Document:

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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

  

					
	 	 	 
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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 
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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

  

			
	 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 
(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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 
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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 
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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 
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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 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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QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

  

	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

 

  

					
	 	 	 
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 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

  

	9.	SIGNATURES 

  

					
	NOVARTIS	 	 	 	FLUIDIGM
			
	  
	 	 	 	  

	 [***]
	 		 	 [***]

  

					
	 	 	 
	Development Quality Agmt	  	17/17	  	Version 1.0
	Core Document	  		  	

  

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions.
  

 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 ENCLOSURE A: List of Quality Liaisons 

[***] 

  

					
	 	 	 
	Development Quality Agmt	  	1/1	  	Version 1.0
	Core Document	  		  	

 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 ENCLOSURE B: Table of Responsibilities 

[***] 

  

					
	 	 	 
	Development Quality Agmt	  	1/1	  	Version 1.0
	Enclosure B	  		  	

  

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions.
  

 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 ENCLOSURE C: List of Approved Critical Sub-Contractors 

[***] 

  

					
	 	 	 
	Development Quality Agmt	  	1/1	  	Version 1.0
	Enclosure C	  		  	

  

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions.
  

 CONFIDENTIAL TREATMENT REQUESTED BY FLUIDIGM CORPORATION 

QUALITY AGREEMENT FOR DEVELOPMENT OF IN-VITRO DIAGNOSTIC DEVICES 

 
  

 

 ENCLOSURE D: History of Changes 

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	Enclosure D	  		  	

  

			
	[***]	  	 Information has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions.Co-Promotion Agreement

 Exhibit 10.24 

 
  

					
		  	

	 	
 

  

	
            FLUIDIGM CORPORATION      
      
 and
 454 LIFE SCIENCES, A ROCHE COMPANY
 CO-PROMOTION AGREEMENT

 
	 
	  
 Fluidigm Corporation
	  	454 Life Sciences	 
	7000 Shoreline Court, Suite 100,	  	20 Commercial Street	 
	South San Francisco,	  	Branford	 
	CA 94080 USA	  	CT 06405 USA	 
	Tel: (650) 266 6000	  	 Tel: (203) 871 2300

 
	 

 This Co-Promotion Agreement (the
“Agreement”) is made this
    20th   day of May, 2010, by and between 454 LIFE SCIENCES CORPORATION, A ROCHE COMPANY (“454 Life Sciences”), a Delaware corporation , and     Fluidigm
Corporation   (“Fluidigm”), both with their principal offices located at the addresses set forth above. 454 Life Sciences and Fluidigm are sometimes referred to herein collectively as the “Parties” and each
individually as a “Party.” 
 PRELIMINARY STATEMENTS 

A.        454 Life Sciences is engaged in the business of manufacturing, marketing and selling
medical products, including GS FLX System and GS Junior System, which is more specifically described in the Product Description contained in Exhibit A (hereinafter referred to as “454 Life Sciences Product”). 

B.        Fluidigm is engaged in the business of manufacturing, marketing and selling medical
products, including Access Array System, which is more specifically described in the Product Description contained in Exhibit B (hereinafter referred to as “Access Array System”). 

C.        454 Life Sciences wishes to promote the Access Array System and Fluidigm wishes to
promote 454 Life Sciences Product(s), both independently and in combination. 

D.        The Parties desire to enter into this Agreement in order to establish the terms of this
co-promotion arrangement between the Parties. 
 DEFINITIONS 
 “Affiliate” –  shall mean a) an organization, which directly or indirectly controls a Party to this Agreement; b) an organization, which is directly or indirectly
controlled by a Party to this Agreement; c) an organization, which is controlled, directly or indirectly, by the ultimate parent company of a Party. Control as per a) to c) is defined as owning more than fifty percent of the voting stock of a
company or having otherwise the power to govern the financial and the operating policies to appoint the management or to appoint the management of an organization. With respect to ROCHE the term “ Affiliate” shall not include Chugai
Pharmaceutical Co. Ltd., 1-1 Nihonbashi-Muromachi 2-chome, Chuo-ku Tokyo, 103-8324, Japan (“Chugai”), unless ROCHE opts for such inclusion of Chugai by giving written notice to Fluidigm. 

