Document:

Solution
for BRI-ROL-001 PHASE I/IIA STUDY OF SV-BR-1-GM REGIMEN IN Metastatic or Locally Recurrent Breast Cancer Patients in Combination
with INCMGA00012 and Epacadostat

 

Project
QTE-9141060, Version 2

Date:
07 Jun 2019

 

Prepared
for

 

BriaCell
Therapeutics Corp 820 Heinz Avenue

Berkeley,
CA 94710 Markus Lacher

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

Phone:
925-681-9553

 

Provided
by

 

Catalent
Pharma Solutions, LLC

 

Address:
10381 Decatur Road, Philadelphia, PA 19154

Account
Executive: Brandon Pena

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

Proposal
Lead: Ken Penkala

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

 

www.catalent.com

more
products. better treatments. reliably supplied.TM

 

 

    	 

    	 

    

 

 

Section
1. Version History

 

Revisions

 

	Version	Date
    Issued	Reason(s)
	01	15May2019	Ballpark
    Estimate
	02	07Jun2019	Updated

 

Section
2. Executive Summary

 

Catalent
Pharma Solutions, LLC(“Catalent”) will perform clinical supply services for BriaCell Therapeutics Corp (““Client”)
under QTE-9141060 (the “Project”). All activities will be conducted per cGMP.

 

This
Quotation is valid for a period of 30 days unless mutually agreed otherwise. The Project will start once the fully executed Quotation
(the “Quotation”), materials and purchase order (if required) is received by Catalent. A signed and effective
Quality Technical Agreement is required to be on file prior to the initiation of any GMP activities.

 

	TOTAL
    PROJECT PRICE	PRICE
    ($)
	Project
    Set-Up Fees	8,900
	Procurement
    Fees (i.e. Booklet Labels, Ancillaries)	4,313
	Packaging
    Fees	53,049
	Catalent
    Estimated Fee-For-Service	78,905
	Estimated
    Courier Fees	4,000
	TOTAL	$149,167

 

Pricing
in this Quotation is based on the following:

 

Primary
/ Secondary Packaging:

 

Primary:

 

	 	●	~66,600
    Epacadostat tablets to be bottled. Produce ~1,200- 56ct. bottles in 2 packaging campaigns.
	 	●	No
    Tooling required. Bottles to be hand-filled

 

Secondary:

 

	 	●	The
    Epacadostat filled bottles will be labeled with a single panel label. Approximately 1,200 labeled bottles will be produced,
    in two packaging campaigns.
	 	●	INCMGA00012-
    Approximately 420 vials will be labeled with a single panel label and placed into a carton. The carton will be labeled with
    a single panel label and rendered tamper evident. Approximately 420 labeled cartons will be produced, in two packaging campaigns.
	 	●	Assumed
    Catalent will provide all labels and cartons.

 

Receipt,
Storage and Distribution:

 

	 	●	A
    Catalent US site (PHL) will provide distribution to clinical sites in the US.
	 	●	Catalent
    assume there will be 10 receipts of product. Two receipts each of: Epacadostat, INCMGA00012, Cyclophosphamide, Candin, and
    Interferon.
	 	●	Catalent
    assumes that Epacadostat and Cyclophosphamide drug will be stored at controlled room temperature conditions.

 

    	 	Catalent Confidential
	Page 2 of 23

     

    

 

 

	 	●	Catalent
    assume that Candin, INCMGA00012, and Intron drug will be stored at 2-8° C temperature conditions.
	 	●	Catalent
    will utilize 10 storage locations for IMP.
	 	●	Catalent
    will utilize 2 storage location for consumable materials.
	 	●	Catalent
    assumes that shipments will occur under CRTand 2-8°C conditions.
	 	●	Catalent
    assumes there will be 2 shipments per site.
	 	●	Catalent
    assumes Cyclophosphamide, Candin, and Interferon will not require repackaging and will be for distribution to sites only.

 

Pricing
includes access to Catalent fusionTM, a web-based portal platform that provides a secure, robust, web-enabled solution allowing
24/7 access to documents, information and reports. Pricing includes a dedicated Project Manager to support all facets of the project
as outlined below.

 

Brexit
Guidance

 

The
UK is currently negotiating the terms of leaving the EU (Brexit) by 31 October 2019. There remains no definitive indication on
changes to future regulatory and cross border trade requirements

 

The
possible need to modify the supply chain for products from UK to EU (and EU to UK) cannot be confirmed until negotiations are
concluded and the cost/complexity is known.

 

Planning
for all scenarios is prudent to ensure continuity of supply to patients regardless of the outcome, as such Catalent recommend
including all 3 EU Sites in regulatory submissions to provide maximum flexibility to use any named Catalent CSS facility in the
future.

 

Section
3. Project Activities

 

3.1.
Project Materials

 

The
following clinical trial materials, components, tooling and miscellaneous items will be required for this study:

 

	Product	Strength	Number
        of

        Batches
        / Lots
	Details
        /

        Comments
	Provided
    By
	Cyclophosphamide	500mg	2	N/A	Catalent
	Intron
    A	40,000
    IU	2	N/A	Catalent
	Candin	N/A	2	N/A	Catalent
	INCMGA00012	375mg	2	N/A	*BriaCell
    Therapeutics
	Epacadostat	300mg	2	N/A	*BriaCell
    Therapeutics
	Bottle-100cc	N/A	1	N/A	Catalent
	Closure
    38/400	N/A	1	N/A	Catalent

 

*Inventory
transfer from Incyte to BriaCell, via existing stock at Catalent.

 

BriaCell
Therapeutics Corp will provide Catalent with a delivery note/packing list of any bulk stock, patient kits or ancillary supplies
to be sent.

 

3.2.
Packaging and Labeling

 

Packaging
will take place under controlled ambient conditions.

 

    	 	Catalent Confidential
	Page 3 of 23

     

    

 

 

3.2.1.
Primary Packaging 

 

Bottle
Filling

 

Catalent
will fill bottles containing Epacadostat in the quantities listed below. Caps and induction seals will be applied to each bottle.

 

	Item	Contents	Quantity
    to be Produced
	Epacadostat	56
    fill count	~420
    Bottles- Run 1
	Epacadostat	56
    fill count	~780
    Bottles- Run 2

 

3.3.
Randomization, Label Translations, Label Designs and Label Printing

 

Randomization

 

	Label
    Randomization	Generation
    of Randomization List	Importation
    of Randomization list
	BriaCell
    Therapeutics	BriaCell
    Therapeutics	BriaCell
    Therapeutics

 

Label
Translations

 

	Provision
    of Master English Label Text	Provision
    of Translated Label Text	Regulatory
    Review Performed By
	BriaCell
    Therapeutics	BriaCell
    Therapeutics	BriaCell
    Therapeutics

 

Label
Design

 

Catalent
will provide label proofs to Client for review and approval prior to printing. The following labels are to be designed:

 

	Label
    Design	Label
    Description	Countries	Label
    Type
	1	Bottle	USA	Single
    Panel
	2	Vial	USA	Single
    Panel
	3	Carton	USA	Single
    Panel

 

Label
Printing

 

All
label printing will be performed internally at Catalent.

 

    	 	Catalent Confidential
	Page 4 of 23

     

    

 

 

3.4.
Secondary Packaging

 

Labeling
and Assembly

 

	 	●	The
    Epacadostat filled bottles will be labeled with a single panel label. Approximately 1,200 labeled bottles will be produced,
    in two packaging campaigns (campaign 1- ~420 bottles, campaign 2- ~780 bottles).
	 	●	INCMGA00012-
    Approximately 420 vials will be labeled with a single panel label and placed into a carton. The carton will be labeled with
    a single panel label and rendered tamper evident. Approximately 420 labeled cartons will be produced, in two packaging campaigns
    (campaign 1- ~147 cartons, campaign 2- ~273 cartons).

 

3.5.
Receipt, Clinical Storage and Distribution

 

3.5.1.
Clinical Storage Conditions

 

Clinical
Trial Materials will be received and stored at Catalent at controlled room temperature (15°C to 25°C) and under refrigeration
(2° to 8°C) in a secure, temperature-controlled, limited-access area.

 

3.5.2.
Distribution Conditions

 

Clinical
Trial Materials will be distributed at controlled room temperature (15°C to 25°C) and under refrigeration (2° to 8°C).

 

Standard
Service – request must be received no later than 12 noon (local time) or 10 am (Germany local time) for shipment to
be processed as requested within 2 working days.

 

For
shipments requiring insulated shippers, Catalent can provide a selection of shippers with standard configurations that have been
performance tested to provide options for a range of conditions. Client is responsible to provide Catalent with proper packing
instructions if a packaging validation has been performed.

 

Premium
Service – Clinical Storage & Distribution:

 

Catalent
may offer a Premium Service where receipts or shipments are required to be processed on a non-standard timeline. If expedited
receipts or shipments are required, charges will be applied to the Project Pricing Fees for services provided by Catalent, as
below. Premium Service charges may also be applied where Client-supplied documentation or information has not been provided in
a manner or timeframe allowing for a standard turnaround time for receipts or shipments. If a premium courier service is required
to support an expedited shipment, then the associated courier fees will also be charged to the Client.

 

Note:
Due to external factors (e.g., surrounding temperature, false storage, false conditioning of a shipper), Catalent does not guarantee
the temperature of any shipment.

 

3.5.3.
Distribution Systems Integration

 

BriaCell
Therapeutics Corp has confirmed that IRT services will be provided by TBD.

 

    	 	Catalent Confidential
	Page 5 of 23

     

    

 

 

fusionInSiteTM
TRD

 

Through
Catalent’s fusionInSiteTM portal, Clients can access in a central place the Temperature Recording Device (“TRD”)
related data associated with their shipments. This is a subscription service per Project which many of Catalent’s third-party
depots also support. Third-party depots provide TRD data to Catalent and this is automatically uploaded against the specific shipment,
enabling the Client to view in fusionInSiteTM.

 

fusionConnectTM
– Receiving Shipment Requests from IRT

 

Catalent
requests that Client send all shipment requests to Catalent’s integration platform, fusionConnectTM, from either Client’s
in-house systems or preferred IRT. Catalent, via fusionConnectTM, will send acknowledgments and additional information when
shipments are dispatched and delivered, adding significant value to the Client’s clinical trial monitoring and management.
Catalent has a standard messaging format to receive and send shipment information and will share technical specifications as part
of the engagement process. If Catalent has not integrated with a particular IRT then it will engage with that IRT to use the Catalent
standard messaging format. Similarly, if the vendor system has not been previously integrated to then a “custom” adapter
will be created, if required at an additional cost.

 

Note:
Client MUST instruct IRT that integration to fusionConnectTM is required.

 

	Inserted
    as additional line in Distribution Pricing section:	Price
	fusionConnectTM
    Study set-up fee	$1,600
	fusionConnectTM
    custom adapter creation fee	Based
    upon agreed specifications

 

3.6.
Clinical Supplies Management

 

Clinical
Supplies Management (CSM) combines the experience of our drug supply professionals with simulation/forecasting capabilities, for
either a single protocol or an entire program, supporting your study from initial strategy to final drug accountability to provide
cost effective approaches and give you peace of mind.

 

Your
Catalent Clinical Supplies Manager will liaise with Catalent Project Managers, the Sponsor, Clinical and IRT personnel to assist
with supply forecasts and managing the supply strategy throughout the project lifecycle. This role includes effective management,
monitoring and re-forecasting of packaging and distribution strategy to maximize the effectiveness of the clinical supply chain
while minimizing cost and risk.

 

Three
levels of service can be provided:

 

	 	●	Clinical
    Supplies Management Consultation brings the experience and expertise of the drug supply process to the client on an “as
    needed” basis at one or more points in the project lifecycle.
	 	 	 
	 	●	Clinical
    Supplies Management brings the experience and expertise of the drug supply process to the client in a full time capacity
    across the complete project lifecycle from initial packaging/distribution strategy to final drug accountability.
	 	 	 
	 	●	Clinical
    Supplies Management combined with Simulation Optimization. Utilization of the Simulation tool executes various scenarios
    based upon numerous Monte Carlo simulations to mirror real life variability in the course of your clinical trial. Simulation
    allows fast comparison of various supply and clinical plan strategies, providing data to answer supply chain costs of What
    If questions such as:

 

	 	○	Variations
    in size of lots; expiry dates; enrollment rates; # sites; # countries; # depots...
	 	○	Order
    quantity and phasing of purchases or manufacture campaigns
	 	○	Central
    vs regional or local randomizations
	 	○	Implications
    to distribution costs of various strategies 

 

Pricing
for any of the above services can be provided upon request.

 

    	 	Catalent Confidential
	Page 6 of 23

     

    

 

 

3.7.
Handling of Returns

 

Catalent
does not customarily receive Returned medications (unused or used) for reuse. Exceptions to this will require review by Catalent.

