Document:

EX-10.22

 Exhibit 10.22 

Execution Version 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] 

HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE 

COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

NCD Meloxicam IV (30mg/ml) 

PRODUCT AGREEMENT 

(Includes Schedules A to D) 

PRODUCT AGREEMENT 

This Product Agreement (this “Product Agreement”) is issued under the Master Manufacturing Services Agreement dated July
14th, 2017 between Patheon UK Limited and Recro Ireland Limited (the “Master Agreement”), and is entered into July 14th, 2017 (the “Effective Date”), between Patheon UK Limited, a corporation existing under the laws of England, having a principal place of business at Kingfisher Drive,
Covingham, Swindon, SN3 5BZ, England (“Patheon”) and Recro Ireland Limited a private limited company incorporated in Ireland with registered number 562027, having its registered office at 25/28 North Wall, Dublin 1,
(“Client”). 
 The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product
Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in
the Master Agreement. 
 The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of
this Product Agreement. 
  

	 	1.	 Product List and Specifications (See Schedule A attached hereto) 

 

	 	2.	 Minimum Order Quantity, Annual Volume, and Price (See Schedule B attached hereto) 

 

	 	3.	 Annual Stability Testing and Validation Activities (if applicable) (See Schedule C attached hereto)

  

	 	4.	 Active Materials, Active Materials Credit Value, and Maximum Credit Value (See Schedule D attached
hereto) 

  

	 	5.	 Yearly Forecasted Volume: (insert for sterile products if applicable under Section 4.2.1 of the
Master Agreement)  

  

											
	 Product
	  	[***]
	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]

  

	 	6.	 Territory: USA and EU 

 

	 	7.	 Manufacturing Site: Patheon Italia Monza Site Viale GB Stucchi 110,
I-20900 Monza Italy. 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

	 	8.	 Inflation Index: pursuant to Section 4.2(a) of the Master Agreement, the inflation index is the
[***] 

  

	 	9.	 Currency: Euros 

 

	 	10.	 Initial Set Exchange Rate: Not Applicable 

 

	 	11.	 Initial Product Term: (per Section 8.1 of the Master Agreement) from the Effective Date
until December 31, 2020 

  

	 	12.	 Notices: (Section 13.9 of the Master Agreement) 

 

	 	13.	 Other Modifications to the Master Agreement: 

[***] 
 [***]. [***] 

 
  

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth
above. 
  

			
	PATHEON UK LIMITED
		
	By:	 	 /s/ Andrew Robinson

	Name:	 	 Andrew Robinson

	Title:	 	 Director

	Date:	 	 17 July 2017

	
	RECRO IRELAND LIMITED
		
	By:	 	 /s/ Brian Harrison

	Name:	 	 Brian Harrison

	Title:	 	 Director

	Date:	 	 14-July 2017

  

			
	  
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HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE 

COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 SCHEDULE A 

PRODUCT LIST AND SPECIFICATIONS 

Product List 
 NCD Meloxicam IV (30mg/ml) 

Specifications 
 Prior to the start of commercial
manufacturing of Product under this Agreement Client will give Patheon the copies of originally executed copies of the Specifications as approved by the applicable Regulatory Authority. If the Specifications received are subsequently amended, then
Client will give Patheon copies of the revised executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised
Specifications. 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 SCHEDULE B 

MINIMUM ORDER QUANTITY (MOQ), ANNUAL VOLUME, AND PRICE 

Process Validation Batches 
  

							
	 Product
	  	[***]	  	[***]	  	[***]
	  	[***]
	Meloxicam sterile liquid vials	  	[***]	  	[***]	  	[***]

  

	*	 Excludes the cost of the secondary packaging conversion price which will be charged at the commercial supply
price as presented in the table on Page 5. 

 Bulk Supply 

 

															
	 Product
	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]

 Note: [***] 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 Packaging Supply Pricing Only 

 

													
	 Product
	  	[***]	  	[***]	  	[***]	  	[***]
	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]

  

	*	 [***]. 

	**	 [***].[***].[***].[***] 

Annual Volumes 
  

											
	 Product
	  	[***]
	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]
	NCD Meloxicam IV (30mg/ml)	  	[***]	  	[***]	  	[***]	  	[***]	  	[***]

  

			
	  
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HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE 

COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 Manufacturing Assumptions: 

API – API (NCD Meloxicam Bulk Intermediate) will be stored under refrigerated conditions
(2-8°C). In the case of capacity constraints Patheon may utilize a GMP approved sub-contract storage facility. In such a case, advance notification will be given to
the client if the use of such storage will be necessary. Consideration will also be made of temperature controls, and shipping validation. 

