Document:

Exhibit 10.4

 

CERTAIN INFORMATION IDENTIFIED IN THIS DOCUMENT,
MARKED BY BRACKETS AND ASTERISKS (“[***]”), HAS BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K UNDER THE SECURITIES
ACT OF 1933, AS AMENDED, BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

EXCLUSIVE LICENSE AGREEMENT

No 201221/1

 

 

December 20, 2021

 

LIPOXEN TECHNOLOGIES LIMITED, a legal entity incorporated and existing under the laws of United Kingdom, registered at the address: 5th Floor, 15 Whitehall, London SW1A 2DD, United Kingdom, represented by its Director James Parslow, acting pursuant to the Articles of Association, hereinafter referred to as "the Licensor", on the one part, and  

 

Public Joint-Stock Company “Pharmsynthez”, a legal entity organized and existing under the laws the Russian Federation, registered at the address: 134, letter 1, Kuzmolovsky urban-type village, Capitolovo station, Vsevolozhsky district, Leningrad region, 188663 Russia, represented by its General Director Efim Alexandrovich Prilezhaev, acting pursuant to the Articles of Association, hereinafter referred to as "the Licensee", on the other part, hereinafter referred to jointly to as “the Parties”, and individually as “the Party”,

 

WHEREAS:

 

1. The Licensor is the owner of Russian patent No 2333223 under application 2006107546/04 dd. August 12, 2004, the start date of the patent validity period: 12.08.2004, for the invention “Sialic acid derivatives, methods for producing thereof, conjugates of the sialic acid derivatives and pharmaceutical composition based thereon”;

 

2.
The Licensor is the owner of Russian patent No 2327703 under application 2006107545/04 dd. August 12, 2004, the start
date of the patent validity period: 12.08.2004, for the invention “Polysialic acid derivatives”; 

 

hereinafter referred to as "the Patents",

 

3. On 4 August 2011 Xenetic Biosciences (UK) Limited (formerly before 5th September 2011 Lipoxen PLC), Lipoxen Technologies Ltd. (Xenetic Biosciences (UK) Limited and Lipoxen Technologies Ltd. are jointly referred to as "Xenetic") and SynBio LLC entered into an Agreement on Co-Development and the Terms of Exclusive Licence (the “Agreement on Co-Development”) pursuant to which Xenetic and SynBio have agreed to collaborate in the development of certain products combining the PolyXen Technology and SynBio Molecules.

 

4. On 17 December 2021 Xenetic Biosciences (UK) Limited, Lipoxen Technologies Limited, SynBio LLC and Public Joint Stock Company Pharmsynthez entered into the Novation of Agreement on Co-Development and the Terms of Exclusive Licence pursuant to which SynBio's rights, obligations and liabilities under the Agreement on Co-Development are assumed by Pharmsynthez.

 

The Licensee wishes to obtain an exclusive license for use of the inventions, which the Patents are issued for, in accordance with the terms of this Agreement, with the purpose of manufacturing, using, offering for sale, selling and otherwise introducing the product, manufactured on the base of the said inventions, and for use of the methods protected by the Patents,

 

 

 

 

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Pursuant to Agreement on Co-Development the Parties have concluded this Agreement as follows:

 

1. Definition of terms

 

The following terms which are used in this Agreement, mean:  

 

1.1. “The Patents” – the patents of the Russian Federation obtained by the Licensor: No 2333223 under application 2006107546/04 dd. August 12, 2004, the start date of the patent validity period: 12.08.2004, for the invention “Sialic acid derivatives, methods for producing thereof, conjugates of the sialic acid derivatives and pharmaceutical composition based thereon”, No 2327703 under application 2006107545/04 dd. August 12, 2004, the start date of the patent validity period: 12.08.2004, for the invention “Polysialic acid derivatives”.

 

1.2. “The Licensed Production” – production that will be manufactured based on this Agreement: “Epolong®, solution for subcutaneous injection, 200 μg/mL, 400 μg/mL”.

 

1.2.1. A polysaccharide
compound or conjugate of an aldehyde derivative as claimed in the Patents, in which a part of the molecule contains a peptide bond formed
with recombinant human erythropoietin which has the following structure (amino acid sequence):

 

 

 

or an amino acid sequence homologous to it by at least 90 %.

 

1.2.2. A polysaccharide compound or conjugate of an aldehyde derivative as claimed in the Patents wherein said protein is recombinant human erythropoietin which has the following structure (amino acid sequence):

 

 

 

or an amino acid sequence homologous to it by at least 90 %.

