Quality Agreement



 EXHIBIT 10.23 
 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 
 QUALITY
AGREEMENT FOR DEVELOPMENT OF IN-VITRO 
 DIAGNOSTICS DEVICES 

 
  
 Between 
 Novartis Vaccines and Diagnostics, Inc. 

4560 Horton Street, Emeryville, CA 94608 
 subsequently referred to as NOVARTIS 
 and 

Fluidigm Corporation 
 7000 Shoreline Court, Suite 100, South San Francisco, CA 94080 
 subsequently
referred to as FLUIDIGM 

  
  

 

			
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 TABLE OF CONTENTS 

 

							
	PREAMBLE	  	 	5	  
			
	1.	 	 PURPOSE AND SCOPE OF THIS DEVELOPMENT QUALITY AGREEMENT
	  	 	5	  
			
	2.	 	 GENERAL PROVISIONS (QUALITY ASSURANCE)
	  	 	6	  
			
	2.1.	 	 STANDARDS
	  	 	6	  
			
	2.2.	 	 QUALITY ASSURANCE SYSTEM
	  	 	7	  
			
	2.3.	 	 INSPECTIONS AND AUDITS
	  	 	8	  
			
	2.4.	 	 SUBCONTRACTING
	  	 	8	  
			
	2.5.	 	 CHANGE MANAGEMENT AND APPROVAL
	  	 	9	  
			
	3.	 	 DESIGN AND DEVELOPMENT
	  	 	9	  
			
	3.1.	 	 QUALIFICATION AND VALIDATION (INCL. COMPUTER SYSTEMS)
	  	 	10	  
			
	3.2.	 	 DESIGN HISTORY FILE (DHF)
	  	 	10	  
			
	4.	 	 MANUFACTURING MATERIALS FOR VALIDATION AND CLINICAL TRIAL PURPOSES
	  	 	11	  
			
	4.1.	 	 STARTING (RAW) MATERIAL
	  	 	11	  
			
	4.1.1	 	 TESTING AND RELEASE
	  	 	11	  
			
	4.1.2	 	 STORAGE
	  	 	11	  
			
	4.2.	 	 MANUFACTURING LINES, LOCATIONS
	  	 	11	  
			
	4.3.	 	 MANUFACTURING AND PACKAGING RECORDS
	  	 	12	  
			
	4.4.	 	 REVIEW OF MANUFACTURING DOCUMENTATION
	  	 	12	  
			
	4.5.	 	 WAREHOUSING
	  	 	12	  
			
	4.6.	 	 PACKAGING FOR DISPATCH AND TRANSPORT
	  	 	13	  
			
	5.	 	 TESTING OF IN-VITRO DIAGNOSTIC DEVICES
	  	 	13	  
			
	5.1.	 	 SAMPLES OF IN-VITRO DIAGNOSTICS DEVICES
	  	 	13	  
			
	5.2.	 	 TECHNOLOGY TRANSFER (HARDWARE AND SOFTWARE)
	  	 	13	  
			
	5.3.	 	 REFERENCE STANDARDS
	  	 	14	  
			
	6.	 	 ARCHIVING OF SAMPLES AND DOCUMENTATION
	  	 	14	  
			
	7.	 	 TERMS AND EXPIRATION
	  	 	14	  
			
	8.	 	 DEFINITIONS
	  	 	16	  
			
	9.	 	 SIGNATURES
	  	 	17	  


  
  

 

			
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 TABLE OF ENCLOSURES 
 ENCLOSURE A: List of Quality Liaisons 
 ENCLOSURE B: Table of Responsibilities

 ENCLOSURE C: List of Approved Sub-Contractors 
 ENCLOSURE D: History of Changes 

  
  

 

			
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 PREAMBLE 
 NOVARTIS and its Affiliates are leading international companies engaged in the marketing and sales of in-vitro diagnostics (IVD) products to support non-invasive prenatal screening. They operate under one
common Quality Management System incorporating GMP guidelines and regulations and subject to all applicable laws. 
 NOVARTIS desires to
collaborate with FLUIDIGM to design and develop certain in-vitro diagnostics devices as further described in a Collaboration and Option Agreement between FLUIDIGM and Novartis Vaccines and Diagnostics, Inc dated as of May
    , 2010 (“COA”). All capitalized terms used but not defined in this Development QAG (including in Section 8 of this Development QAG) will have the meanings set forth in the COA. 

