Document:

Exhibit
10.44 

 

GMP-Manufacturing
Services Agreement

 

by
and between

 

Variation
Biotechnologies, Inc.

 

and

 

Paragon
Bioservices, Inc.

 

    
	 	Page 1 of 43	 

     

    

 

TABLE
OF CONTENTS

 

	 	 	 	Page
	 	 	 	 
	Article
    1 	DEFINITIONS	 	5
	 	 	 	 
	Article
    2	PROJECT
    SCOPE; PROJECT PLAN; PROJECT MANAGEMENT	 	 
	 	 	 	 
	2.1	Commitment
    to Development and Manufacture.	 	12
	2.2	Project
    Plan.	 	13
	2.3	Project
    Management.	 	13
	2.4	Change
    Order Process.	 	13
	 	 	 	 
	Article
    3	TECHNOLOGY
    TRANSFER; PROCESS DEVELOPMENT; ENGINEERING RUNS	 	 
	 	 	 	 
	3.1	Technology
    Transfer.	 	14
	3.2	Process
    Development Runs.	 	14
	3.3	Engineering
    Runs.	 	16
	3.4	Product
    Delivery.	 	16
	 	 	 	 
	Article
    4	MANUFACTURING
    AND PROCESSING ACTIVITIES	 	 
	 	 	 	 
	4.1	Paragon
    Facility.	 	16
	4.2	Quality
    Agreement.	 	16
	4.3	Control
    of Cell Banks.	 	16
	4.4	Raw
    Materials and Consumables.	 	16
	4.5	Storage
    and Use of Materials and Product (During Project).	 	17
	4.6	Handling
    of Wastes.	 	16
	4.7	Approval
    of Subcontracting.	 	18
	4.8	Document
    Changes.	 	18
	4.9	Manufacturing
    Audits	 	18
	 	 	 	 
	Article
    5	PRODUCTION
    RUNS	 	 
	 	 	 	 
	5.1	Production
    Runs.	 	18
	5.2	Batch
    Documentation	 	19
	5.3	Delivery
    Terms.	 	19
	5.4	Retention
    and Reserve Samples.	 	19
	5.5	Analytical
    Testing.	 	19
	5.6	Accurate
    Documentation.	 	20
	 	 	 	 
	Article
    6	PAYMENTS	 	 
	 	 	 	 
	6.1	Reservation
    Fee.	 	20
	6.2	Reimbursement
    for Designated Equipment	 	20
	6.3	Payments
    and Payment Schedule; Invoicing; Payment Terms.	 	20

 

    
	 	Page 2 of 43	 

     

    

 

TABLE OF CONTENTS

(Continued)

 

	 	 	 	Page
	 	 	 	 
	Article
    7	Regulatory
    matters	 	 
	 	 	 	 
	7.1	Permits.	 	21
	7.2	Compliance
    with cGMPs; Monitoring of Records.	 	21
	7.3	Records.	 	21
	7.4	Regulatory
    Communications and Correspondence.	 	21
	7.5	Regulatory
    Filings and Maintenance.	 	22
	7.6	Cooperation
    in Obtaining Government Approvals.	 	22
	7.7	Ownership
    of Regulatory Filings.	 	22
	7.8	Health
    and Safety Information.	 	22
	7.9	Accident
    Reports.	 	23
	 	 	 	 
	Article
    8	QUALITY
    ASSURANCE; QUALITY CONTROL; VALIDATION	 	 
	 	 	 	 
	8.1	Responsibility
    for Quality Assurance and Quality Control.	 	23
	8.2	Validation
    of Paragon Facility; Utilities and Equipment.	 	23
	 	 	 	 
	Article
    9	NON-CONFORMANCE	 	 
	 	 	 	 
	9.1	Notice
    of Nonconformity.	 	23
	9.2	No
    Paragon Liability.	 	23
	9.3	Paragon
    Liability for Non-Conforming Product; Replacement.	 	24
	9.4	Cooperation
    in Investigations; Disposition of Non-Conforming Product.	 	24
	9.5	Dispute
    Resolution	 	25
	 	 	 	 
	Article
    10	RIGHTS
    TO CLIENT MATERIALS, INTELLECTUAL PROPERTY, EQUIPMENT	 	 
	 	 	 	 
	10.1	Client
    Materials.	 	25
	10.2	License
    to Client.	 	26
	10.3	Project
    Intellectual Property.	 	26
	10.4	Third
    Party Intellectual Property.	 	26
	10.5	Ownership
    of Designated Equipment.	 	27
	 	 	 	 
	Article
    11	RESPONSIBILITIES
    AND WARRANTIES	 	 
	 	 	 	 
	11.1	Client.	 	27
	11.2	Paragon.	 	27
	11.3	Disclaimer
    by Paragon.	 	28
	 	 	 	 
	Article
    12	INDEMNIFICATION	 	 
	 	 	 	 
	12.1	Indemnification
    by Client.	 	28
	12.2	Indemnification
    by Paragon.	 	28
	12.3	Indemnification
    Procedures.	 	29
	12.4	Insurance.	 	29
	12.5	Limitation
    of Liability.	 	29

 

    
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	 	 	 	Page
	 	 	 	 
	Article
    13	CONFIDENTIALITY	 	 
	 	 	 	 
	13.1	Prior
    Confidential Disclosure Agreement.	 	30
	13.2	Paragon
    Confidentiality Obligations.	 	30
	13.3	Client
    Confidentiality Obligations.	 	30
	13.4	Responsibility
    for Compliance with Confidentiality and Nonuse Obligations.	 	30
	13.5	No
    Licenses.	 	31
	13.6	Protection
    of Inadvertent Disclosures.	 	31
	13.7	Use
    of Names.	 	31
	13.8	Press
    Releases	 	31
	 	 	 	 
	Article
    14	TERM;
    TERMINATION	 	 
	 	 	 	 
	14.1	Term.	 	31
	14.2	Termination.	 	32
	14.3	Consequences
    of Termination.	 	32
	14.4	Termination
    of Agreement for Insolvency.	 	33
	14.5	Other
    Termination of Agreement.	 	34
	14.6	Cumulative
    Remedies.	 	34
	14.7	Accrued
    Rights.	 	34
	14.8	Surviving
    Rights.	 	34
	 	 	 	 
	Article
    15	FORCE
    MAJEURE	 	 
	 	 	 	 
	15.1	Effects
    of Force Majeure.	 	34
	15.2	Notice
    of Force Majeure.	 	35
	 	 	 	 
	Article
    16	MISCELLANEOUS	 	 
	 	 	 	 
	16.1	Notices.	 	35
	16.2	Applicable
    Law.	 	36
	16.3	Headings.	 	37
	16.4	Exhibits.	 	37
	16.5	Security
    Procedures.	 	37
	16.6	Assignment.	 	37
	16.7	Severability.	 	37
	16.8	Independent
    Contractors.	 	37
	16.9	Waiver.	 	37
	16.10	Counterparts.	 	38
	16.11	No
    Solicitation of Employees.	 	38
	16.12	Entirety;
    Amendments.	 	38
	16.13	Preference.	 	38
	 	 	 
	EXHIBIT A Project Plan/Payment Schedule	 	41
	EXHIBIT B Quality Agreement	 	43

 

    
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GMP-MANUFACTURING
SERVICES AGREEMENT

 

This
GMP-Manufacturing Services Agreement (this “Agreement” or “GMP-MSA”) is effective as of September
26, 2014 (the “Effective Date”), by and between Variation Biotechnologies, Inc., federally incorporated in
Canada and having its principal office at 310 Hunt Club Rd. East, 2nd Floor, Ottawa, ON, Canada, K1V 1C1 (“Client”)
and Paragon Bioservices, Inc., a Maryland corporation having its principal office at University of Maryland Biopark, Building
Two, Suite 401, 801 W. Baltimore Street, Baltimore, MD 21201 (“Paragon”) (each, a “Party”
and together the “Parties”).

 

RECITALS

 

WHEREAS,
Paragon has process development, manufacturing and related services experience and expertise and operates a facility that is suitable
for providing services for the preparation and characterization of one or more master cell banks, working cell banks and/or virus
banks, and for the manufacture of active pharmaceutical ingredients or drug substances, for research and development and/or clinical
trial uses; and.

 

WHEREAS,
Client desires to engage Paragon to conduct services which may include process development and manufacturing services in connection
with the supply of research or clinical quantities of such Client’s drug substance(s), master cell banks, working cell banks
and/or virus banks, and Paragon desires to perform such services for Client, all on the terms and conditions set forth in this
Agreement.

 

NOW,
THEREFORE, in consideration of the mutual promises and covenants herein contained and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound hereby, the Parties hereto agree as
follows:

 

Article
1

DEFINITIONS

 

The
following capitalized terms, whether used in the singular or plural, shall have the meanings assigned to them below for purposes
of this Agreement:

 

1.1
“Acquisition Cost” means the actual price paid by Paragon to any Third Party (net of any discounts, rebates,
credits or the like) for any materials (including the supplies, Raw Materials, Resins, Consumables, and Designated Equipment)
or outsourced services used in or for the manufacture of the Product under this Agreement, including, but not limited to, shipping
and handling costs and customs duties incurred and paid by Paragon to that Third Party in connection with the acquisition of such
materials or services, plus fifteen percent (15%) of such actual price to cover Paragon’s acquisition and storage costs
for such materials or costs of engagement and oversight of a service provider.

 

1.2
“Additional Services” means any service that is not contained in the Project Plan and that requires a Change
Order from Client in order to authorize Paragon to commence the same or any service specifically identified as an Additional Service
in this Agreement.

 

    
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1.3
“Affiliate” means, with respect to either Party, any other corporation or business entity that directly, or
indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party. For purposes
of this definition, the term “control” means direct or indirect ownership of more than fifty percent (50%)
of the securities or other ownership interests representing the equity voting stock or general partnership or membership interest
of such entity or the power to direct or cause the direction of the management or policies of such entity, whether through the
ownership of voting securities, by contract, or otherwise.

 

1.4“Agreement”
means this Manufacturing and Process Development Services Agreement, together with all exhibits appended hereto.

 

1.5“Batch”
means a specific quantity of Product produced from a single Run.

 

1.6“Batch
Documentation” means all of the documentation associated with the manufacture and testing of a given Batch, including
without limitation batch manufacturing records, sampling documentation, test results, Investigative and Corrective Action Reports,
deviation reports, all applicable Manufacturing Process data (including any pertinent output from instrumentation), the Certificate
of Analysis.

 

1.7“Batch
Record” means the executed Master Manufacturing Record, specifications, in process and release test results, exception
documentation, such as deviations and investigation reports, and additional documentation which may have been generated as part
of the manufacturing record of each Batch.

 

1.8
“Cell Line“ means the 293SF-3F6 (ATCC Safe Deposit No. GSD-0551) cell line for expression of the Drug Substance.

 

1.9“Certificate
of Compliance/Certificate of Analysis” means a document prepared by Paragon stating that the Batch has been manufactured
according to the requirements of cGMP and the approved Material Specifications and Product Specifications and listing final Product
release tests performed by Paragon, or Qualified Subcontractors, the specifications and test results.

 

1.10“cGMP”
means the regulatory requirements for current good manufacturing practices promulgated by the FDA under 21 C.F.R. Parts 210, 211,
600 and 610 (as applicable to clinical bulk Drug Substance only) and ICH, Guidance for Industry Q7A Good Manufacturing Practice
Guidance for Active Pharmaceutical Ingredients and Guidance for Industry cGMP for Phase I Investigational drugs as the same may
be amended from time to time.

 

1.11“Change
Order” means a document mutually approved in writing by both Parties in accordance with the procedures set forth in
Section 2.4 that describes in reasonable detail an amendment or modification (a) to the Project and/or the Project Plan,
or (b) to any document(s) which are part of Paragon’s cGMP document system, including but not limited to Master Manufacturing
Records, standard operating procedures and Materials Specifications.

 

1.12“Client”
shall have the meaning set forth in the Preamble.

 

    
	 	Page 6 of 43	 

     

    

 

1.13“Client
Confidential Information” means the Drug Substance, Cell Line, Master Cell Bank, Working Cell Bank, any Manufacturing
Process documentation provided by Client to Paragon, and all elements of the Manufacturing Process provided by Client to Paragon,
data and information, business plans, regulatory and product strategies and all technical and other information, whether patented
or unpatented, relating to Client products, processes, test methods, operations, technologies, forecasts and business information
that is disclosed or supplied to Paragon by or on behalf of Client during the term of this Agreement. Each Manufacturing Process
developed by Paragon for Client, and all Product specific portions of documents and records describing or relating to the Manufacturing
Process shall be deemed to be Client Confidential Information.

 

1.14“Client
Intellectual Property” means all Intellectual Property owned or controlled by Client.

 

1.15“Confidentiality
Agreement” means the two-way confidential disclosure agreement between the Parties, dated October 19, 2011.

 

1.16“Confidential
Information” means Client Confidential Information and/or Paragon Confidential Information, as the context requires.

 

1.17“Conforming
Product” means Product that conforms to all of the warranties set forth in Section 11.2.1

 

1.18“Consumable”
means all bags, liners and other single use or regularly replaced materials that are required to perform the Manufacturing Process
(excluding Raw Materials, Resins and Wearables).

 

1.19“Designated
Carrier” means the common carrier selected by Client (or identified by Paragon and approved by Client) to take delivery
of Product at the Paragon Facility on Client’s behalf or that Paragon will use, following approval of the Batch Documentation,
to ship Product to Client or a Client designated recipient.

 

1.20“Designated
Equipment” means those certain pieces of equipment or components, and related documentation, described as such in the
Project Plan that are used to produce only Client Product that are owned by Client and located at the Paragon Facility. Client
will reimburse Paragon for such purchased equipment or components, and subsequent related validation, operation, calibration and
maintenance of such Designated Equipment in accordance with Section 6.2.

 

1.21“Drug
Product” means a finished dosage form, for example, tablet, capsule, or solution, that contains a Drug Substance, generally,
but not necessarily, in association with one or more other ingredients.

 

1.22“Drug
Substance” means the Client’s component that is intended to furnish pharmacological activity or other direct effect
in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body
of man or other animals. For each Client Drug Substance to be manufactured by Paragon, the parties will agree to and execute a
SOW as set forth in Section 1.67, which shall identify the specific Drug Substance for that SOW.

 

    
	 	Page 7 of 43	 

     

    

 

1.23“Effective
Date” shall have the meaning set forth in the Preamble.

 

1.24“Engineering
Batch” means a Batch produced from an Engineering Run.

 

1.25“Engineering
Run” means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps.

 

1.26“Engineering
Targets” means one or more mutually agreed broad attributes that applicable for a particular Project, which may be utilized
to demonstrate that there has been no gross deviation from the proposed process of the draft master manufacturing record, provided
that such attributes shall be “Engineering Targets” only if mutually agreed by the Parties for Engineering Run(s)
and specifically set out in the Project Plan.

 

1.27
“FDA” means the United States Food and Drug Administration, or any successor agency thereto.

 

1.28“Intellectual
Property” means all worldwide Patents, copyrights, trade secrets, know-how and all other intellectual property rights
that are owned or controlled by a Party, including all applications and registrations with respect thereto, but excluding all
trademarks, trade names, service marks, logos and other corporate identifiers. For purposes of this definition, “controlled
by” means possession of the right to grant a license or sublicense as provided for herein without violating (a) any
law or governmental regulation applicable to such license or sublicense or (b) the terms of any agreement or other arrangement
with any Third Party that exists as of the Effective Date or, if such right is acquired after the Effective Date, as of the date
the Party first gained possession of such right.

 

1.29“Investigative
and Corrective Action Reports” or “ICAR” means the document that is used to record the investigation
of, as well as the review and disposition of, a failure related to a cGMP manufacturing process or system`.

 

1.30“Letter
of Intent” means that certain agreement between the Parties, dated March 27, 2014, capturing the intent of the Parties
to permit technology transfer and process development to begin while the Parties negotiated this MSA.

 

1.31“Manufacturing
Process” or “Process” means the process, or applicable portion(s) thereof for the manufacture, analysis,
documentation, quality evaluation, storage, and shipping of components, intermediates and Product pursuant to this Agreement as
such process may be developed and/or changed from time to time in accordance with this Agreement.

 

1.32“Master
Cell Bank” means Client’s reference deposit or collection of vials of the Cell Line, from which the Working Cell
Bank is derived for a Project.

 

1.33“Master
Manufacturing Record” means, for each Project, the template document, proposed by Paragon and approved by Client, that
defines the final and complete manufacturing methods, test methods, Product Specifications, materials, and other procedures, directions
and controls associated with the manufacture and testing of Product. Batch Documentation shall be prepared based on the Master
Manufacturing Record. The Master Manufacturing Record shall also include or incorporate by reference, without limitation, such
information as Materials Specifications, in process and final Product sampling standards, equipment and instrumentation specifications
and standard operating procedures, including, without limitation, standard operating procedures for in-process quality control
testing.

 

    
	 	Page 8 of 43	 

     

    

 

1.34“Materials
Specification” means a document detailing the chemical, physical, microbiological and biological test methods and/or
specifications for required for release of each Raw Material, Resin or Consumable, each as mutually approved by the Parties and
made a part of the Master Production Record.

 

1.35“Non-Conforming
Product” means Product whose manufacture, analysis and/or packaging fails to conform to all of the warranties set forth
in Section 11.2.1.

 

1.36“Paragon”
shall have the meaning set forth in the Preamble.

 

1.37“Paragon
Confidential Information” means all technical and other information, whether patented or unpatented, relating to the
Paragon Facility and/or Paragon processes, methods, operations, technologies, strategies, pricing and business information that
is disclosed or supplied to, or used on behalf of, Client by Paragon pursuant to this Agreement, or of which Client may become
aware through the presence of its employees or agents at the Paragon Facility, including, without limitation, trade secrets, know-how,
processes, concepts, experimental methods and results and business and scientific plans and information and facility layout and
schematics.

 

1.38“Paragon
Facility” means the facilities operated by Paragon at University of Maryland Biopark, Building Two, Suite 401, 801 W.
Baltimore Street, Baltimore, MD 21201.

 

1.39“Paragon
Intellectual Property” means all Intellectual Property owned or controlled by Paragon.

 

1.40“Party”
and “Parties” each shall have the meaning set forth in the Preamble.

 

1.41“Patents”
shall mean, with respect to an invention, any patent or patent application, and any patent issuing therefrom, together with any
extensions, reissues, reexaminations, substitutions, renewals, divisions, continuations and continuations-in-part thereof, and
any patent or patent application claiming priority to any application in common with any such patent containing a disclosure substantially
similar to that of any such patent, all to the extent the foregoing contain claims covering such invention.

 

1.42“Payment
Schedule” shall mean the schedule of payments to be made by Client to Paragon in consideration of Paragon’s services
hereunder, as set forth in the payment schedule portion of the SOW and/or Project Plan.

 

1.43“Process
Development” means the conduct by Paragon of activities to develop, confirm and/or refine processes for producing the
Product and/or activities to develop and/or scale-up a Manufacturing Process suitable for cGMP manufacture of the Product as set
forth in Section 3.1(b).

 

    
	 	Page 9 of 43	 

     

    

 

1.44“Process
Development Batch” means a Batch produced from a Process Development Run.

 

1.45“Process
Development Run” means a Run used to demonstrate the transfer in to Paragon and/or development at Paragon of the Manufacturing
Process.

 

1.46“Product”
means Drug Substance, Drug Product, Master Cell Bank and/or Working Cell Bank that has(have) been manufactured by Paragon pursuant
to this Agreement.

 

1.47“Product
Specifications” means any chemical, physical, microbiological and biological test methods and any specifications (if
any) required for release (by Paragon to Client) of Product that have been mutually approved by the Parties and made a part of
the Master Manufacturing Record.

 

1.48“Production
Batch” means a Batch produced from a Production Run.

 

1.49“Production
Run” means a Run conducted in accordance with the Master Manufacturing Record that is initiated following the commencement
of manufacture pursuant to Section 7.1 and is used to create Product for research and development or for clinical use by the Client.

