Document:

cers-ex108_180.htm

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE CERUS CORPORATION HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO CERUS CORPORATION IF PUBLICLY DISCLOSED.

Exhibit 10.8

 

This Amendment #2 to the Amended and Restated Manufacturing and Supply Agreement (this “Amendment”) is made as of December 23, 2020, 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 the State of Delaware (“Cerus”). Each of the foregoing are parties to that certain Amended and Restated Manufacturing and Supply Agreement, effective as of July 1, 2015 (as amended, restated or otherwise modified, the “Agreement”).  Capitalized terms used herein and not otherwise defined shall have the meanings set forth therefor in the Agreement.  

Recitals

WHEREAS, the parties desire to amend the Agreement as provided in this Amendment; and  

WHEREAS, this Amendment is an amendment of the Agreement pursuant to and within the scope of Section 12.4 of the Agreement.

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, the Parties agree as follows:

1.The definition of the term “Funded Projects” is hereby amended in its entirety to read as follows:

 “Funded Projects” means the projects set forth on Exhibit F.

 

2.Section 2.2(c) of the Agreement is hereby amended in its entirety to read as follows:

Changes in Manufacturing Location. The Fresenius Kabi facility in La Châtre, France shall be the primary manufacturing site and product development support center for the Manufactured Products (the “Facility”). Fresenius Kabi will not make any change in its manufacturing location without Cerus’ prior written consent, which consent will not be unreasonably withheld or delayed, and, in any event, will not change any location until the new location is fully-qualified and licensed with each applicable Party’s regulatory group for the manufacture of the Manufactured Products for sale or clinical testing. Changes in manufacturing location include changes in manufacturing location for raw materials, components, subassemblies, or finished goods; changes in location or subcontractor for sterilization processes; and changes in chemical and physical facilities.  In the event that annual production volumes for a Manufactured Product reach [***] or more of the maximum annual production capacity for the Facility, as set forth in the Business 

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Continuity Plan Fresenius Kabi shall identify and qualify a second Fresenius Kabi facility with ISO 13485 certification and an FDA establishment license for the manufacture of the applicable Manufactured Product, which second facility shall have low overhead and labor costs associated with the manufacture of goods (the “Second Facility”).  The transfer pricing for Manufactured Products manufactured at such Second Facility shall be subject to mutual agreement by the Parties based on good faith discussions, taking into account Fresenius Kabi’s costs and cost savings, the effects of any efficiencies realized as a result, any amortization of capital equipment costs incurred and contemplated by Section 4.4(c) hereof, and such other factors as may be reasonably relevant; provided, however, in no event shall such prices exceed those as set forth on Exhibit D-1 or, with respect to [***], Exhibit D-1A.  Allocation of costs for any such changes is further described in Section 4.4(c).

3.Section 4.1(a) of the Agreement is hereby amended in its entirety to read as follows:

Transfer Pricing for Sets.  The [***] transfer price at which the Sets will be invoiced to Cerus (the “Transfer Price”) for the Current Pricing Term shall be determined based upon the [***].  For [***], Fresenius Kabi shall invoice Cerus the Transfer Price for [***], which price shall be reconciled against [***] and the difference invoiced or credited within [***] of the [***].  Notwithstanding anything to the contrary, in the event [***], the price shall [***].  The Transfer Price [***] is set forth on Exhibit D-1 and the Transfer Price [***] is set forth on Exhibit D-1A.  The Transfer Prices set forth on Exhibits D-1 and D-1A include the “Cerus Transfer Price” for the Cerus-Supplied Materials as set forth in Exhibit D-2.  

4.Section 4.1(c) of the Agreement is hereby amended in its entirety to read as follows:

