Services and Supply Agreement



  
 Exhibit 10.23

 [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the omitted portions. 
 SERVICES AND SUPPLY
AGREEMENT 
 THIS SERVICES AND SUPPLY AGREEMENT, together with exhibits attached
hereto (the “Agreement”), effective as of January 1, 2009 (the “Effective Date”), is entered into by and between DIADEXUS, INC., a Delaware corporation, having its
principal place of business at 343 Oyster Point Boulevard, South San Francisco, California 94080 (“diaDexus”), and DIAZYME LABORATORIES, a division of General Atomics, having its
principal place of business at 12889 Gregg Court, Poway, California 92064 (“Supplier”). diaDexus and Supplier may each be referred to herein individually as a “Party” or, collectively, as “Parties.” 

RECITALS 
 WHEREAS, Supplier has expertise in the manufacture of certain clinical chemistry diagnostic test kits, and; 

WHEREAS, diaDexus has technology and intellectual property related to certain
reagents and diagnostic test kits, and; 
 WHEREAS, diaDexus and Supplier
wish to enter into an agreement under which diaDexus will provide to Supplier certain clinical chemistry components in bulk form, and Supplier shall test and repackage those components into kits for diaDexus’ customers, as set forth in more
detail herein. 
 NOW, THEREFORE, in consideration of the
promises and undertakings set forth herein, the Parties agree as follows: 
 DEFINITIONS 

Capitalized terms not otherwise defined herein will have the meaning set forth below: 

“Affiliate” means any corporation, firm, limited liability company, partnership or other entity that
directly or indirectly controls or is controlled by or is under common control with diaDexus or Supplier, respectively. Solely for purposes of the definition of Affiliate, “control” or “controlled” means ownership, directly or
through one (1) or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interests in the
case of any other type of legal entity, or any other arrangement whereby an entity controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity. 

“Certificate of Analysis” shall mean a certificate of analysis signed and dated by an individual
authorized by diaDexus to certify that the results of assays conducted on an indicated lot of Products hereunder conform to the Specifications therefore. The Certificate of Analysis shall include a description of the reagent, lot numbers, reagent
expiration dating, and other pertinent information. 

  

					
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“Confidential Information” shall mean any proprietary information, technical data, trade secrets or
know-how, including, but not limited to, research, product plans, products, services, customers, customer lists, markets, software, developments, inventions, processes, formulas, technology, designs, drawings, engineering, hardware configuration
information, marketing, finances or other business information disclosed by the disclosing Party directly or indirectly in writing, orally, or by drawings. 
 “Control” means, with respect to any information or an intellectual property right, possession of the ability, whether arising by ownership or license, to grant a license or sublicense as
provided for herein under such information or right without violating the terms of any written agreement with any third party. 
 “Critical Components” means those certain materials supplied in bulk by diaDexus and specified in Exhibit A attached hereto. 

“Customer” means diaDexus’ end user customer(s) to which Supplier ships Product. 

“diaDexus Technology” means the diaDexus Patent Rights and diaDexus Know-How, as defined below:

 (a)    “diaDexus Patent Rights” means any and all Patent Rights
covering the diaDexus Know-How. 
 (b)    “diaDexus Know-How” means the
information, data, skills, processes, methods, know-how, trade secrets and experience, including, without limitation, formulas and specifications, whether patentable or not, that are controlled by diaDexus at anytime during the Term and that are
necessary for Supplier to use the Critical Components solely in the manufacture of Products under this Agreement. 
 “Lot” means a particular manufacturing run of either Critical Components from diaDexus to Supplier, or Product in its final kitted format from Supplier, which has been manufactured or
packaged all at the same time. 
 “Patent Right” means: (a) all issued and existing
patents, including any extensions, supplemental protection certificates, registrations, confirmations, reissues, reexaminations or renewals thereof; and (b) all pending applications, including any provisional applications, converted provisional
applications, continuing prosecution applications and continuation, divisional, or continuation-in-part applications thereof, for any of the foregoing. 
 “Pricing” shall mean with respect to each Product, the price set forth in Exhibit B as of the Effective Date. 

“Product” shall mean the final format kitted items as described on Exhibit C, as may be amended from
time to time in writing by the Parties, which have been tested and re-packaged into kits by Supplier from the bulk components provided by diaDexus under this Agreement. 

