Document:

Exhibit 10.6.1

 

FIRST AMENDMENT TO DISTRIBUTION AGREEMENT

 

This First Amendment to Distribution Agreement, made as of
this 2nd day of October, 2019 (the “Effective Date”), is by and between Fresenius Medical Care Holdings,
Inc. (“Fresenius”) and Humacyte, Inc. (“Humacyte”) (collectively, the “Parties”).

 

WHEREAS, the Parties are parties to that Distribution
Agreement dated June 25, 2018 (the “Agreement”); and

 

WHEREAS, the Parties wish to amend the Agreement pursuant
to the terms and conditions described herein.

 

NOW, THEREFORE, in consideration of the mutual covenants
contained herein, the Parties agree to amend the Agreement as follows:

 

		1.	Section 2.2.1 of the Agreement is hereby deleted in its entirety and replaced by the following as of the Effective Date:

 

“2.2.1 Composition.
Each Party will appoint [***] to the JSC, with each representative [***]. As of the Effective Date, as defined
in the First Amendment to Distribution Agreement, such representatives are as follows:

 

	
        Humacyte Appointees:

        [***]
	
        Fresenius Appointees:

        [***]

 

The Humacyte [***]. The JSC may change its
size from time to time by consent of the Parties, provided that the JSC will consist at all times of an equal number of representatives
of each Party. [***] The JSC may invite non-members to participate in the discussions and meetings of the JSC, but such
participants will have no voting authority at the JSC and must be bound under written obligations of confidentiality no less protective
of the Parties’ Confidential Information than those set forth in this Agreement. The JSC will be co-chaired, with one (1)
chairperson designated by each Party, whose responsibilities will include conducting meetings, including, when feasible, ensuring
that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JSC will alternate between
the chairpersons from meeting-to-meeting, with Fresenius’ chairperson running the first meeting. The chairperson for a particular
meeting will prepare and circulate agendas in advance thereof and will ensure the preparation and approval of minutes for such
meeting. The chairpersons have no additional powers or rights beyond those held by the other JSC representatives.”

 

		2.	Except as otherwise amended by the terms herein, all terms and conditions of the Agreement shall remain in full force and effect
and are hereby affirmed and ratified.

 

IN WITNESS WHEREOF, the Parties have executed this First
Amendment to Distribution Agreement on the dates shown below.

 

     

     

    

 

	FRESENIUS:	 	HUMACYTE:
	 	 	 
	Fresenius Medical Care Holdings, Inc.	 	Humacyte, Inc.
	 	 	 	 	 
	By:	/s/ William Valle	 	By:	/s/ Jeffrey Lawson 
	Name:	William Valle	 	Name:	Jeffrey Lawson
	Its:	President	 	Its:	CEO
	 	 	 	 	 
	Date: 	10/7/19	 	Date:	October 2, 2019Exhibit 10.6.2

 

SECOND AMENDMENT TO DISTRIBUTION AGREEMENT

 

This SECOND AMENDMENT
TO DISTRIBUTION AGREEMENT (this “Second Amendment”), entered into as of February 16, 2021 (the “Second
Amendment Date”), and effective as of the Second Amendment Date, is made and entered into by and between Fresenius Medical
Care Holdings, Inc., a corporation organized and existing
under the Laws of the State of New York (“Fresenius”), and Humacyte, Inc., a corporation organized and existing
under the Laws of the State of Delaware (“Humacyte”).

 

WHEREAS, Fresenius
and Humacyte entered into that certain Distribution Agreement, effective as of June 25, 2018 (the “Original Agreement”),
as amended by that certain First Amendment, dated as of October 2, 2019 (the “First Amendment”);

 

WHEREAS, the term “Agreement”
where used in the Original Agreement and this Second Amendment, is deemed inclusive of the Original Agreement as amended by the
First Amendment and this Second Amendment; and

 

WHEREAS, Fresenius
and Humacyte each wish to amend and update certain aspects of the Agreement.

 

NOW, THEREFORE, in
consideration of the mutual covenants and obligations set forth out in this Second Amendment and other good and valuable consideration,
the sufficiency of which are acknowledged, the parties to this Second Amendment agree as follows:

 

		1.	Definitions; Cross References.

 

		1.1	All terms not expressly defined or modified in this Second Amendment shall have the meaning ascribed
therefor in the Agreement.

 

		1.2	Unless otherwise indicated, all references to Sections and Articles herein are references to the
corresponding Section or Article of the Agreement.

