Document:

AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

Exhibit 10.5

 

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 NO. 2 TO THE

 

EXCLUSIVE COLLABORATION AND LICENSE
AGREEMENT

 

by and between

 

CureVac
AG (formerly CureVac GmbH), a German limited liability company with offices at Paul-Ehrlich-Str. 15, 72076
Tübingen, Germany ("CureVac"), and

 

Boehringer
Ingelheim International GmbH, a German limited liability company with offices at Binger Straße 173, 55216
Ingelheim am Rhein, Germany ("BI").

 

WHEREAS,
the Parties entered into that certain Exclusive Collaboration and License Agreement effective as of August 21, 2014 (the
 "Original Agreement"), as amended by the first amendment
effective as of June 30, 2015 (the "Amendment No. 1") (the Original
Agreement, as amended by Amendment No. 1, the "Agreement");

 

WHEREAS, the Parties wish to exchange
the target product profiles described in the Agreement due to changes in the NSCLC treatment landscape and subsequent
adaptation in the development strategy;

 

WHEREAS, the Parties wish to clarify certain
matters relating to the Development of CV9202;

 

NOW, THEREFORE, the Parties hereby agree
as follows:

 

		1.	Definitions. Terms defined in this Amendment No.
                                                                                                                                                 2 are used with those meanings in this Amendment No. 2. Terms not defined in this Amendment No. 2 are used with the meanings
                                                                                                                                                 as defined in the Agreement.

 

		2.	Diligence. Section 4.2.3 of the Agreement is hereby
replaced in its entirety as follows:

 

"Provided that CureVac has
delivered to BI or BI’s CRO the following amounts of Clinical Trial supply

 

[*****]

 

BI
shall initiate the clinical development with CV9202 in combination with a checkpoint inhibitor [*****] (the "Checkpoint
Inhibitor Vaccine") in a Phase 1/11 Clinical Trial in stage IV NSCLC (other than a Clinical Trial
sponsored by LICR) and not terminate or halt the Nonclinical and Clinical Development unless there are substantial and
reasonable technical, safety, efficacy and/or regulatory reasons for doing so, and details of such technical safety,
efficacy and/or regulatory have been notified to CureVac in writing through the JSC.”

 

		3.	CV9202 Development Plan. The Parties agree that
                                                                                                                                                 Exhibit 4.2 to the Agreement is hereby replaced in its entirety by Exhibit 4.2 attached to this Amendment No. 2. For
                                                                                                                                                 clarity, no decision or confirmation by the JSC is required for this amendment of the CV9202 Development Plan. However, the
                                                                                                                                                 JSC is entitled to review, validate, modify, update and amend the amended CV9202 Development Plan, as set forth in Article 8
                                                                                                                                                 of the Agreement.

 

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	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

		4.	Development and Regulatory Milestone Payments for the First Indication.
Section 7.3.1 of the Agreement is hereby replaced in its entirety as follows:

 

"Development and Regulatory
Milestone Payments for the First Indication (on the Effective Date expected to be [*****]

 

[*****]

 

Provided,
however, that if BI suspends the Development of the Checkpoint Inhibitor Vaccine and/or the Chemo-Radiation
Vaccine and replaces such TPP by another TPP, the applicable above milestone payments under (a) to (e) shall be payable for
the other TPP replacing the replaced TPP. For the avoidance of doubt, milestone payments already paid for the Development of
a TPP prior to suspension shall not be payable for the other TPP replacing the replaced TPP.

 

		5.	Commercial Supply Waiver. The deadline set forth
                                                                                                                                                 in Section 6.2(b) of the Agreement until which CureVac has the right to waive its right and obligation to Manufacture all
                                                                                                                                                 Licensed Vaccines for the Commercialization of the Licensed Products (the "Commercial
                                                                                                                                                 Supply Waiver") by notifying BI of such waiver in writing on or before [*****] is hereby extended
                                                                                                                                                 until [*****] CureVac shall use Commercially Reasonable Efforts to provide sufficient funds and personnel resources to be
                                                                                                                                                 allocated for (i) the construction and qualification of a [*****] pilot plant in CureVac’s current site (GMP III)
                                                                                                                                                 and (ii) the construction and qualification of the new [*****] plant (GMP IV).