 

If
requested, Catalent will receive the Clinical Trial Materials from the clinical site and perform accountability to the shipping
unit level.

 

A
shipper returned from the study site(s) may contain more than one patient pack but should not exceed 10kg weight. Catalent will
not accept sharps or used syringes with needles intact as returned clinical supplies. These supplies are considered medical waste.

 

Returned
unused Clinical Trial Materials will be stored in an appropriate area at ambient temperature (unless otherwise specified) and
kept segregated until requested by BriaCell Therapeutics to arrange for destruction.

 

On
destruction, a Certificate of Destruction will be provided to BriaCell Therapeutics.

 

Section
4. Project Pricing Detail

 

4.1.
Set Up Fees

 

	PROJECT
    SET UP
	Item	Description	Unit
        Price

        ($)
	Est.
    Quantity	Est.

        Price ($)

	Set-up
        Fee – Packaging

        Primary
        packaging and/or Secondary packaging

        Single
        panel label application 2 dose strengths
	Per
    initial set-up	$1,800	2	3,600
	 	Per
    subsequent set-up (assumes same scope as Initial run)	$900	2	1,800
	Set-up
        Fee – Distribution One country,

        One
        Catalent facility Non-hazardous, not controlled drug
	Per
    study set-up - US	$3,500	1	3,500
	Subtotal	$8,900

 

    	 	Catalent Confidential
	Page 7 of 23

     

    

 

 

4.2.
Fixed Fees

 

Catalent
PHL

 

	PACKAGING
    AND LABELING
	Description	Price
    ($)
	Batch
    Records and Labor- Epacadostat Bottle Filling Campaign 1	7,500
	Batch
    Records and Labor- Epacadostat Bottle Labeling Campaign 1	7,500
	Batch
    Records and Labor- INCMGA00012 Campaign 1	9,571
	Batch
    Records and Labor- Epacadostat Bottle Filling Campaign 2	7,500
	Batch
    Records and Labor- Epacadostat Bottle Labeling Campaign 2	10,044
	Batch
    Records and Labor- INCMGA00012 Campaign 2	10,934
	Components	4,313
	Subtotal	$57,362

 

4.3.
Fee-For-Service

 

Catalent
US (PHL)

 

	PROJECT
    MANAGEMENT
	Item	Description	Unit
        Price

        ($)
	Est.
    Quantity	Est.

        Price
        ($)

	Management
    Fee – includes Project Management Service to support monitoring of study execution-	Per
    Month (Non CRO)	$495	24	11,880
	Subtotal	$11,880

 

	RECEIPT
    AND STORAGE
	Item	Description	Unit
        Price 

        ($)
	Est.
    Quantity	Est.
        

        Price
        ($)

	Receipt
    of supplies	Per
    Ambient Lot per pallet*	$350	4	1,400
	Per
    Lot of Ambient Materials/Ancillary items*	$350	2	700
	Per
    Refrigerated Lot per pallet*	$600	6	3,600
	Premium
    Receipts	Per
    Receipt (within 48 Hours)	$500	TBC	TBC
	Per
    Receipt (within 96 Hours)	$300	TBC	TBC
	Bulk
    Drug Lot Sampling - (Ambient)	Per
    Occurrence	$300	TBC	TBC
	Bulk
    Drug Lot Sampling- (Refrigerated)	Per
    Occurrence	$500	TBC	TBC
	Storage
of clinical trial materials – per location or partial location per month
	Controlled
    Room Temp (15°C to 25°C)	$100	144
    (6 locations for 24 months)	14,400
	Refrigerated
    Temp (2°C to 8°C)	$200	144
    (6 locations for 24 months)	28,800
	Subtotal	$48,900

 

*Should
non-barcoded supplies or unreadable barcodes be received at Catalent, then additional charges may be applicable for the application
of barcodes. A receipt fee will be charged for each pallet or lot, whichever is the greater number, received in a delivery (e.g.,
if 4 lots are received on 1 pallet, 4 receipt fees will be charged; if 1 lot is received on 3 pallets, 3 receipt fees will be
charged).

 

    	 	Catalent Confidential
	Page 8 of 23

     

    

 

 

	DISTRIBUTION
	Item	Description	Unit
        Price 

        ($)
	Est.
    Quantity	Est.
        

        Price
        ($)

	Manual
    preparation for shipment (up to 20 items)	Controlled
    Room Temperature (15°C to 25°C) - Administration fee per shipment	$195
    domestic	10	1,950
	 	Refrigerated
    (2°C to 8°C) - Administration fee per shipment	$195
    domestic	10	1,950
	Items
    21-100	Ambient/Controlled
    Room Temp/Refrigerated	$7
    per item	TBC	TBC
	Items
    101-300	$5
    per item	TBC	TBC
	Items
    301+	$3
    per item	TBC	TBC
	Premium
    Shipments (Same Day)	Per
    shipment	$500	TBC	TBC
	Premium
    Shipments (Next Day)	Per
    Shipment	$300	TBC	TBC
	Surcharge
    Standard Hazardous Shipment	Per
    Shipment	$100	TBC	TBC
	Surcharge
    Bulk Hazardous Shipment	Per
    Shipment	$250	TBC	TBC
	Performance
    tested insulated shippers/ temperature recording devices (TRD’s)	Per
    Small shipper	$110	TBC	TBC
	Per
    Medium Shipper	$115	TBC	TBC
	Per
    Large Shipper	$125	TBC	TBC
	Per
    Extra Large Shipper	$200	10	2,000
	Per
    Extra Large Shipper	$200	10	2,000
	Per
    Standard USB Temperature Recording Device	$75	10	750
	Subtotal	$8,650

 

*Plus
insulated shippers/TRDs, as appropriate.

 

    	 	Catalent Confidential
	Page 9 of 23

     

    

 

 

Catalent
KCM (for returned goods)

 

	RETURNS
    AND DESTRUCTION
	Item	Description	Unit

        Price
        ($)
	Est.
    Quantity	Est.

        Price
        ($)

	Returns
    protocol initiation	Per
    protocol	$1,400	1	1,400
	Returns
    receipt	Per
    shipper received (Standard ambient receipts)	$300	5	1,500
	Accountability
    processing (standard process)	Per
    hour	$175	5	875
	Pre-prepared
    returns kits (includes carton, airway bill, packing materials; tamper seals/secure materials added as applicable)	Per
    carton	$85	TBC	TBC
	Pre-prepared
    return Label only	Per
    label	$15	TBC	TBC
	Storage
    of returned medication	Per
    month – per location or partial location	$100	12	1,200
	Preparation
    for destruction (may include any material pertaining to this Project, not solely returned drug supplies)	Price
    per hour	$175	10	1,750
	Destruction
    (not controlled or hazardous)	Per
    pound (minimum charge of $500)	$3	167	500
	Subtotal	$7,225

 

Catalent
PHL (Destruction Only – onsite materials)

 

	DESTRUCTION
	Item	Description	Unit
        Price 

        ($)
	Est.
    Quantity	Est.

        Price
        ($)

	Preparation
    for destruction (may include any material pertaining to this Project, not solely returned drug supplies)	Price
    per hour	$175	10	1,750
	 	 	 	 	 
	Destruction
    (not controlled or hazardous)	Per
    pound (minimum charge of $500)	$3	167	500
	Subtotal	$2,250

 

    	 	Catalent Confidential
	Page 10 of 23

     

    

 

 

4.4.
Estimated Courier Fees*

 

	ESTIMATED
    COURIER FEES*
	Depot
    Proposed	Country	Total
        Qty. of 

        Shipments
	Shipper	Est.
        Price 

        Per
        

        Shipment
        

        ($)
	Est.
        Total 

        Price
        ($)

	PHL	USA	20	TBC	200	4,000
	Total
    Estimated Fees for Couriers	$4,000

 

*Please
note customs duty charges are not included in the above costs. Courier Fees have been calculated with no knowledge of where the
sites are to be located.

 

The
above prices are based on using Catalent’s standard courier service. Should a premium courier service be required (i.e.,
World Courier, Marken, etc.), revised pricing would apply and the cost for the hire/use of premium courier shippers will be included
within the courier cost.

 

Catalent
will provide a listing of prices (including courier charges) for each shipment made but is unable to provide copies of original
courier invoices. Examples of formats of these listings are available upon request. Courier Charges to be billed to:

 

	Catalent
    Account: [X]	Client
    Account: [  ]

 

Note
– if Catalent is to use BriaCell Therapeutics’ courier account for shipments to site, an additional charge is applicable
to cover the administration of using this account. Should Catalent be asked to investigate damage or temperature excursions in
transit when using Client’s courier account, an additional charge of $120 per hour will be applicable.

 

4.5.
Revisions to Pricing

 

Catalent
reserves the right to revise quoted price for any project because of initial scope change, planned deviations, revisions in specifications,
modifications of test methods, undocumented requirements, retesting, requirements outside of Catalent SOPs, or any unforeseen
difficulty in executing the project.

 

In
addition, the quoted prices are subject to annual review to account for changes in inflation, increased overhead charges, etc.
Any additional work will be performed based on written agreement from Client and will be documented on a Catalent QAR.

 

    	 	Catalent Confidential
	Page 11 of 23

     

    

 

 

Section
5. Invoicing Terms and Payment Terms

 

5.1.
Invoicing Terms

 

Catalent
will issue invoices for completed milestones. If a milestone includes multiple batches or packaging runs, each batch may be invoiced
when completed along with any release testing that may be required.

 

Client
Invoices should be emailed to the following address:

 

BriaCell
Therapeutics Corp Markus Lacher

820
Heinz Avenue

Berkeley,
CA 94710

 

Set
Up Fees

 

	DESCRIPTION	PRICE
    ($)
	Upon
    signature of Packaging Request—initial run (Project set-up)	3,600
	Upon
    signature of Packaging Request—subsequent run 1	900
	Upon
    signature of Packaging Request—subsequent run 2	900
	Upon
    signature of Distribution Summary – PHL	3,500
	TOTAL	$8,900

 

Fixed
Fees

 

	DESCRIPTION	PRICE
    ($)
	Upon
    signature of this Quotation (procurement items, materials ONLY)	4,313
	Upon
    completion of Primary Packaging	17,071
	Upon
    completion of Secondary Packaging	35,978
	TOTAL	$57,362

 

Fee-For-Service

 

	DESCRIPTION	PRICE
    ($)
	FFS
    prices will be billed independently as incurred	78,905
	TOTAL	$78,905

 

    	 	Catalent Confidential
	Page 12 of 23

     

    

 

 

Courier
Fees

 

	DESCRIPTION	PRICE ($)
	Will be billed independently as incurred	4,000
	TOTAL	$4,000

 

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

 

 5.2. Payment Terms

 

Payments
for all invoices are due within 30 days following the date of the invoice and are non-refundable. Any applicable wire transfer
fees must be included in the payment issued to Catalent. Notwithstanding any other provision of this Quotation, if at any time
any payment is not received by Catalent by its due date, then Catalent may, in addition to any other remedies available at equity
or in law, (A) charge interest on the outstanding sum from the due date (both before and after any judgment) at 2% per month until
paid in full (or, if less, the maximum amount permitted by Applicable Laws); (B) suspend any further performance hereunder until
such invoice is paid in full; (C) require payment in advance before performing any further Services or making any further shipment
of Product; and/or (D) terminate this Quotation, all without releasing Client from its obligations under this Quotation.

 

5.3.
Advance Payment

 

Notwithstanding
any other provision of this Quotation, if at any time Catalent determines that Client’s credit is impaired, Catalent may
require payment in advance before performing any further services or making any further shipment of Product. If Client shall fail,
within a reasonable time, to make such payment in advance, or if Client shall fail to make any payment when due, Catalent shall
have the right, at its option, to suspend any further performance hereunder until such default is corrected, without thereby releasing
Client from its obligations under this Agreement.

 

Section
6. Scheduling/Deliverables

 

6.1.
Scheduling

 

A
signed Quotation, purchase order number (where applicable), a signed protocol (if applicable) and all Client-supplied materials
must be received by Catalent for this Project to be scheduled. A signed and effective Quality Technical Agreement must be on file
prior to the initiation of any GMP activities.

 

Once
scheduled, Client will be notified by the Project Manager of the anticipated start and completion date of the Project activities.

 

The
parties to this Quotation agree that, notwithstanding the 30-day period of acceptance set forth in Section A of the Terms and
Conditions governing this Quotation, this Quotation must be signed and delivered by 07Jul2019 in order to schedule project
key dates.

 

The
parties intend this acceptance date to take precedence and control over Section A of the Terms and Conditions, notwithstanding
any amendments thereto agreed in accordance with its terms.

 

Provided
that (i) all project set-up milestones communicated in a Project Plan by the Project Manager are met, and (ii) Catalent receives
all supplies, information, materials and Client approvals, in accordance with the dates communicated, Catalent will target the
following dates (“Target Dates”) set out below.