  

					
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 “Quality
Agreement” shall mean the agreement entered into by the Parties within sixty (60) days of this Agreement’s execution and substantially in the form attached hereto as Exhibit D. 

“Specifications” means (a) the written specifications for the Critical Components supplied by diaDexus under this
Agreement, and/or (b) the written specifications for the Products as of the Effective Date, as such specifications may be modified solely by diaDexus from time to time with [*] advanced notice to Supplier, and against which the
components and Products will be tested. 
 “Supplier Technology” means the Supplier Patent Rights and Supplier
Know-How, as defined below: 
 (a)    Supplier Patent Rights” means any and all Patent Rights
covering the Supplier Know-How. 
 (b)    “Supplier Know-How” means the information, data,
skills, processes, methods, know-how, trade secrets and experience, including, without limitation, formulas and specifications, whether patentable or not, that are controlled by Supplier at any time during the Term and that are necessary for
diaDexus to sell or offer to sell the Products under this Agreement. 
 “Term” shall have the meaning set forth
in Section 7.1. 
 SUPPLY 
 Terms and Conditions. All supply of Critical Components by diaDexus to Supplier and all supply of Products by Supplier to Customer(s) shall be subject to the terms and conditions of this Agreement.
ANY TERMS OR CONDITIONS OF ANY PURCHASE ORDER OR ACKNOWLEDGMENT GIVEN OR RECEIVED WHICH ARE ADDITIONAL TO OR INCONSISTENT WITH THIS AGREEMENT SHALL HAVE NO EFFECT AND SUCH TERMS AND CONDITIONS ARE HEREBY EXCLUDED AND REJECTED. 

Supply. Subject to the terms and conditions of this Agreement, diaDexus shall supply Critical Components to Supplier and Supplier
shall supply Products to diaDexus’ Customer. All such Critical Components and Products shall comply with all applicable Specifications. 
 2.3    Forecasts. Upon the Effective Date and each quarter afterward, diaDexus shall provide Supplier with a non-binding written rolling forecast (“Forecast”) of the
quantities of each Product that it expects to sell to Customers [*]. 
 2.4    Supply of Critical
Components and Quality Testing 
 (a)    Supply of Critical Components. At the time diaDexus
wishes Supplier to begin production of Products, and quarterly thereafter, diaDexus shall provide to Supplier, at diaDexus’ expense, a quantity of Critical Components that diaDexus believes will be sufficient

  

[*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.
Confidential treatment has been requested with respect to the omitted portions. 

  

					
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to meet Supplier’s needs for [*], pursuant to the Forecast. Supplier shall use any and all such Critical Components solely in the manufacture of Products under this Agreement, and
shall keep written records of the amounts used for each Lot. The Critical Components supplied by diaDexus [*]; provided, however, that diaDexus retains sole ownership and title of the Critical Components at all times; and, provided further,
that Supplier shall use Critical Components only in Products supplied to diaDexus or its Customers, and not waste, discard, damage or destroy any such Critical Components other than wastage associated with normal manufacturing processes used by
Supplier under this Agreement, including, but not limited to, void volume losses, QC testing, and retention samples. diaDexus shall have the right to audit Supplier’s use of Critical Components supplied under this Agreement upon reasonable
written notice to Supplier. 
 (b)    Quality Control (“QC”) Testing. All
QC testing will follow Supplier’s standard procedures, and is subject to [*]. Upon receipt of Critical Components, Supplier shall perform sufficient incoming QC testing on such Critical Components to evaluate their suitability for use by
Supplier under this Agreement. Should the Critical Components fail the incoming QC test, Supplier shall notify diaDexus, and diaDexus may request an additional round of QC testing [*], or request return of such Critical Components to diaDexus
at diaDexus’ expense. [*] 
 2.5    Orders. 

(a) Production Orders. diaDexus shall place firm Product production orders, setting forth the number of units of
each Product to be assembled, with Supplier [*] prior to required release of Products into Supplier inventory. Provided the production order is free of material errors and is consistent with the Forecast, Supplier shall accept and acknowledge
each production order in writing (which shall include designated email addresses or facsimile numbers), subject to the terms and conditions of this Agreement. 
 (b) Customer Orders. diaDexus shall place [*], purchase orders with Supplier [*] prior to each requested shipping date to Customers, setting forth the number of units of each Product,
delivery dates, and exact shipping instructions, including carrier, for each identified ship-to Customer. However, upon receipt of request from diaDexus in the form of a typed Customer purchase order from diaDexus via fax or e-mail, provided
finished Product inventory levels are adequate to meet the need, Supplier will use its best efforts to drop ship such order to Customer the same day of order provided such order is received by Supplier [*] of same ship date. Customer purchase
orders received by Supplier [*] shall ship to Customer no later than the following day, provided finished Product inventory levels are adequate to meet the need. 

