Document:

FIRST
AMENDMENT TO THE CLINICAL TRIAL AGREEMENT

 

This
First Amendment to the Clinical Trial Agreement (“First Amendment”)
is made on 2019 May 7, 2019 (“Effective Date”) by and between St. Joseph Heritage Healthcare
(“Institution”) and Cancer Insight, LLC (“CRO”). CRO and Institution
are herein referred to collectively as “Parties.” Individually, each of CRO and Institution is
a “Party.”

 

WHEREAS,
the Parties previously entered into a Clinical Trial Agreement (“Agreement”), with an effective date of January 26,
2018, pertaining to the performance of the clinical study titled and described as “A Phase I/IIa Rollover Study of the Whole-Cell
Vaccine BriaVax in Metastatic or Locally Recurrent Breast Cancer Patients in Combination with Ipilimumab or Pembrolizumab”
(the “Study”);

 

WHEREAS,
the Parties desire to amend the Agreement.

 

NOW,
THEREFORE, in consideration of the mutual promises contained herein, the Parties agree as follows:

 

		A.	EXHIBIT
                                         B BUDGET Section C to the Agreement is hereby amended and replaced in its entirety as
                                         follows:

 

The
compensation per Study subject will be earned by Institution and made payable by Sponsor as follows:

 

		i.	$2,270.00
                                         will be paid upon completion of the baseline visit, as defined by the Protocol;

 

		ii.	$2,920.00
                                         will be paid upon completion of Cycle One, as defined by
                                         the Protocol;

 

		iii	$2,790.00
                                         will be paid upon completion of Cycle Two, as defined by
                                         the Protocol;

 

		iv.	$2,790.00
                                         will be paid upon completion of Cycle Three, as defined by the Protocol;

 

		v.	$2,790.00
                                         will be paid upon completion of Cycle Four, as defined by
                                         the Protocol;

 

		vi.	$3,105.00
                                         will be paid upon completion of Cycle Five, as defined by
                                         the Protocol;

 

		vii.	$2,790.00
                                         will be paid upon completion of Cycle Six, as defined by the Protocol;

  

    	 	Page 1 of 3	 

     

    

 

		viii.	$2,790.00
                                         will be paid upon completion of Cycle Seven, as defined by the Protocol;

 

		ix.	$2,790.00
                                         will be paid upon completion of Cycle Eight, as defined by
                                         the Protocol;

 

		x.	$3,105.00
                                         will be paid upon completion of Cycle Nine, as defined by the Protocol;

 

		xi.	$2,790.00
                                         will be paid upon completion of Cycle Ten, as defined by
                                         the Protocol;

 

		xii.	$2,790.00
                                         will be paid upon completion of Cycle Eleven, as defined by the Protocol;

 

		xiii.	$2,790.00
                                         will be paid upon completion of Cycle Twelve, as defined by the Protocol;

 

		xiv.	$2,790.00
                                         will be paid upon completion of Cycle Thirteen, as defined by the Protocol;

 

		xv.	$2,790.00
                                         will be paid upon completion of Cycle Fourteen, as defined by the Protocol;

 

		xvi.	$2,790.00
                                         will be paid upon completion of Cycle Fifteen, as defined by the Protocol;

 

		xvii.	$2,790.00
                                         will be paid upon completion of Cycle Sixteen, as defined by the Protocol;

 

		xviii.	$3,105.00
                                         will be paid upon completion of Cycle Seventeen, as defined by
                                         the Protocol;

 

		xix.	$3,005.00
                                         will be paid upon completion of the end of treatment visit, as defined by the Protocol.

 

		xx.	$2,155.00
                                         will be paid upon completion of the final assessment follow-up visit, as defined by the
                                         Protocol.

 

		B.	$325.00
                                         shall be paid by Sponsor for each SAE report completed (including follow up).

 

		C.	$75.00
                                         shall be paid by Sponsor for Institution’s attendance at telephone conferences,
                                         invoiced monthly.

 

    	 	Page 2 of 3	 

     

    

 

	 	D.	Non-advertising
                                         recruitment and screening fees period covered at $300.00 per month during enrollment

 

		E.	Except
                                         as expressly modified herein, all other terms, conditions, and provisions of the Agreement
                                         shall remain in full force and effect.

 

The
authorized representatives of the Parties have signed this First Amendment as set forth below.

