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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 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

  
  

 

			
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	 Development Quality Agmt
 Core
Document
	  	16/17	  	Version 1.0

  

 

 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.

 

					
	 Development Quality Agmt
 Core
Document
	  	17/17	  	Version 1.0

  

 

 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

  
  

 

					
	 Development Quality Agmt
 Core
Document
	  	1/3	  	Version 1.0

  

 

 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.

 

					
	 Development Quality Agmt

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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	[***]	  	 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
	  	1/5	  	Version 1.0

  

 

 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.

 

					
	 Development Quality Agmt

Enclosure B
	  	2/5	  	Version 1.0

  

 

 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.

 

					
	 Development Quality Agmt

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.

 

					
	 Development Quality Agmt

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.

 

					
	 Development Quality Agmt

Enclosure D
	  	1/1	  	Version 1.0Enertopia Corp.: Exhibit 10.1 - Filed by newsfilecorp.com

ENERTOPIA CORPORATION.

January 31, 2011

0901502 B.C. Ltd (“Vendor”)

826 Leon Avenue 
Kelowna, BC, V1Y 6J8 
Canada 

Attention: Kristian Ross and Bill
Iversen

	Re: 	Proposed Terms of Acquisition of certain located mining
      claims in New Mexico, USA 

This offer letter (the “Offer”) sets out certain basic
terms and conditions by which Enertopia Corporation (“Enertopia”)
proposes to enter into negotiations to effect the optional acquisition of
certain located mining claims (the “Claims”) in New Mexico covering
approximately 1,230 acres from 0901502 B.C. Ltd. 0901502 B.C. Ltd holds the
Claims directly, and indirectly through mineral property option agreements (the
original optionors are hereby referred to as the “Underlying Owners”).
Upon the closing date of the transaction (the “Effective Date”) 0901502
B.C. Ltd will have the right to transfer, option, sell or assign the Claims to
Enertopia. The located mining claims and any underlying agreements will be
acquired by Enertopia through a mineral property option agreement, an assignment
agreement or an asset acquisition (the “Transaction”) on the terms set
forth below. 

Upon acceptance of this Offer by 0901502 B.C. Ltd, both 0901502
B.C. Ltd and Enertopia are obligated to use their best efforts to complete the
Transaction contemplated herein which is subject to the negotiation of
definitive documentation (the “Transaction Document”) which shall contain
the terms and conditions as set out in this Offer together with all schedules
and such other terms and conditions as are customary for transactions of the
nature contemplated herein. This Offer is intended to bind the parties, and it
is further intended that the terms set forth below will provide the basis upon
which Enertopia and 0901502 B.C. Ltd will negotiate in good faith the
Transaction Documents. The Transaction Document will supersede this Offer and
shall include definitive schedules describing the located mining claims and any
underlying agreements. All documentation shall be in a form and content
satisfactory to each of 0901502 B.C. Ltd and Enertopia and is subject to
receiving the approval of their respective boards of directors prior to signing,
and in the case of Enertopia the receipt of any necessary regulatory
approval(s). When used in this Offer capitalized terms not otherwise defined
herein but defined in any of Policy 1 or Policy 8 of the Canadian National Stock
Exchange (the “Exchange”) will have the meanings ascribed thereto in such
applicable Exchange Policy. Each of Enertopia and 0901502 B.C. Ltd acknowledges
that the initial 500,000 Enertopia shares (as defined below) to be received by
persons or companies who become shareholders of Enertopia following completion
of the Transaction may be subject to a legend restricting trading of these
shares as required by the applicable regulatory authorities. 

	1. 	Transaction Description

The Transaction may be effected in one
of several different ways including a, mineral property option agreement,
assignment agreement or an asset acquisition.

The parties will jointly determine the
optimum structure for the Transaction in order to best satisfy tax planning,
regulatory and other considerations. Prior to the Transaction 0901502 B.C. Ltd
shall confirm that it owns or controls the Claims.

- 2 -

	2. 	Purchase Price for the Claims
  

The consideration payable by Enertopia to 0901502 B.C. Ltd
pursuant to this Offer shall consist of:

	 	(a) 	
      paying $7,500 on signing the Offer; such payment is
      refundable by 0901502 B.C. Ltd if 0901502 B.C. Ltd fails to deliver the
      Claims to Enertopia co-incidental with signing of Transaction Documents as
      described above,

	 	 	 
	 	(b) 	
      paying $51,000 on signing of the definitive agreement
      (the “Agreement”) and issuing 500,000 common shares in the capital stock
      of Enertopia as soon as practicable following the execution of the
      Agreement,

	 	 	 
	 	(c) 	
      issuing an optional 150,000 shares in the capital stock
      of Enertopia on or before the first anniversary of the
Agreement,

	 	 	 
	 	(d) 	
      issuing an optional 150,000 shares in the capital stock
      of Enertopia on or before the second anniversary of the Agreement,
    and

	 	 	 
	 	(e) 	
      issuing an optional 200,000 shares in the capital stock
      of Enertopia on or before the third anniversary of the
  Agreement.

