Amendment to the Agreement signed by NRC on March 30, 2020 and Amendment One signed by NRC on December 21, 2020 effective July 8, 2021

EX-10.4 2 ex10-4.htm

Exhibit 10.4

Business Confidential – Protected B

THIS IS AN AMENDING AGREEMENT

BETWEEN:	NATIONAL RESEARCH COUNCIL OF CANADA

	a departmental corporation forming part of the Government of Canada created by the National Research Council Act (R.S.C. 1985, c. N-15), and an agent of Her Majesty the Queen in Right of Canada whose head office address is:

		1200 Montreal Road
		Ottawa, Ontario K1A 0R6	(called the “NRC”)

AND:	VARIATION BIOTECHNOLOGIES INC.

	a Company incorporated under the Canada Business Corporations Act under number 393728-3 whose Registered Office Address is located in:

		300 Hunt Club Road East, 2^nd Floor
		Ottawa, Ontario K1V 1C1	(called the “Collaborator” or “VBI”)

			(Collectively known as the “Parties”)

WHEREAS the parties entered into an Agreement signed by the NRC on 30 March 2020 (called the “Original Agreement”) and an Amendment One signed by NRC on 21 December 2020 (called “Amendment One”) by which the Parties agreed to collaborate in a “Project”, described as: COVID-19 vaccine evaluation. Original and Amendment One Agreements are now called “The Agreements”.

WHEREAS this Amending Agreement includes certain special obligations which relate solely to Tasks performed for the purpose of developing a vaccine against the South Africa (Beta) variant of COVID-19, which project is being funded by the Coalition for Epidemic Preparedness Innovations (CEPI). These special obligations are required by the terms of the funding agreement between Collaborator and CEPI.

WHEREAS the parties wish to amend the Agreements. In consideration of the mutual covenants hereunder, the parties agree as follows

1.	The Agreements shall be read with the amended terms stated below. With respect to all other terms, the Parties confirm the Agreements.

2.	The attached “SCHEDULE OF PAYMENTS” is in addition to, the “Schedule of Payments” from the Agreements except that the amount shown for Task 1.7 shall replace the amount shown for Task 1.7 in Amendment One and the amount shown for Task 1.8 shall replace the amount shown for Task 1.8-1.9 in Amendment One. Furthermore, Annex B to Amendment One has been cancelled.

3.	The attached “NEW STATEMENT OF WORK AND DELIVERABLES” is in addition and, in the case of Tasks 1.7, 1.8 and 1.9 and Annex B is an amendment to the “STATEMENT OF WORK AND DELIVERABLES” in the Agreements.

4.	The estimated total value of this Project amendment two is: minimum of $[]* (without options) to a maximum of $[] (with options)* as stated in the Statement of Work.

5.	The Collaborator is a Canadian Small and Medium Enterprise (SME) or a Canadian educational institution, including a community college, CEGEP, polytechnic or university, and benefits from a Fee Reduction of minimum of $[] (without options) to a maximum of $[] (with options). The Collaborator hereby warrants that, at the time of signing this Agreement, it is a SME and has 500 or fewer full-time equivalent employees, or it is a Canadian educational institution.

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 1 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

6.	The amount that the Collaborator will pay to the NRC in cash for this amendment two is: minimum of $[] (without options)* to a maximum of $[] (with options)* as stated in the Statement of Work.

7.	The estimated value of the NRC’s in-kind contribution for this amendment is: $[].*

8.	The following special provisions apply to Tasks carried out pursuant to this Amending Agreement:

	(a)	NRC shall exert reasonable efforts to retain records of its activities regarding the work performed pursuant to this Amending Agreement for a period of at least 5 years from the date of completion of the work, to the extent that it does not contradict with any applicable laws, regulations, or policies of the NRC and can provide a copy of such documentation to Collaborator upon request.

	(b)	NRC shall exert reasonable efforts to retain, for a period of at least 5 years (to the extent that it does not contradict with any applicable laws, regulations, or policies of the NRC) from the date of completion of the work described in this Amending Agreement, documentation supporting the amounts invoiced to and paid by Collaborator pursuant to this Amending Agreement and can provide a copy of such documentation to Collaborator upon request.

	(c)	Each of NRC and Collaborator agree that it shall carry its obligations hereunder in accordance with laws and regulations that are applicable to its activities and operations.

	(d)	Section IU-8 of the Original Agreement is amended to add the following last paragraph:

		Collaborator shall be permitted to disclose Confidential Non-Project Information to CEPI solely to the extent required to comply with its obligations pursuant to its funding agreement with CEPI, including its obligations pursuant to the CEPI Third Party Code. NRC will have the right to review the Confidential Information prior to any disclosure to CEPI;

	(e)	The NRC is part of the Government of Canada and confirms that it is in compliance with laws, regulations, and policies whose goals are aligned with the goals of the CEPI Third Party Code.

9.	This Amending Agreement may be executed in one or more counterparts and by the different parties hereto in separate counterparts, each of which when executed shall be deemed to be an original but all of which taken together shall constitute one valid and binding agreement. A portable document format (PDF) copy of an executed counterpart signature page will be as valid as an originally executed counterpart for purposes of signing this Amending Agreement.