 

 

 

 

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1.3. “The Licensed Methods” – the methods of manufacturing of the Licensed Production.

 

1.4. “Confidentiality” – observance of measures on prevention of casual or deliberate disclosure of confidential information (know-how), concerning inventions under the Patents to the third parties.

 

1.5. "Payments” – payments at which all possible taxes and tax collections are paid as it should be, not contradicting the current legislation of the Russian Federation.

 

1.6. "Territory” – territory of application of the inventions reflected in THE PATENTS, namely the Russian Federation.

 

1.7. "The Licensee Market" – the Russian Federation and the commonwealth of independent states comprising the following countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Republic of Moldova, Tajikistan, Turkmenistan, Ukraine and Uzbekistan.

 

1.8. "Quarter" – the quarterly periods ending 31 March, 30 June, 30 September and 31 December.

 

1.9. "The Licensee Net Sales" – the amount received by the Licensee and/or its affiliates from third parties in respect of sales and/or supplies of the Licensed Production in arms length transactions in the Licensee Market (or the amount received if the transactions had been at arms length) less the following items provided they are shown in writing on the relevant invoice or in other documentary evidence: sales taxes, costs of delivery, customary trade discounts actually granted, amounts actually repaid or credited for defective or returned production.

 

2. Subject-matter of the Agreement

 

2.1. The Licensor gives to the Licensee on period of validity of this Agreement for the compensation paid by the Licensee, the exclusive license for use of the inventions protected by the Patents for the purpose of manufacturing, using, offering for sale, selling and otherwise introducing the Licensed Production.

 

2.2. The Licensee is granted the right to manufacture, application, the offer to sale, sale and other introduction into economic circulation of the Licensed Production, and use of the Licensed Methods.

 

2.3. The Licensee has the right to grant sublicense(s) to any third parties in relation to the rights (or their parts) granted to him under this Agreement after receipt of a prior written consent of the Licensor provided that the Licensee bears responsibility before the Licensor for actions and omissions of the sublicensees concerning infringement of the rights granted to the Licensee under this Agreement and transferred by the Licensee to the sublicensee.

 

3. Improvements

 

3.1. During the validity period of this Agreement the Parties undertake to inform immediately each other about all improvements made by them concerning the Licensed Production.

 

3.2. The Parties undertake to offer first of all each other all above-stated improvements. Conditions of transfer of these improvements will be additionally co-ordinated by the Parties.

 

 

 

 

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4. Obligations and responsibility

 

4.1. The Licensor declares that at the moment of signing of this Agreement he does not know about the rights of the third parties which could be injured by granting license under this Agreement.

 

4.2. The Licensor does not bear responsibility for use of the Licensed Production by the Licensee, as well as at introduction of the Licensed Production into economic circulation.

 

4.3. The Licensor declares that materials and documents transferred to the Licensee will be complete and qualitatively made. (the Parties can also stipulate other requirements to the documentation and other information).

 

4.4. The Licensor is obliged to support the exclusive right to the invention under the Patent during all period of validity of the Agreement.

 

4.5. The Licensee undertakes to make the Licensed Production in full conformity with instructions of the Licensor in a part concerning inventions.

 

4.6. The size of the indemnification and contractual fines which one Party can declare because of various infringements of conditions of this Agreement cannot exceed in aggregate received or paid on Section 6 of this Agreement of the sums if the Parties have not agreed about other.

 

5. Payments

 

5.1. Pursuant to clause 2 of Schedule 10 to Agreement on Co-Development for granting of the rights provided by this Agreement, the Licensee shall pay to the Licensor a royalty of 10 % (ten per cent) of all the Licensee Net Sales. The royalty payable to the Licensor shall become due 30 (thirty) days after the expiry of the Quarter in which the Licensed Production was sold and/or supplied by the Licensee.

 

5.2. All fees, gathering and other costs connected with the conclusion and registration of this Agreement are paid by the Licensee.

 

6. Confidentiality maintenance

 

6.1. The Parties incur obligations on observance of confidentiality of the information received from the Licensor concerning manufacturing of the Licensed Production. The Parties will take all necessary measures to prevent full or partial disclosure of the specified data or acquaintance with them by the third parties if other is not provided by this Agreement.

 

7. Protection of the transferred rights

 

7.1. During the whole period of validity of this Agreement the Licensee will not litigate patents of the Licensor or to contribute to this.

 

7.2. If the Licensor intends to stop Patents maintenance in force he beforehand informs about this the Licensee and in this case the Parties will settle their relations following from this Agreement under the additional agreement.

