Document:

Exhibit 10.47

 

REDACTED

Certain identified
information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii) would likely
cause competitive harm if publicly disclosed.

 

Amendment Three
to Development and Option Agreement

 

This Amendment Three
to the Development and Option Agreement (this "Amendment"), dated as of December 24, 2020 (the "Amendment
Three Effective Date"), is made by and between CureVac AG, a German stock corporation with offices at Friedrich-Miescher-Strasse
15, 72076 Tübingen, Germany ("CureVac"), and Acuitas Therapeutics Inc., a British Columbia corporation with
offices at 6190 Agronomy Road, Suite 405, Vancouver, British Columbia, V6T 1Z3, Canada ("Acuitas") and amends
the Development and Option Agreement dated April 29, 2016 (as amended by Side Agreement and Amendment Number One dated December
1, 2016 and Amendment Two to the Development and Option Agreement dated July 10, 2020) between CureVac and Acuitas (as amended,
the “Development and Option Agreement”). Each of CureVac and Acuitas may be referred to herein as a "Party"
or together as the "Parties."

 

WHEREAS, Acuitas
and CureVac entered into the Development and Option Agreement relating to the evaluation of and options to license Acuitas LNP
Technology for the research, development, manufacture and/or commercialisation of products incorporating Acuitas LNP Technology
and CureVac Technology;

 

WHEREAS, pursuant
to the Side Agreement and Amendment Number One dated December 1, 2016 to the Development and Option Agreement, Acuitas and CureVac
agreed, inter-alia, to include in the Work Plan the evaluation of Acuitas LNP Technology together with CureVac Technology
relating to Gene Editing and to discuss and negotiate in good faith the terms and conditions under which the Development and Option
Agreement will be amended to encompass Licensed Products useful for Gene Editing purposes;

 

WHEREAS, pursuant
to Amendment Two to the Development and Option Agreement, Acuitas and CureVac agreed that CureVac will have the right to exchange
up to [*****] Targets, and any associated [*****] Targets being the subject of Non-exclusive License Agreement(s), with [*****]
alternate [*****] Targets and, optionally, any alternate [*****] Targets associated therewith for a period of [*****] from the
Amendment Two Effective Date.

 

WHEREAS, CureVac
and Acuitas now wish to amend the Development and Option Agreement to include therein the terms and conditions for Extension Term
Options (as defined below);

 

NOW, THEREFORE,
in consideration of the mutual covenants and representations contained herein, and for other good and valuable consideration,
the amount and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

Section One.

Defined Terms
and Amendment of Article 1 of the Development and Option Agreement.

 

		1.1	Capitalized terms not defined herein
                                         have the definitions set forth in the Development and Option Agreement.

 

		1.2	The following new definitions are hereby
                                         added to Article 1 of the Development and Option Agreement:

 

“1.12a “Base
Term” means the period starting on April 29, 2016 and ending on April 29, 2021.”

 

“1.12b “Base
Term Option” has the meaning set forth in Section 5.1.”

 

“1.32a “Extension
Term” means the period starting on April 29, 2021 and ending on April 29, 2025.”

 

    1 

     

    

 

“1.32b “Extension
Term License Agreement” means each Non-exclusive License Agreement entered into by the Parties upon exercise by CureVac
of an Extension Term Option as set forth in Section 5.1.”

 

“1.32c “Extension Term Option”
has the meaning set forth in Sections 5.1.”

 

“1.32d “Extension Term Start
Date” means April 29, 2021.”

 

		1.3	Each of the following definitions of
                                         the Development and Option Agreement are hereby replaced in their entirety with the respective
                                         following amended definition:

 

“1.34 "FTE
Costs" mean the actual FTEs employed by Acuitas in the conduct of the Works and Services multiplied by an annual rate
per FTE equal to [*****] (U.S. $[*****]) for the Base Term and [*****] (U.S. $[*****]) for the Extension Term. Such FTE Costs
represent reimbursement for all costs of providing the Works and Services (including salaries, benefits, lab supplies, reagents,
equipment and overhead, as well as other G&A costs).”

 

“1.56 “Option”
means each Base Term Option or each Extension Term Option, as the case may be.”