 

1.50
“Project” means the full range of development and manufacturing services to be provided under this Agreement
as more fully described in each SOW and Project Plan.

 

1.51“Project
Manager” shall have the meaning set forth in Section 2.3.

 

1.52“Project
Plan” means the scope of work for technology transfer, process development, process implementation, manufacturing and
overall project scope for each Project, to be attached as Schedule 2 to the SOW for the Project and incorporated into this Agreement
by reference upon signature by Paragon and Client. Each Project Plan shall include the final schedule of stages and payments for
the Project.

 

1.53“Project
Rates” means the applicable rates at which Paragon will charge Client for the various services performed hereunder,
as set out in the applicable SOW.

 

1.54“Quality
Agreement” means the master quality agreement between the Parties, to be attached to the Agreement as Exhibit B and
incorporated herein by reference, unless the parties mutually agree that a new project-specific Quality Agreement be executed
for one or more GMP Projects.

 

1.55“Quality
Review and Approval” means Paragon’s review and approval, by Paragon’s quality assurance department, of
a Production Run Batch and the associated Batch Documentation for accuracy and completeness.

 

    
	 	Page 10 of 43	 

     

    

 

1.56“Qualified
Subcontractor” means a Subcontractor that is a contract testing laboratory or a cell bank manufacturer with whom Paragon
has a signed agreement with provisions that protects Client Confidential Information that has been audited and approved as a supplier
by Paragon’s quality assurance department to provide the services to be subcontracted.

 

1.57“Raw
Material” means all ingredients, solvents and other items that are components of the Product or that are required to
perform the Manufacturing Process (excluding any Consumables and Resins).

 

1.58“Reference
Material” means Product that is generated from a Run that is well characterized, packaged and stored in a controlled
manner, and used as a standard or reference for analytical testing purposes.

 

1.59“Registration”
shall have the meaning set forth in Section 7.1.

 

1.60“Regulatory
Authority” means the FDA

 

1.61“Regulatory
Filing” means any or all applications, including but not limited to the Biologics License Application (“BLA”),
or its equivalent submitted to Regulatory Authorities for the purpose of registering the final dosage form of the Product or the
Manufacturing Process as required by statute, and any amendments or supplements thereto, and any other filings required by the
Regulatory Authorities relating to the manufacture, testing, sale or distribution of the final dosage form of the Product.

 

1.62“Replacement
Product” shall have the meaning set forth in Section 9.3.

 

1.63“Reservation
Fee” means the fee set forth in Section 6.1, which will reserve specific suite availability at the Paragon Facility
for one or more Production Runs for a Project.

 

1.64“Resin”
means all chromatographic media intended to refine or purify the Product, as specified in the Master Manufacturing Record.

 

1.65“Run”
means a single complete operation of all, or a discreet portion of (if appropriate from the context), the Manufacturing Process
at the Paragon Facility.

 

1.66“Shipping
Guidelines” means written procedures, as supplied by Client in writing, that specify the Designated Carrier and describe
the methods of shipping any and all Client property, including the Product.

 

1.67“Statement
of Work” or “SOW” means a mutually agreed upon document setting forth the scope of the Project, general
statement of stages and activities, the schedule of payments and milestones, deliverables and other pertinent information, in
order to initiate technology transfer, process development (if appropriate) and preparation of the Project Plan, becoming a part
of Exhibit A to this Agreement upon signature by both parties. A template for the SOW is appended hereto as Exhibit A.

 

1.68“Storage
Guidelines” means Paragon’s procedures (based on information provided by the Client), as approved by Client in
writing, that describe the methods of packaging, preserving, monitoring and storing any and all Client property, including the
Product, Cell Line, Master Cell Bank, and Working Cell Bank.

 

    
	 	Page 11 of 43	 

     

    

 

1.69“Subcontractor”
means any independent entity that Paragon or Client contracts with to perform any services or meet any obligations that are required
under the terms and conditions of this Agreement, as provided in Section 4.7.

 

1.70“Technology
Transfer” means the transfer from Client to Paragon of all information, data and technology in Client’s possession
and control that is necessary for Paragon to perform process development and scale-up related to the planned manufacture of Product
on Client’s behalf, including that necessary for development of the Manufacturing Process.

 

1.71“Term”
shall have the meaning set forth in Section 14.1.

 

1.72“Third
Party” means any party other than Client, Paragon and their respective Affiliates.

 

1.73
“Waste” shall mean any “hazardous substance” and/or “hazardous material”
as provided under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any “hazardous waste”
as provided under the Resource Conservation and Recovery Act (RCRA), and/or any other waste material, pollutant and/or contaminant
of any kind including, without limitation, any routine process waste or any by-product arising from any activities conducted pursuant
to this Agreement.

 

1.74“Working
Cell Bank” means a vialed collection of serially subcultivated cells that are derived from the Master Cell Bank, unless
otherwise instructed in writing by the Client. The Working Cell Bank is used to establish seed cultures of the Cell Line to initiate
the Manufacturing Process.

 

Article
2

PROJECT SCOPE; PROJECT PLAN; PROJECT MANAGEMENT

 

2.1Commitment
to Development and Manufacture.

 

2.1.1Development.
For each Project which comprises a process development component, Client hereby retains Paragon to develop the Manufacturing Process
at the Paragon Facility, and Paragon shall use commercially reasonable efforts to develop the same, subject to the terms and conditions
set forth in this Agreement. During the Term, Client will be provided with a final report on the development work completed under
this agreement and Client shall make all scheduled payments, as set forth in the Project Plan, for Paragon’s services, including,
without limitation, technology transfer and process development services, and costs for design and engineering services to prepare
for implementing the Manufacturing Process at the Paragon Facility, and for all Acquisition Costs for performing the development
services. Product produced during the development activities shall be provided to Client as provided in Article 3.

 

    
	 	Page 12 of 43	 

     

    

 

2.1.2Manufacture.
Subject to the terms and conditions set forth in this Agreement and subject to the successful completion of the development of
the Manufacturing Process at the Paragon Facility as defined in each Project Plan, during the Term, Client retains Paragon as
a manufacturer of Product for research and/or clinical trial uses. Paragon shall provide sufficient services and capacity to manufacture
Product for Client in accordance with the Project Plan and the Master Manufacturing Record. Paragon will provide Client with the
Product and with documentation as set forth in Section 5.2, and Client shall make the payments pursuant to the Payment Schedule
to purchase such services and capacity from Paragon.

 

2.2Project
Plan. For each Project, the parties shall mutually develop and agree on an SOW setting forth the scope of the GMP Project,
general statement of stages and activities, the schedule of payments and milestones, deliverables and other pertinent information,
in order to initiate technology transfer, process development (if appropriate) and preparation of the GMP Project Plan, becoming
a part of Exhibit A to this Agreement upon signature by both parties. A template for the SOW is appended hereto as Exhibit A.
The Project proposal shall become Schedule 1 to the SOW and the Project Rate Sheet shall become Schedule 3 to the SOW. Next, the
parties shall mutually develop and agree on a Project Plan in order to enable the Parties to fulfill their respective obligations
under this Agreement, which shall automatically become a part of this Agreement (as Schedule 2 to the SOW) upon execution by both
parties. The Parties shall implement the Project Plan for each Project. As of the Effective Date, the Parties agree and acknowledge
that certain activities described in the initial Project Plan have been completed or are already in process, in accordance with
the terms and conditions of the Letter of Intent, and such activities are denoted as such in the Project Plan. The SOWs or Project
Plans may be amended by agreement of the Parties in accordance with Section 2.4.

 

2.3Project
Management. The day-to-day interactions and management with respect to each Project will be performed by two project managers,
one appointed by each Party and each one having the authority to manage the Project in conjunction with the other project manager
and to further the aims of the Parties day-to-day (each, a “Project Manager”). The Project Managers shall be the principal
point of contact between the Parties. As part of their duties, the Project Managers shall be responsible for monitoring and revising
the Project Plan (in accordance with the procedures set forth in Section 2.4), establishing operating guidelines for the Project,
defining communication formats, forming and approving Project teams and monitoring the general progress of the Project. The Project
Managers shall be appointed by each respective Party for each Project and may thereafter be removed and a new Project Manager
appointed by each respective Party, at such Party’s sole discretion, with notice of such appointment provided to the other
Party.

 

2.4Change
Order Process. 

 

2.4.1Paragon
Initiated Changes. Before Paragon may amend the Project Plan, Paragon shall prepare a Change Order describing in reasonable
detail the nature of such change(s), and propose such Change Order to Client for Client’s review. All approved Change Orders
shall be signed by the Project Manager of each Party or by such other authorized representatives of Paragon and Client that the
Project Managers may designate. If any changes contemplated by a Change Order will have a financial or other impact on the scope
of the Project, Paragon shall provide Client with a written description of such impacts in the Change Order. If Client approves
the Change Order notwithstanding Paragon’s notice of any resulting cost increase, Client shall reimburse Paragon for the
cost of such changes as detailed in the Change Order. Upon Paragon and Client’s approval of the Change Order, the Change
Order will be implemented as soon as it is commercially practical to do so in a good faith effort to meet the development and
manufacturing timelines as set forth in the Project Plan.

 

    
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2.4.2Client
Initiated Changes. Client shall have the right to request reasonable modifications to the Project and/or the Project Plan
by providing notice thereof to Paragon. Upon receipt of such notice, Paragon shall generate a Change Order in accordance with
the process described in Section 2.4.1, and submit such Change Order to Client for Client’s review. If Client approves the
Change Order notwithstanding Paragon’s notice of any resulting cost increase, Client shall reimburse Paragon for the cost
of such changes as detailed in the Change Order. Upon Client’s approval of such Change Order, the Change Order will be implemented
as soon as it is commercially practical to do so in a good faith effort to meet the development and manufacturing timelines as
set forth in the Project Plan or as described in the Change Order.

 

2.4.3Changes
to Documentation. The procedures of Section 2.4.1 or 2.4.2 shall be employed for any changes requested to document(s) which
are part of Paragon’s cGMP document system, as set forth in Section 4.8, provided that the approval of the appropriate Paragon
department heads (including the quality assurance department) shall be required prior to any such change. In the event of any
requested change to a Client-specific document, Client approval shall also be required.

 

Article
3

TECHNOLOGY TRANSFER; process development; ENGINEERING RUNS

 

3.1Technology
Transfer. The Parties understand and agree that the success of the activities contemplated by this Agreement require effective
and expeditious technology transfer to Paragon, with the goal being to train and assist designated Paragon scientists in understanding
and developing proficiency in the use of Client’s processes for producing the Product, to enable Paragon to develop and/or
scale-up a Manufacturing Process suitable for cGMP manufacture of the Product. For each Project, Client shall use commercially
reasonable efforts to transfer to Paragon all material information and technology reasonably necessary for Paragon to perform
process development related to, and subsequently to manufacture Product on Client’s behalf hereunder. Without limiting the
foregoing, Client shall use commercially reasonable efforts to (i) provide to Paragon all pertinent documentation, records, notes,
reports, SOPs, batch records, specifications, and published papers regarding the Product (including any Client specifications
for the Product), the Cell Line(s), the Master Cell Bank and the Working Cell Bank (as applicable when supplied by Client)) and
any related materials, and/or manufacture of the Product (including identification of raw materials to be used by Paragon and
assays to be used by Paragon or transferred to a Qualified Subcontractor), and (ii) provide reasonable access to Client’s
scientists who developed or are familiar with the Product and the Client’s processes, and (iii) supply Paragon with all
Product-specific controls and standards. Paragon shall assign a dedicated project team, including appropriately trained and experienced
technical staff, and shall use commercially reasonable efforts to accept and implement the transferred information and materials
provided by Client. Following technology transfer, one or more Process Development Runs would be conducted as set forth in Section
3.2, or, if mutually agreed in writing by the Parties, one or more Engineering Runs would be conducted as set forth in Section
3.3, as appropriate for the Project. It is understood and agreed that Paragon’s ability to conduct scheduled Process Development
and Engineering Runs is contingent on timely technology transfer of Client’s processes.

 

    
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3.2Process
Development Runs. If called for in the Project Plan, Paragon shall perform one or more Process Development Runs and manufacture
Process Development Batches in accordance with the Project Plan. Paragon will provide the services to perform such Process Development
Runs and produce such Process Development Batches in accordance with the Project Plan, and Client shall make the payments pursuant
to the Payment Schedule to purchase such services and manufacture as further set forth in Article 6. Paragon shall provide Client
with all Process Development Batches requested by Client that result from any partial or completed Process Development Runs. There
will be no specifications for acceptance of Process Development Batches, but the parties may mutually agree on certain target
quality attributes, if set forth in the applicable Project Plan. Paragon shall provide analytical testing of the batch as agreed
by the parties in each Project Plan and will report the results to Client. Client shall have the right to make whatever further
use of such Process Development Batches as it shall determine, provided that such use does not violate any applicable laws, rules
or regulations. Paragon shall in no way be responsible for any claims, demands, losses, liabilities, expenses or damages, whatsoever,
arising out of or in any way related to Client’s use of such Process Development Batches.

 

3.3Engineering
Runs. If called for in the Project Plan, Paragon shall perform Engineering Runs and manufacture Engineering Batches in accordance
with the Project Plan. Paragon and Client may agree to include one or more Engineering Targets in the Project Plan for a Project.
Paragon will provide the services to perform such Engineering Runs and produce such Engineering Batches in accordance with the
Project Plan and Client shall make the payments pursuant to the Payment Schedule to purchase such services and manufacture as
further set forth in Article 6. Paragon shall provide Client with any Engineering Batches requested by Client that results from
any partial or completed Engineering Runs, except to the extent that Reference Material is to be retained for use in connection
with manufacture of Product in one or more Production Runs. Except for the Engineering Targets, there will be no specifications
for acceptance of Engineering Batches, but the parties may mutually agree on certain additional target quality attributes to aim
for, if set forth in the applicable Project Plan. Mutually agreed Engineering Targets shall be the sole and exclusive basis for
alleging any “failure” with respect to an Engineering Run. In the event (i) an Engineering Batch does not meet the
Engineering Target(s), or (ii) Paragon proceeds with an Engineering Batch without stopping at any “go/no-go” decision
point agreed to in the Project Plan or Master Batch Record and receiving written instructions from Client to proceed (which instructions
can be provided by any writing, including email); then at Client’s written request Paragon will repeat the Engineering Run
once at no additional charge to Client assuming Client previously paid all invoices and payments associated with the failed Engineering
Run (if such invoices and payments had not been paid previously, they shall be due and paid pursuant to the Payment Schedule).
Except as in the preceding sentence, Paragon shall have no obligation to repeat any Engineering Run unless Client and Paragon
execute a Change Order for such additional Run and the appropriate additional costs. Except as provided in this Section 3.3, Client
waives all other remedies at law or in equity in connection with asserted failures in any Engineering Runs. Paragon shall provide
analytical testing of the batch as agreed by the parties in each Project Plan and will report the results to Client. Client shall
have the right to make whatever further use of such Engineering Batches as it shall determine, provided that such use does not
violate any applicable laws, rules or regulations. Paragon shall in no way be responsible for any claims, demands, losses, liabilities,
expenses or damages, whatsoever, arising out of or in any way related to Client’s use of such Engineering Batches.

 

    
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3.4Product
Delivery. At Client’s request, Product produced during Process Development Runs and Engineering Runs shall be provided
to the Client. Costs associated with shipment of Product shall be billed to Client.

 

3.5Analytical
Testing. All analytical testing to be performed by Paragon shall be specified and agreed to in advance and included in the
Master Manufacturing Record and in the budget for the Project.

 

Article
4

MANUFACTURING AND PROCESSING ACTIVITIES

 

4.1Paragon
Facility. All Product manufactured for Client hereunder shall be manufactured solely by Paragon at the Paragon Facility. Paragon
shall be solely responsible for all scheduling related to the Paragon Facility and for the operation of such facility.

 

4.2Quality
Agreement. The Quality Agreement (Exhibit B) specifies applicable quality requirements and procedures relating to manufacture,
testing and shipment of Product by Paragon under this Agreement, all of which shall be deemed a material part of this Agreement.
All quality or other testing to be performed by Paragon shall be specified and agreed to in advance and included in the Quality
Agreement.

 

4.3Control
of Cell Banks. Paragon shall maintain all portions of each Cell Line, Master Cell Bank, or Working Cell Bank that it receives
from Client, Client’s agents, or Paragon’s Qualified Subcontractor, as the case may be, in safe and secure storage
under its control in the Paragon Facility in accordance with the Storage Guidelines, and Paragon shall not transfer the Cell Line,
Master Cell Bank, or Working Cell Bank to any Third Party that is not specifically authorized in advance and in writing by Client.
Paragon shall not use any Cell Line, Master Cell Bank, or Working Cell Bank for any purpose except as authorized by this Agreement
or authorized in writing by Client. Notwithstanding the foregoing, it is understood and agreed that Paragon shall only maintain
that portion of the Master Cell Bank that is needed to conduct the activities of this Agreement and Client shall make arrangements
for retention or transfer of the remainder by or to Client or Client’s designated repository. At the conclusion of the Project,
any retained portion of the Master Cell Bank and any remaining vials of the Working Cell Bank shall be returned to the Client
or a designee as directed by Client, at Client expense.

 

4.4Raw
Materials and Consumables. 

 

4.4.1Procurement.
Unless specifically stated otherwise in the Project Plan, Paragon shall be responsible for the procurement of all Raw Materials,
Resins and Consumables necessary for the manufacture of the Product. Paragon shall not be responsible for delays in the purchase
and/or delivery of Raw Materials, Resins, and Consumables that occur despite Paragon using commercially reasonable efforts to
avoid such delays. All materials (including Raw Materials, Resins and Consumables) shall be invoiced to Client by Paragon at the
relevant Acquisition Cost. An estimate of the applicable Acquisition Cost(s) shall be set out by Paragon in each Project Plan.
Paragon will provide Client with periodic updates as to Acquisition Costs to-date versus the estimate and will notify Client in
the event the estimate will be exceeded. Client confirmation shall be obtained for exceeding the estimate by more than twenty
percent (20%), provided that if Client does not confirm the excess Acquisition Costs, Paragon will be relieved of any obligation
to proceed with the corresponding activities under the Project Plan.

 

    
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4.4.2Compliance
with Specifications. All Raw Materials, Resins and Consumables used in the Manufacturing Process shall comply with any applicable
Materials Specifications, or as otherwise agreed in writing by the Parties. Where the Materials Specification requires specific
testing or evaluation, Paragon or a Paragon Qualified Subcontractor approved in accordance with Section 4.7 shall perform such
testing and/or evaluation of the Raw Materials, Resins and Consumables as set forth in the Materials Specification.

 

4.5Storage
and Use of Materials and Product (During Project). Paragon shall ensure that all Raw Materials, Resins and Consumables that
are in Paragon’s control and are to be used in the manufacture of Product, as well as all Manufacturing Process intermediates
and Product in Paragon’s control, are stored in accordance with the terms and conditions of the Storage Guidelines, the
Material Specifications and/or the Master Manufacturing Record (as applicable), or as otherwise mutually agreed to by Paragon
and Client and/or as recommended in writing by Third Party suppliers.

 

4.6Handling
of Wastes. 

 

4.6.1Hazards.
Client must notify Paragon of any hazardous conditions or Wastes known to Client that may exist or be produced by Paragon in the
course of performing the services contemplated by this Agreement, including providing the information set forth in Section 7.8.1.
Paragon shall in accordance with Paragon’s internal procedures, inform its employees, contractors and other personnel of
any known or reasonably ascertainable chemical hazards associated with the Raw Materials, Product or any Wastes generated through
performance of the manufacturing and processing activities hereunder, and provide such persons with training, as required by Paragon’s
internal procedures, in the proper methods of handling and disposing of such items.