(c) Order Acceptance. Provided a production order pursuant to Section 2.5(a) or a Customer order pursuant to
Section 2.5(b) is free of material errors, Supplier shall accept and acknowledge each order in writing (which shall include designated email addresses or facsimile numbers), subject to the terms and conditions of this Agreement. If there is an
error in an order, Supplier shall promptly inform diaDexus, and diaDexus shall issue a revised, corrected order in a timely manner. If there is any conflict between the order(s) and this Agreement, the terms of this Agreement shall govern.

  
 [*] Certain information in this document has
been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
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2.6    Prices.  diaDexus shall pay to Supplier the Price for QC testing and for
Product supplied by Supplier under this Agreement, as set forth in Exhibit B. 

2.7    Delivery.  All Product delivered pursuant to the terms of this Agreement
shall be suitably packed for shipment in accordance with the acceptable industry standards, marked for shipment to the destination point indicated in the purchase order, and shipped [*]. Such packing, and the manner of shipment, shall be
sufficient to prevent damage, contamination, or degradation during shipment and during unpacking at the destination. All freight, insurance and other shipping expenses from the point of shipment shall be borne [*]. The carrier shall be
selected by diaDexus. Supplier shall use commercially reasonable efforts to ship quantities of Product for delivery on the dates specified in the applicable purchase order submitted in accordance with this Agreement. 

2.8    Invoicing.  For each calendar month, Supplier shall submit monthly invoices
for (a) [*], and (b) kit assembly, packaging fees, and shipping and handling fees for semi-finished and finished Products in connection with customer orders shipped by Supplier to diaDexus or its Customers. All invoices shall
be sent to diaDexus’ address for notices in Article 8 herein, or such other address as designated by diaDexus in writing, and each such invoice shall state the aggregate and unit prices for the Products produced or shipped, and shall separately
itemize any shipping, packaging, handling, storage, insurance, taxes or other costs incident to the transfer or shipment [*]. 
 2.9    Product Handling 

(a)    Storage.  Supplier shall store all unused Critical Components and
unshipped Products under proper conditions for [*], in such a manner as to maximize the life span and prevent spoilage, including, without limitation, any storage criteria set forth in the Specifications. 

(b)    Retained Samples.  Supplier shall retain and properly store samples
of Product as mutually agreed by the Parties. All retained samples will be properly stored for a period of [*]. 
 (c)    Replacement Product.  If either Supplier or diaDexus determines that a Critical Component or Product does not comply with the applicable Specifications,
diaDexus shall provide replacement Critical Components as necessary. 

(d)    Labeling.  Supplier shall clearly label, in accordance with the
requirements as mutually agreed, each Product for supply hereunder. 
  
 [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  

					
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(e)    Inspection of Supplier Facilities.  diaDexus shall have the right, at
reasonable mutually agreed times during normal business hours and upon request made upon prior notice to Supplier, to inspect Supplier’s facilities used for manufacturing the Products for diaDexus, and Supplier’s batch records,
work-in-progress and production records for the Products supplied to diaDexus under this Agreement. 

(f)    Technical Contacts.  Technical inquiries, results of QC tests,
analyses and reports shall be in writing and shall be sent to the respective parties at the addresses below by electronic mail or facsimile. 
  

					
	 For diaDexus:
	 	 For Supplier:

			
	 Name:  Mary Jane Cerelli
	 	  Name:
	 	         Abhijit
Datta                     



					
			
	 Telephone:  650-246-6539
	 	            Telephone:
	  	
    858-455-4762               




					
			
	 Fax:  650-246-6499
	 	    Fax:
	  	
            858-455-4750               
  



					
			
	 eMail:  MCerelli@diaDexus.com
	 	       eMail:
	  	   abhijit.datta@diazyme.com  


 ARTICLE 3 
 PAYMENT 

3.1    Payment.  diaDexus shall make full payment to Supplier for all Products
tested and shipped hereunder no later than thirty (30) days from the date of Supplier’s invoice. 