 

“1.57 “Option
Exercise Fee”,

 

(a)  with
respect to each Base Term Option, means: (i) with respect to each Non-exclusive License Agreement for which CureVac has exercised
a Base Term Option in accordance with Article 5, [*****] (U.S, $[*****]); and (ii) with respect to each Exclusive License Agreement
for which CureVac has exercised a Base Term Option to enter into in accordance with Article 5, [*****] (U.S. $[*****]). In addition,
in the event that upon a Base Term Option exercise a License Agreement includes more than [*****] Targets, each [*****] Target
in excess of [*****] will have an additional Option Exercise Fee under a Non-exclusive License Agreement of [*****] (U.S. $[*****])
[*****] (U.S. $[*****]) [*****] and under an Exclusive License Agreement an additional Option Exercise Fee of [*****] (U.S. $[*****])
[*****] (U.S. $[*****]) [*****]; and

 

(b)  
with respect to each Extension Term Option, for each Non-exclusive License Agreement for which CureVac has exercised an Extension
Term Option in accordance with Article 5: (i) [*****] (U.S. $[*****]) for each such exercised Extension Term Option for a Licensed
Product that is not a Licensed Vaccine Product; and (ii) [*****] (U.S. $[*****]) for each such exercised Extension Term
Option for a for a Licensed Product that is a Licensed Vaccine Product. In addition, in the event that upon an Extension
Term Option exercise a Non-exclusive License Agreement includes more than [*****] Targets, each [*****] Target in excess of [*****]
 will have an additional Option Exercise Fee under such a Non-exclusive License Agreement of [*****] (U.S. $[*****]) [*****]
(U.S. $[*****]) [*****].”

 

    2 

     

    

 

Section Two.

Amendment of Article
4 of the Development and Option Agreement.

 

		2.1	Sections 4.2(d) (ii) and (iii) of the
                                         Development and Option Agreement are hereby replaced in their entirety with the respective
                                         following amended Sections:

 

“(ii) Maximum Number
Reserved Targets. CureVac will have the right to select up to [*****] Targets to be subject to Base Term Options at
any one time to be placed on the Reserved Target List provided no more than [*****] may be exclusive Reserved Targets. Furthermore,
CureVac will have the right during the Extension Term to select up to an additional [*****] Targets to be subject to Extension
Term Options at any one time to be placed on the Reserved Target List, but each of such [*****] Targets only as a non-exclusive
Reserved Target.”

 

“(iii) Reserved
Vaccine Target List. In the case of Targets intended to be used in a Licensed Vaccine Product, CureVac will notify the
Escrow Agent of the [*****] Target and the [*****] Targets, if any. The [*****] Target will count as a single
Reserved Target, however, [*****] Targets will not be counted against the total number of Reserved Targets available to
CureVac, provided, however, that the total number of [*****] Targets on the Reserved Target List: (i) subject to Base
Term Options cannot be more than [*****] at any time, of which not more than [*****] and (ii) subject to Extension
Term Options cannot be more than [*****] of which up to [*****] can be [*****]. For the avoidance of doubt, if CureVac
exercises an Option in respect of a License Agreement that includes  [*****] Targets, the number of [*****] Targets
on the Reserved Target List reduces respectively by the number of [*****] Targets included in such License
Agreement.”

 

		2.2	Section 4.4 of the Development and Option
                                         Agreement is hereby replaced in its entirety with the following amended Section:

 

“4.4 Fees.

 

(a) Target
Reservation and Maintenance Fees. CureVac will pay to Acuitas the fees shown below per Contract Year for each Reserved
Target added to the Reserved Target List pursuant to Section 4.2 as a non-exclusive Target:

 

		(i)	[*****]; and

 

		(ii)	[*****]; and

 

		(iii)	[*****]; or

 

		(iv)	[*****].

 

or the fees shown below per Contract Year for each
Reserved Target added to the Reserved Target List pursuant to Section 4.2 as an exclusive Target:

 

		(v)	[*****]; and

 

    3 

     

    

 

		(vi)	[*****]; and

 

		(vii)	[*****].

 

In the case of Targets for Vaccines, instead
of the fees set forth in (i) to (vii) above, CureVac will pay to Acuitas the fees shown below per Contract Year for each non-exclusively
Reserved [*****] Target added to the Reserved Target List pursuant to Section 4.2 together with each associated [*****] Target:

 

		(viii)	[*****]; and

 

		(ix)	[*****]; and

 

		(x)	[*****].

 

		(xi)	[*****].

