Exhibit 10.4


 


	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	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. 1 TO THE


 


EXCLUSIVE COLLABORATION AND LICENSE
AGREEMENT


 


by and between


 


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 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 ("Agreement");


 


WHEREAS, the Parties acknowledge that certain
developments subsequent to the Agreement’s Effective Date, [*****] necessitate changes to the setup of the Clinical Trials
combining CV9202 and chemo-radiotherapy set forth in the CV9202 Development Plan;


 


WHEREAS, the Parties acknowledge that implementing
the above-mentioned changes to the setup of the Clinical Trials might have a significant impact on the time point of the milestone
payments set forth in Section 7.3 of the Agreement;


 


WHEREAS, the Parties desire to reiterate
and strengthen their common aspiration that CureVac will continue to progress the CMC Development and Manufacture of the Licensed
Vaccines;


 


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



 


		2.	CV9202 Development Plan. CureVac agrees that Exhibit 4.2 to the Agreement is hereby replaced
in its entirety by Exhibit 4.2 attached to this Amendment No. 1. 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.



 


		3.	[*****] Milestone Payment. Sections 7.3.1(c) and 7.3.1(d) of the Agreement are replaced
in their entirety as follows:



 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


		"(c)	[*****]



 


[*****]


 


		(d)	[*****]



 


[*****];"


 


		4.	New CMC Development Milestone Payments. New Section 7.3.3 is added to the Agreement as follows:



 


"CMC Development Milestone
Payments:


 


		(a)	Upon the earlier of [*****]



 


[*****];


 


		(b)	Upon the earlier of (i) [*****]



 


[*****].


 


For clarity, if CureVac achieves
the milestone event set forth in Section 7.3.1(d) prior to achieving the milestone events under Section 7.3.3, the milestone payments
under Sections 7.3.1(d), 7.3.3(a) and under Section 7.3.3(b) will all become payable with achieving milestone event under Section
7.3.1(d), [*****] The milestone events under Sections 7.3.3(a) and 7.3.3(b) only lead to separate payments if they occur prior
the achievement of the milestone event under Section 7.3.1(d). For further clarity, none of the two (2) milestone payments set
forth in this Section 7.3.3 is payable more than once."


 


		5.	Financial Manufacturing Support. Both Parties agree to find an appropriate financial solution
for the significant delay of the milestone payment for [*****] due to the revised CV9202 Development Plan to allow CureVac to further
invest in connection with the CMC Development and/or the construction of the commercial-scale production facility in which Licensed
Vaccines would be Manufactured ("Financial Manufacturing Support"). BI and CureVac will negotiate in good faith
and agree until [*****] on the terms and conditions of such Financial Manufacturing Support ([*****]). The terms and conditions
will provide that the Financial Manufacturing Support will be provided by BI earliest on [*****] and only (i) upon CureVac's written
request, (ii) if no Change of Control has occurred and (iii) CureVac continues its CMC Development activities as foreseen in the
CV9202 Development Plan and there are no reasonable grounds for BI to believe that CureVac is unable or unwilling to successfully
complete these CMC Development activities.



 


		6.	Consulting Support for Commercial Facility. CureVac has already asked and may ask BI for
consulting support relating to (i) the upgrade of CureVac's current manufacturing plant to a pilot plant (including scale-up of
the mRNA manufacturing process) and (ii) the construction of CureVac's future commercial-scale production facility in which Licensed
Vaccines would be Manufactured. In such case BI shall, at no cost to CureVac, provide all or parts of the asked for consulting
support to CureVac. With respect to such consulting support rendered after the Effective Date, (i) BI makes no representation or
warranty (express, implied, statutory or otherwise), (ii) Section 12.2 of the Agreement does not apply, and (iii) notwithstanding
Section 11.4 of the Agreement, BI's liability (whether based on contract, tort or otherwise) is limited to intentional acts, provided
that nothing in this Section 6 of this Amendment No. 1 excludes or limits liability for cases for which a limitation of liability
is not possible under Applicable Laws.



 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


		7.	Immunomonitoring. Phase I/II Clinical Trials and Phase II Clinical Trials immunomonitoring
services by CureVac are considered fee-for-service work packages. The Parties acknowledge that within the scope of this fee-for-service
work some of CureVac's immunomonitoring Know-How needs to be transferred to BI in order to enable BI to set up the study support
for the Clinical Trials appropriately. Exhibit 7A to this Amendment No. 1 lists the immunomonitoring technical documentation
to be provided by CureVac to BI. BI experts will work together with CureVac on a validation plan, a sample analysis plan and fulfillment
of GCP requirements. In addition, BI has the right to perform quality control checks of the immunomonitoring measurements. The
required activities are defined in more detail in the updated CV9202 Development Plan. If CureVac cannot provide the required capacity
for a potential immunomonitoring program for Phase III Clinical Trials, BI has the right to request transfer by CureVac of the
required immunomonitoring methods to a reasonably acceptable Third Party CRO to be selected by the Joint Project Team. The working
hours of CureVac personnel for such method transfer shall be reimbursed by BI at the FTE Rates in accordance with a budget to be
set forth in the CV9202 Development Plan.



 


		8.	Regulatory Matters. In accordance with Section 4.3 of the Agreement, the Parties’
respective responsibilities and the costs relating to regulatory matters are further clarified in Exhibit 4.3A attached
to this Amendment No. 1.



 


		9.	Pharmacovigilance. The last sentence of Section 5.3 of the Agreement is replaced as follows:



 


"Detailed pharmacovigilance
responsibilities and obligations are set forth in the pharmacovigilance agreement by and between the Parties effective as of [*****]."


 


		10.	Phase ID Clinical Supply and Commercial Supply. The deadlines set forth in Section 6.2 of
the Agreement until which the Parties shall (i) negotiate in good faith commercially reasonable terms and conditions 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 and (ii) 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, each of (i) and (ii) unless CureVac
is providing notice of waiver as set forth in Section 6.2 (a) or (b) before or during such negotiations, are hereby extended until
[*****].



 


		11.	Plasmid DNA as Precursor for Licensed Vaccines. The deadlines set forth in Section 6.4 of
the Agreement are hereby extended until [*****].



 


		12.	Full Force and Effect. The Parties confirm that the Agreement, as amended by this Amendment
No. 1, is in full force and effect.



 


		13.	Amendment Effective Date. This Amendment No. 1 shall enter into force on June 30, 2015.



 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


IN WITNESS WHEREOF, the Parties have caused
this Amendment to be executed by their duly authorized representatives. This Amendment 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 GMBH	 	BOEHRINGER INGELHEIM



INTERNATIONAL GMBH
	Date: 09.07.2015	 	Date: June 30, 2015
	 	 	ppa.
	By:	/s/ Dr. Florian von der Mülbe	 	By:	/s/ Dr. Jochen Gann
	Name:	Dr. Florian von der Mülbe	 	Name:	Dr. Jochen Gann
	Title:	COO	 	Title:	Corp. Vice President


 


	ppa.	 	ppa.
	By:	/s/ Dr. Franz-Werner Haas	 	By:	/s/ Dr. Martin Schwarz
	Name:	Dr. Franz-Werner Haas	 	Name:	Dr. Martin Schwarz
	Title:	CCO	 	Title:	Corp. Vice President


 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


Exhibit 4.2: CV9202 Development
Plan


 


[*****]


 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


Exhibit 4.3A


 


[Untitled list of tasks]


 


[*****]


 






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	AMENDMENT NO. 1 TO EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT	CONFIDENTIAL


 


Exhibit 7A:


 


[*****]


 






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