Transfer Pricing for New Manufactured Products. The initial transfer price for the RBC Sets, or any Components or New Product to be manufactured and supplied by Fresenius Kabi that is not manufactured and supplied by Fresenius Kabi to Cerus as of the Effective Date, shall be negotiated in good faith by the Parties and shall be set at an amount equal to [***] percent ([***]%) of the Cost of Goods for the applicable product (the “New Product Transfer Price”); provided however, that the pricing for Intersol Solution shall be in accordance with Section 18 of the Commercialization Agreement. Such New Product Transfer Price shall be fixed for a period of [***] years. Thereafter, adjustments to the New Product Transfer Price of such product shall be done in accordance with Sections 4.1(d) and (e) below. Further, the Parties shall negotiate in good faith discounted transfer pricing for such Components or New Products based on [***] consistent with the [***] set forth on Exhibit D-1 or Exhibit D-1A, respectively. In order to verify the Cost of Goods comprising the New Product Transfer Price pursuant to this Section 4.1(c), Fresenius Kabi shall provide to Cerus a written report of the calculation of the Cost of Goods for the applicable product at least [***] days prior to the commencing manufacture of such Components or New Products, as applicable. Cerus shall have the right to cause an independent, certified public accounting firm selected from among the “Big 4” nationally recognized accounting firms, or such other firm of national standing that is reasonably acceptable to Fresenius Kabi to audit Fresenius Kabi’ records relating to the Cost of Goods 

 

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for such product to confirm the amount of the costs and expenses reflected in such report. The accounting firm shall be obligated to keep in strict confidence his findings also vis-à-vis Cerus and will inform Cerus and Fresenius Kabi only about whether or not the calculation of the applicable New Product Transfer Price has been correct and the amount, if any, of the deviation from the charged New Product Transfer Price. Cerus shall bear the full cost of such audit unless such audit discloses an over-charging by Fresenius Kabi of [***] percent ([***]%) or more, in which event Fresenius Kabi shall bear the costs of such audit.

5.Section 4.1(d) of the Agreement is hereby amended in its entirety to read as follows:

Pricing Negotiation for New Pricing Terms.  Pricing discussions with respect to the Transfer Price to be in effect for each calendar year beginning with [***] through the remainder of the Initial Term (the “Remainder Term”) shall begin no later than [***], and the parties shall negotiate the new Transfer Price for such Remainder Term in good faith.  The new Transfer Price set forth on Exhibit D-1A shall take effect beginning [***].  Pricing discussions with respect to the Transfer Price to be in effect for [***] for the Remainder Term, or for any Renewal Term, shall commence no later than [***] of the calendar year preceding each such calendar year or Renewal Term and shall be subject to the good faith negotiation of the Parties with respect thereto. The new Transfer Price shall take effect [***] of the calendar year immediately following such pricing discussions or, with respect to a Renewal Terms, [***] of the first calendar year of such Renewal Term.

 

6.A new Exhibit D-1A shall be inserted in the Agreement, which exhibit is attached hereto as Attachment 1.

7.Exhibit D-2 of the Agreement is hereby amended in its entirety to read as Attachment 2 attached hereto.

8.Except as modified herein, the provisions of the Agreement shall remain unchanged and in full force and effect.

9.This Amendment may be executed in any number of counterparts, each of which shall be an original, but all of which together shall be deemed to constitute one instrument.

 

 

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

 

Fresenius Kabi Deutschland GmbH 

 

By: /s/ Dr. Christian Hauer

Name:Dr. Christian Hauer

Title:President TCT Division

 

By: /s/ Dirk Roehner

Name:Dirk Roehner

Title:CFO TCT Division

 

Cerus Corporation

 

 

By: /s/ Kevin D. Green

Name: Kevin D. Green

Title: Vice President Finance and Chief Financial Officer

 

SIGNATURE PAGE 

 

 

 

 

 

ATTACHMENT 1

 

EXHIBIT D-1A

 

[***]

ATTACHMENT 1 

 

ATTACHMENT 2

EXHIBIT D-2

Cerus Transfer Pricing

[***]cers-ex1014_181.htm

Exhibit 10.14

 

Execution Version

 

amendment No. 1 to CREDIT, SECURITY AND GUARANTY AGREEMENT (TERM LOAN)

This AMENDMENT NO. 1 TO CREDIT, SECURITY AND GUARANTY AGREEMENT (TERM  LOAN) (this “Agreement”) is made as of 31st day of December, 2020, by and among CERUS CORPORATION, a Delaware corporation (“Borrower”), MidCap Financial Trust, a Delaware statutory trust, as Agent (in such capacity, together with its successors and assigns, “Agent”) and the other financial institutions or other entities from time to time parties to the Credit Agreement referenced below, each as a Lender.