 

7.3. In cases of illegal use by third parties of inventions protected by the Patents that have become known to the Licensee, he will immediately notify the Licensor.  If claims or lawsuits are filed against the Licensee regarding the violation of the rights of third parties in connection with the use of the license under this Agreement, the Licensee will notify the Licensor about this. In both cases the Licensor shall settle such claims or undertake other actions excluding occurrence of expenses and losses for the Licensee.

 

8. The Resolution of disputes

 

8.1. In case of disputes between the Licensor and the Licensee on the issues provided for in this Agreement, the Parties will take all measures to resolve them through negotiations among themselves.

 

 

 

 

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8.2. In case of impossibility to resolve these disputes through negotiations, they must be resolved in accordance with the procedure established by the law of the Russian Federation.

 

9. Period of validity of the Agreement

 

9.1. This Agreement is concluded for the validity period of the Patents and comes into force from the date of its registration at the Rospatent.

 

9.2. Each of the Parties will in writing notify other Party on intention ahead of schedule to terminate this Agreement if the other Party does not carry out of any essential obligation under this Agreement. To the Party which has not carried out of the obligations, it will be given 6 (six) months for infringement elimination. In a case if the infringement will not be eliminated, the Agreement is subject to prescheduled cancellation in the order established by the effective laws of the Russian Federation.

 

10. Other conditions

 

10.1. All changes and additions to this Agreement shall be made in writing and signed by the authorized persons and approved by competent bodies if such approval is necessary.

 

10.2. In all the rest that is not provided by this Agreement, the Parties are ruled by the Agreement on Co-Development and the effective laws of the Russian Federation. If any of the provisions of this Agreement contradicts the Agreement on Co-Development, the provisions of the Agreement on Co-Development shall prevail.

 

10.3. This Agreement is made in three original copies: one for each of the Parties and one – for filing to the Rospatent.

 

11. Addresses and bank details 

 

LICENSOR: 

LIPOXEN TECHNOLOGIES LIMITED

Registered Office at: 5th Floor, 15 Whitehall, London SW1A 2DD, United Kingdom   

 

[***]

 

 

LICENSEE:

 Public Joint-Stock Company “Pharmsynthez”   

 

[***]

 

 

Signature of the Licensee:

 

___________________________

Efim A. Prilezhaev, CEO
of PJSC “Pharmsynthez” 

 

 

Signature of the Licensor:

 

___________________________

James Parslow, Director
of Lipoxen Technologies Limited

 

 

    	 	5Exhibit 10.28

 

CERTAIN INFORMATION IDENTIFIED IN THIS DOCUMENT,
MARKED BY BRACKETS AND ASTERISKS (“[***]”), HAS BEEN EXCLUDED PURSUANT TO ITEM 601(B)(10) OF REGULATION S-K UNDER THE SECURITIES
ACT OF 1933, AS AMENDED, BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED.

 

AMENDMENT NUMBER ONE TO THE MASTER SERVICES
AGREEMENT

 

THIS AMENDMENT NUMBER ONE TO THE MASTER SERVICES
AGREEMENT (this “Amendment One”), is made effective October 12, 2021 (the “Effective Date) between Xenetic Biosciences,
Inc. a Nevada corporation having its place of business at 40 Speen Street, Suite 102, Framingham, Massachusetts 01701 (“Sponsor”)
and PJSC Pharmsynthez, a Russian public joint stock company having an address of No 134, Liter 1, Poselok Kuzmolovsky, St. Kapitolovo,
Vsevolozhsky Raion, Leningradskaya Oblast, 188663, Russia (“Pharms”). Individually, each of Sponsor and Pharms is a “Party”
and collectively, “Parties.”

 

WHEREAS, Sponsor and Pharms entered into a Master
Services Agreement (the “Agreement”) on June 12, 2020; and

 

WHEREAS, Sponsor and Pharms desire to terminate
all existing Work Orders immediately that were initiated pursuant to the terms of Section 1 of the Agreement;

 

WHEREAS, Sponsor has agreed to pay to Pharms a
one-time payment of forty thousand United States Dollars ($40,000 USD) upon entry of the Parties into a new Work Order pursuant to this
Amendment One. The Parties agree that this payment provides full satisfaction for any outstanding monetary or any other compensation that
may be owed by Sponsor to Pharms pursuant to the Agreement and any Work Order that existed prior to entry of the Parties into this Amendment
One;

 

WHEREAS, Sponsor and Pharms further agree that
Sponsor shall be under no obligation to make any other payments other than those expressly set forth in any future Work Order entered
into following the Effective Date of this Amendment One;

 

WHEREAS, Sponsor and Pharms also agree to delete
Exhibit A attached to the Agreement and replace it with a new Exhibit A, which is attached hereto.