 

or the fees shown below per
Contract Year for each exclusively Reserved [*****] Target added to the Reserved Target List pursuant to Section 4.2 together
with each associated [*****] Target:

 

		(xii)	[*****]; and

 

		(xiii)	[*****]; and

 

		(xiv)	[*****].”

 

    4 

     

    

 

Section Three.

Amendment of Article
5 of the Development and Option Agreement.

 

		3.1	Section 5.1 of the Development and Option
                                         Agreement is hereby replaced in its entirety with the following amended Section:

 

“5.1 Options.
From the period commencing on the Effective Date and ending on the expiration of the Term (the "Option Period"),
on a Reserved Target by Reserved Target basis, CureVac will have: (i) options originating from those granted during the Base Term
(each a "Base Term Option), to enter into a maximum of [*****] License Agreements; and (ii) options originating
from those granted during the Extension Term (each an “Extension Term Option”) to enter into a maximum of an
additional [*****] Extension Term License Agreements in each case, under the Acuitas LNP Technology with respect to Licensed
Product(s) containing mRNA Construct(s) intended to express such Reserved Targets in the applicable form (non-exclusive or exclusive
as the case may be for Base Term Options and non-exclusive for Extension Term Options) set forth in Exhibit 1.54 and Exhibit 1.31,
provided that the Exhibits to such template agreements are to be prepared or updated in accordance with the terms of the respective
License Agreement and this Agreement. In the event CureVac opts for an exclusive license of a Reserved Target for Licensed Vaccine
Products, the exercise notice will identify the [*****] Target and the [*****] Target(s), if any, and the exclusivity
will apply with respect to the [*****] Target only. Such license will cover any combination of the [*****] Target, with
or without and with one or several of the [*****] Targets, if any. CureVac may exercise each such Option by providing to
Acuitas, prior to the expiration of the Term, written notice of Option exercise, setting forth the particular Reserved Target
which is intended to be expressed by the Licensed Products (each such notice, an "Option Notice"). A separate
Option Notice and Option Exercise Fee will be required for each License Agreement with respect to which CureVac exercises an Option
pursuant to this Section 5.1, and CureVac will pay to Acuitas the Option Exercise Fee for each such License Agreement as set forth
in Section 5.3. If not exercised prior to the expiration of the Term, the Options granted to CureVac under this Article 5 with
respect to all Licensed Products will terminate in full and will no longer be exercisable. In the event that, during the Term,
CureVac terminates a license(s) granted during the Base Term other than an Exchange License as set forth in Section 5.4, the Target(s)
subject to the license(s) will be removed from the Reserved Target List and CureVac may during the Term replace such Target(s)
on the Reserved Target List in accordance with Article 4 and may during the Term exercise a Base Term Option to take a license
to such Target(s) in accordance with this Article 5, provided, however, that if CureVac terminates such license(s) and
replaces such Target(s) during the Term, CureVac may only take a Non-exclusive License Agreement, and the financial terms applicable
for an Extension Term License Agreement shall apply mutatis mutandis. In the event that CureVac terminates an Extension
Term License Agreement(s) during the Extension Term, the Target(s) subject to the Extension Term License Agreement(s) will be
removed from the Reserved Target List and CureVac may during the Extension Term replace such Target(s) on the Reserved Target
List in accordance with Article 4 and may during the Extension Term exercise an Extension Term Option to take a Non-exclusive
License Agreement to such Target(s) in accordance with this Article 5. For clarity no more than [*****] Base Term active
License Agreements and no more than [*****] Extension Term active License Agreements can be held at any one time. For avoidance
of doubt, milestones and fees paid with respect to any license that is terminated will not be creditable against any future Option
exercise.”

 

		3.2	A new Section 5.5 is hereby appended
                                         to the end of Article 5 of the Development and Option Agreement as follows:

 

“5.5 Extension Term Technology Access
Fee. CureVac will pay to Acuitas a technology access fee for the Extension Term equal to Three Million Dollars (U.S. $3,000,000)
payable within thirty (30) days of the Amendment Three Effective Date and Two Hundred and Fifty Thousand Dollars (U.S. $250,000)
per Extension Term Option within [*****] of the first and second anniversaries of the Extension Term Start Date for each
of the Extension Term Options not yet exercised on such anniversary.”

 

    5 

     

    

 

Section Four.