Batch size – Recro has confirmed that the maximum theoretical bulk batch size will be [***]. 

Manufacturing campaign – PV batches may not be produced in campaign. The Parties will meet and agree the appropriate protocols in this
regard before the applicable manufacturing slots are reserved. 
 Product sterilization, filling process, and sealing – An aseptic
filtration, filling and sealing process will be performed. Sterile filtration (0.22mm) of the solution will be performed prior to filling vials. Empty vials will be washed and depyrogenated using an in
line washing and tunnel machine prior to filling vials. 
 Hold times – The process is carried out at room temperature. Only standard
light protection is employed and no special precautions are required during formulation, filling, and inspection. During storage, brite stock will be wrapped in opaque black plastic. 

Cleaning – Full cleaning occurs after each batch. 

Visual inspection – 100% vials visual inspection is carried out by semiautomatic means. 

Finished product storage – Finished product will be stored under controlled room temperature conditions – USP (15-30°C). 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 Packaging Assumptions: 

Primary packaging components: 
  

			
	 Component
	  	Specification
	Vial	  	[***]
	Stopper	  	[***]
	Seal	  	[***]

 Secondary packaging – To be definitively established- see above “Packaging Supply” 

 

	 	•	 	 Secondary packaging – A single vial will be labelled and packaged in a pre-printed single carton with a patient information leaflet. Single cartons, or bundles of 10 cartons (bundled utilising cellophane wrap), will then be packed into tertiary containers and then into a bulk
shipper. 

  

	 	•	 	 Secondary packaging campaign – [***]. Packaging orders must be placed in
multiples of [***]. A whole bulk batch will be packed off into a single Stock Keeping Unit (SKU). PV batches will not be packaged in campaign. 

To be definitively established- see above “Packaging Supply” 

Tertiary packaging – According to Patheon’s standard shipment preparations. 

Testing Assumptions: 
 Patheon
will only perform API ID testing. 
 QC test methods must be fully validated and robust at the time of manufacture. 

 

			
	 Testing Requirements

	 In-Process
Controls
	  	Finished Product Testing
	[***]	  	[***]
	[***]	  	

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 Supply Chain Assumptions: 

Patheon will procure components (excluding the preprinted cartons and inserts which will be furnished by Client free of charge) and excipients
for the manufacture of Meloxicam sterile liquid vials from Patheon qualified suppliers. Should Client require Patheon to source any materials from specified suppliers, then these suppliers will remain under the quality audit control of Client unless
an agreement is reached for Patheon to take on this responsibility. 
 Components and excipients will be supplied by Patheon in accordance
with the specifications agreed. Patheon will issue formal Patheon specifications for each material. 
 Each lot of incoming components and
excipients will be sampled and tested according to the agreed specifications. 
 The API will be provided free issue/released to Patheon by
Client or its qualified supplier. 
 The API and all excipients used for the manufacture will be GMP grade and from TSE/BSE certified
sources. 
 Finished product will be made available at Patheon’s proposed manufacturing site (supplied EXW according to Incoterms® 2010). 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 The following cost items are included in the Price for the Products: 

[***] 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 The following cost items are not included in the Price for the Products: 

[***] 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 SCHEDULE C 

ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)] 

If applicable Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. This agreement will specify the
commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing. At the time of signing it is not envisaged that
any stability testing will be performed by Patheon. Patheon will ensure that the required number of samples are taken for Recro’s designated stability program. The samples will be made available at Patheon’s manufacturing site (EXW
according to Incoterms® 2010). 

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 SCHEDULE D 

ACTIVE MATERIALS 
  

			
	 Active Materials
	  	Supplier
	NCD Meloxicam Bulk Intermediate	  	Alkermes

 ACTIVE MATERIALS CREDIT VALUE 

The Active Materials Credit Value will be as follows: 
  

					
	 PRODUCT
	  	ACTIVE MATERIALS	  	ACTIVE MATERIALS
CREDIT VALUE
	NCD Meloxicam IV (30mg/ml)	  	Meloxicam	  	[***]

 MAXIMUM CREDIT VALUE 

Patheon’s liability for Active Materials calculated in accordance with Section 2.2 of the Master Agreement for any Product in a Year will not
exceed, in the aggregate, the maximum credit value set forth below: 
  

			
	 PRODUCT
	  	MAXIMUM CREDIT VALUE
	NCD Meloxicam IV (30mg/ml)	  	[***]

  

			
	  
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COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. 
  

