Document:

EXHIBIT 10.4(vii)

  

  

  
    SOUTHERN BANK

    SEVERANCE AGREEMENT

    

    

    

    

    This Severance Agreement (the “Agreement”) dated as of November 7, 2019 is between
      Southern Bank, a Missouri state chartered trust company with banking powers (the “Bank” or the “Employer”), and Rick Windes (the “Executive”).

    

    

    WHEREAS, the Executive is presently employed as Chief Lending Officer of the Bank;

    

    

    WHEREAS, the Employer desires to be ensured of the Executive’s continued active
      participation in the business of the Employer;

    

    

    WHEREAS, in order to induce the Executive to remain in the employ of the Employer
      and in consideration of the Executive’s agreeing to remain in the employ of the Employer, the parties desire to specify the severance benefits which shall be due to the Executive in the event that his employment with the Employer is terminated under
      specified circumstances; and

    

    

    WHEREAS, the Executive is willing to serve the Bank on the terms and conditions
      hereinafter set forth.

    

    

    NOW THEREFORE, in consideration of the premises and the mutual agreements herein
      contained, the parties hereby agree as follows:

    

    

    1. Definitions.  The following words and terms shall have the meanings set forth below for the purposes of this
        Agreement:

    

    

    (a) Cause. Termination of the Executive’s employment for “Cause” shall mean termination because of personal
        dishonesty, incompetence, willful misconduct, breach of fiduciary duty involving personal profit, intentional failure to perform stated duties, willful violation of any law, rule or regulation (other than traffic violations or similar offenses) or
        final cease-and-desist order, willful conduct which is materially detrimental (monetarily or otherwise) to the Employer or material breach of any provision of this Agreement.

    

    

    (b) Change in Control.  “Change in Control” shall mean a change in the ownership of the
        Corporation or the Bank, a change in the effective control of the Corporation or the Bank or a change in the ownership of a substantial portion of the assets of the Corporation or the Bank, in each case as provided under Section 409A of the Code
        and the regulations thereunder.

    

    

    (c) Code.  “Code” shall mean the Internal Revenue Code of 1986, as amended.

    

    

    (d) Corporation.  “Corporation” shall mean Southern Missouri Bancorp, Inc., the holding company for the Bank, or
        any successor thereto.

    

    

    
      

      

    

    
    

    

    (e) Date of Termination.  “Date of Termination” shall mean (i) if the Executive’s employment is terminated for
        Cause, the date on which the Notice of Termination is given, and (ii) if the Executive’s employment is terminated for any other reason, the date specified in such Notice of Termination.

    

    

    (f) Disability. “Disability” shall mean the Executive (i) is unable to engage in any substantial
        gainful activity by reason of any medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, or (ii) is, by reason of any
        medically determinable physical or mental impairment which can be expected to result in death or can be expected to last for a continuous period of not less than twelve (12) months, receiving income replacement benefits for a period of not less
        than three (3) months under an accident and health plan covering employees of the Bank.

    

    

    (g) Good Reason.  “Good Reason” means the occurrence of any of the following events: (i) any
        material breach of this Agreement by the Employer, (ii) a material diminution in the Executive’s base compensation, (iii) a material diminution in the Executive’s authority, duties or responsibilities, (iv) a material diminution in the authority,
        duties or responsibilities of the supervisor to whom the Executive is required to report, or (v) a change of more than thirty (30) miles in the geographic location at which the Executive performs his services as of the date of this Agreement;
        provided, however, that prior to any termination of employment for Good Reason, the Executive must first provide written notice to the Employer within ninety (90) days of the initial existence of the condition, describing the existence of such
        condition, and the Employer shall thereafter have the right to remedy the condition within thirty (30) days of the date the Employer received the written notice from the Executive.  If the Employer remedies the condition within such thirty (30) day
        cure period, then no Good Reason shall be deemed to exist with respect to such condition.  If the Employer does not remedy the condition within such thirty (30) day cure period, then the Executive may deliver a Notice of Termination for Good Reason
        at any time within sixty (60) days following the expiration of such cure period.

    

    

    (h) Notice of Termination.  Any purported termination of the Executive’s employment by the Employer for any
        reason, including without limitation for Cause, Disability or Retirement, or by the Executive for any reason, including without limitation for Good Reason, shall be communicated by a written “Notice of Termination” to the other party hereto.  For
        purposes of this Agreement, a “Notice of Termination” shall mean a dated notice which (i) indicates the specific termination provision in this Agreement relied upon, (ii) sets forth in reasonable detail the facts and circumstances claimed to
        provide a basis for termination of the Executive’s employment under the provision so indicated, (iii) specifies a Date of Termination, which shall be not less than thirty (30) nor more than ninety (90) days after such Notice of Termination is
        given, except in the case of the Employer’s termination of the Executive’s employment for Cause, which shall be effective immediately; and (iv) is given in the manner specified in Section 8 hereof.

    

    

    (i) Retirement.  “Retirement” shall mean voluntary termination by the Executive in accordance with the
        Employer’s retirement policies, including early retirement, generally applicable to the Employer’s salaried employees.

    

    

    
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    2. Term of Agreement.

    

    

    Subject to the terms hereof, the term of this Agreement shall commence on the date hereof and terminate on December 31,
      2020. Beginning on December 31, 2020 and on each December 31st thereafter, the term of this Agreement shall be extended for a period of one additional year, unless either the Employer or the Executive has given notice to the other party
      hereto in writing at least 60 days prior to such annual renewal date that the term of this Agreement shall not be extended further; provided, however, notwithstanding the foregoing to the contrary, if a
      Change in Control occurs during the term of this Agreement, then the remaining term of this Agreement shall be automatically extended until the one-year anniversary of the completion of the Change in Control. If any party gives timely notice that the
      term will not be extended as of any such December 31st, then this Agreement shall terminate at the conclusion of its remaining term.  References herein to the term of this Agreement shall refer both to the initial term and successive
      terms.

    

    

    3. Benefits Upon Termination in Connection with or Following a Change in Control.

    

    

    (a) If the Executive’s employment is terminated by the Employer in connection with or within one year following a Change in Control by (i) the Employer
        other than for Cause, Disability, Retirement or as a result of Executive’s death or (ii) the Executive for Good Reason, then the Employer shall, subject to the provisions of Section 3(b) and Section 4 hereof, if applicable:

    

    

    
      
        	

              	(1)	
                pay to the Executive, in a lump sum within five (5) business days following the Date of Termination, a cash severance amount equal to one
                  times the Executive’s “base amount” as defined in Section 280G of the Code;

              

      

    

    

    

    (2) maintain and provide for a period ending at the earlier of (i) the one year anniversary of the Date
        of Termination or (ii) the date of the Executive’s full-time employment by another employer (provided that the Executive is entitled under the terms of such employment to benefits substantially similar to those described in this subparagraph (2)),
        at no cost to the Executive, the continued participation of the Executive (including his dependents who are covered by the Bank as of the Date of Termination) in all group insurance, life insurance, health, dental, vision and accident insurance,
        and disability insurance plans offered by the Employer in which the Executive and his covered dependents were participating immediately prior to the Date of Termination, in each case subject to clauses (3) and (4) of this Section 3(a);

    

    

    (3) in the event that the continued participation of the Executive and his covered dependents in any group insurance
        plan as provided in clause (2) of this Section 3(a) is barred or would trigger the payment of an excise tax under Section 4980D of the Code, or during the period set forth in Section 3(a)(2) any such group insurance plan is discontinued, then the
        Bank shall at its election either (i) arrange to provide the Executive and his covered dependents with alternative benefits substantially similar to those which the Executive and his covered dependents were entitled to receive under such group
        insurance plans immediately prior to the Date of Termination, provided that the alternative benefits do not

    
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    trigger the payment of an excise tax under Section 4980D of the Code, or (ii) pay to the Executive within
      10 business days following the Date of Termination (or within 10 business days following the discontinuation of the benefits if later) a lump sum cash amount equal to the projected cost to the Bank of providing continued coverage to the Executive and
      his covered dependents until the one year anniversary of the Date of Termination, with the projected cost to be based on the costs being incurred immediately prior to
      the Date of Termination (or the discontinuation of the benefits if later), as increased by 15% on each scheduled renewal date; and

    

    

    (4) any insurance premiums payable by the Bank pursuant to subsections (2) or (3) of this Section 3(a) shall be payable
        at such times and in such amounts (except that the Employer shall also pay any employee portion of the premiums) as if the Executive was still an employee of the Bank (or its successor), subject to any increases in such amounts imposed by the
        insurance company or COBRA, and the amount of insurance premiums required to be paid by the Bank in any taxable year shall not affect the amount of insurance premiums required to be paid by the Bank in any other taxable year.

    

    

    (b) The Bank’s obligation to pay severance and provide insurance benefits under Section 3(a) above is expressly conditioned upon the Executive executing
        and not revoking a general release to be provided to him by the Bank, which would release any and all claims, charges and complaints which the Executive may have against the Bank, its affiliates, assigns and successors, as well as the directors,
        officers and employees of such entities, in connection with the Executive’s employment and the termination of such employment.  Notwithstanding any other provision contained in this Agreement, in the event the time period that the Executive has to
        consider the terms of such general release (including any revocation period under such release) commences in one calendar year and ends in the succeeding calendar year, then no cash payments shall be made under Section 3(a) until the succeeding
        calendar year.

    

    

    4. Limitation of Benefits under Certain Circumstances.  If the payments and benefits pursuant to Section 3
        hereof, either alone or together with other payments and benefits which the Executive has the right to receive from the Employer and the Corporation or their successors, would constitute a “parachute payment” under Section 280G of the Code, then
        the payments and benefits payable by the Employer pursuant to Section 3 hereof shall be reduced by the minimum amount necessary to result in no portion of the payments and benefits payable by the Employer under Section 3 being non‐deductible to the
        Employer pursuant to Section 280G of the Code and subject to the excise tax imposed under Section 4999 of the Code.  If the payments and benefits under Section 3 are required to be reduced, the cash severance shall be reduced first, followed by a
        reduction in the insurance benefits.  The determination of any reduction in the payments and benefits to be made pursuant to Section 3 shall be based upon the opinion of independent tax counsel selected by the Employer and paid by the Employer. 
        Such counsel shall promptly prepare the foregoing opinion, but in no event later than thirty (30) days from the Date of Termination, and may use such actuaries as such counsel deems necessary or advisable for the purpose.  Nothing contained in this
        Section 4 shall result in a reduction of any payments or benefits to which the Executive may be entitled upon termination of employment under any circumstances other than as specified in this Section 4, or a reduction in the payments and benefits
        specified in Section 3 below zero.

    
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    5. Mitigation; Exclusivity of Benefits.

    

    

    (a) The Executive shall not be required to mitigate the amount of any benefits hereunder by seeking other employment or otherwise, nor shall the amount
        of any such benefits be reduced by any compensation earned by the Executive as a result of employment by another employer after the Date of Termination or otherwise, except as set forth in Section 3(a)(2)(ii) above.

    

    

    (b) The specific arrangements referred to herein are not intended to exclude any other benefits which may be available to the Executive upon a
        termination of employment with the Employer pursuant to employee benefit plans of the Employer or otherwise.

    

    

    6. Withholding.  All payments required to be made by the Employer hereunder to the Executive shall be subject
        to the withholding of such amounts, if any, relating to tax and other payroll deductions as the Employer may reasonably determine should be withheld pursuant to any applicable law or regulation.

    

    

    7. Assignability.  The Employer may assign this Agreement and its rights and obligations hereunder in whole,
        but not in part, to any corporation, bank or other entity with or into which the Employer may hereafter merge or consolidate or to which the Employer may transfer all or substantially all of its assets, if in any such case said corporation, bank or
        other entity shall by operation of law or expressly in writing assume all obligations of the Employer hereunder as fully as if it had been originally made a party hereto, but may not otherwise assign this Agreement or its rights and obligations
        hereunder.  The Executive may not assign or transfer this Agreement or any rights or obligations hereunder.

    

    

    8. Notice.  For the purposes of this Agreement, notices and all other communications provided for in this
        Agreement shall be in writing and shall be deemed to have been duly given when delivered or mailed by certified or registered mail, return receipt requested, postage prepaid, addressed to the respective addresses set forth below:

    

    

    	 	
            To the Employer:

          	
            President and Chief Executive Officer

          
	 	 	
            Southern Bank

          
	 	 	
            2991 Oak Grove Road

          
	 	 	
            Poplar Bluff, Missouri 63901

          
	 	 	 
	 	
            To the Executive:

          	
            Rick Windes

          
	 	 	
            At the address last appearing on the

            personnel records of the Employer

          

    

    

    9. Non-Solicitation Provisions. The Executive agrees that during the term of this Agreement and for the one year period immediately following the Date of Termination (the “Non-Solicitation Period”), the Executive will not (i) solicit or induce, or cause others to solicit or induce, any employee of the Bank or any
        of its affiliates or subsidiaries to leave the employment of such entities, or (ii) solicit (whether by mail, telephone, personal meeting or any other means, excluding general solicitations of the public that are not based in whole or in part on
        any list of customers of

    
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    the Bank or any of its affiliates or subsidiaries) any customer of the Bank or any of its affiliates or subsidiaries to transact business
      with any other entity which is engaged in any line of business conducted by the Bank or any of its affiliates or subsidiaries during the Non-Solicitation Period (including but not limited to entities which lend money and take deposits), or to reduce
      or refrain from doing any business with the Bank or its affiliates or subsidiaries, or interfere with or damage (or attempt to interfere with or damage) any relationship between the Bank or its affiliates or subsidiaries and any such customers.  All
      references in this Section 9 to the Bank or any of its affiliates or subsidiaries shall include any successors of such entities.

    

    

    10. Amendment; Waiver.  No provisions of this Agreement may be modified, waived or discharged unless such
        waiver, modification or discharge is agreed to in writing and signed by the Executive and such officer or officers as may be specifically designated by the Board of Directors of the Employer to sign on its behalf.  No waiver by any party hereto at
        any time of any breach by any other party hereto of, or compliance with, any condition or provision of this Agreement to be performed by such other party shall be deemed a waiver of similar or dissimilar provisions or conditions at the same or at
        any prior or subsequent time.  In addition, notwithstanding anything in this Agreement to the contrary, the Employer may amend in good faith any terms of this Agreement, including retroactively, in order to comply with Section 409A of the Code.

    

    

    11. Governing Law.  The validity, interpretation, construction and performance of this Agreement shall be
        governed by the laws of the United States where applicable and otherwise by the substantive laws of the State of Missouri.

    

    

    12. Nature of Obligations.

    

    

    (a) Nothing contained herein shall be deemed to create other than a terminable at will employment relationship between the Employer and the Executive,
        and the Employer may terminate the Executive’s employment at any time, subject to providing any payments specified herein in accordance with the terms hereof.

    

    

    (b) Nothing contained herein shall create or require the Employer to create a trust of any kind to fund any benefits which may be payable hereunder, and
        to the extent that the Executive acquires a right to receive benefits from the Employer hereunder, such right shall be no greater than the right of any unsecured general creditor of the Employer.

    

    

    13. Headings.  The section headings contained in this Agreement are for reference purposes only and shall
        not affect in any way the meaning or interpretation of this Agreement.

    

    

    14. Validity.  The invalidity or unenforceability of any provision of this Agreement shall not affect the
        validity or enforceability of any other provisions of this Agreement, which shall remain in full force and effect.

    

    

    15. Changes in Statutes or Regulations.  If any statutory or regulatory provision
        referenced herein is subsequently changed or re-numbered, or is replaced by a separate provision, then the references in this Agreement to such statutory or regulatory provision shall be deemed to be a reference to such section as amended,
        re-numbered or replaced.

    
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    16. Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall be
        deemed to be an original and all of which together will constitute one and the same instrument.

    

    

    17. Regulatory Prohibition.  Notwithstanding any other provision of this Agreement to the contrary, any
        renewal of this Agreement and any payments made to the Executive pursuant to this Agreement, or otherwise, are subject to and conditioned upon their compliance with Section 18(k) of the Federal Deposit Insurance Act (12 U.S.C. §1828(k)) and the
        regulations promulgated thereunder, including 12 C.F.R. Part 359.  In the event of the Executive’s termination of employment with the Bank for Cause, all employment relationships and managerial duties with the Bank shall immediately cease
        regardless of whether the Executive is in the employ of the Corporation following such termination.  Furthermore, following such termination for Cause, the Executive will not, directly or indirectly, influence or participate in the affairs or the
        operations of the Bank.