 

		2.	Certain Agreements and Amendments of the Agreement.

 

		2.1	The following definitions are hereby deleted from Article 1 in their entirety: [***], “Listed
Countries”, [***], “Specified Payors”, “US Promotion Contingencies”, “US
Promotion Diligence Obligation” and “US Team Diligence Obligation”.

 

		2.2	The following terms in Article 1 and as used throughout the Agreement are hereby revised to remove
references to “/Japan” from the terms and the corresponding definitions: “EU/Japan”, “EU/Japan
Development Report”, “EU/Japan Development Term”, “EU/Japan Launch Date”, and “EU/Japan
Plans”.

 

		2.3	The definition “Additional Product Distribution Agreements” in Article 1 is
hereby amended by replacing “worldwide distribution rights” with “distribution rights in the Territory”.

 

    

    

    

 

		2.4	The definition of “EU” in Article 1 is hereby deleted in its entirety and replaced
with the following definition:

 

““EU”
means the European Union, together with the United Kingdom of Great Britain and Northern Ireland.”

 

		2.5	The definition of “European Union” in Article 1 is hereby deleted in its entirety
and replaced with the following definition:

 

““European Union”
means the economic, scientific and political organization of member states as it may be constituted from time to time, which as
of the Effective Date consists of Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany,
Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia,
Spain, Sweden and that certain portion of Cyprus included in such organization.”

 

		2.6	The definition of “Field” in Article 1 is hereby deleted in its entirety and
replaced with the following definition:

 

““Field”
means vascular creation, repair, replacement, or reconstruction. For clarity, the “Field” does not include coronary
artery bypass graft, pediatric heart surgery, or adhering pancreatic islet cells onto the outer surface of the Distribution Product
for use in diabetic patients.”

 

		2.7	The definition “Follow-On Distribution Agreement” in Article 1 is hereby amended
by replacing “worldwide distribution rights” with “distribution rights in the Territory”.

 

		2.8	The definition of [***] in Article 1 is hereby deleted in its entirety and replaced with the following
definition:

 

[***]

 

		2.9	The definition of “ROW” in Article 1 is hereby deleted in its entirety and replaced
with the following definition:

 

““ROW”
means all territories and countries of the world other than the EU, the United States, and the Terminated Territory.”

 

		2.10	The definition of “Territory” in Article 1 is hereby deleted in its entirety
and replaced by the following definition:

 

““Territory”
means the EU and ROW, but, for clarity, in all cases excluding any country that is in the Terminated Territory.”

 

		2.11	The definition of [***] in Article 1 is hereby deleted in its entirety and replaced with
the following definition:

 

[***]

 

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		2.12	The definition of “US Launch Date” in Article 1 is hereby amended by adding
[***] before [***] and by deleting [***] and [***] and the remainder of such definition.

 

		2.13	Section 2.1 is hereby deleted in its entirety and replaced with the following:

 

“Overview.
Except as otherwise expressly set forth in this Agreement, Fresenius will be the exclusive distributor of the Distribution Product
in the Field throughout the Territory. Humacyte will Develop the Distribution Product and seek Regulatory Approval therefor in
the US and EU and Fresenius will Develop the Distribution Product and seek Regulatory Approval therefor in the ROW, all in accordance
with this Agreement. Except as otherwise set forth in this Agreement, Humacyte will be responsible for all Commercialization of
the Distribution Product in the US and Fresenius will be responsible for all Commercialization of the Distribution Product in the
Field in the Territory. The Parties anticipate entering into a country specific license and distribution agreement for each country
in the Territory in which Fresenius will Commercialize the Distribution Product, as and to the extent needed or reasonably requested
by a Party to address country specific terms or requirements (including the General Data Protection Regulation); any such agreement
will be substantially similar to the terms of this Agreement, mutatis mutandis.”

 

		2.14	In Section 2.2.2.4, the phrase “in the Territory” is hereby deleted in its entirety.

 

		2.15	In Section 2.2.2.6, the phrase [***] is hereby deleted and replaced with [***].

 

		2.16	Section 2.2.2.8 is hereby deleted in its entirety and replaced with “Reserved.”.

 

		2.17	The following text is hereby added to the end of Section 3.1:

 

“Humacyte will [***] Develop
and Commercialize the Distribution Product in the United States. Fresenius will [***] provide reasonable support to collaborate
with Humacyte in its Commercialization of the Distribution Product in the Field in the United States, including adoption of the
Distribution Product as a standard of care in patients for which such use is supported by superior clinical results and health
economic analyses, through collaboration with the [***] and introductions to procurement specialists for its [***] businesses.”