 

Client
Required Target Dates:

 

	Target
    Packaging Completion date	August
    2019
	Target
    Shipment Availability date	September
    2019

 

BriaCell
Therapeutics Corp has not provided required Target Dates for this work, so assumptions have been made without an assessment of
operations capacity. These dates will be revised and confirmed upon receipt of additional information from BriaCell Therapeutics
Corp.

 

    	 	Catalent Confidential
	Page 13 of 23

     

    

 

 

Section
7. Additional Project Terms

 

7.1.
Premium Services

 

Where
supplies, information, materials or approvals are received later than the dates defined in the Project Plan, Catalent may offer
a premium service whereby the original Target Dates (or such revised Target Dates as may be agreed between the parties in writing),
may be achieved (“Premium Service”). If the delays in the Client providing supplies, information, materials or approvals
are caused by a late deliverable from Catalent, and are not attributable to the Client or a third party, Catalent will target
to deliver to the original Target Dates.

 

Premium
Service – Manufacturing & Packaging

 

Catalent
may offer a Premium Service where Manufacturing & Packaging work is required to be delivered on an accelerated, non-standard
timeline. If communicated prior to acceptance of this Quotation, charges will be included in the Project Pricing section of the
Quotation for the expedited delivery of work to non-standard timelines. If a Premium Service is required after acceptance of this
original Quotation, then charges will be applied as below or, in exceptional circumstances, a Quotation Amendment Request (“QAR”)
may be issued. Catalent will notify the Client in advance of the Premium Service level that will be applied.

 

	Premium
    Service Level	Premium
                                         Service Charges

        (%
        charged in addition to the service being expedited; i.e., set-up, label design, packaging, etc.)

	Silver

        (Acceleration
        of work to mitigate delays to achieve original Target Date with standard working resources and hours)
	 

        50%

	Gold

        (Acceleration
        of work to mitigate delays to achieve original Target Date with over-time or additional working resources and hours)
	 

        100%

	Platinum

        (Acceleration
        of work to mitigate delays and deliver to revised Target Date with over-time or additional working resources and
        hours)
	 

        150%

	Diamond

        (Acceleration
        of work to mitigate delays and deliver to revised Target Date with additional shifts deployed and over-time and/or
        resource)
	 

        200%
        or QAR may be issued to detail specific pricing.

 

7.2.
Cancellations and Postponements

 

Client
shall have the right to cancel or postpone their reserved manufacturing or packaging slot at any time upon written notice to Catalent.

 

If
this Project is cancelled by Client, Catalent will invoice Client the cost of any samples/materials, work performed before cancellation,
reference materials, equipment, and supplies purchased by Catalent specifically for this Project.

 

For
batch manufacturing or packaging, if Client cancels or postpones their reserved manufacturing/ packaging slot, Catalent reserves
the right to invoice fees according to the following calendar day schedule.

 

    	 	Catalent Confidential
	Page 14 of 23

     

    

 

 

	Notification
    Prior to Date of Packaging or Manufacturing	Fee
    (% of Total Packaging or Manufacturing Cost)
	20
    – 29 days	25
    %
	10
    – 19 days	50
    %
	4
    – 9 days	75
    %
	0
    – 3 days	90
    %

 

For
shipment requests, if Client cancels a requested shipment prior to picking of the shipment then the administration fee only for
the shipment will be charged. If Client cancels a requested shipment after picking of the shipment has started then the full value
of the shipment (administration fee and any associated pick fees) will be charged.

 

7.3.
Mutual Termination Rights

 

Either
party may terminate this Quotation immediately without further action if (A) the other party files a petition in bankruptcy, or
enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver, administrative receiver,
trustee or administrator, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating
it to be bankrupt or insolvent and such order is not discharged within 30 days, or takes any equivalent or similar action in consequence
of debt in any jurisdiction; or (B) the other party materially breaches any of the provisions of this Quotation, and such breach
is not cured within 60 days after the giving of written notice requiring the breach to be remedied.

 

If
this Quotation is terminated, Client shall pay Catalent for all Services performed up to the date of termination plus any applicable
cancellation fees pursuant to Section 7.2, and shall reimburse Catalent for all costs and expenses incurred, and all non-cancelable
commitments made, in the performance of Services, including (A) any costs incurred to wind down and cease any ongoing Services
and (B) all costs for Client-specific purchases made by Catalent.

 

7.4.
Additional Fees

 

In
addition to the fixed fees, the following charges may apply. No charges will be issued unless the materials are required or the
service is needed.

 

	Activity	Description	Price
    per Unit
	Administrative
    Fees	Administrative
tasks such as photocopying of raw data
	$150
    per hour

 

	Other
    Charges	Description
	Project-specific
    travel and/or meetings	Airfare
    costs will be issued through to Client. A daily per diem for travel time, accommodation, food, and transportation will be
    agreed between Catalent and Client. A QAR will be issued related to any travel requirements.
	Additional
    or non-standard Project Management Service	Project
                                                                                                                        Management Services associated with study set up and monitoring of study execution and close-out includes: weekly team
                                                                                                                        teleconference with Client to update project status and activities. Generation of Catalent Project Management documentation
                                                                                                                        to support set-up and monitoring of study execution – scope documents, agendas and minutes, Project timeline (Gantt)
                                                                                                                        etc.

	 	Any
                                                                                                                            additional or special requests e.g. Completion of Client required documentation/reports, required solely for
                                                                                                                            Client’s Project will be discussed, agreed and invoiced to Client following Client approval

 

    	 	Catalent Confidential
	Page 15 of 23

     

    

 

 

7.4.1.
Government Fees and Expenses

 

Client
shall reimburse Catalent for any payments Catalent is required to make to any regulatory authority resulting directly from Catalent’s
formulation, development, manufacturing, processing, filling, packaging, storing or testing of Client’s product or Client-supplied
materials including without limitation any payments or fees Catalent is required to make pursuant to the Generic Drug User Fee
Amendments of 2017 (“GDUFA Fees”). For generic drugs, GDUFA Fees apply when the ANDA is filed and are due thereafter
on an annual basis, unless otherwise specifically agreed in a supply agreement between Catalent and Client. Catalent will invoice
Client for Client’s pro-rata share of the annual GDUFA Fees Catalent incurs for each Catalent manufacturing or packaging
facility identified in Client’s ANDA(s) pursuant to FDA regulations (this includes but is not limited to any Catalent facility
which manufactured or packaged Client’s registration batches). Catalent will invoice Client for reimbursement of all other
payments or fees at the time they are incurred by Catalent. Client shall pay all such invoices within 30 days from the date of
such invoice.

 

7.5.
Project Management

 

Following
execution of this Quotation, Catalent will conduct the work detailed herein under the leadership of a Project Manager (“PM”).
As the Client advocate, the Project Manager will serve as the primary point of contact for communication between Client and Catalent
to ensure effective flow of information and rapid resolution of any issues. To achieve this, Catalent will establish and maintain
a cohesive and highly effective project team throughout the project lifecycle.

 

	PROJECT
    MANAGEMENT
	Activity	Monthly
    Management Fee
	Bi-Weekly (Non-CRO) one-hour meetings during the maintenance of the project (after set up phase is complete)

                                                                                 
	

        √

	Monitor the compliance to the project plan and update the plan

                                                                                 
	√
	Ongoing Identification of project risks and ensure they are recognized and satisfactorily addressed.

                                                                                 
	

        √

	Monitor the project deliverables to ensure milestones are delivered per agreed-upon timeline

                                                                                 
	

        √

	Ongoing study communication and maintenance of day to day activities.

                                                                                 
	

                                                                                √

	Monitor
    adherence to the contractual scope and initiate Quotation Amendment Records as required (If a detailed budget tracker is required
    this may be provided as an additional PM service).	√

 

    	 	Catalent Confidential
	Page 16 of 23

     

    

 

 

Collectively
the Monthly Management Fee accounts for up to a total of 4hrs (or 8hrs for CRO) of project management activities as detailed above.
Any changes in scope (either by activity or time), such as revisions to documents or additional meetings would be billed at the
hourly PM Fee rate. Monthly Management Fees (if applicable) will commence upon signature of this contract

 

	PROJECT
    SET-UP MEETINGS
	Activity	Packaging
    set up	Distribution

                                                                                Set up

	Kick-off
    meeting with Client to review Quotation; includes meeting minutes	√	√
	Preparation
    of project documentation	√	√
	Internal
    kick-off meeting at all Catalent facilities involved in the Project	√	√
	Weekly
    one-hour meetings during project set-up	√	 
	Distribution
    project set-up meetings	 	√
	Country
    set-ups	 	√

 

Any
changes in scope requiring revisions to documents or additional meetings would be billed at the hourly PM Fee rate.

 

 7.6. Project Notes/Assumptions

 

		●	Prices
                                         are based on utilizing Catalent approved suppliers for raw materials and/or packaging
                                         components. If raw materials and/or packaging components are required to be supplied
                                         by un- approved vendors the Client may either supply the raw material and/or packaging
                                         component from a Client-approved vendor or Catalent will audit the vendor at the Client’s
                                         cost.

 

		●	Prices
                                         are based on using Catalent’s standard practices. If additional services are required
                                         that exceed the standard Catalent practices (i.e., per a Client-specific Quality Agreement)
                                         additional costs may be incurred.

 

		●	The
                                         storage rate provided in this Quotation is for the standard Catalent unit of storage
                                         for that particular storage temperature. Dependent upon the location and requirements,
                                         Catalent may also utilize different types of storage unit to provide more cost-effective
                                         storage solutions or to increase process efficiency. Should items be stored in a non-standard
                                         storage location the Client will be charged an appropriate percentage of the standard
                                         unit price.

 

		●	Catalent
                                         has commercial agreements with its suppliers and vendors that are not limited to the
                                         goods and services to be procured under this work order; Catalent does not pass through
                                         benefits (cash discounts, trade discounts, rebates or allowances), if any, received under
                                         such agreements.

 

    	 	Catalent Confidential
	Page 17 of 23

     

    

 

	 	●	Pricing
        for components/materials does not include incoming freight charges, associated shipping materials, insurance charges,
        taxes or customs charges into the country of the receiving Catalent facility. Charges will be invoiced once they are received
        and are payable by Client.

         

		●	Catalent
                                         shall not be obligated to perform any services which would involve any countries that
                                         are targeted by the comprehensive sanctions, restrictions or embargoes administered by
                                         the United Nations, European Union, United Kingdom or United States.

 

Section
8. Terms and Conditions

 

This
Quotation is governed by Catalent’s Standard Terms and Conditions attached to this Quotation (the “Terms and Conditions”).

 

    	 	Catalent Confidential
	Page 18 of 23

     

    

 

 

 

    	 	Catalent Confidential
	Page 19 of 23

     

    

 

 

Catalent
Standard Terms and Conditions

 

These
Catalent Standard Terms and Conditions (“Terms and Conditions”) constitute a part of this Quotation to which
they are attached (collectively, this “Quotation”), provided, that these Terms and Conditions supersede
any conflicting terms and conditions set forth in this Quotation to which they are attached or any other document, including Client’s
purchase orders. Catalent shall have the right to cause any of its Affiliates to perform any of its obligations hereunder; provided
that Catalent shall remain liable for the performance of such Affiliates.

 

 A. Definitions.

 

“Affiliate(s)”
means, with respect to Client or any third party, any corporation, firm, partnership or other entity that controls, is controlled
by or is under common control with such entity; and with respect to Catalent, “Affiliate(s)” means Catalent, Inc.,
and any corporation, firm, partnership or other entity controlled by Catalent, Inc. For the purposes of this definition, “control”
means the ownership of at least fifty percent (50%) of the voting share capital of an entity or any other comparable equity or
ownership interest.

 

“Applicable
Laws” means, with respect to Client, all laws, ordinances, rules and regulations, currently in effect or enacted or
promulgated during the term of this Quotation, and as amended from time to time, of each jurisdiction in which Client-supplied
Materials and Product are produced, marketed, distributed, used or sold; and with respect to Catalent, all laws, ordinances, rules
and regulations, currently in effect or enacted or promulgated during the term of this Quotation, and as amended from time to
time, of each jurisdiction in which Catalent performs the Project; provided that cGMP shall not constitute Applicable Laws
except to the extent expressly stated in the applicable Quotation.

 

“Client-supplied
Materials” means any materials to be supplied by or on behalf of Client to Catalent for use in the Project, including
but not limited to, API, any client trial materials, Product, reference materials, and any Comparator Drug supplied by Client
or procured by Catalent at the direction of Client.

 

“Comparator
Drug” means any investigational or marketed product or placebo which is used as a reference in a clinical trial.

 

“Product”
means the pharmaceutical product, which is the subject of the Project pursuant to this Quotation. “Project”
means the services performed by Catalent for Client under this Quotation.