    

    

    18. Payment of Costs and Legal Fees and Reinstatement of Benefits.  In the event any dispute or
        controversy arising under or in connection with the Executive’s termination is resolved in favor of the Executive, whether by judgment, arbitration or settlement, the Executive shall be entitled to the payment of (a) all legal fees incurred by the
        Executive in resolving such dispute or controversy, and (b) any back-pay, including base salary, bonuses and any other cash compensation, fringe benefits and any compensation and benefits due to the Executive under this Agreement.

    

    

    19. Entire Agreement.  This Agreement embodies the entire agreement between the Employer and the Executive
        with respect to the matters agreed to herein. All prior agreements, if any, between the Employer and the Executive with respect to the matters agreed to herein are hereby superseded and shall have no force or effect.

    

    

    IN WITNESS WHEREOF, the parties have executed this Agreement as of
      the date first written above.

    

    

    	
            Attest:

          	 	
            SOUTHERN BANK

          
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	
            By:

          	/s/ Lorna Brannum 

          	 	 	/s/ Greg A. Steffens 

          
	
            Name:

          	
            Lorna Brannum

          	 	
            By:

          	
            Greg A. Steffens

          
	
            Title:

          	
            Secretary

          	 	
            Its:

          	
            President and Chief Executive Officer

          
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	
            EXECUTIVE

          
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	
            By:

          	/s/ Rick Windes 

          
	 	 	 	
            Name:

          	
            Rick Windes

          

    

    

  

  

  

  

  

  7Master
Services Agreement

 

This
Master Services Agreement (this “Agreement”) dated March 17, 2017 (the “Effective
Date”), between BriaCell Therapeutics Corporation, having a place of business at 820 Heinz Ave.,
Berkeley, CA 94710 (“Client”) and KBI Biopharma, Inc., having a place of business at 1101 Hamlin
Road, Durham, North Carolina 27704 (“KBI Biopharma”) (Client and KBI Biopharma, each a “Party”,
and collectively, the “Parties”).

 

Whereas,
Client is engaged in the discovery and development of new biological therapeutics;

 

Whereas,
KBI Biopharma is in the business of providing biological development and clinical manufacturing services; and

 

Whereas,
Client desires KBI Biopharma to perform certain services in accordance with the terms of this Agreement and KBI Biopharma desires
to perform such services.

 

Now,
therefore, in consideration of the above statements, which form part of this Agreement, and other good and valuable consideration,
the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:

 

	1.	Services
    to be Performed
	 	 
	1.1	Scope.
    KBI Biopharma shall use reasonable commercial efforts to perform the services (the “Services”) detailed
    in the applicable proposal, the first of which has been executed by the Parties and attached hereto as Attachment One
    and incorporated herein by reference (each referred to as a “Proposal”). Any deliverables to be
    provided to Client as a result of the performance by KBI Biopharma of the Services shall be set forth in the Proposal (the
    “Deliverables”). In the event that Client requests KBI Biopharma to perform services beyond the
    scope of services specifically stated in the Proposal, KBI Biopharma shall have no obligation to perform such supplemental
    services unless and until a Change Order or new a Proposal is executed in accordance with Article 5 below, or unless the Parties
    agree in writing on a proposal for additional services to be performed under this Agreement.
	 	 
	1.2	Additional
    Services. The Parties may agree upon additional services to be performed under the terms of this Agreement, as may be
    described in purchase orders or proposals to be mutually agreed upon by the Parties in writing. Such additional proposals
    or purchase orders, when signed by both Parties, shall be included in the term “Proposal” as used in this Agreement
    and the additional services described therein shall be included in the term “Services” as used in this Agreement.
	 	 
	1.3	Compliance
    with Laws. As applicable to the Services, KBI Biopharma shall perform the Services in all material aspects in compliance
    with current cGMP and other applicable rules, regulations and guidelines of the U.S. Food and Drug Administration (“FDA”),
    as then in effect, governing the manufacture, testing and quality control of investigational drugs. For purposes of the foregoing,
    “cGMP” means the current Good Manufacturing Practices as promulgated under each of the following
    as in effect on the date of this Agreement and as amended or revised after the date of this Agreement and in effect at the
    time of the performance of the Services: (a) the U.S. Food, Drug & Cosmetics Act (21 U.S.C. § 301 et seq.)
    and related U.S. regulations, including 21 Code of Federal Regulations (Chapters 210 and 211) and (b) the ICH guide Q7 “ICH
    Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” as applied to investigational drugs (Section
    19). Client shall have responsibility for determining regulatory strategy and for all regulatory decisions except for those
    matters that KBI Biopharma, in its reasonable discretion deems contrary to regulatory requirements or commitments made by
    KBI Biopharma to regulatory authorities, of which matters KBI Biopharma shall promptly notify Client in writing. Should the
    U.S. government regulatory requirements change, KBI Biopharma will use reasonable efforts to satisfy the new requirements.
    Notwithstanding the foregoing, in the event that compliance with such new U.S. regulatory requirements necessitates a change
    in the scope or nature of the Services to be completed, KBI Biopharma will submit to Client a Change Order in accordance with
    Article 5.

 

    	 	1	 

    	 

    

 

	2.	Client
    Obligations
	 	 
	2.1	General.
    Unless otherwise agreed to by the Parties in writing, in each case in accordance with the Proposal, Client is solely responsible
    for, and performance hereunder by KBI Biopharma is contingent upon: (a) provision of complete and accurate scientific data
    regarding the product which is the subject of the Proposal (the “Product”) and such other data that
    is to be supplied by Client pursuant to the Proposal; (b) provision of all information necessary to effect the reliable transfer
    of methods to KBI Biopharma; (c) provision of specific reagents, reference standards or other materials necessary for execution
    of Services, as may be described in the Proposal; (d) if applicable, review and approval of in-process and finished product
    test results to ensure conformity of such results with required Product specifications, regardless of which Party is responsible
    for finished Product release; (e) preparation of all submissions to regulatory authorities; and (f) performance of all other
    obligations of Client set forth in the Proposal. Client shall perform its obligations as set forth in this Agreement, support
    and cooperate with KBI Biopharma in the execution of the Services and shall not engage in any act or omission, which may reasonably
    be expected to prevent or delay the successful execution of the Services. Such support and cooperation shall include, but
    not be limited to, informing KBI Biopharma of global regulatory strategy for development and approval of the Product to the
    extent relevant to the Proposal, prompt review and approval of documents requiring Client’s signature, timely delivery
    of methods and materials and prompt response to other similar issues.
	 	 
	2.2	Provision
    of Regulatory Submissions. Prior to making any submission for regulatory approval of the Product, upon the request of
    KBI Biopharma, Client shall provide copies of all relevant regulatory submissions relating to KBI Biopharma’s manufacturing
    procedures (if applicable to the Services) to KBI Biopharma for review and reasonable opportunity to comment.
	 	 
	2.3	Information
    Regarding Hazardous Materials. Client shall provide to KBI Biopharma, on an on-going basis throughout the Term (as defined
    below), any applicable safe handling instructions for any substance or material provided by or on behalf of Client to KBI
    Biopharma in sufficient time for review and training by KBI Biopharma prior to delivery of any such substance or material
    to KBI Biopharma. Where appropriate or required by law, Client shall provide a Material Safety Data Sheet and instructions
    for proper storage for all Client-provided materials, finished product and reference standards.
	 	 
	2.4	Other
    Company Materials. As soon as practicable following the execution of this Agreement, Client shall provide to KBI Biopharma
    all materials, know-how, information and technical assistance under Client’s control which is associated with the Product
    or otherwise required for the performance of the Services in accordance with the Proposal. Client agrees that such materials,
    know-how, information and technical assistance shall be complete and accurate to the extent required for KBI Biopharma to
    perform the Services. Client hereby grants to KBI Biopharma during the Term of this Agreement the right to use any and all
    patent rights, trade secrets, intellectual property and other materials under Client’s control solely in accordance
    with terms and conditions of this Agreement and to the extent necessary for KBI Biopharma to perform the Services.

 

    	 	2	 

    	 

    

 

	3.	Performance
	 	 
	3.1	Schedule.
    Due to the unpredictable nature of biological processes, the timelines and schedules for the performance of the Services (including
    without limitation the dates for production and delivery of Product) and the yield or quantity of Product as set out in the
    Proposal are estimates. KBI Biopharma shall keep Client regularly informed in writing of any such changes that are necessary
    to the Proposal, and agrees that such changes will be made to the minimum extent reasonably necessary and KBI Biopharma will
    not make any changes in the specifications covering the manufacturing or processing of the Product or the production process
    without the express written consent of Client. Client shall not be entitled to cancel any unfulfilled part of the Services
    or refuse acceptance of Product related to the Proposal on reasonable grounds of late performance of the Services or late
    delivery of the Product subject to the provisions of this Section 3.1, provided that Client has received regular communications
    during the development process and is aware of the reasons for such late delivery or late performance. If Client has not received
    regular communications during the development process and is not aware of the reasons for such late delivery or late performance,
    Client shall be entitled to cancel any unfulfilled part of the Services or refuse acceptance of Product related to the Proposal.
    In such event, KBI Biopharma shall not be liable for any loss, damage, costs or expenses of any nature, whether direct, indirect,
    incidental or consequential, arising out of any delay in performance or delivery howsoever caused or arising out of any failure
    to produce the estimated quantities of Product for delivery on the estimated schedule, except to the extent caused by the
    gross negligence of KBI Biopharma, or otherwise specifically agreed to in a Proposal.
	 	 
	3.2	Technical
    Difficulties. If it becomes apparent to either KBI Biopharma or Client at any stage in the provision of any Services that,
    as a result of scientific or technical reasons out of the reasonable control of either Party, it will not be possible to complete
    the Services in the manner described in this Agreement or the Proposal or any Change Order thereto, the Parties will (a) identify
    the problem, (b) submit the problem in writing to senior management of each Party, and (c) negotiate in good faith for a thirty
    (30) day period from the date senior management of the Parties first convene regarding how to resolve such problem in a commercially
    reasonable manner. If the Parties do not agree on a commercially reasonable resolution to the problems within such thirty
    (30) day period, KBI Biopharma and Client shall each have the right to terminate this Agreement by written notice to the other
    Party, subject to Section 24.2.
	 	 
	3.3	Quality
    Agreement. In the event that the Proposal specifically enumerates Services that include the contract manufacturing and
    performance of the activities are subject to cGMP, within fifteen (15) days of the execution of this Agreement, or as soon
    as practicable after the execution hereof, the Parties shall develop and agree upon the outline of a quality agreement describing
    the regulatory and compliance roles and responsibilities of each Party, including without limitation, procedures for handling
    Product recalls and non-conforming Product, the format and content of which shall be agreed upon by the Parties (the “Quality
    Agreement”). Within sixty (60) days of the execution of this Agreement, the Parties shall agree to and execute
    a definitive Quality Agreement. Upon execution by both Parties, the Quality Agreement shall be incorporated herein and attached
    hereto as Attachment Two.
	 	 
	3.4	Non-Conforming
    Services. Within thirty (30) days of delivery of the Product, Client shall inform KBI Biopharma of any material non-conformity
    with required specifications set forth in the Proposal, as may be further provided in the Quality Agreement. In the event
    that such non-conformity is attributable to KBI’s breach of its obligations under this Agreement, then, as Client’s
    initial remedy, KBI Biopharma shall, subject to Client providing the active pharmaceutical ingredient, biological material
    or other source materials, as applicable, re-perform such non-conforming Services as soon as possible with no additional fees
    to Client. If upon repeat of the Services, KBI Biopharma is unable to deliver a conforming Product, either party may terminate
    this Agreement or if the Parties so agree, they shall work together in good faith generate a Product that conforms to the
    specifications.

 

    	 	3	 

    	 

    

 

	4.	Work
    Output
	 	 
	 	All
    reports specified in the Proposal and other applicable cGMP documentation (“Work Output”) will be
    prepared using KBI Biopharma’s standard format(s) unless otherwise specified in the Proposal or this Agreement. Client
    will be supplied with copies of Work Output generated as a result of the Services as set forth in the Proposal or Quality
    Agreement. All Work Output and any required Product samples will be at Client’s option, (a) delivered to Client at any
    address as Client may specify in such request, or (b) archived by KBI Biopharma for a period of five (5) years following completion
    of the Services unless otherwise provided in the Proposal or required by applicable U.S. laws or regulations. At such time
    after completion of the Services, Work Output and Product samples will be sent to Client and a reasonable return fee will
    be charged. If Client chooses to have KBI Biopharma dispose of Work Output and Product samples, a reasonable disposal fee
    will be charged. Not more than once annually, KBI Biopharma shall, during normal working hours, and with reasonable advance
    notice, permit Client or its authorized agents to inspect, audit and/or reproduce Records (i) to the extent necessary to adequately
    evaluate invoices submitted to Client by KBI Biopharma hereunder, (ii) as required by governmental authorities or (iii) as
    desired by Client for any other valid business purpose related to this Agreement.
	 	 
	5.	Change
    Orders
	 	 
	5.1	Change
    Orders. The budget for the Services specified in the Proposal and the estimated timelines specified therein are subject
    to a number of general and Proposal-specific assumptions. The assumptions relate to the design and objectives of the Proposal,
    manpower requirements, timing, capital expenditure requirements, if any, and other matters relating to the completion of the
    Services as may be set forth in the Proposal (“Proposal Assumptions”). KBI Biopharma also assumes
    that Client will cooperate and fully perform its obligations under this Agreement and the Proposal in a timely manner, that
    no event outside of KBI Biopharma’s control will occur (including without limitation a Force Majeure Event), and that
    there are no changes to any applicable laws, rules or regulations relating to the performance of the Services (the foregoing
    assumptions together with the Proposal Assumptions, collectively, the “Assumptions”). In the event
    of a failure of any of the Assumptions, the objectives of the Proposal cannot be achieved based on the Assumptions, or Client
    requests a change to the Proposal, then the scope of services to be performed shall be amended as provided in this Article
    5 (a “Modification”). Modifications shall also arise in the event (i) Client revises KBI Biopharma’s
    responsibilities, the specifications, the Proposal instructions, procedures, Assumptions, processes, test protocols, test
    methods, or analytical requirements; or (ii) Client’s requirements or any Client provided information is inaccurate
    or incomplete.
	 	 
	5.2	Change
    Order Process. In the event a Modification is requested by Client or by KBI Biopharma, KBI Biopharma shall provide Client
    with a change order containing an estimate of the required Modifications to the budget, activities and/or duration specified
    in the Proposal (“Change Order”). Client and KBI Biopharma shall negotiate in good faith for a period
    of ten (10) business days following receipt of such Change Order by Client (the “Change Order Negotiation Period”)
    to agree on a Change Order that is mutually acceptable. If practicable, and agreed to by Client, KBI Biopharma shall continue
    work on the Services during any such negotiations, but shall have no obligation to commence work with respect to any Change
    Order unless authorized in writing by Client. In the event the Parties are unable to agree upon such Change Order within the
    Change Order Negotiation Period, KBI Biopharma may elect to terminate this Agreement, or if reasonably possible, to perform
    the Services without regard to the unresolved Change Order; provided, however, that the estimated timelines shall be adjusted
    to reflect any delay during the Change Order Negotiation Period. In the event that this Agreement is so terminated, the provisions
    with respect to the effect of termination set forth in Section 24.5 shall apply. Any disputes arising from this Section 5.2
    shall be resolved in accordance with the dispute resolution procedures set forth in Article 22.

 

    	 	4	 

    	 

    

 

	5.3	Regulatory
    Changes. Notwithstanding the foregoing, with respect to any changes or modifications to the Proposal, Services or Product
    specifications dictated by the FDA or other applicable law or authority, Client shall be responsible for the costs of making
    such changes (including without limitation capital costs), validating the manufacturing process after any such change is made,
    and any increases in the cost of manufacturing the Product or provision of Services as a result of such change. With respect
    to any such changes dictated by the FDA or other applicable law or authority, the Parties will promptly meet to discuss the
    actions necessary to comply with such changes and the costs associated therewith. If, after reasonable efforts, the Parties
    are unable to agree on such changes (including the costs payable by Client pursuant to this Section 5.3), or if KBI Biopharma
    is unable to comply with such changes or modifications through the exercise of commercially reasonable efforts, KBI Biopharma
    may, in its sole discretion, terminate this Agreement upon written notice to Client.
	 	 