The COA contemplates a Collaboration Plan for the Parties’ Collaboration Activities. FLUIDIGM and NOVARTIS wish to further define their roles and
responsibilities according to such Collaboration Plan as set forth in this quality agreement (“Development QAG”). In addition to the requirements below the parties shall follow the corresponding international guidelines prevailing
at the time of the development activities. 
 NOVARTIS and its Affiliates will be the legal manufacturer of the Novartis Licensed Products and
will be responsible for the Design History File (“DHF”) for each of the Novartis Licensed Products. 
 1. PURPOSE AND SCOPE
OF THIS DEVELOPMENT QUALITY AGREEMENT 
 The purpose of this Development QAG is to ensure a mutual understanding of the roles and
responsibilities of FLUIDIGM and NOVARTIS as they relate to the development of Novartis Licensed Products in the Primary Field and Secondary Field per COA. Changes beyond the scope outlined herein for the development of such Novartis Licensed
Product (or activities related thereto) are not permitted without Novartis’ prior approval with amendment to this Development QAG or the establishment of a separate quality agreement covering said products or activities. For clarity, the
manufacture by FLUIDIGM of Novartis Licensed Products in the Primary Field and Secondary Field shall be subject to a separate manufacturing quality agreement. This Development QAG is also intended to assure that the Novartis Licensed Products are in


  
  

 

			
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compliance with the relevant regulatory requirements, and ISO standards as applicable for the defined intended use of the Novartis Licensed Products. This Development QAG forms an integrated part
of the COA. It defines the Parties’ respective contacts for all technical and quality matters (see Enclosure A). The roles and responsibilities of both Parties are assigned in Enclosure B. Since NOVARTIS will rely on decisions
made by FLUIDIGM and its critical Subcontractors as defined in FLUIDIGM’s quality system (the list of such critical Subcontractors as set forth in Enclosure C) pertaining to the design, development and/or manufacture of Novartis Licensed
Products, this Development QAG also includes a process for the auditing and approval of such FLUIDIGM critical Subcontractors as listed in Enclosure C. Changes to this Development QAG will be listed in Enclosure D. The enclosures must
be signed by the quality responsible persons of the respective Parties. 
 2. GENERAL PROVISIONS (QUALITY ASSURANCE) 

Standards 
 The following documents
represent the key standards under which this Development QAG was based: 

  
  

 

			
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	 Organization
	  	 Guideline

	FDA	  	 21 CFR Part 808 (Exemptions from Federal Preemption of State and Local Medical Device Requirements)

21 CFR Part 820 (Quality System Regulation)
 21
CFR Part 809 (In Vitro Diagnostic Products for Human Use)
 21 CFR Part 11 Electronic Records; Electronic Signatures

FDA recognized consensus standards mutually agreed as appropriate for the development of the products

		
	EU/EEC	  	98/79/EC In Vitro Diagnostics Medical Device Directive (IVDD)
		
	ISO	  	 ISO 13485:2003, Medical devices. Quality management systems - Requirements for regulatory purposes

ISO 14971, Risk Management for Medical Devices

CMDCAS – Canadian Medical Devices Conformity Assessment System
 Harmonized standards as applicable mutually agreed as appropriate for the development of the products

		
	Novartis Diagnostics	  	Third Party Warehouse, Distribution and Services Quality Requirements Manual (Doc# 255957)

 Table 1: Guidelines to Quality Assurance of In-Vitro Diagnostics devices 
 Quality
Assurance System 
 FLUIDIGM covenants that it maintains or will maintain an ISO 13485/FDA Quality System Regulations (QSR) compliant quality
management system with respect to the Novartis Licensed Products. Unless otherwise required by this Development QAG, the provisions of FLUIDIGM’s quality management system and standard operating procedures shall be applied to FLUIDIGM’s
development of the Novartis Licensed Products. FLUIDIGM shall ensure that, with respect to the development activities it is to perform under the COA, the design and development processes for the Novartis Licensed Products meet NOVARTIS requirements
and comply with all applicable laws. 
 FLUIDIGM shall ensure that, with respect to the development activities it is to perform under the COA,
the development of test methods, specifications and manufacturing processes for the Novartis Licensed Products comply to NOVARTIS requirements in all respects with the Collaboration Plan (and all mutually agreed upon written amendments) and that
each Novartis Licensed Product as developed will comply in all material respects with the general guidelines 

  
  

 

			
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(see table 1), each of which is considered a requirement for quality assurance. 