 

B. 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 Project
specifications, instructions, procedures, assumptions, processes, test protocols, test methods or analytical requirements;
(iii) for such other reasons set forth in this Quotation; or (iv) any unforeseen circumstances which affect the Project. Any
revision to this Quotation shall be set forth in a Quotation Amendment Record (“QAR”) signed by both
parties in accordance with Article R. In addition, the prices provided in this Quotation are subject to annual review to
address changes in inflation, increased overhead charges, and other commercially reasonable factors.

 

C. Client
Obligations. Client grants Catalent full authority to use any Client-supplied Materials and Product for purposes of the
Project. Unless otherwise agreed to by the parties in writing, Client is solely responsible at its cost and expense to (i)
provide complete and accurate scientific data regarding the Project; (ii) deliver to Catalent all Client-supplied Materials
and Product in quantities and quality sufficient to meet the requirements of the Project within timelines consistent with the
Project, and provide a Safety Data Sheet as required; (iii) prepare all submissions to regulatory authorities and obtain
Catalent’s prior written consent (which will not be unreasonably withheld) before identifying Catalent in such
regulatory submissions; (iv) if applicable, review and approve all in-process and finished Product test results to ensure
conformity of such results with the Product specifications, regardless of which party is responsible for finished Product
release; and (v) perform such other obligations of Client set forth in this Quotation. Client shall retain title to
Client-supplied Materials at all times and shall bear the risk of loss thereof.

 

    	 	Catalent Confidential
	Page 20 of 23

     

    

 

 

D. Delivery.
(i) Catalent shall deliver all Product, Comparator Drug and other materials the subject of the Project EXW (Incoterms 2010)
Catalent’s facilities. To the extent not already held by Client, title shall pass to Client upon such tender of
delivery. When Catalent provides storage under the Project, title and risk of loss shall pass to Client upon transfer to
storage. (ii) In the event Catalent arranges shipping or performs similar loading and/or logistics under the Project for
Client at Client’s request, such loading and/or logistics are performed by Catalent at Client’s expense and on
Client’s behalf as a convenience to Client only and does not alter subsection (i) herein.

 

E. Invoices
and Payments. Catalent will invoice Client as set forth in this Quotation. Payments for all invoices are due within 30
days following the date of the invoice and are non-refundable. Payment for Comparator Drug is as set forth in the terms of
the Quotation. Notwithstanding any other provision of this Quotation, if at any time any payment is not received by Catalent
by its due date, then Catalent may, in addition to any other remedies available at equity or in law, (i) charge interest on
the outstanding sum from the due date (both before and after any judgment) at 2% per month until paid in full (or, if less,
the maximum amount permitted by Applicable Laws); (ii) suspend any further performance of the Project hereunder until such
invoice is paid in full, without releasing Client from its obligations under this Quotation; (iii) require payment in advance
before any further performance of the Project or making any further shipments hereunder; and/or (iv) terminate this
Quotation, all without releasing Client from its obligations under this Quotation; and Client shall reimburse Catalent for
all costs and expenses incurred and all non- cancellable commitments made under the Project. 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 for Client-supplied materials and Product
arising from the Project are the responsibility of Client, whether paid by Catalent or Client.

 

G. Regulatory
Compliance. Catalent shall obtain and maintain all permits and licenses with respect to general facility operations in
the jurisdiction in which Catalent performs the Project. Client shall be responsible at its cost to obtain and maintain all
other regulatory approvals, authorizations, certifications and permits relating to Product and Client-supplied Materials,
including without limitation, those relating to the import, export, use, distribution and sale of Product and Client-supplied
Materials. Client shall reimburse Catalent for any payments Catalent is required to make to any regulatory or governmental
authority pursuant to Applicable Laws resulting directly from Catalent’s formulation, development, manufacturing,
processing, filling, packaging, storing or testing of Client’s Product or Client-supplied Materials. Catalent shall not
be obligated to perform any services under the Project which would involve any countries that are targeted by the
comprehensive sanctions, restrictions or embargoes administered by the United Nations, European Union, United Kingdom or
United States.

 

H. Audits.
Client may conduct one quality assurance facility audit every other year at no cost, at reasonable times during regular
business hours. Additional audits will be invoiced separately at the current rate for such audit unless such audit is for a
material quality or compliance issue concerning the Project.

 

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

 

J. 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
Affiliates who require such information to perform such party’s obligations under this Quotation, or (b) as required to
be disclosed by law or regulation; 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 21 of 23

     

    

 

 

 K. Intellectual Property. For purposes hereof, “Background IP” means all intellectual property and embodiments thereof owned by or licensed to Client or Catalent, respectively, as of the date hereof, or developed by Client or Catalent, respectively, other than in connection with the Project; “Invention” means any intellectual property developed by either party in connection with the Project; “Client Inventions” means any Invention that relates exclusively to the Client Background IP or Client’s patented or proprietary API, as applicable; and “Catalent Inventions” means any Invention, other than a Client Invention, that relates exclusively to the Catalent Background IP or relates to developing, formulating, manufacturing, filling, processing, packaging, analyzing or testing pharmaceutical products. All Client Background IP and Client Inventions shall be owned solely by Client and no right therein is granted to Catalent under this Quotation except as necessary for use in performing the Project. All Catalent Background IP and Catalent Inventions 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.

 

L. Client
Warranties. Client is solely responsible at its cost and expense to (i) provide complete and accurate scientific data
regarding the Project; and (ii) hold, use and/or dispose of Client-supplied Materials and Product provided by Catalent in
accordance with Applicable Laws. Client warrants that no transactions or dealings under this Quotation shall be conducted
with or for an individual or entity that is designated as the target of any sanctions, restrictions or embargoes administered
by the United Nations, European Union, United Kingdom or the United States of America.

 

M. Catalent
Warranties. Catalent will perform the Project in accordance with the written specifications and Project instructions
expressly set forth or referenced in this Quotation. Catalent warrants that no transactions or dealings under this Quotation
shall be conducted with or for an individual or entity that is designated as the target of any sanctions, restrictions or
embargoes administered by the United Nations, European Union, United Kingdom or the United States of America. 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.

 

N. Indemnification.
Client will indemnify, defend and hold harmless Catalent, its Affiliates and their respective directors, officers, employees
and agents from and against any third-party claim arising directly or indirectly from (i) the manufacture, promotion,
marketing, distribution or sale of, or use of or exposure to, the Product and Client-supplied Materials that are the subject
of the Project, including Product liability and strict liability, (ii) the negligence or willful misconduct of Client, (iii)
the breach of its representations, warranties or obligations set out in this Quotation by Client, or (iv) any actual or
alleged infringement of any third-party intellectual property arising out of the use of Client information, Product and
Client-supplied Materials; 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, defend and hold harmless
Client, its Affiliates and their respective directors, officers, employees and agents from and against any third-party claim
arising directly or indirectly from the negligence or willful misconduct of Catalent or the breach of its representations,
warranties or obligations set out in this Quotation by Catalent.

 

O. Limitations
of Liability. CATALENT’S TOTAL LIABILITY UNDER THIS QUOTATION OR QAR SHALL IN NO EVENT EXCEED THE TOTAL FEES PAID
UNDER THIS QUOTATION OR QAR, RESPECTIVELY (BUT EXCLUDING TOTAL FEES PAYABLE AND PAID BY CLIENT TO CATALENT FOR COMPARATOR
DRUG).

 

CATALENT
SHALL HAVE NO LIABILITY UNDER THIS QUOTATION OR QAR FOR ANY AND ALL CLAIMS FOR LOST, DAMAGED OR DESTROYED CLIENT-SUPPLIED MATERIALS,
WHETHER OR NOT SUCH CLIENT- SUPPLIED MATERIALS ARE USED IN THE PROJECT OR INCORPORATED INTO FINISHED PRODUCT.

 

NEITHER
PARTY SHALL BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES OR
PROFITS (WHETHER DIRECT OR INDIRECT) OR LOSS OF DATA, ARISING OUT OF PERFORMANCE UNDER THIS QUOTATION OR QAR, WHETHER IN CONTRACT
OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

    	 	Catalent Confidential
	Page 22 of 23

     

    

 

 

P. Insurance.
Each party shall, at its own cost and expense, obtain and maintain in full force and effect during the term of this
Quotation the following: (i) Commercial General Liability Insurance with a per-occurrence limit of not less than $1,000,000;
(ii) Products and Completed Operations Liability Insurance with a per-occurrence limit of not less than $10,000,000; and
(iii) Workers’ Compensation Insurance with statutory limits and Employers Liability Insurance with limits of not less
than $1,000,000 per accident. Client shall maintain All Risk Property Insurance, including transit coverage, in an amount
equal to the full replacement value of its property while in, or in transit to or from, a Catalent facility. Each party shall
be named as an additional insured within the other party’s products liability insurance policies; provided that
such additional insured status will apply solely to the extent of the insured party’s indemnity obligations under this
Quotation and obtain a waiver of subrogation clause from its property insurance carriers in favor of the other
party.

 

Q. Termination.
Either party may terminate this Quotation immediately without further action if (i) the other party files a petition in
bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver,
administrative receiver, trustee or administrator, or makes an assignment for the benefit of creditors, or suffers or permits
the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within 30 days, or takes
any equivalent or similar action in consequence of debt in any jurisdiction; or (ii) notwithstanding Article E, the other
party materially breaches any of the provisions of this Quotation, and such breach is not cured within 60 days after the
giving of written notice requiring the breach to be remedied.

 

R. Amendment
and Precedence. 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 the Project. No term of this Quotation may be
amended except upon written agreement signed by both parties.

 

S. No
Waiver. Failure by either party to insist upon strict compliance with any term of this Quotation in any one or more
instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any
subsequent failure.

 

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

 

U. No
Third-Party Beneficiaries. This Quotation shall not confer any rights or remedies upon any person or entity other than
the parties named herein and their respective successors and permitted assigns.

 

V. Governing
Law and Dispute Resolution. This Quotation shall be governed by and construed under the laws of the State of New York,
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. If a dispute arises between the parties in connection with this Quotation, the respective
senior executives of Catalent and Client shall first attempt to resolve the dispute. If such executives cannot resolve the
dispute, such dispute shall be resolved in the English language, in New York by binding arbitration in accordance with the
then existing commercial arbitration rules of The CPR Institute for Conflict and Dispute Resolution, New York, NY.

 

W. 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 Laws, 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 prior to issuing the press release or public disclosure.

 

X. Right
to Dispose and Settle. If Catalent requests in writing from Client direction with respect to disposal of any inventories
of Client-supplied Materials, Product, samples or other items 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.

 

Y. Force
Majeure. Except as to payments required under this Quotation, 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, earthquakes, floods or weather, strikes or lockouts, factory shutdowns, embargoes, wars, armed hostilities, terrorist
events, 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.

 

Z. Survival.
Subject to execution, the rights and obligations of Client and Catalent in Articles E (Invoices and Payments), F (Taxes), G
(Regulatory Compliance), I (Regulatory Inspections), J (Confidentiality), K (Intellectual Property), L (Client Warranties), M
(Catalent Warranties), N (Indemnification), O (Limitations of Liability), P (Insurance), U (No Third-Party Beneficiaries), V
(Governing Law and Dispute Resolution), W (Publicity), X (Right to Dispose and Settle), and Z (Survival) of these Terms and
Conditions shall survive termination or expiration of this Quotation.