 

		2.18	Section 4.2 is hereby deleted in its entirety and replaced with the following:

 

“Communications with US
Regulatory Authorities. Humacyte will provide the JSC for its review and discussion a brief description in English of the principal
issues raised in each Material Communication with Regulatory Authorities in the US with respect to the Distribution Product in
the Field. Humacyte will provide such descriptions of such Material Communications to the JSC within [***] after
receipt thereof. With respect to any Material Communication with a Regulatory Authority in the US related to the Distribution Product
in the Field, Humacyte will allow Fresenius a reasonable opportunity to review and comment on such proposed response to such Material
Communication in advance of the transmission of such response, and Humacyte will reasonably consider all comments timely provided
by Fresenius in connection therewith but shall be under no obligation to follow any recommendations or satisfy any requests contained
in such comments.”

 

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		2.19	Section 5.1.1 is hereby deleted in its entirety and replaced with the following:

 

[***]

 

		2.20	In Section 5.2.1, the phrase “each Listed Country in the EU/Japan [***] is hereby deleted
and replaced with “the EU”.

 

		2.21	The third sentence of Section 5.2.1 is hereby deleted in its entirety and replaced with the following:

 

“For each
of the countries contemplated by Section 5.2.3, the Parties will each use Commercially Reasonable Efforts to achieve the
Market Entry Criteria with respect to such country, provided that [***] (a) if the Distribution Product is eligible [***] (b) if
the Distribution Product is [***].”

 

		2.22	Section 5.2.3 is hereby deleted in its entirety and replaced with the following:

 

“For each
country in the EU for which the Market Entry Criteria are satisfied, and for any country in the EU for which the Market Entry Criteria
are not satisfied but with respect to which the Parties mutually agree in writing to conduct the activities contemplated by this
Section 5.2.3, in each case, Humacyte will be responsible for, and will use Commercially Reasonable Efforts to conduct,
the Market Entry Activities for such country other than Market Entry Activities relating to Pricing Approval, and Fresenius will
be responsible for, and will use Commercially Reasonable Efforts to conduct, the Market Entry Activities for such country relating
to Pricing Approvals. Notwithstanding the foregoing, [***].”

 

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		2.23	Section 6.3.1 is hereby deleted in its entirety and replaced with the following:

 

“Humacyte
will notify Fresenius within [***] of Humacyte’s receipt of any meeting, visit or inspection notice from any Regulatory Authority
in the EU pertaining to the Distribution Product in the Field [***] on a country-by-country basis [***].”

 

		2.24	Section 7.1.1 is hereby deleted in its entirety and replaced with the following:

 

[***]

 

		2.25	The second and third sentences of Section 7.2.1 are hereby deleted in their entirety and replaced
with the following:

 

“Fresenius
will be responsible for drafting the business plans and economic models for Developing and Commercializing the Distribution Product
in the Field in the ROW (the “ROW Plans”). The Parties will each use Commercially Reasonable Efforts to achieve
the Market Entry Criteria with respect to each country in the ROW.”

  

		2.26	In Section 7.2.2, the phrase [***] is hereby deleted and replaced with [***].

 

		2.27	The phrase [***] in each of Sections 8.3.1 and 8.3.2 shall be replaced in each instance with [***].

 

		2.28	Section 9.1.2.1 is hereby deleted in its entirety and replaced with the following:

 

“Fresenius
will be solely responsible for all Commercialization activities in the Field in the Territory for the Distribution Product, including
setting all re-sale prices for Distribution Product in the Territory, handling all returns, order processing, invoicing and collection,
booking of sales, inventory and receivables, and managed and government pricing programs; provided that Fresenius will carry out
Commercialization activities, whether itself or through a Third Party, in each country in the Territory in a manner and pursuant
to arrangements consistent with Fresenius’ ordinary course of business in such country [***].”

 

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		2.29	Sections 9.1.2.4, 9.1.3, 9.3.2 and 9.3.3 are hereby deleted in their entirety and replaced with
“Reserved.”.

 

		2.30	Section 9.4.1 is hereby deleted in its entirety and replaced with the following:

 

“Branding. Humacyte
will lead and develop (and thereafter modify and update) a Branding Strategy for the Distribution Product in the Field in the US.
Fresenius will lead and develop (and thereafter modify and update) a Branding Strategy for the Distribution Product in the Field
in the Territory. Fresenius’ Branding Strategy may include using in the tradename of the Distribution Product the mark chosen
by Humacyte for use in the tradename of the Distribution Product in the Field in the US [***].”