	5.4	Non-Material
    Changes. Notwithstanding the foregoing, Client acknowledges, however, that KBI Biopharma is given flexibility to conduct
    the Services, although not expressly stated in the Proposal, at the time and in the manner that KBI Biopharma deems reasonably
    necessary to fulfill its obligations under this Agreement. Such flexibility includes the right to make non-Material Changes
    to the Services and the Proposal, provided that KBI Biopharma implements all such changes only (a) in accordance with KBI
    Biopharma’s written standard operating procedures governing change control and (b) after confirming that such change
    does not affect either the related Product specifications if such specifications and requirements are fixed in writing by
    the Parties. As used herein, “Material Change” is defined as any variation, alteration or modification
    of activities, materials, or methods provided in the Proposal that (i) impacts the regulatory commitments or filings for the
    Product, (ii) affects the quality, purity, identity or strength of the Product, or (iii) materially increases the cost of
    manufacturing the Product.
	 	 
	6.	Compensation
	 	 
	6.1	Fees
    and Invoices. In consideration for KBI Biopharma performing the Services, Client shall pay to KBI Biopharma such amounts
    as described in the Price and Payment Terms section of the Proposal and as otherwise described in this Agreement. Following
    payment of an initial fee as provided in Section 6.2, the remainder of the service fees may be invoiced by KBI Biopharma monthly
    based on a billing schedule derived from the project schedule. Payments are due thirty (30) days from the date of receipt
    of each invoice, except as specifically provided in this Agreement. Charges for materials may be invoiced to Client and are
    payable at the time that KBI Biopharma orders such materials for Client’s project. Client agrees to pay to KBI Biopharma
    the cost of materials, consumables, and third party services plus a 5% fee to compensate KBI Biopharma for the cost of purchasing,
    material handling, inventory and administration and management of third party services necessary for KBI Biopharma to perform
    the Services. Late payments are subject to an interest charge of one and one half percent (11⁄2%) per month or, if less, the
    maximum legal interest rate per month. Failure to bill for interest due shall not be a waiver of KBI Biopharma’s right
    to charge interest. All payments are non-refundable. If paid by wire transfer, any applicable wire transfer fees must be included
    in the payment issued to KBI Biopharma. Client shall be responsible for, and shall promptly pay to KBI Biopharma upon demand,
    all costs and expenses (including without limitation reasonable attorneys’ fees and court costs) incurred by KBI Biopharma
    in connection with the collection of payments due under this Agreement. Unless within thirty (30) days of the date of invoice,
    Client has advised KBI Biopharma in good faith and in writing the specific basis for disputing an invoice, Client’s
    failure to promptly pay an invoice may, at KBI Biopharma’s election, constitute a material breach of this Agreement,
    and in addition to other remedies available to KBI Biopharma under Section 24.3, KBI Biopharma shall be entitled to suspend
    performance of Services until Client has paid any past due invoices.

 

    	 	5	 

    	 

    

 

	6.2	Start-up
    Payment. KBI Biopharma requires payment of an initial fee of one third of the service fees specified in the Proposal,
    prior to commencement of Services, and before KBI Biopharma will begin facilities preparation and resource allocation commitments
    with respect to Client’s project(s). Initial fees are due upon execution of this Agreement or the applicable Proposal,
    whichever occurs later. The initial fee shall be applied to the final project invoice. Upon termination of a Proposal or this
    Agreement, any remaining portion of the initial fee shall be applied to any outstanding amounts due from Client under the
    applicable Proposal. Unless otherwise provided in this Agreement or the applicable Proposal, initial fees are non-creditable,
    nonrefundable, non-transferable to any Services other than under the applicable Proposal.
	 	 
	6.3	Client
    Delays. KBI Biopharma has allocated resources to the Services that may be difficult or impractical to reallocate to other
    programs in the event of a delay attributable to Client’s failure to comply with its obligations under this Agreement,
    Client’s written request for delay, or scientific or technical issues related to Client’s Product which are outside
    of KBI Biopharma’s control. In recognition of this, KBI Biopharma shall be entitled to charge reasonable wind down and
    restart fees resulting from such delays. Where the Services include manufacturing Services, in the event that Client cancels
    or postpones a manufacturing run (based on the manufacturing slots reserved for Client in the most recent schedule provided
    to Client) for any reason other than a material breach of this Agreement by KBI Biopharma, or in the event that a manufacturing
    run is cancelled or postponed for scientific or technical issues related to Client’s Product which are outside of KBI
    Biopharma’s control, Client shall pay KBI Biopharma, upon receipt of an invoice, the following amounts, less all amounts
    already paid to KBI Biopharma for the applicable manufacturing Services:

 

	 	(i)	One
    hundred percent (75%) of the price of the Services for the applicable manufacturing run if such cancellation or postponement
    occurs thirty (30) days or fewer prior to the scheduled vial thaw date (as communicated by KBI Biopharma to Client in writing)
    or at any time following the scheduled vial thaw date;
	 	 	 
	 	(ii)	Seventy-five
    percent (50%) of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs
    from thirty-one (31) to sixty (60) days prior to the scheduled vial thaw date;
	 	 	 
	 	(iii)	Fifty
    percent (25%) of the price of the Services for the applicable manufacturing run if such cancellation or postponement occurs
    from sixty-one (61) to ninety (90) days prior to the scheduled vial thaw date; or

 

	6.4	Taxes.
    Any federal, state, county or municipal sales or use tax, excise tax, customs charges, duties or similar charge, or any other
    tax assessment (other than that assessed against KBI Biopharma’s income), license, fee or other charge lawfully assessed
    or charged on the manufacture, sale or transportation of Product sold or Services performed pursuant to this Agreement, and
    all government license filing fees and, if applicable, Prescription API User (PDUFA) annual establishment fees with respect
    to all Products and Services shall be paid by Client.
	 	 
	7.	Confidentiality
	 	 
	7.1	Confidential
    Information. During the Term and for a period of five (5) years thereafter, each Party shall maintain in confidence all
    information and materials of the other Party disclosed or provided to it (the “Recipient”) by the
    other Party (the “Disclosing Party”) including the terms and conditions (but not the existence)
    of this Agreement. Confidential information shall be identified as confidential in writing or, if disclosed verbally or by
    observation, summarized in writing and submitted to Recipient within thirty (30) days of the oral or visual disclosure thereof
    (together with all embodiments thereof, the “Confidential Information”); provided, however, (a)
    information need not be labeled or marked “confidential” to be deemed Confidential Information hereunder, if under
    the circumstances it is, or should be, understood to be confidential; and (b) in accordance with Section 7.2, information
    learned, observed or obtained by Client during any visit to KBI Biopharma’s facilities shall be deemed “Confidential
    Information” of KBI Biopharma hereunder, regardless of whether such information is marked “confidential”
    or subsequently summarized in writing.

 

    	 	6	 

    	 

    

 

	7.2	Exceptions.
    Notwithstanding the foregoing, Confidential Information shall not include that portion of information or materials that the
    Recipient can demonstrate by contemporaneous written records was:

 

	 	(i)	known
    to the public at the time of its disclosure to the Recipient, or thereafter became generally known to the public, other than
    as a result of actions or omissions of the Recipient in violation of this Agreement;
	 	 	 
	 	(ii)	disclosed
    to the Recipient on an unrestricted basis from a source unrelated to the Disclosing Party and not known by the Recipient to
    be under a duty of confidentiality to the Disclosing Party, as evidenced by competent written proof; or
	 	 	 
	 	(iii)	independently
    developed by the Recipient, or known by the Recipient prior the date of disclosure by the Recipient, without the use of Confidential
    Information of the Disclosing Party, as evidenced by competent written proof.

 

	7.3	Additional
    Protections. Each Party shall take all reasonable steps to maintain the confidentiality of the Confidential Information
    of the other Party, which steps shall be no less protective than those that such Party takes to protect its own information
    and materials of a similar nature, but in no event less than a reasonable degree of care. Neither Party shall use or permit
    the use of any Confidential Information of the other Party except for the purposes of carrying out its obligations or exercising
    its rights under this Agreement. All Confidential Information of a Party, including all copies and derivations thereof, is
    and shall remain the sole and exclusive property of the Disclosing Party and subject to the restrictions provided for herein.
    Neither Party shall disclose any Confidential Information of the other Party other than to those of its directors, officers,
    employees, independent contractors, and external advisors directly concerned with the carrying out of this Agreement, on a
    strictly applied “need to know” basis, provided that any such disclosure is made subject to obligations of confidentiality
    no less stringent than the obligations provided herein.
	 	 
	7.4	Permitted
    Disclosures. The obligations set forth in this Article 7 shall not apply to the extent that Recipient is required to disclose
    information by law, judicial order by a court of competent jurisdiction, or the rules of a securities exchange or requirement
    of a governmental agency for purposes of obtaining approval to test or market Product, or disclosures of information to a
    patent office for the purposes of filing a patent application as permitted in this Agreement; provided, however, that the
    Recipient shall provide prior written notice thereof to the Disclosing Party and sufficient opportunity for the Disclosing
    Party to review and comment on such required disclosure and request confidential treatment thereof or a protective order therefore
    and shall reasonably cooperate with the disclosing Party, at the disclosing Party’s expense, to seek appropriate measures
    requiring, amongst other things, that the Confidential Information so disclosed be used only for the purposes for which the
    order was issued and the Confidential Information so disclosed be redacted to limit the extent of disclosure to the minimum
    extent required to comply with the relevant court or government body order or law. Any disclosure permitted pursuant to this
    Section 7.4 shall not be considered an exception under Section 7.2.
	 	 
	7.5	Iniunctive
    Relief. The Parties acknowledge that either Party’s breach of this Article 7 may cause the other Party irreparable
    injury for which it may not have an adequate remedy at law. In the event of a breach, the non-breaching Party shall be entitled
    to seek injunctive relief in addition to any other remedies it may have at law or in equity, in accordance with Article 21.
	 	 
	8.	Inventions
	 	 
	8.1	Inventions.
    At Client’s request, KBI Biopharma will, at no cost, assign to Client any all data, ideas, information, developments,
    and inventions that are Product improvements, or improvements to Client Materials discovered by KBI Biopharma employees exclusively
    as a result of performing the Services under this Agreement (“Product Invention”); provided Client
    requests such assignment, in writing, within one (1) year of notification of such Product Invention. If Client requests and
    at Client’s expense, KBI Biopharma will execute any and all applications, assignments or other instruments and give
    testimony which shall be necessary to apply for and obtain letters of patent of the US or of any foreign country with respect
    to the Product Invention and Client shall compensate KBI Biopharma for the time devoted to such activities and reimburse it
    for expenses incurred. For Product Inventions assigned pursuant to this section, Client shall provide KBI Biopharma a royalty-free
    license to use such Product Inventions to the extent necessary to perform the Services.

 

    	 	7	 

    	 

    

 

	8.2	Process
    Technology and Process Inventions. Notwithstanding the foregoing, Client acknowledges that KBI Biopharma possesses and
    shall retain full ownership of information and technology relating to general manufacturing and analytical methods and processes,
    (“Process Technology”) and KBI Biopharma shall retain all rights to any data, ideas, know-how, information,
    developments, and inventions related to the Process Technology that are developed, conceived or reduced to practice in connection
    with the Services which can be generally applied to the production of biologics other than the Product and which do not use,
    reference, rely on or incorporate Client Materials (collectively, “Process Inventions”).
	 	 
	8.3	Process
    Technology and Process Inventions License. For Process Technology and Process Inventions, KBI Biopharma will grant to
    Client a perpetual, world-wide, royalty-free, non-exclusive license under terms mutually agreed to by the Parties for Client
    to use such Process Technology and/or Process Inventions to manufacture or have manufactured the Product. If KBI Biopharma
    requests, and at KBI Biopharma’s expense, Client will execute any and all applications, assignments or other instruments
    and give testimony which shall be necessary to apply for and obtain letters of patent of the US or of any foreign country
    with respect to the Process Inventions and KBI Biopharma shall compensate Client for the time devoted to such activities and
    reimburse it for expenses incurred.
	 	 
	8.4	Client
    Materials. All Client Materials that KBI Biopharma may have access to in order to perform the Services shall be owned
    exclusively by the Client. Nothing in this Agreement shall be deemed to grant any rights to KBI Biopharma in any Client Materials,
    other than the right for KBI Biopharma to use such Client Materials to perform the Services. For the purposes hereof, “Client
    Materials” means all Client proprietary materials and information, intellectual property and developments, including
    without limitation, all patents, patent applications, know-how, inventions, designs, concepts, technical information, manuals,
    or instructions which, as of the Effective Date, are owned, licensed or controlled by Client relating to the development,
    formulation, manufacture, processing, packaging, analysis or testing of the Product. In the event that Client loses or forfeits
    its rights in such proprietary Client Materials during the Term of this Agreement for any reason, Client shall provide notice
    of same to KBI Biopharma immediately and this Agreement shall be subject to immediate termination by KBI Biopharma at that
    time, subject to Section 24.2.
	 	 
	9.	Use
    of Intellectual Property Rights

 

Except
as expressly stated in this Agreement, no intellectual property rights of any kind or nature are conveyed by this Agreement and
neither Party shall have any right, title or interest in or to the other Party’s intellectual property rights for any purpose
whatsoever without such other Party’s prior written consent.

 

	10.	Facility
    Visits and Audits
	 	 
	10.1	Scope
    of Visit. Client shall have the right, upon no less than thirty (30) days’ prior written notice to KBI Biopharma,
    to visit KBI Biopharma and during regular business hours to observe the progress of the Services (i.e., person in the plant)
    and to inspect related records and data for the purpose of making quality control inspections so as to assure compliance with
    this Agreement. The form, participants, duration and procedures of all visits shall be subject to KBI Biopharma’s reasonable
    approval.

 

    	 	8	 

    	 

    

 

	10.2	Client
    Obligations. It shall be the duty of Client to follow KBI Biopharma’s reasonable safety rules while in, on or about
    KBI Biopharma’s premises. In addition, Client agrees that it and its subcontractors, employees, representatives, and
    guests of any of them shall: (a) be subject to the nondisclosure obligation described in Article 7, (b) follow such security
    and facility access procedures as are designated by KBI Biopharma, (c) be accompanied by a KBI Biopharma representative, (d)
    not enter areas of any KBI Biopharma facility at times when any third party’s products are being manufactured to assure
    protection of KBI Biopharma’s or third party’s confidential information, (e) stay within the areas of KBI Biopharma’s
    facilities designated for the visit and shall not visit areas of the facility other than those areas necessary for the performance
    of the facility visit provided for herein without KBI Biopharma’s prior written permission, and (f) use good faith efforts
    to avoid disrupting KBI Biopharma’s operations. All information learned, observed or obtained by Client during any visit
    to KBI Biopharma’s facilities shall be deemed “Confidential Information” of KBI Biopharma under Article
    7, regardless of whether such information is marked “Confidential” or subsequently summarized in writing. Client
    warrants that it, and its subcontractors, employees, agents, representatives, and any personnel acting on behalf of Client
    hereunder who visit the KBI Biopharma facility: (i) are not debarred, under subsections 306(a) or (b) of the Generic Drug
    Enforcement Act of 1992, as each may be amended from time to time, and (ii) will at all times comply with all safety and security
    regulations in effect from time to time and communicated by KBI Biopharma, and (iii) will at all times comply with Article
    7 with respect to the confidentiality and use of KBI Biopharma Confidential Information.
	 	 
	10.3	Costs.
    Client may conduct one (1) such quality assurance facility visit per calendar year using no more than two (2) auditors for
    a maximum of two (2) days at no cost to Client. Additional audits will be invoiced separately on a time and materials basis
    at the then current rate for such services.
	 	 
	11.	Regulatory
    Inspections
	 	 
	11.1	General.
    KBI Biopharma will promptly notify Client of any regulatory inspections directly relating to the Services, in accordance with
    the terms of the Quality Agreement (if applicable). KBI Biopharma agrees to reasonably cooperate with all regulatory authorities
    and submit to reasonable inspections by such authorities.
	 	 
	11.2	Costs.
    Client shall be responsible for, and shall promptly pay, all documented costs charged by a regulatory authority for inspections
    directly related to the Services to be provided in the Proposal. Subject to advance written approval of Client, KBI Biopharma’s
    costs in connection with regulatory inspections will be invoiced separately on a time and materials basis at the then current
    rate for such services.
	 	 
	12.	Warranties
	 	 
	12.1	Warranties
                                         of KBI Biopharma.

         

        12.1.1
        As of the Effective Date, KBI Biopharma represents and warrants to Client that it has all requisite corporate power and
        authority to enter into and perform all of its obligations under this Agreement. The execution and delivery of this Agreement
        and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate
        action in respect thereof on the part of KBI Biopharma. Neither the execution and delivery of this Agreement nor the performance
        of the transactions contemplated hereby, nor compliance by KBI Biopharma with the provisions hereof, shall conflict with
        any obligations or agreements of KBI Biopharma to any person, contractual or otherwise.