SIGNED by the Collaborator at Ottawa, Ontario

		*VARIATION BIOTECHNOLOGIES INC.*

Date:	July 6, 2021	Per:	/s/ Jeff Baxter
			Jeff Baxter
			CEO

SIGNED by the NRC at Ottawa, Ontario

NATIONAL RESEARCH COUNCIL OF CANADA

Date:	July 8, 2021	Per:	/s/ Lakshmi Krishnan
			Lakshmi Krishnan, Ph.D.
			A/Vice President, Life Sciences

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 2 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

ANNEX SP – SCHEDULE OF PAYMENTS TO NRC

Billing address: See page 1

Billing contact:

Name:	Andrea McRae
Title:	Project Manager
Telephone:	[***]	Email:	[***]

SP-1

The Collaborator shall be invoiced as follows:

Invoicing Schedule (Estimated Dates)		Amount Due*
STAGE 1
1. Invoice to be issued on signature of this amendment for Task 1.7		[***]
2. Invoice to be issued upon completion of Task 1.8		[***]
3. Invoice to be issued on completion of Task 1.10		[***]
4. Invoice to be issued upon completion of Task 1.11		[***]
5. Invoice to be issued upon completion of Task 1.12		[***]
6. Invoice to be issued upon completion of Task 1.13		[]*
7. Invoice to be issued upon completion of Task 1.14		[***]
8. Invoice to be issued upon approval to exercise Optional Task 1.9.1		[***]
9. Invoice to be issued upon approval to exercise Optional Task 1.9.2		[]*
10. Invoice to be issued upon approval to exercise Optional Task 1.15.1		[***]
11. Invoice to be issued upon approval to exercise Optional Task 1.15.2		[***]
12. Invoice to be issued upon approval to exercise Optional Task 1.16.1		[***]
13. Invoice to be issued upon approval to exercise Optional Task 1.16.2		[***]
STAGE 2
14. Invoice to be issued on signature of this amendment for Tasks 2.6 and 2.7.1		[***]
15. Invoice to be issued on completion of Tasks 2.7.2, 2.7.3 and 2.7.4		[***]
16. Invoice to be issued upon approval to exercise Optional Task 2.7.5.1		[***]
17. Invoice to be issued upon approval to exercise Optional Task 2.7.5.2		[***]

*Plus applicable taxes

SP-2

All amounts shall be due 30 days from the date of the invoice.

SP-3

Payments must be made to: “Receiver General - National Research Council of Canada” and addressed to:

Accounts Receivable

National Research Council of Canada

1200 Montreal Road

Ottawa, Ontario, K1A 0R6 CANADA

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NRC Ref. #: A-0040072 (orig. A-0035546)

SP-4

Payments can be made by cheque, MasterCard, Visa or American Express; or by wire transfer. Wire transfer information is available upon request. The Collaborator is responsible for all bank charges associated with wire transfers. Any inquiries may be directed to: ***@***.

SP-5

The Collaborator shall provide any Invoicing Reference Number at the time of Agreement signature or promptly thereafter. The NRC will not delay or cancel invoicing nor defer accrual of interest due to the Collaborator’s failure to provide an Invoicing Reference Number.

SP-6

The NRC may suspend its performance of any obligations under this Agreement so long as any payment is overdue for any reason.

SP-7

If this Agreement is amended to increase the scope of the Services, the NRC reserves the right to calculate costing for its additional Project activities at its rates that are in effect at that time. Any such cost increases shall be approved, in writing, by both Parties.

SP-8

If the NRC expects that the value of its estimated contribution will be exceeded by more than 10%, it shall promptly notify the other Party. The Parties shall then negotiate a further agreement on costs or payments, and either Party may suspend the performance of any obligations, other than confidentiality, intellectual property and accrued obligations to pay, until a further agreement is reached. If the Parties fail to agree on an amendment within 60 days of the notice, then this Agreement shall terminate on the 60^th day after the notice, unless the Parties agree otherwise in writing.

SP-9

If a surplus of prepayment remains as a result of premature termination, it will be refunded.

SP-10

If an instrument tendered in payment or settlement of an amount due to the NRC is dishonoured for any reason, the NRC will invoice an additional administrative charge of CAD 25 and this amount will be due as invoiced.

SP-11

Interest is payable on all overdue amounts. Interest is calculated and compounded monthly at the average bank rate plus 3% and accrues during the period beginning on the due date and ending on the day before the day on which payment is received by the NRC. For purposes of this paragraph “bank rate” means the rate of interest established periodically by the Bank of Canada as the minimum rate at which the Bank of Canada makes short term advances to members of the Canadian Payments Association, and “average bank rate” means the weighted arithmetic average of the bank rates that are established during the month before the month in respect of which interest is being calculated.