Inspections and Audits 
 FLUIDIGM agrees
that its facilities, operations and quality systems which are used by FLUIDIGM in performing its development activities under the COA will be audited by NOVARTIS (during reasonable business hours) to ensure compliance with development requirements
of the QSR/ISO 13485:2003 Standard and applicable NOVARTIS requirements set forth herein. QSR requirements and applicable NOVARTIS requirements set forth herein shall be implemented, and subsequently followed, by FLUIDIGM as required in an audit
report/action plan that will be agreed to between the Parties. During the development and design transfer phase of the design process, NOVARTIS shall be entitled to perform audits for cause (e.g. undesirable events or data audit of design history
documentation) and at reasonable intervals (during reasonable business hours) to ensure the quality and data integrity of each Novartis Licensed Product under development. Each party will bear their own expense for such audits. Any significant audit
findings of which NOVARTIS notifies FLUIDIGM in writing shall be resolved to Novartis’ reasonable satisfaction prior to delivery of any Novartis Licensed Product to Novartis. 
 FLUIDIGM will correct any observations arising from any such audit in a timely manner in accordance with the audit report/action plan agreed to between the parties. NOVARTIS shall have the right to reject
any development related activities if activities are observed that violate agreed upon standards and regulations. In such case, FLUIDIGM shall implement all such agreed upon applicable corrective actions before continuation of the development
activities. 
 FLUIDIGM shall promptly notify NOVARTIS about any issues encountered during inspection by a Regulatory Authority or other
governmental authority or agency that is reasonably likely to adversely affect the quality of any Novartis Licensed Products being developed under the COA and must provide a redacted copy of the inspection report and the corrective actions to
NOVARTIS within fifteen (15) business days after notice of such reports. 
 Subcontracting 

FLUIDIGM shall have the rights to outsource any specific tasks related to the development of Novartis Licensed Products to one or more third parties on
its behalf. A list of critical Subcontractors (as defined in Section 8) agreed upon by Quality from both parties are listed in Enclosure C. To the extent pertaining to the Novartis Licensed Products being developed under


  
  

 

			
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the COA, all additions of critical Subcontractors or changes to the services provided by the Subcontractors in Enclosure C require written approval by FLUIDIGM and NOVARTIS, such approval not to
be unreasonably withheld. FLUIDIGM shall ensure that each such Subcontractor has an appropriate quality system which ensures adequate quality of materials and services are provided, and without limiting the foregoing, FLUIDIGM agrees to establish
quality agreements with each of its critical Subcontractors (or otherwise establish quality metrics that will govern the development work conducted by the applicable critical Subcontractor) before commencing development activities. 

FLUIDIGM shall remain solely and fully responsible to NOVARTIS for the performance of the work by Subcontractors in accordance with the requirements set
forth in this Development QAG. FLUIDIGM shall provide copies of audit reports of these Subcontractors for Novartis Licensed Products if NOVARTIS requests the copies for the purpose of reviewing for audit completeness and assessment of qualification.
In addition, NOVARTIS may request, based on the assessment of critical Subcontractors’ audit reports, or for cause (e.g. undesirable events or data audit of design history documentation) the right to accompany FLUIDIGM personnel during audits
of the critical FLUIDIGM Subcontractors to ensure the quality and data integrity of each Novartis Licensed Product under development. Each party will bear its own expense for such audits. 
 Change Management and Approval 
 Changes to this Development QAG and its relevant enclosures
shall only be made by mutual agreement between the Parties and must be in writing. 
 FLUIDIGM and NOVARTIS will document design changes,
according to the Development Plan, relevant to the development of Novartis Licensed Products, such as to the product requirements and verification testing procedures or such as to changes that could interfere with the quality and safety of the final
products. 
 3. DESIGN AND DEVELOPMENT 
 Each Development Plan shall incorporate COA Collaboration Plan activities and Quality Assurance requirements with respect to design control, validation and product registration requirements. Deliverables
for each Novartis Licensed Product shall be as set forth in the Collaboration Plan and the applicable Development Plan. 