         

        12.1.2
        KBI Biopharma warrants to Client that it will render the Services with due care, consistent with industry standards for
        work of a similar nature.

         

        12.1.3
        KBI Biopharma represents to Client that it is not debarred, and warrants to Client that it will not knowingly use in any
        capacity the services of any person debarred, under subsections 306(a) or (b) of the Generic Drug Enforcement Act of 1992,
        as each may be amended from time to time.

 

    	 	9	 

    	 

    

 

	 	12.1.4
                                         EXCEPT AS EXPRESSLY WARRANTED IN THIS SECTION 12.1, KBI BIOPHARMA MAKES NO REPRESENTATION
                                         OR WARRANTY WITH RESPECT TO THE SERVICES OR PRODUCT, EXPRESS OR IMPLIED, IN ANY MANNER
                                         AND EITHER IN FACT OR BY OPERATION OF LAW, AND SPECIFICALLY DISCLAIMS ANY AND ALL IMPLIED
                                         OR STATUTORY WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY,
                                         FITNESS FOR A PARTICULAR PURPOSE, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF
                                         TRADE OR NONINFRINGEMENT. KBI BIOPHARMA MAKES NO WARRANTIES THAT THE EXECUTION OF THE
                                         SERVICES WILL RESULT IN ANY SPECIFIC QUANTITY OR AMOUNT OF PRODUCT.

         

        12.1.5
        KBI Biopharma has warranted, in Section 12.1.2, that the Services will be rendered with due care; however, no predetermined
        results are assured. Client understands and agrees that the Services are experimental in nature, that biopharmaceutical
        process development is subject to certain inherent risks, and as such, nothing in this Agreement shall be construed as
        a guarantee or warranty by KBI Biopharma that the Services, the Products, the Deliverables, or the materials, data, information
        of other results produced in connection therewith, will meet or otherwise satisfy any of the objectives, goals or targets
        stated in the Proposal. Client hereby acknowledges and agrees that there is absolutely no guarantee:

 

	 	(i)	that
    the results of the Services will be successful in any way or will be commercially exploitable, profitable or approved by any
    regulatory authority;
	 	 	 
	 	(ii)	that
    the Product, or any product, resulting from the Services will fulfill certain specifications or certain yields; or
	 	 	 
	 	(iii)	the
                                         Products, the Services and/or the results of the Services will satisfy the requirements
                                         of any regulatory agencies at the time of submission of such results to such agencies.

        

	 	 	 
	 	12.1.6 Client’s sole and exclusive remedy and KBI Biopharma’s sole and exclusive obligation under the warranties provided in this Agreement shall be the remedy provided in Section 3.4.

 

	12.2	Warranties
                                         of Client.

         

        12.2.1
        As of the Effective Date, Client represents and warrants to KBI Biopharma that it has all requisite corporate power and
        authority to enter into and perform all of its obligations under this Agreement. The execution and delivery of this Agreement
        and the consummation of the transactions contemplated hereby have been duly and validly authorized by all necessary corporate
        action in respect thereof on the part of Client. Neither the execution and delivery of this Agreement nor the performance
        of the transactions contemplated hereby, nor compliance by Client with the provisions hereof, shall conflict with any
        obligations or agreements of Client to any person, contractual or otherwise.

         

        12.2.2
        Client represents and warrants to KBI Biopharma that it holds legal title to, or is fully entitled to provide, the materials,
        methods, plans, processes and other intellectual property necessary to conduct the Services and that KBI Biopharma’s
        performance of the Services will not violate or infringe on the patents, trademarks, service marks, copyrights, or intellectual
        property of any nature of any third party.

         

        12.2.3
        Client represents and warrants to KBI Biopharma that all materials provided by Client for use in the performance of the
        Services shall be free of contaminants and shall be fit for use in the performance of the Services.

         

        12.2.4
        Client represents and warrants to KBI Biopharma that it will hold, use and/or dispose of Product and all materials provided
        by KBI Biopharma in accordance with all applicable laws, rules and regulations.

 

    	 	10	 

    	 

    

 

	 	12.2.5
    Client represents and warrants to KBI Biopharma that no specific safe handling instructions are applicable to any substance
    or material provided by Client to KBI Biopharma, except as disclosed to KBI Biopharma in writing in sufficient time for review
    and training by KBI Biopharma prior to delivery of any such substance or material to KBI Biopharma.
	 	 
	13.	Indemnification
	 	 
	13.1	Indemnification
    by KBI Biopharma. Subject to Section 13.2 below, KBI Biopharma will indemnify, defend and hold harmless Client and its
    shareholders, directors, officers, employees and agents (each, a “Client Indemnitee”) from and
    against     all costs, losses, expenses (including reasonable attorneys’ fees) and direct damages (collectively,
    “Losses”)     resulting from all lawsuits, claims, demands, actions and other
    proceedings by or on behalf of any third party (collectively     “Claims”) to the extent arising
    out of or resulting from: (i) KBI Biopharma’s material breach     of any covenant, warranty, or a failure of any
    material representation made hereunder by KBI Biopharma; or (ii) KBI Biopharma’s     gross negligence or intentional
    misconduct, except in each case to the extent such Claims or Losses arise from negligence     or intentional misconduct on
    the part of a Client Indemnitee or a breach of this Agreement by Client.
	 	 
	13.2	Indemnification
    by Client. Client will indemnify, defend and hold harmless KBI Biopharma and its shareholders, directors, officers, employees
    and agents (each, a “KBI Biopharma Indemnitee”) from and against all Losses resulting from all Claims
    to the extent arising out of or resulting from: (i) Client’s material breach of any covenant, warranty, or a failure
    of any material representation made hereunder by Client; (ii) Client’s development (including the conduct of clinical
    trials in humans), handling, manufacturing, testing, storage, transportation, disposal, marketing, commercialization (including
    any recalls, field corrections or market withdrawals), distribution, promotion, sale or use of the Product or Deliverables
    (including without limitation as a result of any illness, injury or death to persons, including employees, agents or contractors
    of Client or damage to property); (iii) Client’s gross negligence or intentional misconduct; (iv) the infringement or
    alleged infringement as a result of, or arising from, the scope of the Services (or execution thereof), as requested by Client
    the Client Materials or the Product on the intellectual property rights of a third party, except in each case to the extent
    such Claims or Losses arise from negligence or intentional misconduct on the part of a KBI Biopharma Indemnitee or a breach
    of this Agreement by KBI Biopharma.
	 	 
	13.3	Indemnification
                                         Procedure. If any Claim covered by Article 13 is brought:

         

        13.3.1
        the indemnified Party shall promptly notify the indemnifying Party in writing of such Claim, provided, however, the failure
        to provide such notice within a reasonable period of time shall not relieve the indemnifying Party of any of its obligations
        hereunder except to the extent the indemnifying Party is prejudiced by such failure or delay;

         

        13.3.2
        the indemnifying Party shall assume, at its cost and expense, the sole defense of such Claim through counsel selected
        by the indemnifying Party and reasonably acceptable to the other Party, except that those indemnified may at their option
        and expense select and be represented by separate counsel;

         

        13.3.3
        the indemnifying Party shall maintain control of such defense and/or the settlement of such Claim;

         

        13.3.4
        the indemnified Party may, at its option and expense, participate in such defense, and if it so participates, the indemnifying
        Party and the indemnified Party shall cooperate with one another in such defense;

         

        13.3.5
        the indemnifying Party will have authority to consent to the entry of any settlement or otherwise to dispose of such Claim
        (provided and only to the extent that an indemnified Party does not have to admit liability and such judgment does not
        involve equitable relief), and an indemnified Party may not consent to the entry of any judgment, enter into any settlement
        or otherwise to dispose of such Claim without the prior written consent of the indemnifying Party (not to be unreasonably
        withheld or delayed); and

 

    	 	11	 

    	 

    

 

	 	13.3.6
    the indemnifying Party shall pay the full amount of any judgment, award or settlement with respect to such Claim and all other
    costs, fees and expenses related to the resolution thereof; provided, however, that such other costs, fees and expenses have
    been incurred or agreed, as the case may be, by the indemnifying Party in its defense or settlement of the Claim.
	 	 
	14.	Limitations
    of Liability
	 	 
	14.1	Notwithstanding
    anything herein to the contrary, KBI Biopharma and Client’s total liability for any loss, including without limitation
    Losses indemnifiable by KBI Biopharma pursuant to Article 13, suffered by the other party resulting from this Agreement, work
    conducted pursuant to any Proposal or any other liability of any nature, shall be limited to the payment of damages which
    shall not exceed the amount paid by Client to KBI Biopharma under the Proposal under which the loss arose. However, the foregoing
    limitations of liability will not apply to breaches of confidentiality obligations under Article 7 or Client’s obligations
    to KBI Biopharma under Section 13, Indemnification.
	 	 
	14.2	EXCEPT
    AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL, INDIRECT, PUNITIVE,
    CONSEQUENTIAL (INCLUDING WITHOUT LIMITATION, LOST PROFITS), EXEMPLARY OR SPECIAL DAMAGES OF ANY TYPE, ARISING IN CONNECTION
    WITH THIS AGREEMENT, ANY PROPOSAL, QUALITY AGREEMENT OR ATTACHMENTS OR DOCUMENTS RELATED THERETO, WHETHER OR NOT FORESEEABLE
    AND WHETHER SUCH DAMAGES ARISE IN TORT, CONTRACT, EQUITY, STRICT LIABILITY, OR OTHERWISE, EVEN IF THE PARTY HAS BEEN ADVISED
    OF THE POSSIBILITY OF SUCH DAMAGES.

 

15
Force Majeure

 

Except
for each Party’s payment, confidentiality and indemnity obligations, the obligations of either Party under this Agreement
shall be excused during each period of delay caused by matters such as acts of God, strikes, supplier delays, shortages of raw
materials, power failure, government orders, changes in governmental regulation (including without limitation, acts of the FDA
or an applicable foreign equivalent), or acts of war or terrorism, which are reasonably beyond the control of the Party obligated
to perform (each, a “Force Majeure Event”). A Force Majeure Event shall not include a lack of funds,
bankruptcy or other financial cause or disadvantage. Nothing contained in this Agreement shall affect either Party’s ability
or discretion regarding any strike or other employee dispute or disturbance and all such strikes, disputes or disturbances shall
be deemed to be beyond the control of such Party. A Force Majeure Event shall be deemed to continue only so long as the affected
Party shall be using its commercially reasonable effort to overcome such condition. If either Party shall be affected by a Force
Majeure Event, such Party shall give the other Party prompt notice thereof, which notice shall contain the affected Party’s
estimate of the duration of such condition and a description of the steps being taken or proposed to be taken to overcome such
Force Majeure Event. Any delay, or invalidity in the results delivered, in the performance of the Services occasioned by any such
cause shall not constitute a default under this Agreement, and the obligations of the Parties shall be suspended during the period
of delay so occasioned. During any period of any Force Majeure Event, the Party that is not directly affected by such Force Majeure
Event may take any reasonable action necessary to mitigate the effects of such Force Majeure Event. If any part of the Services
is invalid as a result of such disability, KBI Biopharma will, upon written request from Client, but at Client’s sole cost
and expense, repeat that part of the Services affected by the Force Majeure Event.

 

	16.	Insurance
	 	 
	16.1	KBI
    Biopharma Insurance. KBI Biopharma shall secure and maintain in full force and effect throughout the Term policies of
    insurance for (a) workers’ compensation in accordance with applicable statutory requirements, employer’s liability
    in an amount not less than $1,000,000, and automobile liability in an amount not less than $1,000,000, (b) commercial general
    liability in an amount not less than $2,000,000 per occurrence and $2,000,000 in the aggregate, and (c) products liability
    in an amount not less than $2,000,000 per occurrence and $2,000,000 in the aggregate.

 

    	 	12	 

    	 

    

 

	16.2	Client
    Insurance. Client shall secure and maintain in full force and effect throughout the Term, and for a period of three (3)
    years after completion of any clinical trials in which any Product provided under this Agreement is used, policies of insurance
    for (a) workers’ compensation in accordance with applicable statutory requirements, employer’s liability in an
    amount not less than $1,000,000, and automobile liability in an amount not less than $1,000,000, (b) primary and noncontributory
    commercial general liability in an amount not less than $2,000,000 per occurrence and $2,000,000 in the aggregate, (c) primary
    and noncontributory products/completed operations liability in an amount not less than $5,000,000 per occurrence and $5,000,000
    in the aggregate, and (d) primary and noncontributory umbrella liability in an amount not less than $5,000,000 per occurrence
    and $5,000,000 in the aggregate.
	 	 
	17.	Independent
    Contractor; Non-Solicitation
	 	 
	17.1	Independent
    Contractor. KBI Biopharma shall perform the Services as an independent contractor of the Client. The relationship between
    the Parties shall not constitute a partnership, joint venture or agency nor constitute either Party as the agent, employee
    or legal representative of the other. The Parties agree that neither shall have power or right to bind or obligate the other,
    nor shall either hold itself out as having such authority.
	 	 
	17.2	Non-Solicitation.
    During the Term of this Agreement and for one (1) year thereafter, each Party agrees not to directly or indirectly solicit
    to hire or hire (in any capacity) any person who is an employee, contractor, consultant or representative of the other Party;
    provided that newspaper, internet or other advertisements to fill job openings shall not be deemed to be “solicitation”
    hereunder. Any exceptions to this provision must be in writing and signed by each Party and, for each person that is hired
    in such manner, the hiring Party shall compensate the other Party at the rate of 30% of such person’s annualized base
    salary.

 

	18.	 Publicity

 

Either
Party may only issue press releases or public disclosures describing the Services provided hereunder with the prior written consent
of the other Party. The use of the name, trademark, logo, or other identifying materials of either Party or its employees in any
publicity, advertising or promotional material shall require the other Party’s express prior written consent.

 

	19.	Shipment
	 	 
	19.1	General.
    Unless otherwise agreed in writing by the Parties, all Deliverables, products, raw materials, samples components or other
    materials provided hereunder by KBI Biopharma shall be made available for shipment Ex Works (INCOTERMS 2010) KBI Biopharma’s
    facilities. For purposes of clarification, Ex Works means that carriage of goods shall be arranged by Client, and the cost
    of such carriage and risk of loss shall transfer to Client when the goods have been made available for shipment at KBI Biopharma’s
    facilities. KBI Biopharma shall package for shipment such product, raw materials, samples, components or other materials at
    Client’s expense (including insurance) and in accordance with Client’s reasonable written instructions.
	 	 
	19.2	Shipping
    Charges. Client shall pay to KBI Biopharma, in addition to actual shipping costs, a handling fee of One Hundred Dollars
    ($100) for each standard shipment of any Deliverables, products, raw materials, samples, components or other materials provided
    hereunder.

 

    	 	13	 

    	 

    

 

	20.	Notices

 

Any notice required to be given pursuant to the terms and provisions hereof shall be in writing and shall
be sent by certified or registered mail, postage prepaid with return receipt requested, or by nationally recognized overnight courier,
postage prepaid with return receipt requested, or by confirmed facsimile (with printed confirmation of receipt), to the other Party
at the following address:

 

If
to Client:

 

BriaCell
Therapeutics Corporation

820
Heinz Ave.

Berkeley,
CA 94710 Attention: William V. Williams, M.D., President and CEO

 

If
to KBI Biopharma:

 

KBI
Biopharma, Inc.

1101
Hamlin Road

Durham,
North Carolina 27704

Attention:
Vice President Finance

 

with
a copy to the Vice President and General Counsel, at the same address.

 

Each
notice shall be deemed sufficiently given, served, sent, or received for all purposes at such time as it is delivered to the addressee
or at such time as delivery is refused by the addressee upon presentation.

 

	21.	Choice
    of Law

 

This
Agreement shall be construed and enforced in accordance with the laws of and in the venue of the State of California, without
regard to its, or any other jurisdiction’s, rules regarding conflicts or choice of laws. The Parties waive application of
the provisions of the 1980 U.N. Convention on Contracts for the International Sale of Goods, as amended.

 

	22.	Dispute
    Resolution
	 	 
	22.1	Initial
    Attempts to Resolve Disputes. If a dispute arises between the Parties in connection with this Agreement, the respective
    presidents or senior executives of KBI Biopharma and Client shall first meet as promptly as practicable and attempt to resolve
    in good faith such dispute. If such parties cannot resolve the dispute within thirty (30) days after written notice given
    by one Party to the other specifically invoking this stage in the dispute resolution procedure, either Party may by written
    notice to the other commence the arbitration process set forth in Section 22.2 below.
	 	 