 

4.6.2Handling;
Notification. At Client’s expense, Paragon or a designated Third Party contractor shall handle, label, package, store,
transport and dispose of all Wastes generated through performance of the manufacturing and processing activities hereunder in
material compliance with all Federal, state and local laws, rules, and regulations applicable to such handling, labeling, packaging,
storage, transport and disposal. Paragon shall promptly notify Client in writing of any unauthorized reportable release or emission
of any Wastes generated through performance of the manufacturing and processing activities hereunder and any potential environmental
violation or litigation related thereto. Each Party shall promptly notify the other of any health hazards or potential health
hazards of which it is or becomes aware concerning exposure to or handling of the Raw Materials, Product or Wastes.

 

    
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4.7Approval
of Subcontracting. Client’s prior written approval shall be required to permit Paragon to subcontract, sublicense or
otherwise delegate all or any portion of its obligations under this Agreement with respect to Client’s Projects or Designated
Equipment. Subcontractors that would perform contract testing or cell bank manufacture must be Qualified Subcontractors.

 

4.8Document
Changes.Any requests by Paragon or Client to have cGMP documentation, including the Master Manufacturing Record and any
standard operating procedures, amended or modified in any way will be handled by a Change Order according to the procedures set
forth in Section 2.4.3 and in the Quality Agreement.

 

4.9Manufacturing
and Analytical Audits. Client shall have the right to perform, directly or through its representatives, general diligence
or “for cause” manufacturing and analytical audits of the Facility and Paragon’s systems as they relate to manufacture
or characterization of Product, at reasonably convenient times and dates scheduled to avoid disruption of Paragon’s cGMP
operations, as set forth in the Quality Agreement, or as otherwise agreed in writing by Paragon and Client. All Paragon personnel
time and resources necessary to complete the first general diligence manufacturing or analytical audit and an additional “for
cause” manufacturing or analytical audit for a calendar year shall be provided at no cost to Client; however, any Paragon
personnel time and resources necessary to complete any additional manufacturing audits (over and above two) in that same year
shall be invoiced to Client at $11,500 per audit. Client shall be responsible for all third party costs of all manufacturing audits
conducted at the written request of Client.

 

Article
5

PRODUCTION RUNS

 

5.1Production
Runs. Promptly following the completion of an Engineering Run (or as otherwise agreed by the Parties in writing), and sign-off
by the Parties on the Product Specifications to be used for the Production Run(s), manufacture of Product by Paragon will commence
under this Agreement in the form of one or more Production Runs as specified in the Project Plan (or as otherwise agreed in writing
by the Parties), and at the scale set forth in the Project Plan. The Parties agree that Paragon, in discussion with Client, will
organize the scheduling of Production Runs to maximize Paragon’s operational schedule, including scheduling the Runs so
as to constitute a campaign of two or more Runs, occurring in sequence, and without planned interruption for suite changeover
or modifications to the Master Manufacturing Record, provided that such scheduling shall be subject to suite availability and
Paragon’s other scheduling needs. However, Production Runs will be scheduled to ensure delivery of Product in accordance
with the Project Plan (including modifications that may be made pursuant to Section 2.4 if agreed to by Paragon without any change
in delivery schedule).

 

    
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5.2Batch
Documentation. Within seven (7) business days following completion of the Quality Review and Approval for each Production
Batch, Paragon shall provide Client with a copy of all applicable Batch Documentation, which shall be in Paragon’s standard
formats, unless otherwise mutually agreed in writing by the Parties. In addition, Paragon shall provide Client with such information
as is reasonably requested in writing by Client relating to the Manufacturing Process, the Master Manufacturing Record, Paragon
services performed under this Agreement or other Product-related documentation. Upon Client’s written acceptance of the
Batch Documentation (or fourteen (14) business days following delivery to Client of the Batch Documentation or additional information,
if Client makes no response) (“Client Approval”) the Batch Documentation shall be deemed approved and the Product
shall be delivered as provided in Section 5.3. Any Client requests for documents or other work product that are not specified
or contemplated in the Project Plan or produced by Paragon in the ordinary course of business, or other substantive requests for
assistance in compiling any Regulatory Filing shall constitute Additional Services, and Paragon shall notify Client of the same,
and, if Client authorizes such services, Paragon shall prepare a Change Order and invoice Client for such Additional Services
in accordance with the Project Rates.

 

5.3Delivery
Terms. Following Client Approval (pursuant to Section 5.2) of the Batch Documentation for each Production Batch, Paragon shall
notify Client and make each Batch available to Client at Paragon’s Facility in accordance with the Shipping Guidelines.
Paragon, at Client’s instruction, shall arrange for shipment of such Batch, at Client’s expense, with Client or the
Designated Carrier to take physical delivery of each Batch within five (5) business days following the date of Client’s
Approval. If any Batch remains at Paragon’s Facility beyond such five (5) business day period, additional storage shall
be paid by Client as Additional Services in accordance with the Project Rates. Client shall hold title to each Batch as of the
earlier of: (a) the date of delivery to the carrier, or (b) five (5) days following the date of Client Approval of the Batch Documentation,
and the risk of loss for a Batch shall be borne by Client from such date. Paragon shall not be required to deliver any Batch to
the Designated Carrier until the Designated Carrier informs Paragon that it has obtained all appropriate approvals and consents
of any governmental authority necessary for the transportation or shipment of such Batch (where “governmental authority”
means any national, multi-national, regional, state or local regulatory agency, department, bureau, or other governmental entity).
Batches resulting from Process Development Runs and Engineering Runs shall also be subject to the delivery terms set forth in
this Section 5.3 as requested by Client pursuant to Section 3.2 or 3.3, respectively.

 

5.4Retention
and Reserve Samples. The Parties shall mutually identify and Paragon shall retain (until Client Approval pursuant to Section
5.2) certain reserve samples of all Raw Materials, intermediate manufacture samples, and Product generated in the manufacture
of Production Batches as set forth in the applicable Materials Specifications, the applicable standard operating procedures, the
Master Manufacturing Record or as otherwise agreed in writing by Paragon and Client as provided in the Quality Agreement. Paragon
may retain a reserve sample of the Product from each Batch for a period of time in Paragon’s sole discretion.

 

5.5Quality
Control Testing. All quality control testing of Product to be performed by Paragon shall be specified and agreed to in advance.
Paragon, or a designated Qualified Subcontractor, shall perform such testing on Batches as set forth in the applicable Master
Manufacturing Record, or as otherwise mutually agreed in writing by Paragon and Client.

 

    
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5.6Accurate
Documentation. Each Party shall use diligent efforts to ensure all records and documentation provided to the other Party in
connection with the manufacture of Product, as more precisely described in the Quality Agreement, or as otherwise agreed in writing
by Paragon and Client, shall be accurate in all material respects.

 

Article
6

PAYMENTS

 

6.1Reservation
Fee. Immediately upon signature of this GMP MSA, Client will pay Paragon $180,000.00 as a non-refundable Reservation Fee in
connection with the initial Project, in order to ensure sufficient process development and manufacturing capacity/personnel resources
at Paragon to produce the Products on behalf of Client. The Project Plan for each subsequent Project shall specify the applicable
Reservation Fee. The Reservation Fee for each Project shall be applied by Paragon to the final invoice issued for the Project.
In the event that the final invoice issued for the Project is less than the Reservation Fee paid for the Project, Paragon shall
remit the difference between the Reservation Fee and the final invoice to the Client within 30 calendar days of completion of
the Project.

 

6.2Reimbursement
for Designated Equipment. Client shall reimburse Paragon for the acquisition, installation and validation of Designated Equipment
in accordance with the project rates, to be discussed with Client prior to acquiring the equipment. However, Client shall not
be required to reimburse Paragon for the costs of acquiring Designated Equipment under this Agreement if Client paid for such
Designated Equipment directly or if Client has already reimbursed Paragon for such costs prior to the Effective Date.

 

6.3Payments
and Payment Schedule; Invoicing; Payment Terms. Except as otherwise expressly set forth in this Agreement, Client shall pay
Paragon for all Technology Transfer, Process Development, engineering and manufacturing services and Engineering Runs, Process
Development Runs and Production Runs conducted in accordance with the applicable Project Plan, and in accordance with the applicable
Payment Schedule. Total costs for each Project are set out in the Project Plan for the Project as described in the Project Plan,
excluding Raw Materials, Consumables and Resins and outsourced services which are estimated to the extent known. Actual costs
for Raw Materials, Consumables and Resins and outsourced services will be based on the Acquisition Cost for each.

 

6.3.1
Paragon will provide invoices to Client as per the Project Plan payment schedule and subject to the progress against the Project
Plan. Unless disputed in good faith, Client agrees to pay invoices within thirty (30) days of receipt. Invoiced amounts may be
withheld only in the event of a good faith dispute on the basis of mathematical error or failure of Paragon to have provided the
service or procured the item to which the amount relates; the undisputed portion of the invoice shall be paid as provided above.

 

6.3.2
Paragon shall provide invoices to Client for all materials (including Raw Materials, Resins and Consumables) and outsourced
services at the relevant Acquisition Cost.

 

    
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6.3.3
All payments to Paragon by Client shall be in United States currency and shall be by check, wire transfer, money order or
other method of payment approved in writing by Paragon. Payment made by check should be sent to:

 

Paragon
Bioservices, Inc.

PO
Box 62204

Baltimore,
MD 21264-2204

 

6.3.4
In the event that Client has not paid an invoice, or disputed it in good faith, on or before the applicable invoice due date,
Client’s failure shall be considered a material breach under Section 14.2.2, subject to the cure provisions set forth therein.
Past due undisputed amounts shall bear interest from the date due until paid at the rate of eighteen percent (18%) per annum,
payable on demand.

 

Article
7

Regulatory matters

 

7.1Permits.
Paragon shall secure and maintain in good order, at its sole cost and expense, such current governmental registrations, permits
and licenses as are required by Governmental Authorities in order for Paragon to perform all of its obligations under this Agreement
(including, without limitation, Annual Registration of Drug Establishment registrations (Form FDA 2656e) granted by the FDA and
any comparable registrations granted by any other Regulatory Authority that is specified in Section 1.60) (each, a “Registration”),
for so long and insofar as is necessary to permit Paragon to perform any of its obligations under this Agreement. Notwithstanding
the foregoing, Client shall be responsible for reimbursing Paragon for the cost of any permits that are solely and specifically
required to manufacture the Product, as specified in the applicable Project Plan(s) to the extent the parties were aware of same
at the time the Project Plan was prepared. Paragon shall make copies of such Registrations and all related documents available
for viewing by Client and its designees for inspection, upon reasonable request from Client. All copies will remain in Paragon’s
control.

 

7.2Compliance
with cGMPs; Monitoring of Records. As further described in the Quality Agreement, or as otherwise agreed in writing by Paragon
and Client, Paragon shall monitor and maintain reasonable records documenting its compliance with cGMPs, including the process
of establishing and implementing the operating procedures, equipment files, and the training of personnel as are necessary to
assure such compliance.

 

7.3Records.
Paragon shall also maintain all records required to be maintained by the terms and conditions of the Quality Agreement.

 

7.4Regulatory
Communications and Correspondence. Any and all communications from and to the FDA or other Regulatory Authorities related
to the final dosage form of the Product or to the manufacture of the Product at the Paragon Facility shall be handled in accordance
with the terms and conditions of the Quality Agreement, or as otherwise agreed in writing by Paragon and Client.

 

    
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7.5Regulatory
Filings and Maintenance. Client is responsible for preparing and maintaining all Regulatory Filings. Subject to Section 8.1,
Paragon shall provide information to support Client’s Regulatory Filings, as necessary, and shall prepare and maintain manufacturing
files, certificates, authorizations, data and other records that directly or indirectly pertain to the manufacture of the Product,
as set forth in the Master Manufacturing Record and required for compliance with cGMP. Any Client requests for documents or other
work product that is not specified or contemplated in the Project Plan or produced by Paragon in the ordinary course of business
or other substantive requests for assistance in compiling any Regulatory Filing shall constitute Additional Services, and Paragon
shall notify Client of the same, and, if Client authorizes such services, Paragon shall prepare a Change Order and invoice Client
for such Additional Services.

 

7.6Cooperation
in Obtaining Government Approvals. As set forth in the Quality Agreement, or as otherwise agreed to in writing by Paragon
and Client, Paragon shall provide Client with such existing documents and information (or copies thereof) held by Paragon to assist
Client in filing Regulatory Filings and in maintaining Regulatory Authority approvals for the Product. In addition, Paragon shall
provide Client with such information for each Project as is reasonably requested in writing by Client relating to the Manufacturing
Process, the Master Manufacturing Record, Paragon services performed under this Agreement or other Product-related documentation.
Any Client requests for documents or other work product that is not specified or contemplated in the Project Plan or produced
by Paragon in the ordinary course of business, or other substantive requests for assistance in compiling any Regulatory Filing
shall constitute Additional Services, and Paragon shall notify Client of the same, and, if Client authorizes such services, Paragon
shall prepare a Change Order and invoice Client for such Additional Services.

 

7.7Ownership
of Regulatory Filings. Client shall be the sole owner of all Regulatory Filings and all governmental approvals obtained by
Client from any Regulatory Authority with respect to the Product or the final dosage form of the Product.

 

7.8Health
and Safety Information.

 

7.8.1Product.
For each Project, Client shall provide Paragon with all information in Client’s possession or control concerning any health
hazards or potential health hazards associated with exposure to or the handling, storage, use or disposal of Raw Materials and/or
Product, including, without limitation, a Material Safety Data Sheet for Product, if one exists. In the event that any such information
is updated or corrected, Client shall promptly notify Paragon thereof and provide Paragon with the updated or corrected information.

 

7.8.2Regulatory
Authority Communications. Client shall be responsible for handling all complaints and communications from Regulatory Authorities
with respect to the Product(s). Paragon shall maintain a system for investigating complaints related to the manufacture of the
Product(s) by Paragon and shall investigate all such complaints and will cooperate in resolving and responding to such communications
to the extent they pertain to the Product’s manufacture and such cooperation is reasonably requested by Client. Client shall
reimburse Paragon for all reasonable costs and expenses incurred by Paragon in connection with the performance of Paragon’s
obligations under this Section 7.8.2., but only to the extent that (a) the relevant documentation is not specified or contemplated
in the Project Plan or produced by Paragon in the ordinary course of business, and (b) Paragon has not made any errors in the
manufacture of the Product or in the preparation of the relevant documentation, which errors were the cause for the Regulatory
Authority complaint or communication.

 

    
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7.9Accident
Reports. Each Party shall report to the other as soon as possible all material accidents related to the manufacture, handling,
use or storage of any Raw Materials or Product(s), including, without limitation: (i) accidents resulting in significant personal
injury requiring more than first aid treatment, (ii) accidents resulting in chronic illness or loss of consciousness, (iii) accidents
resulting in material property damage, (iv) accidents resulting in material environmental release, and (v) accidents that result
in regulatory, safety, health or environmental audits.

 

Article
8

QUALITY ASSURANCE; QUALITY CONTROL; VALIDATION

 

8.1Responsibility
for Quality Assurance and Quality Control. Responsibility for quality assurance and quality control of Product shall be allocated
between Client and Paragon as set forth in the Quality Agreement, Exhibit B.

 

8.2Validation
of Paragon Facility; Utilities and Equipment. Paragon shall maintain cGMP validation of the Paragon Facility, as well as the
utilities and equipment used in the manufacture of Product at the Paragon Facility, and shall make relevant validation reports
applicable thereto (redacted to remove information not related to the manufacture of Product) available to Client for review at
Paragon’s Facility, at Client’s reasonable request.

 

Article
9

NON-CONFORMANCE

 

9.1Notice
of Nonconformity. In the event that Client believes that a Production Batch is Non-Conforming Product, Client may reject the
same by giving written notice thereof to Paragon within fourteen (14) days after the delivery of the Batch Documentation and/or
receipt of the Product pursuant to Section 5.3 (for reasons that cannot be determined from the Batch Documentation), whichever
is later. Such written notice shall specify the manner in which such Production Batch fails to conform to the warranties set forth
in Section 11.2.1, and shall be accompanied by any test results or reports evidencing such nonconformity.

 

9.2No
Paragon Liability. If, following the receipt of a notice from Client pursuant to Section 9.1, it is determined by agreement
of the Parties (or in the absence of such agreement, in accordance with Section 9.5) that the Production Batch is Conforming Product,
then Paragon shall have no liability to Client with respect to such Batch, and Client shall pay all invoices and payments associated
with manufacture of such Production Batch and for the fees associated with independent testing, if any, and the Production Batch
shall be treated in all other respects under this Agreement as though it conformed with all of the warranties set forth in Section
11.2.1 of this Agreement.

 

    
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9.3Paragon
Liability for Non-Conforming Product; Replacement. If, following the receipt of a notice from Client pursuant to Section 9.1,
it is determined by agreement of the Parties (or in the absence of such agreement, pursuant to Section 9.5) that such Production
Batch is Non-Conforming Product, then Paragon shall proceed expeditiously and in good faith to replace such Non-Conforming Product
with Conforming Product (the “Replacement Product”). Paragon shall promptly (a) acquire and quarantine all
Raw Materials, Resins and Consumables necessary for conducting the required Production Run(s) to produce the Replacement Product,
(b) prepare the documentation for such Production Run(s), (c) conduct appropriate quality investigation of the non-conformity
and resolve or correct as appropriate, in consultation with Client and with appropriate sign-off by Paragon and Client for any
changes deemed necessary for such Production Run(s), and (d) within five (5) business days following completion of item “(c)”
schedule the Production Run(s) in the cGMP manufacturing suite at the very next available time period. The work set out in steps
(a) through (d) above, as well as any other Materials, Consumables and Resins and delivery of Replacement Product shall be at
no additional cost to Client assuming Client previously paid all invoices and payments associated with manufacture of the Non-Conforming
Product, in which case no additional payment for the Replacement Product will be required (if such invoices and payments had not
been paid previously, they shall be immediately due, except for the final payment that would be due upon completion of the final
GMP milestone or step, which shall be due on delivery of the Replacement Product). Delivery of Replacement Product shall be Client’s
sole remedy with respect to Non-Conforming Product, and in furtherance thereof Client waives all other remedies at law or in equity.
Paragon shall be responsible for the fees associated with independent testing, if any, in the event of findings as set forth in
this Section 9.3.

 

9.4Cooperation
in Investigations; Disposition of Non-Conforming Product. If Client rejects a Batch as Non-Conforming Product pursuant to
Section 9.1, the Party then in possession of the Batch shall not dispose of or allow such Product to be disposed of without written
authorization and instructions from the other Party either to dispose of such Non-Conforming Product or to return it to the other
Party, at the receiving Party’s expense, should the other Party wish to have additional testing conducted by a qualified
independent Third-Party laboratory or for purposes of disposal. Each Party shall act in good faith and shall cooperate with the
other Party, with any qualified independent Third-Party laboratory in connection with an investigation, as to the existence of
or source of nonconformity with respect to a Production Batch supplied under this Agreement. In testing the Production Batch,
any independent Third-Party laboratory shall use analytical testing methods as specified in the Product Specifications for such
Product. The Party in possession shall dispose of any Non-Conforming Product in accordance with all relevant laws, rules and regulations
with respect to such disposal, at Paragon’s cost if Paragon was liable for the nonconformity in accordance with Section
9.3 and at Client’s cost if Paragon was not liable for the nonconformity in accordance with Section 9.2, unless Client notifies
Paragon in writing that it wishes to retain Non-Conforming Product for evaluation of process development efforts and the Parties
agree on payment terms. The Client agrees that at no time shall a Non-Conforming Product be used in pre-clinical GLP studies or
clinical studies; provided that if the parties agree to payment terms for any Non-Conforming Product that Client desires to use,
then upon payment of such amount, Client shall have the right to use such Non-Conforming Product and Client shall be solely responsible
for all costs, expenses and liabilities associated with storing, handling, using and testing the retained Non-Conforming Product.
If the parties cannot agree on the payment amount within thirty (30) days, the Non-Conforming Product shall be destroyed by the
Party in possessionas provided above.