 “Applicable Laws” means all applicable common law, statutes, ordinances, rules,
regulations, codes, requirements, laws or orders of any Governmental Authority, including Regulatory Laws. 
 “Confidential
Information” – any and all of the following information of 454 Life Sciences (and/or its Affiliates) or Fluidigm (each, a “Disclosing Party”) that may be hereafter disclosed in any form, whether in writing,
orally, electronically or otherwise, or otherwise made available by observation, inspection or otherwise by such Disclosing Party to the other Party (the “Receiving Party”): (a) all information that is a trade secret under
applicable trade secret law or other legal requirement; (b) all information concerning product specifications, data, know-how, formulae, compositions, processes, designs, sketches, photographs, graphs, drawings, samples, inventions and ideas,
past, current and planned research and development, current and planned manufacturing or distribution methods and processes, customer lists, current and anticipated customer requirements, price lists, market studies, business plans, computer
hardware, software and computer software and database technologies, systems, structures and architectures; (c) all information concerning the business and affairs of the Disclosing Party (and/or its Affiliates) (which includes historical and
current financial statements, financial projections and budgets, historical, current and projected sales, capital spending budgets and plans, business plans, strategic plans, marketing and advertising plans, publications, client and customer lists
and files, contracts, the names and backgrounds of key personnel and personnel training techniques and materials, however documented), and all information obtained from review of the Disclosing Party’s documents or property or discussions with
the Disclosing Party regardless of the form of the communication; and (d) all notes, analyses, compilations, studies, summaries and other material prepared by the Receiving Party to the extent containing or based, in whole or in part, upon any
information included in the foregoing. For purposes of this Agreement, “454 Life Sciences Confidential Information” shall mean Confidential Information that is disclosed by 454 Life Sciences to Fluidigm, and “Fluidigm Confidential
Information” shall mean Confidential Information that is disclosed by Fluidigm to 454 Life Sciences. 
 “Effective Date”
shall mean the date appearing in the first paragraph of this Agreement. 
 “Governmental Authority” means all agencies,
commissions, officials, courts and other governmental and regulatory authorities and instrumentalities of the United States and any other countries in which the Products are manufactured, marketed, sold, tested, investigated or regulated, and all
states or other political subdivisions thereof and supranational bodies applicable thereto. 
 “Manufacturer” means a
manufacturer, remanufacturer, repackager and/or relabeler of a product, and/or a person who initiates specifications for a product that is manufactured by a second party. 
 “Manufacturing Processes” means the methods, processes, materials (including, without limitation, raw materials and manufacturing materials), controls and facilities (including, without
limitation, the equipment and equipment location) used in the manufacturing operations to produce the Product(s), including without limitation, the design, manufacture, packaging, labeling, handling, storage, distribution, installation and servicing
of the Product(s), as applicable, given the nature of the Product. 
 “Recall” means the removal or correction (including
repair, modification, adjustment, relabeling, destruction, or inspection) of a marketed product. 

  
 2 

 “Regulatory Authority” means with respect to any country or jurisdiction, any Governmental
Authority involved in granting approval of or regulating the investigation, manufacture, distribution, marketing, sale, pricing or reimbursement of the Products in that country or jurisdiction, including the FDA in the United States. 

“Regulatory Laws” means all Applicable Laws governing (i) marketing approval or clearance, import, export, testing, investigation,
design, manufacture, packaging, labeling, handling, storage, distribution, installation, servicing, marketing, or sale; (ii) recordkeeping and reporting; (iii) Recalls; or (iv) similar regulatory matters, with respect to the Products.

 “Term” means the term of the Agreement as set forth herein. 

TERMS 

NOW, THEREFORE, in consideration of the foregoing premises and the covenants set forth in this Agreement, and other good and valuable
consideration, the sufficiency of which is hereby acknowledged, the Parties, desiring to be legally bound, agree as follows: 
  

	 	1.	Roles. For purposes of this Agreement, the Parties shall have the following roles: 

 

	 	 (a)	454 Life Sciences or one of its Affiliates is the manufacturer of the 454 Life Sciences Product(s). 454 Life Sciences is a promoter of the Access Array
System and shall have the right to promote the Access Array System pursuant to the terms and conditions herein. 

  

	 	 (b)	Fluidigm is the manufacturer of the Access Array System. Fluidigm is a promoter of the 454 Life Sciences Products and shall have the right to promote the 454 Life
Sciences Products pursuant to the terms and conditions herein. 

  

	 	 (c)	In no instance shall either Party promote the Products as a system that would require clearance or approval by the FDA. 

 

	 	 (d)	Each Party may, in its discretion, undertake activities such as: (1) Providing general customer input, feedback, or information to the other Party at the other
Party’s request without initiating specifications for a device; or (2) providing an output specification for an existing, legally marketed medical device in response to the other Party’s unsolicited request for such information.
However, nothing in this Agreement shall be deemed to obligate either Party to undertake any activity that could reasonably result in that Party being deemed a Manufacturer under the Regulatory Laws of the other Party’s product(s).

  

	 	 (e)	Both Parties agree to promote products as per Exhibit C. Nothing in this Agreement shall be deemed to obligate either Party to any sales, revenue or profits for the
other Party as a result of the Party’s promotion of the other Party’s product. 