 

	St. Joseph Heritage Healthcare	 	Cancer Insight, LLC
	 	 	 	 	 
	By:		 	By:	
	 	 	 	 	 
	Name:	David S Kim	 	Name:	Steven White
	 	 	 	 	 
	Title:	CMO	 	Title:	COO
	 	 	 	 	 
	Date:	Apr 15, 2019	 	Date:	May 7, 2019

 

	READ AND ACKNOWLEDGED:	 
	BriaCell Therapeutics, LLC	 
	 	 	 
	By:		 
	 	 	 
	Name:	William Williams	 
	 	 	 
	Title:	President and CEO	 
	 	 	 
	Date:	May 7, 2019	 

 

    	 	Page 3 of 3HLA Typing Service Agreement

 

between

 

HistoGenetics,
LLC., 300 Executive Blvd., Ossining, NY 10562, USA (“HistoGenetics”),

 

and BriaCell Therapeutics
Corp, 820 Heinz Avenue, Berkeley, CA 94710 (“BriaCell”).

 

HistoGenetics
is an independent private company that specializes in HLA typing by DNA sequencing
(SBT).

 

Subject of
the Agreement

 

Performance of
HLA high-resolution typing using NGS for Briacell by
HistoGenetics

 

	1.	Sample Delivery and Duration
	 	 
	l.1.	BriaCell will ship to HistoGenetics time to time samples for HLA-A, -B, -C, -DRB1, - DRB345, -DQAl, -DQBl, -DPAl and DPBl typing by NGS (Next Generation Sequencing).
	 	 
	1.2.	HistoGenetics is strongly committed and recognized as a laboratory with a high quality level. Therefore HistoGenetics will be accredited at ASHI for HLA typing and PCR-SBT. HistoGenetics will inform BriaCell immediately if the ASHI accreditation of HistoGenetics has expired.
	 	 
	1.3.	Tum-around time is 18 days.

 

	2.	Quality Specifications
	 	 
	2.1.	Typing resolution: HLA-A, -B, -C, -DRBl, -DRB345, -DQA l, -DQBl, -DPAl and DPB1 8x High Resolution typing by PacBio SMRT sequencing. Illumina technology may be use for confirmation of Homozygous typing.
	 	 
	2.2.	Typing methodology and resolution is 8x high resolution by NGS including whole gene for class I and exon 2 to 3’UTR for class IL All fields are resolved without NMDP codes.
	 	 
	2.3.	HistoGenetics will update the HLA database that is used to analyze the results yearly but when a new variant is found it will compare it to the latest database.
	 	 
	2.4.	Upon request HistoGenetics will provide the raw data to BriaCell at no charge. The raw data will be provided as text string in XML-format according to the NMDP standard. Raw data for additional or non NGS typings can be submitted in different formats, if these are previously agreed on by HistoGenetics and BriaCell.

 

    	 	 	ML 03 June 2019 
 1

    	 

    

 

	3.	Sample Volume and Pricing
	 	 
	3.1.	Pricing is based on about
    50-100 samples per
    24 months. The cost of
    HLA-A, -B, -C,
    -DRBl, -DRB345,
    -DQA I, -DQBl, -DPAl
    and DPBl 8x high resolution typing by NGS is $250/sample.
	 	 
	3.2.	HistoGenetics shall invoice all completed work performed on a monthly basis. Payment terms is net 30 days from the invoice date.

 

	4.	Term and Termination
	 	 
	4.1.	This Agreement is entered
    into effective, as
    of June 1st,
    2019 for a
    two year period.
	 	 
	4.2.	The right to terminate this Agreement for good cause upon written notice with immediate effect shall remain unaffected. This Agreement may be terminated in the event of but not limited to

 

	 	4.2.1	by Briacell in the event of the suspension or revocation of the ASHI accreditation of HistoGenetics.
	 	 	 
	 	4.2.2	by either party upon insolvency or bankruptcy of the other party.

 

	5.	Miscellaneous
	 	 
	5.1.	HistoGenetics stores material for 3 months. The samples will be destroyed after that period unless instructed otherwise by the Briacell.
	 	 
	5.2.	Orders and electronic result reporting are processed as currently agreed upon.
	 	 
	5.3.	If processes need to be altered both parties will collaborate to implement necessary changes.
	 	 
	5.4.	HistoGenetics will therefore inform Briacell in advance of any planned major change in the legal structure of HistoGenetics and especially in the structure of the top management.
	 	 