	22.2	Arbitration.
    If a dispute has not been resolved by negotiation as provided in Section 22.1 above, then, except as otherwise provided in
    this Section 22.2, the dispute will be finally settled by binding arbitration in accordance with the Commercial Arbitration
    Rules of the AAA then in effect, by three (3) arbitrators, one of whom will be designated by each Party and the third of whom
    will be designated by the two so designated. The arbitration, it shall be conducted in English and held in New York, New York.
    The arbitrators will render their award in writing and, unless all Parties agree otherwise, will include an explanation in
    reasonable detail of the reasons for their award. Judgment upon the award rendered by the arbitrators may be entered in any
    court having jurisdiction thereof. The Parties expressly waive any putative right they may otherwise have to seek an award
    arising out of any dispute hereunder of punitive damages or any other damages limited or excluded by this Agreement. The arbitrator
    will have the authority to grant injunctive relief and other specific performance. The arbitrator will, in rendering its decision,
    apply the substantive law of the State of New York, without regard to its conflict of laws provisions. The decision and/or
    award rendered by the arbitrator will be final and non-appealable (except for an alleged act of corruption or fraud on the
    part of the arbitrator).

 

    	 	14	 

    	 

    

 

	22.3	Expenses.
    All expenses and fees of the arbitrators and expenses for hearing facilities and other expenses of the arbitration will be
    borne equally by the Parties unless the Parties agree otherwise or unless the arbitrators in the award assess such expenses
    against one of the Parties or allocate such expenses other than equally between the Parties. Each of the Parties will bear
    its own counsel fees and the expenses of its witnesses except (i) to the extent otherwise provided in this Agreement or by
    applicable law or (ii) to the extent the arbitrators in their discretion determine for any reason to allocate such fees and
    expenses among the Parties in a different manner. Any attorney or retired judge who serves as an arbitrator will be compensated
    at a rate equal to his or her current regular hourly billing rate unless otherwise mutually agreed upon by the Parties and
    the arbitrator.
	 	 
	22.4	Interlocutory
    Relief. Compliance with this Article 22 is a condition precedent to seeking relief in any court or tribunal in respect
    of a dispute, but nothing in this Article 22 will prevent a Party from seeking interlocutory relief in the courts of appropriate
    jurisdiction provided in Article 21, pending the arbitrator’s determination of the merits of the controversy, if applicable
    to protect the Confidential Information, property or other rights of that Party. For such disputes, the Parties agree to and
    submit to the sole and exclusive jurisdiction of the New York courts, both state and federal.
	 	 
	23.	Assignment
    and Delegation
	 	 
	23.1	Assignment.
    This Agreement between the Parties shall not be assigned in whole or in part by either Party without the prior written consent
    of the other, which consent shall not be unreasonably withheld or delayed; provided, however, either Party may assign this
    Agreement in its entirety without the other Party’s consent, upon written notice to the other Party, as part of: (a)
    the sale of all or substantially all of the assets or the entire business to which this Agreement relates, or (b) a merger,
    consolidation, reorganization or other combination with or into another person or entity, in each case, pursuant to which
    the surviving entity or assignee assumes in writing the assigning or merging Party’s obligations hereunder. Any attempt
    to assign, or purported assignment of, this Agreement in contravention to this Section 23.1 shall be void ab initio
    and of no effect. This Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective
    successors and permitted assigns.
	 	 
	23.2	Delegation.
    Neither Party may delegate any performance under this Agreement; however, performance of the Services hereunder may be delegated
    or subcontracted by KBI Biopharma with the written consent of Client, which consent shall not be unreasonably withheld.
	 	 
	24.	Term
    and Termination
	 	 
	24.1	Term.
    The term of this Agreement (the “Term”) shall be from the Effective Date until the fifth
    anniversary thereof, unless extended or earlier terminated as provided herein. If the Services have not been completed at
    the end of the initial term, the Term will thereafter be extended for successive one year periods until the Services have
    been completed. Additionally, the Agreement may be terminated sooner as provided in Section 24.2 or 24.3, or the Term may
    be extended by written agreement of the Parties.
	 	 
	24.2	Termination
    without Breach. Client may terminate this Agreement or a Proposal prior to completion of the Proposal by providing sixty
    (60) days written notice to KBI Biopharma, subject to the conditions of this Section 24.2. Upon receipt of such notice of
    termination, KBI Biopharma will promptly scale down the affected portion of the Proposal and use reasonable commercial efforts
    to avoid (or minimize, where non-cancellable) additional expenses. It is understood between the Parties that KBI Biopharma
    will incur substantial costs for reservations of resources and planning in order to undertake the provision of Services. Therefore,
    in the event that this Agreement or a Proposal is terminated for any reason other than (i) by Client for KBI Biopharma’s
    material breach in accordance with Section 24.3 or (ii) by Client in accordance with Section 24.4, Client shall pay KBI Biopharma
    upon receipt of invoice all of its costs for Services performed and expenses incurred or irrevocably obligated related to
    the Proposal and wind down of activities, plus, as liquidated damages and not as a penalty, an amount equal to the greater
    of (a) twenty percent (20%) of the cost of the Services not yet performed as of the effective date of termination for any
    Proposal terminated under this Section 24.2; or (b) the amounts due pursuant to Section 6.3 for cancellation or postponement
    of any manufacturing runs scheduled within 180 days of the termination.

 

    	 	15	 

    	 

    

 

	24.3	Termination
    for Breach. In the event of a material breach of this Agreement by a Party that is not cured within thirty (30) days of
    written notice of such breach by the non-breaching Party, the non-breaching Party may terminate this Agreement or a Proposal
    immediately upon written notice. Upon such termination, KBI Biopharma will promptly scale down the affected portion of the
    Proposal and use its reasonable commercial efforts to avoid (or minimize, where non-cancellable) additional expenses. It is
    understood between the Parties that KBI Biopharma will incur substantial costs for reservations of resources and planning
    in order to undertake the provision of Services. Therefore, in the event of termination under this Section 24.3 by KBI Biopharma,
    Client shall pay KBI Biopharma upon receipt of invoice all of its costs incurred or irrevocably obligated related to the Proposal
    and wind down of activities, plus, as liquidated damages and not as a penalty, an amount equal to the greater of (a) fifty
    percent (50%) of the cost of the Services not yet performed as of the effective date of termination for any Proposal terminated
    under this Section 24.2; or (b) the amounts due pursuant to Section 6.3 for cancellation or postponement of any manufacturing
    runs scheduled within 180 days of the termination. . In the event of termination under this Section 24.3 by Client, Client’s
    sole remedy shall be a reduction in the total contract price for the Services in an amount equal to the difference between:
    (i) the total contract price for the Proposal; and, (ii) the price of the Services properly performed.
	 	 
	24.4	Bankruptcy.
    This Agreement may be terminated upon written notice by a Party in the event: (i) the other Party voluntarily enters into
    bankruptcy proceedings; (ii) the other Party makes an assignment for the benefit of creditors; (iii) a petition is filed against
    the other Party under a bankruptcy law, a corporate reorganization law, or any other law for relief of debtors or similar
    law analogous in purpose or effect, which petition is not stayed or dismissed within thirty (30) days of filing thereof; or
    (iv) the other Party enters into liquidation or dissolution proceedings or a receiver is appointed with respect to any assets
    of the other Party, which appointment is not vacated within one hundred and twenty (120) days.
	 	 
	24.5	Effects
    of Termination. Upon termination of this Agreement for any reason, each Party shall, as soon as practicable, but in any
    event within ten (10) business days of the effective date of termination, return to the other all Confidential Information
    which it possesses that belongs to the other Party, except that each may retain a copy in its law department for record keeping
    purposes. Upon termination of this Agreement, KBI Biopharma will furnish to Client a complete inventory of all work in progress
    and an inventory of all Product processed pursuant to the Proposal. Upon termination of this Agreement, neither Party shall
    use or exploit in any manner whatsoever any intellectual property rights or Confidential Information of the other Party, except
    as may be specifically provided in this Agreement. With respect to the liquidated damages set forth in Section 24.2 and Section
    24.3, the Parties acknowledge and agree that (i) actual damages would be difficult or impracticable to ascertain, (ii) the
    amounts set forth in Section 24.2 or Section 24.3, as applicable, represent the Parties reasonable estimate of such damages,
    and (iii) the amounts set forth in this Section 24.2 or Section 24.3, as applicable, are not unreasonable under the circumstances
    existing at the time this Agreement was entered.
	 	 
	25.	Survival

 

Articles
4, 7, 8, 9, 13, 14, 18, 20, 21, 22, 25, 26, and Sections 6.4, 12.2.4, 16.2, 24.2, 24.3 and 24.5 hereof shall survive
termination or expiration of this Agreement. Expiration or termination shall not extinguish the rights and remedies of
either Party with respect to any antecedent breach of any of the provisions of this Agreement or payments due or earned under
this Agreement.

 

    	 	16	 

    	 

    

 

	26.	Severability

 

In
the event that any one or more of the provisions of this Agreement should be held for any reason by any court or authority having
final jurisdiction over this Agreement, or over any of the Parties to this Agreement, to be invalid, illegal, or unenforceable,
such provision or provisions shall be reformed to approximate as nearly as possible the intent of the Parties, and if not reformable,
shall be divisible and deleted in such jurisdictions; elsewhere, this Agreement shall not be affected.

 

	27.	Waiver
    and Remedies

 

The
delay or waiver (or single or partial exercise) by either Party hereto of any right, power, or privilege hereunder, or of any
failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right, power,
or privilege hereunder or of any other breach by or failure of such other Party, whether of a similar nature or otherwise. Any
such waiver must be made in writing. Except as may otherwise be specifically set forth in this Agreement, no remedy referred to
in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in
this Agreement or otherwise available under law or equity. No Party shall have any right of set off with respect to amounts it
has an obligation to pay hereunder. No provision of this Agreement shall in any way inure to the benefit of any third person so
as to constitute to any such person a third-party beneficiary of this Agreement or otherwise give rise to any cause of action
in any person not a Party hereto.

 

	28.	Entire
    Agreement, Amendment, Construction, Precedence

 

This
Agreement, the Proposal(s), and any applicable Quality Agreement constitute the entire agreement between the Parties and supersede
all prior and contemporaneous negotiations, representations, commitments, agreements and understandings between the Parties (whether
written or oral) relating to the subject matter hereof. This Agreement may not be amended or modified without the mutual written
consent of both Parties. In the event of any conflict among the components of this Agreement, the following order of precedence
shall apply: (i) the terms and conditions of the Agreement, (ii) the Quality Agreement (if existing), and (iii) the Proposal.
If Client chooses to issue a purchase order for the delivery of the Services or any component thereof, such purchase order should
reference this Agreement and shall be issued solely for the convenience of Client and to provide subject matter description; however,
any legal terms and conditions contained or referenced therein shall be of no effect.

 

	29.	Counterparts

 

This
Agreement, the Quality Agreement(s), the Proposal(s) and any other attachment may be executed in counterparts, each of which will
be deemed an original but all of which together will constitute a single instrument. A facsimile or electronic transmission of
the above referenced documents, or a counterpart, shall be legal and binding on the Parties.

 

[Signature
Page Follows.]

 

    	 	17	 

    	 

    

 

The
Parties by their authorized representative execute this Agreement as of the Effective Date.

 

	KBI BIOPHARMA, INC.	 	BRIACELL THERAPEUTICS CORPORATION
	 	 	 	 	 
	By:	 	 	By	
	Name:	Tim Melly	 	Name	William V. William
	Title:	President	 	Title	PRESIDENT & CEO
	Date	17 May 2017	 	Date	17 May 2017

 

    	 	18	 

    	 

    

 

Attachment
One: Proposal

 

    	 	19	 

    	 

    

 

Attachment
Two: Quality Agreement

 

    	 	20	 

    	 

    

 

 

 

 

CONFIDENTIAL

 

Proposal
for the Generation of MCBs and WCBs for tumor cell lines, SV-BR-1 and SV-BR-1-GM

 

	Prepared
    for:	William
    V. Williams, M.D.
	 	President
    and CEO
	 	BriaCell
    Therapeutics Corporation 
	 	Havertown, PA, USA
	 	C:
    302-290-9017
	 	 
	Prepared
    by:	KBI
    Biopharma, Inc.
	 	P.O.
    Box 15579
	 	1101
    Hamlin Road
	 	Durham,
    NC 27704
	 	 
	Proposal
    Number:	17.BCL.01
    
	 	 
	Version:	01
	 	 
	Issue
    Date:	March
    3, 2017

 

This
proposal is valid until thirty days from the issue date, after which budget estimates and timing are subject to revision. This
proposal is provided for the sole use of BriaCell in assessing the merits of services offered by KBI Biopharma, Inc. The content
of this document has been developed on a project-specific basis based on information provided by BriaCell. Budget and timelines
are presented in the proposal, however, these are subject to terms and conditions to be agreed upon.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  2 of 17

    

 

Background
& Summary

 

In
its Request for Proposal, BriaCell has requested that KBI Biopharma, Inc. (KBI) provide a proposal for the generation of Master
Cell Banks (MCBs) and Working Cell Banks (WCBs) of the tumor cell lines, SV-BR-1 and SV-BR-1-GM. In response, KBI is pleased to
submit this proposal.

 

Version
History

 

	Revision
    Number	 	Description
    of Changes
	00	 	Initial
    Version
	01	 	Correction
    to total cost of MCBs

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  3 of 17

    

 

	1.0	Scope
                                         Responsibilities

 

This
section outlines responsibilities for KBI and BriaCell as they apply to the work scope.

 

		1.1	Safety

 

1.1.1
BriaCell will provide all sample/material handling data for the materials associated with this project (if available). If
materials have any special handling considerations, BriaCell will notify KBI prior to the initiation of the project.

 

1.1.2
KBI will review all safety handling data for the materials associated with this project. Should the materials have any special
handling considerations KBI may apply a reasonable additional fee to cover actual costs of handling. It is expected that KBI will
request specific viral and adventitious agents testing by a third party prior to initiating cell line cell culture in Process
Development.

 

		1.2	Methods/Documentation

 

1.2.1 BriaCell
will provide all relevant project-related documentation to be used for this project.

 

1.2.2
KBI will review all relevant project-related documentation
and methods received from BriaCell.

 

1.2.3 All
documentation for developed or revised methods will be provided by KBI for review and approval by BriaCell prior to implementation.

 

1.2.4 All test methods and
related documentation will be sent to a third party upon request of BriaCell.

 

1.2.5 Reviewed Data Summaries
with raw data files will be posted to KBI/BriaCell data sharing site where applicable.

 

		1.3	Sample/Materials

 

1.3.1 BriaCell will provide
all non-standard samples/materials necessary to perform this project.

 

1.3.2
KBI will, on behalf of BriaCell (and at BriaCell’s expense), procure all necessary standard raw materials, reagents
and disposables necessary to perform the project, and invoice BriaCell for such supplies as pass through expense. KBI will, as
necessary, log in all samples/materials according to current Standard Operating Procedures. The sample/material lot numbers will
be recorded in the laboratory notebooks or standardized data sheets at the time of use.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  4 of 17

    

 

	2.0	Scope
                                         of Work

 

Cryopreserved
vials of both SV-BR-1 and SV-BR-1-GM will be sourced from their respective tissue banks held at the American Tissue Culture Collection
(ATCC). Due to the limited availability of these cell lines from ATCC, KBI proposes to generate a small number of vials (approximately
50) of each cell line as Research Cell Banks (RCBs). KBI will confirm comparability of the RCBs to source material from the ATCC
as defined by the secretion of GM-CSF from SV-BR-1-GM, and the submission of sample vials from the RCBs for identity and purity
testing for Her2/Neu and ER/PgR at a laboratory selected by BriaCell.

 

KBI
will perform two (2) development quarter-scale MCB runs from each RCB in KBI’s Process Development (PD) laboratory to enable
process evaluation, including yield during cell line expansion, and critical process attributes. Draft Master Batch Records (MBRs)
and Analytical Test Methods (ATMs) will be written prior to initiating one (1) engineering run for each cell line at full-scale,
achieved by process scale out from methods generated in development.

 

Successful
completion of engineering runs will trigger tech-transfer to the Manufacturing facility. After Quality Assurance review and approval
of MBRs and ATMs, a single manufacturing run for each cell line will be initiated to generate MCBs for both SV-BR-1 and SV-BR-1-GM
to meet Briacell’s requirements of 200 vials of SV-BR-1-GM, and 100 vials of SV-BR-1, each vial containing approximately
1.5x107 viable cells.

