hereof, each Plaintiff, on the one hand, and Defendant, on the other hand, on behalf of itself and its predecessors, successors, assigns, shareholders, officers, directors, employees, trustees, agents, representatives, licensees, licensors, parents, subsidiaries and Affiliates and all others claiming by, through and under them, hereby fully, finally, irrevocably and forever (but subject to this Section 2.3) releases, relinquishes, acquits and discharges the other Party and its predecessors, successors, assigns, shareholders, officers, directors, employees, agents, representatives, licensees, licensors, parents, subsidiaries, Affiliates, customers, suppliers, importers, manufacturers, and distributors, if any, from any and all claims, demands, causes of action, liabilities, losses, all manner of actions, judgments, settlements, interest, damages, punitive damages and other damages or costs of whatever nature (including costs, expenses, and attorneys’ fees), whether known or unknown, foreseen or unforeseen, certain or contingent, accruing before the Effective Date, arising out of, derived from, predicated upon, or relating to the Hospira Product and Hospira NDA or its filing; provided, however, that nothing herein shall (i) constitute a release of any obligations of Plaintiffs or Defendant (or their respective Affiliates) under this Agreement or prevent a Party from invoking the continuing jurisdiction of the District Court in the Lawsuits to enforce the terms and provisions of this Agreement or (ii) prevent or impair the right of any Party to bring a proceeding in court or any other forum for a breach of this Agreement or any representation, warranty, or covenant herein, or with respect to any product other than the Hospira Product, or any proceeding outside of the Territory. Notwithstanding anything to the contrary, nothing included herein is intended to restrict, limit, or otherwise abrogate any rights Hospira and its Affiliates have under 35 U.S.C.
§ 271(e)(1).

2.4Unknown Claims. Each Party, on behalf of itself and its Affiliates, hereby expressly waives and relinquishes any and all provisions, rights and benefits conferred by Section 1542 of the California Civil Code, which provides as follows:
			
	10

			
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Exhibit 10.4

A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS WHICH THE CREDITOR DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE, WHICH IF KNOWN TO HIM OR HER MUST HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR.

Further, each Paiiy, on behalf of itself and its Affiliates, and its and their respective directors, officers, members, managers, paitners, employees, agents, representatives, assigns, predecessors, successors or other related persons or entities, expressly waive and relinquish all rights and benefits afforded by any law in any other jurisdiction similai·to Section 1542 of the California Civil Code.

1.1

1.2

1.3No Assignment of Claims. Each Paiiy represents and wanants and covenants that it has not heretofore assigned or ti·ansfe1Ted, and will not assign or othe1wise ti·ansfer, to any 
			
	11

			
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Exhibit 10.4

person or entity any matters released by such Paiiy in Section 2.3, and each such Paiiy agrees to indemnify and hold haimless the other Paiiies and the other persons and entities released under Section 2.3 from and against all such released matters ai·ising from any such alleged or actual assignment or ti·ansfer.

1.4Reliance on Agreement. For the avoidance of doubt, nothing herein shall be construed as an admission or waiver as to any factual or legal matter by any Paiiy or its Affiliates with respect to (a) any jurisdiction outside of the Tenito1y, (b) any products other than the Hospira Product or (c) any patents other than the Licensed Patents or Other Patents solely with respect to the Hospira Product and Hospira NDA. No Pai·ty shall seek to rely upon or enter this Agreement or any admission
			
	12

			
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Exhibit 10.4

herein into evidence in any proceeding other than a proceeding relating to a claimed breach of this Agreement.
3.LICENSE; RESTRICTIONS

			
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Exhibit 10.4

1.5License Grant. Subject to the tenns and conditions of this A hereby grant to Hospira and its Affiliates
as permitted under Section 8.10), non-exc us1ve, revoca e    ursuant to
Section 5.4) license under the Licensed Patents to manufacture, have

aintiffs (except

manufactured, use, sell, offer to sell, and impo1i the Hospira Product in the Tenito1 as of and followin the License Effective Date.

Plaintiffs shall impose the foregoing license on its Affiliates and any Third Party to which Plaintiffs may assign, license, sublicense, or othe1wise transfer any rights to or under (in each case, that includes the right to asse1i) the Licensed Patents.
			
