Exhibit 10.11


 


FORM OF 


 


 


 


 


Transition, Services and Resupply
Agreement


 


# 15-8-311


 


by and among


 


AS Kevelt,


 


OJSC Pharmsynthez


 


and


 


Xenetic Biosciences, Inc.


 


 


 


 


 



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Transition and Resupply Agreement


 


This Transition,
Services and Resupply Agreement (the “Transition and Resupply Agreement”), dated as of October __, 2015 (“Effective
Date”) is entered into among AS Kevelt, an Estonian pharmaceutical company (“Kevelt”), OJSC Pharmsynthez, a Russian
pharmaceutical company and parent of Kevelt (“Pharmsynthez”) and Xenetic Biosciences, Inc., a Nevada corporation (“Xenetic”).


 


RECITALS


 


WHEREAS, Xenetic
has acquired all the assets, intellectual property and material related to Virexxa for any Permitted Uses from Kevelt and Pharmsynthez
through an Asset Purchase Agreement entered into on October __, 2015 (the “Agreement”);


 


WHEREAS, Xenetic
in accepting the transfer of the assets, intellectual property and material related to Virexxa has also taken on all rights to
continue any ongoing clinical trials, though not the obligation to do so, initiate any new preclinical and/or clinical trials,
obtain marketing authorization, distribute, offer to sell and sell Virexxa worldwide;


 


WHEREAS, the Agreement
contemplates that Kevelt and Pharmsynthez will continue to manufacture and supply for research, clinical and commercial purposes
Virexxa to Xenetic and if requested, transfer the manufacturing to a Xenetic or a third party selected by Xenetic to supply and
manufacture Virexxa; and


 


WHEREAS, Kevelt
and Pharmsynthez wish to fulfill the commitments set forth in this Transition and Resupply Agreement.


 


NOW, THEREFORE,
in consideration of the premises and mutual covenants hereinafter set forth, the sufficiency of which is hereby acknowledged,
Xenetic, Kevelt and Pharmsynthez (individually each referred to as a “Party” and collectively as “Parties”)
hereby agree as follows:


 


Article I.



Definitions


 


Any capitalized
terms not defined in this Transition and Resupply Agreement shall have the meaning given such term(s) in the Agreement. Any references
in this Transition and Resupply Agreement to “Articles” and/or “Sections” shall refer to Articles and/or
Sections of this Transition and Resupply Agreement, unless specified to be referring to Articles and/or Sections of the Agreement.
For purposes of this Transition and Resupply Agreement, the following capitalized terms, whether used in the singular or plural,
shall have the following meanings:


 






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Section
1.01        “Kevelt/Pharmsynthez
Manufacturing Know-How” means Virexxa batch formula and production related data,
methods, processes, standard operating procedures (“SOP”), and relevant proprietary information together with all applicable
improvements, that are owned by Kevelt and Pharmsynthez or their Affiliates.


 


Section
1.02        “Kevelt/Pharmsynthez
Patents” means the Patents Owned by Kevelt and/or Pharmsynthez and their Affiliates
as of the Effective Date having one or more valid and unexpired claims (i) that cover Virexxa; or (ii) that cover processes directed
to formulating and manufacturing Virexxa. For purposes of this Transition andResupply Agreement, the phrase “valid and unexpired
claim” shall mean a composition of matter, method of use or method of manufacture claim (or equivalent thereof) of an issued
and unexpired Patent, or a composition of matter, method of use or method of manufacture claim (or equivalent thereof) of a pending
application, which (i) has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed for appeal; and (ii) has not been abandoned, disclaimed,
denied or admitted to be invalid or unenforceable through reissue or disclaimer or otherwise. 


 


Section
1.03         “Deliver”
or “Delivery,” with respect to Virexxa means, and shall take place upon, the
transfer of possession of Virexxa to a Xenetic EXW (Incoterms 2010) at the place the Virexxa will be shipped to Xenetic.


 


Section
1.04        “Excluded Uses”
shall mean the use of Virexxa in the Retained Territory for the treatment of all diseases included in Exhibit A (Indications for
Excluded Uses).


 


Section
1.05        “Permitted Uses”
shall mean the use of Virexxa and the Intellectual Property for the treatment of all diseases and conditions other than the Excluded
Uses. Permitted Uses shall include but not be limited to the treatment of cancer indications and the use of the Intellectual Property
as an immune modulator or in association with interferon.


 


Section
1.06        “Specification(s)”
means the requirements, standards, quality control testing and other attributes pertaining to
Virexxa, as set forth in a specification that shall be agreed upon by the Parties following the entry of the Parties into this
Transition and Resupply Agreement and as approved by the appropriate governmental agencies and bodies.


 


Section
1.09        “Virexxa” shall mean medicinal product Sodium Cridanimod (Virexxa®) (Oxodihydroacridinylacetate
sodium containing a Sodium 2-(9-oxoacridin-10-yl) acetate, any
derivatives, isomers, substitutions or any other form, as an active pharmaceutical ingredient, developed by Kevelt and/or
Pharmsynthez and having properties described in the Chemical, Manufacturing and Controls (“CMC”) and medicinal
product dossier (“MPD”) for the Permitted Uses. 


 






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Article
II.






Manufacture and
Supply, Technology Transfer and Transition


 


Section
2.01        Virexxa Manufacturing
Procedures, Standards and Compliance with Laws. All Virexxa used for pre-clinical, clinical and
commercial purposes but not more than a maximum of 5,000 ampoules per month at 250 mg per ampoule or total equivalent amount will
be manufactured, tested and released as described in the most current version of the CMC (Annex [B].) by Kevelt and/or Pharmsynthez
according to established current good manufacturing practices (“cGMPs”) and agreed upon by the Parties standard operating
procedures (SOPs) , and applicable corresponding regulations in any country where the Virexxa CMC is approved for pre-clinical,
clinical and/or commercial purposes, including, but not limited to those required by the United States Food and Drug Administration
(FDA) and the European Medicines Agency (EMA). During the term of this Transition and Resupply Agreement, Kevelt and/or Pharmsynthez
will be fully responsible for maintaining its facilities and procedures, in compliance with cGMPs, standards that are agreed upon
by the Parties and applicable corresponding regulations.


 


Section
2.02        Certificate
of Analysis. Kevelt and/or Pharmsynthez shall deliver to Xenetic with fulfillment of each Virexxa
order a certificate of analysis confirming that such order meets the Specifications applicable to Virexxa (each, a “Certificate
of Analysis”) and a certificate of compliance of such order. Kevelt and/or Pharmsynthez shall test manufactured batches hereunder
in accordance with approved specifications covered by the CMC. Xenetic shall be responsible for reasonable inspection of each order
for physical damage in shipping and storage. Within thirty (30) days after receipt of each order of Virexxa, at Xenetic together
with Kevelt’s and or Pharmsynthez's Certificate of Analysis and certificate of compliance pertaining to each such order,
Xenetic shall notify Kevelt and/or Pharmsynthez if, in Xenetic's determination, such order fails to conform to the Specifications.
Xenetic shall provide written notice of rejection of the applicable order to Kevelt and/or Pharmsynthez within such thirty (30)
day period. Orders not rejected within such thirty (30) day period in a written notice of rejection sent to Kevelt and/or Pharmsynthez
shall be deemed to have been accepted by Xenetic. Once Xenetic accepts an order of Virexxa within the thirty (30) day period, it
shall not have the right to reject such order thereafter. If Xenetic determines that such order does not conform to Specifications,
it shall send to Kevelt and/or Pharmsynthez, via fax, email, overnight delivery service or certified mail, return receipt requested,
within such thirty (30) business day period a written notice of rejection with a reasonably detailed description setting forth
the reasons the order is being rejected, along with a sample of the rejected order to Kevelt and/or Pharmsynthez. If Kevelt and/or
Pharmsynthez agree that the order is defective or non-conforming, it will, at its option (i) replace such order, though such replacement
shall not include material that was rejected and reprocessed to meet the required specification, or (ii) reimburse Xenetic its
out-of-pocket costs paid for such material. Furthermore, Kevelt and Pharmsynthez shall pay for the shipping cost associated with
the delivery of the replacement order, if any. If Kevelt and/or Pharmsynthez do not agree with Xenetic's determination that such
order is defective or non-conforming, then after reasonable efforts to resolve the disagreement, either Party may submit a sample
from the order to a mutually agreed upon independent third party laboratory for resolution of the dispute. The independent laboratory’s
results shall be final and binding. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing
and review shall be borne by the Party against whom the independent laboratory rules. For purposes of this Section 2.02, the thirty
(30) day period shall commence on the date of Xenetic’s receipt of the order and the related Certificate of Analysis.