 

    	 	Catalent Confidential
	Page 23 of 23QUALITY
AGREEMENT

 

Between

 

BriaCell
Therapeutics Corp

820 Heinz Avenue

Berkley, CA 94710

 

And

 

Catalent
Pharma Solutions, LLC

14 Schoolhouse Road

Somerset, NJ 08873, US

 

(represented
by its signing affiliates)

 

For
Oral Drug Delivery and Clinical Supply Services

 

Effective
date: from date of final signature

 

Next
Review: Three (3) years from effective date

 

    	 	 	Page 1 of 21

    	 

    

 

APPROVALS

 

Customer

 

	 	 	2019
    June 25	 
	Printed
    Name William V. Williams	 	Date	 
	Function
    President and CEO	 	 	 

 

Catalent

 

	 	 	25
    June 2019	 
	Christine
    O’Connell	 	Date	 
	Interim
    Director, Quality, CSS	 	 	 
	Philadelphia	 	 	 

 

    	 	 	Page 2 of 21

    	 

    

 

CATALENT
SITES INCLUDED

 

	Catalent
    Site	 	Applicable*
	 	 	 
	Bathgate,
    UK	Catalent CTS (Edinburgh) Ltd

                                                                                1
Inchwood Park, Bathgate

                                                                                West
Lothian, EH48 2FY, UK
	Yes
    [  ] No [X]
	 	 	 
	Bolton,
    UK	Catalent UK Packaging Ltd

                                                                                Lancaster
Way

                                                                                Wingates
Industrial Estate

                                                                                Westhoughton,
Bolton

                                                                                Lancashire,
BL5 3XX, UK
	Yes
    [  ] No [X]
	 	 	 
	Kakegawa,
    JP	1656 Kurami, Kakegawa.shi,

                                                                                Shizuoka
436-0341, Japan
	Yes
    [  ] No [X]
	 	 	 
	Kansas
    City, US	Catalent CTS, LLC

                                                                                Oral
Drug Delivery (ODD)

                                                                                10245
Hickman Mills Drive

                                                                                Kansas
City, MO 64137, US
	Yes
    [  ] No [X]
	 	 	 
	 	Catalent CTS, LLC

                                                                                Clinical
Supply Services (CSS)

                                                                                10245
Hickman Mills Drive

                                                                                Kansas
City, MO 64137, US
	Yes
    [  ] No [X]
	 	 	 
	Philadelphia,
    US	Catalent Pharma Solutions, LLC

                                                                                10381
Decatur Road,

                                                                                Philadelphia,
PA 19154, US
	Yes
    [X] No [  ]
	 	 	 
	Schorndorf,
    DE	Catalent Germany Schorndorf GmbH

                                                                                Clinical
Supply Services (CSS)

                                                                                Steinbeisstrasse
1-2,

                                                                                73614
Schorndorf, Germany
	Yes
    [  ] No [X]
	 	 	 
	 	Catalent Germany Schorndorf GmbH

                                                                                Product
Development (PD/ADT)

                                                                                Steinbeisstrasse
1-2,

                                                                                73614
Schorndorf, Germany
	Yes
    [  ] No [X]
	 	 	 
	Shanghai,
    CN	Catalent Pharma Solutions

                                                                                Section
C, Building 10,

                                                                                No.
353 North Riying Road,

                                                                                Shanghai
Waigaoqiao

                                                                                Free
Trade Zone, China
	Yes
    [  ] No [X]
	 	 	 
	Singapore,
    SG	Catalent Pharma Solutions

                                                                                No.
1 Jalan Kilang #02-01/02

                                                                                Singapore
159402
	Yes
    [  ] No [X]

 

*Check
all sites included/not included in scope of this Quality Agreement

 

    	 	 	Page 3 of 21

    	 

    

 

This
is a Quality Agreement for ORAL DRUG DELIVERY and CLINICAL SUPPLY SERVICES provided by Catalent Pharma Solutions. This Quality
Agreement defines the duties of Catalent Pharma Solutions, LLC (CATALENT/CPS) and BriaCell Therapeutics Corp (CUSTOMER)
for the supply of clinical trial materials.

 

This
Quality Agreement takes the form of a detailed checklist of all the activities associated with the supply of clinical trial materials
including procurement, receipt, testing, storage, manufacturing, labeling, QP certification, packaging, distribution, returns
and destruction for Investigational Medicinal Product(s). Responsibility for each activity is assigned to either CATALENT or
CUSTOMER in the appropriate box in the Responsibility Delegation Checklist, which follows.

 

In
order to ensure quality assurance, CATALENT will perform the activities defined herein in accordance with Standard Operating
Procedures (defined below) to the extent that a Standard Operating Procedure Is applicable to such activity. In the event of a
conflict between the terms of this Quality Agreement and a Standard Operating Procedure, the Quality Agreement shall control.

 

This
Quality Agreement is subject to the terms of a Services agreement between Catalent Pharma Solutions and the Customer. In the event
of a conflict between any of the provisions of this Quality Agreement and the Services Agreement with respect to quality-related
activities, including responsibility for compliance with Good Manufacturing Practices and all other regulatory obligations as
they pertain to the Product the provision of the Quality Agreement shall govern. In the event of a conflict between any of these
provisions and the Services Agreement with respect to all other matters, including allocation of risk, intellectual property rights,
liability and financial responsibility, the provisions of the Services Agreement shall govern.

 

This
Quality Agreement implies that the CUSTOMER is the sponsor of any clinical trials that CATALENT is providing Clinical Supplies
Services for. It is the responsibility of CUSTOMER to inform CATALENT if this is not the case.

 

CUSTOMER
must inform CATALENT if at any time materials processed by CATALENT are intended for commercial use or a regulatory filing or
when a clinical product receives a commercial approval.

 

    	 	 	Page 4 of 21

    	 

    

 

For
purposes of this Quality Agreement, the following definitions shall apply:

 

	A.	“Active
    Pharmaceutical ingredient” (API) shall mean the active pharmaceutical ingredient used in the manufacture of the
    Product as identified in the Specifications.
	 	 
	B.	“Adverse
    Drug Event” (ADE) shall mean any adverse event associated with the use of a drug in humans, whether or not considered
    drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional
    practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from
    drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
	 	 
	C.	“Applicable
    Laws” means, with respect to CUSTOMER, all laws, ordinances, rules and regulations, as amended from time to time,
    of each jurisdiction in which API or Product is produced, marketed, distributed, used or sold; and with respect to Catalent,
    all laws, ordinances, rules and regulations, as amended from time to time, of the jurisdiction in which Catalent performs
    the services.
	 	 
	D.	“Authorized
    Person” (AP) means a person acting on behalf of the manufacturer or the importer, who is authorized to certify or
    re-certify batches of IMPs for use in clinical studies. This person is called a Qualified Person (QP) in the European Union
    and other European countries, in other recognized countries, he may be called a QA person (= Quality Assurance person), or
    a “Responsible Pharmacist” in accordance with the local regulations.
	 	 
	E.	“Certificate
    of Analysis” (CoA) is a listing of all results for tests conducted on samples of a lot of product compared to the
    specifications defined by the CUSTOMER and listed in the regulatory applications and application compendia.
	 	 
	F.	“Certificate
    of Compliance/Conformance” (CoC) is a statement that the lot of product was manufactured, packaged/labelled and
    tested (as applicable) in accordance with cGMP, identifies the master batch record documents and lists any incident reports
    and investigations identified associated with the lot of Product.
	 	 
	G.	“Certificate
    of Manufacture” (CoM) is a statement that the lot of product was manufactured in accordance with cGMPs and the batch
    record. It lists any incident reports and investigations identified with the lot of Product and the BSE Statement for the
    batch.
	 	 
	 	Note:
    Contents of CoC and CoM may be combined into one document named “Certificate of Compliance”
	 	 
	H.	“Certifying
    site” is the site of the Authorized Person which certifies distribution of the batch to the study site or other
    logistics centers. This certification is issued after the IMP has been analyzed by a recognized laboratory and found to be
    intact and no further manufacturing activities involving drug manipulation, other than re-packaging, if required, are performed.
    Usually, for IMPs import, the Certifying Site is the manufacturing site in a recognized country, or the logistics center overseas
    for a multi-national trial.
	 	 
	I.	“Code
    of Federal Regulations (USA)” (CFR) is the codification of the general and permanent rules published in the Federal
    Register by the executive departments and agencies of the Federal Government.
	 	 
	J.
    	“Controlled
    Drug Substances” (CDS) is any drug or therapeutic agent, commonly understood to include narcotics with a potential
    for abuse or addiction, which is held under strict governmental control, as defined by local regulations.
	 	 
	K.	“Current
    Good Manufacturing Practice” (cGMP) means current Good Manufacturing Practices promulgated by the Regulatory Authorities
    in the jurisdictions included in Applicable Laws (as applicable to CUSTOMER and Catalent, respectively). In the European Union,
    this includes Directive 2003/94/EC (as supplemented by Volume 4 of EudraLex published by the European Commission), as amended,
    if and as implemented in the relevant constituent country, and in the United States, this includes 21 C.F.R. Parts 210 and
    211, as amended.
	 	 
	L.	“Debarred”
    shall mean the penalty imposed by the US FDA pursuant to 21 USC 335a(a) or 335a(b) on persons or companies that have engaged
    in criminal conduct with respect to the development or approval of new or generic drugs or engaged in certain other types
    of criminal conduct. A debarred person or company is precluded from submitting or assisting in the submission of an NDA or
    ANDA and may not provide services in any capacity to a party that has an approved or pending drug application.
	 	 
	M.	“Drug
    Enforcement Administration” (DEA) is the US federal agency responsible for enforcing laws and regulations governing
    narcotics and controlled substances.
	 	 
	N.	“For
    Cause Audit” shall mean any of a series of inspections conducted for various compelling reasons (non-conformance/complaints,
    unfavorable regulatory action etc.).

 

    	 	 	Page 5 of 21

    	 

    

 

	O.	“Good
    Distribution Practice” shall mean that part of quality assurance which ensures that the quality of medicinal products
    is maintained throughout all stages of the supply chain from the site of manufacturer to the pharmacy or person authorized
    or entitled to supply medicinal products to the public.
	 	 
	P.	“Manipulation”:
    A manufacturing process conducted on an imported IMP which may affect product identity, product stability, or product
    quality, such as blinding, preparation\processing, filling\pressing, primary packaging (changing the primary or secondary
    package - in certain cases), dividing a bulk into containers or mixing several components including the active material in
    order to produce an IMP, dividing-up.
	 	 
	Q.	“Materials”
    shall mean collectively all manufacturing and packaging components and components (including raw materials, API, labels,
    product inserts, and other labeling for Products) required to manufacture or package the Products in accordance with the specifications.
	 	 
	R.	“Out
    of Specification” (OOS) shall mean a result that falls outside of the test’s acceptance criteria (e.g. criteria
    established in filed applications, approved marketing submissions, official compendia, or by the manufacturer or the customer).
	 	 
	S.	“Process”
    or “Processing” shall mean the compounding, filling, producing and/or packaging of the Raw Materials into
    Product in accordance with the Specifications. Such activities Include Product labelling, analytical/microbial testing, Inspection.
	 	 
	T.	“Product”
    shall mean such drug product being manufactured, packaged and/or tested by Catalent pursuant to a Services Agreement.
    The term “Product” shall comprise both “Bulk Product” and “Finished Product” where Bulk
    Product means such Product which has completed all parts of the Process up to but not including final packaging and where
    Finished Product shall mean Product which has undergone all stages of the Process including packaging in its final container.
	 	 
	U.	“Re-certifying
    site” is the site importing the certified IMP and re-certifying it for distribution in Territory via the importer’s
    Authorized Person, where applicable. The re-certifying site is usually holder of Manufacturer/Importer Authorization.
	 	 
	V.	“Regulatory
    Authority” shall mean any regulatory authority within a Territory involved in regulating any aspect of the development,
    manufacture, market approval, sale, distribution, packaging or use of the Product.
	 	 
	W.	“Reprocessing”
    shall mean the duplication of a step or steps currently in the manufacturing formula in order to bring the batch into
    conformance with specifications, and which will not alter the safety, identity, strength, quality or purity of the drug product
    beyond the established requirements.
	 	 
	X.	“Rework”
    shall mean any additional steps that are not part of the manufacturing formula, taken to process a batch to bring the
    batch into conformance with the specifications and which will not alter the safety, identity, strength, quality or purity
    of the drug product beyond the established requirements.
	 	 
	Y.	“Services
    Agreement” shall mean the agreement entered into between Catalent and Customer which sets forth the terms and conditions
    agreed between the parties governing the provision of services by Catalent on behalf of Customer, including but not limited
    to supply agreements, standard or negotiated terms and conditions, master clinical or commercial services agreements, development
    and manufacturing agreements (collectively referred to herein as “Services Agreement”).
	 	 
	Z.	“Standard
    Operating Procedures” (SOP) shall mean the standard operating procedures in effect at Catalent which have been approved
    by Catalent Quality Assurance department and which are applicable to the Processing. The Standard Operating Procedures shall
    be in compliance with cGMP.