3.2    Mode of Payment.  All payments shall be made by direct wire transfer of
United States Dollars in immediately available funds in the requisite amount to such bank account as Supplier may from time to time designate by written notice to diaDexus. 
 ARTICLE 4 
 LICENSE 

4.1    Grant to Supplier.  diaDexus hereby grants Supplier a non-exclusive license,
without the right to sublicense, under the diaDexus Technology, to use the Critical Components solely within the United States in the manufacture of Products. 
 4.2    Grant to diaDexus.  Supplier hereby grants diaDexus a non-exclusive, worldwide license, with the right to sublicense, under the Supplier Technology, for the
sole purpose of selling Products and only to the extent required for diaDexus to sell or offer for sale Products. 
 4.3    Technology Transfer.  Each Party shall, in good faith, promptly and completely transfer whatever Supplier Know-How or diaDexus Know-How, as applicable, to the
other Party that is required in order to enable such other Party to exercise its rights and fulfill its obligations under this Agreement. 

  

					
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4.4    No Other Rights.  Except for the rights expressly granted under this
Agreement, no right, title or interest of any nature whatsoever is granted by either Party. For the avoidance of doubt, Supplier has no right under the diaDexus Technology to (a) make, have made, sell or offer to sell Critical Components
anywhere in the world or (b) sell or offer to sell Products anywhere in the world. Nothing in this Agreement grants diaDexus any right under the Supplier Technology for any purpose other than the sale of Products. 

ARTICLE 5 

CONFIDENTIALITY 
 5.1    Confidentiality Obligations.  Each Party agrees that, for the Term of this Agreement and for five (5) years thereafter, such Party will keep, and will
ensure that its officers, directors, employees and agents keep, completely confidential and will not publish or otherwise disclose and will not use for any purpose except as permitted hereunder any Confidential Information furnished to it by the
other Party pursuant to this Agreement. The foregoing obligations will not apply to any information to the extent that it can be established by such receiving Party that such information: 

(a)    was already and rightfully known to the receiving Party as evidenced by its written
records, other than under an obligation of confidentiality, at the time of disclosure; 

(b)    was generally available to the public or was otherwise part of the public domain at
the time of its disclosure to the receiving Party; 
 (c)    became generally
available to the public or otherwise becomes publicly known after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; 

(d)    was subsequently lawfully disclosed to the receiving Party by a third party other than
in contravention of a confidentiality obligation of such third party to the disclosing Party; or 

(e)    was developed or discovered by employees of the receiving Party or its Affiliates who
had no access to the Confidential Information of the disclosing Party. 

5.2    Permitted Disclosures.    Each Party may disclose the other’s
Confidential Information to the extent such disclosure is reasonably necessary in prosecuting or defending litigation, (subject to the prior written consent of the other Party, which consent will not be unreasonably withheld or delayed), complying
with applicable governmental regulations, conducting clinical trials or otherwise in performing its obligations or exercising its rights hereunder. If a Party is required to make any such disclosure of the other Party’s Confidential
Information, it will give reasonable advance notice to that other Party of such disclosure requirement, will cooperate with the other Party in its efforts to secure confidential treatment of such Confidential Information prior to its disclosure, and
will use all reasonable efforts to secure confidential treatment of such information prior to its disclosure (whether through protective orders or confidentiality agreements or otherwise). 

  

					
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 ARTICLE 6

 REPRESENTATIONS AND WARRANTIES 

6.1    Representations by Supplier  

(a)    Supplier represents and warrants that as of the Effective Date: (i) it is duly
organized and validly existing under the laws of the jurisdiction of its incorporation and has full corporate power and authority to enter into this Agreement; (ii) it has taken all corporate actions necessary to authorize the execution and
delivery of this Agreement and the performance of its obligations under this Agreement; and (iii) the performance of its obligations under this Agreement do not conflict with, or constitute a default under its charter documents, any contractual
obligation of Supplier or any court order. 
 (b)    Subject to the terms and
conditions of this Agreement, Supplier represents and warrants that the Products manufactured and supplied by Supplier hereunder will conform to the applicable Specifications at the time of delivery of the Products by Supplier to the carrier for
shipment to Customers. Subject to the terms and conditions of this Agreement, Supplier further represents and warrants that title to all Products supplied by Supplier hereunder shall pass to diaDexus free and clear of all security interests, liens
and other encumbrances, provided that diaDexus is not in breach of this Agreement for non-payment. 