Amendment of Article
9 of the Development and Option Agreement

 

Section 9.1 of the Development and Option Agreement is hereby
replaced in its entirety with the following amended Section:

 

“9.1 Term. This
Agreement will commence as of the Effective Date and, unless sooner terminated or extended in accordance with the terms hereof
or by mutual written consent, will continue for a period of nine (9) years (the "Term").”

 

Section Five.

Amendment of the
Exhibit 1.54 of the Development and Option Agreement

 

		5.1	Section 4.1 of Exhibit 1.54 of the Development
                                         and Option Agreement is hereby replaced in its entirety with the following amended Section,
                                         but only in respect of each Non-exclusive License Agreement that results from an exercise
                                         of an Extension Term Option.

 

“4.1 Milestone
Payments. Subject to any crediting as set forth in Section 4.2b, CureVac will make milestone payments (each, a
 "Milestone Payment") to Acuitas upon the first occurrence of each of the milestone events (each, a
 "Milestone Event") by Licensed Product as set forth below in the respective table of this Section 4.1, as is
applicable to whether the respective Licensed Product is a Licensed Vaccine Product or not. CureVac will notify Acuitas of
the achievement of each Milestone Event within [*****] of such achievement. Each Milestone Payment will be payable to
Acuitas by CureVac within [*****] of the achievement of the specified Milestone Event and receipt of a respective
invoice from Acuitas, and such payments when owed or paid will be non-refundable and non-creditable. If one or more of the
Milestone Events set forth below are not achieved or not required for any reason, the payment for such skipped Milestone
Event will be due [*****]. The maximum total of all Milestone Payments for all Licensed Products that all are not Licensed
Vaccine Products payable under this License Agreement is U.S.$ [*****]. The maximum total of all Milestone Payments
for all Licensed Products that all are Licensed Vaccine Products payable under this License Agreement is U.S.$ [*****], provided, however, that such maximum amounts do not apply in the event CureVac elects the Alternative
Royalty, as set forth below.

 

	Milestone
    Event for Licensed Products not	Milestone
    Payment
	being
    Licensed Vaccine Products	 
	[*****]	[*****]
	[*****]	[*****]

 

    6 

     

    

 

	Milestone
    Event for Licensed Products not	Milestone
    Payment
	being
    Licensed Vaccine Products	 
	[*****]	[*****]
	[*****]	[*****]
	[*****]	[*****]

 

	Milestone
    Event for Licensed Vaccine Products	Milestone
    Payment
	[*****]	[*****]
	[*****]	[*****]
	[*****]	[*****]
	[*****]	[*****]
	[*****]	[*****]
	 	”

 

		5.2	A new Section 4.2b is hereby added
                                         after Section 4.2 of Exhibit 1.54 of the Development and Option Agreement as follows,
                                         but only in respect of each Non-exclusive License Agreement that results from an exercise
                                         of an Extension Term Option.

 

“4.2b License
Maintenance Fee. On the [*****] anniversary of the Effective Date, and on each of the next [*****] subsequent
anniversaries thereof, Acuitas shall be due a license maintenance fee from CureVac, for
maintaining the license for [*****] starting on such anniversary, in an amount
of: (i) [*****] (U.S. $[*****]) per year for this License Agreement being in respect of Licensed Product that is not
Licensed Vaccine Product; or (ii) [*****] (U.S. $[*****]) per year for this License
Agreement being in respect of Licensed Product that is Licensed Vaccine Product (each, a “License
Maintenance Fee”); provided however, that in each case no such License Maintenance Fee shall be due or
payable [*****]. Any License Maintenance Fees due under this License Agreement
will be payable to Acuitas by CureVac within [*****] of receipt of a respective
invoice from Acuitas issued within [*****] of the respective anniversary, and
any and all such License Maintenance Fees actually paid will be creditable, up to a maximum amount of: (a) [*****]
(U.S. $[*****]) for Licensed Product that is not Licensed Vaccine Product; or (b) [*****] (U.S. $[*****] for
Licensed Product that is Licensed Vaccine Product, in each case against the Milestone Payment payable under this
License Agreement in respect of the [*****].”

 

    7

     

    

 

		5.3	Section 4.3(a) of Exhibit 1.54 of the
                                         Development and Option Agreement is hereby replaced in its entirety with the following
                                         amended Section, but only in respect of each Non-exclusive License Agreement that results
                                         from an exercise of an Extension Term Option.