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Exhibit 10.4

1.1

1.2No Other Licenses: Disclaimer. Other than the license and other rights expressly granted or pennitted in Sections 3.1, 3.2, 3.5, and 3.6, respectively, nothing in this 
			
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Exhibit 10.4

Agreement will or shall be construed as granting Defendant any other license or other rights. Notwithstanding anything to the contl'aiy in this Agreement, nothing
9
			
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Exhibit 10.4

in this Agreement will, or be construed as: (a) creating an obligation by Plaintiffs (or confening a right by Defendant) to bring or prosecute actions or suits against any Third Party for infringement of the Licensed Patents; (b) confening a right to use any ti-ademark or ti·ade name of any Party; (c) granting by implication, estoppel or othe1wise, any licenses or rights under any patent rights, except as expressly described in this Agreement; (d) granting b im lication, esto    el or othe1wise an waiver or other ri hts with res ect to

or (ii) any bendamustine product in any dosage fonn other than the rights expressly granted in Sections 3.1, 3.2, 3.5, and 3.6, with respect to the Hospira Product.

1.3Covenant Not to Challenge and Assist Challenges to the Licensed Patents and Other Patents.

(a)Except to the extent required by law or order of a comi or administi·ative agency of competent jurisdiction, Hospira hereby covenants and agrees that, from and after the Effective Date, it shall not, and shall cause its Affiliates not to: (i)(A) challenge, dispute or contest the validity, enforceability, patentability, priority of invention or other claim to priority, or patent te1m adjust:Inent of the Licensed Patents or Other Patents, or (B) assert the non-infringement of the Licensed Patents or Other Patents with respect to the manufacture, use, sale, offer to sell, impo1iation or disti·ibution of any NDA Product or ANDA Product, in each case ((A) or (B)), in any reexamination, inter partes proceeding, protest, observation, comment, opposition, third-paiiy submission, post grant proceeding, inter partes review, post grant review, covered business method review, derivation proceeding, interference or other action or proceeding in the United States Patent and Trademark Office ("USPTO") or any United States comi proceedings or ti-ibunal, or submit or cause, in any manner, to be submitted, any conespondence or communication with the USPTO with respect to the Licensed Patents and Other Patents; or (ii) assist, encourage, finance, or join any proceeding with any Third Pa1iy challenging, disputing or contesting, or who may challenge, dispute or contest, the validity, enforceability, patentability, priority of invention or other claim to priority, or patent tenn adjustment of the Licensed Patents or Other Patents, or asse1iing the non-infringement of any of the Licensed Patents or Other Patents in connection with an NDA Product or ANDA Product.
			
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Exhibit 10.4

(b)
			
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Exhibit 10.4

(a)Without limiting the generality of the foregoing, Defendant shall instrnct the attorneys and expe1ts engaged by or on its behalf in connection with the Lawsuits not to use or transfer to any Third Party any confidential infonnation of Hospira or its Affiliates or any work product or other materials generated in connection with the Lawsuits, unless such disclosure is compelled by law.

1.6Covenant Not to Sue. As pait of the license rights granted in this Section 3, with respect to the Hospira Product, and effective on the License Effective Date, Plaintiffs and their Affiliates nTevocably covenant not to sue (provided HospiI·a has not materially breached this Agreement, and subject to Section 5.3), asse1t any claim or othe1wise paiticipate in any action or proceeding against, Defendant and its Affiliates, and their impo1ters, suppliers, manufacturers, distributors, and customers for infringement of the Licensed Patents and Other Patents solely with respect to Defendant's or its Affiliates' (a) making, having made, using, selling, offering for sale, and nnpo1tation of Hospira Product in the TeITito1 as of and followin the License Effective Date ursuant to Section 3.1
b

Plaintiffs shall impose the foregoing covenant not to sue on its Affiliates and any Thn·d Party to which Plaintiffs may assign license, sublicense, or othe1wise transfer any rights to or under (in each case, that includes the right to asse1t) the Licensed Patents or Other Patents.
			