 






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Section
2.03        Replacement
of Defective Item. IN ACCORDANCE WITH THE TERMS SET FORTH IN THIS TRANSITION AND RESUPPLY AGREEMENT,
KEVELT AND/OR PHARMSYNTHEZ SHALL REPLACE, AT ITS SOLE EXPENSE, ALL ITEMS THAT DO NOT COMPLY OR ARE FOUND NOT TO COMPLY WITH THE
SPECIFICATIONS (“DEFECTIVE ITEM”), OR SHALL CREDIT XENETIC FOR AMOUNTS ALREADY PAID FOR THE DEFECTIVE ITEM. THE OBLIGATION
OF KEVELT AND/OR PHARMSYNTHEZ TO REPLACE DEFECTIVE ITEMS IN ACCORDANCE WITH THE SPECIFICATIONS OR PROVIDE CREDIT SHALL BE XENETIC’S
SOLE AND EXCLUSIVE REMEDY UNDER THIS TRANSITION AND RESUPPLY AGREEMENT FOR DEFECTIVE ITEMS, AND IS IN LIEU OF ANY OTHER REMEDY,
EXPRESS OR IMPLIED.


 


Section
2.04        Delivery. Kevelt
and/or Pharmsynthez shall tender Virexxa for delivery, EXW Tallinn (Incoterms 2010). Xenetic shall be responsible for all costs
and risk of loss associated with the shipping of Virexxa, other materials shipped (from and after Delivery) and shipping instructions.


 


Section
2.05        Manufacture
of Virexxa.


 


(a)     Manufacture.
With respect to Virexxa, from the Effective Date, Kevelt and Pharmsynthez will be responsible for supplying Xenetic with Virexxa
under the following terms and conditions:




 


(i)          Forecasting.
In accordance with Section 2.01, Virexxa shall be supplied by Kevelt and/or Pharmsynthez to Xeneticin an amount that does not
exceed 5,000 ampoules of Virexxa per month. On or before the first day of each calendar month, Xenetic shall furnish to Kevelt
and/or Pharmsynthez a written six (6) month rolling forecast of the quantity of Virexxa that Xenetic estimates it will order from
Kevelt and/or Pharmsynthez during such six (6) month forecast period (the “Forecast”; the first of which is attached
hereto as Schedule 1). The first three (3) months of each Forecast shall constitute a binding order for the quantities of Virexxa
specified therein (the “Firm Commitment”), and the following three (3) months of the Forecast shall be non-binding,
good faith estimates.


 






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(ii)          Purchase Orders. On or before the first (1st) day of each calendar month, Xenetic shall submit a purchase
order for the Firm Commitment portion of the Forecast, as to which no purchase order has been previously submitted, which specifies
the actual quantities of Virexxa to be delivered to Xenetic hereunder for the relevant calendar month and the requested shipping
dates for each order (“Purchase Order”). As the Forecast contains Firm Commitments for the first three (3) months,
the Purchase Orders to be presented during such months, may vary in quantities through such three (3) months, but the summarized
quantities for the said period must meet the quantities as stated in the Firm Commitment. All Purchase Orders shall reflect orders
of a size that the Parties have agreed are within the reasonably anticipated capacity of Kevelt and/or Pharmsynthez.


 


(iii)          Raw Material
or Capacity Shortage. In the event that Kevelt and/or Pharmsynthez is unable to supply Xenetic with Virexxa in the quantities
ordered by Xenetic in accordance with Section 2.05(a)(ii), due to Kevelt’s and/or Pharmsynthez’s insufficient supplies
of raw materials necessary to manufacture Virexxa or other manufacturing capacity constraints, Kevelt and/or Pharmsynthez shall
use commercially reasonable efforts to equitably allocate available raw materials or manufacturing capacity, as the case may be,
in a manner consistent with the Parties’ anticipated needs. Notwithstanding the foregoing, Kevelt and/or Pharmsynthez shall
prioritize allocation of manufacturing capacity and raw materials to the manufacture of Virexxa for Xenetic.


 


(iv)          Xenetic Modification or Cancellation. Xenetic may request modification of the delivery date or quantity of Virexxa
in a Purchase Order only by submitting a written change order to the Party to whom such Purchase Order was submitted, though such
modification request shall not change the amount of Virexxa Xenetic is to purchase based on the then relevant Forecast as set
forth in Section 2.05(a)(i). Such change order shall be effective and binding against the Party to whom the Purchase Order was
submitted only upon written acceptance by such Party. Notwithstanding the foregoing, Xenetic shall remain responsible for the
Firm Commitment portion of the Forecast. The manufacturing Party (Kevelt and/or Pharmsynthez) shall notify Xenetic of its approval
or rejection of any such change order within fourteen (14) business days after receipt thereof.


 


(v)          Transitional
Period Plan. Upon notice by Xenetic of Xenetic’s intent to transfer the manufacturing to itself or a third party manufacturer
selected by Xenetic at Xenetic’s sole discretion, the Parties shall negotiate in good faith and devise a transitional period
plan which will set forth, among other things, the Parties’ responsibilities relating to the manufacture of Virexxa during
the transfer of manufacturing technology from Kevelt and/or Pharmsynthez to Xenetic, the time frame for such transfer, and the
Parties’ mutually determined collaborative and comprehensive plan that will ensure a supply of Virexxa and a smooth transition
of manufacturing of Virexxa from Kevelt and/or Pharmsynthez to Xenetic.


 






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Section
2.06        Technology
Transfer. The Parties shall cooperate to expedite transfer of Kevelt’s and Pharmsynthez’sVirexxa
manufacturing technology to a facility designated by Xenetic, where Virexxa manufacturing will be conducted by or on behalf of
Xenetic. Kevelt and Pharmsynthez will make employees of appropriate skill and experience reasonably available to Xenetic to facilitate
such transfer. Kevelt, Pharmsynthez and Xenetic will cooperate to minimize the expenses associated with such transfer and to ensure
that the transfer of Virexxa manufacturing is effectively coordinated.


 


Section
2.07        Hiring of Employees.
With the written consent of the Party from whom such employees are to be hired, such consent
not to be unreasonably withheld, Xenetic shall have the right, but not the obligation,
to hire or contract with Kevelt and Pharmsynthez employees, including those Kevelt and Pharmsynthez employees that are involved
in the manufacture, quality assurance, quality control, packaging and clinical and commercial regulatory approvals for Virexxa,
as are needed to facilitate the transfer of Virexxa to Xenetic’s facility or one selected by Xenetic. Any such hiring decisions,
and the terms thereof, shall be solely at Xenetic’s discretion. To the extent requested by Xenetic, Kevelt and Pharmsynthez
shall assist Xenetic in making its hire/no hire decision regarding Kevelt and Pharmsynthez employees.