 

    
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9.5Dispute
Resolution. The parties shall endeavor to resolve any dispute between them under this Article 9, but if the Parties are unable
to resolve a dispute, despite their good faith efforts, either Party may refer the dispute to the Chief Executive Officer (or
other designee) of each Party. In the event that no agreement is reached by the Chief Executive Officers (or other designees)
with respect to such dispute within thirty (30) days after its referral to them, either Party may, by written notice to the other
Party, refer the dispute to an independent Third Party testing laboratory mutually agreed by the Parties, who shall execute a
confidentiality agreement in a reasonable and customary form approved in advance in writing by the Parties. The laboratory shall
be asked to determine the existence of or source of nonconformity with respect to a Production Batch supplied under this Section
with respect to a specific non-conformity asserted by Client. Paragon shall immediately submit to such laboratory one or more
retained samples of Product from the same Batch as such suspected Non-Conforming Product, and Client shall submit to such laboratory
one or more samples of Product from the same Batch as such suspected Non-Conforming Product together with a complete copy of the
relevant Product Specifications, Storage Guidelines and Shipping Guidelines (and any other relevant documentation) and the warranty
in Section 11.2.1. The testing laboratory shall test the samples and determine whether the Product is Conforming Product or Non-Conforming
Product with respect to the specific alleged non-conformity. Pending the determination of the testing laboratory, the Parties
shall continue to perform their respective obligations under this Agreement. The testing laboratory decision shall be rendered
in writing explaining the reasons for such decision promptly following submission of the Product samples to the testing laboratory,
and shall be binding and not be appealable to any court in any jurisdiction. The Parties agree that they shall share equally the
necessary up-front cost of the testing laboratory, pending to the provisions of Sections 9.2 or 9.3 following conclusion of the
investigation, following which any such amounts paid by the prevailing Party will be promptly reimbursed by the non-prevailing
Party. In addition, if the prevailing Party engaged its own third Party laboratory to either identify or refute an alleged non-conformity
(as the case may be), the non-prevailing Party shall reimburse the prevailing party for the reasonable out-of-pocket costs incurred
for such laboratory engagement.

 

Article
10

RIGHTS TO CLIENT MATERIALS, intellectual property, EQUIPMENT

 

10.1Client
Materials. As between the Parties, Client shall own all rights in and title to the biological materials described as each
Cell Line, the Master Cell Bank, the Working Cell Bank, the Product, any Manufacturing Process provided by Client to Paragon,
and the Reference Material(s). During the Term, Client hereby grants to Paragon a fully paid, royalty-free, non-exclusive restricted
license under any and all Client Intellectual Property only to the extent necessary for Paragon to perform its obligations under
this Agreement, including, without limitation, all rights necessary for the development and use of each Cell Line, the Drug Substance,
the Manufacturing Process, and/or the Client Confidential Information, to practice such Client Intellectual Property for the sole
and limited purpose of Paragon’s performance of its obligations under this Agreement, including, without limitation, the
manufacture of Product for Client.

 

    
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10.2License
to Client. With respect to any Manufacturing Process or portion thereof that is developed by Paragon hereunder, Paragon retains
the right to use any underlying process, protocol, technology, know-how or the like in conducting its laboratory and manufacturing
operations and activities, and all rights, title and interest in and to any Paragon Intellectual Property rights therein. Paragon
hereby grants to Client an irrevocable, fully paid, royalty-free, non-exclusive, restricted, worldwide license, with the right
to grant and authorize sublicenses, under any and all Paragon Intellectual Property that Paragon incorporates into any Manufacturing
Process, or that is necessary to the practice of the Manufacturing Process, or that relates solely to the Cell Line, the Master
Cell Bank or the Working Cell Bank, to practice such Paragon Intellectual Property for the sole and limited purpose of using Product
produced hereunder for research and development and/or clinical trial purposes, including formulating and/or compounding the final
dosage form of the Product therefrom for use in clinical trials, or the practice of the Manufacturing Process by or on behalf
of Client or a Client sublicensee for the manufacture of Drug Substance or Product for use or sale by or on behalf of Client or
its sublicensee.

 

10.3Project
Intellectual Property. All Intellectual Property created or developed by Paragon specifically for Client in the course of
performing under this MSA or which utilizes Client Confidential Information or is specifically related thereto shall be the exclusive
property of Client. Paragon hereby assigns to Client all right, title, and interest in all such Intellectual Property, free and
clear of all liens, claims, and encumbrances, and shall take any actions, including but not limited to the execution of documents,
reasonably requested by Client and at Client’s expense, to effect the purposes of the foregoing. Notwithstanding the foregoing,
Client shall have no ownership rights in any Intellectual Property relating to or based on Paragon’s existing Intellectual
Property or relating generally to Paragon’s business of conducting laboratory and/or GMP or non-GMP manufacturing services
(but such Intellectual Property shall be subject to the license granted in Section 10.2).

 

10.4Third
Party Intellectual Property. Client understands that Third Party intellectual property may apply to the Product and to its
manufacture and use, and/or to future manufacture and use of a commercial product comprising each Drug Substance to which this
Agreement relates. Client agrees that as between the Parties, it is solely Client’s responsibility to determine whether
any such intellectual property, including Third Party Patents, applies to its activities and Product and to obtain license(s)
thereto, including those specific to the Products, including without limitation the Cell Line used to produce the Product; provided
that Paragon will advise Client in writing in reasonable detail of the technical processes it will use in the Manufacturing Process,
including any Third Party rights and/or in-licenses that, to Paragon’s knowledge, are required, but is under no obligation
to undertake any patent infringement or patent clearance studies or to obtain any patent opinions, or to seek or secure any licenses
to Third-Party Patent(s) on Client’s behalf. Paragon agrees that it will not knowingly involve any Third Party intellectual
property. In the event of any conflict between this Section 10.4 and the indemnity of Section 12.2(c), the indemnity of Section
12.3(c) shall control.

 

    
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10.5Ownership
of Designated Equipment. In the event Paragon must purchase any Designated Equipment required specifically for Client’s
Project and Client reimburses Paragon for the cost of such Designated Equipment, Client shall own all right, title and interest
in and to any and all such Designated Equipment. All Designated Equipment shall be maintained by Paragon per Paragon’s maintenance
program, provided that any out-of-pocket costs for necessary repairs shall be paid by Client, so long as such repairs are in consultation
with and approved by Client. Client shall be liable for all damage and risk of loss to the Designated Equipment, unless caused
by Paragon’s negligence or willful misconduct. Paragon may request permission to use the Equipment in connection with work
for a third party, but may only do so if granted written permission by Client with payment to Client as may be agreed to in writing
by both Parties. Disposition of Designated Equipment upon expiration or termination of this MSA shall be pursuant to Section 14.3.4.
Paragon may request to purchase from Client any Designated Equipment and terms of sale will be as may be agreed to in writing
by both Parties.

 

Article
11

RESPONSIBILITIES AND WARRANTIES

 

11.1Client.

 

11.1.1Materials
and Information. For each Project, Client has (or will have) the right, power and authority to supply to Paragon or allow
Paragon the use of, for purposes of the activities contemplated by this Agreement, the applicable Cell Line, Master Cell Bank,
Working Cell Bank, Client Confidential Information (including, without limitation, any portion of the Master Manufacturing Record
and/or Manufacturing Process supplied by Client to Paragon), and any other information or materials supplied by Client to Paragon.

 

11.1.2Hazard
Information. For each Project, Client has made Paragon aware of any known risks and special handling precautions or protocols
(other than routine laboratory risks for materials of the same nature) that are known to Client with respect to handling the Cell
Line, the Master Cell Bank, the Working Cell Bank, the Raw Materials, the Product, and any Wastes that may be generated through
performance of the process development and manufacturing activities contemplated hereunder, or Client will provide such information
in advance of Paragon working with any of the above items.

 

11.2Paragon.

 

11.2.1Product.
Paragon warrants to Client that each Production Batch of Product manufactured hereunder: (i) was manufactured and analyzed in
conformance with the Master Manufacturing Record; (ii) was manufactured in compliance with cGMP; (iii) was packaged, labeled,
stored and shipped in accordance with the Storage Guidelines and Shipping Guidelines; and (iv) was transferred free and clear
of any liens or encumbrances of any kind to the extent arising through or as a result of the acts or omissions of Paragon.

 

11.2.2Paragon
Facility. Paragon lawfully controls operations in the Paragon Facility, and will maintain the Paragon Facility in accordance
with cGMP and in such condition as will allow Paragon to manufacture the Product(s) in compliance with cGMP and in conformance
with the applicable Master Manufacturing Record.

 

    
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11.2.3Debarment.
Paragon has not, does not and will not employ any individual who is debarred under Section 306(b)(1)(b) of the FDC Act, and will
provide a certification that it has not, does not and will not use in any capacity the services of any person debarred under Section
306(b) of the FDC Act in connection with the manufacture of the Product.

 

11.3Disclaimer
by Paragon. Other than quality control testing, if any, of Product by Paragon pursuant to this Agreement, Paragon shall not
be in any way responsible for Product testing. OTHER THAN AS SET FORTH IN SECTION 11.2.1, ALL OTHER WARRANTIES, BOTH EXPRESS AND
IMPLIED, ARE HEREBY EXPRESSLY DISCLAIMED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OF THE PRODUCT(S) OR THE SERVICES PROVIDED HEREUNDER. OTHER THAN THE PROCESS DEVELOPMENT AND MANUFACTURING SERVICES PROVIDED
HEREUNDER, PARAGON HAS NOT PARTICIPATED IN THE RESEARCH AND DEVELOPMENT OF THE PRODUCT OR THE PRODUCT(S), NOR HAS PARAGON IN ANY
WAY EVALUATED ANY PRODUCT’S SAFETY OR EFFICACY IN HUMANS OR OTHERS.

 

Article
12

INDEMNIFICATION

 

12.1Indemnification
by Client. Subject to and except to the extent of any indemnification from Paragon pursuant to Section 12.2 below, Client
shall indemnify, defend and hold Paragon, its Affiliates, and their respective directors, officers, employees and agents harmless
from and against all losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including, without limitation,
reasonable attorneys’ fees and expenses), (collectively, the “Liabilities”) to the extent such Liabilities
arise out of or result from any claim, lawsuit or other action or threat by a Third Party arising out of (a) the manufacture,
packaging, testing, labeling, handling, distribution, marketing, use, import, export or sale of the Product, in any form, including
but not limited to, any third-party infringement claims based on claims that the Product, or its use, or its manufacture (to the
extent specific to the Product) infringes such third party’s Intellectual Property (b) any material breach of Section 11.1
of this Agreement, (c) Client’s grossly negligent acts or omissions or willful misconduct in the performance of its obligations
under this Agreement, (d) Client’s use of the results of this Agreement, including but not limited to use of the Manufacturing
Process and/or Product and any results of research and development and/or clinical trials using any Product and/or Client’s
commercialization of any such items. In the event that Client has the right to retain and use Non-Conforming Product as set forth
in Section 9.4, Client’s indemnity hereunder with respect to such Non-Conforming Product and any use thereof shall be without
exception.

 

12.2Indemnification
by Paragon. Subject to and except to the extent of any indemnification from Client pursuant to Section 12.1 above, Paragon
shall indemnify, defend and hold Client, and its Affiliates, directors, officers, employees and agents harmless from and against
all Liabilities to the extent such Liabilities arise out of or result from any claim, lawsuit or other action or threat by a Third
Party arising out of (a) any material breach of Section 11.2.1 of this Agreement, or (b) Paragon’s grossly negligent acts
or omissions or willful misconduct in the performance of its obligations under this Agreement, or (c) any third-party infringement
claims based on claims that the services (to the extent not specific to the Product) infringe such third party’s Intellectual
Property, excluding: claims to the extent based on Client’s Materials and/or Product, claims based on processes or materials
used at the instruction of Client, and claims based on disclosure by Paragon to Client of the technical processes it will use
in the Manufacturing Process.

 

    
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12.3Indemnification
Procedures. 

 

12.3.1Identification
of Indemnitor and Indemnitee. An “Indemnitor” means the indemnifying Party. An “Indemnitee”
means the indemnified Party, its Affiliates, and their respective directors, officers, employees and agents.

 

12.3.2Indemnification
Procedures. An Indemnitee which intends to claim indemnification under Section 12.1 or Section 12.2 hereof shall promptly
notify the Indemnitor in writing of any claim, lawsuit or other action in respect of which the Indemnitee, its Affiliates, or
any of their respective directors, officers, employees and agents intend to claim such indemnification. The Indemnitee shall permit,
and shall cause its Affiliates and their respective directors, officers, employees and agents to permit, the Indemnitor, at its
discretion, to settle any such claim, lawsuit or other action and agrees to the complete control of such defense or settlement
by the Indemnitor; provided, however, that in order for the Indemnitor to exercise such rights, such settlement
shall not adversely affect the Indemnitee’s rights under this Agreement or impose any obligations on the Indemnitee in addition
to those set forth herein. No such claim, lawsuit or other action shall be settled without the prior written consent of the Indemnitor,
which consent shall not be unreasonably withheld, and the Indemnitor shall not be responsible for any legal fees or other costs
incurred other than as provided herein. The Indemnitee, its Affiliates and their respective directors, officers, employees and
agents shall cooperate fully with the Indemnitor and its legal representatives in the investigation and defense of any claim,
lawsuit or other action covered by this indemnification, all at the reasonable expense of the Indemnitor. The Indemnitee shall
have the right, but not the obligation, to be represented by counsel of its own selection and expense.

 

12.4
Insurance. Each Party shall maintain appropriate commercial general liability insurance sufficient to cover its interest
or potential liabilities hereunder, in an amount equal to at least $2 million dollars, including, but not limited to worker’s
compensation, if applicable, and comprehensive general liability. Client’s comprehensive general liability shall include
product liability insurance. Each party shall provide to the other upon request, a copy of its insurance certificate evidencing
such insurance.

 

12.5Limitation
of Liability. Use of any of the results of this MSA, including but not limited to any Product or Manufacturing Process produced,
or any data, results or information derived from the activities hereof for any regulatory submissions or for any other research
or commercial purposes is done at the sole discretion and responsibility of Client. Both Parties agree that to the fullest extent
permitted by law, and except with respect to the indemnification provided herein for third party claims, each Party’s liability
to the other Party for any and all injuries, claims, losses, expenses, or damages, whatsoever, arising out of or in any way related
to the activities of this Agreement, from any cause or causes, including, but not limited to, negligence, errors, omissions or
strict liability, shall not exceed that amount equivalent to the total charges paid by Client to Paragon for the applicable Project
under this MSA. To the extent that this clause conflicts with any other clause, this clause shall take precedence over such conflicting
clause. Notwithstanding anything to the contrary herein, and except with respect to such damages if included within a third party
claim covered by the indemnification provided herein, in no event shall either Party be liable to the other for any lost profits,
contracts, business, business opportunity or goodwill, or any other incidental, exemplary, indirect, consequential or punitive
damages, even if such Party has been advised of the possibility of such damages arising out of or in connection with this MSA.

 

    
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Article
13

CONFIDENTIALITY

 

13.1Prior
Confidential Disclosure Agreement. The Confidentiality Agreement shall remain in full force and effect to govern Confidential
Information (as defined in such Confidentiality Agreement and the Letter of Intent) exchanged between the Parties under such agreements
and under this Agreement (either Client Confidential Information or Paragon Confidential Information, as the context requires)
and shall be subject to the terms of this Agreement.

 

13.2Paragon
Confidentiality Obligations. Paragon shall not use Client Confidential Information except as authorized under this Agreement
and shall not disclose Client Confidential Information to any third party other than consultants or authorized Subcontractors
who are bound by similar obligations of confidentiality and nonuse and who have a need to know such information in order to perform
their duties or services in connection with Paragon’s obligations under this Agreement.

 

13.3Client
Confidentiality Obligations. Client shall not use Paragon Confidential Information except as authorized under this Agreement
and shall not disclose any Paragon Confidential Information to any third party other than: (i) consultants, or agents of Client
or Client’s Affiliates who are bound by similar obligations of confidentiality and nonuse and who have a need to know such
information in order to perform their duties or services in connection with Client’s obligations under this Agreement or
the development or commercialization of the Product; or (ii) Regulatory Authorities that require such information in connection
with making Regulatory Filings and maintaining Regulatory Authority approvals for the Product(s); or (iii) to sublicensees in
connection with the exercise of the licenses granted to Client under Article 10.

 

13.4Responsibility
for Compliance with Confidentiality and Nonuse Obligations. Each Party shall use reasonable and customary precautions to safeguard
the other Party’s Confidential Information, including ensuring that all employees, consultants, agents, Subcontractors or
sublicensees who are provided access to such Confidential Information are informed of the confidential and proprietary nature
of such Confidential Information and have undertaken confidentiality and nonuse obligations to protect the Confidential Information
in a manner consistent with the obligations of this Agreement. Each Party shall be responsible for any intentional misuse or misappropriation
by such Party, its Affiliates, or the employees, consultants, agents, Subcontractors or sublicensees of such Party or such Party’s
Affiliates, of the other Party’s Confidential Information.

 

    
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13.5No
Licenses. Except as expressly provided in Article 10 hereof, no right or license, either express or implied, is granted under
any intellectual property right or by virtue of the disclosure of Confidential Information under this Agreement, or otherwise.

 

13.6Protection
of Inadvertent Disclosures. Client agrees that in the event Client inadvertently becomes aware of any information related
to other Paragon clients through the presence of Client’s employees, agents or advisors at Paragon offices or at the Paragon
Facility, that such information will be kept strictly confidential in the same manner as Paragon Confidential Information, provided,
however, that Client shall make no use of the information for any purpose whatsoever, either related to this Agreement or otherwise.
Paragon agrees that in the event Paragon inadvertently becomes aware of any information related to other Client projects through
the presence of Paragon’s employees, agents or advisors at Client’s facilities, that such information will be kept
strictly confidential in the same manner as Client Confidential Information, provided, however, that Paragon shall make no use
of the information for any purpose whatsoever, either related to this Agreement or otherwise.

 

13.7Use
of Names. Neither Party shall make use of the name of the other Party in any advertising or promotional material, or otherwise,
in connection with this Agreement or any related agreements, without the prior written consent of such other Party. Client consent
is given for Paragon to list Client in its listing of clients and manufacturing activities, stating only that the activities involved
process development and manufacture of “an active pharmaceutical ingredient,” if no press release is issued.

 

13.8Press
Releases. The Parties agree that any initial public announcement of the execution of this Agreement shall be in the form of
a mutual press release to be agreed upon by the Parties; provided, that the Parties shall also agree on the timing of such public
announcement. After such press release is published, each Party shall be entitled to make or publish any public statement consistent
with the contents thereof. Except as set forth in the preceding sentence, no press release, publicity or other form of public
written disclosure related to this Agreement shall be permitted by either Party unless the other Party has indicated its consent
to the form of the release in writing. This Section shall not apply to any disclosure that is deemed necessary, in the reasonable
judgment of the responsible Party, to comply with national, federal or state laws or regulations (including the rules and regulations
of any national stock exchange on which such Party’s securities are traded).

 

Article
14

TERM; TERMINATION

 

14.1Term.
Unless sooner terminated pursuant to the terms of this Agreement, the term of this Agreement shall commence on the Effective Date
and shall continue in effect indefinitely unless and until terminated as provided in Section 14.4 or 14.5 (such period during
which this Agreement is in effect, the “Term”). Each Project Plan shall remain in effect from the date of its
execution by both parties until completion of the Project according to the Project Plan or until termination of the Project Plan
as provided in this Article 14.

 

    
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14.2Termination
of Project Plan. Any individual Project Plan under the Agreement may be terminated as follows:

 

14.2.1Failure
to Establish the Manufacturing Process. A Project Plan may be terminated by mutual written agreement of the Parties in the
event that Paragon is unable to develop a Manufacturing Process for a Drug Substance in accordance with Section 2.1.1, despite
the use of commercially reasonable efforts to do so.

 

14.2.2Material
Breach. Either Party may terminate a Project Plan, effective upon written notice to the other Party, for any material breach
by the other Party of its obligations with respect to the Project Plan, if such breach is not cured within thirty (30) days after
written notice of such breach to the breaching Party; provided, however, if such breach is not capable of being cured within
such thirty (30) day period, the cure period shall be extended for such amount of time as may be reasonably necessary to cure
such breach, so long as the breaching Party is making diligent efforts to do so.