 

NOW, THEREFORE, in consideration of the foregoing
and the covenants and promises contained in this Amendment One and in accordance with and subject to the terms and conditions specified
below, the Parties agree as follows:

 

AMENDMENT OF THE AGREEMENT

 

The Parties hereby agree to amend the Agreement as of the Effective
Date of Amendment One as provided below. Capitalized terms used in this Amendment that are not otherwise defined herein shall have the
meanings provided in the Agreement.

 

1.                 
All Work Orders that were initiated under Section 1, and more particularly, Section 1.3 of the Agreement that have not been completed
as of the Effective Date of Amendment One shall herein be immediately terminated (the “Terminated Work Orders”). Sponsor shall
owe no additional monetary or any other compensation for the services and expenses set forth in these Terminated Work Orders other than
that set forth below in Paragraph 3. Additionally, Pharms shall owe no further Services to Sponsor pursuant to the Terminated Work Orders.

 

2.                  
Sponsor and Pharms shall enter into a new Work Order upon entry of the Parties into this Amendment One, which shall abide by the
requirements of Section 1 and more particularly, Section 1.3 of the Agreement.

 

 

 

    	 	1	 

     

    

 

3.                 
Upon entry of the Parties into the new Work Order, Sponsor shall make a one-time payment of forty thousand United States Dollars
($40,000 USD) to Pharms. The Parties agree that twenty-one thousand United States Dollars ($21,000 USD) shall constitute a one-time payment
in full for all money and any other compensation owed by Sponsor to Pharms prior to the entry of the Parties into this Amendment One and
the new Work Order. For purposes of clarity, other compensation includes, but is not limited to, in kind services by Sponsor, shares of
stock in Sponsor (also commonly referred to as equity in Sponsor) or other compensation that was owed by Sponsor to Pharms. The remaining
nineteen thousand United States Dollars ($19,000 USD) will be creditable against and will pay for any out of pocket costs and expenses
by Pharms on behalf of Sponsor pursuant to any new Work Orders initiated following the Effective Date of this Amendment One.

 

4.                  
Section 2.6 is hereby deleted in its entirety and replaced by the new Section 2.6 set forth below:

 

2.6. Milestones. In the event that
milestones shall be provided under a Work Order under this Agreement, and such milestones shall involve one or-more payments by Sponsor
to Pharms, the Parties agree that a table shall be attached to the Work Order that sets forth the milestone event that triggers the payment
and the amount of the payment to be made in USD or shares of Sponsor’s common stock. To the extent that the milestone payment is
made in shares of the Sponsor. the shares shall be priced as reflected in the relevant Work Order. The Parties additionally agree that
the decision whether to pay the milestone payment in cash or in shares shall be at the sole discretion of the Sponsor. Further, if the
milestone payment is provided in shares of Sponsor stock, the shares shall be issued in the name of those individuals that Pharms identifies
in writing to Sponsor prior to the issuance of the shares, subject in all respects to compliance with Section 2.7. In the event of any
change in the number or kind of outstanding shares of the Company’s common stock by reason of a stock split, stock dividend, recapitalization
or reorganization, the number of any shares subject to issuance under this Agreement as set forth under a Work Order shall be appropriately
adjusted by the Sponsor in its sole discretion, and the decision of the Sponsor regarding any such adjustment shall be final, binding
and conclusive.

 

5.                 
Exhibit A is hereby deleted in its entirety and replaced by the Exhibit A attached hereto this Amendment One.

 

6.                 
Miscellaneous

 

a.                  
Full Force and Effect. Except as expressly amended by this Amendment One, the Agreement shall remain unchanged and continue
in full force and effect as provided therein.

 

b.                 
Entire Agreement of the Parties. This Amendment One and the Agreement constitute the complete final and exclusive understanding
and agreement of Sponsor and Pharms with respect to the subject matter of the Agreement, and supersede any and all prior or contemporaneous
negotiations, correspondence, understandings and agreements, whether oral or written, between Sponsor and Pharms respecting the subject
matter of the Agreement.

 

c.                  
Counterparts. This Amendment One may be executed in two or more counterparts, each of which shall be deemed an original,
but all of which together shall constitute one and the same instrument. One or more counterparts of this Amendment One may be executed
my facsimile or other electronic means.