 

Per
discussions with BriaCell, KBI will not initiate the generation of WCBs until BriaCell is able to provide methods to KBI. This
proposal does include estimates for WCB generation based upon current projected methods provided by BriaCell. Table 1 describes
the timing for the generation of both MCBs and WBCs for each tumor cell line.

 

		2.1	Generation
                                         of a small Research Cell Bank (RCB) for both SV-BR-1 and SV-BR-1-GM

 

2.1.1 Objective

 

The
availability of cellular material for MCB generation from the ATCC tissue bank is insufficient to allow robust methods development,
and the generation of MCBs at the proposed scale in manufacturing. Therefore, KBI will initiate a culture protocol to facilitate
methods development, and act as the source material for final MCB manufacturing.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
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2.1.2 Activities

 

	 	●	KBI
    will initiate one (1) Pre-Development run from one (1) vial each of SV-BR-1-GM and SV-BR-1, sourced from the appropriate ATCC
    tissue bank.
	 	 	 
	 	●	Cell
    lines will be cultured per guidance provided in BriaCell’s current Chemistry, Manufacturing and Controls (CMC) per IND
    BB-IND 10312 Serial 0051.
	 	 	 
	 	●	Trypsin-LE
    SELECT will be used for all cell passage methods as cultures approach confluency.
	 	 	 
	 	●	KBI
    will cryopreserve all cell preparations in Cryostor 10 (Bio-life) in appropriately labelled 1.8mL screw-top cryovials.
	 	 	 
	 	●	Table
    1 lays out the proposed culture methods, time in culture, culture vessel configuration and expected yields on completion of
    each run.

 

	Table 1	 	Initiation	 	Day 0	 	Day 14	 	Day 20	 	Day 26	 	Day 32	 	Day 32
	Culture Vessel	 	
        Thaw 1 vial of ATCC-MCB,

        recovery of

        5x106/vial
	 	6 well plate (n=1)	 	T-75 Flask (n=3)	 	
        T-225

        Flask (n=3)
	 	1X Cell Stack (n=2)	 	10X Cell Stack (n=1)	 	Harvest and cryo RCB at 1.5x107/mL in 1.8mL vials (n=50)
	Seed/Vessel (x106)	 	 	0.5/well	 	2	 	6	 	20	 	160	 
	
        Harvest/Vessel

        (x106)
	 	 	1/well	 	8	 	20	 	80	 	800	 
	Harvest Total (x106)	 	 	6	 	24	 	60	 	160	 	800	 

 

	 	●	BriaCell
    will be made aware of any troubleshooting needed for methods in this section. Should any method need additional development,
    BriaCell and KBI will agree upon this scope in a change order.

 

2.1.3 Assumptions

 

		●	There
                                         is limited availability of both SV-BR-1 and SV-BR-1-GM from tissue banks held at the
                                         ATCC. This proposal assumes that sufficient cells of sufficient quality can be recovered
                                         post-thaw to initiate cell cultures.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  6 of 17

    

 

2.1.4 Deliverables

 

		●	RCB
                                         for SV-BR-1-GM and SV-BR-1 (approximately 50 vials per RCB).
	 	 	 
		●	Excel
                                         Data Summary and Technical Report, ATMs for cell count and viability for each RCB detailed
                                         in this section.

 

		2.2	GM-CSF
                                         Secretion Bioassay Qualification

 

2.2.1 Objective

 

A
systematic approach will be taken for bioassay qualification using design of experiments (DoE) to determine critical assay parameters
and assess assay accuracy, precision, linearity, and robustness.

 

2.2.2 Activities

 

		●	The
                                         Millipore MILLIPLEX® Human GM-CSF 96-well Plate Assay will be used for the quantification
                                         of GM-CSF in cell culture supernatants per the manufacturer’s specifications. Secreted
                                         cytokine will be detected on the Luminex Magpix platform.
	 	 	 
		●	During
                                         development we will identify the assay parameters which are critical for successful assay
                                         performance. From this, we will establish levels for each parameter that will ultimately
                                         corresponded to ranges in the Analytical Test Method (ATM).
	 	 	 
		●	For
                                         assay qualification using a reference standard, recombinant human GM-CSF will be titred
                                         into cell culture supernatant obtained from both SV-BR-1 and SV-BR-1-GM cell lines cryopreserved
                                         as RCBs to serve as the test matrix. For the reference matrix, recombinant human GM-CSF
                                         will be titred into the assay diluent provided in the assay kit.
	 	 	 
		●	For
                                         assay qualification using a test sample, we will use the SV-BR- 1-GM cell culture supernatant
                                         obtained from cell lines cryopreserved from Pre-Development runs. Supernatants will be
                                         titred into the assay at 200%, 150%, 100%, 75%, 50%, 25% to test titrability.
	 	 	 
		●	Each
                                         experimental assay will contain reference standard curves diluted in reference or test
                                         matrix as well as test samples over a range of six concentrations. Each sample will be
                                         replicated 3 times on a single plate and each assay plate will be independently run on
                                         3 independent days.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  7 of 17

    

 

		●	Analysis
                                         of these assays will provide measurements of accuracy, precision, and linearity. Our
                                         previous experience and published literature suggest that variance should not exceed
                                         15% for intra- assay and 25% for inter-assay.
	 	 	 
		●	We
                                         will use the fit for five parameter curve fitting method (log scale) to determine the
                                         fit using fitted curves for both reference and test materials.
	 	 	 
		●	Data
                                         will be expressed as mean ± standard deviation and a comparison of means will
                                         use an unpaired T-test. The threshold for a significant difference is p<0.05.
	 	 	 
		●	BriaCell
                                         will be made aware of any troubleshooting needed for methods in this section. Should
                                         any method need additional development, BriaCell and KBI will agree upon this scope in
                                         a change order.

 

2.2.3 Assumptions

 

		●	This
                                         proposal assumes that the cell line culture media will not interfere significantly with
                                         the assay performance. In the event that significant interference is noted, further assay
                                         development may be required.

 

2.2.4 Deliverables

 

		●	Excel
                                         Data Summary and Technical Report, plus finalized ATM records will be shared with BriaCell.

 

		2.3	RCB
                                         comparability to ATCC source material

 

2.3.1 Objective

 

Having
generated RCBs for both SV-BR-1 and SV-BR-1-GM, comparability studies will be conducted against the ATCC source material to confirm
GM- CSF secretion, viability, identity and purity.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  8 of 17

    

 

2.3.2 Activities

 

		●	A
                                         sample vial of each cell line will be thawed from both the ATCC archive, and the respective
                                         RCB. GM-CSF secretion for each cell line will be monitored employing methods outlined
                                         in Table 2 using a qualified Miltenyi Milliplex bead-based assay for GM-CSF.

 

	Table 2	 	Initiation	 	Day 0	 	Day 2	 	Day 3	 	Day 4	 	Day 5	 	Day 6/7
	Culture Vessel	 	Thaw 1 vial each of ATCC-MCB and RCB for SV- BR-1-GM and SV-BR-1	 	6 well plate (n=1)	 	6 well plate (n=1)	 	6 well plate (n=1)	 	6 well plate (n=1)	 	6 well plate (n=1)	 	Perform Bead- based GM-CSF Secretion Measurement
	Seed/Vessel (x106)	 	 	0.5/well	 	0.5/well	 	0.5/well	 	0.5/well	 	0.5/well	 
	Procedure	 	 	
        Initiate 3 wells for cell count, 3 wells for
        GM-CSF

        measurement
	 	Change Media	 	Harvest 3 wells for cell count, 3 wells for GM-CSF measurement	 	Harvest 3 wells for cell count, 3 wells for GM-CSF measurement	 	Harvest 3 wells for cell count, 3 wells for GM-CSF measurement	 

 

		●	Sample
                                         vials from the two RCBs will be provided to BriaCell for identity (Her2/Neu positive
                                         by IHC) and purity (ER/PgR negative by IHC) testing at a reference laboratory of their
                                         choice. BriaCell is responsible for fees associated with this analysis.
	 	 	 
		●	Sample
                                         vials from each RCB will be submitted for specific viral and adventitious agents testing
                                         to a third party (with pass through cost to BriaCell) to confirm the pathogen-free status
                                         of the cell lines.

 

2.3.3 Assumptions

 

		●	The
                                         specification for positive GM-CSF activity is the secretion of ≥ 10ng of cytokine
                                         per 1x106 cells. In the event that the RCB for SV- BR-1-GM fails to meet this specification,
                                         further characterization of both the ATCC material, and associated RCB may be required,
                                         which will be reviewed with BriaCell prior to any modification in scope via change order.
	 	 	 
		●	Should
                                         cell lines fail purity, identity or pathogen-screening tests, BriaCell will be notified,
                                         and data reviewed prior to the initiation of a change order.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  9 of 17

    

 

2.3.4 Deliverables

 

		●	Excel
                                         Data Summary, Technical Report, plus ATM reports for GM- CSF secretion studies.

 

		2.4	MCB
                                         Process Development

 

2.4.1 Objective

 

Having
successfully established RCBs for both SV-BR-1 and SV-BR-1-GM, KBI will initiate process development studies to describe a preferred
manufacturing method that would be scalable to meet the Proposal’s specifications in regard to the content and size of the
respective manufactured MCBs. BriaCell has reported that propagation of these cell lines from recently cryopreserved lots generally
results in more rapid expansion of those cells post-thaw. The use of the newly generated RCBs offers the opportunity to develop
a shorter, more efficient cell expansion culture process than originally proposed per BriaCell’s CMC.

 

2.4.2 Activities

 

		●	KBI
                                         will perform four (4) development runs, two (2) per cell line. Based upon the growth
                                         characteristics per BriaCell’s previous experience, and the estimated size of the
                                         tumor cells themselves, KBI proposes to execute the following method listed in Table
                                         3. The method predicts the recovery of ~8x108 tumor cells on day 21 of culture. This
                                         represents a one-quarter scale in terms of the numbers of cells required to generate
                                         a MCB consisting of 200 vials containing ~1.5x107
cells per vial.

 

	Table 3	 	Initiation	 	Day 0	 	Day 6	 	Day 12	 	Day 21
	Culture Vessel	 	Thaw 1 vial of RCB, recovery of 12x106/vial	 	T-225 Flask (n=2)	 	1X Cell Stack (n=2)	 	10X Cell Stack (n=1)	 	Harvest and cryo at 1.5x107/mL in 1.8mL vials (n=50)
	
        Seed/Vessel

        (x106)
	 	 	6	 	20	 	160	 
	Harvest/Vessel (x106)	 	 	25	 	80	 	800	 
	
        Harvest Total

        (x106)
	 	 	50	 	160	 	800	 

 

		●	KBI
                                         will monitor the secretion of GM-CSF in media 72hrs after each passage step to determine
                                         if the secretion of GM-CSF can be used as an in-process quality attribute to chart the
                                         progress of SV-BR-1- GM through the protocol.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  10 of 17

    

 

2.4.3 Assumptions

 

		●	KBI
                                         has prospectively designed the expansion protocol in this section of the proposal, and
                                         may modify this protocol before initiation, based on experience from generating the RCBs

 

2.4.4
Deliverables

 

		●	Excel
                                         Data Summary and Technical Report, plus ATM reports (cell counts, viability, GM-CSF secretion)
                                         for each Development run detailed in this section.

 

		2.5	MCB
                                         Engineering runs

 

2.5.1 Objectives

 

A
full-scale engineering run for each cell line will be initiated on successful completion of a quarter-scale development protocol
(section 2.3). The process will take the form of a ‘scale-out’, whereby cells will be cultured in multiple parallel
culture vessels, as opposed to a ‘scale-up’ approach, where changes in culture vessel configuration would be required.
Scale-out represents a lower risk of a negative outcome compared to ‘scale-up’.

 

2.5.2 Activities

 

		●	Draft
                                         Master Batch Records (MBRs) will be prepared in advance of executing engineering runs,
                                         based upon methods utilized and documented in section 2.3.
	 	 	 
		●	Table
                                         4 lists the proposed procedure, and expected yields at each point of passage, and the
                                         final yield of product targeted by the protocol.
	 	 	 
		●	The
                                         procedure will be executed on both SV-BR-1 and SV-BR-1-GM.
	 	 	 
		●	Cryopreserved
                                         products from engineering runs will be thawed and subjected to quantification of GM-CSF
                                         secretion as described in section 2.2.2. The specification calls for the thawed product
                                         to exhibit a post thaw viability ≥ 70%, with ≥ 10ng GM-CSF per ~1x106 SV-BR-1-GM.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  11 of 17

    

 

	Table 4	 	Initiation	 	Day 0	 	Day 6	 	Day 12	 	Day 21
	Culture Vessel	 	
        Thaw 4 vials of PD-MCB,

        recovery of 12x106/vial
	 	T-225 Flask (n=8)	 	1X Cell Stack (n=8)	 	10X Cell Stack (n=4)	 	Harvest and cryo at 1.5x107/mL in 1.8mL vials (n=200)
	Seed/Vessel (x106)	 	 	6	 	20	 	160	 
	
        Harvest/Vessel

        (x106)
	 	 	25	 	80	 	800	 
	Harvest Total (x106)	 	 	150	 	640	 	3200	 

 

2.5.3 Assumptions

 

		●	Successful
                                         completion of the objective in section 2.3 should de-risk the ‘scale-out’
                                         procedure for engineering runs. Should the engineering runs fail to meet specifications
                                         in terms of cellular yield or quality, further methods development may be required, BriaCell
                                         and KBI will agree upon this scope in a change order.

 

2.5.4
Deliverables

 

		●	KBI
                                         will provide completed MBRs, and any associated deviations for BriaCell review, in addition
                                         to a Technical Report containing a full description and outcomes for the two engineering
                                         runs.
	 	 	 
		●	KBI
                                         QA approved MBRs and ATMs will be provided to BriaCell for review and signoff prior to
                                         initiating formal manufacturing of each MCB.

 

		2.6	Generation
                                         of final MCBs for SV-BR-1 and SV-BR-1-GM

 

2.6.1 Activities

 

		●	One
                                         manufacturing run will be performed with each cell line per QA approved MBRs, subsequent
                                         to successful engineering runs, in KBI’s cellular therapy manufacturing core.

 

2.6.2 Assumptions

 

		●	Every
                                         effort will be made to ensure the success of the final manufacture of each MCB. Should
                                         a cell bank not meet the intended specifications, a second manufacturing run may be contemplated
                                         after consultation with BriaCell, and a change in scope agreed by change order.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  12 of 17

    

 

2.6.3 Deliverables

 

		●	KBI
                                         will provide MCBs for SV-BR-1 and SV-BR-1-GM at the proposed scale (100 vials for SV-BR-1,
                                         and 200 vials for SV-BR-GM) at ~1.5x107
cells per vial. The cell banks will be thawed and evaluated for viability (>70%), cell count per vial (target of ≤ 1.0x107
viable cells) and potency as defined by GM-CSF secretion (≥ 10ng per 1.0x106 cells per 24 hours). Final products will be confirmed
as sterile (aerobic and anaerobic by 7-day Bac-T 3D Alert), and free of endotoxin (< 5 EU/ml) and mycoplasma negative (PCR).

 

		2.7	Optional
                                         scope of work for the derivation of WCBs for SV-BR-1 and SV-BR-1-GM

 

2.7.1 Objective

 

To
generate WCBs for both cell lines, based on a period of limited cell culture of MCB cells, followed by harvest, attenuation by
irradiation and cryopreservation.

 

At
this time, no methods development at KBI is envisaged. On transfer of methods from BriaCell, KBI would initiate development, engineering,
and final manufacturing of each WCB.

 

2.7.2 Activities

 

		●	Based
                                         on the projected growth characteristics of cells during MCB generation, KBI would estimate
                                         the need to initiate the SV-BR-1-GM cell line in sixteen T225 culture vessels, followed
                                         by 21 days of cell culture terminating in twelve, 10-layer cell stacks to meet the necessary
                                         yield of cells to form the proposed WCB for SV-BR-1-GM.
	 	 	 
		●	KBI
                                         could initiate, with BriaCell’s approval, a development program for WCBs using
                                         cells derived from Process Development and/or Engineering runs for the MCBs, thereby
                                         reducing time to completion of the manufactured WCBs. Alternatively, development at KBI
                                         could be delayed until completion of manufacturing of MCBs.
	 	 	 