 

    	 	 	Page 6 of 21

    	 

    

 

RESPONSIBILITY
DELEGATION CHECKLIST

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	1.	Regulatory
    Authorizations & GMP Compliance	 	 
	 	 	 	 
	1.1	Will
    maintain all licenses, registrations and other authorizations as are required to operate a GMP pharmaceutical manufacturing,
    packaging or testing facility, (as appropriate), under Applicable Laws.	 	X
	 	 	 	 
	1.2	Will
    prepare, maintain and update the Regulatory Dossiers (e.g., IMPD) in accordance with all Applicable Laws.	X	 
	 	 	 	 
	1.3	Will
    be responsible for Annual Report or Product Quality Review unless otherwise contracted. (Applies to commercial product
    only)	N/A	 
	 	 	 	 
	1.4	Will
    provide to CUSTOMER data for compilation of Annual Report or Product Quality Review on request. (Applies to commercial
    product only)	 	N/A
	 	 	 	 
	1.5	Will
    maintain and operate the Facility in compliance with cGMP and all other Applicable Laws.	 	X
	 	 	 	 
	1.6	Will
    process, store and package the Product in accordance with cGMP and all other Applicable Laws.	 	X
	 	 	 	 
	1.7	Is
    not debarred and does not employ or use the services of any individual who is debarred or who has engaged in activities that
    could lead to being debarred.	X	X
	 	 	 	 
	1.8	Shall
    obtain Catalent’s approval for any representation made to a Regulatory Authority in a regulatory filing or similar communication
    regarding the services provided by Catalent for the Customer and/or Catalent’s establishment information to ensure the
    communication is accurate and consistent with Catalent’s processes, procedures, establishment information and understanding
    of work being conducted on behalf of the Customer.	X	 
	 	 	 	 
	1.9	Shall
    provide Catalent, upon request, a copy of relevant portions of Customer’s regulatory filing that includes Catalent data
    and/or representations regarding Catalent’s facility, equipment or other Catalent property that the Customer intends
    to submit or has submitted to any Regulatory Authority.	X	 
	 	 	 	 
	1.10	Will
    provide applicable regulatory filing documentation (e.g. Formulation, Excipient, API classifications) to support risk based
    analysis of Suppliers.	X	 
	 	 	 	 
	2.	Regulatory
    Actions & Inspections	 	 
	 	 	 	 
	2.1	Will
    notify CUSTOMER within two (2) business days of any FDA, MHRA, DEA or other Regulatory Authority notice of inspection or inspection
    of the Facilities directly relating to the customer’s Product.	 	X
	 	 	 	 
	2.2	Will
    notify the other party(s) within two (2) business days of any FDA, MHRA, DEA or other Regulatory Authority investigation relating
    to the Product.	X	X
	 	 	 	 
	2.3	Will
    provide redacted copies of any FDA Form 483 observations, Warning Letters or the like from applicable Regulatory Authorities
    including DEA (where applicable) within two (2) business days of receipt and subsequent response(s) directly relating to the
    Product.	X	X
	 	 	 	 
	2.4	Will
    notify the other party(s) within two (2) business days of any Regulatory Authority request for Product samples or Product
    records directly relating to the Product.	X	X

 

    	 	 	Page 7 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	2.5	Will
    notify the other party(s) of any requests for information, notices of violations or other communication from a Regulatory
    Authority relating to environmental, occupational health and safety compliance if related directly to the Product.	X	X
	 	 	 	 
	2.6	Will
                                         make copies available, upon request, of any documentation necessary for either party
                                         to respond to inquiries by the FDA, MHRA or other Regulatory Authorities directly related
                                         to Product.

                                                                                                    

        Note:
        Catalent confidential information will be provided directly to the requesting Regulatory Agency.
	X	X
	 	 	 	 
	3.	Audits	 	 
	 	 	 	 
	3.1	Will
    be entitled to conduct one quality audit of each of the Facilities per 24 months to evaluate cGMP compliance. Audits will
    be scheduled at mutually agreed upon times and limited to two auditors / two days unless otherwise agreed. Will be entitled
    to be present during processing of CUSTOMER product to have oversight of the process.	X	 
	 	 	 	 
	3.2	Will
    conduct internal audits of quality systems, manufacturing, and site-specific testing processes, in accordance with the cGMP
    and applicable Standard Operating Procedures.	 	X
	 	 	 	 
	3.3	Will
    host “for cause audits” at a mutually agreed time provided CATALENT is given a minimum of two (2) weeks prior
    written notice of such audits.	 	X
	 	 	 	 
	3.4	Any
    representative of CUSTOMER who is not an employee of CUSTOMER (i.e. consultant) shall be required to sign confidentiality
    agreements with CATALENT and CUSTOMER before auditing CATALENT facilities. CATALENT will provide such agreement either prior
    to or at the time of the visit.	X	X
	 	 	 	 
	4.	Change
    Control	 	 
	 	 	 	 
	4.1	Will
    have established written procedures for control of planned changes impacting the product or services provided.	 	X
	 	 	 	 
	4.2	Will
    notify CUSTOMER of intent to make changes that could directly impact the product or services provided.	 	X
	 	 	 	 
	4.3	CUSTOMER
    is responsible for confirming any changes are within the scope of their regulatory filing.	X	 
	 	 	 	 
	4.4	Changes
    impacting product quality (e.g. batch records, product specifications, test methods or other established controlled documentation)
    that are specific to CUSTOMER product(s) must be approved by CATALENT and CUSTOMER if applicable per site specific procedures.
    Notification to the Catalent QP will be performed, if applicable. Unplanned changes which affect product quality will be documented
    in a Deviation Report.	 	X
	 	 	 	 
	4.5	Will
    have a system for assigning and tracking corrective and preventative actions (CAPA) through to completion	 	X
	 	 	 	 
	4.6	Where
                                         CATALENT performs final QP certification; changes made by non CATALENT sites impacting
                                         product quality (e.g. batch records, product specifications, test methods or other established
                                         controlled documentation) that are specific to CUSTOMER product(s) must be provided to
                                         the CATALENT QP.

                                                                                                    

        Note:
        Unplanned changes which affect product quality will be documented in a Deviation Report per Section 12.
	X	 

 

    	 	 	Page 8 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	4.7	Where
    Catalent performs final QP certification; provide all changes to the regulatory filings (i.e. IND, NDA, CTA/IMPD) or where
    the customer performs final QP certification those changes that affect the processes performed by CATALENT site(s).	X	 
	 	 	 	 
	5.	Supply
    of Materials	 	 
	 	 	 	 
	5.1	Where
    CATALENT supplies materials, a supplier contractor evaluation and management program will be maintained. This will include
    the evaluation and control of risk for TSE and BSE. Catalent will only use approved suppliers and contractors for GMP activities.	 	X
	 	 	 	 
	5.2	Will
                                         supply applicable statements and/or documentation such as copies of supplier API audits
                                         demonstrating approval status, QP Declaration, Quality Agreements, etc. to CATALENT/CUSTOMER
                                         to ensure compliance with cGMP and Applicable Laws including the El) Falsified Medicines
                                         Directive regarding Supplier

         

        Qualification/Management
        including the API distributor, if applicable.
	X	X
	 	 	 	 
	5.3	Where
    CUSTOMER supplies materials, a supplier contractor evaluation and management program will be maintained. This will include
    the evaluation and control of risk for TSE and BSE. CUSTOMER will only use approved suppliers and contractors for GMP materials/activities.	X	 

 

	5.4	For
    customer provided product, the following documents must be provided to CATALENT by CUSTOMER prior to or with a shipment to
    enable CATALENT to process the materials through its systems:	X	 
	 	 	 	 	 	 
	 	 	●	Material
    Safety Data Sheet (MSDS)or equivalent	 	 
	 	 	 	 	 	 
	 	 	●	Certificates
    of Analysis or Conformance	 	 
	 	 	 	 	 	 
	 	 	●	Evidence
    of Compliance with BSE/TSE guidance 410 (current version)	 	 
	 	 	 	 	 	 
	 	 	●	Evidence
    of Compliance with ICH Q3C guidance on residual solvents (where applicable)	 	 
	 	 	 	 	 	 
	 	 	●	Written
    confirmation that vendor/supplier of materials has been evaluated/approved/maintained by CUSTOMER	 	 
	 	 	 	 	 	 
	 	 	●	Notification
    of controlled/dangerous substances (where applicable)	 	 

 

	5.5	CUSTOMER
    is responsible for providing CATALENT with any updates to the material safety data sheet or other pertinent information as
    it becomes available.	X	 

 

    	 	 	Page 9 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	5.6	Where
    CUSTOMER provides materials, CUSTOMER will be responsible for ensuring the safe and secure shipment of any materials to CATALENT.
    CUSTOMER must ensure that all materials are suitable for their intended purposes. Labelling or supplied documentation of products
    or materials delivered to CATALENT must include the following information:	X	 
	 	 	 	 
	 	 	●	Description,
    including strength	 	 
	 	 	 	 	 	 
	 	 	●	Item
    code or part number	 	 
	 	 	 	 	 	 
	 	 	●	Batch
    or lot number	 	 
	 	 	 	 	 	 
	 	 	●	Storage
    conditions	 	 
	 	 	 	 	 	 
	 	 	●	CUSTOMER
    name and address	 	 
	 	 	 	 	 	 
	 	 	●	Date
    of manufacture, expiry/retest date	 	 
	 	 	 	 	 	 
	 	 	●	Quantity
    and/or weight	 	 
	 	 	 	 	 	 
	 	 	●	Average
    unit weight (where applicable)	 	 
	 	 	 	 	 	 
	 	 	●	Container
    numbers	 	 
	 	 	 	 	 	 
	 	 	●	Country
    of origin	 	 
	 	 	 	 	 	 
	 	Containers
    must be tamper sealed in such a way that any tamper sealing is evident. Temperature monitoring is required for supply of cold
    chain product or for any product which require temperature control during shipment.	 	 

 

	5.7	For
    CUSTOMER supplied materials CUSTOMER will supply appropriate statement regarding supplier qualification, risk assessment and/or
    audits indicating approval status to CATALENT to ensure compliance with cGMP and Applicable Laws regarding Supplier Qualification/Management.	X	 
	 	 	 	 
	5.8	Is
    responsible for notifying CUSTOMER of any observed deficiencies with provided materials or documents.	 	X
	 	 	 	 
	5.9	For
    CATALENT supplied materials, will approve raw material suppliers providing raw materials used in the Bulk Product to ensure
    full compliance with cGMP and Applicable Laws.	 	X
	 	 	 	 
	5.10	For
    CATALENT supplied packaging materials, will approve packaging material suppliers selected by CATALENT providing packaging
    materials used to package the Finished Product to ensure full compliance with cGMP and Applicable Laws.	 	X
	 	 	 	 
	5.11	Will
    receive and release materials to in-house procedures and specifications to establish their suitability for use.	 	X
	 	 	 	 
	5.12	Deliveries
    to CATALENT must take place within opening hours. CATALENT cannot guarantee proper handling of materials delivered outside
    normal delivery hours.	X	 
	 	 	 	 
	5.13	CUSTOMER
    is responsible for notifying CATALENT regarding any recalls of CUSTOMER provided drug product, comparator product, placebo,
    or any other materials within one (1) business day of discovery.	X	 
	 	 	 	 
	5.14	To
    the extent CUSTOMER requests that a particular supplier be used by CATALENT, that supplier must comply with CATALENT’s
    Standards of Business Conduct and Supplier Approval requirements. To the extent the supplier does not comply with CATALENT’s
    Standards of Business Conduct or meet approval requirements, CATALENT has the right to cease doing business with that supplier
    and will work with the customer to approve another supplier to perform similar services or transfer quality responsibility
    to the customer.	X	 
	 	 	 	 
	6.	Cleaning,
    Qualification and Validation	 	 
	 	 	 	 
	6.1	Will
    have a cleaning program in place to ensure appropriate cleaning is performed in between the handling of different materials.	 	X

 

    	 	 	Page 10 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	6.2	Will
    qualify, maintain and calibrate (as required) all equipment, instruments, systems, facilities and utilities used in the processing
    of GMP materials and products.	 	X
	 	 	 	 
	6.3	Will
    ensure facilities are designed and maintained in a manner which prevents product contamination.	 	X
	 	 	 	 
	7.	Label
    Control	 	 
	 	 	 	 
	7.1	Responsible
                                         to provide label text in accordance with regulatory requirements for locations where
                                         the product will be distributed.

        CUSTOMER
        shall not print Catalent’s information onto a label without prior agreement by Catalent, unless required by the
        applicable regulation.
	X	 
	 	 	 	 
	7.2	Responsible
    for labeling Product in accordance with the Specifications, and applicable regulations.	 	X
	 	 	 	 
	7.3	Responsible
    to provide all artwork for labelling and packaging.	 	X
	 	 	 	 
	7.4	Responsible
    to prepare all artwork for labelling and packaging.	 	X
	 	 	 	 
	7.5	Responsible
    to approve all artwork for labelling and packaging.	X	 
	 	 	 	 
	8.	Batch
    Processing	 	 
	 	 	 	 
	8.1	Responsible
    for processing the Product at the Facilities in accordance with the batch record, Standard Operating Procedures referenced
    therein, and the Specifications.	 	X
	 	 	 	 
	8.2	Responsible
    to review and approve batch records before and after packaging.	 	X
	 	 	 	 
	8.3	Responsible
    to review and approve batch records in line with site local procedures.	X	 
	 	 	 	 
	9.	Rework	 	 
	 	 	 	 
	9.1	Will
    not rework, reprocess or otherwise manipulate GMP materials outside of the defined process noted in manufacturing or packaging
    records without written approval by CUSTOMER and under applicable change control/ change management or deviation management
    processes.	 	X
	 	 	 	 
	10.	Documentation	 	 
	 	 	 	 
	10.1	Is
    responsible for ensuring that all relevant data and documentation generated is recorded according to the requirements of applicable
    GMPs and local SOPs. Will make data and documentation specific to CUSTOMER available for review upon request.	 	X
	 	 	 	 
	10.2	Will
    maintain a document control system for the management and tracking of GMP documentation.	 	X
	 	 	 	 
	10.3	Must
    inform CATALENT of any proposed changes to regulatory documents relative to services and certifications provided by CATALENT
    and supply said changes in writing. These changes must be notified as far in advance as is possible and be agreed upon by
    both parties to become effective at CATALENT.	X	 
	 	 	 	 
	10.4	Is
    responsible for retaining all relevant GMP data and documentation in a secure manner according to Catalent Retention Policies.
    Thereafter, the data and documentation can be sent to CUSTOMER; continue to be stored according to contractual requirements;
    or destroyed per CUSTOMER’S written approval.	 	X

 

    	 	 	Page 11 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 	 
	11.	Samples
    and Stability testing	 	 
	 	 	 	 
	11.1	Retention
                                         samples:

         

        Unless
        otherwise instructed by the CUSTOMER, CATALENT will retain samples of all materials (supplied by CATALENT) in accordance
        with Site SOPs. Catalent will also retain samples of the finished product in quantities defined in Site SOPs or Project
        Documentation.
	 	X
	 	 	 	 
	11.2	Reference
                                         samples:

         

        Is
        responsible for retaining sufficient quantities of reference samples, excipients and packaging components. The reference
        samples should be taken and stored in accordance to the appropriate EU and US regulatory requirements.