 


Section
2.08        Costs of Technology
Transfer. Except for such costs to be borne by Kevelt and Pharmsynthez as set forth herein, Xenetic
shall be solely responsible for any and all costs associated with the transfer of manufacturing of Virexxa to the facility where
Virexxa is to be manufactured by or on behalf of Xenetic. To facilitate the transfer, Kevelt and Pharmsynthez shall provide all
employees necessary to effectuate the transfer at minimum cost to Xenetic, other than reimbursement to Kevelt and Pharmsynthez
of out-of-pocket expenses related thereto. Kevelt and Pharmsynthez shall be responsible for all costs associated with their termination
of manufacturing Virexxa (including any severance or other payments owed to employees following the termination of manufacturing
Virexxa by Kevelt and Pharmsynthez).


 


Section
2.09        Batch Records
and Data. Upon Xenetic’s request, within thirty (30) days following Delivery of a lot of
Virexxa, Kevelt and Pharmsynthez shall provide Xenetic with properly completed copies of batch records consisting of complete information
relating to the production operations and the controls of each batch; provided, however, that if testing reveals an “out-of-Specification”
result, Kevelt and Pharmsynthez shall provide such batch records within seven (7) days following resolution of the “out-of-Specification”
result. The Parties agree that Kevelt and Pharmsynthez shall provide these records to Xenetic solely for the purpose of assisting
with the transfer of Virexxa manufacturing technology, and Xenetic shall not bear the responsibility for correction of any “out-of-Specification”
results.


 






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Article
III.


Transition 


 


Section 3.01
Kevelt and/or Pharmsynthez Provision of Information and Documents to Xenetic


 


(a)     Following
entry of the Parties into this Transition and Resupply Agreement, Kevelt and Pharmsynthez shall provide to Xenetic the following
within thirty sixty (60) days of the Effective Date:


 


(i) a list
all notebooks, records, data, results, information, filings, regulatory papers submissions and submission related correspondence
and information regarding Virexxa requested or ordered by Xenetic or known by Kevelt and/or Pharmsynthez to be necessary for Xenetic
to carry out the research, development and commercialization of Virexxa® pursuant to the terms of the IP Asset Purchase Agreement,
whether in paper, electronic or some other form, including their location, the identity of all individuals with access to them
and the date such notebooks, records, data, results, information, filings, regulatory papers, information shall be provided to
Xenetic;


 


(ii) all copies
of original notebooks, records, data, results, filings, submissions and submission related correspondence regulatory papers and
information regarding Virexxa, whether in paper, electronic or some other form;


 


(iii) a list
of all Approved Suppliers to Kevelt and/or Pharmsynthez that have been, are or will be involved in the research, development, commercialization,
testing or manufacturing of Virexxa, including their addresses and contact information;


 


(iv) a list
of all information, know-how and/or trade secrets in the possession of Kevelt and/or Pharmsynthez that relate in any manner to
Virexxa for the Permitted Uses


 


(v) a list
identifying all current stocks of Virexxa in the possession of Kevelt and/or Pharmsynthez or their Affiliates, contractors, or
other third parties contracted in any manner by Kevelt and/or Pharmsynthez and the date upon which ownership such stocks of Virexxa
shall be transferred to Xenetic, a valuation of the value of such stocks of Virexxa and instructions provided to Xenetic to effectuate
the transfer of such stocks of Virexxa to Xenetic; and,


 


(vi) copies
of all documents and records related to communications with regulatory authorities relating to the Permitted Uses, including, those
related to current or previous clinical development, manufacturing, product safety and pharmacovigilance.


 


(vii) copies
of all documents and records related to the manufacture of Virexxa, including, the manufacture of bulk API as well as final drug
product.


 


(viii) any
other material information or records related in any manner to Virexxa for the Permitted Uses.


 






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Article
IV.


Records; Regulatory Matters


 


Section
4.01        Record keeping.
Kevelt and/or Pharmsynthez shall maintain true and accurate books, records, test and laboratory
data, reports and all other information relating to manufacturing under this Transition and Resupply Agreement, including all information
required to be maintained by applicable laws and regulations, including but not limited to cGMP. Such information shall be maintained
in forms, notebooks and records for a period of at least one (1) years from the relevant finished Virexxa expiration date, or longer
if required under applicable laws.


 


Section
4.02        Regulatory
Responsibility and Compliance.


 


		(a)	Kevelt and/or Pharmsynthez agrees to use commercially reasonable efforts to cause, within three
(3) months after the Effective Date, the transfer of title and ownership to Xenetic of any and all regulatory approvals and related
regulatory filings relating to Virexxa for the Permitted Uses which are owned by Kevelt and/or Pharmsynthez and are filed, issued
and in full force and effect as of the Effective Date.



 


		(b)	Kevelt and/or Pharmsynthez shall be responsible for transferring according to Section 4.02(a) and
Xenetic shall be responsible for obtaining and maintaining any establishment licenses or permits required by the FDA or other regulatory
authorities, by applicable laws or by regulatory authorities that pertain to Virexxa manufacturing. Kevelt and/or Pharmsynthez
hereby grant to Xenetic the right to reference such establishment files for the purpose of obtaining and maintaining regulatory
approval.



 


Section
4.03        Governmental
Inspections and Requests. Kevelt and/or Pharmsynthez shall advise Xenetic within three (3) Business
Days if an authorized agent of any regulatory authority visits a facility where manufacturing activity with respect to Virexxa
takes place, where the interest of the regulatory authority is specifically related to manufacturing activity with respect to Virexxa.
In such circumstance, Kevelt and/or Pharmsynthez shall furnish to Xenetic a copy of sections of the report by such regulatory authority,
which are specifically related to Virexxa within five (5) days of receipt of such report if such report is received in English
by Kevelt and/or Pharmsynthez. If the sections of the report by such regulatory authority are not in English, the receiving Party
shall translate the sections of the report into English and shall provide such translated sections of the report to Xenetic within
ten (10) days of receipt of such report. Further, upon receipt of a regulatory authority written request to inspect a Kevelt and/or
Pharmsynthez manufacturing facility, or to audit Kevelt’s and/or Pharmsynthez’s books and records with respect to manufacturing
of Virexxa under this Transition and Resupply Agreement, Kevelt and/or Pharmsynthez shall notify Xenetic thereof within three (3)
days, and shall provide Xenetic with a copy of any written document received from such regulatory authority if the document is
written in English. If the document is not written in English, Pharmsynthez and/or Kevelt shall provide Xenetic with an English
translation within ten (10) days of the receipt of the document. Kevelt and/or Pharmsynthez shall provide Xenetic with notice of
any such non-written inspection request from a regulatory authority which specifically relates to Virexxa as promptly as reasonably
practicable under the circumstances. Kevelt and/or Pharmsynthez shall also provide to Xenetic such notice as is reasonably practicable
under the circumstances of any action by a regulatory authority, resulting from an inspection of a facility where manufacturing
activity with respect to Virexxa takes place, which is reasonably anticipated to materially affect Kevelt’s and/or Pharmsynthez’s
ability to perform its obligations under this Transition and Resupply Agreement. Nothing in this Section 4.03 shall require Kevelt
and/or Pharmsynthez to submit to Xenetic any books, records, data or information relating to the manufacture or distribution of
any products other than Virexxa.


 






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Section
4.04        Recall and
Field Corrective Action.