(c)    Supplier represents and warrants that all Products manufactured and provided by
Supplier under this Agreement shall be in compliance with (i) applicable current good manufacturing practices, as defined by the United States Food and Drug Administration, and (ii) all material respects of the Quality Agreement attached
in Exhibit D. 
 (d)    Supplier represents and warrants that Critical Components,
Lots, and Products shall not be (i) used by Supplier in human subjects, clinical trials, research or patient clinical management, (ii) except as contemplated or described in this Agreement, transferred, distributed or sold anywhere in the
world, and (iii) disassembled, reverse engineered or otherwise manipulated, modified in any manner or duplicated anywhere in the world. 
 (e)    Supplier represents and warrants that use of Critical Components and the manufacture and packaging of Products shall be conducted only in Supplier’s facility in
Poway, California, U.S.A. For the avoidance of doubt, except as provided in this Agreement, Supplier shall not transfer, disassemble, reverse engineer, modify in any manner, duplicate, make, have made, distribute, sell or offer to sell Critical
Components, Lots, and Products anywhere in the world. 
 6.2    Representations by
diaDexus 
 (a)    diaDexus represents and warrants that, as of the Effective
Date: (i) it is duly organized and validly existing under the laws of the jurisdiction of its incorporation and has 

  

					
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full corporate power and authority to enter into this Agreement; (ii) it has taken all corporate actions necessary to authorize the execution and delivery of this Agreement and the
performance of its obligations under this Agreement; and (iii) the performance of its obligations under this Agreement do not conflict with, or constitute a default under its charter documents, any contractual obligation of diaDexus or any
court order. 
 (b)    diaDexus represents and warrants that all Critical Components
and any other materials supplied to Supplier under this Agreement shall be in compliance with (i) applicable current good manufacturing practices, as defined by the United States Food and Drug Administration, and (ii) all material respects
of the Quality Agreement attached in Exhibit D. 
 6.3    Disclaimer of
Warranties.  EXCEPT AS SPECIFICALLY SET FORTH IN THIS ARTICLE 6 OR ARTICLE 2.9(a), NO PARTY MAKES ANY OTHER REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR USE, NON-INFRINGEMENT, AND ANY OTHER STATUTORY WARRANTY. 
 ARTICLE 7 

TERM AND TERMINATION 
 7.1    Term.  This Agreement will commence upon the Effective Date and, unless earlier terminated, shall continue in effect [*] (the “Term”).

 7.2    Termination for Cause.  Either Party shall have the right to
terminate this Agreement if the other Party has materially breached the Agreement, including non-payment. Such terminating Party shall notify the breaching Party in writing of such breach and, if such breach remains uncured thirty (30) days
after the date such notice was sent (except in the case of any breach for non-payment of amounts owed, in which case, if such breach is not cured within ten (10) days after the date such notice was sent), the non-breaching Party shall have a
right to terminate the Agreement immediately by sending a written termination notice to the breaching Party. 

7.3    Termination for Convenience.  Either Party shall have the right, upon ninety
(90) days written notice to the other, to terminate this Agreement for any reason or no reason. 

7.4    Consequences of Termination or Expiration 

(a)    Return of Materials.  Upon termination or expiration of this
Agreement each Party will promptly return all records, Critical Components, Products and other materials in its possession or control containing or comprising the other Party’s Know-How or other Confidential Information to which the former
Party does not expressly retain rights hereunder. For the avoidance of doubt, diaDexus retains all rights to Critical Components and Products and shall have the right to obtain any inventory of Product held by Supplier. 

 
 [*] Certain information in this document has been omitted
and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
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(b)    Accrued Liability.  Termination or expiration of this Agreement for
any reason shall not release either Party hereto from any liability which at the time of such termination or expiration has already accrued to the other Party. Such termination or expiration will not relieve a Party from accrued payment obligations
or from obligations which are expressly indicated in this Agreement to survive termination or expiration of this Agreement. 
 (c)    Survival.  Upon the expiration or termination of this Agreement, any and all licenses granted hereunder will terminate automatically. The following
Articles and Sections of this Agreement shall survive its termination or expiration: Articles 1, 3 and 5 and Sections 4.2, 6.3, 7.4, 8.1, 8.2, 8.4, 8.5, 8.6, 8.7, 8.8, 8.9(a), 8.9(b), 8.10, 8.11, 8.12 and 8.13. 