 

14.2.3Force
Majeure. Either Party shall have the right to terminate a Project Plan, by providing written notice thereof to the other Party,
such termination to be effective thirty (30) days from the date of such notice, if, as a result of a Force Majeure Event (as defined
in Section 15.1), a Party is unable fully to perform its obligations under the Project Plan for any period of sixty (60) days.

 

14.3Consequences
of Completion or Termination of Project Plan. 

 

14.3.1Payment
of Amounts Due. Termination of any individual Project Plan for any reason shall not exempt any Party from paying to the other
Party any amounts already owing to such Party at the time of such termination. Client shall pay any unpaid Acquisition Costs for
all Raw Materials, Resins, Consumables and Designated Equipment purchased or ordered or for non-cancelable outsourced services
ordered under any terminated Project Plan (or Run(s)) in anticipation of the specified Process Development Run(s), Engineering
Run(s), and Production Run(s), in each case to the extent Paragon is unable to reuse or reallocate such resources.

 

14.3.2At
the time of termination, any advanced payments made by Client shall be applied to the total expenses incurred per the Project
Plan(s) and as listed in Section 14.3.1 and any prior unpaid invoice amounts. Any remaining balance will be returned to Client
within 30 days following the later of termination or completion of the initiated or scheduled activities (provided that advance
payments retained by Paragon shall be at least equal to the amount of the Reservation Fee). Any balance due shall be paid to Paragon
within 30 days following the date of Paragon’s invoice for same.

 

14.3.3
Raw Materials, Consumables and Resins. Upon expiration of a Project Plan, Client shall purchase from Paragon (to the extent not
already paid for by Client), at the Acquisition Cost, all remaining usable Raw Materials, Consumables and Resins acquired and
paid for by Paragon for the manufacture of Product under this Agreement that conform to any applicable Material Specifications.
To effect such purchase, Paragon shall invoice Client therefor and Client shall pay the invoiced amount within thirty (30) days
following the date of the invoice.

 

    
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14.3.4Return
of Materials and Client Confidential Information; Transfer of Designated Equipment.

 

(a)
Client Materials - Paragon will inform Client of need to return or dispose of any Client owned property (Cell Line, Master
Cell Bank, Working Cell Bank, Resins, Designated Equipment, Product, Raw Materials, Consumables, etc.). Unless otherwise agreed
by the Parties in writing, within sixty (60) days following expiration or termination of a Project Plan, Paragon shall promptly
(except as may be needed to complete any Runs that are in process) at Client’s sole cost and expense: (i) return (or, at
Client’s written election, destroy) all quantities of the Cell Line, Master Cell Bank, Working Cell Bank, residual paste,
or other biological material received or produced by Paragon under this Agreement, and (ii) deliver to Client all Reference Materials
being held by Paragon.

 

(b)
Client Confidential Information - Upon written request of Client, Paragon shall return to Client all Client Confidential
Information received in tangible form in connection with the Project Plan, except for a single copy and/or sample which may be
retained solely for purposes of determining Paragons obligations hereunder and which shall remain subject to the obligations of
nonuse and confidentiality set forth in this Agreement.

 

(c)
Unclaimed Designated Equipment - If any Designated Equipment, remains at the Paragon Facility for a period longer than
sixty (60) days after expiration or termination of a Project Plan (unless it is to be used in connection with another Project
Plan for Client), Paragon shall have no obligation to store or return items. All right title and interest in such Designated Equipment
shall vest in Paragon upon expiration of the sixty day period and Paragon shall thereafter be free to use, sell or transfer the
Designated Equipment as it sees fit.

 

14.3.5
Return of Paragon Confidential Information. Upon expiration or termination of a Project Plan and upon the written request
of Paragon, Client shall promptly return to Paragon all Paragon Confidential Information received thereunder in tangible form,
except for a single copy which may be retained for documentation purposes only and which shall remain subject to the obligations
of nonuse and confidentiality set forth in this Agreement.

 

14.4Termination
of Agreement for Insolvency. Either Party may terminate this Agreement upon written notice to the other Party, upon (a) the
dissolution, termination of existence, liquidation or business failure of the other Party; (b) the appointment of a custodian
or receiver for the other Party who has not been terminated or dismissed within ninety (90) days of such appointment (provided,
however, that Paragon shall not be obligated to continue services hereunder during such period relating to Client, unless Client
is expressly authorized by the custodian or receiver to make payments to Paragon therefor); (c) the institution by the other Party
of any proceeding under national, federal or state bankruptcy, reorganization, receivership or other similar laws affecting the
rights of creditors generally or the making by such Party of a composition or any assignment for the benefit of creditors under
any national, federal or state bankruptcy, reorganization, receivership or other similar law affecting the rights of creditors
generally, which proceeding is not dismissed within ninety (90) days of filing (provided, however, that Paragon shall not be obligated
to continue services hereunder during such period relating to Client, unless Client is expressly authorized by applicable court
or other authority to make payments to Paragon therefor). All rights and licenses granted pursuant to this Agreement are, and
shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11 of the United States Code, licenses of rights of “intellectual
property” as defined therein. Termination under this paragraph shall have the effect of terminating outstanding Project
Plans and Section 14.3 shall apply.

 

    
	 	Page 33 of 43	 

     

    

 

14.5Other
Termination of Agreement. If all Project Plans have been completed or terminated pursuant to Section 14.2 and the steps outlined
in Section 14.3 have been completed, either Party may terminate this Agreement upon written notice to the other Party, effective
upon receipt of such notice.

 

14.6Cumulative
Remedies. Any right to terminate this Agreement shall be in addition to and not in lieu of all other rights or remedies that
the Party giving notice of termination may have at law or in equity or otherwise.

 

14.7Accrued
Rights. Except as otherwise expressly set forth herein, any termination or expiration of a Project Plan or this Agreement
shall be without prejudice to any right which shall have accrued to the benefit of either Party and shall not relieve either Party
of any obligation which has accrued prior to the effective date of such termination or expiration, which obligations shall remain
in full force and effect for the period provided therein or, if no period is provided therein, then such obligations shall remain
in full force and effect indefinitely.

 

14.8Surviving
Rights. Article 1, Section 3.4 (provided that Client is not in default hereunder), Section 4.3 (only with respect to the prohibition
against use or transfer to Third Parties), Section 4.6 (only with respect to hazards that may exist or handling of materials which
may take place after the termination date), Article 5 (only with respect to work in progress as of the termination date), Article
6 (only with respect to invoices unpaid as of the termination date or issued thereafter for work in progress as of the termination
date and to application of the Reservation Fee credit thereto), Sections 7.2 - 7.7 and 7.8.2, Article 9, Article 10, Section 11.3,
Article 12, Article 13, Section 14.3, Section 14.6, Section 14.7 and Section 14.8, and Article 16, and the rights and obligations
contained therein shall survive the termination or expiration of this Agreement.

 

Article
15

FORCE MAJEURE

 

15.1Effects
of Force Majeure. No Party shall be in breach of this Agreement if there is any failure of performance under this Agreement
(except for payment of any amounts due under this Agreement) occasioned by any reason beyond the control and without the fault
or negligence of the Party affected thereby, including, without limitation, an act of God, fire, flood, act of government or state,
war, civil commotion, insurrection, acts of terrorism, embargo, sabotage, prevention from or hindrance in obtaining energy or
other utilities, a shortage of Raw Materials, Resins, Consumables or other necessary components due to force majeure at Paragon’s
supplier(s), labor disputes of whatever nature, or any other reason beyond the control and without the fault or negligence of
the Party affected thereby (a “Force Majeure Event”). Such excuse shall continue as long as the Force Majeure
Event continues. Upon cessation of such Force Majeure Event, the affected Party shall promptly resume performance under this Agreement
as soon as it is commercially reasonable for the Party to do so.

 

    
	 	Page 34 of 43	 

     

    

 

15.2Notice
of Force Majeure. Each Party agrees to give the other Party prompt written notice of the occurrence of any Force Majeure Event,
the nature thereof, and the extent to which the affected Party will be unable to fully perform its obligations under this Agreement.
Each Party further agrees to use commercially reasonable efforts to correct the Force Majeure Event as quickly as practicable
(provided that in no event shall a Party be required to settle any labor dispute) and to give the other Party prompt written notice
when it is again fully able to perform such obligations. This Agreement may be terminated as a result of a Force Majeure Event
only in accordance with Section 14.2.3 hereof.

 

Article
16

MISCELLANEOUS

 

16.1Notices.
Any notice required or permitted to be given under this Agreement by any Party shall be in writing and shall be (a) delivered
personally, (b) sent by registered mail, return receipt requested, postage prepaid, (c) sent by a nationally-recognized courier
service guaranteeing next-day or second day delivery, charges prepaid, or (d) delivered electronically (with documented evidence
of transmission), to the addresses of the other Party set forth below, or at such other addresses as may from time to time be
furnished by similar notice by any Party. The effective date of any notice under this Agreement shall be the date of receipt by
the receiving Party.

 

    
	 	Page 35 of 43	 

     

    

 

If
to Paragon:

 

For
Project communications:

 

	 	Attn:
    (as per each Project Plan)
	 	Paragon
    Bioservices, Inc.
	 	University
    of Maryland Biopark 
	 	Building
    Two, Suite 401
	 	801
    W. Baltimore Street
	 	Baltimore,
    MD 21201
	 	 
	 	Telephone:
    410-975-4050 
	 	Email:

 

For
all other communications:

 

	 	Attn:
    Marco A. Chacon, President & CEO
	 	Paragon
    Bioservices, Inc.
	 	University
    of Maryland Biopark 
	 	Building
    Two, Suite 401
	 	801
    W. Baltimore Street
	 	Baltimore,
    MD 21201
	 	 
	 	Telephone:
    410-975-4050 
	 	 
	 	Email:

 

If
to Client: 

 

For
Project communications:

 

	 	Attn:
    Misha Nossov
	 	Variation
    Biotechnologies, Inc.
	 	310
    Hunt Club Rd East, 2nd Floor
	 	Ottawa,
    ON, K1V 1C1
	 	 
	 	Telephone
    613-749-4200 x 142
	 	Email:
    mnossov@vbivaccines.com

 

For
all other communications:

 

	 	VBI
    Vaccines, Inc.
	 	Attn:
    Adam Buckley
	 	222
    Third Street, Suite 2241
	 	Cambridge,
    MA 02142
	 	 
	 	Telephone
    617-830-3031 x122
	 	Email:
    abuckley@vbivaccines.com

 

16.2Applicable
Law. This Agreement shall be construed, interpreted and enforced in accordance with the internal substantive laws of the State
of Delaware, without giving effect to its conflicts of laws provisions. With the exception of disputes submitted to arbitration
under Article 13, all suits, disputes, actions, and other legal proceedings (collectively, “Suits”) related
to or arising out of this Agreement, shall be brought in the Federal District Court in the District of Maryland, which shall have
the exclusive jurisdiction over such Suits, and to the personal jurisdiction of which Client and Paragon irrevocably submit.

 

    
	 	Page 36 of 43	 

     

    

 

16.3Headings.
All headings in this Agreement are for convenience of reference only and shall not affect the interpretation of this Agreement.

 

16.4Exhibits.
All exhibits referred to herein form an integral part of this Agreement and are incorporated into this Agreement by such reference.

 

16.5Security
Procedures. All Client personnel visiting or having access to the Paragon Facility agree to abide by Paragon policies, operating
procedures and security procedures as established by Paragon and communicated to Client or to such personnel. Client shall be
liable for any breaches of security by Client personnel.

 

16.6Assignment.
This Agreement shall be binding upon the successors and assigns of the Parties and the name of a Party appearing herein shall
be deemed to include the names of its successors and assigns. Neither Party may assign its interest under this Agreement without
the prior written consent of the other Party, such consent not to be unreasonably withheld; provided, however, either
Party may assign its interest under this Agreement to an Affiliate, without the prior written consent of the other Party, and
Client may assign its interest under this Agreement to a successor in interest to of all or substantially all of the business
or assets of Client to which the Product pertains. Any permitted assignment of this Agreement by either Party will be conditioned
upon that Party’s permitted assignee agreeing in writing to comply with all the terms and conditions contained in this Agreement.
Any purported assignment without a required consent shall be void. No assignment shall relieve any Party of responsibility for
the performance of any obligation that accrued prior to the effective date of such assignment.

 

16.7Severability.
If any part of this Agreement shall be found to be invalid or unenforceable under applicable law in any jurisdiction, such part
shall be ineffective only to the extent of such invalidity or unenforceability in such jurisdiction, without in any way affecting
the remaining parts of this Agreement in that jurisdiction or the validity or enforceability of the Agreement as a whole in any
other jurisdiction. In addition, the part that is ineffective shall be reformed in a mutually agreeable manner so as to as nearly
approximate the intent of the Parties as possible.

 

16.8Independent
Contractors. Each of the Parties is an independent contractor and nothing herein contained shall be deemed to constitute the
relationship of partners, joint venturers, nor of principal and agent between the Parties. 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.

 

16.9Waiver.
No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall
be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term,
provision or condition of this Agreement.

 

    
	 	Page 37 of 43	 

     

    

 

16.10Counterparts.
This Agreement and any amendment hereto may be executed in any number of counterparts, each of which shall for all purposes be
deemed an original and all of which shall constitute the same instrument. This Agreement shall be effective upon full execution
and delivery by facsimile, PDF, or original, and a facsimile or PDF signature document shall be deemed to be and shall be as effective
as an original signature document.

 

16.11No
Solicitation of Employees. Paragon and Client each agree not to solicit for employment, directly or indirectly, any officer
or employee of the other Party or its Affiliates, provided that: (a) this shall not preclude a Party from hiring any such officer
or employee of the other Party who had been terminated prior to commencement of such employment discussions and (b) nothing herein
shall restrict either Party from soliciting any such officer or employee by general employment advertising (so long as such advertising
is not specifically targeted at the employees of the other Party) or third party employment agencies (so long as such agencies
are not directed, either directly or indirectly, to target such employees).

 

16.12Entirety;
Amendments. This Agreement, together with the Confidentiality Agreement, including any exhibits attached hereto and referenced
herein, constitute the full understanding of the Parties and a complete and exclusive statement of the terms of their agreement
with respect to the specific subject matter hereof, and no terms, conditions, understandings or agreements purporting to modify
or vary the terms thereof shall be binding unless hereafter made in a written instrument referencing amendment of this Agreement
and signed by each of the Parties.

 

16.13Preference.
The terms of this Agreement shall prevail in the event of a conflict between this Agreement and any exhibits or appendices.

 

IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Effective Date.

 

	 	VARIATION
    BIOTECHNOLOGIES, INC.
	 	 
	 	By:	/s/
    J. Baxter
	 	Name:	 
	 	Title:	CEO
	 	Date:	10-9-14
	 	 
	 	PARAGON
    BIOSERVICES, INC.
	 	 
	 	By:	/s/
    Marco A. Chacon
	 	Name:	Marco
    A. Chacon, Ph.D.
	 	Title:	President
    & CEO
	 	Date:	09-26-14

 

	Attachments:	Exhibit
    A - SOW/Project Plan/Project Rate Sheet for each Project
	 	Exhibit
    B - Quality Agreement

 

    
	 	Page 38 of 43	 

     

    

 

Form
of Exhibit A

 

[An
SOW in this general form shall be attached for each Project, numbered A-1, A-2, etc. and with the Proposal appended as Schedule
1. Once completed and mutually agreed to, the Project Plan shall be appended as Schedule 2. If appropriate for the Project, Schedule
3 may list the Drug Substance(s) and/or Product(s)]

 

-------------------------

 

Exhibit
A-__<INSERT NUMBER -1, -2, etc.>

Statement
of Work (SOW) for New Project (#                      
)

 

Project #                       
dated                       

(“<TITLE>”)
(“Project”).

 

Project
Letter of Intent (LOI) date [IF APPLICABLE]:

 

Effective
Date:                       

 

In
accordance with that certain Manufacturing and Process Development Services Agreement executed by                    
(“Client”), and Paragon Bioservices, Inc. (“Paragon”) dated                        (the “Agreement”), Client and Paragon agree to add a new Project to the Agreement, as follows:

 

1.
Services. Paragon will perform the services described in the attached Schedule 1 to this Exhibit (“Proposal”)
in accordance with the terms and conditions of the Agreement and this SOW. Following execution of this SOW and as part of the
services, Paragon, working together with Client, will prepare the Project Plan, which shall become Schedule 2 to this SOW upon
completion and signature by both parties.

 

2.
Project Managers. As of the date of this SOW, the Project managers shall be:

For
Client:                       

For
Paragon: 

 

3.
Compensation. In support of the services, Client shall provide to Paragon the fees set forth in Schedule 1 (“Fees”)
according to the Payment Schedule set forth below. The non-refundable capacity reservation fee of $                     (the “Reservation
Fee”) shall be due upon execution of this SOW.><was paid upon execution of the LOI.>

 

(a)
Paragon shall invoice Client and Client shall make payments upon completion of milestones as follows: [THIS IS A SAMPLE SCHEDULE.
EACH PROJECT SCHEDULE MAY DIFFER.]

 

	$                      
    	Payment
    1 	Due
    upon execution of <LOI><SOW> (Reservation Fee)
	$                      
    	Payment
    2	Due
    upon approval of Project Plan
	$                      
    	Payment
    3	Due
    upon approval of GMP Suite Activation
	$                      
    	Payment
    4	Due
    upon completion of completion of Engineering Run
	 	 	(if
    Engineering Run is performed)
	Balance	Payment
    5	Due
    upon release of bulk drug substance

 

    
	 	Page 39 of 43	 

     

    

 

(b)
Paragon shall invoice Client monthly for the Acquisition Cost for any materials (including the Raw Materials, Resins, Consumables,
and Designated Equipment) or outsourced services procured for use in or for the activities pursuant to this SOW. Payment shall
be due and payable within thirty (30) days following the date of the invoice sent by Paragon to Client.

 

(c)
Payments should be sent to:

Paragon
Bioservices, Inc.

PO
Box 62204

Baltimore,
MD 21264-2204

 

(d)
Project Rate: $            /hour

 

4.
Definitions. Terms used in this SOW shall have the definitions set forth in the Agreement or in this SOW, as applicable.

 

5.
Terms and Conditions. The terms and conditions of the Agreement (together with any mutually executed amendments or addenda
thereto) shall govern and control the performance of the services in all respects.

 

 

	VARIATION
    BIOTECHNOLOGIES, INC. 	 	PARAGON
    BIOSERVICES, INC. 
	 	 	 
	By:	 	 	By:	/s/
    Marco A. Chacon
	Title:	 	 	 	Marco
    A. Chacon
	Date:	 	 	Title:	President
    & CEO
	 	 	 	Date:
    	09-26-14

 

 

	Attachments:	Schedule
    1 (Proposal for Project
    #                   
    dated                    
	 	(“<TITLE>“)
	 	 
	 	Schedule
    2 (upon completion and signature by both parties, the Project Plan shall become Schedule 2 to this SOW)
	 	 
	 	Schedule
    (Drug Substance(s) and/or Product(s) [USE IF APPROPRIATE FOR MULTI-PRODUCT PROJECTS]

 

-----------------------

 

Schedule
3 to SOW for Project #       

(Drug
Substance(s) and/or Product(s)

[USE
IF APPROPRIATE FOR MULTI-PRODUCT PROJECTS]

 

    
	 	Page 40 of 43	 

     

    

 

Exhibit
A-1

Statement
of Work (SOW) for New Project (#2013-329R4)

 

Project
#2013-329R4 dated March 19, 2014

 

(“Process
Development and GMP Production of Enveloped Virus-Like Particles in HEK293 Cells”) (“Project”).