  
  

 

			
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 Qualification and Validation (incl. Computer Systems) 

Quality Processes: FLUIDIGM shall ensure that appropriate processes for document control, design and development (including design change control),
risk management, supplier management, equipment calibration/maintenance and environmental control (appropriate laboratory facilities including security, cleanliness and environment controls) which comply with this Development QAG are fully
implemented, and subsequently maintained, before starting any activity related to the Collaboration Plan of the development of any Novartis Licensed Products. All such processes must pass NOVARTIS divisional quality audits against the relevant
development sections of ISO 13485:2003 and FDA QSR requirements before any such development work can be accepted. Development work pertaining to the Collaboration Plan performed before the establishment of appropriate ISO and FDA Quality System
controls as they relate to said development will not be accepted by NOVARTIS as evidentiary work for including in the product Design History File. 
 Equipment: The development activities of FLUIDIGM under the Collaboration Plan shall be conducted using calibrated and qualified equipment. Qualification reports shall be approved by FLUIDIGM.
FLUIDIGM shall make all approved validation protocols, reports, testing protocols and/or certifications available to NOVARTIS on request. 

Computer Systems: FLUIDIGM shall ensure that computer systems and software used directly for operations in verification or validation testing of
Novartis Licensed Products are validated. FLUIDIGM shall make all approved validation protocols, reports, testing protocols, raw data and system operation procedures pertaining to the development of Novartis Licensed Products under the COA available
for inspection by NOVARTIS on request. 
 Design History File (DHF) 
 Until the agreed phase of transfer to NOVARTIS, FLUIDIGM shall hold and maintain the assigned elements of the design history file (DHF) containing the development and all changes to the device in
accordance with FDA 21 CFR 820.30 and ISO 13485:2003 requirements. Design documents intended for DHF or regulatory submission as determined by Quality Assurance from both parties must include NOVARTIS quality approval signatures. FLUIDIGM shall make
all elements of the DHF held by FLUIDIGM available to NOVARTIS for inspection upon request. Any observed deviation shall be reviewed and corrected as required to the extent agreed by both parties before transfer of the DHF materials to NOVARTIS.
Upon completion of FLUIDIGM’s 

  
  

 

			
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design and development activities with respect to any Novartis Licensed Product under the COA, the design documents for such Novartis Licensed Product shall be transferred to NOVARTIS for
retention; provided that, FLUIDIGM shall be entitled to retain and use copies of all such design documents as and to the extent permitted under the COA. 
 4. MANUFACTURING MATERIALS FOR VALIDATION AND CLINICAL TRIAL PURPOSES 
 Starting (RAW)
Material 
 4.1.1 Testing and Release 
 Each batch/lot or serialized part, first article or part of all starting and auxiliary materials procured by FLUIDIGM must meet the approved specifications for that part or material, the evidence of that
compliance must be documented and released for production of Novartis Licensed Products used for validation activities and clinical trial purposes; provided, however, that FLUIDIGM may rely on its suppliers to meet specifications where such
suppliers provide evidence of conformity. 
 Unless otherwise agreed in writing, FLUIDIGM shall perform all quality control testing according to
test methods and acceptance criteria agreed with NOVARTIS; provided, however, that FLUIDIGM may rely on its suppliers to perform such testing where such suppliers provide evidence of such test methods and acceptance criteria. 

4.1.2 Storage 
 FLUIDIGM shall use
adequate storage containers and storage/transport conditions to ensure that the specified quality of Starting (Raw) Materials is not impaired. FLUIDIGM will only store Starting (Raw) Materials under FLUIDIGM’s standard storage conditions which
have been agreed upon by NOVARTIS to be suitable and appropriate for the above purpose. 
 Manufacturing Lines, Locations 

All Novartis Licensed Products shall be assembled using location, line and production units which comply with the then-current version of the master
manufacturing and packaging procedures described in the Device Master Record (DMR), approved development procedures or the respective/corresponding regulatory dossier. 