 

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	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

		6.	Commercial Supply Agreement. The deadline set
                                                                                                                                                 forth in Section 6.2 of the Agreement until which the Parties shall negotiate in good faith commercially reasonable terms and
                                                                                                                                                 conditions of a commercial supply agreement and conclude such commercial supply agreement in accordance with the terms
                                                                                                                                                 and conditions of the binding term sheet attached to the Agreement as Exhibit 6.2B, unless CureVac is providing timely
                                                                                                                                                 notice of waiver as set forth in Section 6.2(b) of the Agreement, is hereby extended until [*****] Such supply
                                                                                                                                                 agreement shall include that CureVac shall reserve manufacturing slots for a total amount of [*****] mRNA in the years
                                                                                                                                                 [*****] ([*****] for initial market supplies.

 

		7.	mRNA Manufacturing Information. To enable BI to
                                                                                                                                                 prepare for a potential future GMP Manufacturing of Licensed Vaccines by a BI Affiliate or a Permitted Third Party CMO (as
                                                                                                                                                 defined in Section 6.3.2 of the Agreement), CureVac shall provide the required (i.e., required for the aforementioned
                                                                                                                                                 purpose), transparent and up-to-date information to BI regarding its mRNA Manufacturing technology for the Licensed Vaccines,
                                                                                                                                                 including: CureVac shall (i) deliver to BI, on or before [*****], the documents, information and data set forth in Exhibit
                                                                                                                                                 6.2C to this Amendment No. 2, (ii) provide to BI on a Calendar Quarterly basis updates with respect to changes to its
                                                                                                                                                 mRNA Manufacturing technology (if any), and (iii) make reasonably available at no cost to BI 4 FTE for one day per Calendar
                                                                                                                                                 Quarter (i.e., with further FTE days to be reimbursed to CureVac) for BI’s questions with respect to the mRNA
                                                                                                                                                 Manufacturing technology and to obtain a response to those questions in a reasonable timely manner; provided, however, that
                                                                                                                                                 any further support, including site visits and trainings will be compensated at the FTE Rate. Further, BI will reimburse
                                                                                                                                                 CureVac’s reasonable out of pocket expenses with respect to such visits and trainings. In the event CureVac does
                                                                                                                                                 not exercise the Commercial Supply Waiver within the prescribed time and achieves all milestone events set forth
                                                                                                                                                 under Section 6.3.1(b) of the Agreement, then, upon CureVac’s request, BI shall
                                                                                                                                                 return or destroy, as instructed by CureVac, all Confidential Information of CureVac set forth above and confirm such
                                                                                                                                                 return or destruction in writing to CureVac, save that BI may retain copies of such CureVac’s Confidential
                                                                                                                                                 Information as set forth in Section 10.5 of the Agreement.

 

		8.	Confidentiality.
                                         Section 4.3 sentence 9 of the Agreement ("In addition to the obligations under Section
                                         10 below, BI shall ensure that such CMC Development- and/or Manufacturing-related documentation,
                                         data and reports are not circulated within BI’s and BI’s Affiliates’
                                         organizations except as required for the purposes mentioned in the foregoing sentence.")
                                         is hereby deleted. The Parties acknowledge and agree that, as a result of the aforementioned
                                         deletion, the side letter to the Agreement dated February 3, 2015 ceases to apply. For
                                         clarity, all CMC Development- and/or Manufacturing-related documentation, data and information,
                                         remain subject to the confidentiality obligations under Section 10 of this Agreement.