 

		2.31	Schedule 9.4.2 and all references thereto are hereby deleted in their entirety.

 

		2.32	Section 9.4.2 is hereby amended by deleting the second sentence thereof in its entirety.

 

		2.33	Section 9.4.3.2 is hereby deleted in its entirety and replaced with the following:

 

“Humacyte will not produce
marketing materials for the Distribution Product in the Field in the Territory. Humacyte will be solely responsible for its Branding
Strategy and for producing marketing materials for the Distribution Product in the United States. Fresenius will provide reasonable
support, including data, to assist Humacyte in the development of health economic support with respect to the Distribution Product
in the United States with the goal of obtaining reimbursement for the Distribution Product in the United States in the Field.”

  

		2.34	Sections 9.6 and 9.7 are hereby deleted in their entirety and replaced with “Reserved.”.

 

		2.35	The following is hereby added as a new Section 9.10, immediately following Section 9.9.5:

 

“Humacyte
Obligations. Humacyte will conduct Commercialization activities in the United States in the Field in accordance with Section
9.9, mutatis mutandis, but only to the extent such Laws and standards of conduct apply to the Commercialization of the
Distribution Product in the United States.”

 

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		2.36	Section 10.1.1 is hereby deleted in its entirety and replaced with the following:

 

“Royalties to Fresenius.
Humacyte will make royalty payments to Fresenius based on [***] of the Distribution Product in the United States in the Field [***]
with the rates set forth in the table below.

 

	Time Period	Royalty Rate on Net Sales
	Until such time that Humacyte has paid to Fresenius a total of [***] in royalty payments pursuant to this Section 10.1.1	[***]
	After Humacyte has paid to Fresenius a total of [***] in royalty payments pursuant to this Section 10.1.1	[***]

 

The Parties acknowledge that for
purposes of this Section 10.1.1, the definition of Net Sales shall apply to Humacyte, mutatis mutandis, where, for
clarity, (a) [***] (b) [***].

 

All such royalty payments to Fresenius
are, in part, consideration for Fresenius’ activities under the Agreement prior to the Second Amendment Date and are in lieu
of any other consideration with respect to the Commercialization of the Distribution Product and any Additional Products in the
US.”

 

		2.37	Section 10.1.5 is hereby amended by adding [***] after [***] and [***].

 

		2.38	The terms of Section 10.2 (as amended by this Amendment) shall apply to both Parties, mutatis
mutandis.

 

		2.39	Section 10.2.3 is hereby deleted in its entirety and replaced with “Reserved.”.

 

		2.40	Section 11.1 is hereby deleted in its entirety and replaced with the following:

  

“Manufacturing Responsibilities.
Humacyte will be solely responsible for Manufacturing (or having Manufactured) all Distribution Product and will [***] Manufacture
(or have Manufactured) Distribution Product in sufficient quantities as required for completion of the activities contemplated
under this Agreement, including (a) for the performance of all Development activities, including all Clinical Studies, and (b)
Fresenius’ sales projections for the Distribution Product in the Field [***]. Humacyte will Manufacture all Distribution
Product to be supplied hereunder at the Facility. Each Unit of Distribution Product delivered to Fresenius will have a remaining
shelf life at delivery not less than [***].”

  

		2.41	Section 11.3.1 is hereby deleted in its entirety and replaced with “Reserved.”.

 

		2.42	Section 11.3.2 is hereby deleted in its entirety and replaced with the following:

 

“Forecasts
for Ex-US. Prior to launching the Distribution Product in a country in the Ex-US, the Parties will agree on the forecast requirements
and order fulfillment requirements for such country.”

 

		2.43	Section 11.4 is hereby deleted in its entirety and replaced with the following:

 

“Shortages. Without
limiting any other rights or remedies that the Parties may have hereunder, in the event of a shortage of (a) any capacity or materials
required to Manufacture Distribution Product or (b) Distribution Product, Humacyte will allocate the available capacity, materials
or Distribution Product, in each case ((a) or (b)), in proportion to the [***]. Prior to the first Launch Date in the Territory,
Humacyte will, for each raw material needed to Manufacture the Distribution Product in the Field, [***] either (a) at least [***]
such raw material to Humacyte or (b) [***] for such raw material under which [***] for the manufacture of such raw material.”

 

		2.44	Section 11.5 is hereby deleted in its entirety and replaced with the following:

 

“Facility Capacity.
From the date that is [***] the first Launch Date in the Territory, and at all times during the Term thereafter, Humacyte will
have the annual capacity to produce, [***] at the Facility, such number of Units of Distribution Product that would accommodate
the greater of the [***] or the [***].

 

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		2.45	Section 11.9 is hereby amended by deleting clause (a) in its entirety and replacing it with “(a)
[***] and”.