 


This Section 4.04
shall govern recall arising after the Effective Date from Virexxa manufactured by Kevelt and/or Pharmsynthez for Xenetic. In
the event that Xenetic believes a recall, field alert, Virexxa withdrawal, or field corrective action may be necessary with regard
to Virexxa provided to Xenetic under this Transition and Resupply Agreement, Xenetic shall immediately notify Kevelt and/or Pharmsynthez
in writing. Xenetic shall provide reasonable cooperation and assistance to Kevelt and/or Pharmsynthez required to allow Kevelt
and/or Pharmsynthez to respond to a recall, field alert, Virexxa withdrawal, or field corrective action. The cost of a Virexxa
product related recall, field alert Virexxa withdrawal or field corrective action shall be borne by Kevelt and/or Pharmsynthez
if such recall, field alert, Virexxa withdrawal, or field corrective action is caused in material part by Kevelt and/or Pharmsynthez's
breach of its obligations under this Transition and Resupply Agreement, or applicable laws, or by its willful misconduct. Xenetic
shall bear responsibility for the cost of a Virexxa product related recall, field alert Virexxa withdrawal or field corrective
action for all other reasons.. For purposes of this Section 4.04, the Party bearing the costs of any recall, field alert, Virexxa
withdrawal, or field corrective action shall only be required to reimburse the other Party for reasonable, actual and documented
out-of-pocket costs incurred by such other Party for such recall, field alert, Virexxa withdrawal, or field corrective action (including
costs of retrieving Virexxa already delivered to customers, costs and expenses such other Party is required to pay for notification,
shipping and handling charges, and all other costs reasonably related to such recall, field alert, Virexxa withdrawal, or field
corrective action), and the cost to replace, or the actual replacement of Virexxa.


 


Section
4.05        Quality Agreement.
The Parties shall execute a separate Quality Agreement, which will reflect the division of quality
responsibilities while Virexxa is manufactured, released and supplied by Kevelt and/or Pharmsynthez for Xenetic (“Quality
Agreement”). Kevelt and/or Pharmsynthez shall use commercially reasonable efforts to comply with the Quality Agreement, but
in any event shall comply with applicable laws. In the event of a conflict between the terms of this Transition and Resupply Agreement
and the Quality Agreement, this Transition and Resupply Agreement shall control, unless the issues relate to quality wherein the
Quality Agreement shall control. Kevelt and/or Pharmsynthez shall in any event comply with applicable laws. The failure of a Party
to comply with a requirement of the Quality Agreement shall not be actionable, unless it constitutes a material violation of law
of any jurisdiction in which Virexxa is distributed.


 






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Section
4.06        Quality, Environmental,
Health and Safety Audits. Kevelt and/or Pharmsynthez shall permit Xenetic’s personnel or
authorized representative, upon reasonable notice, at reasonable intervals, and for reasonable duration during regular business
hours, to visit the facility where Virexxa is manufactured, tested, or stored by, or on behalf of, Kevelt and/or Pharmsynthez;
or to audit compliance with this Transition and Resupply Agreement, however, that such audits shall be conducted not more than
twice in any twelve (12) month period, other than "for cause" audits, which Xenetic shall be entitled to conduct following
the implementation of measures in response to letters from the FDA to Kevelt and/or Pharmsynthez pertaining to the manufacture
of Virexxa.


 


All information
obtained by Xenetic in any such review, including without limitation the findings and results related thereto, shall be deemed
Kevelt and/or Pharmsynthez Confidential Information. Kevelt and/or Pharmsynthez will have responsibility to audit its permitted
subcontractors and suppliers at reasonable intervals for compliance with (i) the Specifications, (ii) current GMPs, and (iii) applicable
laws. Xenetic shall have the right to confirm audits of subcontractors and suppliers of Kevelt and/or Pharmsynthez for Virexxa
manufactured under this Transition and Resupply Agreement.


 


Section
4.07        Complaints
and Adverse Events. The Party responsible for all permits and licenses required by any regulatory
authority with respect to Virexxa under this Transition and Resupply Agreement, including any product licenses, applications and
amendments in connection therewith, shall be responsible for evaluating and investigating complaints and for reporting all Adverse
Events to regulatory authorities in any country Virexxa is used and/or sold. If the responsible Party becomes aware of any Adverse
Event, it shall evaluate, investigate and determine the necessity of reporting all information in its possession regarding such
Adverse Event as soon as practicable, in order to fulfill regulatory reporting obligations within the time frames required by regulatory
authorities and law; provided, however, that Kevelt and/or Pharmsynthez shall not be required to communicate with customers of
Xenetic. The Parties will comply with all applicable reporting laws, rules and regulations governing Adverse Events. Xenetic and
Kevelt and/or Pharmsynthez agree to supply all complaint information (including Adverse Event information) to the responsible Party
within three (3) Business Days of learning of a complaint or event; to cooperate with investigations and corrective actions; and
to comply with all applicable reporting laws, rules and regulations governing Adverse Events. 


 


Section
4.08        Compliance.
The obligations of Kevelt and/or Pharmsynthez and Xenetic set forth in this Article 4 are intended
to comply with the laws, rules and regulations of each country in which Virexxa is approved. The requirements of this Article 4
shall therefore be construed and interpreted to comply with all such laws, rules and regulations. To the extent provisions of this
Article 4 do not adequately reflect any such law, rule or regulation, such provisions shall be revised to the extent reasonably
necessary to make such provisions legal and valid in accordance with such laws, rules and regulations.


 






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Article V.


Cost for Manufacturing
and Supply of Virexxa to Xenetic


 


Section
5.01        Virexxa Manufacturing
and Supply Costs. Xenetic shall pay to the manufacturer of Virexxa, Kevelt and/or Pharmsynthez
all the manufacturing cost of Virexxa, which includes, but is not limited to, all direct costs related to the manufacturing of
Virexxa and related operational expenses as stated in the pre-approved costs specifications (which forms an annex of this Transition,
Manufacturing and Supply Agreement, plus fifteen percent (15%) on a per unit basis (“Purchase Price”). Xenetic shall
be entitled to audit such manufacturing costs pursuant to the terms of this Transition and Resupply Agreement.


 


Section
5.02        Invoicing.
Kevelt and/or Pharmsynthez shall provide Xenetic with an invoice following the delivery of Virexxa.
Xenetic shall pay Kevelt and/or Pharmsynthez within thirty (30) days of the receipt of an invoice. 



 


Section
5.03        Currency. Unless
otherwise agreed by the Parties in writing, all amounts paid by Xenetic under this Transition- and Resupply Agreement shall be
paid to Kevelt and/or Pharmsynthez in Euros by wire transfer to a financial institution to be designated by Kevelt and/or Pharmsynthez.
Subject to Section 5.02, such payments shall be without deduction of collection, wire transfer or other charges, and, specifically,
without deduction of withholding or similar taxes or other government imposed fees or taxes. The pre-approved cost specification
shall state a currency exchange rate range based on which the Purchase Price is determined. In case the currency exchange rate
fluctuation exceeds such rate range, the Purchase Price shall be modified by the percentage exceeding the agreed range.


 


Section
5.04        Interest Due.
In case of any delay in payment by Xenetic to Kevelt and/or Pharmsynthez, interest on the overdue payment shall accrue at an annual
interest rate equal to seven and one half percent (7.5%), except to the extent that a regulatory or other governmental agency requires
that the annual interest rate exceed that stated in this Section 5.04, the rate shall be raised to that set forth by the regulatory
or other governmental agency with the understanding that Kevelt and/or Pharmsynthez shall provide documentary verification that
such rate increase is legally required. The foregoing interest shall be due from Xenetic without any special notice, and shall
be in addition to any other remedies that Kevelt and/or Pharmsynthez may have pursuant to this Transition- and Resupply Agreement.