RECITALS

A.Agent, Lenders and Borrowers have entered into that certain Credit, Security and Guaranty Agreement (Term Loan), dated as of March 29, 2019 (as amended, restated, supplemented or otherwise modified prior to the date hereof, the “Existing Credit Agreement” and, as the same is amended hereby and as it may be further amended, modified, supplemented and restated from time to time, the “Credit Agreement”), pursuant to which the Lenders have agreed to make certain advances of money and to extend certain financial accommodations to Borrower in the amounts and manner set forth in the Credit Agreement.

 

B.Borrower has requested, and Agent and Lenders have agreed, on and subject to the terms and conditions set forth in this Agreement and the other Financing Documents, to amend certain terms of the Existing Credit Agreement in accordance with the terms and conditions set forth in this Agreement.  

AGREEMENT

NOW, THEREFORE, in consideration of the foregoing, the terms and conditions set forth in this Agreement, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Agent, Lenders and Borrower hereby agree as follows:

1.Recitals.  This Agreement shall constitute a Financing Document and the Recitals and each reference to the Credit Agreement, unless otherwise expressly noted, will be deemed to reference the Credit Agreement as amended hereby.  The Recitals set forth above shall be construed as part of this Agreement as if set forth fully in the body of this Agreement and capitalized terms used but not otherwise defined herein shall have the meanings ascribed to them in the Credit Agreement (including those capitalized terms used in the Recitals hereto).

2.Amendment to Existing Credit Agreement.  Subject to the terms and conditions of this Agreement, including, without limitation, the conditions to effectiveness set forth in Section 4 below, the Existing Credit Agreement is hereby amended as follows:

(a)The definition of “Term Loan Tranche 2 Commitment Termination Date” set forth in Section 1.1 of the Existing Credit Agreement is hereby amended and restated in its entirety to read as follows:

““Term Loan Tranche 2 Commitment Termination Date” means the earlier of (a) March 31, 2021 and (b) the date on which Agent provides notice to Borrowers, following the occurrence of an Event of Default (which has not been waived or cured as of the date such notice is given), that the Term Loan Tranche 2 Commitments have been terminated.”

 

(b)The definition of “Term Loan Tranche 3 Commitment Termination Date” set forth in Section 1.1 of the Existing Credit Agreement is hereby amended and restated in its entirety to read as follows:

““Term Loan Tranche 3 Commitment Termination Date” means the earlier of (a) September 30, 2021 and (b) the date on which Agent provides notice to Borrowers, following the occurrence of an Event of Default (which has not been waived or cured as of the date such notice is given), that the Term Loan Tranche 3 Commitments have been terminated.” 

 

3.Representations and Warranties; Reaffirmation of Security Interest.  Each Borrower hereby confirms that all of the representations and warranties set forth in the Credit Agreement are true and correct in all material respects (without duplication of any materiality qualifier in the text of such representation or warranty) with respect to such Borrower as of the date hereof except to the extent that any such representation or warranty relates to a specific date in which case such representation or warranty shall be true and correct as of such earlier date.  Without limiting the foregoing, each Borrower represents and warrants that prior to and after giving effect to the agreements set forth herein, no Default or Event of Default shall exist under any of the Financing Documents. Nothing herein is intended to impair or limit the validity, priority or extent of Agent’s security interests in and Liens on the Collateral.  Each Borrower acknowledges and agrees that the Credit Agreement, the other Financing Documents and this Agreement constitute the legal, valid and binding obligation of such Borrower, and are enforceable against such Borrower in accordance with its terms, except as the enforceability thereof may be limited by bankruptcy, insolvency or other similar laws relating to the enforcement of creditors’ rights generally and by general equitable principles.  Each Borrower hereby confirms that the Collateral will (i) not be affected by this Agreement and will continue to be in full force and effect and (ii) extend to the liabilities and obligations of the Credit Parties under the Existing Credit Agreement as amended by this Agreement. 

4.Conditions to Effectiveness.  This Agreement shall become effective as of the date on which each of the following conditions has been satisfied: 

(a)Agent shall have received (including by way electronic transmission) a duly authorized, executed and delivered counterpart of the signature page to this Agreement from each Borrower, Agent and each Lender;

(b)all representations and warranties of Credit Parties contained herein shall be true and correct in all material respects (without duplication of any materiality qualifier in the text of such representation or warranty) as of the date hereof except to the extent that any such representation or warranty relates to a specific date in which case such representation or warranty shall be true and correct in all material respects as of such earlier date (and such parties’ delivery of their respective signatures hereto shall be deemed to be its certification thereof); and

(c)immediately prior to and after giving effect to this Agreement, no Default or Event of Default exists under any of the Financing Documents.