	5.5.	HistoGenetics will
    report new alleles of BriaCell donors
    to the WHO nomenclature committee. HistoGenetics
    will also provide BriaCell with
    all information that are necessary for scientific analysis of new
    alleles. Respective results will
    be jointly published by BriaCell and
    HistoGenetics.
	 	 
	5.6.	This Agreement shall be governed by and
    construed in accordance
    with the laws of the New York
    State, without giving effect to
    its choice of law principles.
	 	 
	5.7.	Exclusive court of jurisdiction is New York Westchester county.

 

    	 	 	ML 03 June 2019 
 2

    	 

    

 

	Briacell	 	HistoGenetics LLC.
	 	 	 
	03 June 2019	 	 
	Date, Signature	 	Date, Signature

 

    	 	 	3Solution
for

Procurement
of Cyclophosphamide, Candin, and Intron-A

Quote/Opportunity
QTE-9141204 , Version 1

DATE:
07-Jun-2019

 

Prepared
for

 

BriaCell
Therapeutics Corp

Markus
Lacher

Senior
Director, R&D and Head of R&D

820
Heinz Avenue

Berkeley,
CA 94710

925-681-9553

 

Provided
by

 

Catalent
Pharma Solutions, LLC

Account
Executive: Brandon Pena

	Phone:
    310-596-0398	Email:
    Brandon.pena@catalent.com

Address:
10381 Decatur Road, Philadelphia, PA 19154

Proposal
Lead: Ken Penkala

	Phone:
    215-501-1260	Email:
    Ken.penkala@catalent.com

www.catalent.com

 

 

    	 	 	 

     

    

 

 

Thank
you for choosing a solution from Catalent.

 

Catalyst
+ Talent. Our name combines these ideas. From drug and biologic development to delivery technologies and supply solutions, we
are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings and
the most innovative technologies in brand and generic pharmaceuticals, veterinary medicine, consumer health, and biologics.

 

We
help you get more molecules to market faster, solve bioavailability and development challenges, enhance product performance and
patient adherence, create the optimal dose form, and drive superior supply chain, manufacturing, and packaging results.

 

Whether
you are looking for a single, tailored solution or multiple answers throughout your product’s lifecycle, we can improve
the total value of your treatments—from discovery to market and beyond.

 

Catalent.
More products. Better treatments. Reliably supplied.TM

 

		DEVELOPMENT		DELIVERY		SUPPLY
	 	BIOLOGICS	 	SOFTGEL
    TECHNOLOGIES	 	CLINICAL
    SUPPLY
	 	PRE-FORMULATION &

                                                                                FORMULATION
	 	ZYDIS® FAST DISSOLVE

                                                                                TECHNOLOGIES
	 	MANUFACTURING

                                                                                                                            STERILE
FILL/FINISH

	 	SOLID
    STATE SERVICES	 	CONTROLLED RELEASE

                                                                                TECHNOLOGIES
	 	PACKAGING
SERVICES &

                                                                                                                            DELIVERY SOLUTIONS

	 	PHARMACEUTICAL &

                                                                                BIOPHARMACEUTICAL

                                                                                LAB SERVICES
	 	INHALATION

                                                                                                                            INJECTABLES
	 	 
	 	REGULATORY

                                                                                CONSULTING
	 	 	 	 

 

    	 	Catalent Confidential
	Page 2 of 13

     

    

 

 

Thank
you for your interest in Catalent Pharma Solutions’ procurement services. Enclosed for your review is a quotation of the
services for the project described below. If you have any additional questions or require further information, please do not hesitate
to contact the Account Executive or Proposal Lead listed above.

 

Section
1. Project Activities/Specifications

 

Catalent
shall endeavor to source and procure from Catalent’s approved supplier (“Supplier”) the following commercially
available or comparator product(s) (the “Product”) for and on behalf of BriaCell Therapeutics Corp (“BriaCell
Therapeutics” or “Client”).

 

Procured
product will be used for project reference QTE-9141060 and will be delivered to Philadelphia.

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	CYCLOPHOSPHAMIDE
                                         500MG

                                                                                VIAL
                                         IN 1CT CARTON (USA) -

                                                                                CAMPAIGN
                                         1
	1
                                         VIAL

                                                                                PER

                                                                                CARTON
	0781-3233-94	414.10	147	60,872.70

	Market
    of Origin:	USA
	Lead
    time:	Product
    currently available: 10-14 days from Catalent PO to delivery at Catalent PHL
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Sandoz
	Storage
    conditions:	Below
    25C
	Expiry:	03/2021
    minimum
	Comments:	Store vials at or below 25°C (77°F). During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide.