 

		9.	Plasmid DNA as Precursor for Licensed Vaccines. Section 6.4
of the Agreement is hereby replaced in its entirety as follows:

 

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	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

"The
Parties agree that CureVac will source plasmid DNA needed as a precursor for the Manufacture of Licensed Vaccines for Phase III
Clinical Trials and commercial supply from Lonza AG or an Affiliate of Lonza AG (Lonza AG and its Affiliates "Lonza")
as first supplier for plasmid DNA needed for Phase III Clinical Trials supply and as first or second supplier for plasmid
DNA needed for commercial supply, under a manufacturing process to be developed by Lonza, or, if Lonza is not available for such
sourcing, by another competent CMO. CureVac shall use Commercially Reasonable Efforts that appropriate supply agreements between
Lonza or such other CMO and CureVac for the precursor for the Manufacture of the Licensed Vaccines will be in place (anticipated
deadline for supply agreement for Phase III: [*****] anticipated deadline for commercial supply agreement: [*****] If CureVac
exercises the Commercial Supply Waiver, BI shall have the right to request that BI will assume all of such CureVac’s rights
and obligations (Vertragsübernahme) under the two supply agreements between CureVac and Lonza, and CureVac shall use
Commercially Reasonable Efforts to procure Lonza’s consent thereto."

 

		10.	Changes to Amendment No. 1. Sections 3, 10 and 11 of Amendment No. 1 are hereby
                                                                 deleted in their entireties.

 

		11.	Full Force and Effect. The Parties confirm that the Agreement, as amended by this
                                                                 Amendment No. 2, is in full force and effect.

 

		12.	Amendment Effective Date. This Amendment No. 2 shall enter into force on August 1,
                                                                 2016.

 

Signature page follows.

 

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	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

IN
WITNESS WHEREOF, the Parties have caused this Amendment No. 2 to be executed by their duly authorized representatives.
This Amendment No. 2 may be executed in one or more counterparts, each of which will be deemed an original, but all of which will
constitute but one and the same instrument.

 

	CUREVAC
    AG	 	BOEHRINGER
        INGELHEIM

         

        INTERNATIONAL
        GMBH

         

	Date:  1.8.16	 	Date:  
	 	 	 
	 	 	ppa.
	 	 	 
	By:	/s/
Dr. Florian von der Mülbe
	 	By:	/s/
Jürgen Beck           

	 	 	 	 	 
	Name:  Dr.
    Florian von der Mülbe	 	Name:
    Jürgen Beck
	 	 	 
	Title:  Chief
    Operating Officer	 	Title:
    Authorized Signatory

 

	ppa.	 	ppa.
	 	 	 
	By:	/s/
Dr. Mariola Fotin-Mleczek
	 	By:	/s/
Dorothee Schwall-Rudolph

	 	 	 	 	 
	Name:  Dr.
    Mariola Fotin-Mleczek	 	Name:
    Dorothee Schwall-Rudolph
	 	 	 
	Title:  Chief
    Scientific Officer	 	Title:
    Authorized Signatory

 

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	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

Exhibit
4.2: CV9202 Development Plan

 

[*****]

 

    6

     

    

 

	AMENDMENT NO. 2 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT 	CONFIDENTIAL

 

Exhibit
6.2C: mRNA Manufacturing Information to Be Provided by CureVac

 

[*****]

 

    7Exhibit 10.6

 

CONFIDENTIAL

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 NO. 3 TO THE

 

EXCLUSIVE COLLABORATION AND LICENSE
AGREEMENT

 

by and between

  

CureVac AG (formerly CureVac GmbH),
a German corporation with offices at Paul-Ehrlich-Str. 15, 72076 Tübingen, Germany ("CureVac"), and

 

Boehringer Ingelheim International GmbH,
a German limited liability company with offices at Binger Straβe 173, 55216 Ingelheim am Rhein, Germany ("BI").

  

WHEREAS, the Parties entered into that
certain Exclusive Collaboration and License Agreement effective as of August 21, 2014 (the "Original Agreement"),
as amended by the first amendment effective as of June 30, 2015 (the "Amendment No. 1") and by the second amendment
effective as of August 1, 2016 (the "Amendment No. 2") (the Original Agreement, as amended by Amendment No. 1
and Amendment No. 2, the "Agreement");

 

WHEREAS, the Parties agree that [*****]
militate in favor of adapting the Development strategy for CV9202 (B11361849);

 

WHEREAS, CureVac chose not to exercise
the waiver set forth in Section 6.2(b) of the Agreement; consequently CureVac has the right and the obligation to Manufacture all
Licensed Vaccines for the Commercialization of the Licensed Products;

 

WHEREAS, the Parties wish to clarify certain
matters relating to the Development of CV9202 (BI1361849);

 

NOW, THEREFORE, the Parties hereby agree
as follows:

  

		1.	Definitions. Terms defined in this Amendment No. 3 are used with those meanings in this
Amendment No. 3. Terms not defined in this Amendment No. 3 are used with the meanings as defined in the Agreement.