         

        Reference
        samples may be stored at CATALENT, if required by the CUSTOMER. The storage requirements and location of reference samples
        will be specified within project specific documentation.
	X	X
	 	 	 	 
	11.3	Stability
                                         Samples:

         

        Will
        conduct stability testing as contracted by CUSTOMER. Stability studies will be performed according to appropriate ICH
        Guidance documents, approved stability protocol and site SOPs, if applicable to the scope of work.
	 	X
	 	 	 	 
	12.	Deviation
    Management and OOS Investigations	 	 
	 	 	 	 
	12.1	Will
    have procedures in place for the investigation, documentation, reporting and resolution of unplanned deviations and OOS investigations
    that occur during manufacturing, testing, packaging and handling of the Product.	 	X
	 	 	 	 
	12.2	Will
    notify CUSTOMER within 2 business days of the date of discovery for any process deviations and OOS investigations, which may
    affect the safety, quality, or performance of the Product.	 	X
	 	 	 	 
	12.3	Will
    provide documentation relating to unplanned deviations and OOS investigations that are Product impacting to the CUSTOMER.	 	X
	 	 	 	 
	12.4	Will
    be responsible for investigating, resolving and documenting all deviations and OOS investigations from the approved Batch
    Record and Specifications.	 	X
	 	 	 	 
	12.5	Will
    be responsible for providing CUSTOMER with a copy of deviation and OOS investigation reports upon request.	 	X
	 	 	 	 
	13.	Complaints	 	 
	 	 	 	 
	13.1	Will
    provide CUSTOMER with any information relating to the Processing and Handling of the Product, which is necessary to address
    a Product quality complaint.	 	X
	 	 	 	 
	13.2	Will
    collect and log all information relating to Product quality complaints forwarded to Catalent per SOPs.	X	X
	 	 	 	 
	13.3	Will
    investigate all Product quality complaints forwarded to Catalent per SOPs.	X	X
	 	 	 	 
	13.4	Will
    issue all reports and follow up corrective action relating to complaints pertaining to the manufacturing process for the Product.	X	X
	 	 	 	 
	13.5	Will
    issue all reports and follow up corrective action relating to complaints pertaining to the finished packaging of the Product.	 	X
	 	 	 	 
	13.6	Will
    investigate and communicate to other parties upon the discovery of any suspected falsified product within one (1) business
    day.	X	X
	 	 	 	 
	13.7	Responsible
    for Adverse Event reporting management or pharmacovigilance activities, including recording, tracking, responding, and investigating.	X	 

 

    	 	 	Page 12 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	13.8	Responsible
    for forwarding in writing all product quality and safety concerns received from third parties and related to CUSTOMER products.
    For suspected adverse events related to product this will be performed within 2 business days.	 	X
	 	 	 	 
	14.	Recalls,
    Field Alerts and Product Withdrawals	 	 
	 	 	 	 
	14.1	Will
    inform CUSTOMER and the Catalent QP, in writing, if applicable, of potential drug product recall or clinical withdrawal situations
    within one (1) business day. Will carry out a product quality investigation per site procedures and advise CUSTOMER and the
    Catalent QP, in writing, if the product is defective or otherwise substandard, which may necessitate a product recall or withdrawal.	 	X
	 	 	 	 
	14.2	If
    a product recall/withdrawal is initiated by CUSTOMER that relates to materials processed by CATALENT, CUSTOMER must notify
    CATALENT immediately or no longer than (1) business day.	X	 
	 	 	 	 
	14.3	Is
    responsible for the decision to recall and for initiating product recall activities.	X	 
	 	 	 	 
	14.4	Will
    reserve the right to contact the appropriate regulatory authorities in the event of a confirmed quality defect in cases where
    the CUSTOMER has not performed this notification. Duplicate notification will be provided to customer.	 	X
	 	 	 	 
	15.	Product
    Release	 	 
	 	 	 	 
	15.1	Is
    responsible for ensuring all products and materials meet the quality standards and requirements for their intended use. Quality
    will disposition drug product or clinical supplies after review of all relevant documents to ensure compliance with GMPs,
    local SOPs and product specifications. According to EU regulations, drug product must be received into Europe before it can
    be QP certified. The responsibility for release of materials (e.g. raw materials or finished product) will be delineated in
    the appropriate Project documentation.	 	X

 

	15.2	For
    each batch manufactured, packaged and/or tested by Catalent, Catalent will provide the following (as applicable based on services
    provided): 	 	X
	 	 	 	 	 	 
	 	 	a)	Copies
    of the completed manufacturing or packaging records.	 	 
	 	 	 	 	 	 
	 	 	b)	A
    Certificate of Manufacture (CoM) or similar document issued by Catalent Quality that confirms drug product has been manufactured
    in accordance with GMPs and the approved batch records (may be combined with the CoC).	 	 
	 	 	 	 	 	 
	 	 	c)	A
    Certificate of Analysis (CoA) or scientific report issued by Catalent (or by the CUSTOMER in the event that Catalent did not
    perform final product testing) confirming that the material was tested in accordance with GMPs and related SOPs and meets
    the requirements of all relevant specifications.	 	 
	 	 	 	 	 	 
	 	 	d)	A
    Certificate of Compliance (CoC) for Packaging/Labeling issued by Catalent Quality confirming materials were processed in accordance
    with GMPs and related SOPs (may be combined with the CoM).	 	 
	 	 	 	 	 	 
	 	 	e)	A
    copy of Deviation Reports, Out of Specification (OOS) investigations and other investigations as appropriate.	 	 

 

	15.3	Responsible
    for final release of Product.	X	 
	 	 	 	 
	15.4	Responsible
    for ensuring compliance with Product Specification File and/or Approved Clinical Trial Application.	X	 

 

	16.	QP
    Certification Not applicable to study	 	 
	 	 	 	 
	16.1	The
    QP should be guided in fulfilling their duties by the Code of Practice for QPs in the Pharmaceutical Industry.	NA
	 	 	 
	16.2	No
    product will be dispatched without prior approval by the CUSTOMER.	 

 

    	 	 	Page 13 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	16.3	The
    sponsor is responsible for ensuring that all products, which they intend to release for distribution to clinical sites, have
    been certified by a QP.	 	 
	 	 	 	 
	16.4	The
    CUSTOMER is responsible for ensuring that the API is manufactured according to GMP. Where product is undergoing QP certification
    by CATALENT, the CUSTOMER must provide information requested by the Catalent QP as evidence of GMP compliance.	 	 
	 	 	 	 
	16.5	CUSTOMER
    is responsible for ensuring the required Ethics Committee and Regulatory approvals are in place before requesting shipment
    to a clinical site.	 	 
	 	 	 	 
	16.6	Responsibility
    for QP certification will be defined for each study in the project documentation.	 	 
	 	 	 	 
	16.7	Where
    CUSTOMER is responsible Tor QP certification of the finished product, the sponsor will provide a final release certificate
    for each batch of product, signed by an eligible QP, as evidence of QP certification prior to CATALENT Internal release and
    distribution of product to site by CATALENT.	 	 
	 	 	 	 
	16.8	For
    manufacture and packaging which takes place within the EU, unless otherwise specified in project documentation, a CATALENT
    QP will provide a certificate confirming that operations carried out at a CATALENT facility have been conducted in compliance
    with EU Good Manufacturing Practice (GMP).	 	 
	 	 	 	 
	16.9	If
    specified in Project documentation, a CATALENT QP will confirm that the product complies with the specification noted in the
    Clinical Trial Application (CTA) and other documents provided by the CUSTOMER. The CATALENT QP will require the CUSTOMER to
    provide that part of the CTA and other specifications pertinent to the activities carried out by Catalent. The CTA must be
    in the English language and the CUSTOMER must confirm that the content of any CTA submitted in another language is identical.	 	 

 

	16.10	If
    the final certification is the responsibility of the CATALENT QP, CATALENT is named as the “Authorized site for release
    of the finished product or Investigational Medicinal Product (IMP) in the Community” as recorded in the CTA. To discharge
    these duties, the CATALENT QP will require CUSTOMER to provide the following:	 	 
	 	 	 	 	 	 
	 	 	●	Clinical
    Trial Application and Investigational Medicinal Product Dossier (CTA and IMPD) or equivalent for each country (provided in
    the English language and confirmation that applications in other languages are equivalent).	 	 
	 	 	 	 	 	 
	 	 	●	Clinical
    Trial Protocol (parts relevant for GMP manufacturing, packaging and labeling activities)	 	 
	 	 	 	 	 	 
	 	 	●	Clinical
        Trial letters of approval (and English or local language translation if original is not provided in English language)
        or confirmation from the sponsor that they are approved if no letter is provided.
	 	 
	 	 	 	 	 	 
	 	 	●	Any
    correspondence between the Authorization Holder and the Competent Authority(s) that changes or adds commitments regarding
    the chemistry, manufacturing and controls from the original submission prior to approval,	 	 
	 	 	 	 	 	 
	 	 	●	Relevant
    records of manufacture, testing, stability reports, assembly, packaging, labeling, storage and distribution	 	 
	 	 	 	 	 	 
	 	 	●	Relevant
    deviation reports	 	 
	 	 	 	 	 	 
	 	 	●	Any
    changes to the authorization either submitted or notified or as an approved variation.	 	 
	 	 	 	 	 	 
	 	 	●	Product
    Specification File (in accordance with that defined within GMP Vol. IV, Annex 13).	 	 
	 	 	 	 	 	 
	 	 	●	Access
    to manufacturing/packaging and testing facilities for API, critical excipients and drug product and their documentation for
    the purpose of EU GMP assessment or audit if required.	 	 

 

    	 	 	Page 14 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 	 
	16.11	The
    CATALENT or CUSTOMER provided QP will discharge these duties in accordance with Good Manufacturing Practice for Medicinal
    Products, Annex 13 and Annex 16 where applicable.	 	 
	 	 	 	 
	16.12	Responsible
    for:	 	 
	 	 	 	 	 	 
	 	 	a)	Notifying
    the CATALENT QP in advance of any proposed variations to the CTA and/or Product Specification File for which the product has
    been released for use.	 	 
	 	 	 	 	 	 
	 	 	b)	Advising
    the CATALENT QP of the outcome of communications with the relevant Competent Authority(s).	 	 
	 	 	 	 	 	 
	 	 	c)	Notifying
    the CATALENT QP in advance of any plans to transfer product between clinical sites or to re-label product at clinical sites.
    A copy of paperwork used to support any of these exercises must be provided to the CATALENT QP for recordkeeping.	 	 
	 	 	 	 	 	 
	 	 	d)	Ensuring
    that all other requirements of Directive 2001/20/EC have been met when using the product in the clinic.	 	 
	 	 	 	 	 	 
	 	 	e)	Being
    liable for the safety and efficacy performance of the product in the clinic.	 	 
	 	 	 	 	 	 
	 	 	f)	Notification
    of CATALENT of any emerging adverse pharmacovigilance data, which may be related to activities carried out by CATALENT.	 	 
	 	 	 	 	 	 
	 	 	g)	Notifying
    the CATALENT QP of on-going stability data to support certification.	 	 
	 	 	 	 	 	 
	 	 	h)	Notifying
    the CATALENT QP of any ongoing complaints, investigations and recalls, from any third party site in the supply chain, which
    affect batch certification.	 	 