	11

			
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Exhibit 10.4

1.7Regulato1y Approval. (a)

			
	12

			
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Exhibit 10.4

(b)        Each Plaintiff hereby agrees any regulato1y exclusivities existing as of the Effective D prevent approval or marketi the License Effective Date p

Product,

at may s of

			
	13

			
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Exhibit 10.4

-    For the avoidance of doubt, each Plaintiff shall cause any Affiliates to waive as a    licable with res ect to the Hos ira Product, any regulato1y exclusivitie        existing as
of the Effective Date, Controlled by that Plaintiff that may prevent approval or marketing of the Hospira Product he
License Effective Date pursuant to Section 3

( c)        If requested by Hospira, Plaintiffs and their Affiliates shall reasonably promptly provide written notice to FDA evidencing the license rights, covenant not to sue and waiver of regulato1y exclusivities granted to Hospira as set fo1ih in this Agreement with respect to the Hospira NDA and Hospira Product and indicating that Plaintiffs and their Affiliates have no objection to final approval of the Hospira NDA, and shall confinn to Hospira that it has done so and Hospira shall then also provide a copy of Plaintiffs' cones ondence to the FDA if re uired b the FDA.

			
	14

			
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Exhibit 10.4

1.4
			
	15

			
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Exhibit 10.4

1.8

4.FTC REVIEW

4.1This Agreement shall be submitted to the federal antitmst agencies pmsuant to the Medicare Modernization Act within ten (10) business days of its execution. Each Party shall notify the other Paiiies when it has submitted this Agreement to such agencies. The Paiiies hereby agree that they will work in good faith to resolve any 
			
	16

			
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Exhibit 10.4

related issues and endeavor to modify this Agreement in view of any objections from such federal antitiust agencies, but no Paiiy shall be required to accept any tenns that materially change or modify the pmposes of this Agreement.
5.TERM AND TERMINATION

5.1Tenn. Unless eai·lier terminated in accordance with the te1ms of this Section 5, the te1m of this Agreement will commence on the Effective Date and will remain in effect until the expiration of the last to expire of the Licensed Patents. For the avoidance of doubt, the respective te1ms of the Licensed Patents include any te1m extensions or adjust:Inents to which the Licensed Patents are entitled, in each case whether granted or allowed before, on, or after the Effective Date, and the tenn of
			
	17

			
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Exhibit 10.4

this Agreement shall nm until the last to expire of such extensions and pediatric exclusivities, whenever granted.

1.1

Plaintiffs and Defendant may tenninate this Agreement at any time in the event that the other Pru    or an of its Affiliates materiall breaches this A ·eement

1.2Effect of Expiration or Te1mination. Expiration or te1mination of this Agreement will not relieve the Pruiies of an obli ation accrnin    rior to such ex iration or tennination.
-    In addition,
expiration or te1mination of this Agreement.
			
	18

			
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Exhibit 10.4

1.3E uitable Remedies· Te1mination for Breach.    tor an of its Affiliates materiall breac        11

			
	19

			
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Exhibit 10.4

6.CONFIDENTIALITY; PUBLICITY

6.1The Pa1iies hereby agree that, except to enforce this Agreement or lmless othe1wise agreed to by the Pruties in writing or as required by law, the Parties, their Affiliates and their respective employees, officers, directors and other
			
	20

			
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Exhibit 10.4

representatives shall not publish or otherwise disclose the contents of this Agreement, except that (a) each Party may disclose this Agreement (i) to its attorneys, advisors, consultants, agents (including Defendant’s manufacturer(s)), and representatives who in each case are subject to obligations of confidentiality consistent with this Agreement, and (ii) if any Party becomes required to disclose this Agreement by law, regulation or order of a court or administrative agency, including reporting requirements to the U.S. Securities and Exchange Commission or by the rules or regulations of any stock exchange to which the Parties are subject, (b) the Parties may communicate with the FDA on a confidential basis prior to the License Effective Date concerning the approval of the Hospira NDA and the licenses and waivers provided for herein, and (c) Plaintiffs may disclose such terms as may be necessary or useful in connection with any proceeding, agreement or settlement discussions relating to the Licensed Patents, Other Patents, or any bendamustine hydrochloride product, including the License Effective Date defined in this Agreement and the fact that the License Effective Date belongs to Defendant. In the event disclosure is required under the foregoing clause (a)(ii), the Party making such disclosure shall (1) provide the other Parties with as much advance notice as reasonably practicable of the required disclosure, (2) cooperate with the other Parties in an attempt to prevent or limit the disclosure, and (3) limit any disclosure to the specific purpose at issue.

1.4Each Party may, with the prior written approval of the other Party (such approval not to be unreasonably withheld), issue a press release or make a public announcement at any time following the Effective Date indicating that the Parties have settled the Lawsuits, and that Hospira has the right to market the Hospira Product in the Territory beginning January 17, 2028, or earlier based on certain circumstances.