5.No Waiver or Novation.  The execution, delivery and effectiveness of this Agreement shall not, except as expressly provided in this Agreement, operate as a waiver of any right, power or remedy of Agent, nor constitute a waiver of any provision of the Credit Agreement, the Financing Documents or any other documents, instruments and agreements executed or delivered in connection with any of the foregoing.  Nothing herein is intended or shall be construed as a waiver of any existing Defaults or Events of Default under the Credit Agreement or the other Financing Documents or any of Agent’s rights and remedies in respect of such Defaults or Events of Default.  This Agreement (together with any other 

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document executed in connection herewith) is not intended to be, nor shall it be construed as, a novation of the Credit Agreement.

6.Affirmation.  Except as specifically amended pursuant to the terms hereof, each Borrower hereby acknowledges and agrees that the Credit Agreement and all other Financing Documents (and all covenants, terms, conditions and agreements therein) shall remain in full force and effect, and are hereby ratified and confirmed in all respects by such Borrower.  Each Borrower covenants and agrees to comply with all of the terms, covenants and conditions of the Credit Agreement and the Financing Documents, notwithstanding any prior course of conduct, waivers, releases or other actions or inactions on Agent’s or any Lender’s part which might otherwise constitute or be construed as a waiver of or amendment to such terms, covenants and conditions.

7.Miscellaneous.

(a)Reference to the Effect on the Credit Agreement.  Upon the effectiveness of this Agreement, each reference in the Credit Agreement to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of similar import shall mean and be a reference to the Credit Agreement, as amended by this Agreement.  Except as specifically amended above, the Credit Agreement, and all other Financing Documents (and all covenants, terms, conditions and agreements therein), shall remain in full force and effect, and are hereby ratified and confirmed in all respects by each Borrower.   

(b)GOVERNING LAW.  THIS AGREEMENT AND ALL DISPUTES AND OTHER MATTERS RELATING HERETO OR THERETO OR ARISING THEREFROM (WHETHER SOUNDING IN CONTRACT LAW, TORT LAW OR OTHERWISE), SHALL BE GOVERNED BY, AND SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, WITHOUT REGARD TO CONFLICTS OF LAWS PRINCIPLES (OTHER THAN SECTION 5-1401 OF THE GENERAL OBLIGATIONS LAW). 

(c)WAIVER OF JURY TRIAL

.   EACH BORROWER, AGENT AND THE LENDERS PARTY HERETO HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY AND AGREES THAT ANY SUCH ACTION OR PROCEEDING SHALL BE TRIED BEFORE A COURT AND NOT BEFORE A JURY.  EACH BORROWER, AGENT AND EACH LENDER ACKNOWLEDGES THAT THIS WAIVER IS A MATERIAL INDUCEMENT TO ENTER INTO A BUSINESS RELATIONSHIP, THAT EACH HAS RELIED ON THE WAIVER IN ENTERING INTO THIS AGREEMENT, AND THAT EACH WILL CONTINUE TO RELY ON THIS WAIVER IN THEIR RELATED FUTURE DEALINGS.  EACH BORROWER, AGENT AND EACH LENDER WARRANTS AND REPRESENTS THAT IT HAS HAD THE OPPORTUNITY OF REVIEWING THIS JURY WAIVER WITH LEGAL COUNSEL, AND THAT IT KNOWINGLY AND VOLUNTARILY WAIVES ITS JURY TRIAL RIGHTS.

(d)Incorporation of Credit Agreement Provisions.  The provisions contained in Section 11.6 (Indemnification), and Section 13.8 (Governing Law; Submission to Jurisdiction) of the Credit Agreement are incorporated herein by reference to the same extent as if reproduced herein in their entirety.

(e)Headings.  Section headings in this Agreement are included for convenience of reference only and shall not constitute a part of this Agreement for any other purpose.