 

	16.13	When
    the final certification is the responsibility of a CUSTOMER provided QP the site performing the QP certification will be named
    as the “Authorized site for the release of the finished IMP in the Community” as recorded in the CTA.	 	 
	 	 	 	 
	16.14	Will
    accept a Product Release Certificate signed by at least an eligible QP from the authorized releasing site based on applicable
    national and EU regulations as evidence of QP Certification to allow release of the IMP for dispatch.	 	 
	 	 	 	 
	17.	Storage	 	 
	 	 	 	 
	17.1	CATALENT
    will follow site SOPs for storage of GMP materials. Proper storage conditions and requirements will be provided to CATALENT
    by CUSTOMER.	X	X
	 	 	 	 
	17.2	Will
    have appropriate systems for controlling and storing quarantined, rejected, returned, suspected counterfeit and recalled materials.	 	X
	 	 	 	 
	17.3	Will
    store the Bulk Product in accordance with the Specifications pending release of the Product.	 	X
	 	 	 	 
	17.4	Will
    store the Bulk Product, pending packaging, and Finished Packaged Product in accordance with the Specifications pending release
    and shipment of the Finished Packaged Product to the CUSTOMER.	 	X
	 	 	 	 
	17.5	Will
    be responsible to ensure storage of the Product in accordance with the Specifications following delivery of such Product to
    CUSTOMER’S authorized carrier.	X	 
	 	 	 	 
	18.	Transport
    & Shipping	 	 
	 	 	 	 
	18.1	CATALENT
    will follow site SOPs for shipment of GMP materials.	X	X
	 	 	 	 
	18.2	Released
    product cannot be shipped without prior written order and approval by CUSTOMER.	 	X

 

    	 	 	Page 15 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	18.3	As
    defined in site SQPs, the shipment of Quarantine materials can be done on an exception basis only and with the proper documentation	 	X
	 	 	 	 
	18.4	CUSTOMER
    Is responsible for determining regulatory and legal requirements and supplying the value for materials for customs’
    purposes. CATALENT assumes an authorized shipment request from CUSTOMER to be the “order to ship” and will presume
    all regulatory requirements have been fulfilled by the CUSTOMER or the CUSTOMER’S agent.	X	X
	 	 	 	 
	18.5	In
    cases where the CUSTOMER requests ‘direct to patient shipments’, this will be defined in a separate protocol and
    is not covered by the agreement.	X	 
	 	 	 	 
	18.6	Shipping
    conditions/requirements will be agreed between CATALENT and CUSTOMER in accordance with GDP rules.	X	X
	 	 	 	 
	18.7	For
    US shipments, CUSTOMER is responsible to confirm that the Product(s) manufacturer is licensed in the intended state(s) of
    distribution, as well as the Products recipient.	X	 

 

	18.8	For
    EU shipments: In order to ensure that the certifying QP has sufficient evidence available to confirm that the required
    storage conditions have been maintained throughout the duration of transportation, temperature controlled shipment with monitoring,
    or where justified, temperature monitoring shall be adopted as the Catalent control strategy.	NA
	 	 	 	 
	 	Control
    Measure Required 	 	Applicable
    Use Criteria	 	 
	 	 	 	 	 	 	 
	 	Temperature
    controlled shipment with monitoring	 	●	All
    cold and frozen chain products	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Temperature
    sensitive ambient products	 	 
	 	 	 	 	 	 	 
	 	 	 	●	High
    value products	 	 
	 	 	 	 	 	 	 
	 	 	 	●	High
    risk products e.g. limited supply available	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Validated
    transportation conditions	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Very
    high degree of assurance that storage conditions stated on product label or Marketing Authorisation will be maintained	 	 
	 	 	 	 	 	 	 
	 	Temperature
    monitoring	 	●	Temperature
    stable products	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Validated
    transportation conditions	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Risk
    assessment conducted	 	 
	 	 	 	 	 	 	 
	 	 	 	●	High
    degree of assurance that storage conditions stated on product label or Marketing Authorisation will be maintained	 	 
	 	 	 	 	 	 	 
	 	No
    controls required1	 	●	Temperature
    stable products	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Validated
    transport conditions	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Risk
    assessment conducted and agreed on mutual basis	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Short
    duration of transportation i.e. < 1 hr	 	 
	 	 	 	 	 	 	 
	 	 	 	●	No
    mandated storage conditions on pack labelling or Marketing Authorisation	 	 
	 	 	 	 	 	 	 
	 	 	 	●	Marketing
    Authorisation fully reflects likely transportation conditions observed	 	 
	 	 	 	 	 	 	 
	 	1
In the very unlikely event that a “No controls strategy” can be adopted the risk assessment shall fully consider
the impact of failure of the validated transportation conditions and mechanism for communicating the failure to the Qualified
Person	 	 

 

	19.	Subcontracting	 	 
	 	 	 	 
	19.1	Will
    obtain prior written agreement from CUSTOMER before subcontracting any portions of the manufacturing, packaging, testing,
    or storage of the Product.	 	X

 

    	 	 	Page 16 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	19.2	Will
    be responsible for establishing a contract relationship when a subcontractor is used to support the Product; Catalent will
    be responsible for the quality, compliance, and regulatory aspects of the materials or services provided by the contractor.	 	X
	 	 	 	 
	19.3	Shall
    ensure that any third party used in performing activities that are the subject of this Quality Agreement complies with Catalent’s
    obligations under this Quality Agreement and will facilitate any CUSTOMER audit required to be performed of the third party.	 	X
	 	 	 	 
	20.	Personnel
    Training	 	 
	 	 	 	 
	20.1	Will
    be responsible for ensuring that a training program is established that maintains, tracks and documents, training of employees
    involved with the clinical supply services.	 	X
	 	 	 	 
	21.	Health
    and Safety	 	 
	 	 	 	 
	21.1	Will
    notify of any problems associated with the product or the work which might pose a hazard to the premises, equipment, personnel,
    other materials or other products.	X	 
	 	 	 	 
	22.	Disputes	 	 
	 	 	 	 
	22.1	Responsible
    to resolve all quality related disagreements between parties. May utilize a third party to assist with dispute resolution.	X	X
	 	 	 	 
	23.	Quality
    Agreement Review	 	 
	 	 	 	 
	23.1	Will
    agree that Quality Agreement shall commence on the effective date and shall remain in effect for as long as Catalent supplies
    Services to the CUSTOMER and for one year beyond its expiry following written and approved termination of the Quality Agreement
    by all parties.	X	X
	 	 	 	 
	23.2	May
    terminate the Quality Agreement upon thirty (30) days written notice to the other party.	X	X
	 	 	 	 
	23.3	Will
    notify all parties of any proposed revisions to the Quality Agreement.	X	X
	 	 	 	 
	23.4	Will
    review the Quality Agreement every three (3) years. Obtain approval from all parties as necessary.	X	X
	 	 	 	 
	23.5	Will
    be responsible for the submission of any amendment to the existing Quality Agreement to all parties for review and approval.	X	X
	 	 	 	 
	24.	Returns
    and Destruction
	 	 
	24.1	Will
    destroy accountable loss (routine rejects generated during processing) as part of normal procedure per local SOPs and according
    to applicable regulations.	 	X
	 	 	 	 
	24.2	It
    is the responsibility of CUSTOMER to authorize in writing the destruction of surplus, expired, rejected or returned drug product.	X	 
	 	 	 	 
	24.3	CATALENT
    will facilitate destruction of materials as appropriate per CUSTOMER’S instructions. Failure to respond to CATALENT’s
    repeated notifications may necessitate transfer of materials to CUSTOMER or destruction of materials in order to maintain
    a state of compliance in GMP storage areas	X	X
	 	 	 	 
	24.4	Responsible
    to agree upon and approve Returns Strategy for clinical trial returned material.	X	 

 

    	 	 	Page 17 of 21

    	 

    

 

	RESPONSIBILITIES	CUSTOMER	CATALENT
	 	 	 
	24.5	Responsible
    for authorizing the reuse of returned clinical trial material that is sent to CATALENT from an investigator site. Where final
    QP Certification is the responsibility of the CATALENT QP the reuse of the supplies will be dependent on the condition of
    the supplies and the product storage history.	X	X
	 	 	 	 
	24.6	The
    reuse of supplies should remain the exception and supplies can only be reused when written authorization, is received from
    CUSTOMER who takes full responsibility for the condition and use of the supplies and the site attests to the fact the materials
    were not compromised and were stored appropriately.	X	 
	 	 	 	 
	24.7	In
                                         accordance with 21CFR312.59, the sponsor may authorize alternative disposition of unused
                                         supplies of the investigational drug provided this alternative disposition does not expose
                                         humans to risks from the drug. The sponsor shall maintain written records of any disposition
                                         of the drug in accordance with 21CFR312.57.

         

        Supplies
        can only be reused when written authorization, is received from CUSTOMFR who takes full responsibility for the condition
        and use of the supplies and the site attests to the fact the materials were not compromised and were stored appropriately.
        Where Catalent performs final QP certification the QP must approve the return of supplies for reuse.
	X	 
	 	 	 	 
	24.8	Customer
    is responsible for clinical sites’ accuracy of returned materials.	X	 
	 	 	 	 
	25.	Blinding
    of Product (Clinical Trial Materials)	 	 
	 	 	 	 
	25.1	Will
    be responsible to ensure that the finished packaged supplies are blinded so that the different treatment groups are not distinguishable.	 	X
	 	 	 	 
	25.2	Responsible
    for the blinding strategy and (as applicable) for the visual match of the components and product supplied.	X	 
	 	 	 	 
	25.3	Implementation
    and maintenance of a procedure for the rapid unblinding of blinded products, as required.	X	 
	 	 	 	 
	25.4	Provides
    CATALENT with a list of contact persons who are NOT authorized to receive unblinding information (can be included in the contact
    list in the appendix).	X	 
	 	 	 	 
	26.	Controlled
    Drug Substances (CDS) Not applicable to Study	 	 
	 	 	 	 
	26.1	Will
    maintain the appropriate registrations as required to handle and process CDS materials as required by local/applicable laws.	NA
	 	 	 	 
	27.	Restricted
    materials	 	 
	 	 	 	 
	27.1	Catalent
    will not manufacture or primary package beta-lactam (penicillin derivatives and cephalosporin) antibiotics. Certain hormones,
    cytotoxic compounds, highly potent drugs and biological preparations shall only be handled if accepted via a risk assessment
    and based on Catalent Site capabilities and license restrictions.	 	X

 

    	 	 	Page 18 of 21

    	 

    

 

QUALITY
AGREEMENT REVISION HISTORY

 

	Version
    

    Number	 	Description
    of Document Revision	 	Date
	 	 	 	 	 
	2.0	 	 	 	 
	 	 	 	 	 
	1.0	 	Original	 	 

 

    	 	 	Page 19 of 21

    	 

    

 

APPENDIX
I

 

KEY
CONTACT INFORMATION

 

CUSTOMER

 

	Function	 	Name	 	e-mail	 	Telephone
	 	 	 	 	 	 	 
	Head
    of R&D	 	Markus
    Lacher	 	mlacher@briacell.com	 	T:
    +1-888-485-6340
	Senior
    Scientist	 	Vivek
    Sukari	 	vivek@briacell.com	 	T:
    +1-888-485-6340
	President
    and CEO	 	William
    Williams	 	williams@briacell.com	 	T:
    +1-302-290-9017
	 	 	 	 	 	 	T:
    +00 0000 000000
	 	 	 	 	 	 	T:
    +00 0000 000000
	 	 	 	 	 	 	T:
    +00 0000 000000

 

*
Contact person is blinded; must not receive unblinding information!

 

CATALENT

 

	Function	 	Name	 	e-mail

    (For all: @catalent.com)	 	Telephone

        Switchboard:

        T: +1

 

	Philadelphia	 	 	 	 	 	 
	 	 	 	 	 	 	 
	Function	 	Name	 	e-mail

    (For all: @catalent.com)	 	Telephone

    Switchboard:

    T: +00 0000 000000
	Interim,
    Director 

Quality, CSS	 	Christine
    O’Connell	 	Christine.Oconnell	 	T:
    +01 215-501-1211
	Quality
    Program Manager	 	Nathan
    Tessitore	 	Nathan.tessitore	 	T:
    +01 215-613-3272
	Interim,
    Director 

    Project Management	 	Erin
    Killeen	 	Erin.Killeen	 	T:
    +01 215-613-3505

 

    	 	 	Page 20 of 21

    	 

    

 

APPENDIX
II

 

PRODUCTS
AND SERVICES COVERED BY THE AGREEMENT

 

Procurement
of Cyclophosphamide, Candin and Intron-A

 

BRI-001
Phase I/IIA Study of BR-l-GM REGIMEN IN Metastatic or Locally Recurrent

Breast Cancer Patients in Combination with INCMGA00012 and Epacadostat

 

    	 	 	Page 21 of 21

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"}]]