 

“(a) Royalty. Subject
to the remainder of this Section 4.3, on a country-by-country basis and a Covered Product-by-Covered Product basis, "Covered
Product" being a Licensed Product which is Covered by one or more Valid Claims, CureVac will pay to Acuitas a royalty
of [*****] ([*****]%) of Net Sales of the Covered Product that is not a Licensed
Vaccine Product, or will pay to Acuitas a royalty of  [*****] ([*****]%) of Net Sales
for the Covered Product that is a Licensed Vaccine Product. On a country-by-country basis, in the event a Licensed Product
is not a Covered Product in such country, CureVac will pay to Acuitas a royalty on Net Sales equal to the Minimum Royalty set
forth in subsection (c) below.”

 

		5.4	Section 4.3(c) of Exhibit 1.54 of the
                                         Development and Option Agreement is hereby replaced in its entirety with the following
                                         amended Section, but only in respect of each Non-exclusive License Agreement that results
                                         from an exercise of an Extension Term Option.

 

“(c)
Minimum Royalty. Except as set forth in subsection (d) below, in no event will the Royalty payable by CureVac to Acuitas
for any Licensed Product (whether or not a Covered Product) be less than: (i) [*****] ([*****]%)
for any Licensed Product that is not a Licensed Vaccine Product; (ii) or  [*****]
([*****]%) for any Licensed Product that is a Licensed Vaccine Product.”

 

		5.5	Section 4.3(d) of Exhibit 1.54 of the
                                         Development and Option Agreement is hereby replaced in its entirety with the following
                                         amended Section, but only in respect of each Non-exclusive License Agreement that results
                                         from an exercise of an Extension Term Option.

 

“(d)
Alternative Royalty. If CureVac sublicenses a Licensed Product to a Sublicensee, CureVac may elect to substitute the royalty
payments set forth in subparagraphs (a) and (c) above for alternative royalty payments consisting of all of the payments set forth
in this subparagraph (d) (each or collectively, as applicable, the “Alternative Royalty/ies”). CureVac will
be entitled to make such election by providing Acuitas with written notice thereof within [*****]
of the effective date of the respective sublicense, and cannot change such election afterwards, provided that if CureVac
grants several sublicenses under a License Agreement, such election can be made separately for each sublicense.

 

(i)     
Sublicensee Royalties. CureVac will pay to Acuitas, on a Calendar Quarter-by-Calendar Quarter basis,  [*****]
([*****]%) of the net royalty payments that CureVac actually receives from such Sublicensee for net sales of Licensed Product
under the sublicense hereunder after any deductions for royalties CureVac actually pays under any license agreement for Technology
that Covers a Licensed Product and CureVac or its Affiliate or Sublicensee, in its reasonable judgment, considers it necessary
or useful to obtain a license to develop, manufacture or commercialize such Licensed Product (“Revised Royalty”).
CureVac warrants to Acuitas that it will use commercially reasonable efforts to maximize royalties in sublicensing transactions
in which it elects to pay Alternative Royalties.

 

    8

     

    

 

(ii)     
Sublicensee Upfront Payments. In the event that CureVac elects to take a Revised Royalty, CureVac will, in addition to
the Revised Royalty, pay Acuitas [*****] ([*****]%) of the Upfront Payments actually
received by CureVac from such Sublicensee for such sublicense rights. “Upfront Payments” means the [*****].

 

(iii)     
Sublicensee Sales-based Milestones. In addition, in the event and to the extent such sublicense hereunder includes Sales-based
Milestones for Licensed Product, CureVac will pay to Acuitas  [*****] ([*****]%) of
such sales-based milestones as CureVac actually receives from such Sublicensee. “Sales-based Milestones” means
milestone payment based on net sales, units sold, market share or any other commercial measure.”

 

(iv)     
For avoidance of doubt, if CureVac elects Alternative Royalties for a Third Party sublicense with respect to Licensed Products,
the Revised Royalty, the Upfront Payments and the Sales-based Milestones will include all royalty, upfront payments and sales
based milestones received by CureVac from such Sublicensee for such Licensed Products, including royalty and upfront payments
made in consideration for the license to the CureVac Technology required for the Licensed Products subject to the Alternative
Royalty.

 

		5.6	Section 4.4(c) of Exhibit 1.54 of the
                                         Development and Option Agreement is amended by appending the following text to its end,
                                         but only in respect of each Non-exclusive License Agreement that results from an exercise
                                         of an Extension Term Option or exercise of a Base Term Option for which financial terms
                                         of an Extension Term License Agreement apply.