 

		2.	Diligence. Section 4.2.3 of the Agreement is hereby deleted in its entirety.

 

		3.	CV9202 Development Plan. The Parties agree that Exhibit 4.2 to the Agreement is hereby replaced
in its entirety by Exhibit 4.2 attached to this Amendment No. 3.

 

For clarity, no decision or
confirmation by the JSC is required for this amendment of the CV9202 Development Plan. However, the JSC is entitled to review,
validate, modify, update and amend the amended CV9202 Development Plan, as set forth in Article 8 of the Agreement.

 

		4.	Phase III Clinical Supply Agreement. The deadline set forth in Section 6.2 of the Agreement
until which the Parties shall negotiate in good faith commercially reasonable terms and conditions

 

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CONFIDENTIAL 

of an amendment to the Clinical
Supply Agreement and conclude such amendment in order to cover Phase III Clinical Trial supply in accordance with the terms and
conditions of the binding term sheet attached to the Agreement as Exhibit 6.2A is hereby extended until [*****].

 

		5.	Commercial Supply Agreement. The deadline set forth in Section 6.2 of the Agreement until
which the Parties shall negotiate in good faith commercially reasonable terms and conditions of a commercial supply agreement and
conclude such commercial supply agreement in accordance with the terms and conditions of the binding term sheet attached to the
Agreement as Exhibit 6.2B is hereby extended until the date that is [*****] after the last patient has been dosed for the
first time in the ongoing Clinical Trial sponsored by LICR (“Last Patient In”). At least [*****] prior
to then to be expected Last Patient In (as set forth in the then-current CV9202 Development Plan) the Parties shall commence negotiations
for the Commercial Supply Agreement. In addition, the Parties shall conclude an amendment to the existing term sheet for commercial
supply (Exhibit 6.2B to the Agreement) until [*****]. Further, CureVac shall provide a plan, to be updated at each JSC meeting,
how CureVac will achieve manufacturing readiness in accordance with the CV9202 Development Plan and to ensure compatibility with
CV9202 project planning at BI. The Commercial Supply Agreement shall include that CureVac shall reserve manufacturing slots for
the estimated total amounts of mRNA as shown in the table below:

 

[*****]

 

		6.	Section 6.3.1(b) Milestones.

 

Section 6.3.1(b) of the Agreement
is hereby replaced in its entirety as follows:

 

		“(b)	fails to achieve any one of the following milestone events

 

		(i)	the JSC decides on achievement of process lock for drug substance (mRNA) development at [*****];

 

		(ii)	the EMA and the FDA accept the comparability of the [*****] to the existing [*****] Manufacturing
process at CureVac's pilot plant on or before [*****] or any later point in time if so delayed by the JSC or such delay is caused
by BI internal processes;

 

		(iii)	the competent health authority (at present: Regierungspräsidum Tübingen) approves
the GMP IV facility on or before [*****]; or

 

		(iv)	the JSC decides on successful completion of drug substance and drug product engineering runs on
or before [*****].

 

	 	7.	Manufacturing Information. Subject to Section 6.3.1 in order to enable BI to prepare for a potential future GMP Manufacturing
of Licensed Vaccines by a BI Affiliate or a Permitted Third Party CMO (as defined in Section 6.3.2 of the Agreement), Section
7 of Amendment No. 2 provides that CureVac shall provide to BI the required (i.e., required for the aforementioned purpose), transparent
and up-to-date information regarding its mRNA Manufacturing technology for the Licensed Vaccines. The Parties agree that the aforementioned
obligation also includes the provision of the following documents, information and data to BI which CureVac shall provide to BI
within [*****] after one of the conditions set forth in Section 6.3.1 has been met, the following documents to the extent they
are available as of the date of the aforementioned condition is met;documents are not available to the extent they are subject
to confidentiality or license restrictions precluding CureVac from disclosing the information contained in such documents to BI:

 

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CONFIDENTIAL

 

		·	Qualitative and quantitative composition final drug product/drug product intermediates
	 	 	 
		·	Raw material/Excipient functionality, specification, quality/grade and suppliers
	 	 	 
		·	Raw material/Excipient/starting material/drug substance/drug product/packaging material: testing procedure, incl. parameters,
methods and equipment
	 	 	 
		·	Raw material/Excipient/starting material/drug substance/drug product/packaging material: storage and stability information
	 	 	 
		·	Presentation of finished drug product (parameters, appearance, packaging materials)
	 	 	 
		·	Description of manufacturing process (master cell bank, plasmid vectors, pDNA, mRNA drug substance and drug product)
	 	 	 
		·	Manufacturing equipment (pDNA, mRNA drug product)
	 	 	 
		·	Essential requirements for manufacturing process/equipment, e.g. special layout of manufacturing area, measures to avoid cross-contamination,
in-process controls during manufacturing.

 

		8.	Scope of Exclusive License. For the avoidance of doubt, during the term of the Agreement
and subject to CureVac’s right to perform its obligations under the Agreement, CureVac will not grant any license under CureVac
Licensed Intellectual Property to any Third Party for the Development or Commercialization of a Licensed Vaccine regardless of
whether the Licensed Vaccine is protamine-complexed or otherwise formulated.

 

		9.	PharmaJet Device. At BI’s request, CureVac and BI shall enter into good faith negotiations
and conclude an agreement under which CureVac grants to BI a non-exclusive sublicense, for the Development and Commercialization
of Licensed Vaccines, under the licenses granted to CureVac under that certain License and Supply Agreement by and between CureVac
and PharmaJet Inc. effective as of January 14, 2013. The parties will also discuss in good faith alternative routes of licensing,
such as a direct license by BI from PharmaJet.

 

		10.	Consulting Support for Commercial Facility. BI’s consulting support for CureVac’s
commercial facility as outlined in Section 6 of Amendment No. 1 is deemed completed. In case further critical topics relating to
CureVac’s commercial facility arise both Parties will discuss whether to resume the consultancy in defined support areas.
Any consultancy resumption requires a unanimous decision of the JSC to be documented in meeting minutes.

 

		11.	Full Force and Effect. The Parties confirm that the Agreement, as amended by this Amendment
No. 3, is in full force and effect.

 

		12.	Amendment Effective Date. This Amendment No. 3 shall enter into force on [*****].

 

Signature page follows.

  

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CONFIDENTIAL

 

IN WITNESS WHEREOF, the Parties have caused
this Amendment No. 3 to be executed by their duly authorized representatives. This Amendment No. 3 may be executed in one or more
counterparts, each of which will be deemed an original, but all of which will constitute but one and the same instrument.

 

	CUREVAC AG	 	BOEHRINGER INGELHEIM

INTERNATIONAL GMBH
	 	 	 
	Date: July 17, 2019	 	Date: August 9, 2019
	 	 	 
	 	 	ppa.
	 	 	 
	By:	/s/ Florian von der Mülbe	 	By:	/s/ Jochen Gann
	 	 	 	 	 
	Name:	Florian von der Mülbe	 	Name:	Jochen Gann
	 	 	 	 	 
	Title:	Chief Production Officer	 	
        Title:
	Authorized Signatory

         

        August 08, 2019

         

	ppa.	 	ppa.
	 	 	 
	By:	/s/ Franz-Werner Haas	 	By:	/s/ Dorothee Schwall-Rudolph
	 	 	 	 	 
	Name:	Franz-Werner Haas	 	Name:	Dorothee Schwall-Rudolph
	 	 	 	 	 
	Title:	Chief Operating Officer	 	Title:	Authorized Signatory

  

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CONFIDENTIAL

Exhibit 4.2: CV9202 Development
Plan

 

[*****]

  

    5

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