 SCHEDULE E 

QUALITY AGREEMENT 
 Either a
copy, or a reference to the relevant Quality Agreement between the Client and Patheon Italy will be appended to this schedule once completed. For the avoidance of doubt, no product may be released for commercial sale until the Quality Agreement is
signed by both parties. 
 [End of Product Agreement] 

  

			
	  
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 Page 13 of 13a-ex101_6.htm

EXECUTION COPY

 

AMENDMENT NO. 2 TO CREDIT AGREEMENT 

This AMENDMENT NO. 2 TO CREDIT AGREEMENT, dated as of October 21, 2019 (this “Amendment”), is made by and among AGILENT TECHNOLOGIES, INC., a Delaware corporation (the “Company”), BNP PARIBAS, as administrative agent for and on behalf of the Lenders (in such capacity, the “Administrative Agent”), and the Lenders listed on the signature pages hereto.  Capitalized terms used but not defined herein have the meaning assigned thereto in the Credit Agreement (as defined below).

PRELIMINARY STATEMENTS

Reference is made to that certain Credit Agreement, dated as of March 13, 2019, as amended by Amendment No. 1 to Credit Agreement and Incremental Assumption Agreement dated as of August 7, 2019 (as so amended, the “Credit Agreement”), among the Company, the lenders party thereto (the “Lenders”) and the Administrative Agent.

Section 2.08(c) of the Credit Agreement permits the Company to establish Incremental Facilities in an aggregate amount not to exceed $500,000,000.  The 2019 Incremental Term Facility utilized the full amount available for Incremental Facilities.  

The Company has requested that the aggregate amount available for Incremental Facilities be refreshed to permit additional Incremental Facilities in an aggregate principal amount of up to $500,000,000. 

The Required Lenders are willing to consent to the Company’s request on the terms and subject to the conditions set forth herein. 

NOW THEREFORE, in consideration of the premises and for other good and valuable consideration (the receipt and sufficiency of which are hereby acknowledged), the parties hereto hereby agree as follows:

SECTION 1.Amendment to Credit Agreement.  Section 2.08(c)(i) of the Credit Agreement is, effective as of the Amendment Effective Date (as hereinafter defined) and subject to the satisfaction of the condition precedent set forth in Section 3, hereby amended by deleting the phrase “the aggregate principal amount of all such increases shall not exceed US$500,000,000” and substituting therefor the phrase “the aggregate principal amount of all such increases, other than the increase effected by the 2019 Incremental Term Facility, shall not exceed US$500,000,000”.

SECTION 2.Representations and Warranties.  To induce the Administrative Agent and the Required Lenders to enter into this Amendment, the Company hereby represents and warrants, on and as of the Amendment Effective Date, that:

(a)  At the time of and after giving effect to this Amendment, no Default has occurred and is continuing.

(b)  The representations and warranties set forth in the Credit Agreement are true and correct in all material respects as of the Amendment Effective Date, provided that 

Agilent – Amendment No. 2

 

2

representations and warranties modified by materiality shall be true and correct in all respects.

SECTION 3.Conditions to Effectiveness of the Amendment.  The Amendment set forth in Section 1 hereof shall become effective as of the first date when, and only when, the Administrative Agent shall have received this Amendment, duly executed and delivered by the Company, the Administrative Agent and the Required Lenders (the “Amendment Effective Date”).

SECTION 4.Reference to and Effect on the Loan Documents.

(a)On and after the Amendment Effective Date, each reference in the Credit Agreement to “this Agreement”, “hereunder”, “hereof” or words of like import referring to the Credit Agreement, and each reference in the Notes and each of the other Loan Documents to “the Credit Agreement”, “thereunder”, “thereof” or words of like import referring to the Credit Agreement, shall mean and be a reference to the Credit Agreement, as amended and modified by this Amendment.

(b)The Credit Agreement, the Notes and each of the other Loan Documents, as specifically amended and modified by this Amendment, are and shall continue to be in full force and effect and are hereby in all respects ratified and confirmed.  