The consideration payable by Enertopia to the Underlying Owners
pursuant to this Offer shall consist of:

	 	(a) 	
      paying $3,000 on signing of the Agreement,

	 	 	 
	 	(b) 	
      paying an optional $7,500 on or before the first
      anniversary of the Agreement,

	 	 	 
	 	(c) 	
      paying an optional $10,000 on or before the second
      anniversary of the Agreement,

	 	 	 
	 	(d) 	
      paying an optional $12,500 on or before the third
      anniversary of the Agreement,

	 	 	 
	 	(e) 	
      paying an optional $25,000 on or before the fourth
      anniversary of the Agreement,

	 	 	 
	 	(f) 	
      paying an optional $25,000 on or before the fifth
      anniversary of the Agreement,

	 	 	 
	 	(g) 	
      paying an optional $50,000 on or before the sixth
      anniversary of the Agreement,

	 	 	 
	 	(h) 	
      paying an optional $200,000 on or before the seventh
      anniversary of the Agreement,

	 	 	 
	 	(i) 	
      paying an optional $200,000 on or before the eighth
      anniversary of the Agreement.

Enertopia is responsible to keep the located mineral claims and
any underlying agreements in good standing during the currency of the
Transaction. 

	3. 	NSR 

There is a 1% Net Smelter Return
(“NSR”) payable on one located mining claim up to a capped $2,000,000 dollars
from commercial production from that one located mining claim to be paid
according to the terms and conditions as set forth in the Transaction
Documents.

- 3 -

	4. 	Terms and Conditions in Favour of
      Enertopia 

Enertopia’s obligation to complete the
Transaction described herein will be subject to the following conditions (the
“Enertopia Closing Conditions”):

	 	(a) 	
      execution of Transaction Documents on substantially the
      same terms described herein, together with such other terms as are
      customary in a transaction of this nature,

	 	 	 
	 	(b) 	
      receipt by Enertopia of all required regulatory approvals
      in form and substance satisfactory to Enertopia,

	 	 	 
	 	(c) 	
      any underlying agreements being assigned to Enertopia,
      upon terms and conditions satisfactory to Enertopia,

	 	 	 
	 	(d) 	
      Enertopia shall have arranged and closed an equity
      financing of Enertopia common shares for minimum gross proceeds of
      $500,000, at a price of $0.10 per share (each, a “Unit”) (the
      “Financing”) on or before 30 days from the date of this Offer. The
      Financing is intended to close prior to completion of the
    Transaction,

	 	 	 
	 	(e) 	
      Enertopia being satisfied acting reasonably as to its due
      diligence investigations of the business, assets and affairs of 0901502
      B.C. Ltd and that that no material adverse change in the condition,
      business, properties or financial affairs of 0901502 B.C. Ltd has occurred
      prior to the Effective Date

	 	 	 
	 	(f) 	
      if required, the receipt of shareholder approval by
      0901502 B.C. Ltd shareholders to the Transaction,

	 	 	 
	 	(g) 	
      if required, the receipt of shareholder approval by
      Enertopia shareholders to the Transaction,

	 	 	 
	 	(h) 	
      all of the representations and warranties of 0901502 B.C.
      Ltd set forth in the Transaction Documents will be true and correct in all
      material respects as at the date made and as at the Effective
  Date;

	 	 	 
	 	(i) 	
      all of the obligations, covenants and requirements of
      0901502 B.C. Ltd described in this Offer and the Transaction Documents
      will have been met and complied with, and

	 	 	 
	 	(j) 	
      the Effective Date shall have occurred on or before
      February 28, 2011 (the “Outside Date”), or such other date as
      Enertopia and 0901502 B.C. Ltd shall agree in
writing.

The Enertopia Closing Conditions are for the exclusive benefit
of Enertopia and may be waived in whole or in part by it at any time.