		●	The
                                         final manufactured WCBs would only be generated from the qualified MCB for each cell
                                         bank.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  13 of 17

    

 

2.7.3 Assumptions

 

		●	BriaCell
                                         will provide a preferred method for the generation of WBCs, which would require only
                                         tech-transfer of protocols to KBI.

 

		●	An
                                         assumption is made that the production of GM-CSF from irradiated, frozen and thawed cells
                                         would be equivalent to cells maintained in culture to form WCBs per BriaCell’s
                                         CMC. It is possible that GM-CSF secretion immediately post-thaw of an attenuated WBC
                                         is reduced, which could impact the potency of the cellular product. Further process development
                                         may be required to optimize the bio- activity of the attenuated and cryopreserved WBC.

 

2.7.4 Deliverables

 

		●	KBI
                                         will provide BriaCell the WCBs per the requested proposal, in addition to all supporting
                                         documentation. The optional cell banks would consist of approximately 400 vials of SR-V-BR-1-GM
                                         at approximately 2.4x107 cells per 1.2ml. SR-BR-1 in two vialing configurations: 100
                                         vials at approximately 2x106 per 0.1mL and 50 vials at approximately 2x107 per mL.

 

KBI
has included in this proposal draft timelines and projected costs for the development of WCBs, subject to change based on a future
fully developed scope of work, should BriaCell wish to explore this optional program further.

 

		3.0	Program
                                         Management

 

3.1.1 Objective

 

		●	Provide
                                         overall management of the project according to scope and contractual terms. Develop &
                                         maintain excellent communications and collaborative relationship with BriaCell.

 

3.1.2 Activities

 

		●	KBI
                                         values collaborative and open relationships with its customers. KBI will appoint a Study
                                         Director from within the project team who will be responsible for project performance,
                                         deliverables, and regular customer communications. The Study Director will be BriaCell’s
                                         primary technical point-of-contact within KBI. Teleconferences will be scheduled once
                                         per week and meetings will be held at KBI as appropriate.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  14 of 17

    

 

4.0
Estimated Timelines

 

KBI
estimates the duration of each individual defined project activity as detailed in Table 5 below. Duration includes report writing.

 

Table
5: Duration of Activities

 

	Master
    Cell Bank Process	 	Location	 	Time
	Generation
    of RCBs	 	PD
    Lab	 	8
    weeks - Inclusive
	GM-CSF
    Assay Qualification	 	PD
    Lab	 
	Process
    Development (1/4 scale)	 	PD
    Lab	 	5
    weeks
	Engineering
    Runs (full scale)	 	PD
    Lab	 	5
    weeks
	Final
    Product Manufacture - SV-BR-1	 	MFG
    Suite	 	5
    weeks - Inclusive
	Final
    Product Manufacture – SV-BR-1-GM	 	MFG
    Suite	 

 

	Working
    Cell Bank Process - OPTIONAL	 	Location	 	Time
	Tech
    Transfer/Process Development	 	PD
    Lab	 	5
    weeks
	Engineering
    Runs	 	PD
    Lab	 	5
    weeks
	Final
    Product Manufacture - SV-BR-1	 	MFG
    Suite	 	5
    weeks - Inclusive
	Final
    Product Manufacture – SV-BR-1-GM	 	MFG
    Suite	 

 

5.0
Price and Budget Estimates

 

Table
6: Estimated Prices for Process Development and MCB manufacturing

 

	Master
    Cell Bank Process	 	Service
    Cost
	Generation
    of RCBs	 	$44,000
	GM-CSF
    Assay Qualification	 	$17,500
	Process
    Development (1/4 scale)	 	$9,000
	Engineering
    Runs (full scale)	 	$31,000
	Final
    Product Manufacture - SV-BR-1	 	$75,000
	Final
    Product Manufacture – SV-BR-1-GM	 	$75,000
	Total	 	$251,500

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  15 of 17

    

 

Table
7: Estimated Prices for Process Development and WCB manufacturing

 

	Working
    Cell Bank Process - OPTIONAL	 	Service
    Cost
	Tech
    Transfer/Process Development	 	$9,000
	Engineering
    Runs	 	$62,000
	Final
    Product Manufacture - SV-BR-1	 	$50,000
	Final
    Product Manufacture – SV-BR-1-GM	 	$100,000
	Total	 	$221,000

 

	6.0	Additional
                                         Fees and Pricing

 

		6.1	Additional
                                         Fees

 

Expenses
incurred by KBI to procure materials and laboratory supplies for the execution of the project will be invoiced to BriaCell. Direct
expenses are estimated to be approximately 15% of the service fee total.

 

		6.2	Revisions
                                         to Pricing

 

KBI
reserves the right to revise quoted costs for any project as a result of changes in initial scope, revisions in protocols, modifications
of test methods, final review of test methods, undocumented requirements, or any unforeseen difficulty in executing the project.
The additional work will be performed based on written agreement from BriaCell and will be documented on a KBI Change Order.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ●

 Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
	CONFIDENTIAL	Page  16 of 17

    

 

	7.0	Invoicing
                                         and Payment Terms

 

		7.1	Invoicing

 

An
initial payment equal to thirty percent (30%) of the project cost will be due immediately upon signing of the contract. The remainder
of the contract will be billed by KBI in semi-monthly invoices based upon a billing schedule derived from the project timeline

 

		7.2	Payment
                                         Terms

 

Payments
toward invoices are due within thirty (30) days of receipt of invoice, except for initial payments, which are due upon receipt
of invoice. If paid by wire transfer, any applicable wire transfer fee must be included in the payment issued to KBI.

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	KBI 17.BCL.01
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8.0
Project Approval and Authorization

 

By
signing below, Briacell agrees to the project details as set forth in this proposal and to negotiate in good faith a definitive
Services Agreement that will include a mutually designed detailed scope-of-work and customary terms and conditions.

 

 

 

P.O.
Box 15579 ●1101 Hamlin Road ● Durham, NC 27704 Phone: (919) 479-9898 ● 

Fax: (919) 620-7786 ● www.kbibiopharma.com

 

    	 	 	 

    	 	 	 

    

 

 

QUALITY
AGREEMENT

 

Effective
Date: 04 May 2017

 

BriaCell
Therapeutics Corporation

820
Heinz Ave.

Berkeley,
CA 94710

 

And

KBI
Biopharma, Inc.

 

    	 	Page 1 of 14

     

    

 

	1.	Purpose	3
	2.	Scope	3
	3.	Definitions	3
	 	3.1.	Deviation Classification	3
	 	3.2.	Disposition	3
	 	3.3.	For Cause Visit	3
	 	3.4.	Major Change	4
	 	3.5.	Product	4
	 	3.6.	Quality and Program Contacts	4
	 	3.7.	Technology Transfer Package	4
	4.	Quality Program	4
	 	4.1.	Management Responsibilities	5
	 	4.2.	Conflict Resolution	5
	 	4.3.	Regulatory	5
	 	4.4.	Manufacturing Process Transfer	5
	 	4.5.	Analytical Method Transfer	5
	 	4.6.	Manufacturing, Batch Disposition, Storage and
    Shipment.	6
	 	4.7.	Stability Testing	6
	 	4.8.	Documentation	7
	 	4.8.1.	Specifications and Test Methods	7
	 	4.8.2.	Data Access	7
	 	4.8.3.	Record Retention	7
	 	4.9.	Materials Used in Manufacturing	7
	 	4.9.1.	Sourcing and Testing	7
	 	4.9.2.	Transmissible Spongiform Encephalopathy (TSE)
    Compliance	8
	 	4.9.3.	Donor Eligibility Requirements	8
	 	4.10.	Major Change Control	8
	 	4.11.	Temporary Changes (Planned Deviations)	9
	 	4.12.	Changes in Personnel supporting the cGMP Manufacturing
    or Testing	9
	 	4.13.	Deviation Control	9
	 	4.14.	Validation, Maintenance and Calibration	9
	 	4.15.	Audits	9
	 	4.15.1.	Client Audits	9
	 	4.15.2.	Supplier Audits	10
	 	4.15.3.	Regulatory Inspections	10
	 	4.16.	Complaints and Adverse Event Reporting	10
	 	4.17.	Periodic Review of Quality Agreement	10
	5.	Key Responsibilities	11
	6.	Revision History	13

 

    	 	Page 2 of 14

     

    

 

1.
Purpose

 

This
Quality Agreement defines the roles, responsibilities, deliverables and reporting time requirements as it applies to the quality
activities for BriaCell Therapeutics Corporation (“Client”) performed at KBI Biopharma, Inc. (KBI Biopharma).

 

2.Scope

 

This
document applies to and is incorporated into the Agreement between KBI Biopharma and the Client dated 17 March 2017. This Quality
Agreement shall cover any KBI Biopharma facility where Human Cell and Tissue Products (HCT/P) GMP services are being performed
for the Client, as applicable.

 

3.
Definitions

 

Any
terms not defined in this Quality Agreement will be interpreted in accordance with the definitions provided in 21 CFR Parts 210
and 211, 21 CFR Part 1271 or other applicable regulatory requirements.

 

3.1.
Deviation Classification

 

Critical:
A deviation that affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or
control, of which the impact to patients (or personnel or environment) is highly probable, including life threatening situation.
Client approval is required for Critical deviation reports.

 

Major:
A deviation that affects a quality attribute, a critical process parameter, an equipment or instrument critical for process or
control of which the impact to patients (or personnel/environment) is unlikely. Client approval is required for Major deviation
reports.

 

Minor:
A deviation that has low or no effect on any quality attribute, a critical process parameter, or an equipment or instrument critical
for process or control. Client approval is not required for Minor deviation reports.

 

Planned
Deviation: A planned departure from an approved procedure, test method, manufacturing record or protocol. The planned deviation
is approved prior to implementation and has a defined expiry period beyond which it is no longer an approved departure. Client
approval is required prior to executing Client-related planned deviations.

 

3.2.
Disposition

 

Determination
by KBI Biopharma Quality Assurance that a Product batch is either Approved, Conditionally Approved or Rejected. Approved batches
have met all testing criteria and GMP manufacturing requirements for which KBI Biopharma is responsible. Conditionally Approved
batches have met all testing requirements with the exception of pending final sterility results. Rejected batches have not met
all testing criteria or GMP manufacturing requirements.

 

3.3.
For Cause Visit

 

The
term “For Cause Visit” is used to describe site visits where the Client may be following up on a reported adverse
event in the field or a deviation impacting the quality of the Client’s drug product. The term “For Cause Visit”
does not apply to business meetings, scope discussions, technical meetings or general quality discussions. The visit scope and
maximum number of participants will be mutually agreed upon in advance.

 

    	 	Page 3 of 14

     

    

 

3.4.
Major Change

 

Any
change that: (a) impacts the regulatory commitments and/or reporting requirements of the Client’s drug product; (b) requires
re-qualification or re-validation of test methods, or reference standards; (c) results in changing or modifying the approved client
specific drug product or material specifications; (d) requires re qualification of facility equipment or utilities; (e) results
in changing or modifying the layout or structure of the facility and/or (f) results in changing or modifying the manufacturing
process or equipment.

 

3.5.
Product

 

May
refer to drug substance or drug product as defined by the statement of work (the proposal).

 

3.6.
Quality and Program Contacts

 

All
communications concerning the scope of this Quality Agreement will be between the Quality Contacts, named in Attachment 1. The
program management contacts and regulatory contacts for either Party are also listed in Attachment 1.

 

In
the event of a change, temporary or otherwise, of either Party’s Quality Contact, the Party making the change will notify
the other Party about the change in writing. Attachment 1 may be revised and approved independently from the main portion of this
Quality Agreement.

 

3.7.
Technology Transfer Package

 

A
set of documents supporting technical transfer of a manufacturing process or analytical methods. Key documentation included in
the package includes the manufacturing process development and qualification/validation reports (as applicable), process flow
diagram, manufacturing batch records, test method development reports, test method qualification/validation reports (as applicable)
and analytical test procedures for the manufacturing process and test methods to be transferred.

 

4.
Quality Program

 

The
quality program at KBI Biopharma provides:

 

	 	●	An
    organization with a focus on building quality into the product, using balanced risk management in quality decisions and meeting
    of company business objectives.
	 	●	An
    understanding of executive management’s responsibility to ensure that the commitment for quality is understood, implemented
    and maintained at all levels of operations.
	 	●	Periodic
    management review of the suitability and effectiveness of the quality program.

 

    	 	Page 4 of 14

     

    

 

4.1.
Management Responsibilities

 

KBI
Biopharma will operate a facility compliant with applicable cGMP regulations with regard to HCT/P manufacture, Quality Control
testing and product stability testing.

 

The
Client is responsible for ensuring that the manufacturing records, test procedures and specifications employed at KBI Biopharma
appropriately reflect the requirements submitted to applicable regulatory authorities. KBI Biopharma is responsible for ensuring
compliance to the manufacturing records, test procedures and specifications for Client Product.

 

4.2.
Conflict Resolution

 

Any
disputes or conflicts relating to this Quality Agreement will be resolved by the Quality Contacts in a timely manner and in compliance
with all applicable quality and regulatory requirements. Such resolutions will be documented and signed by the Quality Contacts
of each company. In the event the issue cannot be resolved at the Contact level, the senior corporate quality officials from each
Party will be responsible for resolution. In the event of any conflict between the Agreement (MSA) and the Quality Agreement,
with respect to matters of product quality or GMP compliance, the Quality Agreement will govern.

 

4.3.
Regulatory

 

All
updates to regulatory applications related to product intermediates and drug product manufacturing and testing are the responsibility
of the Client. KBI Biopharma will provide the Client all necessary information that it possesses, pertinent to manufacturing,
testing and facility information.

 

The
Client will fulfill all reporting requirements to the respective regulatory agency or agencies with regard to the Client registration
documentation. KBI Biopharma will fulfill all reporting requirements with regard to manufacturing, testing and site registration
that may be required to support the Client related activities.

 

4.4.
Manufacturing Process Transfer

 

Manufacturing
processes will be developed by KBI Biopharma or transferred from the Client site using mutually agreed upon protocols. The Client
will be responsible for training KBI Biopharma personnel to perform the manufacturing processes that are transferred to KBI Biopharma.
KBI Biopharma will be responsible for generating process development reports for any manufacturing process developed by KBI Biopharma
and manufacturing records for any product to be manufactured by KBI Biopharma. The Client and KBI Biopharma will jointly review
and approve the master manufacturing records prior to implementation of GMP manufacturing.

 

KBI
Biopharma will be responsible for any subsequent process transfers to other manufacturing sites identified by the Client.

 

4.5.
Analytical Method Transfer

 

Analytical
test methods will be developed by KBI Biopharma or transferred from the Client site using mutually agreed upon protocols. The
Client will be responsible for training KBI Biopharma personnel to use product assays or product specific test methods that are
transferred to KBI Biopharma. KBI Biopharma will be responsible for generating protocols to confirm method equivalency, validating
or qualifying the test methods and providing a final report for method transfer to the Client. The Client and KBI Biopharma will
jointly review and approve the validation or qualification protocol, final report and test methods prior to implementation of
routine testing.

 

    	 	Page 5 of 14

     

    

 

KBI
Biopharma will be responsible for any subsequent analytical method transfers to other sites identified by the Client.

 

4.6.
Manufacturing, Batch Disposition, Storage and Shipment

 

KBI
Biopharma will manufacture, package, label and perform release testing of the Client’s Product per Client approved and/or
established manufacturing records, test methods and product specifications as detailed in regulatory submissions.

 

All
in-process Product labeling will be performed per KBI Biopharma procedure. Final Product label content will be approved by the
Client. KBI Biopharma will be responsible for providing analytical reference standards for testing and for proper maintenance
of the inventory of reference standards in its possession.

 

KBI
Biopharma Quality will conduct a review of the manufacturing batch records, in process and release test results and any associated
deviations and calibration documentation to disposition the batch. The disposition documentation provided to the Client will include
a Certificate of Conformance, an approved Certificate of Analysis, copies of batch records and copies of deviation reports.

 

All
questions or comments on the batch disposition documentation should be forwarded to KBI Biopharma QA within ten (10) business
days after receipt. KBI Biopharma will reply to these comments within ten (10) business days of receipt.

 

The
Product will be available for shipment once it is fully dispositioned by KBI Biopharma. Disposition status may be Approved, Conditionally
Approved or Rejected based on product type and/or clinical administration requirements as agreed by the Client. KBI agrees to
provide Product chain of custody that details Product accountability through final product receipt at Clients storage location.

 

KBI
Biopharma will store Client Product at agreed storage conditions, and will maintain temperature and humidity logs (as applicable)
of the storage environment for the duration of the storage period. QA reserve samples (Product retains) will be stored for two
(2) years. Client Product will be shipped to alternate storage, manufacturing or clinical locations using agreed shippers, shipping
containers and shipping conditions.