(c)Save as expressly provided herein, the execution, delivery and effectiveness of this Amendment (i) shall not operate as a waiver of any right, power, privilege or remedy of any Lender, any Issuing Bank, any Swingline Lender or the Administrative Agent under any of the Loan Documents and (ii) shall not alter, modify, amend or in any way affect any of the terms, conditions, obligations, covenants or other agreements contained in the any of the Loan Document, all of which are ratified and affirmed in all respects and shall continue in full force and effect.  

SECTION 5.Execution in Counterparts.  This Amendment may be executed in counterparts (and by different parties hereto in different counterparts), each of which shall constitute an original, but all of which taken together shall constitute a single contract.  Delivery of an executed counterpart of a signature page to this Amendment by facsimile or other electronic image scan transmission shall be effective as delivery of a manually executed counterpart of this Amendment. 

SECTION 6.Expenses.  The Company agrees to reimburse the Administrative Agent for its reasonable and documented out-of-pocket costs and expenses incurred in connection with this Amendment, in accordance with the provisions of Section 10.03(a) of the Credit Agreement.

SECTION 7.Miscellaneous.  The headings of this Amendment are for purposes of reference only and shall not limit or otherwise affect the meaning hereof.  This Amendment shall be binding upon and inure to the benefit of the parties hereto and to the Credit Agreement and the other Loan Documents and their respective successors and permitted assigns.

SECTION 8.Loan Document.  Each of the parties hereto hereby agrees that this Amendment shall be a Loan Document for all purposes of the Credit Agreement and the other Loan Documents, and the definition of “Loan Documents” set forth in the Credit Agreement shall 

NYDOCS02/1196248 Agilent – Amendment No. 2 

 

 

3

be deemed to have been amended to include this Amendment therein.

SECTION 9.GOVERNING LAW.  This Amendment shall be construed in accordance with and governed by the law of the state of New York.

 

[Remainder of Page Intentionally Left Blank]

 

 

 

NYDOCS02/1196248 Agilent – Amendment No. 2 

 

 

 

IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be duly executed and delivered as of the day and year first above written.

AGILENT TECHNOLOGIES, INC.

 

By:  /s/ Guillermo Gualino
Name: Guillermo Gualino 
Title: Vice President and Treasurer 

 

 

 

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

BNP PARIBAS,
as Administrative Agent and a Lender

By:  /s/ Brendan Heneghan
Name:  Brendan Heneghan
Title:  Director

By:  /s/ Karim Remtoula
Name:  Karim Remtoula
Title:  Vice President

 

 

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

CITIBANK, N.A.

	
 
	

	
 

By:  /s/ Susan M. Olsen
Name:  Susan M. Olsen
Title:  Vice President

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

Bank of America, N.A.

	
 
	

	
 

By:  /s/ Jason Auguste
Name:  Jason Auguste
Title:  Vice President

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

Wells Fargo Bank, National Association

	
 
	

	
 

By:  /s/ Sara Barton
Name:  Sara Barton
Title:  Vice President

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

BARCLAYS BANK PLC

	
 
	

	
 

By:  /s/ Martin Corrigan
Name:  Martin Corrigan
Title:  Vice President

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH

	
 
	

	
 

By:  /s/ John D. Toronto
Name:  John D. Toronto
Title:  Authorized Signatory

By:  /s/ Andrew Griffin
Name:  Andrew Griffin
Title:  Authorized Signatory

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

Mizuho Bank, Ltd.

	
 
	

	
 

By:  /s/ Tracy Rahn
Name:  Tracy Rahn
Title:  Authorized Signatory

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

JPMORGAN CHASE BANK, N.A.

	
 
	

	
 

By:  /s/ Joseph McShane
Name:  Joseph McShane
Title:  Vice President

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

MUFG Bank LTD.

	
 
	

	
 

By:  /s/ David Meisner
Name:  David Meisner
Title:  Vice President

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

DBS Bank Ltd.

	
 
	

	
 

By:  /s/ Yeo How Ngee
Name:  Yeo How Ngee
Title:  Managing Director

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

HSBC BANK USA, NATIONAL ASSOCIATION

	
 
	

	
 

By:  /s/ David Wagstaff
Name:  David Wagstaff
Title:  Managing Director

 

Agilent – Amendment No. 2 

 

 

SIGNATURE PAGE TO
AGILENT TECHNOLOGIES, INC.
AMENDMENT NO. 2 TO CREDIT AGREEMENT

KEYBANK NATIONAL ASSOCIATION

	
 
	

	
 

By:  /s/ Tad L. Stainbrook
Name:  Tad L. Stainbrook
Title:  Vice President

 

 

Agilent – Amendment No. 2

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