ARTICLE 8 

GENERAL PROVISIONS 

8.1    Relationship of the Parties.  The Parties are independent contractors.
Nothing in this Agreement is intended or will be deemed to constitute a partnership, agency or employer-employee relationship between the Parties. Neither Party will incur any debts or make any commitments for the other Party. 

8.2    Assignments.  Except as expressly provided herein, neither this Agreement nor
any interest hereunder will be assignable, nor any other obligation delegable, by a Party without the prior written consent of the other Party; provided, however, that a Party shall have the right to assign and otherwise transfer this Agreement as a
whole without consent to any Affiliate or successor that acquires all or substantially all of the business or assets of such Party by way of merger, consolidation, other business reorganization, or the sale of stock or assets, provided that the
assigning Party notifies the other Party in writing in advance of such assignment, and such Affiliate or successor agrees in writing to be bound by the terms and conditions of this Agreement. This Agreement shall be binding upon successors and
permitted assigns of the Parties. Any assignment not in accordance with this Section 8.2 will be null and void. 
 8.3    Force Majeure.  With the exception of payment of overdue invoices, no Party shall be liable to the other for failure or delay in the
performance of any of its obligations under this Agreement for the time and to the extent such failure or delay is caused by earthquake, riot, civil commotion, war, terrorist acts, strike, flood, firestorm, evacuations or governmental acts or
restriction, or other cause that is beyond the reasonable control of the respective Party. The excused Party shall be excused for a time period reasonably sufficient to remedy the effects of such an event. The Party affected by such force
majeure will provide the other Party with full particulars thereof as soon as it becomes aware of the same (including its best estimate of the likely extent and duration of the interference with its activities), and will use commercially
reasonable efforts to overcome the difficulties created thereby and to resume performance of its obligations as soon as practicable. If the performance of any such obligation under this Agreement is delayed owing to such a force majeure event
for any continuous period of more than thirty (30) days, the Parties hereto will consult with respect to an equitable solution, including the possibility of the mutual termination of this Agreement. 

  

					
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8.4    Entire Agreement of the Parties; Amendments.  This Agreement and any exhibits
or schedules attached hereto constitutes and contains the entire understanding and agreement of the Parties respecting the subject matter hereof and cancels and supersedes any and all prior and contemporaneous negotiations, correspondence,
understandings and agreements between the Parties, whether oral or written, regarding such subject matter. No waiver, modification or amendment of any provision of this Agreement will be valid or effective unless made in writing and signed by the
Parties. 
 8.5    Captions.  The captions to this Agreement are for
convenience only, and are to be of no force or effect in construing or interpreting any of the provisions of this Agreement. 
 8.6    Governing Law; Dispute Resolution.  This Agreement will be governed by and interpreted in accordance with the laws of the State of California, applicable to
contracts entered into and to be performed wholly within the State of California, excluding conflict of laws principles. If any claim, dispute, or controversy arising out of or in connection with this Agreement or the breach or alleged breach of
this Agreement is not resolved by informal discussion of the parties within thirty (30) business days after each party is notified of such dispute, the dispute shall be referred to the CEOs of each party. Upon such referral, these two
individuals shall undertake good faith discussions, and shall be empowered to reach a prompt, final resolution of the issue that shall be binding upon both parties. If these two individuals do not resolve the dispute within thirty (30) days
after such referral, and the parties do not mutually agree in writing to extend such resolution period, the matter may be submitted for adjudication to any Superior Court of California in the Counties of San Mateo or San Diego, or to the United
States District Court for the Northern or the Southern District of California. 

8.7    Notices and Deliveries.  Any notice, request, delivery, approval or consent
required or permitted to be given under this Agreement will be in writing and will be deemed to have been sufficiently given if delivered in person, transmitted by facsimile (receipt verified) or by express courier service (signature required) or
five (5) days after it was sent by registered letter, return receipt requested (or its equivalent), provided that no postal or carrier strike or other disruption is then in effect or comes into effect within two (2) days after such
mailing, to the Party to which it is directed at its address or facsimile number shown below or such other address or facsimile number as such Party will have last given by notice to the other Party. 