(Rate information may be found at http://www.tpsgc-pwgsc.gc.ca/recgen/txt/tipp-ppir-eng.html. This site provides information on the rate used by departments of the Government of Canada to calculate the interest on overdue accounts payable and is the same rate used by the NRC to charge interest on overdue accounts receivable under the Interest and Administrative Charges Regulations, SOR/96-188. This web site address, and the information set out there, is provided here for convenience. In case of rate discrepancy, the rates quoted by the Bank of Canada shall prevail.)

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HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 4 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

Statement of Work

Covid-19 Vaccine Evaluation – Amendment two

1.	Workplan

	Stage 1: Candidate Identification & Immunogenicity

	Tasks 1.5 and 1.6 in Amendment 1 have been completed and invoiced.

		The following tasks are amended/added to the workplan:

		Work related to ISED funding (Products: VBI-2901; VBI -2902)

		Task 1.7: [***]

		[***]

		*Estimated budget: $[**]

		Task 1.8 Phase I clinical sample testing by PRNT (R&D assay) for both Wuhan and South African:

		[***]

	*Estimated budget: $[**]

		OPTIONAL: Task 1.9 Phase II clinical sample testing by PRNT (R&D assay) to be conducted upon Collaborator request.

		[***]

		*Estimated budget: $[**]

		Tasks captured below are new work added and relate to new variants under project funded by CEPI

		Task 1.10 Study 29B688: Mouse study (72 mice, 2 doses) and PRNT (R&D assay) for both Wuhan and South African

		[***]

	*Estimated budget: $[**]

		Task 1.11 Study TBD1: Mouse study (48 mice, 2 doses) and PRNT (R&D assay) for both Wuhan and South African

		[***]

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 5 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

Estimated budget: $[***]

	Task 1.12 Study TBD2: Mouse study (48 mice, 2 doses) and PRNT (R&D assay)

	[***]

	*Estimated budget: $[**]

	Task 1.13 PRNTs (R&D assay) for both Wuhan and South African strain on samples from Hamster Challenge Study 1 done at VIDO.

	[*] Estimated budget: $[*]

	Task 1.14 PRNTs (R&D assay) for both Wuhan and South African on samples from Hamster Challenge Study 2 done at VIDO

	[***]

	*Estimated budget: $[**]

	OPTIONAL: Task 1.15 Phase I clinical sample testing by PRNT (R&D assay) to be conducted upon Collaborator request.

	[***]

	*Estimated budget: $[**]

	OPTIONAL: Task 1.16 Phase II clinical sample testing by PRNT (R&D assay) to be conducted upon client request.

	[***]

*Estimated budget: $[**]

	[***]

	Stage 2: Tech Transfer & Process Development Activities

		The following Tasks have been completed:

		Task 2.1 - [***] eVLP Purification

		Task 2.4.1 [*] production of [*]

		The following tasks are amended/added to the workplan:

		Task 2.2 Process transfer [***]. This includes:

		Subtasks [*] are cancelled ([*]).

		Task 2.3

		Task 2.4 [***] process scale up (including new IEX step) No changes to subtasks 2.4.1 and 2.4.2

		2.4.3 [***]

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 6 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

		*Estimated budget: $[**]

		Work related to new variants under project funded by CEPI

		Task 2.6 [***]

		[***]

		*Estimated budget: $[**]

	Task 2.7 Upstream Optimization

		[***]

		[***]

		Estimated budget: [***]

	Stage 4: At Risk Domestic Production during Stage 4 and Prior to Approval

		Task 4.1: [***]

		Task 4.2: [***]

		Task 4.3: [***]

		[***]

	●	Deliverables[***]

2. Assumptions

	●	[***]

3. Estimated Budget

Budget Summary: VBI Covid-19 Vaccine Evaluation- Amendment 2 – STAGE 1
Work Task	Task Value	CAN SME Fee Reduction	NRC Task Price*
[***]	[***]	[***]	[***]
[***]

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 7 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)

4.	Project Schedule

		[***]

5.	Responsibilities

NRC Responsibilities

	●	Perform the above work according to high standards of quality;
	●	The NRC will repeat, at its own cost, any portion of work whose failure was due to error by the NRC personnel or to power or equipment failure;
	●	Maintain good lines of communication with Variation Biotechnologies Inc.;
	●	To report any problems encountered to Variation Biotechnologies Inc. immediately;
	●	NRC cannot guarantee that a specific amount/level of purity or of product will be obtained.
	●	Samples will be stored within an NRC facility for the duration of the project, unless stated otherwise. NRC will dispose of any remaining samples or may transfer to Variation Biotechnologies Inc. upon request.

*Variation Biotechnologies Inc. Responsibilities*

	●	Provide to the NRC all of the necessary information;
	●	Provide to the NRC a copy of the Informed Consent Form for the clinical trial samples;
	●	Provide to NRC the plasmids needed for all productions;
	●	Maintain good lines of communication with the NRC;
	●	Shipment of product will be charged to Variation Biotechnologies Inc.’s courier account.

HUMAN HEALTH THERAPEUTICS – Vaccines and Emerging infections RI	Page 8 of 8
NRC Ref. #: A-0040072 (orig. A-0035546)