  

	 	2.	Compliance with Laws  

  

	 	 (a)	 Each Party represents, warrants and covenants that none of its Product(s) covered by this Agreement, at the time of introduction into interstate
commerce, is adulterated or misbranded within the meaning of the Federal Food, Drug, and 

  
 3 

	 	 
Cosmetic Act, as amended (21 U.S.C. 321-394) (the “Act”), or similar law of any other jurisdiction. The representations, warranties, and covenants set forth in this Section 2(a)
shall be deemed to be made and given on a continuing basis throughout the Term of this Agreement. 

  

	 	 (b)	Each Party represents, warrants and covenants that that it will take no action, including, without limitation, disseminating any promotional labeling or advertising, or
making oral statements, that will cause either Party’s Product(s) distributed under this Agreement to be adulterated or misbranded within the meaning of the Act, or similar law of any other jurisdiction. 

 

	 	 (c)	Each Party represents and warrants that it will comply with all Applicable Laws in the performance of its respective duties and actions undertaken pursuant to this
Agreement. 

  

	3.	Product Quality and Change Notification. 

  

	 	 (a)	Each Party shall ensure that the sale and distribution of Product(s) distributed pursuant to this Agreement, including, without limitation, the dissemination of any
promotional labeling or advertising, or the making of oral statements is in accordance with and conforms to the Product Description and any other requirements set forth herein. 

 

	 	 (b)	Each Party shall ensure that the sale and distribution of Product(s) distributed pursuant to this Agreement, including, without limitation, the dissemination of any
promotional labeling or advertising, or the making of oral statements, is in accordance with and conforms to all Applicable Laws and any operating procedures, quality requirements and other standards set forth herein. 

 

	 	 (c)	Neither Party shall make any change to the other Party’s Product(s), including promotional labeling and advertising matter, without prior written consent from the
other Party. 

  

	 	 (d)	Each Party shall notify the other Party at least five (5) business days prior to implementing any change to the Product(s) distributed including, without
limitation, disseminating any promotional labeling or advertising, or making oral statements pursuant to this Agreement, if such change would reasonably be expected to affect the Product’s or the dissemination of any promotional labeling or
advertising or the making of any oral statements compliance with Applicable Laws. Such notification shall include an explanation that describes the probable effect on the proposed change on the Product(s), promotional labeling or advertising or
future oral statements and compliance with the Applicable Laws. 

  

	4.	Recalls 

  

	 	 (a)	 If either Party, in good faith, determines that a Recall may be warranted of the Product(s), such Party shall promptly notify the other Party in
writing and shall advise such other Party of the reasons underlying its determination that a Recall may be warranted. The Parties shall consult with each other as to any action to be taken regarding such Recall; provided, however, that in the case
of a 

  
 4 

	 	 
disagreement, each Party shall have the final decision-making authority with respect to any action to be taken regarding such Recall of its respective Product(s). 

 

	 	 (b)	If either Party determines that a Recall of the other Party’s Product is warranted and the other Party decides not to Recall the Product, the Party that believes a
Recall is warranted may terminate this Agreement immediately, upon written notice to the other Party. 

  

	5.	Product Complaints. 

  

	 	 (a)	It is not the Parties’ intent that either Party will take complaint calls on behalf of the other Party. However, in the event that either Party does receive a
complaint call about the other Party’s Product(s), the Party will attempt to immediately transfer the information to the other Party’s designated customer service center. For 454 Life Sciences, that designated customer service center is
Roche Applied Science, at service.sequencing@roche.com. For Fluidigm, the designated customer service center is Fluidigm Technical Support at techsupport@fluidigm.com. The Party receiving the complaint will log the contact information for the caller
and provide it to the other Party within one (1) business day of receipt of such call. Each Party shall maintain adequate and accessible documentation of all such contact information associated with complaints regarding the Product(s).

  

	6.	Reporting Obligations. 

Each Party shall be responsible for reporting adverse device events, malfunctions, incidents, and other reportable events that the Party
is required to report pursuant to the Applicable Laws of any jurisdiction in which the Product(s) is marketed or sold. Each Party shall provide such assistance and information as the other Party reasonably requests to fulfill its reporting
obligations for the Product(s). 
  

	7.	Governmental Inspections and Inquiries. 

 If either Party receives notice of an inspection, audit, or inquiry by a Governmental Authority relating to the Product(s), arising from any activities under this Agreement, or concerning either
Party’s compliance with Applicable Laws in connection with its activities under this Agreement, the Party will notify the other Party as soon as possible, but in no event later than one (1) business day after receipt of such notice or
notification. The Parties agree to cooperate with each other during any inspection, investigation or other inquiry, including by providing information or documentation as requested by the Governmental Authority. 