 

Project
Letter of Intent (LOI) date: March 27, 2014

 

Effective
Date:                     , 2014

 

In
accordance with that certain Manufacturing and Process Development Services Agreement executed by Variation Biotechnologies
(US), Inc. (“Client”), and Paragon Bioservices, Inc. (“Paragon”) dated                    ,
2014 (the “Agreement”), Client and Paragon agree to add a new Project to the Agreement, as follows:

 

1.
Services. Paragon will perform the services described in the attached Schedule 1 to this Exhibit (“Proposal”)
in accordance with the terms and conditions of the Agreement and this SOW. Following execution of this SOW and as part of the
services, Paragon, working together with Client, will prepare the Project Plan, which shall become Schedule 2 to this SOW upon
completion and signature by both parties.

 

2.
Project Managers. As of the date of this SOW, the Project managers shall be:

 

	 	For
    Client:	Misha
    Nossov (mnossov@vbivaccines.com)
	 	For
    Paragon: 	Kristen
    Franklin (kfrankin@paragonbioservices.com)

 

3. Compensation.
In support of the services, Client shall provide to Paragon the fees set forth in Schedule 1 (“Fees”) according
to the Payment Schedule set forth below. The non-refundable capacity reservation fee of $180,000.00 (the
“Reservation Fee”) shall be due upon execution of the Agreement.

 

(a)
Paragon shall invoice Client and Client shall make payments for the stages set forth in the Timing and Pricing Summary section
of the Proposal (page 19) as follows:

 

At
the initiation of each stage, 50% of the cost for that stage is to be invoiced and paid up front, including the project management
and administration costs. Each stage will be initiated by provision of a draft invoice related to the stage or stages in question
and start will be subject to the written confirmation by email from Client’s VP Operations. At the completion of each stage,
as defined by the shipment of deliverables to Client, the remaining balance for that stage is invoiced and due.

 

(b)
Paragon shall invoice Client monthly for the Acquisition Cost for any materials (including the Raw Materials, Resins, Consumables,
and Designated Equipment) or outsourced services procured for use in or for the activities pursuant to this SOW. Payment shall
be due and payable within thirty (30) days following the date of the invoice sent by Paragon to Client.

 

(c)
Payments should be sent to:

Paragon
Bioservices, Inc.

PO
Box 62204

Baltimore,
MD 21264-2204

 

    
	 	Page 41 of 43	 

     

    

 

(d)
Project Rate: $250.00/hour

 

4.
Definitions. Terms used in this SOW shall have the definitions set forth in the Agreement or in this SOW, as applicable.

 

5.
Terms and Conditions. The terms and conditions of the Agreement (together with any mutually executed amendments or addenda
thereto) shall govern and control the performance of the services in all respects.

 

	VARIATION
BIOTECHNOLOGIES, INC.
	 	PARAGON
BIOSERVICES, INC.

	 	 	 
	By:	/s/
    J. Baxter	 	By:	/s/
    Marco A. Chacon
	Title:	CEO	 	 	Marco
    A. Chacon
	Date:	10-9-2014	 	Title:	President
    & CEO
	 	 	Date:	09-26-14

 

	Attachments:	Schedule
    1 (Proposal for “Project #2013-329R4 dated March 19, 2014; “Process Development and GMP Production of Enveloped
    Virus-Like Particles in HEK293 Cells”) 
	 	 
	 	Schedule
    2 (upon completion and signature by both parties, the Project Plan shall become Schedule 2 to this SOW)

 

    
	 	Page 42 of 43	 

     

    

 

Exhibit
B

 

Quality
Agreement

 

    
	 	Page 43 of 43Exhibit 10.45 

 

Confidential

 

LICENSE
AGREEMENT

Ref.
– DGRTT-SAIC: L 06005

 

BETWEEN:

 

L’UNIVERSITÉ
PIERRE ET MARIE CURIE, PARIS 6,

Scientific,
cultural and professional public establishment, 19751722000012 – code APE: 8542Z, with its main office located at 4 place
Jussieu 75252 Paris cedex 05, represented by its President, Mr. Jean-Charles POMEROL.

 

Hereafter
“UPMC”

AND

 

L’institut
National de la Santé et de la Recherche Médicale

Scientific
and Technological Public establishment with its main office located at 101 rue de Tolbiac – 75654 Paris Cedex 13, represented
by its CEO, Mr. BRECHOT,

 

Hereafter
“INSERM”

 

AND

 

L’école
Normale Supérieure de Lyon, with its main office located at 46 Allée d’Italie – 69364 LYON CEDEX 07,
represented by its Director, Mr. Phillippe GILLET.

 

Hereafter
“ENS Lyon”

 

ON
THE ONE HAND,

AND:

 

The
Company EPIXIS S.A., with a capital of 37,000 Euros, registered at the Register of Commerce and Companies of Paris under the number
B 449 397 793, located at 16-18 rue de la Glacière -75013 PARIS, represented by Mrs. Charlotte DALBA as CEO.

Hereafter
“EPIXIS”

 

ON
THE OTHER HAND,

 

Hereafter,
collectively or individually, “Parties”

 

 

    	 

    	 	 	 

    

 

Whereas:

 

UPMC
holds the rights on a patent portfolio from the work of Professor David Klatzmann, and developed in part inside Laboratory UMR
7087, as listed in Appendix 1.

 

UMR
7087 or the Biology and Therapeutics of Immune Pathologies Laboratory comes under the supervision of the UPMC and the CNRS. The
UPMC and the CNRS have agreed that the license agreement negotiated by UPMC with the Company EPIXIS would only be signed by UPMC.

 

UPMC
received the agreement and mandate from the University Paris Nord – Paris XII April 25th 1997 and February 18th
2004 to become owner of the share of industrial property rights regarding the patent category FR 9604370 of April 5th
1996 (UPMC reference V 96 072) and EP 00 402978 of October 26th 2000 (UPMC reference W20022) from the University
Paris Nord – Paris XIII under the title of inventor for M. Jean-loup Sakzmann and to conduct operations pertaining to the
enhancement of the patent category stated hereafter and to sign this license agreement with EPIXIS.

 

The
invention protected by the patent category, based on the European priority request No. 00402978 of October 26th 2000,
is the result of a scientific collaboration between Professor David Klatzmann from Laboratory UMR 7087 and Mr. François-Loic
Cosset from Laboratory U 758 (former U412), and under the supervision of INSERM and ENS Lyon. Therefore, in line with their cooperation
agreement signed May 5th 2000, UPMC and INSERM shall co-sign the license agreement for this patent category.

 

In
line with their agreement signed November 21st 2001, ENS Lyon and INSERM shall co-sign the license agreement negotiated
by UPMC with the Company EPIXIS.

 

The
purpose of EPIXIS, a biotechnology company created July 23th 2003, is to develop a technological platform in the field of genetic
vaccination, and plans the study and the research of all processes or diagnostic products, preventive and therapeutic genetic
vaccines for medical or veterinary use, as well as the study and research of related reagents, hoping to obtain a license of the
aforesaid patents for their development.

 

UPMC,
INSERM and ENS Lyon are willing to propose such a license, and the purpose of this Agreement is to define the terms and conditions
of this license.

 

THEREFORE,
IT HAS BEEN AGREED AS FOLLOWS

 

ARTICLE
1 – DEFINITIONS

 

Throughout
this contract and unless any other meaning is clearly stated, the terms specified below shall have the following meanings:

 

    	 

    	 	 	 

    

 

“Agreement”
means:

 

The
body of this contract, as well as any appendices pertaining thereto.

 

“Patent(s)”
means:

 

-
The patent category outlined in Appendix 1 based on priority patent application FR 9604370 dated April 5, 1996 (reference no.
UPMC V 96 072), entitled “Defective viral vaccine particles obtained in vivo or ex vivo,” as well as any French or
foreign patent application or patent lodged or granted on the basis of that priority application, any extension, partial extension,
addition, division, and any issued patents or any equivalent title stemming therefrom, notably any Supplementary Protection Certificate
(SPC) or any patent that is relodged, reissued, or reexamined on the basis of this patent application or these issued patents.

 

-
The patent category outlined in Appendix 1 based on priority patent application EP 00 402978 dated October 26, 2000 (reference
no. UPMC W20022), entitled ““Synthetic viruses and uses thereof,” as well as any French or foreign patent application
or patent lodged or granted on the basis of that priority application, any extension, partial extension, addition, division, and
any issued patents or any equivalent title stemming therefrom, notably any Supplementary Protection Certificate (SPC) or any patent
that is relodged, reissued, or reexamined on the basis of this patent application or these issued patents.

 

Each
of the two aforementioned patent categories shall hereinafter be individually referred to as a “Patent Category.”

 

“Area”
means:

 

Genetic
vaccination for preventative or therapeutic use against microbial pathologies or cancers in humans and animals.

 

“Establishment(s)”
means:

 

Collectively,
UPMC, Université Paris Nord – Paris 13, ENS Lyon, and INSERM.

 

“Subsidiary”
of EPIXIS means:

 

Any
trading company, consisting of capital or persons, operating under French or foreign law by means of equity participation or any
other means but with at least 50% of voting power or the power to determine the company’s affairs held by EPIXIS, is controlled
by EPIXIS or placed under the same control as EPIXIS.

 

Control
is understood as the direct or indirect holding of more than 50% of the share capital of a legal entity or of more than 50% of
the voting power of this legal entity’s shareholders or associates or as the direct or indirect holding of the power to
make decisions within the legal entity.

 

    	 

    	 	 	 

    

 

The
rights granted to the Subsidiaries in accordance with the terms of the Agreement are only applicable for legal entities acting
as Subsidiaries when said rights are being exercised. If, for the duration of the Agreement, a legal entity should no longer be
deemed a Subsidiary, then the rights that have been acquired by this legal entity as a Subsidiary shall immediately cease without
the need for written consent from UPMC.

 

“Product(s)”
means:

 

All
products, compositions, processes, and/or services, including the production, implementation, completion, obtaining, holding,
use, offer, and/or sale thereof shall, in the absence of a license, constitute an infringement upon any Patent claim that has
not been terminated or otherwise invalidated by a final decision.

 

“Territory”
means:

 

The
United States of America, Japan, Canada, and Europe, it being understood that the European portion of the Territory comprises
Germany, France, Italy, Spain, Great Britain, and other states designated in European application no. EP 01 988766.0 dated October
25, 2001, namely Belgium, Austria, Switzerland, Liechtenstein, Denmark, Finland, Greece, Ireland, Luxembourg, Monaco, the Netherlands,
Portugal, Sweden, Cyprus, and Turkey.

 

“Development
Projects” means:

 

All
projects and research that are directly or indirectly undertaken by EPIXIS or on behalf of EPIXIS in accordance with the technical
and commercial development plan drawn up by EPIXIS as set forth in article 3 of the Agreement, including the projects and research
that are required for the development and marketing of the Products.

 

“Net
Sales” means:

 

The
amount of sales, exclusive of tax, of a particular Product in all forms, including services billed to a third party in a particular
country by EPIXIS or its Subsidiaries after the following items are deduction, it being understood that the total amount of these
deductions may not, under any circumstances, exceed 5% of the invoiced amounts:

 

	-	 miscellaneous
    discounts, kickbacks, and growth rebates actually granted and deducted in terms of percentages in accordance with accepted
    professional standards,
	 	 
	-	credits
    allocated for Products that have been returned or refused by clients within the relevant acceptable time frames,
	 	 
	-	transport,
    packaging, and insurance costs associated with transport,
	 	 
	-	other
    withheld taxes
	 	 
	-	billed
    customs duties.

 

    	 

    	 	 	 

    

 

Net
Sales do not include pass-through sales of Products between EPIXIS and its Subsidiaries or between its Subsidiaries. Only the
final amount billed by EPIXIS and its Subsidiaries shall be taken into account in the calculation of Net Sales, completed in accordance
with the aforementioned provisions.

 

ARTICLE
2 – NATURE, PURPOSE, AND SCOPE OF THE LICENSE

 

	2.1.
    	The
    Establishments hereby agree, subject to the provisos and conditions stipulated herein, to grant EPIXIS, which agrees, an exclusive
    license for the use of the Patents within the Area with a view to develop, promote, use, manufacture, arrange for the manufacture
    of, implement, arrange for the implementation of, distribute, market, or arrange for the marketing of the Products within
    the Territory for the duration of the Agreement.
	 	 
	2.2
    	EPIXIS
    acknowledges that it has had access, at the latest on the date when this document entered into force, to all necessary information
    from UPMC and/or its patent agent(s) assigned for the management of the Patents that has enabled EPIXIS to fully assess the
    content and scope of the Patents, as well as the licensing rights that are being granted to EPIXIS in accordance with the
    terms of this document.
	 	 
	2.3
    	The
    license, as defined in article 2.1. above, shall entitle EPIXIS to grant sublicenses to any unaffiliated third parties of
    its choice, subject to the following provisos:
	(i)
    	written
    consent must first be issued by UPMC authorizing the sublicensee and the terms of the sublicense and any amendment, it being
    understood that UPMC cannot refuse its consent without providing a valid reason in light of the interests of the Establishments;
    UPMC shall then notify EPIXIS of its consent or refusal within a period of 45 (forty-five) days from the date when EPIXIS
    received the correspondence containing the draft sublicense agreement. If UPMC fails to provide a reason for refusal within
    the specified time period, UPMC’s consent shall be considered to have been obtained;
	 	 
	(ii)	a
    copy of each sublicense contract and each amendment should be issued to UPMC no later than thirty (30) days after its establishment.
    UPMC shall also consider information from the other Establishments regarding any sublicense established by EPIXIS as soon
    as possible.
	 	
	 	EPIXIS’s
    sublicensees are not entitled to award sublicenses in turn.
	 	 
	 	EPIXIS
    shall remain solely responsible for the proper fulfillment of the sublicenses and shall be solely responsible to the Establishments
    with regard to the fulfillment, by the sublicensees, of all obligations imposed on EPIXIS in accordance with the terms of
    the Agreement. EPIXIS shall notably agree to include confidentiality and accounting clauses and guarantees in its sublicense
    contracts that are at least equivalent to those specified in this document.

 

    	 

    	 	 	 

    

 

	 	2.4
    The Parties hereby agree that EPIXIS shall be authorized to extend the enjoyment of rights, except for the right to grant
    sublicenses, that are granted in the Agreement to future Subsidiaries, subject to the following provisos:
	 	 
	 	-
    EPIXIS shall continue to assume sole responsibility for the fulfillment of obligations imposed on EPIXIS by this Agreement,
    as far as it and its Subsidiaries are concerned, and
	 	 
	 	-
    EPIXIS has notified UPMC, by registered letter with acknowledgment of receipt, of the identity of the Subsidiary in question
    before extending the enjoyment of the license to include any of its Subsidiaries.
	 	 
	2.5
    	For
    the entire duration of the Agreement, the Establishments shall retain the right to use the Patents for their requirements
    for research undertaken by the Establishments alone or in collaboration with third parties and for their teaching needs; the
    Establishments shall also retain the right to grant Patent licenses, under the conditions stipulated in articles 3.3 and 5.2
    of this Agreement, and to grant licenses to any third parties of their choice outside of the Area.

 

ARTICLE
3 – USAGE OBLIGATION - DEVELOPMENT – MARKETING

 

	3.1.
    	EPIXIS
    acknowledges, by the terms of the Agreement, that it has the competencies required for the use of the Patents and for the
    development, use, production, and marketing of the Products. EPIXIS agrees to exercise due diligence and to spare no effort
    when undertaking, directly or indirectly, the Development Projects and to use the Patents effectively, seriously, loyally,
    and on an going basis, notably obtaining the required administrative authorizations, and to market the Products while ensuring
    the use of appropriate sales promotion techniques.
	 	 
	 	EPIXIS
    has provided UPMC with a technical and commercial development plan (hereinafter referred to as the “Development Plan”),
    which is enclosed in Appendix No. 2 of the Agreement, being an integral part thereof. The objective of the Development Plan
    is to stipulate the conditions whereby EPIXIS intends to undertake the Development Projects, set up each Patent Category,
    and implement the expected timetable for the completion of said Development Projects and the marketing of the Products.
	 	 
	3.2
    	EPIXIS
    agrees to keep UPMC regularly informed of progress with regard to the development of the Products. To this end, at the end
    of each year of the contract, EPIXIS shall provide UPMC (DRITT-Management Department for Technological Transfers and Industrial
    Relations) with a written report that illustrates the progress made in the areas of research and development, the set-up of
    Patent Categories, and, if necessary, preclinical and clinical studies were conducted during the year in question, as well
    as any application files concerning Product sales and marketing authorizations that were drawn up during the year in question;
    EPIXIS shall also update the Development Plan. Furthermore, EPIXIS agrees to readily inform UPMC in writing of any expected
    event or event that has taken place that would be likely to substantially delay or compromise the aforementioned prospects;
    EPIXIS shall, furthermore, provide detailed explanations regarding measures that it intends to adopt in order to rectify the
    situation and ensure the initial prospects.
	 	 
	 	UPMC
    shall notify the other Establishments as soon as possible.
	 	 

    	 

    	 	 	 

    

 

	3.3
    	If
    EPIXIS does not complete, either directly or indirectly, the various phases of the Development Projects within a reasonable
    period of time after the signing of the Agreement with respect to the Development Plan and to the time frames required within
    the relevant professional sector, then the Parties shall consult with each other in order to assess the reasons for the delay
    in the development of the Product(s) and to determine, if necessary, any follow-up action to be taken with regard to the relations
    established in accordance with the terms of this document.
	 	 
	 	The
    Parties hereby agree that the conditions of this license may be revised by UPMC if it is found that EPIXIS has not demonstrated
    reasonable effort to complete the development phases, and, in particular, UPMC, acting on behalf of the Establishments, may
    terminate all or part of the license under the conditions specified in article 11 or convert the nature of this license, as
    defined in article 2.1 above, from an exclusive to a non-exclusive license. Any changes to the Agreement made by virtue of
    this article 3.3 shall be covered by an amendment signed by the Parties.
	 	 
	3.4.
    	EPIXIS
    and its sublicensees agree to comply with legislation and regulations in force in France and abroad for the undertaking of
    the Development Projects and the use of the Products and to spare no effort in obtaining the authorizations required by the
    applicable laws and regulations of the countries where EPIXIS and/or its sublicensees intend to market the Product(s).
	 	 
	 	EPIXIS
    shall be responsible for obtaining and keeping up to date, in its own name and at its own expense, or in the name of anyone
    that EPIXIS should designate, the registrations and marketing authorizations required for the Product(s) within the Territory
    by the local legislation applicable within the countries covered by the Territory.
	 	 
	3.5.
    	Within
    the context of the clinical studies that shall be implemented by or at the behest of EPIXIS, EPIXIS agrees to fulfill all
    obligations required by the laws and regulations in force in the relevant countries and, for studies conducted in France,
    to fulfill the obligations set forth in the law on the protection of people who participate in biomedical research that was
    passed on December 20, 1988 and later modified. EPIXIS shall protect UPMC, INSERM, ENS-Lyon, and Université Paris XIII
    from any accusations or any legal action that may be initiated by third parties in relation to the clinical studies.
	 	 
	 	These
    paragraphs 3.4 and 3.5 shall remain applicable notwithstanding the cancellation or termination of this Agreement.

 

    	 

    	 	 	 

    

 

	3.6.	EPIXIS
    shall be free to pursue its own policies regarding the promotion, production, and distribution of the Product(s) as long as
    the prior consent of UPMC, INSERM, ENS-Lyon, and Université Paris XIII is obtained for any use of their names in accordance
    with the provisions of article 9.

 

ARTICLE
4 – FINANCIAL CONDITIONS

 

	4.1	In
    exchange for the licensing rights granted by virtue of the Agreement, EPIXIS agrees:
	 	 
	 	-
    to provide the funding needed for the proper undertaking of the Development Projects, it being understood that it shall be
    the responsibility of EPIXIS to define the means to be allocated for this purpose;
	 	 
	 	-
    to pay UPMC any sublicensing fees and income derived from the use of the Products within the Area;
	 	 
	 	-
    to pay lump-sum amounts related to the undertaking of certain stages in the development of the Products;
	 	 
	 	-
    to be responsible for industrial property fees related to the Patents in accordance with the provisions of articles 4.8 and
    5 of this agreement.
	 	 