  
  

 

			
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 Manufacturing and Packaging Records 
 FLUIDIGM shall carry out all manufacture and packaging of the Novartis Licensed Products according to agreed manufacturing procedures and packaging instructions from NOVARTIS. FLUIDIGM shall submit the
device master record for each Novartis Licensed Product to NOVARTIS before the first start of product manufacture and before any approved change is implemented. 
 FLUIDIGM shall compile and archive clear structured device history record documentation for each of the Novartis Licensed Product. All manufacturing records and testing documentation kept by FLUIDIGM will
comply with the applicable GMP guidelines. 
 Upon request by NOVARTIS or any Regulatory Authority, FLUIDIGM shall provide NOVARTIS with copies
of the following documents within an agreed upon period (or as required by any such Regulatory Authority): 
  

	 	•	 	 Complete device history record of Novartis Licensed Products, 



 

	 	•	 	 Certificate(s) of analysis of Starting (Raw) Materials, 



 

	 	•	 	 Certificate(s) of inspection of components used to assemble the device, 



 

	 	•	 	 Certificate(s) of analysis of primary Packaging Materials and 



 

	 	•	 	 Test methods used. 



Review of Manufacturing Documentation 

After detailed review of the appropriate manufacturing documentation for each Novartis Licensed Product by FLUIDIGM, FLUIDIGM shall include or attach a
statement of compliance with the applicable sections of the GMP requirements, signed by a qualified FLUIDIGM quality assurance representative, to the certificate of analysis (CoA) for each Novartis Licensed Product. A suitable format of this
statement or document will be mutually agreed upon between the Parties after FLUIDIGM has provided NOVARTIS with the required batch documentation as defined in the device master record. 
 Warehousing 
 FLUIDIGM will maintain adequate controls in accordance with the NOVARTIS Third Party
Warehouse, Distribution and Services Quality Requirements Manual (Doc# 255957), sections 1, 2, 4, 6, for any Novartis Licensed Products produced for validation and clinical trials in its 

  
  

 

			
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warehousing facilities to assure that these products are not damaged during storage. The Novartis Licensed Products produced by FLUIDIGM for use in NORVATIS’ validation and clinical trials
will be stored in an appropriate location and environment to reasonably ensure that no damage occurs during storage to such products due to temperature, humidity, dirt, or other harmful agents potentially materially impacting the performance of
these products prior to shipment to NOVARTIS or the trial sites. FLUIDIGM shall ensure or require that all Novartis Licensed Products are stored according to specifications established by the parties during the development of such Novartis Licensed
Product. In the event that, to FLUIDIGM’s knowledge, the quality of any Novartis Licensed Products in any warehouse of FLUIDIGM or a critical Subcontractor could be adversely affected for any reason, FLUIDIGM shall take prompt action to prevent
further damage. In such case FLUIDIGM shall inform NOVARTIS in writing within a reasonable time frame but no longer than five (5) Business Days. 
 Packaging for Dispatch and Transport 
 FLUIDIGM shall ensure that all applicable quality and
regulatory requirements regarding the packaging for dispatch and transport to the agreed hand-over point are met with respect to each Novartis Licensed Product. 
 5. TESTING OF IN-VITRO DIAGNOSTIC DEVICES 
 Samples of In-vitro Diagnostics Devices

 FLUIDIGM, when requested, will provide NOVARTIS with samples of pilot Novartis Licensed Products for testing by NOVARTIS during
development stage according to the applicable Collaboration Plan and Development Plan. Samples must be representative of the method or prototype being developed. 
 Technology Transfer (Hardware and Software) 

  
  

 

			
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 Wherever the applicable Development Plan or COA requires that test methods be transferred, FLUIDIGM will
conduct a formal method transfer to NOVARTIS according to the Collaboration Plan and the applicable Development Plan. All data supporting the transfer must be reviewed by NOVARTIS Quality prior to final approval of the technology transfer.

 Reference Standards 
 The
reference standards for testing of Novartis Licensed Products, by-products or degradation products will be established by FLUIDIGM and will be provided to NOVARTIS on request. 
 6. ARCHIVING OF SAMPLES AND DOCUMENTATION 
 FLUIDIGM will ensure or require that (reference)
samples and documentation related to the development will be archived under defined conditions as follows: 
  

			
	 Item
	  	 Period

	Starting (raw) material (samples)	  	N/A
		
	Design History Files	  	All originals transferred to NOVARTIS, including electronic files and raw data
		
	Design Verification Documentation	  	All originals transferred to NOVARTIS

 Table 2:
Storage periods of samples and documentation 
 Following the end of the applicable archiving period FLUIDIGM shall provide the documentation to
NOVARTIS; provided that, FLUIDIGM shall be entitled to retain and use copies of all such documentation as and to the extent permitted under the COA. 
 7. TERMS AND EXPIRATION 
 This Development QAG forms an integrated part of the COA and shall
come into force together with the COA and sign-off by the Parties hereto; provided that in the event of any conflict or inconsistency between the provisions of the COA and any provision of this Development QAG, the provisions of the COA shall
prevail. The Development QAG and its enclosures shall be subject to regular review by the Parties or amended as needed. 
 This Development QAG
shall be terminated upon expiration or termination of the COA. 