 

	8.	Regulatory Documentation. 

  

	 	 (a)	Each Party shall accurately prepare and maintain all necessary and customary records related to the Product(s) and the activities undertaken pursuant to this Agreement,
in compliance with all Applicable Laws. 

  

	 	 (b)	Each Party shall have access to and the right to reference, copy, retain copies of, and use all such records, upon request and without charge, in each case only to the
extent necessary for compliance with all Applicable Laws. 

  
 5 

  

	9.	Violations.  Each Party shall notify the other Party no later than one (1) business day after becoming aware of any violation of any Applicable
Laws or requirements set forth herein, or otherwise relating to or arising out of activities taken pursuant to this Agreement. 

  

	10.	Use of Trade Names and Marks; Promotional Materials.  Fluidigm shall not, in the course of its marketing efforts, use 454 Life Sciences’s
corporate name, the 454 Life Sciences Products trade name(s), the names of any other 454 Life Sciences products, or any 454 Life Sciences logo, trademark, service mark or other trade dress or marks without the prior written approval of 454 Life
Sciences in each instance, such approval not to be unreasonably withheld or delayed. 454 Life Sciences shall not, in the course of its marketing efforts, use Fluidigm’s corporate name, the Access Array System trade name, the names of any other
Fluidigm products, or any Fluidigm logo, trademark, service mark or other trade dress or marks without the prior written approval of Fluidigm in each instance, such approval not to be unreasonably withheld or delayed. All promotional materials,
including web site content, prepared by Fluidigm that reference Roche Diagnostics or the 454 Life Sciences Products must first be reviewed and approved in writing by 454 Life Sciences, except that 454 Life Sciences may provide Fluidigm with certain
template materials that may be reproduced in accordance with specific guidelines established by 454 Life Sciences without the necessity of gaining 454 Life Sciences approval for each individual use. Any such template materials will be identified as
such in writing, along with any limitations relating to their use. 

  

	11.	No Expansion of Warranties.  In the course of performance hereunder, neither Party shall make or expand any representation or warranty respecting the
other Party’s Products, unless approved in advance by the Party offering such Product. 

  

	12.	Confidentiality.  In the event that either Party discloses to the other Confidential Information, the following terms shall govern.

  

	 	    (a)	Confidentiality and Restricted Use.  Each Receiving Party of Confidential Information hereunder acknowledges the confidential and proprietary nature of
the Confidential Information of the Disclosing Party and agrees that, for a period of five (5) years following the expiration or termination of this Agreement, such Confidential Information (i) shall be kept confidential by the Receiving
Party; (ii) shall not be used for any reason or purpose other than in furtherance of such Party’s performance of its obligations hereunder; (iii) shall not be shared with or disclosed to any Affiliate or internal operating division of
the Receiving Party other than the Receiving Party’s core internal functions and the Receiving Party’s operating division(s) directly responsible for performance under this Agreement; and (iv) without limiting the foregoing, shall not
be disclosed by the Receiving Party to any person or entity, except in each case as otherwise expressly permitted by the terms of this Agreement or with the prior written consent of an authorized representative of the Disclosing Party.

  

	 	    (b)	 Exceptions.  The restrictions set forth above do not apply to that part of the Confidential Information of a Disclosing Party that the
Receiving Party demonstrates (i) was, is or becomes generally available to the public other than as a result of a breach of this Agreement by the Receiving Party; (ii) was or is

  
 6 

	 	 
developed by the Receiving Party independently of and without reference to any Confidential Information of the Disclosing Party; or (iii) was, is or becomes available to the Receiving Party
on a non-confidential basis from a third party not bound by a confidentiality agreement or any legal, fiduciary, or other obligation restricting disclosure. 

 

	 	    (c)	Legal Proceedings.  If the Receiving Party becomes compelled in any legal proceeding or is requested by a Governmental Authority having the requisite
legal or regulatory jurisdiction and authority to make any disclosure that is prohibited or otherwise constrained by this Section, the Receiving Party shall provide the applicable Disclosing Party with prompt notice of such compulsion or request so
that it may seek an appropriate protective order or other appropriate remedy or waive compliance with the provisions of this Section. In the absence of a protective order or other remedy, the Receiving Party may disclose that portion (and only that
portion) of the Confidential Information of the Disclosing Party that, based upon advice of the Receiving Party’s counsel, the Receiving Party is legally compelled to disclose or that has been requested by such Governmental Authority;
provided, however, that the Receiving Party shall use reasonable efforts to obtain reliable assurance that confidential treatment will be accorded by any person, entity or governmental body to whom any Confidential Information is so
disclosed. The provisions of this paragraph do not apply to any legal proceedings between the Parties to this Agreement. 