                                                                                147 units provides 73,500mg of cyclophosphamide.

                                                                                Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

    	 	Catalent Confidential
	Page 3 of 13

     

    

 

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	CANDIN
                                         1ML MULTIDOSE (0.1ML

                                                                                DOSE;
                                         10 DOSE) VIAL IN CARTON

                                                                                (USA)
                                         - CAMPAIGN 1
	1
                                         VIAL

                                                                                PER

                                                                                CARTON
	59584-138-01	222.00	42	9,324.00

	Market
    of Origin:	USA
	Lead
    time:	Checking
    with manufacturer on availability (for product that is readily available: 10- 14 days from Catalent PO to delivery at Catalent
    PHL)
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Nielsen
    BioSciences
	Storage
    conditions:	Refrigerated
    (2-8C)
	Expiry:	TBC
	Comments:	Store between 2° to 8°C (35° to 46°F).

                                                                                42 units will provide 42vials (10 tests/doses per vial would provide 420 tests/dose). Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	INTRON-A
        (INTERFERON ALFA-2B)

        25MILLION
        IU VIAL IN CARTON

        (USA)
        - CAMPAIGN 1
	1
        VIAL

        PER

        CARTON
	0085-1133-01	1,305.00	63	82,215.00

	Market
    of Origin:	USA
	Lead
    time:	Product
    currently available: 10-14 days from Catalent PO to delivery at Catalent PHL (note this has been on backorder previously)
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Merck
	Storage
    conditions:	Refrigerated
    (2-8C)
	Expiry:	10/2020
    minimum
	Comments:	INTRON A Solution for Injection in vials should be stored in the refrigerator at 2° to 8°C (36°-46°F). INTRON A Solution for Injection should not be frozen and should be kept away from heat. Throw away any unused INTRON A Solution for Injection remaining in the vial after one month.

                                                                                Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

    	 	Catalent Confidential
	Page 4 of 13

     

    

 

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	CYCLOPHOSPHAMIDE
                                         500MG

                                                                                VIAL
                                         IN 1CT CARTON (USA) -

                                                                                CAMPAIGN
                                         2
	1
                                         VIAL

                                                                                PER

                                                                                CARTON
	0781-3233-94	414.10	273	113,049.30

	Market
    of Origin:	USA
	Lead
    time:	Product
    currently available: 10-14 days from Catalent PO to delivery at Catalent PHL
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Sandoz
	Storage
    conditions:	Below
    25C
	Expiry:	03/2021
    minimum
	Comments:	Store vials at or below 25°C (77°F). During transport or storage of cyclophosphamide vials, temperature influences can lead to melting of the active ingredient, cyclophosphamide.

                                                                                273 units provides 136,500mg of cyclophosphamide.

                                                                                Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	CANDIN
        1ML MULTIDOSE (0.1ML

        DOSE;
        10 DOSE) VIAL IN CARTON

        (USA)
        - CAMPAIGN 2
	1
        VIAL

        PER

        CARTON
	59584-138-01	222.00	78	17,316.00

	Market
    of Origin:	USA
	Lead
    time:	Checking
    with manufacturer on availability (for product that is readily available: 10- 14 days from Catalent PO to delivery at Catalent
    PHL)
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Nielsen
    BioSciences
	Storage
    conditions:	Refrigerated
    (2-8C)
	Expiry:	TBC
	Comments:	Store between 2° to 8°C (35° to 46°F).

                                                                                78 units will provide 78 vials (780 tests/doses per vial would provide 1200 tests/dose).

                                                                                Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

    	 	Catalent Confidential
	Page 5 of 13

     

    

 

 

	Product
    Description	Pack
    Size	MA#/NDC#	Unit
    Price	Est.
    Qty	Est.
    Price
	INTRON-A
                                         (INTERFERON ALFA-2B)

                                                                                25MILLION
                                         IU VIAL IN CARTON

                                                                                (USA)
                                         - CAMPAIGN 2
	1
                                         VIAL

                                                                                PER

                                                                                CARTON
	0085-1133-01	1305.00	117	152,685.00

	Market
    of Origin:	USA
	Lead
    time:	Product
    currently available: 10-14 days from Catalent PO to delivery at Catalent PHL (note this has been on backorder previously)
	 	 
	No.
    of batches:	1
	Documentation	Catalent
    Supply Chain Memo
	Manufacturer:	Merck
	Storage
    conditions:	Refrigerated
    (2-8C)
	Expiry:	10/2020
    minimum
	Comments:	INTRON A Solution for Injection in vials should be stored in the refrigerator at 2° to 8°C (36°-46°F).