  
  

 

			
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 Unless otherwise reasonably agreed by both parties, each party represents and warrants that it shall
obtain and maintain all necessary permits, registrations and licenses required to design and develop the Novartis Licensed Products and it shall produce the Novartis Licensed Products, and dispose of all waste, in compliance in all material
respects, with all applicable environmental laws, regulations, and standards, to the extent any such activities are conducted by such party. In performing activities under this Development QAG, each party agrees to act reasonably, including without
limitation, not unreasonably withholding its agreement to any action plan or other matter to be performed by the other party. 
 Each Party
represents and warrants to the other, respectively, that each is fully authorized to execute this Development QAG, and to be bound and perform according to its terms. 
 The failure by either Party to exercise or enforce any of the terms or conditions of this Development QAG shall not constitute or be deemed a waiver of that Party’s right thereafter to enforce each
and every term and condition of this Development QAG. 
 If any one or more of the provisions of this Development QAG shall, for any reason, be
held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provision of this Development QAG, and this Development QAG shall be construed as if such invalid, illegal or
unenforceable provision had never been contained herein. 
 The limitation of liability set out in Section 10.5(a) of the COA shall be
deemed incorporated into this Agreement by reference, except that, for such purposes, each reference in Section 10.5(a) of the COA to “this Agreement” shall be deemed to be a reference to this Development QAG. 

  
  

 

			
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 8. DEFINITIONS 
  

			
	Development Plan	  	The development plan is written by Novartis with inputs from Fluidigm and approved by both parties. The development plan documents the roles and responsibilities for each party and
function, methods for development, strategies for verification and validation, and requirements for commercialization of Novartis Licensed Products.
		
	QSR	  	Quality system regulations as defined by 21 CFR Part 820
		
	GMP	  	Good Manufacturing Practices as defined by the FDA QSR
		
	Packaging Material	  	Any material employed in the packaging of a product, excluding any outer packaging used for transportation or shipment. Primary Packaging Material is in direct contact with the
product, secondary packaging refers to all other materials.
		
	Starting (Raw) Material	  	Any material used in the production of a subcomponent, component of the final developed product.
		
	Subcontractors	  	 A third party supplier utilized by FLUIDIGM to perform any of the following activities:

 

•      the design and development of Novartis Licensed Products,

 

•      the manufacture of Novartis Licensed Products for validation and
clinical trial purposes;
  

•      the design and/or manufacture of custom components or materials
(including software) for Novartis Licensed Products.

		
	Other definitions	  	See COA


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 9. SIGNATURES 
  

					
	NOVARTIS	 		 	FLUIDIGM
			
	  
	 		 	  

	Matthew Powell	 		 	Robert C. Jones
	Vice President, Quality Operations	 		 	 Executive Vice President,

Research and Development



  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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 Core
Document
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 ENCLOSURE A: List of Quality Liaisons 

NOVARTIS 
  

					
	 Name
	  	 Function
	  	 Address

	Matthew Powell	  	 Vice President,
 Quality
Operations
	  	4560 Horton Street
 M/S Q-400

Emeryville, CA 94608-2916

			
	 Telephone
	  	 Fax
	  	 e-mail

	510-923-4689	  	510-923-3420	  	matthew.powell@novartis.com
			
	 Name
	  	 Function
	  	 Address

	Elizabeth Tang	  	QA Franchise Manager	  	4560 Horton Street
 M/S Q-225

Emeryville, CA 94608-2916

			
	 Telephone
	  	 Fax
	  	 e-mail

	510-923-2518	  	510-923-3420	  	elizabeth.tang@novartis.com


  
  

 

					
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 FLUIDIGM 

 

					
	 Name
	  	 Function
	  	 Address

	Robert C. Jones	  	 Executive Vice President,

Research and Development
	  	7000 Shoreline Court, Suite 100,
 South San Francisco, CA
94080

			
	 Telephone
	  	 Fax
	  	 e-mail

	650-266-6000	  	650-871-7152	  	bob.jones@fluidigm.com
			
	 Name
	  	 Function
	  	 Address

		  		  	
			