  

	 	    (d)	Return or Destruction of Confidential Information.  Upon expiration or earlier termination of this Agreement, the Receiving Party shall promptly
deliver to the Disclosing Party all Confidential Information of the Disclosing Party, together with all copies thereof, in the possession, custody or control of the Receiving Party or, alternatively, with the written consent of the Disclosing Party,
destroy all such Confidential Information and certify such destruction in writing to the Disclosing Party; provided, however, that the Receiving Party may retain one copy of such Confidential Information in its legal department to
facilitate the resolution of any controversies after the Disclosing Party’s Confidential Information is returned. 

  

	13.	Product Warranty.  Any and all warranties which may be provided with respect to any particular Product are detailed in the applicable Product
packaging/labeling. Both Parties expressly acknowledge and agree that neither Party makes any representation, guarantee or warranty, express or implied, as to the merchantability or fitness for a particular purpose of Products, and neither Party
shall make any statements or representations that may cause an expansion of the other Party’s’ Product warranties. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES.

  

	14.	 Indemnity.  454 Life Sciences agrees to indemnify and hold Fluidigm harmless from all liabilities, arising from 454 Life
Sciences’s negligence or willful misconduct or 454 Life Sciences’s failure to perform its duties or obligations as set forth in this Agreement, except to the extent caused by Fluidigm’s negligence or willful misconduct. Fluidigm
agrees to indemnify and hold 454 Life Sciences harmless from all liabilities, including reasonable attorneys fees, arising from its negligence, willful misconduct, failure to perform its duties or obligations as set forth in this Agreement, or
misuse of the Product(s), except to the extent caused by 454 Life Sciences’s negligence or willful 

  
 7 

	 	 
misconduct. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES. 

 

	15.	Term and Termination.  The term of this Agreement shall begin as of the Effective Date and continue until the occurrence of any of the following:

  

	 	    (a)	Either Party shall have the right to terminate this Agreement, with or without cause, at any time upon thirty (30) days prior written notice to the other Party.

  

	 	    (b)	This Agreement may be terminated at any time upon the mutual agreement of the Parties, in writing. 

 

	 	    (c)	In the event of a default or material breach of this Agreement, the non-defaulting Party shall provide the other Party with written notice of such default or material
breach. If such breach or default has not been cured within thirty (30) days of receipt of such written notice, the non-defaulting Party may terminate this Agreement immediately upon written notice. 

 

	 	    (d)	This Agreement may be terminated by a Party on notice to the other Party: (i) upon the occurrence of the other Party hereto (1) applying for or consenting to
the appointment of, or the taking of possession by, a receiver, custodian, trustee or liquidator of itself or of all or a substantial part of its property, (2) making a general assignment for the benefit of its creditors, (3) commencing a
voluntary case under the United States Bankruptcy Code or other similar law, as now or hereafter in effect (the “Bankruptcy Code”), (4) filing a petition seeking to take advantage of any law (the “Bankruptcy Laws”) relating
to bankruptcy, insolvency, reorganization, winding-up, or composition or readjustment of debts, (5) failing to controvert in a timely and appropriate manner, or acquiesce in writing to, any petition filed against it in any involuntary case
under the Bankruptcy Code, or (6) taking any corporate action for the purpose of effecting any of the foregoing; or (ii) if a proceeding or case shall be commenced against the other Party hereto in any court of competent jurisdiction,
seeking (1) its liquidation, reorganization, dissolution or winding-up, or the composition or readjustment of its debts, (2) the appointment of a trustee, receiver, custodian, liquidator or the like of the Party or of all or any
substantial part of its assets, or (3) similar relief under any Bankruptcy Laws, or an order, judgment or decree approving any of the foregoing shall be entered and continue un-stayed for a period of 60 days; or an order for relief against the
other Party hereto shall be entered in an involuntary case under the Bankruptcy Code. 

 Termination of this
Agreement for any reason shall not release any Party hereto from any liability (or obligation assumed and substantially undertaken but not yet accrued) which, at the time of such termination, has already accrued to the other Party or which is
attributable to a period prior to such termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder at law or in equity which accrued or are based upon any event occurring prior to such termination, subject to
any limitations on damages expressly set forth herein. 
  

	16.	 Additional Representations of Parties.  Each Party hereby represents and warrants that it is authorized to enter into this Agreement,
and that execution, delivery and performance of this Agreement will not, with or without notice, the passage of time or both, result in any violation of, be in conflict with, or constitute a default under any

  
 8 

	 	 
contract, obligation or commitment to which it is a party or by which it is bound, or to its knowledge, any statute, rule or governmental regulation applicable to it. Each Party further warrants
that it owns all necessary intellectual property and/or proprietary rights required for performance of this Agreement, and agrees that it shall indemnify, defend and hold harmless the other Party against any costs, expenses, damages payable to third
parties (e.g., by settlement agreed by the indemnifying Party or judgment), and liabilities (including reasonable attorneys’ fees and expenses) resulting from such breach. Any claim for indemnification pursuant to this paragraph shall be
subject to the indemnification provisions set forth above. 