                                                                                INTRON A Solution for Injection should not be frozen and should be kept away from heat. Throw away any unused INTRON A Solution for Injection remaining in the vial after one month.

                                                                                Catalent anticipates 2 purchases for the lifetime of this study - Catalent will capture 2 incoming freight charges w/ temperature monitor and 2 procurement fees (1 per purchase). Catalent will only bill for incoming freight/procurements/temperature monitor per purchase.

 

	PROCUREMENT
    FEES*
	 	Unit
    Price	Est.
    Quantity	Est.
    Price
	Procurement
    Fee	2,500	2	5,000
	Freight
    Charges	1,260	2	2,520
	Subtotal	$7,520

 

	Subtotal	$442,982

 

*Pricing
does not include shipping materials, insurance charges, taxes or customs charges into the country of the receiving Catalent facility.
Charges will follow once received and will be invoiced to and are payable by Client.

 

The
above price may change due to changes in market price at time of purchase. Any such change in price will be captured in a
revision to this Quotation (a “Quote Amendment Record” or “QAR”). Please note
that ordered Products are non-returnable. Expiration dating cannot be guaranteed until an order is successfully placed.
Orders are subject to approval by Supplier.

 

    	 	Catalent Confidential
	Page 6 of 13

     

    

 

 

ADDITIONAL
INFORMATION

 

Any
purchase of Product by Catalent shall be subject to the Catalent Standard Comparator Procurement Terms and Conditions attached
and the following specific terms and conditions which are especially drawn to Client’s attention:

 

	 	●	Payment
    for Product(s) must be received from Client prior to Catalent placing the order. For purchases ordered by e-mail, Client shall
    pay Catalent for such Product within following such e-mail. Catalent will reserve the right to hol the material until such
    funds are received.
	 	 	 
	 	●	Subject
    to the cancellation right as per the following bullet point, Product orders are final and not subject to cancellation by Client
    for any reason. Once a Product order is placed, Client is fully responsible for the total amount due and no refund will be
    due or payable by Catalent.
	 	 	 
	 	●	In
    exceptional cases, Client shall be entitled to cancel a Product order, PROVIDED that Catalent can cancel its respective own
    Product order pursuant to the terms and conditions applicable between Catalent and its Product Supplier without any liability,
    financial or otherwise, for Catalent. In such case, Catalent will issue a credit note to Client for the respective amount
    already paid. In no event shall Catalent however be obliged to any refund or reimbursement if Catalent does not receive any
    refund for the respective Product order from its own Supplier.
	 	 	 
	 	●	Subject
    to situations described in the following sentence, Client shall pay all invoices within thirty(30) days from the receipt of
    Product by Catalent. Irrespective of the foregoing, Client shall first pay Catalent funds in advance to any
    Product purchase in all cases where Catalent is obliged to make an advance payment to its own Supplier pursuant to the contractual
    arrangement between Catalent and the respective Supplier.
	 	 	 
	 	●	The
    Product is sourced from the Supplier by Catalent on Client’s behalf. Subject to Client’s full satisfaction of
    its payment obligations herein, title in Product shall pass from Supplier to Client immediately upon receipt of the Product
    by Catalent and Catalent shall not obtain title to the same at any time.
	 	 	 
	 	●	Catalent
    shall not be responsible for the Products during transit, including any cost of insurance for such Products, or any risks
    of loss or damage to Product associated with transit or customs delays, storage, and handling, and under no circumstances
    shall Catalent be responsible for insuring the Product against such risks.
	 	 	 
	 	●	Additional
    information such as EudraCT number or Usage and Consumption statement stating that goods are solely to be used within a clinical
    trial may be required to complete purchase.
	 	 	 
	 	●	Risk
    of loss of or damage to Product shall at all times be vested in Client and under no circumstances shall Catalent be responsible
    for insuring the Product against such risks.
	 	 	 
	 	●	This
    quote assumes the client will act as Importer of Record and arrange the broker for any shipments from the EU to the US.