(f)Counterparts.  This Agreement may be signed in any number of counterparts, each of which shall be deemed an original and all of which when taken together shall constitute one and the same instrument.  Delivery of an executed counterpart of this Agreement by facsimile or by electronic mail delivery of an electronic version (e.g., .pdf or .tif file) of an executed signature page shall be effective as 

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delivery of an original executed counterpart hereof and shall bind the parties hereto.   Signatures by facsimile or by electronic mail delivery of an electronic version of any executed signature page shall bind the parties hereto.  In furtherance of the foregoing, the words “execution”, “signed”, “signature”, “delivery” and words of like import in or relating to any document to be signed in connection with this Agreement and the transactions contemplated hereby or thereby shall be deemed to include Electronic Signatures, deliveries or the keeping of records in electronic form, each of which shall be of the same legal effect, validity or enforceability as a manually executed signature, physical delivery thereof or the use of a paper-based recordkeeping system, as the case may be, to the extent and as provided for in any applicable law, including the Federal Electronic Signatures in Global and National Commerce Act, the New York State Electronic Signatures and Records Act, or any other similar state laws based on the Uniform Electronic Transactions Act.  As used herein, “Electronic Signature” means an electronic sound, symbol, or process attached to, or associated with, a contract or other record and adopted by a Person with the intent to sign, authenticate or accept such contract or other record.

(g)Entire Agreement.This Agreement constitutes the entire agreement and understanding among the parties hereto and supersedes any and all prior agreements and understandings, oral or written, relating to the subject matter hereof.

(h)Severability.  In case any provision of or obligation under this Agreement shall be invalid, illegal or unenforceable in any applicable jurisdiction, the validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other jurisdiction, shall not in any way be affected or impaired thereby.

(i) Successors/Assigns.  This Agreement shall bind, and the rights hereunder shall inure to, the respective successors and assigns of the parties hereto, subject to the provisions of the Credit Agreement and the other Financing Documents.

[SIGNATURES APPEAR ON FOLLOWING PAGES]

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IN WITNESS WHEREOF, intending to be legally bound, the undersigned have executed this Agreement as of the day and year first hereinabove set forth.

 

 

	
AGENT:
	
MIDCAP FINANCIAL TRUST 

	

	
 

By: Apollo Capital Management, L.P.,

its investment manager

 

By:Apollo Capital Management GP, LLC,

its general partner

 

By:/s/ Maurice Amsellem______________________
Name: Maurice Amsellem
Title: Authorized Signatory 

 

 

5

 

LENDER:MIDCAP FINANCIAL TRUST

 

By: Apollo Capital Management, L.P., 

its investment manager

 

By: Apollo Capital Management GP, LLC, 

its general partner

 

 

By: /s/ Maurice Amsellem_____________________

Name: Maurice Amsellem

	

	
Title:   Authorized Signatory

 

 

LENDER:MIDCAP FUNDING XIII TRUST

 

By: Apollo Capital Management, L.P., 

its investment manager

 

By: Apollo Capital Management GP, LLC, 

its general partner

 

 

By: /s/ Maurice Amsellem_____________________

Name: Maurice Amsellem

	

	
Title:   Authorized Signatory

 

 

MIDCAP FUNDING XXX TRUST

 

By: Apollo Capital Management, L.P., 

its investment manager

 

By: Apollo Capital Management GP, LLC, 

its general partner

 

 

By: /s/ Maurice Amsellem_____________________

Name: Maurice Amsellem

	

	
Title:   Authorized Signatory

 

 

6

 

	
LENDER:
	
APOLLO INVESTMENT CORPORATION

 

	

	
By: Apollo Investment Management, L.P., as Advisor

By: ACC Management, LLC, as its General Partner

By:/s/ Joseph D. Glatt
Name: Joseph D. Glatt
Title: Vice President

 

 

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LENDER:ELM 2020-3 TRUST

	

	
 

 

By: MidCap Financial Services Capital Management, LLC, as Servicer

 

By: /s/ John O’Dea_____________________________
Name: John O’Dea
Title: Authorized Signatory

 

 

 

LENDER:ELM 2020-4 TRUST

	

	
 

 

By: MidCap Financial Services Capital Management, LLC, as Servicer

 

By:/s/ John O’Dea_____________________________
Name: John O’Dea
Title: Authorized Signatory

 

 

 

 

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BORROWERS:

 

 

 

 
	
CERUS CORPORATION

By:/s/ Kevin D. Green
Name: Kevin D. Green
Title: VP, Finance and Chief Financial Officer

 

 

 

	
 
	
 

 

 

 

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