	4.2
    Fees
	 	 
	4.2.1
    	In
    the event of use by EPIXIS or by its Subsidiaries, EPIXIS agrees to pay UPMC a fee based on Net Sales based on the following
    calculation:
	 	 
	●	2.50
    % of the annual Net Sales amount if it falls between zero and fifty million (50,000,000) Euros;
	 	 
	●	2.75
    % of the annual Net Sales amount if it falls between fifty million and one (50,000,001) Euros and one hundred million (100,000,000)
    Euros;
	 	 
	●	3.0
    % of the annual Net Sales amount if it exceeds one hundred million (100,000,000) Euros.
	 	 
	 	Fees
    shall be due for each Product and each Country within the Territory starting from the date when the Agreement enters into
    force and as long as the Product is covered by at least one Patent claim within the relevant country.

 

    	 

    	 	 	 

    

 

	4.2.2
    	Minimum
    fees: As soon as a Product begins to be marketed by EPIXIS or by its Subsidiaries, EPIXIS agrees to pay UPMC minimum annual
    fees for each of the Products that have been developed; the amount of these fees, exclusive of taxes, shall be negotiated
    by the Parties before the aforementioned date, and EPIXIS must notify UPMC, by registered letter with acknowledgment of receipt
    six (6) months in advance, of the date when each Product shall first be marketed. The Parties’ intent is that these
    minimum annual fees should provide UPMC with ongoing assurance of the due diligence demonstrated by EPIXIS regarding the use
    of each Product, and the size of the market and the competition shall be taken into account during negotiations; the conditions
    must reflect typical conditions in comparable cases within the relevant industrial sector.

 

	4.3	Sublicensing
    income
	 	 
	 	In
    the event of indirect use through the granting of rights to use the Patents to third parties, such as through sublicense contracts
    or sublicensing options for the Patents in accordance with the provisions of article 2.3 of this Agreement, EPIXIS agrees
    to pay UPMC a percentage of all amounts: lump-sum amounts, guaranteed minimums, upfront and success fees, market values (in
    the event of licensing between competitors or exchanges), fees, annual payments...levied on third-party sublicensees.

 

The
following rates shall be applied:

 

-
thirty percent (30%) of said amounts if the sublicense or sublicensing option is signed with the third party before the start
of phase I;

 

-
eighteen percent (18%) if the sublicense or sublicensing option is signed with the third party before the start of phase II;

 

-
fifteen percent (15%) if the sublicense or sublicensing option is signed with the third party before the start of phase III, and

 

-
ten percent (10%) if the sublicense or sublicensing option is signed with the third party after the start of phase III.

 

For
any sublicensing option signed with a third party, EPIXIS agrees to inform UPMC of this in writing and to send UPMC a copy of
the sublicensing option agreement no later than 30 days after it is established and agrees to pay the percentage owed to UPMC
by the earlier of the following deadlines: (i) the deadline for the option or (ii) the deadline for the third party to exercise
the option. It is the responsibility of EPIXIS to inform UPMC of this in writing.

 

The
licensing option or sublicensing income shall be payable to UPMC for each sublicense contract or sublicensing option, each Product,
and each of the countries within the Territory starting on the date when this contract enters into force and throughout the entire
duration of the Agreement.

 

In
the event that said sublicense is granted in exchange for equity participation in the capital of EPIXIS, UPMC and EPIXIS shall
consult with each other as soon as possible in order to determine fair compensation for the Establishments.

 

Under
no circumstances shall the amounts collected by EPIXIS in exchange for research and development collaborations with third parties
be considered as sublicensing income. Similarly, the Parties have agreed that the amounts paid to EPIXIS by a sublicensee with
the sole objective of funding the development of a Product by EPIXIS shall not result in compensation given to UPMC as specified
in this article 4.3. These exclusions suggest that the contractual document that sets forth the debt shall sufficiently individualize
the payment and characterize its cause by detaching it from any license or sublicense contract or from any licensing or sublicensing
option. In the event of any doubt regarding the cause of the debt, the corresponding amount shall remain part of the basis for
charges.

 

    	 

    	 	 	 

    

 

	4.4	Adjustment
	 	 
	4.4.1
    	If
    EPIXIS must, in order to avoid a situation of infringement, obtain one or more licenses for one or more patented third-party
    technologies required for the use of the Patent(s) licensed by the Establishments, EPIXIS shall be entitled, after having
    obtained the relevant usage license(s) from the third party or third parties and after consent is granted by UPMC, to deduct
    half the fee(s) payable to this (these) third party (third parties) from the fee stipulated in article 4.2.1 above.
	 	 
	 	For
    the application of the reduction specified in this article, UPMC, based on all items issued by EPIXIS, shall specify whether
    it considers that said license has been contractually established in a reasonable manner. In the event of a refusal, UPMC
    shall support its decision by presenting the opinion of a patent attorney.
	 	 
	4.4.2	If
    a Product is being marketed by EPIXIS or by its Subsidiaries as part of a combination incorporating one or more additional
    active substances that are not associated with the Patents but are covered by third-party patents, UPMC and EPIXIS shall then
    hold negotiations in good faith, after EPIXIS or its Subsidiaries have obtained one or more relevant licenses to use the patents
    held by said third party (third parties), to determine to what extent the Product should actually be reflected in the sale
    price. As needed, these negotiations may be held with the relevant third parties. In this event, the Net Sales may, for instance,
    be calculated y multiplying the Net Sales by the fraction A/(A+B) where A represents the market price of the compound(s) covered
    by the Patent(s) and B represents the additional active substances that are not associated with said Patent(s).
	 	 
	 	It
    is understood that this paragraph 4.4.2 may only be applied if the third parties that own the rights to the patented additional
    active substances are also subjected to a rule of calculation that is negotiated with EPIXIS in order to determine to what
    extent their products should actually be reflected in the sale price in such a way that is not discriminatory for UPMC.
	 	 
	4.4.3
    	For
    the application of the reduction set forth in articles 4.4.1 and 4.4.2 above, EPIXIS or its Subsidiaries agree first to send
    UPMC, on a confidential basis, a copy of the contract(s) that EPIXIS has signed with said third party (third parties).
	 	 
	 	Furthermore,
    any deduction accepted by UPMC by virtue of articles 4.4.1 and 4.4.2 shall be determined on a country-by-country and a Product-by-Product
    basis.
	 	 
	 	Any
    reduction, as set forth in articles 4.4.1 and/or 4.4.2 of the Agreement, may be applied only after the Parties have issued
    their agreement in writing.

 

    	 

    	 	 	 

    

 

	4.4.4
    	It
    is understood that the maximum reduction that may be applied to the fee defined in article 4.2.1 above resulting from (i)
    the reduction, set forth in article 4.4.1 of the Agreement that is, granted by UPMC regardless of any dependency or dependencies
    on one or more third parties and/or (ii) the adjustment set forth in article 4.4.2 of the Agreement may not exceed fifty percent
    (50%) of the amount payable to UPMC by virtue of article 4.2.1 above.
	 	 
	4.5
    	EPIXIS
    shall be solely responsible for the payment of fees and other income of any type payable to UPMC by virtue of the Agreement.

 

	4.7	Lump-sum
    amounts

 

The
Parties have agreed that EPIXIS shall pay UPMC, for each Product developed by EPIXIS or by its Subsidiaries, the following non-refundable
amounts during the completion of the stages described below:

 

-
Twenty-five thousand (25,000) Euros, exclusive of tax: when the results from pre-clinical studies are sufficient to allow a Product
to enter the clinical phase, including phase I-II studies,

 

-
Seventy-five thousand (75,000) Euros, exclusive of tax: when a Product enters phase II, an event that is defined by the enrollment
of the first patient,

 

-
One hundred twenty-five thousand (125,000) Euros, exclusive of tax: when a Product enters phase III,

 

-
Two hundred fifty thousand (250,000) Euros, exclusive of tax: when a Product is first marketed.

 

If
any of the phases should overlap or be combined with another phase (as in the so-called “Fast Track” procedure), the
amounts due for both phases shall become payable at the conclusion of these combined phases.

 

The
aforementioned amounts shall be paid by EPIXIS no later than sixty (60) days after the event in question and for each Product
insofar as it leads to a specific clinical development; EPIXIS agrees to inform UPMC of this event by registered letter with acknowledgment
of receipt no later than fifteen (15) days after the event in question in order for a bill to be issued by UPMC.

 

	4.8	Industrial
    Property fees

 

EPIXIS
agrees to reimburse UPMC for all amounts incurred by UPMC on or after January 1, 2004 until the date when the Agreement was signed
for the lodging, extension, obtaining, examination, and maintenance in force of Patents in France and abroad, as well as the cost
of entering application US 10/415242 in the United States national phase. It is understood that this reimbursement may not be
deducted from the fees or any other amounts that are payable by EPIXIS and defined in articles 4.1 through 4.7 of the Agreement.

 

    	 

    	 	 	 

    

 

The
reimbursement shall be paid by EPIXIS as follows:

 

-
When the Agreement is signed, and in consideration of the initial estimate of industrial property fees enclosed in Appendix 3,
ten thousand (10,000) Euros, exclusive of tax, shall be paid by EPIXIS to UPMC when UPMC issues a bill to EPIXIS.

 

-
The remainder shall be paid by EPIXIS to UPMC by the earlier of the following deadlines: (I) the signing of the first license
or the exercise of the licensing option or (ii) when EPIXIS acquires cumulative funding of at least two hundred thousand (200,000)
Euros. It is the responsibility of EPIXIS to inform UPMC in advance of the earlier of these deadlines by registered letter with
acknowledgment of receipt. UPMC shall then issue EPIXIS an updated statement of fees and draw up a bill, addressed to EPIXIS,
for the balance due.

 

If
the Agreement is terminated or expires before the earlier of the two deadlines, EPIXIS agrees to issue the reimbursement defined
in the paragraph above no later than the date when the Agreement has been terminated or has expired.

 

	4.9	Net
    Sales Report and Payment

 

The
Net Sales report for any Product and/or all other amounts collected, detailed on a country-by-country and a Patent Category-by-Patent
Category basis, shall be issued on December 31 of each year, certified by the EPIXIS auditor, and issued to UPMC on March 1 of
the following year, even if there were no sales during the year in question. The same obligations shall apply to EPIXIS for Products
sold by an affiliated or unaffiliated sublicensee; the aforementioned transactions shall be detailed on a sublicensee-by-sublicensee
basis.

 

After
UPMC accepts this report, the amounts due for the year in question must be paid no later than thirty (30) days after the bill
issued by UPMC is received. Payments shall be made to the Accounting Officer with the following account:

 

RECETTE
GENERALE DES FINANCES DE PARIS

94
RUE REAUMUR

75002
PARIS

 

ACCOUNT
No. 10071 75000 00001005793 64

 

Legal
taxes, notably the VAT at the current rate, that are to be paid by EPIXIS shall be added to the amounts due.

 

If
any amount is not paid to UPMC by the aforementioned deadline, late interest charges shall be applied, calculated pro rata temporis
in accordance with the rules that apply to French public establishments (the Banque de France base lending rate for February 28
of the year in question plus two percent (2 %) without detriment of UPMC’s right to terminate the Agreement under the conditions
specified in this document).

 

    	 

    	 	 	 

    

 

For
the purposes of the Agreement, fees stemming from Net Sales and all amounts that are listed in currencies other than the Euro
must e converted at the exchange rate in effect on the second to last Wednesday of the month preceding the billing month, as indicated
by the Banque de France.

 

All
amounts collected by UPMC by virtue of the Agreement shall remain, in any event, permanently and irrevocably acquired and may,
under no circumstances, be returned to EPIXIS. Furthermore, the balance payable by EPIXIS on the date when the Agreement expires
or is terminated must be paid to UPMC.

 

UPMC
shall handle the redistribution to the other Establishments of some or all of the amounts collected within the context of the
Agreement.

 

	4.10	Auditing

 

EPIXIS
shall agree to keep specific accounts or arrange for the keeping of specific accounts for sublicensees with regard to the amounts
received for the sale of the Products; this process shall include all items needed for the precise assessment of sales transactions
that have taken place and for the monitoring of payments.

 

These
specific accounts shall be available to UPMC each year until the end of a five (5)-year period following the year in question.

 

When
requested by UPMC, but no more than once per calendar year, EPIXIS shall agree to authorize a certified public accountant (or
chartered accountant) selected by UPMC to inspect said accounts in order to verify the accuracy of the fee calculation. Said accountant’s
assignment shall concern, at most, the five (5) years prior to his or her assessment. This accountant’s fees and expenses
shall be paid solely by UPMC, unless an adjustment of more than five percent (5%) of the amounts actually paid by EPIXIS is made
following said assessment, in which case the accountant’s fees and expenses shall be payable by EPIXIS.

 

The
provisions of this article 4.10 shall remain in force for the entire duration of the Agreement and for a period of five (5) years
following the cancellation or termination of the Agreement.

 

ARTICLE
5 – MAINTENANCE IN FORCE – INDUSTRIAL PROPERTY - INFRINGEMENT

 

	5.1	EPIXIS
    agrees to be responsible for all intellectual property fees for the for the lodging, examination, obtaining, translation,
    extension, maintenance in force, and defense of Patents in front of a Patent Office in the countries within the Territory
    where the Patents have been lodged or issued for the entire duration of the Agreement upon the direct presentation of bills
    by the agent in charge of handling these operations. It is understood that these expenditures shall not be deductible from
    fees, other income, or any other amounts, including lump-sum amounts, as specified in article 4 of the Agreement.

 

    	 

    	 	 	 

    

 

	5.2
    	Subject
    to the payment of intellectual property fees by EPIXIS, as stipulated in article 5.1 above, UPMC agrees to continue handling
    the Patent file procedures, especially those pertaining to the lodging of Patents, the monitoring of examination and issue
    procedures, maintenance in force, and Patent defense procedures, concerning opposition or interference, in front of a Patent
    Office in cooperation with EPIXIS, for the entire duration of the Agreement. UPMC shall provide EPIXIS copies of the main
    pieces of correspondence exchanged with its agents, as well as those exchanged with the Patent Offices.

 

If
EPIXIS decides not to continue to pay said intellectual property fees for the aforementioned operations in a country within the
Territory, EPIXIS shall notify UPMC, in a motivated manner by registered letter with acknowledgment of receipt, of its intent:

 

-
at least three (3) months prior to the deadline for the next decision to be issued concerning the Patent,

 

-
or, at the latest, eight (8) business days following the disclosure of the next decision to be made when the Patent Office deadline
is less than three (3) months so that the UPMC may, if it so desires, continue the aforementioned operations at its own expense.
In this case, EPIXIS shall lose, as of the date when the UPMC receives the above- mentioned notification from EPIXIS, the licensing
rights that have been allocated to it by the terms of the Agreement pertaining to the Patent(s) in the relevant country, as well
as the exclusivity granted by the Agreement; moreover, UPMC shall be free to issue usage licenses to third parties.

 

If
EPIXIS fails to issue notification to UPMC under the conditions set forth in this article 5.2, the consent of EPIXIS shall be
considered to have been acquired for the commitment of all industrial property expenses, and EPIXIS agrees to pay bills pertaining
to Patent fees no later than thirty (30) days after the bills are issued.

 

If
EPIXIS, in consideration of the industrial and commercial use of the Products that it is planning or carrying out, would like
to extend the Patent protection period through the use of Supplementary Protection Certificates (SPCs) in one or more countries
where UPMC has lodged a Patent (please refer to Appendix I), EPIXIS shall notify UPMC of its intent by registered letter with
acknowledgment of receipt so that EPIXIS and UPMC may work together to assess the possibility of submitting one or more SPC applications
and to take the necessary steps as soon as possible, it being understood that all expenses pertaining to these operations shall
be payable solely by EPIXIS upon direct presentation of bills by the agent responsible for submitting these SPC applications.

 

    	 

    	 	 	 

    

 

	5.3	Infringement:
	 	 
	5.3.1	EPIXIS
    and its sublicensees shall act in the best interests of UPMC and the relevant inventors within the context of any legal action
    that should be deemed necessary in order to defend rights related to the Patent(s) and, in particular, if an infringement
    case should be initiated by EPIXIS and/or its sublicensees against an infringing third party or by a third party against EPIXIS
    and/or its sublicensees.
	 	 
	5.3.2	UPMC
    and EPIXIS shall inform each other as soon as possible of any act of Patent infringement by a third party that comes to their
    knowledge. The Parties shall consult with each other in order to define the best strategy to take and shall provide each other
    with any available materials that allow for an assessment of the nature and scope of the infringement.

 

If
a lawsuit is deemed necessary and effective, it shall be initiated by EPIXIS or its sublicensees, which may, after the issue of
a registered letter with acknowledgment of receipt to UPMC for information, may open, on its/their initiative alone, in its/their
name, and at its/their expense, an infringement case. If this lawsuit initiated by EPIXIS is declared inadmissible because it
lacks standing as a plaintiff to act or if it may reasonably be foreseen that an infringement case that EPIXIS plans to open by
virtue of this Article 5.3.2 shall be declared inadmissible on said grounds, UPMC shall provide, when a written request is issued
by EPIXIS in a timely manner, all powers that EPIXIS will need in order to act in the name and place of UPMC

 

EPIXIS
or its sublicensees shall keep all damages, fees, and costs that may be allocated to them resulting from lawsuits initiated against
an infringer or an imitator. However, it has been agreed that, after the deduction of all court costs, the damages that will be
allocated to EPIXIS and its sublicensees shall be incorporated into the Net Sales and all amounts and shall entitle UPMC to the
payment of fees and income in accordance with the provisions of article 4 above.

 

If
EPIXIS or its sublicensees decide not to submit an infringement case, they agree to inform UPMC in writing of this decision as
soon as possible, and the Establishments may decide to start legal proceedings in their own name and at their own expense; if
they decide to initiate such proceedings, EPIXIS shall agree to provide them with reasonable technical and legal assistance to
this end. The Establishments that initiate such legal action shall collect all damages that the courts may award to them.

 

The
Parties agree to provide each other with all documents and materials that they may need for the aforementioned proceedings.

 

	5.3.3
    	If
    an infringement case is initiated against EPIXIS or its sublicensees, EPIXIS or its sublicensees shall notify the Establishments
    of said case and may not ask the Establishments for any compensation for amounts that have already been paid or for any reduction
    in any amounts that are still payable by virtue of articles 4 and 5 above. EPIXIS or its sublicensees shall be solely responsible
    for the relevant court costs, as well as for the sentences that may be handed down against them.

 

    	 

    	 	 	 

    

  

This
article 5.3 shall remain applicable notwithstanding the cancellation or termination of the Agreement.

 

ARTICLE
6 – ENHANCEMENT

 

	6.1
    	The
    Establishments shall not be forced to add enhancements or improvements to the inventions that are covered by the Patents.
	 	 
	6.2
    	Each
    Party shall be the sole owner of the enhancement that it adds to Patents after the date when the Agreement enters into force
    as long as these enhancements are obtained by the Party independently of the other Party or of its inventors and shall be
    free to protect them in its own name and at its own expense by means of any industrial property title that it should deem
    appropriate.
	 	 
	 	EPIXIS
    shall henceforth acknowledge that, with regard to all enhancements or improvements, UPMC and the other Establishments have
    full and complete ownership of Intellectual Property rights pertaining to the rights of its/their agents, especially if they
    have been recognized as inventors of patentable enhancements.
	 	 
	6.3
    	It
    has been specified that, by virtue of the Agreement, the Establishments are in no way obligated to keep EPIXIS informed of
    any enhancements or improvements to inventions covered by Patents that may be developed by them or their agents after the
    date when the Agreement enters into force.
	 	 
	 	If
    EPIXIS identifies any enhancements developed and patented by the team of Mr. David Klatzmann exclusively at the UMR 7087 Laboratory
    and would like to obtain a license to use said enhancements, it shall notify UPMC of this intent with a registered letter
    with acknowledgment of receipt. The relevant parties shall hold negotiations in good faith to determine the conditions for
    a usage license within the Territory and within the Area subject to the rights of third parties.
	 	 