 






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Section
5.05        Taxes. The
Parties agree that any taxes that either Party is required by law to withhold from amounts payable to the other Party under this
Transition- and Resupply Agreement (whether under this Article 5 or otherwise) shall be deducted by the paying Party from the amounts
paid to the non-paying Party hereunder at the rate(s) required by applicable law, and shall be promptly paid to the appropriate
governmental authority on behalf of the non-paying Party. However, the pre-approved cost specification as stated in the annex of
this Transition, Manufacturing and Supply Agreement, shall state the Purchase Price after all such tax withholdings. The paying
Party shall promptly provide to the non-paying Party receipts from the government or taxing authority evidencing payment of such
taxes, if available, or other written proof of payment if official receipts are not available, and shall provide reasonable assistance
to the non-paying Party to obtain tax credits therefor.


 


Section
5.06         Manufacturing
Cost Audit. Upon the written request of Xenetic, Kevelt and/or Pharmsynthez shall permit an independent
certified public accounting firm of recognized national standing in the United States, selected by Xenetic and reasonably acceptable
to Kevelt and/or Pharmsynthez, at the Xenetic’s expense, to have access to Kevelt’s and/or Pharmsynthez’s records
related to all manufacturing costs billed to Xenetic as may be reasonably necessary to verify the accuracy of any amounts payable
by Xenetic to Kevelt and/or Pharmsynthez under this Transition- and Resupply Agreement. Such audits shall be conducted under conditions
of confidentiality and may be made no more than once each calendar year, during normal business hours at reasonable times mutually
agreed by the Parties. If the audit discloses that the manufacturing costs charged to Xenetic by Kevelt and/or Pharmsynthez was
over twelve and a half percent (12.5%) higher than the actual manufacturing costs, then Kevelt and/or Pharmsynthez shall pay the
reasonable fees and expenses charged by such accounting firm and reimburse Xenetic the amount overcharged along with a charge of
ten percent (10%) interest on the amount overcharged.


 


Article VI.


Representations
and Warranties


 


Section
6.01        Representations
and Warranties of KEVELT AND/OR PHARMSYNTHEZ.


 


 (a)     Authorization. Kevelt and/or Pharmsynthez, jointly and severally, represents, warrants and covenants that:




 


(i) this
Transition- and Resupply Agreement has been duly executed and delivered by Kevelt and/or Pharmsynthez and constitutes
a valid and binding obligation of Kevelt and/or Pharmsynthez, enforceable against Kevelt and/or Pharmsynthez in accordance
with its terms, except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization,
moratorium and other laws relating to or affecting creditors’ rights generally and by general equitable principles;


 






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(ii) the
execution, delivery and performance of this Manufacturing Agreement have been duly authorized by all necessary action on the
part of Kevelt and/or Pharmsynthez, its officers and directors and does not conflict with any agreement, instrument or
understanding, oral or written, to which Kevelt and/or Pharmsynthez is a party or by which it may be bound, and, to the best
of its knowledge, does not violate any material law or regulation of any court, governmental body or administrative or other
agency having authority over it;


 


(iii) Kevelt
and/or Pharmsynthez has full power and authority to perform the obligations set forth herein, and that Kevelt and/or Pharmsynthez
is not subject to any order, decree or injunction by a court of competent jurisdiction which may prevent or materially delay the
consummation of the transactions contemplated by this Transition and Resupply Agreement;


 


(iv) Kevelt
and/or Pharmsynthez is duly organized, validly existing and in good standing under the laws of the jurisdiction where it is
organized; and


 


		(b)	Kevelt and/or Pharmsynthez’s Rights (Virexxa). As of the Effective Date, Kevelt and/or
Pharmsynthez, jointly and severally, represent and warrant, with respect to manufacture and supply of Virexxa as of the Effective
Date, that to its knowledge, upon reasonable inquiry, the granting of the rights to Xenetic hereunder does not conflict with any
contractual obligation to any Third Party.



 


		(c)	No Conflicting Agreements. Kevelt and/or Pharmsynthez, jointly and severally, represent and warrant that they have not
to their knowledge granted, and during the term of this Transition and Resupply Agreement will not grant, any right to a Third
Party that would conflict with the licenses and rights granted to Xenetic hereunder.



 


Section
6.02        Representations
and Warranties of Xenetic.


 


		(a)	Authorization. Xenetic represents, warrants and covenants that:



 


(i) this
Transition- and Resupply Agreement has been duly executed and delivered by Xenetic and constitutes a valid and binding
obligation of Xenetic, enforceable against Xenetic in accordance with its terms, except as enforceability may be limited by
bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting
creditors’ rights generally and by general equitable principles;


 


(ii) the
execution, delivery and performance of this Transition and Resupply Agreement by Xenetic have been duly authorized by all
necessary action on the part of Xenetic, its officers and directors, and does not conflict with any agreement, instrument or
understanding, oral or written, to which Xenetic is a party or by which it may be bound, and, to the best of its knowledge,
does not violate any material law or regulation of any court, governmental body or administrative or other agency having
authority over it;


 






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(iii) Xenetic
has full power and authority to perform the obligations set forth herein, and that Xenetic is not subject to any order, decree
or injunction by a court of competent jurisdiction which may prevent or materially delay the consummation of the transactions contemplated
by this Transition and Resupply Agreement; and


 


(iv) Xenetic
is duly organized, validly existing and in good standing under the laws of the jurisdiction where it is organized.


 


		(b)	No Impairing Agreements. Xenetic represents, warrants and covenants that, during the term
of this Transition and Resupply Agreement, it will not knowingly enter into any agreements, oral or written, that would in any
way impair its ability to fulfill its obligations under this Transition and Resupply Agreement.



 


Article VII.


Limitations on
Representations and Warranties


 


Limitations on Representations and Warranties.
THE LIMITED WARRANTIES CONTAINED IN ARTICLE 5 ARE THE SOLE WARRANTIES GIVEN BY THE PARTIES HEREUNDER, AND ARE MADE EXPRESSLY IN
LIEU OF AND EXCLUDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT OR OTHERWISE,
AND ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES PROVIDED BY COMMON LAW, STATUTE OR OTHERWISE ARE HEREBY DISCLAIMED
BY BOTH PARTIES. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR INDIRECT, PUNITIVE, SPECIAL, CONSEQUENTIAL OR
EXEMPLARY DAMAGES OF ANY KIND, INCLUDING WITHOUT LIMITATION, LOSS OF PROFITS AND LOSS OR INTERRUPTION OF BUSINESS. THE FOREGOING
PROVISION SHALL NOT BE CONSTRUED TO LIMIT A PARTY'S INDEMNIFICATION OBLIGATION UNDER THIS TRANSITION AND RESUPPLY AGREEMENT FOR
THIRD PARTY CLAIMS WHICH MAY INCLUDE CONSEQUENTIAL, PUNITIVE OR OTHER TYPES OF DAMAGES.


 






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Article VIII.


Confidentiality


 


Section
8.01        Confidentiality.


 


	 	(a)	No Disclosure or Use. During the term of this Transition and Resupply Agreement, and for a period of ten (10) years
thereafter, each Party shall keep confidential all information received from the other Party (the “Confidential Information”),
and shall not disclose or use such Confidential Information without the other Party’s explicit written consent, except to
the extent contemplated by this Transition and Resupply Agreement. This restriction shall not, however, prevent disclosure of such
Confidential Information if and to the extent that disclosure is clearly required by law; provided that the disclosing Party informs
the other Party without delay of any such requirement, in order to allow such other Party to object to such disclosure and to seek
an appropriate protective order or similar protection prior to disclosure.
	 	 	 
		(b)	No Misappropriation. The Parties agree that the transfer of rights in regulatory documentation
by one Party to the other Party pursuant to this Transition and Resupply Agreement shall not, to the actual knowledge of the transferring
Party, misappropriate the proprietary or trade secret information of a Third Party.