 

“In the event that CureVac
elects to substitute the royalties payments set forth in subparagraphs (a) and (c) of Section 4.3 above for the Alternative Royalty,
then (x) in addition to the foregoing reporting obligations, CureVac shall (a) furnish Acuitas an alternative written report (“Alternative
Report”) for each Calendar Quarter showing the amount of Revised Royalty, Upfront Payment and/or Sales-based Milestones
(as applicable) received from the respective Sublicensee and the Alterative Royalty due for such Calendar Quarter and (b) a reasonably
redacted copy of such sublicense agreement as set forth in Section 2.3(b)(ii), but disclosing all financial terms. Alternative
Reports shall be provided within [*****] of the end of the Calendar Quarter for which
any Alternative Royalties are due; and (y) notwithstanding the foregoing payment obligation, instead, Alternative Royalty payments
for each such Calendar Quarter shall be due at the same time as the Alternative Reports for such Calendar Quarter.”

 

    9

     

    

 

		5.7	For clarity, any Non-exclusive License
                                         Agreement for which Base Term Option license financial terms apply, Article 4 of Exhibit
                                         1.54 of the Development and Option Agreement shall remain in the form as set forth in
                                         Article 4 of Exhibit 1.54 of the Development and Option Agreement on the Effective Date.

 

Section Six.

Amendment of the
definition of “Sublicensee” in each of Exhibits 1.31, 1.54 of the Development and 

Option Agreement and each License Agreement

 

		6.1	Each of: (i) definition 1.52 of Exhibit
                                         1.31 of the Development and Option Agreement; (ii) definition 1.52 of Exhibit 1.54 of
                                         the Development and Option Agreement; and (iii) definition 1.52 of each and all License
                                         Agreements entered into between the Parties prior to the Amendment Three Effective Date
                                         is hereby replaced in its entirety with the following amended definition:

 

“1.52 “Sublicensee”
means any Third Party that is granted a sublicense as permitted by Section 2.3, either directly by CureVac or its Affiliates or
indirectly by any other Sublicensee hereunder.”

 

Section Seven.

Miscellaneous.

 

Except as amended hereby, all other provisions
of the Development and Option Agreement (including Exhibit 1.54 thereof) shall remain unchanged and in full force and effect in
accordance with their terms. In the event of a conflict between the terms and conditions of this Amendment and the terms and conditions
of the Development and Option Agreement, the terms and conditions of this Amendment shall control.

 

This Amendment may be executed simultaneously
in two (2) or more counterparts, and by PDF or other electronic transmission, each of which counterparts shall be deemed an original,
but all of which together shall constitute one and the same instrument, provided that all such counterparts, in the aggregate,
shall contain the signatures of all parties hereto.

 

[Signature page to
follow]

 

    10

     

    

 

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

 

CUREVAC
AG

 

	By:	/s/ [*****]	 	 
	 	 	 	 
	 	(Signature)	 	 
	 	 	 	 
	Name:	[*****]	 	 
	 	 	 	 
	Title:	[*****]	 	 

 

	By:	/s/ [*****]	 	 
	 	(Signature)	 	 
	 	 	 	           
	Name:	[*****]	 	 
	 	 	 	 
	Title:	[*****]	 	 

 

ACUITAS THERAPEUTICS
INC.

 

	By:	/s/ [*****]	 
	 	(Signature)	 	 
	 	 	               	               
	Name:	[*****]	 	 
	 	 	 	 
	Title:	[*****]	 	 

 

    11Exhibit 10.48

REDACTED 

Certain
identified information, indicated by [*****], has been excluded from the exhibit because it is both (i) not material and (ii)
would likely cause competitive harm if publicly disclosed.

 

 

Amendment Number 1

To the "Framework Partnering
Agreement" Dated 15 February 2019

 

(CEPI Identification #: [•])

 

Summary

 

	COUNTERPARTY
    INFORMATION
	Name:	CureVac AG (“Partner”)
	Mailing
    Address:	[*****]
	Project
    Lead:	[*****]
	Management
    Contact:	[*****]

 

	CEPI
    INFORMATION
	Name:	Coalition
    for Epidemic Preparedness Innovations ("CEPI")
	Mailing
    Address:	PO
    Box 123 Torshov, N-0412 Oslo, Norway
	Visiting
    Address:	Marcus
    Thranes gate 2, N-0412 Oslo, Norway
	Project
    Lead:	[*****]
	Management
    Contact:	[*****]

 

	AMENDMENT
    AGREEMENT INFORMATION
	Project
    Name	Vaccine
    Platform Development
	CEPI
    Programme Name	 
	Effective
    Date	Date
    of last signature below
	This
    Amendment:	The
    Amendment Number 1 means this Summary sheet together with the following pages.

