[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

Exhibit 10.1

 

AMENDMENT TO AMENDED AND RESTATED

MANUFACTURING AND SUPPLY AGREEMENT

 

THIS AMENDMENT TO AMENDED AND RESTATED MANUFACTURING AND SUPPLY AGREEMENT (this
“2018 Amendment”) is entered into by and between Fresenius Kabi Deutschland
GmbH, a company organized under the laws of Germany (together with its
affiliates “Fresenius Kabi”), and Cerus Corporation, a company organized under
the laws of Delaware (“Cerus”).  Fresenius Kabi and Cerus are sometimes referred
to herein as a “Party” and collectively as the “Parties.” This 2018 Amendment
shall be effective as of August 10, 2018 (the “Effective Date”).

WHEREAS, Cerus and Fresenius Kabi are parties to that certain Amended and
Restated Manufacturing and Supply Agreement dated July 1, 2015 (the
“Agreement”); and

WHEREAS, the Parties now wish to amend the Agreement in the manner set forth in
this 2018 Amendment.

NOW THEREFORE, in consideration of the premises and covenants set forth herein
and other good and valuable consideration, the receipt and sufficiency of which
is hereby acknowledged, Fresenius Kabi and Cerus agree as follows:

1.Defined Terms.  Unless otherwise defined herein, all capitalized terms used in
this 2018 Amendment shall have the same meaning as assigned to them in the
Agreement.

2.Transfer Price amendment.  The Parties agree to amend the Transfer Price grid
contained in Exhibit D-1 of the Agreement as follows:  

[*]  

3.Capacity.  

a.The parties acknowledge that once the [*] is operational and begins to [*],
Fresenius Kabi’s capacity limit is [*] annually (based on [*]) until [*] (the
“Capacity Constraint”). Cerus agrees that Fresenius Kabi shall not be deemed in
breach of this Agreement if Fresenius Kabi is unable to fulfill firm purchase
orders in excess of the Capacity Constraint; provided, however, that the Parties
will use commercially reasonable efforts to increase the Capacity Constraint to
[*] beginning for [*].

b.The following restriction on purchase order quantities set forth in Section
2.4 of the Agreement (the “Order Restriction”) shall be waived for [*]:

“With respect to the Sets, the [*] variation for the [*] constituting a firm
purchase order shall not be greater than [*] ordered for the applicable Set in
the preceding [*] period unless otherwise agreed to by the parties.”

c.Cerus shall provide to Fresenius Kabi on or prior to [*], a [*] forecast by
product code, of which the first [*], will constitute firm purchase orders for
Platelet Sets and Plasma Sets (the “Firm Purchase Orders”).  The Parties hereby
agree that any Sets ordered pursuant to the Firm Purchase Orders [*] Fresenius
Kabi [*] the Firm Purchase

 

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Orders [*] in one or more [*].  For the purposes of clarity and avoidance of
doubt, Cerus acknowledges that [*] in accordance with accepted Firm Purchase
Orders within [*].  Commencing [*], all firm purchase orders shall [*] based on
the preceding [*] period unless otherwise agreed to by the Parties.  Further,
the Parties agree that, subsequent to [*] shall be subject to [*].  

d.This 2018 Amendment shall not serve as evidence of Cerus’ reasonable
requirements for orders under the Agreement, but rather such requirements shall
be set forth in accordance with the terms of the Agreement.  Further, unless
specifically set forth herein, nothing contained in this 2018 Amendment shall be
deemed to obligate Fresenius Kabi to increase its overall supply obligations in
future periods.

4.[*].

a.Fresenius Kabi shall commence and [*] the purchase and installation of [*] at
the Facility [*].

b.If the aggregate number of Sets ordered pursuant to Cerus’ firm purchase
orders for the [*] period beginning with the first day of [*] below [*], then
Cerus will be obligated [*] to [*] via [*] due [*], which amount shall be set
forth in [*] to Cerus.

c.In the event that Cerus met the volume requirements set forth in Section 3.b.
above as of [*], but the aggregate number of Sets ordered pursuant to Cerus’
firm purchase orders for the [*] period beginning on [*] below [*], then Cerus
will be obligated to [*] via [*] due [*], which amount shall be set forth in [*]
to Cerus.

5.At Risk Containers.  In order to support increased demand, once sealing
validations are completed, Fresenius Kabi shall immediately commence
manufacturing bags on the [*] at the Facility, which the Parties hereby
acknowledge is prior to Cerus obtaining regulatory approvals thereof (the “At
Risk Containers”).  The Parties shall [*] of the At Risk Containers in the event
the At Risk Containers [*].  For the avoidance of doubt, nothing in this Section
5 shall obligate the Parties to manufacture Sets using the At Risk Containers
unless mutually agreed in writing by the Parties.  The quantity of At Risk
Containers to be manufactured will be mutually agreed upon in writing by Cerus
and Fresenius Kabi.  

6.Third-Party Component Inventory Management.   The Parties agree to negotiate
in good faith [*] Fresenius Kabi with respect to certain third-party sourced
components, as required for production of the Sets, that are held in Fresenius
Kabi’s inventory storage facility(ies).    

7.Section 9.6 payment acceleration.   Section 9.6 of the Agreement is replaced
in its entirety by the following provision:

“Section 9.6.  Milestone Payment.  Cerus shall make a one-time, lump sum payment
of €5.5 million to Fresenius Kabi by wire transfer no later than August 1,
2019.”

8.Reaffirmation.  Except as provided herein, the Agreement remains in full force
and effect in accordance with its original terms, except as expressly modified
hereby.

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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9.Counterparts. This 2018 Amendment may be executed in any number of
counterparts with the same effect as if all parties had signed the same
document, and all counterparts shall be construed together and shall constitute
the same instrument.

 

 

[Signature Page to Follow]

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by
their duly authorized representatives as of the date set forth below.

Fresenius Kabi Deutschland GmbH

 

By: /s/ Christian Hauer

 

Name:Christian Hauer

 

Title:President, Medical Devices Division, Managing Director

 

By: /s/ Dirk Röhner

 

Name:Dirk Röhner

 

Title:CFO, Senior Vice President Finance & HR Medical Devices Division, Managing
Director

 

Cerus Corporation

 

By: /s/ William M. Greenman

 

Name:William M. Greenman

 

Title:President and CEO

 

 

 

[*] = Certain confidential information contained in this document, marked by
brackets, has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.