 


		(c)	Exceptions. The above obligations shall not apply, or shall cease to apply, to Confidential Information of the disclosing
Party which:



 


(i) is now, or
hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available;


 


(ii) is known
by the receiving Party at the time of receiving such Confidential Information, as evidenced by its written records;


 


(iii) is
hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure;


 


(iv) is
independently developed by the receiving Party without resort to the Confidential Information of the disclosing Party or any
breach of this Article 7;


 


(v) is entered
into evidence in a legal proceeding or submitted for use in a dispute resolution proceeding to enforce one or more rights of
a Party under this Transition and Resupply Agreement; provided that the receiving Party shall give the disclosing Party
prompt written notice and sufficient opportunity to object to such use or disclosure, or to request confidential treatment of
the Confidential Information; or


 


(vi) is the
subject of a written permission to disclose provided by the disclosing Party.


 






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Section
8.02        Permitted Disclosures.


 


(a) Each
Party may disclose Confidential Information: (i) for the purpose of preparing, filing, prosecuting and maintaining Patents; (ii)
for obtaining Regulatory Approvals; (iii) for the manufacture, marketing, distribution or sale of Virexxa; or (iv) to any individuals
that are required by law, contract or otherwise not to use or disclose such Confidential Information except as permitted by this
Transition and Resupply Agreement. Each Party will use at least the same standard of care as it uses to protect proprietary or
confidential information of its own to ensure that such individuals do not disclose or make any unauthorized use of the Confidential
Information.


 


(b) In order
to exploit rights retained by or granted to the Parties under this Transition and Resupply Agreement, each Party may publish or
publicly present any research or other data which may involve the disclosure of Confidential Information; provided that the publishing
Party agrees to furnish the non-publishing Party with copies of any proposed oral, written, graphic or electronic public disclosure
prior to submission for publication or presentation. The non-publishing Party shall then have thirty (30) days to review such contemplated
publication or presentation. At the end of the thirty (30) day period, the publishing Party may proceed with the contemplated publication
or presentation unless (i) the non-publishing Party reasonably requests additional time to fully protect its intellectual property
rights, in which case any such contemplated publication or presentation containing the details of a patentable invention must be
withheld by the publishing Party for an additional period of thirty (30) days or until a patent application is filed thereon by
the non-publishing Party, whichever is earlier in time; or (ii) the non-publishing Party reasonably requests that trade secret
information or other Confidential Information of the non-publishing Party be redacted from the contemplated publication or presentation,
in which case any such request shall be honored by the publishing Party.


 


Section 8.03        Disclosure of Transition
and Resupply Agreement. Except as required by law, neither Kevelt and/or Pharmsynthez nor Xenetic shall release to any Third
Party or publish in any way any Confidential Information with respect to the terms of this Transition and Resupply Agreement or
concerning their cooperation without the prior written consent of the other Party, which consent will not be unreasonably withheld
or delayed; provided; however, that either Party may disclose the terms of this Transition and Resupply Agreement (a) to the extent
required to comply with applicable laws, and (b) in any instance where a Party becomes legally compelled (by deposition, interrogatory,
request for documents, subpoena, civil investigative demand or similar process). Notwithstanding any other provision of this Transition
and Resupply Agreement, each Party may disclose the terms of this Transition and Resupply Agreement (i) to its legal counsel or
(ii) to lenders, investment bankers, attorneys, financial advisors and other financial institutions of its choice solely for purposes
of financing the business operations of such Party, or to a potential acquirer of all or substantially all of the assets or equity
interests of such Party (a) upon the written consent of the other Party, or (b) if the Party disclosing such terms obtains a signed
confidentiality agreement with such intended recipient with respect to such Confidential Information, upon terms substantially
similar to those contained in this Article 7.


 


Section 8.04        Confidential
Information of Each Party. The Parties agree that the material financial terms of the Transition and Resupply Agreement shall
be considered the Confidential Information of both Parties.


 


Section 8.05       
Employee Obligations. Each Party shall undertake to ensure that all of its employees who have access to Confidential Information
are under obligations of confidentiality to such Party.


 






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Article IX.


Term
and Termination


 


Section
9.01        Term.


 


		(a)	Term. The supply of Virexxa by Kevelt and/or Pharmsyntez shall continue until as the earliest
of (i) such time as Xenetic requests the transfer of the manufacturing process to itself or a Third Party manufacturer selected
by Xenetic pursuant to Article II of this Transition, Services and Resupply Agreement; (ii) such time as Xenetic discontinues the
development of a Virexxa clinical or commercial program; (iii) eight (8) years from the Effective Date or (iv) upon Xenetic’s
written notice to be provided no later than three (3) months prior to the termination date.



 


		(b)	Termination with Cause. Either Party may terminate this Transition and Resupply Agreement
for cause pursuant to Sections 9.02 and 9.03.



 


		(c)	Accrued Obligations. Except where explicitly provided elsewhere herein, termination of this
Transition and Resupply Agreement for any reason, will not affect: (i) obligations of the Parties, including any payments which
have accrued as of the date of termination or expiration, or (ii) rights and obligations of the Parties at law or in equity which,
from the context thereof, are intended to survive termination of this Transition and Resuupply Agreement; nor prejudice any Party’s
right to obtain performance of any obligation then due and owing.



 


Section
9.02        Termination
for Insolvency. Either Party may terminate this Transition-
and Resupply Agreement immediately upon delivery of written notice to the other Party: (i) upon the institution by or against the
other Party of insolvency, receivership or bankruptcy proceedings or any other proceedings for the settlement of the other Party’s
debts; provided, however, with respect to involuntary proceedings, that such proceedings are not dismissed within sixty (60) days;
(ii) upon the other Party’s making an assignment for the benefit of creditors; or (iii) upon the other Party’s dissolution
or ceasing to do business. 


 


Section
9.03         Termination
for Material Breach.  Either Party may terminate this Transition and Resupply Agreement upon
sixty (60) days prior written notice to the other Party upon a material breach by the other Party of any of its obligations under
this Transition and Resupply Agreement (and such obligations specifically include a failure by a Party to pay any amount owing
under this Transition and Resupply Agreement); provided, however, that such termination shall become effective only if the breaching
Party shall fail to: (i) remedy or cure the breach within such sixty (60) day period, or initiate a remedy or cure within such
period if it is not practicable to complete the cure in such period; or (ii) within sixty (60) days after the date of the non-breaching
Party’s written notice of material breach, provide written notice of the breaching Party’s dispute of the alleged breach
or failure to cure and its invocation of the dispute resolution provisions set forth in the IP Asset Acquisition Agreement. If
the non-breaching Party elects not to terminate this Transition and Resupply Agreement pursuant to this Section 9.03, then the
non-breaching Party shall be entitled to seek, any equitable remedies and damages permitted by law, except to the extent otherwise
limited by this Transition and Resupply Agreement or the Agreement.


 






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Article X.


Product Liability, Indemnification and Insurance


 


Section
10.01    Responsibility and Control. Xenetic
and Kevelt and/or Pharmsynthez shall each be solely responsible for the safety of its own employees, agents, Affiliates or independent
contractors with respect to its performance under this Transition and Resupply Agreement, and each shall hold the other Party harmless
with regard to any liability for damages or personal injuries resulting from acts of its respective employees, agents, Affiliates
or independent contractors.