 

 

 

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IN WITNESS WHEREOF, the undersigned, intending
to be legally bound, have duly executed this Agreement as of the Effective Date.

 

 

ACKNOWLEDGED. ACCEPTED AND AGREED TO:

 

 

PJSC Pharmsynthez

 

 

By: /s/ Prilezhaev Efim

(Signature)

 

 

Print: Prilezhaev Efim

 

 

Title: Chief Executive Officer 

 

 

Date: ___________________________________________

 

 

 

 

Xenetic Biosciences, Inc.

 

By: /s/ Jeffrey F. Eisenberg

(Signature)

 

 

Print: Jeffrey F. Eisenberg

 

 

Title: Chief Executive Officer 

 

 

Date:     October 12, 2021                                                        

 

 

 

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EXHIBIT A

PROGRAM SUMMARY

 

 

Introduction 

 

Xenetic Biosciences is developing a CAR T platform
(termed ‘XCART’) for the treatment of certain non-Hodgkin Lymphoma (NHL) subtypes, by targeting a patient- and tumor- specific
lymphoma neoantigen, namely the unique B-cell receptor (BCR) displayed by a given malignant B-cell clone.

 

XCART will utilize a universal ‘CAR cassette’,
into which neoantigen-specific, antigen-binding domains (ABDs) can be inserted to create a patient-specific CAR. The resulting CAR construct
can then be engineered into an autologous CAR T product for treatment of the patient’s lymphoma.

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	 	4	 

     

    

 

EXHIBIT B

SAMPLE WORK ORDER

 

WORK ORDER

 

This Work Order (“Work Order”) is
between Xenetic Biosciences, Inc., 40 Speen St., Ste 102, Framingham, MA 01701 (“Sponsor”) and PJSC Pharmsynthez, No134, Liter
1, Poselok Kuzmolovsky, St. Kapitolovo, Vsevolozhsky Raion, Leningradskaya Oblast, 188663, Russia (“Pharms”) and relates to
the Master Services Agreement dated as of June 12, 2020, as amended by Amendment No. 1 to the Master Services Agreement, dated as of October
12, 2021 (the “Agreement”), which is incorporated by reference herein. Pursuant to the Agreement, Pharms has agreed to perform
certain services in accordance with written Work Orders, such as this one, entered into from time-to-time. This Work Order sets forth
the obligations of the parties with regard to conducting certain services associated with development of Sponsor’s XCART technology.

 

The parties hereby agree as follows:

 

1.                 
Work Order. This document constitutes a “Work Order” under the Agreement and this Work Order and the services
contemplated herein are subject to the terms and provisions of the Agreement.

 

2.                 
Services and Payment of Fees and Expenses. The specific services contemplated by this Work Order (the “Services”)
and the related payment terms and obligations are set forth on Attachment 1 hereto, which is incorporated herein by reference:

 

3.                 
Term. The term of this Work Order shall commence on the date of execution and shall continue until the Services described
are completed, unless this Work Order is terminated in accordance with the Agreement. If the Agreement is terminated or expires, but this
Work Order is not terminated or completed, then the terms of the Agreement shall continue to apply to this Work Order until the Work Order
is either terminated or completed.

 

4.                 
Amendments. No modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed
and delivered by each party to the other.

 

5.                 
Standard Operating Procedures. Pharms shall conduct the Study according to the formats and procedures set forth in Pharms’s
Standard Operating Procedures (“SOPs”).

 

6.                 
Third Parties. The Third Party vendors who will be performing services on the Study are set forth in Attachment 1. Sponsor
has provided its written consent and approves such Third Party vendors listed and referred to within this Agreement.

 

 

 

 

 

 

 

 

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ACKNOWLEDGED, ACCEPTED AND AGREED TO:

 

 

PJSC Pharmsynthez

 

By: __________________________________

(Signature)

 

 

Print: Prilezhaev Efim

 

 

Title: Chief Executive Officer 

 

 

Date: _____________________________________

 

 

 

 

 

 

Xenetic Biosciences, Inc.

 

By: __________________________________

(Signature)

 

 

Print: Curtis Lockshin 

 

 

Title: Chief Scientific Officer 

 

 

Date: _____________________________________

 

 

 

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ATTACHMENT 1: SCOPE OF WORK/PROJECT BUDGET

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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ATTACHMENT 2: THIRD PARTY AGREEMENTS

 

[Pharms to complete]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	 	8

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