 

ADDITIONAL
COMPARATOR PROCUREMENT PURCHASES

 

In
the event that Client desires to order quantities of Product in addition to the quantities estimated in the first Table of this
Section 1 (“Comparator Procurement”), Client may order such quantities (not to exceed 5 times the quantity
in the Quotation, in the aggregate for the duration of this Quotation (such aggregate quantities being herein, the “Cap”))
by sending an e-mail requesting such additional Product that contains all of the following. E-mail requests may be accepted for
up to two years after the execution date of this Contract or until price changes occur for the product(s). Changes in price will
require a Quotation Amendment Record (“QAR”) to be processed and accepted by both parties.

 

	 	●	The
    e-mail shall be addressed to:
	 	 	G-CP-ALL-GlobalComparatorProcurement@catalent.com
	 	 	 
	 	●	The
    e-mail shall be sent from the Client’s authorized representative.
	 	 	 
	 	●	The
    e-mail shall contain the following: “This e-mail is intended to serve as a binding purchase order and shall be governed
    by the terms and conditions set forth in Quotation #, entitled “Procurement of XXXX, dated 6/7/2019” including
    without limitation, the Agreed Comparator Terms and Conditions attached thereto, and any QAR associated with such Quotation.”

 

    	 	Catalent Confidential
	Page 7 of 13

     

    

 

 

Client
may place orders via one or more e-mails in the above manner for each Product, until such time as the applicable Cap for such
Product.

 

Catalent
provides Global Regulatory Consulting (GRC) to assist with product development including regulatory assistance for clinical trials
involving a comparator product arm. Catalent’s GRC group can guide clients on the regulatory requirements for comparator
products on a country-by-country basis. The GRC group also provides regulatory review and advice on label requirements for each
country in the global clinical trial, in addition to clinical trial applications support. Catalent can provide a “right-sized”
consulting solution, utilizing the most appropriate level of consultant for the work. Pricing for these services is available
upon request.

 

Payment
for Product must be received prior to ordering and should be made to:

 

	Site	 	Account
    Details
	Philadelphia	 	Electronic
                                         Wire / ACH Instructions

        J.P.
        Morgan Chase

        ABA # 021-000-021

        Swift
        Code: CHASUS33 (for international

        payments only)

        Account
        # 844024851

        FBO:
        Catalent Pharma Solutions

 

Please
notify Kathryn.luchtmann@catalent.com when payment is sent.

 

Section
2. Invoicing Terms

 

Fixed
Fees

 

	DESCRIPTION	 	PRICE ($)	 
	Upon signature of this Quotation	 	$	442,982	 
	TOTAL	 	$	442,982	 

 

This
Quotation does not include an estimate for VAT which, if applicable, will be applied to invoices at the current and relevant VAT
rate which can vary from jurisdiction to jurisdiction. This should be taken into account for study budgeting purposes, as appropriate.
More detail on current VAT rates, including eligibility for reclaiming VAT, is available from the relevant local government body.

 

    	 	Catalent Confidential
	Page 8 of 13

     

    

 

 

 

    	 	Catalent Confidential
	Page 9 of 13

     

    

 

 

Why
Catalent?

 

Unrivaled
experience, deepest expertise, and a track record of market success on a global scale.

 

We
serve 49 of the top 50 pharmaceutical and 36 of the top 50 biotech companies.

 

We
support thousands of innovative prescription, generics, and consumer health companies.

 

We
operate 20+ global sites across 100+ markets.

 

We
create expert solutions from over 1,000 scientists, including key opinion leaders in drug development and delivery.

 

We
support 40% of recent new U.S. drug approvals. We manufacture or package 100 billion units annually. We are the industry
leader in drug delivery technology.

 

We
use a multi-faceted approach to solve bioavailability and patient adherence challenges.

 

We
provide end-to-end biologics technologies, from gene expression to fill/finish.

 

We
offer fully-integrated medication supply chain solutions.

 

We
have a proven track record in regulatory compliance in all key jurisdictions.

 

We
are fully dedicated to high standards of quality, cGMP leadership and LEAN operational excellence.

 

    	 	Catalent Confidential
	Page 10 of 13

     

    

 

 

Catalent
Standard Comparator Procurement Terms and Conditions

 

A.
Expiration. This Quotation is valid for 30 days from the date hereof, and becomes binding if signed and delivered by both
parties during that period.

 

B.
Audits. Client may conduct one quality assurance facility audit per year at no cost. Additional audits will be invoiced
separately at the current rate for such services unless such audit is for cause.

 

C.
Regulatory Inspections. Catalent will promptly notify Client of any regulatory inspections directly relating to the Product.
Client shall reimburse Catalent for reasonable and documented costs associated with such regulatory inspections.