	5. 	Terms and Conditions in Favour of 0901502
      B.C. Ltd 

0901502 B.C. Ltd’s obligation to complete the Transaction will
be subject to the following conditions (the “0901502 B.C. Ltd Closing
Conditions”):

	 	(a) 	
      execution of the Transaction Documents on substantially
      the same terms described herein, together with such other terms as are
      customary in a transaction of this nature,

	 	 	 
	 	(b) 	
      receipt by Enertopia of all required regulatory approvals
      in form and substances satisfactory to 0901502 B.C.
Ltd,

- 4 -

	 	(c) 	
      if required, the receipt of shareholder approval by
      0901502 B.C. Ltd’s shareholders to the Transaction,

	 	 	 
	 	(d) 	
      if required, the receipt of shareholder approval by
      Enertopia’s shareholders to the Transaction,

	 	 	 
	 	(e) 	
      0901502 B.C. Ltd being satisfied acting reasonably as to
      its due diligence investigations of the business, assets and affairs of
      Enertopia and that that no material adverse change in the condition,
      business, properties or financial affairs of Enertopia has occurred prior
      to the Effective Date

	 	 	 
	 	(f) 	
      all of the representations and warranties of Enertopia
      which are set forth in the Transaction Documents will be true and correct
      in all material respects as at the date made and as at the Effective
      Date;

	 	 	 
	 	(g) 	
      the Effective Date shall have occurred by the Outside
      Date, or such other date as Enertopia and 0901502 B.C. Ltd shall agree in
      writing and

	 	 	 
	 	(h) 	
      all of the covenants, obligations and requirements of
      Enertopia described in the Transaction Documents will have been met and
      complied with.

The 0901502 B.C. Ltd Closing Conditions are for the exclusive
benefit of 0901502 B.C. Ltd and may be waived in whole or in part by it at any
time.

	6. 	Standstill 

During the period from the satisfactory completion of due
diligence until this Offer is either superseded by the Transaction Documents or
February 28, 2011 or such other date agreed upon by the parties, 0901502 B.C.
Ltd agrees that it will:

	 	(a) 	
      not solicit offers or have discussion with any third
      parties regarding the sale of the Concessions.

	7. 	Transactional Support

The parties acknowledge that the
Transaction Documents will provide that Enertopia and 0901502 B.C. Ltd shall use
their best efforts to ensure that the transactions contemplated in this Offer
receive all applicable regulatory, shareholder and director approvals. 

	8. 	Access to Information

Upon acceptance of this Offer and until the completion of the
transactions contemplated by this Offer or the termination of the negotiations
contemplated herein, each party will allow the other and its respective
authorized representatives, including legal counsel and financial advisors,
access to all information, books or records relevant for the purpose of the
transactions contemplated herein. Each party hereto agrees that all information
and documents so obtained will be kept confidential and the contents thereof
will not be disclosed to any person without the prior written consent of the
disclosing party.

- 5 -

	9. 	Expenses and Commission

Each of Enertopia and 0901502 B.C. Ltd shall be responsible for
their own expenses and costs related to the transactions contemplated herein
including, without limitation, all costs and charges incurred prior to the date
of this Offer and all legal, advisory and accounting fees and disbursements
relating to the transactions contemplated herein.

	10. 	Other Items 

The Transaction Documents shall also contain such other terms,
conditions and agreements to which the parties hereto may reasonably request and
agree in order to complete the transactions contemplated in this Offer.

	11. 	Use and Confidentiality

All of the information and other data to which the each party
and/or their respective representatives are given access as set forth above will
be used by such party solely for the purpose of analyzing the other party hereto
and will be treated on a confidential basis. The terms, conditions and existence
of this Offer and all further discussions between the parties will also be
treated on a confidential basis, subject to appropriate disclosure to regulatory
authorities and as otherwise required by the requirements of any regulatory
authorities or securities exchanges which may be applicable.

All announcements pertaining to the contemplated transaction
will be subject to approval by the other party before public disclosure, subject
to a party's need to immediately comply with the requirements of any regulatory
authority (in which case best efforts will be made to obtain the other party's
approval). 0901502 B.C. Ltd acknowledges the requirement for Enertopia to issue
a press release announcing the entering into of the Offer, a draft of which will
be made available for review and comment by 0901502 B.C. Ltd, prior to
dissemination.

- 6 -

If this Offer is acceptable, please communicate your acceptance
by executing the duplicate copy hereof in the appropriate space below and
returning such executed copy to us, marked "STRICTLY CONFIDENTIAL" prior
to 4:00 p.m. on February 3, 2011, or such other date as Enertopia and
0901502 B.C. Ltd may agree in writing. This offer maybe signed in as many
counterparts as may be necessary, each of which so signed shall be deemed to be
an original ( and each signed copy sent by email or electronic facsimile
transmission shall be deemed to be an original), and such counterparts together
shall constitute one and the same instrument and notwithstanding the date of
execution shall be deemed to bear the date as set forth above.

ENERTOPIA CORPORATION.

	Per: 		 
	 	Robert McAllister, President 	 

THIS OFFER is hereby accepted on the terms and

conditions set forth herein as of the ____ day of ______________, 2011.

0901502 B.C. LTD MINERAL EXPLORATION

	Per: 		 
	 	Kristian
      Ross 	 
	 	  	 
	 	  	 
	 	  	 
	Per: 		 
	 	Bill
      Iversen

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