  

	17.	Third Party Claim of Infringement 

  

	 	    (a)	If a claim of patent infringement or misappropriation or wrongful use of a trade secret or other proprietary right is brought against a Party hereto in any country by
reason of any act conducted in the furtherance of this Agreement, or if a Party becomes aware of any act potentially infringing a patent or other proprietary right owned by a third party in any country, such Party shall promptly give notice thereof
to the other Party and provide it with all information in its possession regarding such claim or potential infringement. 

  

	 	    (b)	Each Party shall indemnify, defend and hold harmless the other Party against any costs, expenses, damages payable to third parties (e.g., by settlement agreed by the
indemnifying Party or judgment), and liabilities (including reasonable attorneys’ fees and expenses) resulting from a claim of patent infringement or misappropriation or wrongful use of a trade secret or other proprietary right to the extent
that such costs, expenses or liabilities are caused by the indemnifying Party’s products, including such Party’s Products, or actions, in connection with this Agreement. 

 

	 	    (c)	 In any claim for indemnification (an “Indemnity Claim”), the indemnified Party agrees to give the indemnifying Party prompt written notice of
any matter upon which such indemnified Party intends to base such a claim under this Agreement. Counsel shall be selected by the indemnifying Party. The indemnified Party may, at its sole option and expense, participate in such defense, and further
agrees to fully cooperate in the conduct of any such defense. With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified Party’s becoming subject to injunctive or other
equitable relief or otherwise adversely affect the business of the indemnified Party in any commercially significant manner, and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the indemnified Party
hereunder, the indemnifying Party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim, on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate; provided that the indemnifying Party
shall provide reasonable evidence of its ability to pay any damages claimed and with respect to any such settlement shall obtain the written release of the indemnified Party from the Indemnity Claim. The indemnifying Party shall obtain the written
consent of the indemnified Party, such consent not to be unreasonably withheld, prior to ceasing to defend, settling or otherwise disposing of any Indemnity Claim if as a result thereof the indemnified Party would become subject to injunctive or
other equitable relief or the business of the indemnified Party would be adversely affected in any manner. In the event that any such indemnity 

  
 9 

	 	 
obligation shall be apportioned greater than 50% to any Party, that Party shall have the right to control the Indemnity Claim, subject to the participation and involvement of the other Party.

  

	18.	Intellectual Property.  Unless specifically granted otherwise, nothing contained in this Agreement shall be construed to grant one Party a license or
in any way give ownership to any of the other Party’s intellectual property, or any intellectual property owned by any Affiliate or any third party. 

  

	19.	Assignment.  Neither this Agreement nor any of the rights, interests nor obligations hereunder may be assigned by either Party without the prior
written consent of the other Party which consent shall not be unreasonably withheld. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns,
and no other person shall have any right, benefit or obligation under this Agreement as a third party beneficiary or otherwise. Any assignment in violation of this paragraph is void. 

 

	20.	Governing Law, Venue, Right to Jury Trial.  The Parties agree that the internal laws of the State of Delaware, without regard to choice of law
principles, will govern this Agreement and any disputes concerning the subject matter addressed herein, and Fluidigm consents to the exclusive jurisdiction of and venue in any state or federal court located within the State of Delaware. Each Party
expressly waives its rights to trial by jury. 

  

	21.	Severability.  Should any provision of this Agreement be held invalid, ineffective or unenforceable, the remaining terms will remain in full
force and effect. 

  

	22.	Force Majeure.  Either Party’s obligations under this Agreement shall be suspended in the event that Party is hindered or prevented from
complying with its obligations because of labor disturbances, wars, acts of domestic or international terrorism, fires, storms, accidents, interferences or any other cause beyond its reasonable control. 

 

	23.	Entire Agreement.  The Parties agree that the terms and conditions in this Agreement (together with any attachments or exhibits thereto), if any, along
with any related license agreements between Fluidigm and 454 Life Sciences or its Affiliates, make up the entire agreement between Fluidigm and 454 Life Sciences with respect to the subject matter hereof. 

 

	24.	Amendment.  This Agreement shall not be amended except by written instrument executed by both Parties. 

 

	25.	Survival.  All rights hereunder shall survive the term of this Agreement. 

 

	26.	Notices.  All notices shall be given in writing by the Party sending the notice and shall be effective when deposited in the U.S. Mail,
certified with return receipt requested, addressed to the Party receiving the notice at its address shown on the face of this Agreement. For notices sent to 454 Life Sciences, duplicate copies should be sent to both the Law Department and the
President of 454 Life Sciences. For notices sent to Fluidigm, duplicate copies should be sent to both the General Counsel and the CEO of Fluidigm. 