 

D.
Price Changes. Catalent may revise the prices provided in this Quotation (i) if Client’s requirements or any Client-provided
information is inaccurate or incomplete; (ii) if Client revises Catalent’s responsibilities or the Product specifications;
or (iii) for such other reasons set forth in this Quotation. Any revision to this Quotation shall be set forth in a Quotation
Amendment Request (“QAR”) signed by both parties in accordance with Section T.

 

E.
Payments. Catalent will invoice Client and Client shall make payment to Catalent as set forth in this Quotation. Catalent
charges a late payment fee of 11⁄2% per month for payments not received by the date specified in this Quotation (or if no
date is specified, within 30 days of invoice date). Failure to bill for interest due shall not be a waiver of Catalent’s
right to charge interest.

 

F.
Taxes. All sales, use, gross receipts, compensating, value-added or other taxes, duties, licenses or fees (excluding Catalent’s
net income and franchise taxes) assessed by any tax jurisdiction arising from procurement of the Product on behalf of Client are
the responsibility of Client, whether paid by Catalent or Client.

 

G.
Delivery. All Products and other materials provided by Catalent are delivered EXW (Incoterms 2010) Catalent’s facilities
unless otherwise agreed in the Quotation. In the event Catalent arranges shipping or performs similar logistics services for Client
at Client’s request, such services are performed by Catalent as a convenience to the Client only and at Client’s cost.
In such case Client shall qualify a minimum of two carriers to ship Product and then designate the priority of such qualified
carriers to Catalent. Catalent shall not be responsible for the Products during transit, including any cost of insurance for such
Products, or any risks associated with transit or customs delays, storage, and handling.

 

H.
Limitations of Liability. CATALENT’S TOTAL LIABILITY UNDER THIS QUOTATION SHALL IN NO EVENT EXCEED THE TOTAL FEES
PAID UNDER THIS QUOTATION OR QAR, RESPECTIVELY (BUT EXCLUDING PASS- THROUGH CHARGES FOR PROCURING COMPARATOR DRUG). CATALENT SHALL
HAVE NO LIABILITY UNDER THIS QUOTATION OR QAR FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED PRODUCT. NEITHER PARTY SHALL
BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF PERFORMANCE UNDER THIS QUOTATION,
INCLUDING WITHOUT LIMITATION LOSS OF REVENUES, PROFITS OR DATA, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED
OF THE POSSIBILITY OF SUCH DAMAGES.

 

I.
Confidentiality. All information disclosed by a party in connection with this Quotation shall be confidential information,
unless such information is (i) already known to the receiving party, on a non-confidential basis, as evidenced by written records;
(ii) independently developed or discovered by the receiving party without the use of the disclosing party’s confidential
information, as evidenced by written records; (iii) in the public domain, other than through the fault of the receiving party;
or (iv) disclosed to the receiving party by a third party not in breach of a duty of confidentiality owed to the disclosing party.
Neither party shall, without the other party’s prior written consent, use the confidential information of the other party
or disclose such information except (a) to provide to employees of the receiving party or its affiliated entities who require
such information to perform such party’s obligations under this Quotation, or (b) as required to be disclosed by law, or
court or administrative order; provided that the receiving party first gives prompt written notice thereof to the disclosing
party. This undertaking shall survive for 7 years following the date of this Quotation.

 

    	 	Catalent Confidential
	Page 11 of 13

     

    

 

 

J.
Intellectual Property. For purposes hereof, “Client IP” means all intellectual property and embodiments thereof
owned by or licensed to Client as of the date hereof or developed by Client with the Product; “Catalent IP” means
all intellectual property and embodiments thereof owned by or licensed to Catalent as of the date hereof. All Client IP shall
be owned solely by Client and no right therein is granted to Catalent under this Quotation. All Catalent IP shall be owned solely
by Catalent and no right therein is granted to Client under this Quotation. The parties shall cooperate to achieve the allocation
of rights to Inventions anticipated herein and each party shall be solely responsible for costs associated with the protection
of its intellectual property.