	 	If
    the relevant parties cannot come to an agreement four (4) months after EPIXIS has issued its notification, then UPMC and the
    other relevant Establishments shall be free to grant rights to said enhancements to any third party of their choice. The aforementioned
    deadline may be extended if the relevant parties issue a joint agreement to this end in writing.

 

    	 

    	 	 	 

    

 

	6.4
    	The
    provisions of Article 6.3 shall be valid only for 18 (eighteen) months following the date when the Agreement was signed and
    as long as this license remains exclusive for this 18-month period.
	 	 
	6.5
    	To
    the exclusion of the stipulations of articles 6.3 and 6.4, it is specified that, by virtue of the Agreement, the Establishments
    shall grant no rights to the enhancements or improvements to the inventions covered by the Patents, especially to the enhancements
    that shall be undertaken by them and their agents after the date when the Agreement enters into force.
	 	 

ARTICLE
7 – WARRANTY – COMPENSATION

 

	7.1.
    	UPMC
    declares and guarantees the material existence of the Patents to EPIXIS and that it is fully authorized to grant the license
    covered by this contract to EPIXIS. The Establishments shall not issue EPIXIS any other guarantee of any type, whether explicit
    or tacit.
	 	 
	7.2.	Nothing
    in the Agreement may be interpreted as:
	 	 
	 	-
    constituting a warranty issued by UPMC, INSERM, ENS-Lyon, and Université Paris XIII or the relevant inventors regarding
    the obtaining, the validity, or the scope of any of the Patents in any country within the Territory,
	 	 
	 	-
    constituting a warranty against the present or future infringement of patents held by third parties or any other intellectual
    property right held by third parties,
	 	 
	 	-
    constituting a warranty of safety, fitness for a particular purpose, or Patent performance in accordance with the terms of
    this contract.
	 	 
	 	EPIXIS,
    its Subsidiaries, and its sublicensees shall be solely responsible for any possible hazards, risks, and dangers with regard
    to the fulfillment of this Agreement and its sublicenses and any legal defects concealed by one or more Patents.
	 	 
	 	Nevertheless,
    UPMC states that, to its knowledge, as of this writing: no demand, claim, or lawsuit has been drawn up or filed in any Court
    by a third party against the Patents. An old lawsuit concerning the ownership and use of the Patents involving the Génopoïétic,
    GPH, and Avax corporations brought before the regional court of Paris culminated in the withdrawal of the parties following
    the signing of a settlement agreement between the Génopoïétic, GPH, and Avax corporations and UPMC on September
    15, 2003.
	 	 
	7.3.
    	EPIXIS
    and its affiliated and unaffiliated sublicensees guarantee UPMC, INSERM, ENS-Lyon, and Université Paris XIII, as well
    as their staff members, protection against any appeal or any judicial proceedings that may be filed against them due to damages
    to persons or to property, whether suffered during one or more clinical trials, due to an infringement of intellectual property
    rights belonging to third parties, or due to the development, holding, and use of the Patents and the marketing of Products
    by EPIXIS and its sublicensees. EPIXIS shall refrain from taking any legal action against UPMC, INSERM, ENS-Lyon, and Université
    Paris XIII in the event that these claims, demands, legal proceedings, and lawsuits should be initiated against EPIXIS or
    its sublicensees by third parties. EPIXIS may not claim any damages as compensation for harm suffered by EPIXIS and/or its
    sublicensees, and EPIXIS agrees to obtain, from its sublicensees, a waiver not to initiate any engage legal action to seek
    damages from the Establishments, thus ensuring that the Establishments are not disturbed in any way whatsoever.

 

    	 

    	 	 	 

    

 

	7.4
    	EPIXIS
    shall ensure that it and its sublicensees hold the necessary insurance policies that provide sufficient liability coverage
    regarding the exercise of this license.
	 	 
	7.5	EPIXIS
    and its sublicensees shall be solely responsible for ensuring that the Products comply with the laws and regulations applicable
    within the relevant countries. EPIXIS and its sublicensees may not call on UPMC, INSERM, ENS-Lyon, and Université Paris
    XIII as guarantors and shall be solely responsible with regard to its/their clients and/or any third party for the quality
    and performance of the Products.
	 	 
	 	This
    article 7 shall remain applicable notwithstanding the cancellation or termination of the Agreement.

 

ARTICLE
8 – CONFIDENTIALITY

 

	8.1	All
    the parties agree to keep strictly confidential, not to communicate or divulge to a third partie without the prior written
    agreement of the other Party, all the information which may come or be brought to the attention of the Parties during the
    implementation of the Agreement, and especially any confidential information pertaining to the developpment work, the patents,
    the Products or identity of a sublicense that one party could receive within the framework of this Agreement (hereafter “Information”).

 

However,
the following will not be considered as confidential information :

 

	-	Information
    considered as public domain at the date of their release, or put into the public domain by a third party in good faith, and
	 	 
	-	Information
    already known by the Party receiving the information on the date of the entry into force of this document, expect if such
    information was received from one of the Parties hereto.
	 	 
	-	Information
    from a third party having the right of disposition.

 

In
any case, It is the responsibility of the party receiving the information to judge if they are considered as confidential information.

 

	8.2	EPIXIS
    will have the right to provide the information to a third party, including to its sublicensees, as long as the disclosure
    of this information is considered useful and necessary for EPIXIS and the use of the license granted herein or to the sublicensees
    for the use of sublicenses granted by EPIXIS. The Establishments will have the right to provide the information to a third
    party, such as the Committee on Professional Conduct or ANVAR, as long as the disclosure of this information is considered
    useful and necessary for the Establishments in the management of the patents and the current license, and as long as the third
    party receiving the information are binded by a similar obligation of confidentiality as the one hereabove.

 

    	 

    	 	 	 

    

 

The
parties agree to take all the appropriate measures required in fulfilling their obligations with regard to Article 8 of this document
through their personnel and any other person connected to their services.

 

EPIXIS
shall include confidentiality obligations that must stay in force over the duration of the Agreement and ten (10) years after
its expiration or termination.

 

ARTICLE
9 – NAME OF THE PARTIES

 

	9.1
    	Each
    party agrees not to use, orally or in writing, the name, business name, mark or any other designation or distinctive signs
    of any other Party or one of its representatives, including in shortened or abbreviated form within the framework of the operation
    and/or promotional activites, whatever the medium used (publicity material, posters, videos...), without receiving a
    prior written consent by the Party involved.
	 	 
	 	The
    forgoing provision does not prohibit a Party to make references to another Party in any document for administrative, regulatory
    or judicial purposes, or for informational purposes by UPMC for Third Parties involved in the Patents, especially the other
    Establishments, the Commission on Professional Conduct or ANVAR.
	 	
	9.2
    	EPIXIS
    agrees to put on the Produts the Patent numbers each time it is required by a country’s legislation, as well as “UPMC
    Licensed” or UPMC-Inserm-ENS Lyon Licensed”, or any other similar definition pre-approved in writing by the Parties.
	 	 
	9.3
    	Any
    public statement or communication pertaining to the signature of the Agreement, exclusively within this framework, the name
    of the Parties or one ot its representatives or employees can be made without any constraint. However, any public statement
    or communication pertaining to its content will not be allowed without the prior written consent of the Parties.
	 	
	 	The
    provisions of Article 9 will remain in force notwithstanding the expiration or termination of this Agreement.

 

ARTICLE
10 – TERM

 

The
agreement shall become retroactively effective on February 28, 2006 and shall remain in force until its expiration date or the
invalidation of the last of the Patents, including any supplementary protection certificates.

 

The
Parties may terminate the agreement at any time by mutual agreement, under terms to be agreed upon in writing.

 

    	 

    	 	 	 

    

 

ARTICLE
11 – CANCELLATION OF THE CONTRACT

 

	11.1
    	This
    contract may be cancelled by operation of law by one of the parties in the event of failure to perform by the other party
    of any of its obligations hereunder, if said party has not rectified said failure to perform within a maximum period of thirty
    (30) days from the date of written notification of said failure to perform, sent by registered letter with return receipt,
    except in the case of proof of an obstacle to performing work following an act of God, and without prejudice to the right
    to compensation of the party affected in such cases. The exercise of the cancellation option does not exempt the defaulting
    party from fulfilling the contractual obligations until the effective date of cancellation.
	 	 
	11.2
    	This
    contract may be cancelled by the UPMC (Pierre and Marie Curie University) by operation of law in the event of the termination
    of or bankruptcy proceedings against EPIXIS, subject to notification sent by registered letter with return receipt that receives
    no reply for more than one (1) month, and subject to the provisions in force of the Commercial Code.
	 	 
	11.3
    	This
    contract may be cancelled by operation of law by UPMC in whole or in part, in the event of substantial modification of the
    distribution of the capital of EPIXIS, in particular through capital contribution, assignment, merger, divisive reorganization,
    or the takeover of EPIXIS operations by another entity, or the transfer of EPIXIS operations to another entity, without prior
    notice and without compensation from UPMC. EPIXIS shall endeavor to immediately inform UPMC of any such substantial modification,
    by registered letter with return receipt. This provision shall not apply in the event of assignment or transfer, whether partial
    or total, to a subsidiary controlled by EPIXIS of the business operations of EPIXIS to which the Agreement pertains, subject
    to adherence to the provisions of this Article, no. 12.1.
	 	 
	 	11.4
    This contract may be cancelled by operation of law by UPMC by on behalf of the Establishments, in whole or in part, in accordance
    with the procedure stipulated in Article 11.1, in one of the following cases:

 

	-
    	inability
    of EPIXIS to acquire the financing necessary to perform its operations within a maximum period of sixteen (16) months from
    the date of the signing of this contract
	 	 
	-
    	if
    no business plan has been sent to UPMC within the time period stipulated in this contract
	 	 
	-
    	if
    it is determined that EPIXIS is not putting forth reasonable effort or is unable to accomplish the development and marketing
    work required, and, in particular, if EPIXIS suspends the development of the products for more than six (6) months
	 	 
	-
    	if
    the minimum annual royalties for each of the products developed has not been worked out and set by the parties by, at the
    latest, the date of the initial marketing of the said Product
	 	 
	-
    	inability
    of EPIXIS to comply carry out the payments as stipulated in this contract
	 	 
	-
    	overall
    lack of sales of a product, or lack of a signed sub-license agreement within the time period of one (1) year from the date
    of acquiring AMM (Autorisation de mise sur le marché - Regulation of Therapeutic Goods) authorization, or the necessary
    equivalent authorization for the use of the products.
	 	 
	-
    	in
    the event of an overall lack of sales of a product for more than two (2) years after the initial marketing has taken place
	 	 
	-
    	in
    the event of non-application of a family of patents throughout the development of a product for more than fifteen (15) months,
    cancellation being applicable to this family of patents for all the countries of the Territory.

 

    	 

    	 	 	 

    

 

	11.5
    	In
    the cases mentioned above, EXPIXIS shall endeavor, in preference and priority to UPMC, to grant it the exclusive right to
    use the findings obtained under within the framework of the development work carried out by EPIXIS, to the extent that these
    findings prove necessary to enable UPMC to make optimum use of the patents with third-party partners and to pursue the development
    and the marketing of the products.
	 	 
	 	In
    this case, the UPMC shall then endeavor to pay to EPIXIS, in the event of the use of the patents by a third party, a fair
    share of the royalties received by UPMC, up to a limit of the amount of the investments supported by EPIXIS for the development
    work, up until the date of withdrawal of EPIXIS. This share shall be established in good faith between the parties.
	 	 
	11.6
    	EPIXIS
    grants UPMC the option, on behalf of the establishments, to immediately terminate the agreement by sending notification forty-five
    (45) days before the termination is to take effect, in the event of contestation by EPIXIS and/or its sub-licensees of the
    validity in whole or in part of the patents, brought before a tribunal or a patent office.
	 	 
	11.7
    	In
    the event of cancellation or expiration of the agreement, EPIXIS shall endeavor, from the date of cancellation or the date
    of expiration:
	 	 
	-
    	to
    no longer use the patents. This Article, no. 11.7, shall remain in force for the patents until they fall into the public domain.
	 	 
	-
    	to
    no longer use and to return without charge to UPMC all confidential information, all documents and items constituting the
    patents, including in particular any sample, product, biological material, without authority to keep any copies.

 

    	 

    	 	 	 

    

 

	11.8
    	In
    the event of cancellation of the agreement and in the event that EPIXIS grants sub-licenses, it is agreed upon by the parties
    that the establishments may stand in for EPIXIS, the sub-licenses becoming direct licenses after agreement between the establishments
    and the sub-licensees.
	 	 
	 	11.9
    In the event that EPIXIS holds, on the date of cancellation or the date of expiration of the agreement, products in inventory,
    EPIXIS shall be authorized to sell these products in the territory for a period of two (2) months following the date of cancellation
    or until the expiration date of the agreement, under the condition that, firstly, a stock status be sent by registered letter
    with return receipt to UPMC at the latest on the date of cancellation or on the date of expiration of the agreement a statement
    of inventory and, secondly, to adhere to the terms and conditions of the agreement, and, in particular, the stipulations of
    Article 4 concerning the financial terms.

 

ARTICLE
12 – MISCELLANIOUS PROVISIONS

 

	12.1	Inaccessibility

 

The
Agreement has been entered into intuitu personae. It is, in full or in part, personal, inaccessible and non-transferable without
the written prior agreement of UPMC.

 

It
is also stated that EPIXIS cannot subcontract, in part or in full, the services entrusted as per the Agreement, unless with a
prior written consent from UPMC. It is further understood that even with an agreement from UPMC, EPIXIS remains responsible for
the payments of the amounts due to UPMC, as per Article 4 of this document, as well as the well executed implementation of the
services of its subcontractors and their strict compliance with the provisions of their contract(s), including all matters stated
in this Agreement.

 

In
the event of a transfer or cession to a subsidiary of EPIXIS, EPIXIS agrees to inform UPMC through a registered letter with acknowledgment
of receipt, the entry in force of such an assignment to the subsidiary since an amendment to the Agreement and a signature from
the Parties and the Subsidiary are required.

 

It
is hereby acknowledged and agreed that any company to which the rights and obligations are to be assigned, transferred or transmitted
will be subject to the same obligations than those placed on EPIXIS, within the framework of this Agreement, unless the new parties
have agreed otherwise and EPIXIS remains a joint guarantor towards the Establishments on compliance by the assignee of all the
rights and obligations pertaining to this Agreement for the remaining duration of this Agreement. Any modification to the terms
and conditions of this Agreement resulting from the transfer or cession, such as the name and address of the assignee, must be
stated in writing and inserted as amendment to this Agreement at the time of the said merger, cession or transfer.

 

    	 

    	 	 	 

    

 

In
the event of a change of control, merger, acquisition, cession, splitting, transfer of EPIXIS or its activities to another entity,
or any other transformation of EPIXIS aimed at amending the characteristics of intuitu personae taken into account for this Agreement.
EPIXIS agrees to inform immediately, by registered mail with acknowledgment of receipt, and the Establishments will not be able
to veto and refuse the transfer of the Agreement, except on serious motives.

 

UPMC,
on behalf of the Establishments, reserves the right, in the event of of a non-compliance of Article 12.1 by EPIXIS, to terminate
immediately this Agreement without notice or compensation, without prejudice to any damages and interests that may be claimed
in order to cover the loss sustained.

 

	12.2	Force
    Majeure

 

Each
Party will be excused of its obligations and will not be held responsible nor liable for any damages/interests towards the other
party if the non-performance is caused by a case of force majeure, such as the disorganisation of its services resulting from
a strike, resignation or any other event beyond its control.

 

	12.3	Independent
    Contracting parties

 

In
any way whatever the Agreement shall be construed as creating an associative relationship or company between the Parties. Each
party must be considered as an independent contracting party.

 

	12.4	Amendments

 

This
Agreement supersedes and replaces all prior agreements between the Parties pertaining to the subject of this Agreement. This Agreement
can only be amended in writing. Any amendment must be signed by an authorized representative for each Party.

 

	12.5	Communication

 

All
types of communication and notice directed to the attention of the Parties, within the framework of the Agreement, shall be done
by confirmed telex, fax or registered letter with acknowledgement of receipt, to the addresses stated below, for as long as no
written letter confirming an address change has been sent.

 

For
UPMC:

Université
Pierre & Marie Curie

Direction
des Relations industrielles et du Transfert Technologique - SAIC

4,
Place Jussieu 75252 PARIS cedex 05

Phone:
01 44 27 30 65

Fax:
01 44 27 74 67

 

    	 

    	 	 	 

    

  

For
THE COMPANY :

EPIXIS

5
rue des Wallons

75013
PARIS

Phone:
01 43 31 80 71

Fax:
01 42 17 74 62

 

Any
notice shall be deemed served on the day received by the recipient, unless the delivery date is a public holiday, in which case
the delivery date shall be considered the first business day after the public holiday.

 

	12.6	Non-waiver
    of Rights

 

In
the event of non-compliance by one of the Parties of the obligations resulting from the Agreement, and if the non-defaulting Party
renounces its rights of the said violation, the non-exercise of its rights shall not be considered as a waiver to exercise the
such rights in the future or in the event a new and similar violation by the defaulting Party of its obligations resulting from
the Agreement.

 

	12.7	Registration

 

All
authority is given to EPIXIS to carry out, at its own expense, any registration formalities of the Agreement or a signed extract
by the Parties of the Agreement, especially the tax registration and the registration to the National Patent Registers.

 

ARTICLE
13 – AGREEMENT

 

This
Agreement is subject to French Law.

 

If
difficulties or disputes arise during the interpretation or the implementation of the Agreement, the Parties shall try to resolve
them amicably.

 

If
the dispute concerns fees or any monies financing the license, EPIXIS agrees to open an interest bearing account and to block
this sum of money throughout the duration of the dispute.

 

The
source of the dispute shall be attested by a registered letter with acknowledgment of receipt, by one of the Parties to the other
Party, setting out the reasons of the dispute.

 

In
case of repeated disagreements, the Courts of Paris shall have sole jurisdiction.

 

    	 

    	 	 	 

    

 

 

Appendix
2: Development plan

 

    	 

    	 	 	 

    

 

    	 

    	 	 	 

    

 

    	 

    	 	 	 

    

 

Appendix
3

 

Estimate
of past and future expenses

 

Period:
years 2004, 2005 and 2006

 

NOTE:
This budget is provided as an example. It is established in euros, exclusive of VAT.

 

	Patents
    	 	Patents	 	2004	 	2005	 	2006

	 	 	 	 	 	 	 	 	 
	Ref
    Becker	Ref

        UPMC
	Date	 	 	 	Invoiced
        and

        paid 
	 	Invoiced
        and

        paid

         
	 	Estimate

         

	B0014
    V96072 04/06	 	 	 	 	 	 	 	 
	“Defective
    viral vaccine particles obtained in vivo or ex vivo.”	 	.
        EP 799 893

         

        .
        US 6,140,114

         

        .
        CA 2251027

         

        .
        JP 09-535922

         
	 	7654.76
        euros

         
	 	3772.35
        euros

         
	 	Annual
        installments DE, ES, FR, GB, IT, CA: 3500 euros, exclusive of tax

         

        If
        CA official letter: 2,000 - 3,300 euros, exclusive of tax

         

        If
        JP official letter: 2,000 - 3,300 euros, exclusive of tax

         

        Total
        without official letter: 3500 euros, exclusive of tax

         

        Total
        with official letter: 7,500 euros – 10,100 euros, exclusive of tax

		 	 	 	 	 	 	 	 
	B0047
    W20022 10/00	 	.
    EP 01 988 766.0	 	589.18	 	776.84	 	EP
    annual installments: 1100 euros, exclusive of tax
	“Synthetic
    viruses and their uses”	 	 .
    US 10,415,242  	 	euros	 	euros	 	If
        EP official letter: 1,600 – 2,200 euros, exclusive of tax

         

        If
        2 US official letters: 3,000 – 4,000 euros, exclusive of tax

         

        Late
        entry to the US national phase: 3,800 euros, exclusive of tax

         

        New
        registration change of name

        Inventor:
        2,000 – 3,000 euros, exclusive of tax

         

        Total:
        11,500 – 14,100 euros, exclusive of tax

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