If to Supplier, addressed to: 
 Diazyme Laboratories Division 
 General Atomics 

12889 Gregg Court 
 Poway, California 92064, USA 
 Attention: Contracts Administrator

 (c/o Steve O’Hara) 

Facsimile No. 858-455-3700 

  

					
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 And,
in the case of formal notices, claims or written demands, with a copy to: 
 Diazyme Laboratories Division

 General Atomics 
 3550 General Atomics Court 
 San Diego, California 92121, USA

 Attention: Legal Counsel 

Facsimile No. 858-455-3213 
 If to diaDexus, addressed to: 
 diaDexus, Inc. 

343 Oyster Point Boulevard 
 South San Francisco, California 94080 
 Attn: President &
CEO 
 Fax: (650) 246-6499 

8.8    No Consequential Damages.  IN NO EVENT WILL EITHER PARTY OR ANY OF ITS
RESPECTIVE AFFILIATES BE LIABLE FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, EXEMPLARY, OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO, LOSS OF PROFITS OR
REVENUE OR CLAIMS OF ANY THIRD PARTIES FOR SUCH DAMAGES. 
 8.9    Indemnity &
Insurance. 
      (a)    diaDexus will
indemnify, defend and hold Supplier, its agents, employees, shareholders, directors, officers, and Affiliates harmless from and against all liability, loss, damage, injury to person or property, costs and expenses, including all attorneys’ fees
of Supplier, from any and all causes of action, suits, claims, demands, liabilities or judgments, of any nature whatsoever, asserted by any third party, alleging or arising out of or resulting directly or indirectly from any: 

(i) acts or omissions of diaDexus, its employees or its agents, by or on behalf of any person or
entity, in connection with the design, marketing, advertising, sale, distribution and/or handling of the Products or any Critical Components; 
 (ii) errors or omissions in the Specifications or defects in the Critical Components; 
 (iii) intellectual property infringement relating to the design of the Products, Specifications, Critical Components or the use by Supplier of diaDexus’ trademarks and packaging in preparation of the
kits pursuant to this Agreement; and 
 (iv) products liability relating solely to the Critical
Components. 
      (b)    Supplier will
indemnify, defend and hold diaDexus, its agents, employees, shareholders, directors, officers, and Affiliates harmless from and against all liability, loss, 

  

					
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damage, injury to person or property, costs and expenses, including all attorneys’ fees of diaDexus, from any and all causes of action, suits, claims, demands, liabilities or judgments, of
any nature whatsoever, asserted by any third party, alleging or arising out of or resulting directly or indirectly from any: 
 (i) acts or omissions of Supplier, its employees or its agents, by or on behalf of any person or entity, in connection with the use, manufacture, sale to diaDexus and/or handling of Product (unless
such claim arises only as a result of Supplier’s compliance with the diaDexus provided Specifications); 
 (ii) intellectual property infringement, not relating to the Critical Components, of the Products as manufactured or delivered by Supplier and except for any claim arising from the Products that is a
direct result of Supplier’s compliance with diaDexus-supplied Specifications; and 
 (iii)
products liability relating to the assembled Products to the extent such liability does not result from Supplier’s use of the Critical Components in the supply of Product or adherence to the Specifications. 

     (c)    Both Parties shall maintain product
liability and general liability insurance per local industry standards and carry coverage similar to that required by other equivalent manufacturers. Each Party agrees that it shall provide the other party within thirty business days (30) of
the signing of this Agreement with a certificate evidencing such insurance and will provide the other Party with at least thirty days prior written notice of any cancellation or change of limits or terms of such policy. 

8.10    Waiver.  A waiver by any Party of any of the terms and conditions of this
Agreement in any instance will not be deemed or construed to be a waiver of such term or condition for the future, or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement will be
cumulative and none of them will be in limitation of any other remedy, right, undertaking, obligation or agreement of either Party. 
 8.11    Severability.  Each provision of this Agreement will be interpreted in such manner as to be effective, valid, and enforceable under applicable law. The Parties
will make a good faith effort to replace the applicable provision with a valid one, which the Parties agree has effect that is consistent with the original provision. 

8.12    Compliance with Laws.  Notwithstanding anything to the contrary contained
herein, all rights and obligations of diaDexus and Supplier are subject to prior compliance with, and each Party shall comply with, all United States and foreign export and import laws, regulations, and orders, and such other United States and
foreign laws, regulations, and orders as may be applicable, including obtaining all necessary approvals required by the applicable agencies of the governments of the United States and foreign jurisdictions. 