 

		2.46	Section 12.1.1 is hereby amended by deleting clause (b) in its entirety and replacing it with “(b)
Humacyte will retain those rights under such (sub)license grant for Humacyte and its Related Parties to Commercialize the Distribution
Product in the Territory solely to support Commercialization of the Distribution Product in the US.”.

 

		2.47	Section 12.2.1 is hereby deleted in its entirety and replaced with “Reserved.”.

  

		2.48	Section 12.2.2 is hereby deleted in its entirety and replaced with the following:

 

“Subject to the terms and
conditions of this Agreement, Fresenius hereby grants Humacyte a non-exclusive, non-transferable (except as provided in Section 18.1),
sublicensable (in accordance with Section 12.3) license (including a right of reference) under the Fresenius Technology
solely to Develop and Manufacture the Distribution Product in the Field anywhere in the world for sale to the Selling Parties in
the Territory.”

 

		2.49	Sections 12.6.1 and 12.6.2 are hereby amended by (a) replacing “worldwide” with “Ex-US”,
and (b) inserting [***] after the word [***] in each instance.

 

		2.50	The following text is hereby added to the end of Section 12.6.2:

 

“This Section
12.6.2 will apply on a [***] basis.”

 

		2.51	The word “and” in Section 15.1(b) is hereby deleted and replaced with “or”.

 

		2.52	Sections 16.4.1.2, 16.5.2.1 and 16.5.3 are hereby amended by deleting “in the Territory”
in each instance.

 

		2.53	Section 17.1 is hereby amended by deleting the following phrase:

 

“; provided
that if at any time from or after the third (3rd) anniversary of the US Launch Date, (i) the Term for all countries in which there
has then occurred a Launch Date has expired, (ii) neither Party has determined that the Market Entry Criteria are satisfied with
respect to any additional country and (iii) the Parties have not otherwise agreed to conduct the Market Entry Activities with respect
to any additional country, then this Agreement will expire in its entirety.”

 

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		2.54	Section 17.2.1 is hereby deleted in its entirety and replaced with “Reserved.”.

 

		2.55	Section 17.8 is hereby deleted in its entirety and replaced with the following:

 

“Survival. In addition
to the termination consequences set forth in Section 17.7, those provisions that by their terms or intended effect
survive the expiration or termination of this Agreement shall so survive any expiration or termination of this Agreement and, in
addition and without limiting the foregoing, the following provisions shall survive expiration or termination of this Agreement
for any reason: Sections 1, 10.1.1, 10.2.4, 12.1.3, 13, 14.6.4 (but only with respect
to amounts due to Third Parties), 14.6.5 (but only with respect to amounts due to Third Parties), 14.6.10, 15,
16.2.3, 16.3.1, 16.4.3, 16.10 and 18. Expiration or termination of this Agreement for any reason
will not relieve the Parties of any liability or obligation which accrued hereunder prior to the effective date of such termination
or expiration, nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity, with
respect to any breach of this Agreement. For the avoidance of doubt, termination of this Agreement will not affect any SDEA, which
will continue to survive so long as any Distribution Product is being Commercialized.”

  

		2.56	Section 18.11 is hereby deleted in its entirety and replaced with the following:

 

“Compliance with Export
Regulations. Neither Party will export from the United States any technology licensed to it by the other Party under this Agreement
except in compliance with United States export Laws and regulations.”

 

		3.	Other Provisions.

 

		3.1	Both Parties hereby confirm that the Agreement is in full force and effect, including as modified
hereby.

 

		3.2	As amended hereby, the Agreement shall remain in full force and effect.

 

		3.3	This Second Amendment will be construed and the respective rights of the Parties determined in
accordance with the substantive Laws of the State of Delaware, notwithstanding any Laws governing conflicts of Laws to the contrary.

 

		3.4	This Second Amendment may be executed in two or more counterparts, including by facsimile of PDF
signature pages, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

 

(Signature page follows)

 

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IN WITNESS WHEREOF,
the Parties have caused this Second Amendment to Distribution Agreement to be executed by their duly authorized representatives
as of the Second Amendment Date.

 

	 	FRESENIUS MEDICAL CARE HOLDINGS, INC.
	 	 	 
	 	By:	/s/ Karen A. Gledhill
	 	Name:	Karen A. Gledhill
	 	Title:	Senior Vice President and General Counsel
	 	 	 
	 	Date: 	February 15, 2021
	 	 	 
	 	HUMACYTE, INC.
	 	 	 
	 	By:	/s/ Laura Niklason
	 	Name:  	Laura Niklason
	 	Title:  	President & CEO
	 	 	 
	 	Date:  	2/15/2021

 

 

 

[Signature Page to Second Amendment to Distribution
Agreement]

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