  
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	27.	Non-waiver.  No term or provision hereof shall be deemed waived and no breach excused unless such waiver or consent shall be in writing and signed by a
duly authorized representative of the Party claimed to have waived or consented. 

  

	28.	Independent Relationship of the Parties.  The Parties intend that an independent contractor relationship shall be created by this Agreement, and
nothing herein shall be construed as creating an employer/employee relationship, partnership, joint venture, or concerted action. 

  

	29.	Miscellaneous.  The titles and headings used in this Agreement are for convenience only and shall not be used to interpret the terms and conditions of
this Agreement. If either Party delays or fails to enforce any of its rights under this Agreement or any Schedule, that Party will be able to enforce its rights at a later time. The terms of this Agreement and all Schedules is the confidential
information of each Party and shall not be disclosed by the other Party to any third party, except (a) as may be required by any court or other governmental body, law or government regulation including applicable securities laws and
regulations, and including to legal and financial advisors in their capacity of advising a Party in such matters; (b) to legal counsel of the Parties, accountants, and other professional advisors; (c) in confidence, to banks, investors and
other financing sources and their advisors; (d) in connection with the enforcement of this Agreement or rights under this Agreement between the Parties; (e) during the course of litigation so long as the disclosure of such terms and
conditions are restricted in the same manner as is the confidential information of other litigating parties and so long as (1) the restrictions are embodied in a court-entered protective order limiting disclosure to outside counsel and
(2) the disclosing Party informs the other Party in writing at least ten (10) business days in advance of the disclosure and discusses the nature and contents of the disclosure, in good faith, with the other Party; or (f) in
confidence, in connection with an actual or prospective merger or acquisition or similar transaction. 

[Remainder of Page Intentionally Left Blank] 

  
 11 

 IN WITNESS WHEREOF, this Agreement is executed as of the date first above written.

  

									
	454 LIFE SCIENCES CORPORATION, A	 		 	FLUIDIGM CORPORATION
	ROCHE COMPANY	 		 	(“Fluidigm”)
	(“454 Life Sciences”)	 		 		 	
		 		 		 	By:	 	 /s/ Vikram Jog

	By:	 	 /s/ Christopher K. McLeod
	 		 		 	

									
		 		 		 	Printed:	 	 Vikram Jog

	Printed:	 	 Christopher K. McLeod
	 		 		 	

									
		 		 		 	Title:	 	 Chief Financial Officer

	Title:	 	 President
	 		 		 	

 

 

  
 12 

 Exhibit A 

Product Description 
 GS FLX System 
 GS FLX Instrument 

The Genome Sequencer instrument is the centerpiece of the Genome Sequencer FLX System. The fluidics subsystem ensures accurate reagent dispensing. It
consists of a reagents cassette holding the reagent containers, a sipper manifold, pumps, valves, and debubblers. The fluidics subsystem flows the sequencing reagents across the wells of the PicoTiterPlate device, and moves the spent reagents from
the PicoTiterPlate device to the waste receptacle. 
 The optics subsystem consists of a CCD camera and a camera controller. The camera captures
the light emitted in the wells of the PicoTiterPlate device during each step of the sequencing cycle, and sends the digital images to the computer subsystem for processing. 

 

			
	Dimensions: upper
assembly	 	 74.3 cm W × 69.8 cm D × 36.1 cm H
 (29.25 in W × 27.5 in D × 14.2 in H)
 including monitor 82.5 cm (32.5 in)
H

		
	Dimensions: lower
assembly	 	 75.2 cm W × 90.8 cm D × 92.7 cm H
 (29.62 in W × 35.75 in D× 36.5 in H)

		
	Weight	 	242 kg (532 lbs)
		
	Power supply	 	 85 - 132 Vac 50/60Hz
 173 -
264 Vac 50/60Hz

		
	Noise level	 	<65 dB(A)
		
	Electromagnetic emission	 	 Class A
 Important: This is
a Class A device. In residential areas, this device may cause radio interference. The user should take the necessary precautions, if appropriate.

		
	Electromagnetic immunity	 	Important: In industrial areas, this device may be influenced by radio interference. The user should take the necessary precautions, if appropriate.

For life science research only. Not for use in diagnostic procedures. 

  
 13 

 GS FLX Titanium Series: 
 The GS FLX Titanium series reagents run on the Genome Sequencer FLX Instrument, a system based on 454’s sequencing-by-synthesis technology. The GS FLX Titanium series improves on the current system
with upgraded reagents, consumables, and software. 
  