     

     

    

 

THIS AMENDMENT NUMBER 1 is made
by and between Partner and CEPI, either of which may be referred to individually as a "Party" and together as the "Parties."

 

Recitals:

 

		A.	This
                                         Amendment Number 1 amends the Framework. Partnering Agreement between the Parties having
                                         an effective date of 15 February 2019 ("FPA").

 

		B.	The
                                         Parties wish to make certain amendments to the FPA to facilitate the development and
                                         commercialization of Partner's COVID-19 vaccine candidate ("CVnCoV"), the initial
                                         development of which is described in the "Work Package Statement for the Development
                                         of CureVac Outbreak Response to Novel Coronovirus (2019-nCoV)" having an effective
                                         date of 29 January 2020. For convenience, this Work Package is referred to as the
                                         "CVnCoV Work Package."

 

		C.	The
                                         Parties contemplate that Partner shall negotiate and sign one or more agreements to provide
                                         CVnCoV to organizations operating under the auspices of the COVAX Facility. Such organizations
                                         presently include Gavi and UNICEF.

 

		D.	The
                                         FPA is amended as follows only for CVnCoV. For the avoidance of doubt, the following
                                         amendments shall not be applicable to any vaccine covered by the FPA other than CVnCoV
                                         and shall not be applicable to the results of any Work Package other than the CVnCoV
                                         Work Package.

 

Agreement:

 

		1.	Trusted
                                         Manufacturers. The FPA provisions related to trusted manufacturers in Clauses 7.6
                                         (Trusted Manufacturers), 7.7 (Partner Nominees for Trusted Manufacturers), 7.8 (CEPI
                                         Nominees for Trusted Manufacturers), 7.9 (Additional Trusted Manufacturers) and 7.10
                                         (Disputes as to Trusted Manufacturers) as well as Section 7.5 (Meetings with Regulatory
                                         Authorities) are waived for CVnCoV. For the avoidance of doubt, Partner maintains the
                                         full right to partner the vaccine for further development (i.e., beyond the CVnCoV Work
                                         Package), manufacture, distribution and commercialisation subject only to Partner's various
                                         obligations in this Amendment Number 1 and the FPA.

 

		2.	Reporting
                                         Requirements. The FPA provisions related quarterly reports in Clause 7.11.5 (Quarterly
                                         Reports) are waived for CVnCoV. Notwithstanding the foregoing, Partner shall submit an
                                         annual report. In lieu of the obligations under Section 7.5, Partner shall inform
                                         CEPI of the outcome of any major meetings with Regulatory Authorities, and any significant
                                         communications from Regulatory Authorities relating to the Platform and/or CVnCoV.

 

		3.	Notification
                                         and Approval of Additional Funders. The FPA provisions related to notification and
                                         prior written consent requirement of CEPI regarding other funders and supporters in Clause
                                         7.11.10 (Partner Funder Requirements) and Clause 3.11 (Third Party funding or support
                                         of the Project) are waived for CVnCoV.
	 	 	 

  

    2

     

    

 

		4.	Achieving Equitable
Access. A new Section 7.11.16 (Achieving Equitable Access) is added after Clause 7.11.15 (Regulatory Filings - which
is waived for CVnCoV) to apply only for CVnCoV:

 

"7.11.16.     Achieving
Equitable Access for Utilization of CVnCoV.

 

		(i)	Equitable
                                         access commitments of Partner pursuant to Clause 7.11.9 (iv) to (vi) shall
                                         be considered to be fulfilled upon (a) the timely, and good faith participation
                                         in the 2021 UNICEF/PAHO tender, and any subsequent corresponding tender for 2022 and
                                         2023 (if applicable); and (b) if such tenders are successful, supply of Partner's
                                         capacity for distribution of CVnCoV vaccine based on the following terms:

-      For
2021 10%, through participation in the currently ongoing UNICEF/PAHO tender process;

-      For
2022 and 2023 (if applicable) 15%, through participation in the applicable COVAX process (i.e., Gavi/UNICEF/PAHO, as applicable)

with a priority towards Gavi/LICs, and at tiered prices, in both cases as may be agreed in the tender
process.