7.REPRESENTATIONS AND WARRANTIES

7.1Each Party represents and warrants to the other, as of the Effective Date of this Agreement, that:

(a)Such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement and to carry out the provisions hereof;

(b)Such Party has taken all corporate action necessary to authorize the execution and delivery of this Agreement and the performance of its obligations under this Agreement;

(c)This Agreement has been duly executed by such Party and constitutes a valid and legally binding obligation of such Party, enforceable in accordance with its terms;

			
	21

			
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Exhibit 10.4

(a)To the knowledge of the Parties, the execution, delivery, and performance of this Agreement does not conflict with any agreement, instrument, or understanding, oral or written, to which such Party is bound nor violate any law or regulation of any court, governmental body, or administrative or other agency having jurisdiction over it;

(b)Such Party represents and warrants that it has been advised by its counsel of its rights and obligations under this Agreement and enters into this Agreement freely, voluntarily, and without duress; and

(c)Such Party represents and warrants that it is not relying on any promises, inducements, or representations other than those provided herein.

1.5Defendant Representations and Warranties. As of the Effective Date, Defendant represents and warrants that: (a) Defendant is the true owner of the Hospira NDA; and (b) Defendant has received no notice or claim and knows of no reason for the assertion of any notice or claim contesting clause (a).

1.6Plaintiffs Representations and Warranties. As of the Effective Date, Plaintiffs represent and warrant that they have the right and authority to (a) enter into this Agreement, (b) settle the Lawsuits between the Parties, and (c) grant the license rights to Defendant as set forth in this Agreement.

1.7Disclaimer. EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NO PARTY MAKES ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF APPLICABLE LAW.

8.GENERAL PROVISIONS

8.1Waiver. None of the provisions of this Agreement will be considered waived by any Party unless such waiver is agreed to, in writing, by authorized agents of such Party. The failure of a Party to insist upon strict conformance to any of the terms and conditions hereof, or failure or delay to exercise any rights provided herein or by law will not be deemed a waiver of any rights of any Party.

8.2Choice of Law and Remedies. The law of the State of Delaware shall govern this Agreement, the interpretation and enforcement of its terms and any claim or cause of action (in law or equity), controversy or dispute arising out of or related to it or its negotiation, execution or performance, whether based on contract, tort, statutory or other law, in each case without giving effect to any conflicts-of-law or other principle requiring the application of the law of any other jurisdiction. The United States District Court for the District of Delaware shall have exclusive jurisdiction in all matters arising under this Agreement, and the Parties hereto expressly consent and submit to the personal and subject matter jurisdiction of the United States District Court for the District of Delaware in connection with matters arising out of or related to this Agreement, and if jurisdiction in the
			
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Exhibit 10.4

United States District Comi for the District of Delaware is not possible, will submit any dispute arising out of or related to this Agreement to another comi of competent jmisdiction in the State of Delaware. This Agreement does not limit or restrict the remedies available to any Paiiy for the breach of another Pa1iy, and the Paiiies expressly reserve any and all remedies available to them, at law or in equity, for breach of this Agreement or othe1wise.

8.3Costs. Each Pai·ty shall each beai·its own costs and legal fees associated with the negotiation and prepai·ation of, and perfonnance under, this Agreement and any activities related to the implementation of this Agreement.

8.4Entire Agreement. This Agreement constitutes the entire agreement among the Paiiies relating to the subject matter hereof and supersedes all previous agxeements and understandings, oral or written, with respect to such matters.

8.5Notice. All notices or other communications hereunder shall be deemed to have been duly given and made if in writing and if served by personal delive1y upon a Paiiy, if delivered by a reputable overnight express comier service (charges prepaid), or if sent by email (with confinnation receipt) to the person at the address set fo1ih below, or such other address as may be designated in writing hereafter, in the same manner, by such person as follows:
Ifto Teva:    Teva Phaimaceuticals Monis Co1porate Center III
400 Inte1pace Pai-Icway, Bldg. A
Pai·si  054 Attn:_, Chief Legal Officer

with a copy to (with such copy not constituting notice):

Williains & Connolly LLP 725 Twelfth St. NW Washin ton DC 20005
Attn: 
Ifto Eagle:    Eagle Phaimaceuticals, Inc.
50 Tice Blvd, Suite 315 Woodcliff Lake NJ 07677
Attn:    General Counsel