			
	Throughput	  	 400-600 million high-quality, filter-passed bases per run*
 1 billion bases per day

		
	Run Time	  	10 hours
		
	Read Length	  	Modal length = 500 bases, Average length = 400 bases
		
	Accuracy	  	Q20 read length of 400 bases (99% at 400 bases and higher for prior bases)
		
	Reads per run	  	>1 million high-quality reads
		
	Data	  	Trace data accepted by NCBI since 2005
		
	Computing
Requirements	  	Cluster recommended (Roche GS FLX Titanium Cluster available)
		
	Robustness	  	No complex optics or lasers; reagents have long shelf life

For life science research only. Not for use in diagnostic procedures. 

  
 14 

 GS Junior System 
 The GS Junior System brings the power of 454 Sequencing technology directly to your laboratory bench top. Benefit from the same proven long-read sequencing performance as the Genome Sequencer FLX System,
scaled to suit the needs of individual labs. Quickly proceed from DNA to data to discovery with a simple sample preparation workflow, overnight sequencing and data processing, and a dedicated suite of data analysis software. 

 

			
	  

System Performance

 

	Throughput	 	  
 >35 million high-quality, filtered bases per run*
  

	Run Time	 	  
 10 hours sequencing
 2 hours data processing

 

	Read Length	 	  
 Modal length = 500 bases
 Average length = 400 bases*

 

	Accuracy	 	  
 Q20 read length of 400 bases
 (99% accuracy at 400 bases)

 

	Reads per Run	 	  
 100,000 reads (on average)
  

	Sample Input	 	  
 gDNA, amplicons, cDNA, or BACs depending on the application
  

	Physical Dimensions            	 	  
 40 cm wide x 60 cm deep x 40 cm high (the size of a laser printer)
 Weight = 55 lbs.

 

	Computing	 	  
 Linux-based OS on HP desktop computer included.
 All software is point-and-click.

 

	  

*Typical results. Average read length and number of reads depend on specific sample and genomic
characteristics
  

 For life science research only. Not
for use in diagnostic procedures. 

  
 15 

 Exhibit B 

Product Description 
 Access Array System 
 The Access ArrayTM Integrated Fluidic Circuit (IFC)
facilitates parallel amplification of 48 unique samples, in effect preparing 48 sequencing libraries, in just a few hours. Every reaction combines both an amplicon tagging and a barcoding (identification) step that enables all 48 amplicons to be
multiplexed at the sequencing step. This powerful chemistry simplifies the up-front preparation and maximizes the utility of today’s next generation sequencers. 
 The Fluidigm Access Array System can be used with any PCR-based sample preparation method and with the reagents and primers of your choice. The system includes Access Array IFCs—single-use
microfluidic chips—two IFC Controller AXs, and the Stand-Alone Thermal Cycler that easily deliver sample throughput and coverage that scale with laboratory needs. 
  

					
	Input	  	Reactions	  	Output
	48 Samples per array	  	2,304 individual PCR reactions	  	Product pooled automatically
			
	48 Primer pairs per array	  	30nL individual reaction volume	  	Each sample is harvested individually
			
	Only 96 pipette steps per array	  	Fixed reaction volumes assure reproducibility	  	Only 48 pipette steps to harvest product

 For research use
only. Not for use in diagnostic procedures. 

  
 16 

 Exhibit C 
 Co-Promotional Activities 
  

	1.	Linking.    Fluidigm and 454 Life Sciences will each appoint an employee within their respective organizations with the authority to manage
the obligations of each Party under this Exhibit C (hereafter the “Agreement Administrator”), subject to (2). The Agreement Administrators will coordinate efforts to establish and maintain at least one link to and from a designated page on
the 454 Life Sciences website to and from a designated page on the Fluidigm website regarding 454 Life Sciences Products and the Access Array System. With the mutual consent of the Agreement Administrators the Parties will establish additional links
from other areas within the Fluidigm website to and from the 454 Life Sciences website, or perform any other act that the Agreement Administrators determine are consistent with, or necessary to achieve, the purpose of this Agreement.

  

	2.	The Parties may during the course of this Agreement also agree on further co-marketing activities such as: 

 

	 	•	 	 Banner advertising on their respective websites 

  

	 	•	 	 Joint promotional material (flyers, brochures etc.) 

  

	 	•	 	 Joint publications and trade show activities 

  

	 	•	 	 Dedicated mini-website to the combination of products 

 

	 	•	 	 Other appropriate co-marketing activities 

 For purposes of clarification, the Agreement Administrators will facilitate discussions related to paragraph 1 or this paragraph 2 but will not have the independent authority to bind the Parties
with respect to paragraph1 or 2 activities. 
  

	3.	Costs.  Each Party shall bear its own costs for complying with its obligations under this Agreement. 

 

	4.	No Commissions/Other Payments.  Neither Party shall be obligated to pay the other Party any amounts for the sale of Product that result from
this Agreement. No commission or other forms of remuneration will be provided by either Party to the other Party pursuant to this Agreement. 

  
 17

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