 

4.7.
Stability Testing

 

If
applicable, KBI Biopharma will perform stability testing of the Client’s drug product per established method/procedure and
review against defined specifications as detailed in regulatory submissions.

 

KBI
Biopharma will be responsible for providing analytical reference standards for testing and for proper maintenance of the inventory
of reference standards in its possession.

 

KBI
Biopharma and the Client will mutually approve the KBI Biopharma protocols generated for the stability study testing to be performed.
The Client will be responsible for determining, amending and reporting expiration dates for all reference standards and Product.

 

    	 	Page 6 of 14

     

    

 

KBI
Biopharma will provide a final stability test result at each time point in the form of a summary report to the Client Quality
Contact after KBI quality review is complete.

 

The
Client QA will conduct a review of this documentation within ten (10) business days after receipt. If any issues are identified
during review, these will be communicated to KBI Biopharma in writing. KBI Biopharma will reply to these comments within ten (10)
business days of receipt.

 

4.8.
Documentation

 

4.8.1.
Specifications and Test Methods

 

Product
specifications will be consistent with the requirements set forth in regulatory filings (where applicable). Where no written test
method is provided by the Client (such as compendia methods), current KBI Biopharma methods or current compendia methods will
be used. Mutually approved Client specifications and methods will be provided to KBI Biopharma thirty (30) days prior to implementation
of cGMP manufacturing or testing.

 

4.8.2.
Data Access

 

Original
(raw) Product data generated in KBI Biopharma laboratories will be stored and retained at KBI Biopharma in accordance with cGMPs
and internal KBI Biopharma guidelines. The Client is to provide five (5) business days advance notice for access to reviewed and
approved data.

 

4.8.3.
Record Retention

 

KBI
Biopharma will retain all manufacturing records, completed testing documentation and manufacturing related documentation according
to KBI Biopharma’s record retention standard operating procedure. These documents will be readily accessible for review
and inspection by the Client and/or regulatory authorities if requested. At the end of the document retention period, KBI Biopharma
will notify the Client and either provide these records to the Client or obtain written permission to destroy any documents that
were stored beyond the required retention period. Client will provide a response within 30 calendar days of notification receipt.

 

4.9.
Materials Used in Manufacturing

 

4.9.1.
Sourcing and Testing

 

Unless
otherwise agreed by the parties, KBI Biopharma will source (select and procure) all raw materials and components used in GMP manufacturing.
The KBI Biopharma vendor quality program requirements, which include material qualification as applicable, will apply to all materials
sourced by KBI Biopharma. Material specifications will be in accordance with requirements set forth in regulatory filings and
as set forth in the Client provided documents.

 

In
the event the Client sources a custom made raw material, the Client will be responsible for releasing the material for manufacturing
use and for monitoring supplier quality.

 

    	 	Page 7 of 14

     

    

 

4.9.2.
Transmissible Spongiform Encephalopathy (TSE) Compliance

 

Where
KBI Biopharma is responsible for selecting raw materials and components: (a) KBI Biopharma will source such materials from non-animal
derived sources whenever possible; and (b) if animal derived materials are necessary, KBI Biopharma will comply with applicable
regulations regarding TSE compliance.

 

4.9.3.
Donor Eligibility Requirements

 

The
Client agrees to provide KBI Biopharma with donor eligibility records to establish donor acceptance prior to any donor material
processing at KBI Biopharma. All donors must be screened as required by 21 CFR 1271.50 and HCT/P records forwarded to KBI Biopharma
as per 21 CFR Part 1271.55

 

Note:
Human cell lines established from human tissue prior to 2005 will be exempt from 21 CFR 1271 donor screening requirements. For
these materials, KBI Biopharma will require defined human pathogen and adventitious agents testing.

 

4.10.
Major Change Control

 

Major
Changes initiated by KBI Biopharma will be communicated to the Client in writing, using the KBI Biopharma Change Control process.
The Client will review Major Changes prior to implementation for conformance to registration commitments and advise KBI Biopharma
on any actions to take in order to assure compliance.

 

Major
Changes initiated by the Client will be communicated to KBI Biopharma in writing using the Client’s process for change control.
KBI Biopharma will review the Major Change prior to implementation and advise the Client on any actions that must be taken to
assure conformance to KBI Biopharma standards.

 

For
Major Changes requiring approval by KBI Biopharma and the Client, both Parties will be responsible for supplying written responses
as soon as reasonably possible but in no event more than ten (10) business days from receipt of the request.

 

Changes
Requiring Approval by KBI Biopharma and Notification of the Client:

 

	 	●	Change
    in the layout or structure of the manufacturing facility, equipment or utilities impacting the Client
	 	●	Changes
    to compendia test methods and specifications

 

Changes
Requiring Pre-Approval of KBI Biopharma and the Client:

 

	 	●	Changes
    to the manufacturing records for Client’s Product
	 	●	Changes
    to a validated manufacturing process
	 	●	Changes
    that require revalidation or requalification of the Client’s product specific release or stability test methods.
	 	●	Changes
    to release or stability testing specifications for the Client Product
	 	●	Change
    of manufacturing site for Client’s Product or testing site for the Client’s product specific release or stability
    test methods
	 	●	Changes
    to materials used in manufacturing (specifications, testing, suppliers or TSE status)

 

    	 	Page 8 of 14

     

    

 

4.11.
Temporary Changes (Planned Deviations)

 

If
a temporary change from the Client’s approved manufacturing record or test method is required, it will be handled as a Planned
Deviation per KBI Biopharma procedure. The Planned Deviation will be approved by the Client prior to implementation.

 

4.12.
Changes in Personnel supporting the cGMP Manufacturing or Testing

 

The
Client will be notified of changes in key personnel (Director-level and above) that support the cGMP manufacturing and testing
referenced in the Scope of this Quality Agreement.

 

4.13.
Deviation Control

 

KBI
Biopharma will notify the Client of any out of specification (OOS) results or other Critical/Major Deviation(s) within one (1)
business day of confirming an OOS or identifying a Critical/Major deviation.

 

OOS
results will be investigated using the KBI Biopharma Laboratory Investigation Procedure, and if any retesting is conducted, the
re-test plan must be approved by KBI Biopharma quality and the Client Quality Contact. For assays where there is a limited storage
hold time for the Quality Control sample, the Client will provide timely (same business day may be required) approval on the retest
plan.

 

Critical
and Major Deviations will be investigated for root cause, product/process impact and fully documented by KBI Biopharma, targeting
thirty (30) days after the date of discovery for completion. Investigations will include appropriate justification, scientific
rationale and supporting data. The Client will review the completed Deviation report and communicate to KBI Biopharma the result
of its review, within five (5) business days.

 

Copies
of all batch related deviation reports will be provided to the Client as part of the batch disposition documentation.

 

4.14.
Validation, Maintenance and Calibration

 

KBI
Biopharma will be responsible for initial qualification, validation and ongoing re validation, as needed, of its facilities, utilities,
computer systems, manufacturing and laboratory equipment.

 

KBI
Biopharma will ensure that equipment used in the manufacture and testing of the Client’s drug product are routinely calibrated
and maintained in a good state of repair.

 

4.15.
Audits

 

4.15.1.
Client Audits

 

The
Client may audit KBI Biopharma premises once annually upon reasonable advance notice, using no more than two (2) auditors for
a maximum of two (2) days for reasons of determining compliance with the terms of the Quality Agreement and general compliance
with the requirements of the applicable internal procedures and regulatory requirements.

 

    	 	Page 9 of 14

     

    

 

The
Client has the right to For Cause Visits with respect to particular functions or areas. KBI Biopharma will schedule and host For
Cause Visits within ten (10) days of KBI Biopharma’s receipt of the Client’s request. If a For Cause Visit is the
result of a reported adverse event, KBI Biopharma will schedule and host the For Cause Visit within forty-eight (48) hours of
KBI Biopharma’s receipt of Client’s request.

 

4.15.2.
Supplier Audits

 

The
auditing of material suppliers will be the responsibility of the Party sourcing the item(s).

 

4.15.3.
Regulatory Inspections

 

KBI
Biopharma will notify the Client, within twenty-four (24) hours, of any unannounced inspections or actions by regulatory agencies
or other enforcement bodies that could potentially impact the Client’s Product. KBI Biopharma will provide the Client with
the results of all such regulatory audits, as they apply to the Client Product, within ten (10) working days of the audit close
out meeting. KBI Biopharma will provide pre-approval inspection and new product approval support.

 

4.16.
Complaints and Adverse Event Reporting

 

KBI
Biopharma will promptly notify the Client of any information coming into its possession concerning the quality of previously released
Client Product. Any determinations on whether a regulatory notification is necessary and the resulting communication with the
regulatory authorities will be the responsibility of the Client Quality Contact.

 

Client
to notify KBI Biopharma within one (1) business day of any complaints or regulatory findings where the Client determines that
the complaint or regulatory finding relates to or impacts Product manufactured by KBI Biopharma. KBI Biopharma will provide the
requested assessments within agreed upon timeframe to meet regulatory reporting requirements.

 

4.17.
Periodic Review of Quality Agreement

 

KBI
Biopharma will initiate a periodic review of the quality agreement 3 years from the date of last approval signature. If the Client
project is no longer active at that time, then no review of the quality agreement will be performed.

 

    	 	Page 10 of 14

     

    

 

5.
Key Responsibilities

 

	Description	 	KBI	 	Client
	General
	Operate
    a cGMP compliant facility with respect to HCT/P manufacture and testing	 	X	 	 
	Ensure
                                         KBl’s manufacturing records, test methods and specifications reflect requirements
                                         submitted to regulatory authorities
	 	 	 	X
	Comply
                                         with Client’s manufacturing records test methods and Product specifications
	 	X	 	 
	Retain
                                         manufacturing records, testing data and documentation related to manufacturing according
                                         to KBI Biopharma’s record retention standard operating procedure
	 	

        X
	 	 
	Notify
                                         other party of major changes and approve major changes, as applicable
	 	X	 	X
	Notify
    other party of changes in key personnel (Director-level and above) that support cGMP manufacturing and testing	 	X	 	 
	Manage
    periodic review of Quality Agreement	 	X	 	 
	Validate,
    calibrate and maintain utilities, manufacturing equipment and testing equipment, as required	 	X	 	 
	Technology
    Transfer and Validation
	Arrange
                                         training of KBI staff for any processes or test methods directly transferred to KBI
	 	 	 	X
	Provide
    training to external staff for any processes or test methods that are transferred to other manufacturing sites	 	X	 	 
	Approve
    process and test method transfer protocols and reports	 	X	 	X
	Approve
                                         process validation and test method validation protocols and reports
	 	X	 	X
	Manufacturing,
    Testing, Storage and Shipment
	Approve
    master manufacturing records	 	X	 	X
	Approve
    non-compendial test methods	 	X	 	X
	Approve
    KBI Product Specification	 	X	 	X
	Provide
    analytical reference standards to support testing	 	X	 	 
	Maintain
                                         inventory of reference standards under appropriate storage conditions
	 	X	 	 
	Monitor
                                         supplier quality, perform qualification and release testing, as required, and release
                                         raw materials for any self-sourced raw materials.
	 	X	 	X
	Comply
                                         with applicable regulations on minimizing risk for TSE when sourcing raw materials
	 	X	 	X
	Provide
                                         donor eligibility records to establish donor acceptance prior to any donor material processing
                                         at KBI. All donors must be screened as required by 21 CFR 1271.50 and HCT/P records forwarded
                                         to KBI as per 21 CFR Part 1271.55

         

        Note:
        Human cell lines established from human tissue prior to 2005 will be exempt from 21 CFR 1271 donor screening requirements.
        For these materials, provide results of human pathogen and adventitious agents testing.

        
	 	 	 	

                                                                             

                                                                             

                                                                             

                                                                             

                                                                             X

	Manufacture
Product in accordance with cGMP requirements following Client’s approved manufacturing records

        
	 	X	 	 

 

    	 	Page 11 of 14

     

    

 

	Description	 	KBI	 	Client
	Perform
                                                                              in-process testing as specified in approved manufacturing records and release testing as defined in KBl’s product
                                                                              Specification
	 	X	 	 
	Review
    executed manufacturing records	 	X	 	X
	Review
    in-process and release testing data	 	X	 	X
	Provide
    final disposition of Product batch	 	X	 	 
	Store
    Product under appropriate conditions until it is shipped.	 	X	 	 
	Maintain
    QA reserve samples from each batch of Product under appropriate storaqe conditions	 	X	 	 
	Prepare
    drug product for shipment using agreed upon shipping containers and shipping conditions	 	X	 	 
	Oversee
    drug product shipment during transit to third party	 	X	 	 
	Stability
    Testing
	Approve
    stability study protocols	 	X	 	X
	Review
    stability testing data	 	X	 	X
	Prepare
    final stability study report and establish and amend expiration dating, as needed	 	X	 	 
	Deviations
    and OOS Events
	Notify
    other party of OOS results and Critical/Major deviations within 1 business day	 	X	 	 
	Approve
    OOS retest plans	 	X	 	X
	Review
    and approve Critical/Major deviation reports	 	X	 	X
	Regulatory
	Update
                                                                              regulatory applications and fulfill registration reporting requirements related to Product manufacturing and Product testing,
                                                                              as required
	 	 	 	X

	Provide
                                                                              Product manufacturing, Product testing and facility information, as requested, to Client for regulatory application
                                                                              updates.
	 	

        X
	 	 
	Update
    site registration, as required to support Client’s manufacturing	 	X		 
	Notify
                                                                              other party within 24 hours of any regulatory inspections or regulatory actions that could impact Client Product
	 	

        X
	 	 
	Notify
                                                                              other party within 1 business day of any deviations, complaints or regulatory findings concerning quality of previously
                                                                              dispositioned Product
	 	X	 	

        X

	Notify
                                                                              regulatory authorities of any deviations, complaints or regulatory findings concerning quality of previously dispositioned
                                                                              drug product, as applicable,
	 	 	 	

        X

	Initiate
    recalls, if applicable.	 	 	 	X

 

    	 	Page 12 of 14

     

    

 

6.
Revision History

 

	Version
    Number	 	Summary
    of Changes
	0	 	New
    Agreement

 

Quality
Agreement Approvals

 

Client
Quality:

 

	Written
    Signature:	
	Printed
    Name:	William
    V. Williams
	Title:	President
    and CEO, BriaCell Therapeutics Corporation
	Date:	2017
    May 4

 

KBI
Biopharma Quality:

 

	Written
    Signature:	
	Printed
    Name:	Christopher
    Garten
	Title:	Vice
    President, Quality
	Date:	04
    May 2017

 

    	 	Page 13 of 14

     

    

 

Attachment
1: Responsible Contacts

 

Responsible
Contact Persons for KBI:

 

	Responsibility	 	Name
     /Title	 	Telephone/
    E-mail
	Quality
    Assurance	 	Chris
    Garten, Vice President, Quality Operations	 	C
                                         : (732) 682-0324

        cgarten@kbibiopharma.com

	Regulatory	 	Kathy
Lee, Senior Vice President, Quality and Regulatory
	 	(919)
                                         479-9898 ext. 2009

        klee@kbibiopharma.com

	Program
    Management	 	Don
    Healey, Ph.D., Senior Vice President Operations & Site Head	 	C:
                                         (832) 585-9637

        dhealey@kbibiopharma.com

 

Responsible
Contact Persons for Client:

 

	Responsibility	 	Name
    /Title	 	Telephone
    / E-mail
	Quality
    Assurance	 	Markus
    Lacher, Sr. Director of Research and Development	 	T:
                                         1-888-485-6340

        C:
        925-681-9553

        mlacher@briacell.com

	Regulatory	 	William
    V. Williams President and CEO	 	T:
                                         6510-446-7581

        C:
        302-290-9017

        williams@briacell.com

	Program
    Management	 	Markus
    Lacher, Sr. Director of Research and Development	 	T:
                                         1-888-485-6340

        C:
        925-681-9553

        mlacher@briacell.com

 

Attachment
1: Approvals

 

Client
Quality:

 

	Written
    Signature:	
	Printed
    Name:	William
    V. Williams
	Title:	President
    and CEO, BriaCell Therapeutics Corporation
	Date:	2017
    May 4

 

KBI
Biopharma Quality: 1

 

	Written
    Signature:	
	Printed
    Name:	Christopher
    Garten
	Title:	Vice
    President, Quality
	Date:	04
    May 2017

 

    	 	Page 14 of 14

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