			
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	04-14-2022

Exhibit 10.4

with a copy to (with such copy not constituting notice):

Latham & Watkins LLP 555 Eleventh Street, NW Suite 1000
Washington, DC 20004-1304 Attn:

If to Defendant:    Hospira, Inc.
275 North Field Drive Lake Forest, IL 60045 Attn:
Executive Vice President, General Counsel with a copy to (with such copy not constituting notice):
Willkie Farr & Gallagher LLP 300 North LaSalle Dr.
Chicago, IL 60654-3406 Attn:

Such notices will be deemed to have been given on the date delivered in the case of delivery by personal delivery or overnight courier or on the date actually received in the case of email delivery.

1.8Severability. When possible, each provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law. If, however, any provision of this Agreement is held to be invalid, illegal, or unenforceable for any reason, the Parties shall negotiate in good faith for a substitute provision to continue the intent and purpose of such invalid provisions, and the validity, legality, and enforceability of the remaining provisions shall not be in any way impaired thereby.

1.9Amendments. No amendment, modification or supplement of any provisions of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.

1.10Descriptive Headings. The captions and descriptive headings of this Agreement are for convenience only and shall be of no force or effect in construing or interpreting any of the provisions of this Agreement.

1.11Third-Party Benefit. None of the provisions of this Agreement shall be for the benefit of, or enforceable by, any Third Party except as otherwise expressly provided herein.

1.12Assignment. Defendant will not assign this Agreement or any part hereof or any interest herein (whether by operation of law or otherwise) without the prior

			
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Exhibit 10.4

written consent of Plaintiffs (such consent not to be unreasonably withheld, conditioned, or delayed); provided, however, that Defendant may assign this Agreement in whole without such prior consent (a) to any Affiliate of Defendant (for as long as such assignee remains an Affiliate of Defendant); or (b) to any successor entity in the case of a merger, consolidation, change in control or sale of all or substantially all of the assets related to this Agreement. Plaintiffs may assign this Agreement or any part hereof or any interest herein (whether by operation of law or otherwise) without the prior written consent of Defendant, provided that in either case, (i) each assigning party shall provide written notice to the other Parties of any permitted assignment of this Agreement, and (ii) such successor agrees in writing for the benefit of the non-assigning Party to assume all of the obligations of the assigning Party. No assignment will be valid unless the permitted assignee(s) assumes all obligations of its assignor under this Agreement. No assignment will relieve any assigning Party of responsibility for the performance of its obligations hereunder. Any purported assignment in violation of this Section 8.10 will be null and void ab initio. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective heirs, successors and permitted assigns. For clarity, any successors or permitted assigns to this Agreement are permitted to assign the Agreement as if they were an original Party or Parties to this Agreement, subject to the same terms and obligations regarding assignment under this Section 8.10 that apply to the original Party or Parties to the Agreement.

1.5Counterparts; Electronic Delivery. This Agreement may be executed in one or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. This Agreement and any signed agreement or instrument entered into in connection with this Agreement, and any amendments hereto or thereto, to the extent delivered by means of electronic mail, shall be treated in all manner and respects as an original agreement or instrument and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. At the request of any Party hereto or to any such agreement or instrument, each other Party hereto or thereto shall re-execute original forms thereof and deliver them to all other Parties.

[SIGNATURES FOLLOW ON NEXT PAGE]
			
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Exhibit 10.4

IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its
duly authorized representative as of the Effective Date.
CEPHALON, INC.    HOSPIRA, INC.

By:    ,S            By:             Name:        f;. Diclf/2.        ,1/4:,v;:f'    Name:     _
Title:

By:
Name:    
Title:     
TEVA PHARMACEUTICALS INTERNATIONAL GMBH

By:             Name:     _
Title:     

By:             Name:     _
Title:     
EAGLE PHARMACEUTICALS, INC.

By:             Name:     _
Title:     
			
	US-DOCS\127266127.19

			
	04-14-2022

Exhibit 10.4

DocuSign Envelope ID: 89815916-D088-4594-92CE-7C6121399F41

IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its duJy authorized representative as of the Effective Date.
CEPHALON, INC.    HOSPIRA, INC.