 


Section
10.02    Xenetic Right to Indemnification.
Kevelt and/or Pharmsynthez shall defend, indemnify, and hold harmless Xenetic, its Affiliates,
successors, and assigns and their respective directors, officers, employees, agents, and independent contractors (collectively
the "Xenetic Indemnitees") from and against any and all liabilities, damages, losses, settlements, claims, actions, suits,
judgments, interest, penalties, fines, costs, or expenses (including, without limitation reasonable attorneys' fees) (any of the
foregoing, "Section 10.02 Damages") incurred or asserted against any Xenetic Indemnitee of whatever kind or nature including,
without limitation, any claim or liability based upon negligence, warranty, strict liability, or violation of governmental regulation,
or otherwise arising from or occurring as a result of a claim or demand made by a Third Party against any Xenetic Indemnitee (a
"Xenetic Third Party Claim") because of (i) the material breach by Kevelt and/or Pharmsynthez, its employees, other agents,
independent contractors, sublicensees or Affiliates of their representations, warranties, or obligations under this Transition
and Resupply Agreement; (ii) the material violation of any applicable law by Kevelt and/or Pharmsynthez; or, (iii) the negligence
or willful misconduct of Kevelt and/or Pharmsynthez, its employees, other agents, independent contractors, sublicensees or Affiliates
in connection with this Transition and Resupply Agreement; provided, however, that Kevelt and/or Pharmsynthez shall have no such
obligation to defend, indemnify, or hold harmless the Xenetic Indemnitees against a Xenetic Third Party Claim to the extent any
Section 10.02 Damages are based upon, or are the result of, or arise from, Xenetic activity and in any event shall not be liable
for Section 10.02 Damages in excess of twenty five million Euros (€25,000,000) in the aggregate for all Xenetic Third Party
Claims collectively. The indemnification provided under clause (a) of this Section 10.02, shall apply only to Virexxa manufactured
by Kevelt and/or Pharmsynthez. The indemnification provided under clauses (i) through (iii) of this Section 10.02, shall be applicable
during the term of this Transition and Resupply Agreement.


 


Section 10.03    Indemnification
Procedures. Promptly after receipt by a Xenetic Indemnitee of notice of any pending or threatened claim against it (an “Action”),
such Xenetic Indemnitee shall give written notice to Kevelt and/or Pharmsynthez to look for indemnification pursuant to this ArticleX
(the “Indemnifying Party”) of the commencement thereof. The failure to so notify the Indemnifying Party shall not
relieve it of any liability that it may have to any Indemnitee hereunder, except to the extent the Indemnifying Party demonstrates
that it is prejudiced thereby. In case any Action that is subject to indemnification under Section 10.02 shall be brought against
an Xenetic Indemnitee and it shall give written notice to Kevelt and/or Pharmsynthez of the commencement thereof, Kevelt and/or
Pharmsynthez shall be entitled to participate therein and, if it so desires, to assume the defense thereof with counsel reasonably
satisfactory to such Xenetic Indemnitee and, after notice from Kevelt and/or Pharmsynthez to the Xenetic Indemnitee of its election
to assume the defense thereof, Kevelt and/or Pharmsynthez shall not be liable to such Xenetic Indemnitee under this ArticleX for
any fees of other counsel or any other expenses, in each case subsequently incurred by such Xenetic Indemnitee in connection with
the defense thereof. Notwithstanding Kevelt’s and/or Pharmsynthez’s election to assume the defense of any such Action
that is subject to indemnification under Section 10.02, the Xenetic Indemnitee shall have the right to employ separate counsel
and to participate in the defense of such Action at its own expense. If a Kevelt and/or Pharmsynthez assumes the defense of such
Action, no compromise or settlement thereof may be effected by Kevelt and/or Pharmsynthez without the Xenetic Indemnitee’s
written consent, which consent shall not be unreasonably withheld or delayed, unless (i) there is no finding or admission of any
violation of law or any violation of the rights of any Third Party and no effect on any other claims that may be made against
the Xenetic Indemnitee and (ii) the sole relief provided is monetary damages that are paid in full by Kevelt and/or Pharmsynthez.


 






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Section 10.04   
Compliance. The Parties shall comply fully with all applicable laws and regulations in connection with their respective
activities under this Transition and Resupply Agreement.


 


Section
10.05    Kevelt and Pharmsynthez Insurance.


 


(a) Kevelt
and Pharmsynthez shall, until expiration of the last batch of Virexxa manufactured hereunder, by Kevelt and/or Pharmsynthez,
obtain and maintain at their own cost and expense, any combination of insurance, for its commercial liability, including, but
not limited to, product liability and contractual liability insurance, with respect to its activities hereunder.


 


(b) Such
insurance or self-insurance shall be in such amounts and subject to such deductibles as the Parties may agree based upon
standards prevailing in the industry at the time, but under no circumstances shall be less than: (i) Four Million Dollars
($4,000,000) per occurrence for damage, injury and/or death to persons prior to regulatory authority approval of Virexxa;
(ii) Ten Million Dollars ($10,000,000) per occurrence for damage, injury and/or death to persons after regulatory authority
approval of Virexxa; or One Million Dollars ($1,000,000) per occurrence for damage/or injury to property. Such insurance
shall be written to cover claims incurred, discovered, manifested, or made in connection with clinical development and
commercial sale of Virexxa. Upon written request of Xenetic, Kevelt and/or Pharmsynthez shall provide to Xenetic copies of
its Certificates of Insurance.


 


(c) All insurance
required of Kevelt and/or Pharmsynthez under this Transition and Resupply Agreement shall, be through a commercially based insurance
company, such insurance shall (i) be issued by reputable, financially sound companies; (ii) provide that the insurance company
will endeavor to provide at least thirty (30) days' notice of cancellation of coverage, non-renewal or material change of
coverage to both Xenetic and Kevelt and/or Pharmsynthez, but its failure to do so shall impose no penalty or additional obligations
under this Transition and Resupply Agreement; and (iii) contain a severability of interest or separation of the insureds provision,
affording defense and coverage for an insured in the event of a claim brought by another insured.


 


(d) Additional
Requirements. All of the foregoing liability policies shall be primary and non-contributory and contain a waiver of subrogation
in favor of the other Party or the other Party’s designee.


 


(e) No Limitation.
Nothing in this Article 9 regarding insurance coverage amounts shall be deemed or interpreted as a limitation on the indemnities
set forth in this Transition and Resupply Agreement.


 






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Article XI.


Miscellaneous
Provisions


 


Section
11.01    Governing Law. This
Transition and Resupply Agreement shall be governed, interpreted and construed in accordance with the laws of the United States
and the State of Massachusetts, without regard to conflict of laws principles thereof.


 


Section
11.02    Waiver. The
failure on the part of Kevelt and/or Pharmsynthez or Xenetic to exercise or enforce any rights conferred upon it hereunder shall
not be deemed to be a waiver of any such rights and shall not operate to bar the exercise or enforcement thereof at any time or
times thereafter. The observance of any term of this Transition and Resupply Agreement may be waived (either generally or in a
particular instance, and either retroactively or prospectively) by the Party entitled to enforce such term, but any such waiver
shall be effective only if set forth in a writing signed by the Party against whom such waiver is to be asserted.


 


Section
11.03    Force Majeure. Neither
Party shall be held liable or responsible to the other Party, nor be deemed to have defaulted under or breached this Transition
and Resupply Agreement, for failure or delay in fulfilling or performing any term of this Transition and Resupply Agreement, other
than an obligation to make a payment, when such failure or delay is caused by or results from fire, floods, earthquakes, embargoes,
prohibitions or interventions, war, acts of war (whether war be declared or not), acts of terrorism, insurrections, riots, civil
commotions, strikes, lockouts, acts of God, or any other cause beyond the reasonable control of the affected Party (hereinafter
a “Force Majeure”). Nothing in this provision shall be interpreted to restrict either Party from exercising its rights
to terminate this Transition and Resupply Agreement pursuant to its terms during such periods of Force Majeure.