 

K.
Warranties. Catalent will supply the Product in accordance with the written specifications and instructions expressly set
forth or referenced in this Quotation and United States current Good Manufacturing Practices or current Good Laboratory Practices,
as applicable. THE WARRANTIES SET FORTH IN THIS ARTICLE ARE THE SOLE AND EXCLUSIVE WARRANTIES MADE BY CATALENT TO CLIENT, AND
CATALENT MAKES NO OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF
MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

 

L.
Client Obligations. Unless otherwise agreed to by the parties in writing, Client is solely responsible at its cost and
expense to (i) provide complete and accurate specification data regarding the Product; (ii) prepare all submissions to regulatory
authorities; and (iii) perform such other obligations of Client set forth in this Quotation.

 

M.
Indemnification. Client will indemnify Catalent, its affiliates and their respective directors, officers, employees and
agents against any third-party claim arising directly or indirectly from (i) the promotion, marketing, distribution or sale of,
or use of or exposure to the Product; (ii) the negligence or willful misconduct of Client; (iii) the breach of this Quotation
by Client; (iv) any actual or alleged infringement or violation of any third-party patent, trade secret, copyright, trademark
or other proprietary rights by intellectual property or other information provided by Client or Client’s exercise or control
over the services provided under this Quotation; in each case, including but not limited to costs associated with responding to
subpoenas and giving testimony relating to disputes between Client and third parties. Catalent will indemnify Client from and
against any third-party claim arising directly or indirectly from the negligence or willful misconduct of Catalent or the breach
of this Quotation by Catalent.

 

N.
Right to Dispose and Settle. If Catalent requests in writing from Client direction with respect to disposal of Product
belonging to Client and is unable to obtain a response from Client within a reasonable time period after making reasonable efforts
to do so, Catalent may in its sole discretion (i) dispose of all such items and (ii) set-off any and all amounts due to Catalent
or any of its affiliates from Client against any credits Client may hold with Catalent or any of its affiliates.

 

O.
Force Majeure. Neither party will be liable for any failure to perform or for delay in performance resulting from any cause
beyond its reasonable control, including without limitation acts of God, fires, floods or weather, strikes or lockouts, factory
shutdowns, embargoes, wars, hostilities or riots, or shortages in transportation. If the cause continues unabated for 90 days,
then both parties shall meet to discuss and negotiate in good faith what modifications to this Quotation should result from such
cause.

 

P.
Use and Disposal. Client represents and warrants to Catalent that Client will hold, use and/or dispose of Product in accordance
with all applicable laws, rules and regulations.

 

Q.
Record Retention. Unless the parties otherwise agree in writing, Catalent will retain batch, laboratory and other technical
records for the minimum period required by applicable law.

 

R.
Independent Contractor. The relationship of the parties is that of independent contractors and not of joint venturers,
co-partners, employer/employee or principal/agent.

 

S.
Publicity. Neither party will make any press release or other public disclosure regarding this Quotation or the transactions
contemplated hereby without the other party’s express prior written consent, except as required by applicable law, by any
governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which
case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the
approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press
release or public disclosure.

 

    	 	Catalent Confidential
	Page 12 of 13

     

    

 

 

T.
Amendment & Precedence. These Catalent Standard Comparator Procurement Terms and Conditions constitute a part of the
Quotation to which they are attached (collectively, “this Quotation”); provided, that these Catalent Standard
Comparator Procurement Terms and Conditions supersede any conflicting terms and conditions set forth in the Quotation to which
they are attached or any other document, including Client purchase order. This Quotation constitutes the entire understanding
between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties, with respect
to Catalent’s services under this Quotation. No term of this Quotation may be amended except upon written agreement of both
parties.

 

U.
Dispute Resolution. If a dispute arises between the parties in connection with this Quotation, the respective presidents
or Senior Executives of Catalent and Client shall first attempt to resolve the dispute. If such parties cannot resolve the dispute,
such dispute shall be resolved in the jurisdiction of the defendant party by binding arbitration in accordance with the then existing
commercial arbitration rules of The CPR Institute for Dispute Resolution, 366 Madison Avenue, New York, NY 10017.

 

V.
Survival. Subject to execution, the rights and obligations of Client and Catalent in Articles E, F, H, I, J, K, M, N, P,
Q, R, S, T, U, V, and W of these Catalent Standard Comparator Procurement Terms and Conditions shall survive termination or expiration
of this Quotation.

 

W.
Governing Law. This Quotation shall be governed by and construed under the laws of the State of New Jersey, USA, excluding
its conflict of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply
to this Quotation.

 

US
version – 31 July 2013

 

    	 	Catalent Confidential
	Page 13 of 13

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00300-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00300-of-00352.parquet"}], [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00300-of-00352.parquet"}]]