			
	04-14-2022

			
	US-OOCS\127266127.19

Exhibit 10.4

By:        

Name: -----------
Title:

By:             Name:      _
Title:     

By:
Name:
Title:    \IP 1 '9C..  #0t    ,4. cl
:i:P'-,h:qafiCV'\
TEVA PHARMACEU'tICALS
INTERNATIONAL GMBH

By:        
Name:

Title:

By:

Naama    saram    _

General Manager

Pascal    Guichard

Name:     

Title:

Associate Director Accounting

EAGLE PHARMACEUTICALS, INC.

By: Name:

Title:
			
	04-14-2022

			
	US-OOCS\127266127.19

Exhibit 10.4

    

IN WITNESS WHEREOF, each Party has caused this Agreement to be executed by its duly authorized representative as of the Effective Date.
CEPHALON, INC.    HOSPIRA, INC.

Exhibit 10.4

By:        
Name:     

By:        

Name:     

Title:         Title:     

By:      Name:      Title:      
TEVA PHARMACEUTICALS INTERNATIONAL GMBH

By:      Name:      Title:     

By:       Name:          Title:      EAGLE PHARMACEUTICALS, INC.

By:
Namerf1/;WJ   0Jrt.Jk:r.
Title:    £V f  (rC  i  CC 0

US-DOCS\127266127.19    04-14-2022

Exhibit 10.4

fN WlTNESS WHEREOF, each Party has caused this Agreement to be executed by its duly authorized representative as of the Effective Date.

CEPHALON, INC.    HOSPIRA, INC.

Exhibit 10.4

By:        

Name: -----------
Title:     

By:             Name: ...::J:e•ft'q     /41..  Afye-,v..;
 /
Title:  Al/ulflt1v :Cn  ff;(.i 
/

Exhibit 10.4

Exhibit 10.4

By:             Name:      Title:
TEVA PHARMACEUTICALS INTERNATIONAL GMBH

By:             Name:          Title:

By:             Name:          Title:
EAGLE PHARMACEUTICALS, INC.

By:

Name:      Title:         

US-DOCS'.t27'.?661:?7. l 9    04-14-2022

Exhibit 10.4

EXHIBIT A
[Attached]

Exhibit 10.4

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

C.A. No. 18-cv-01704

STIPULATION AND [PROPOSED] ORDER

By virtue of a settlement agreement between the parties, and pursuant to Federal Rules of Civil Procedure 41(a)(l) and 41(c), Plaintiffs Teva Pharmaceuticals International GmbH, Cephalon, Inc., and Eagle Pharmaceuticals, Inc. (collectively, “Plaintiffs”) and Defendant Hospira, Inc. (“Hospira”) hereby stipulate and agree that Plaintiffs’ action against Hospira with respect to Hospira’s NDA Product, including all claims and defenses asserted by Plaintiffs against Hospira and all claims and defenses asserted by Hospira against Plaintiffs with respect to Hospira’s NDA Product, are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. It is further stipulated that the U.S. District Court for the District of Delaware retains jurisdiction to enforce and resolve any disputes arising under the Agreement.

Exhibit 10.4

Respectfully submitted, [Signature Block]

Exhibit 10.4

IT IS SO ORDERED this     day of     , 2022

The Honorable Colm F. Connolly

Exhibit 10.4

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE

C.A. No. 21-cv-01619

STIPULATION AND [PROPOSED] ORDER

By virtue of a settlement agreement between the parties, and pursuant to Federal Rules of Civil Procedure 41(a)(l) and 41(c), Plaintiffs Teva Pharmaceuticals International GmbH, Cephalon, Inc., and Eagle Pharmaceuticals, Inc. (collectively, “Plaintiffs”) and Defendant Hospira, Inc. (“Hospira”) hereby stipulate and agree that Plaintiffs’ action against Hospira with respect to Hospira’s NDA Product, including all claims and defenses asserted by Plaintiffs against Hospira and all claims and defenses asserted by Hospira against Plaintiffs with respect to Hospira’s NDA Product, are hereby dismissed with prejudice and without costs, disbursements, or attorneys’ fees to any party. It is further stipulated that the U.S. District Court for the District of Delaware retains jurisdiction to enforce and resolve any disputes arising under the Agreement.

Exhibit 10.4

Respectfully submitted, [Signature Block]

Exhibit 10.4

IT IS SO ORDERED this     day of     , 2022

The Honorable Colm F. Connolly

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