	 Telephone
	  	 Fax
	  	 e-mail

		  		  	

 CONTRACTOR 
  

					
	 Name
	  	 Function
	  	 Address

		  		  	
			
	 Telephone
	  	 Fax
	  	 e-mail

		  		  	

  

					
	NOVARTIS	 		 	FLUIDIGM
			
	  
	 		 	  



  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
	 Development Quality Agmt

Enclosure A
	  	2/3	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  


					
	Matthew Powell	 		 	Robert C. Jones
	Vice President, Quality Operations	 		 	Executive Vice President,
		 		 	Research and Development


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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Enclosure A
	  	3/3	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 ENCLOSURE B: Table of Responsibilities 

N        =        NOVARTIS 

F        =        FLUIDIGM 

 

			
	 GENERAL REQUIREMENTS

		
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	 DESIGN & DEVELOPMENT

		
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  


			
	 DESIGN & DEVELOPMENT

		
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	 MANUFACTURE OF IN-VITRO DIAGNOSTICS DEVICE FOR VALIDATION AND CLINICAL TRIALS

		
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	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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Enclosure B
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  


			
	 MANUFACTURE OF IN-VITRO DIAGNOSTICS DEVICE FOR VALIDATION AND CLINICAL TRIALS

		
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	 PRIMARY PACKAGING FOR CLINICAL TRIAL LOTS

		
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	 SECONDARY PACKAGING FOR CLINICAL TRIAL LOTS

		
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	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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Enclosure B
	  	3/5	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  


			
	 SECONDARY PACKAGING FOR CLINICAL TRIAL LOTS

		
	 [***]
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	 RELEASE FOR SHIPMENT TO NOVARTIS FOR CLINICAL TRIAL LOTS

		
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	 DUTY OF CARE CHECK (UPON RECEIPT) FOR CLINICAL TRIAL LOTS

		
	 [***]
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	 [***]
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	NOVARTIS	 		  	FLUIDIGM
			
	  
	 		  	  

	Matthew Powell	 		  	Robert C. Jones


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
	 Development Quality Agmt

Enclosure B
	  	4/5	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  


					
	Vice President, Quality Operations	 		  	Executive Vice President,
		 		  	Research and Development


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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Enclosure B
	  	5/5	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 ENCLOSURE C: List of Approved Critical Sub-Contractors 

 

							
	 Name
	  	 Service
	  	  	  	 Date

	 Name1 Legal Form
 (City -
Country)
	  	{add letter(s)}	  	Last Audit	  	{dd.mm.yyyy}
		  		  	Quality agreement	  	{dd.mm.yyyy}
				
		  		  	Part of Authorization	  	yes/no

  

			
	    A	  	= Material supplier (optional)
	    B	  	= Performs verification testing
	    C	  	= Performs software development
	    D	  	= Performs hardware development
	    E	  	= Performs assay development
	    F	  	= Provides other services

  

					
	NOVARTIS	 		  	FLUIDIGM
			
	  
	 		  	  

	Matthew Powell	 		  	Robert C. Jones
	Vice President, Quality Operations	 		  	Executive Vice President,
		 		  	Research and Development


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
	 Development Quality Agmt

Enclosure C
	  	1/1	  	Version 1.0

  

 









 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 
  

 
  

 ENCLOSURE D: History of Changes 

 

							
	 Document Part
	  	 Version
	  	 Date
	  	 Reason for change

	Core Part	  	1.0	  	{dd.mm.yyyy}	  	Original
				
	Enclosure A	  	1.0	  	{dd.mm.yyyy}	  	Original
				
	Enclosure B	  	1.0	  	{dd.mm.yyyy}	  	Original
				
	Enclosure C	  	1.0	  	{dd.mm.yyyy}	  	Original
				
	Enclosure D	  	1.0	  	{dd.mm.yyyy}	  	Original

  

					
	NOVARTIS	 		  	FLUIDIGM
			
	  
	 		  	  

	Matthew Powell	 		  	Robert C. Jones
	Vice President, Quality Operations	 		  	Executive Vice President,
		 		  	Research and Development


  
  

 

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange Commission.

Confidential treatment has been requested with respect to the omitted portions.



 

					
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Enclosure D
	  	1/1	  	Version 1.0