 


Section
11.04    Severability. It
is the intention of the Parties to comply with all applicable laws, domestic or foreign, in connection with the performance of
its obligations hereunder. In the event that any provision of this Transition and Resupply Agreement, or any part hereof, is found
invalid or unenforceable, the remainder of this Transition and Resupply Agreement will be binding on the Parties hereto, and will
be construed as if the invalid or unenforceable provision or part thereof had been deleted, and this Transition and Resupply Agreement
shall be deemed modified to the extent necessary to render the surviving provisions enforceable to the fullest extent permitted
by law.


 


Section
11.05    Survival. The
following Articles and Sections shall survive termination or expiration of this Transition and Resupply Agreement, with such limitations
as are noted: Article 1, to the extent definitions are embodied in the following listed Articles and Sections of this Transition
and Resupply Agreement; Articles 4, 7 and 8; Sections 9.01(b),; and Articles 10 and 11.


 






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Section
11.06    Government Acts. In
the event that any act, regulation, directive, or law of a government, including its departments, agencies or courts, (a “Government
Act”) should make impossible or prohibit, restrain, modify or limit any material act or obligation of Kevelt and/or Pharmsynthez
or Xenetic under this Transition and Resupply Agreement, the Party, not so affected shall have the right, at its option, to suspend
or terminate this Transition and Resupply Agreement. Such right of suspension or termination may be exercised as to the country
which committed the Government Act only if after thirty (30) days of good faith negotiations between the Parties, the Parties cannot
agree to make such modifications to this Transition and Resupply Agreement as may be necessary to fairly address the Government
Act.


 


Section
11.07    Government Approvals. Each
Party will use commercially reasonable efforts to obtain any government approval required to enable this Transition and Resupply
Agreement to become effective, or to enable any payment hereunder to be made, or enable any other obligation hereunder to be observed
or performed. Each Party will keep the other Party informed of its progress in obtaining any such governmental approvals.


 


Section
11.08    Assignment. This
Transition and Resupply Agreement may not be assigned in part or in whole, or delegated in whole or in part, by either Party without
the prior written consent of the other Party; provided, however, that either Party may assign this Transition and Resupply Agreement,
without the consent of the other Party, (a) in part or in whole to any of its Affiliates, if the assigning Party remains liable
for the full performance of its Affiliates’ obligations hereunder, or (b) in connection with the transfer or sale of all
or substantially all of its assets or business to which this Transfer and Supply Agreement relates, or in the event of its merger
or consolidation with, acquisition by, or sale to another company. The Parties acknowledge that Xenetic may elect to assign to
one or more Third Parties, on a country-by-country or region-by-region basis, certain of its rights and to delegate certain of
its obligations under this Transition and Resupply Agreement; provided, however, that Xenetic may not assign such rights or delegate
such obligations in the United States, Europe or Japan to a Third Party without Kevelt’s and/or Pharmsynthez’s prior
written consent.


 


Section
11.09    Binding Agreement. This
Transition and Resupply Agreement shall be binding upon and inure to the benefit of all successors and permitted assigns of the
Parties.


 


Section
11.10    Counterparts. This
Transition and Resupply Agreement may be executed by original or facsimile signature in several counterparts, all of which shall
be deemed to be originals, and all of which shall constitute one and the same Transition and Resupply Agreement.


 


Section
11.11    No Agency. Nothing
herein contained shall be deemed to create an agency, joint venture, amalgamation, partnership or similar relationship between
Kevelt and/or Pharmsynthez and Xenetic. Notwithstanding any of the provisions of this Transition and Resupply Agreement, neither
Party shall at any time enter into, incur, or hold itself out to Third Parties as having authority to enter into or incur, on behalf
of the other Party, any commitment, expense, or liability whatsoever, and all such commitments, expenses and liabilities undertaken
or incurred by one Party in connection with or relating to the development, manufacture or sale of Virexxa shall be undertaken,
incurred or paid exclusively by that Party, and not as an agent or representative of the other Party.


 






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Section
11.12    Notice. All
notices, requests, consents, claims, demands, waivers and other communications hereunder shall be in writing and shall be deemed
to have been given (a) when delivered by hand (with written confirmation of receipt); (b) when received by the addressee if sent
by a nationally recognized overnight courier (receipt requested); (c) on the date sent by facsimile or e-mail of a PDF document
(with confirmation of transmission) if sent during normal business hours of the recipient, and on the next Business Day if sent
after normal business hours of the recipient or (d) on the third day after the date mailed, by certified or registered mail, return
receipt requested, postage prepaid. Such communications must be sent to the respective parties at the following addresses (or at
such other address for a party as shall be specified in a notice given in accordance with this Section 10.13):


 


	If to Kevelt and/or Pharmsynthez:	
        AS KEVELT

        3/1, Teaduspargi Str.,

        12618 Tallinn, Estonia

        Facsimile: +372
        670 1219

        E-mail: a.ahtloo@kevelt.ee

        Attention: Allan Ahtloo

         

        OJSC Pharmsynthez

        188663
        Leningradskaya oblast, Vsevolozhsky

        rayon,
urban village Kuzmolovsky, station

        Capitolovo, No 134 liter 1, Russian Federation 

        Facsimile: 7 (812) 329-8089

        E-mail: pkruglyakov@pharmsynthez.com

        Attention:Petr Kruglyakov,
        CEO

	 	 
	with a copy to:	
        Covington & Burling LLP

        The New York Times Building

        620 Eighth Avenue

        New York, New York 10018

        Facsimile:(646) 441-9113

        Email: mgehl@cov.com

        Attention: Matthew Gehl

	 	 
	If to Xenetic:	
        Xenetic Biosciences, Inc.

        99 Hayden Avenue, Suite 230

        Lexington, Mass. 02421

        Facsimile:[FAX NUMBER]

        E-mail: s.maguire@xeneticbio.com

        Attention: Scott Maguire, CEO

	 	 
	with a copy to:	
        Taft, Stettinius & Hollister LLP

        111 E. Wacker Drive, Suite 2800

        Chicago, IL 60601

        Facsimile: 312-275-7569

        E-mail: mgoldsmith@taftlaw.com

        Attention: Mitchell D. Goldsmith, Esq.



 






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Section
11.13    Headings. The
Article, Section and subsection headings are for convenience only and will not be deemed to affect in any way the language of the
provisions to which they refer.


 


Section
11.14    Authority. The
undersigned represent that they are authorized to sign this Transition and Resupply Agreement on behalf of the Parties hereto.


 


Section
11.15    No Implied Licenses. Nothing
in this Transition and Resupply Agreement shall be construed as granting either Party by implication, estoppel or otherwise, any
license rights.


 


Section
11.16    Entire Agreement. This
Transition and Resupply Agreement contains the entire understanding of the Parties relating to the matters referred to herein,
and may only be amended by a written document, duly executed on behalf of the respective Parties. , Services 


 


[Signature
Page Follows]


 






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IN WITNESS WHEREOF,
the parties hereto have caused this Agreement to be executed as of the date first written above by their respective officers thereunto
duly authorized.


 


	 	
        SELLER:

         

        AS KEVELT

         

	 	
        

        By__________________________________

        Name: Allan Ahtloo

        Title:



 


	 	
        PARENT:

         

        OJSC PHARMSYNTHEZ

         

	 	
        

        By__________________________________

        Name: Peter V. Kruglyakov

        Title:

	 	
         

        BUYER:

        

        XENETIC BIOSCIENCES, INC.

         

	
         

         

         

         

         

         

         
	
        

        By___________________________________

        Name:

        Title:



 


 






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