 

		(ii)	Partner
                                         to participate in the ongoing UNICEF/PAHO tender to secure up to [*****] doses of COVID vaccine
                                         in 2021. Of Partner's planned total capacity for distribution of CVnCoV vaccines in 2021
                                         (est. [*****] mds.), 10% allocation (est. [*****] mds.) to the UNICEF/PAHO tender starting in
                                         Q3 2021.

 

		(iii)	For
                                         the avoidance of doubt, the definitive number of doses and pricing for the supply of
                                         the CVnCoV vaccine shall be as determined by agreement between Partner and Gavi/UNICEF/PAHO,
                                         and will be no higher than the lowest price charged by Partner for the sale of CVnCoV
                                         vaccines to a third party of a similar volume and to a country of similar income level.

 

		(iv)	Proposed
                                         pricing by Partner for negotiations with Gavi/UNICEF/PAHO for
supply in 2021:

-      [*****]

-      [*****]

-      [*****]

-      [*****]

 

		(v)	Supply
                                         of CVnCoV vaccines in 2022 based on the same principles, but providing up to 15% of Partner's
                                         capacity for distribution of CVnCoV vaccine (est. [*****] mds.), at the same pricing as 2021.

    3

     

    

 

	 	(vi)	Partner makes no supply commitments beyond 2022, except as may be agreed between Partner and Gavi/UNICEF/PAHO.
	 	 	 
		(vii)	The
                                         commitment to participate in the tender / negotiate with Gavi/UNICEF/PAHO Facility shall
                                         remain binding on Partner through [*****] and continue as long as good faith
                                         negotiations between the parties continue.

 

		(viii)	Terms
                                         and conditions of supply of CVnCoV doses must be made in a timely manner that enables
                                         COVAX represented economies to receive the vaccine as soon as reasonably possible after
                                         receipt of Marketing Authorization, respecting Partner's existing contractual obligations,
                                         and latest [*****]. Partner will equally respect its supply commitments
                                         towards its customers that receive CVnCoV on a [*****],
                                         both with respect to timing and completeness of commitments.

 

		(ix)	Distribution
                                         of CVnCoV doses shall be made to any and all country income levels based upon COVAX country
                                         participation and associated allocation model.

 

		(x)	For
                                         the avoidance of doubt, Partner is otherwise is free to dispose of the remaining doses
                                         of CVnCoV in its sole discretion.

 

		5.	Approvals
                                         for Contractors and Subcontractors. The FPA provisions related to approvals by the
                                         JMAG for the use of contractors and subcontractors in Clause 10.1 (Contractors and Sub-Contrators)
                                         are waived for CVnCoV.

 

		6.	Public
                                         Health License. The FPA provisions related to the public health license in Sections
                                         11 (Public Health License) and 12 (Conditions Precedent and Exercise of the Public Health
                                         License) are waived for CVnCoV.

 

		7.	Commercial
                                         Benefit Sharing. The FPA provisions related to the sharing of commercial benefits
                                         in Section 13 (Commercial Benefits Arising from Commercial Use) are waived for CVnCoV.

 

		8.	No
                                         Additional Funding from CEPI. For the avoidance of doubt, CEPI will not provide any
                                         additional funding beyond the previously agreed $15.3M for the CVnCoV Work Package.

 

Save as
set out above, all terms and conditions of the FPA shall remain unchanged and shall remain in full force and effect.

    4

     

    

 

Signed for and on behalf of COALITION
FOR EPIDEMIC PREPAREDNESS INNOVATIONS by:

 

 

	Signature:	[*****]	 
	 	 	 
	Name:	[*****]	 
	 	 	 
	Title:	[*****]	 
	 	 	 
	Date:	December 11, 2020	 
	 	 	 
	 	 	 
	Signed for and on behalf of CureVac AG by:	 
	 	 	 
	Signature:	[*****]	 
	 	 	 
	Name:	[*****]	 
	 	 	 
	Title:	[*****]	 
	 	 	 
	Date:	December 11, 2020	 
	 	 	 
	Signed for and on behalf of CureVac AG by:
	 
	 	 	 
	Signature:	[*****]	 
	 	 	 
	Name:	[*****]	 
	 	 	 
	Title:	[*****]	 
	 	 	 
	Date:	December 11, 2020	 

    5

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