  

					
		 	Confidential	 	Page 13 of 34









  

8.13    Counterparts.  This Agreement may be executed in one or more counterparts,
each of which will be deemed an original but all of which will constitute one and the same instrument. 
 [REMAINDER OF
PAGE INTENTIONALLY LEFT BLANK] 

  

					
		 	Confidential	 	Page 14 of 34









  

IN WITNESS WHEREOF, the Parties have caused this
Agreement to be executed by their respective duly authorized officers as of the Effective Date, each copy of which will for all purposes be deemed to be an original. 
  

			
	DIAZYME LABORATORIES
	a division of General Atomics
		
	By:	 	        /s/ Chong Yuan                 
       
	Name: Chong Yuan
	Title: Managing Director
		
	By:	 	        /s/ Anthony Navarra                

	Name: Anthony Navarra
	Title: Senior Vice President
	
	DIADEXUS, INC.
		
	By:	 	        /s/
Patrick Plewman                  
	Name: Patrick Plewman
	Title: President & CEO


  

					
		 	Confidential	 	Page 15 of 34









  
 EXHIBIT A

 COMPONENTS 
 [*] 
  
 [*] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted
portions. 

  

					
		 	Confidential	 	Page 16 of 34









  
 EXHIBIT B

 PRICING 
 [*] 
 [*] Two pages have been omitted and filed separately with the Securities and
Exchange Commission. Confidential treatment has been requested with respect to the omitted portion. 

  

					
		 	Confidential	 	Page 17 of 34









  
 EXHIBIT C

 PRODUCTS 
 The Critical Components in bulk format from diaDexus will be tested and repackaged by Supplier into unique configurations of finished kits [*]: 

[*] 
 [*] Certain information in this
document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. 

  

					
		 	Confidential	 	Page 19 of 34









  
 EXHIBIT D

 QUALITY AGREEMENT 

See Attached 

  

					
		 	Confidential	 	Page 20 of 34









  
 QUALITY AGREEMENT

 This Quality Agreement (the “Quality Agreement”) is entered into and effective the 1st day of January 2009 (the “Effective Date”) by and between Diazyme
Laboratories, a division of General Atomics, a company duly established and organized under the laws of the United States of America, having a principal place of business at 12889 Gregg Court, Poway, CA 92064, USA on behalf of itself, its Affiliates
and related entities (herein “SUPPLIER”), and diaDexus, Inc., a Delaware corporation duly established and organized under the laws of the United States of America, having its principal place of business at 343 Oyster Point Boulevard, South
San Francisco, CA 94080, USA, on behalf of itself, its Affiliates, and related entities (herein “COMPANY”). SUPPLIER and COMPANY are hereby referred to individually as a “PARTY” and collectively as “PARTIES.”

 WHEREAS, COMPANY and SUPPLIER have entered into the Services and Supply Agreement on January 1, 2009 (herein after the
“AGREEMENT”); and 
 WHEREAS, COMPANY and SUPPLIER desire for services provided under the AGREEMENT to meet certain quality tasks
and responsibilities. 
 SCOPE 
 General Scope

 This Quality Agreement shall define the Quality Tasks and Responsibilities of the SUPPLIER and COMPANY and forms an integral part of
the AGREEMENT. 
 Product Specification 
 This
Quality Agreement covers PRODUCT intended for supply that applies the same specifications and release requirements as contained in approved filings as defined in the SPECIFICATIONS. 
 DEFINITIONS 
 In addition to other terms defined in the AGREEMENT or elsewhere herein, the following terms shall
have the following meanings when used herein (any term defined in the singular shall have the same meaning when used in the plural and vice versa, unless stated otherwise). Any capitalized terms used herein and not otherwise defined shall have the
same meaning as set forth in the AGREEMENT. 
 CGMP means the current Good Manufacturing Practices pursuant to
(a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), and (b) relevant U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Parts 7, 11,803, 806 and 820).

 COA means a Certificate of Analysis, a document listing testing parameters, specifications and test results.

 COMPONENT means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended
to be included as part of the finished, packaged, and labeled device. 
 CONTROL NUMBER means any distinctive symbols,
such as a distinctive combination of letters or numbers, or both, from which the history of the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined. 

CUSTOMER ORDER means the written communication between COMPANY and SUPPLIER, setting forth the number of units of each PRODUCT,
delivery dates, and exact shipping instructions for each identified ship-to customer of COMPANY. 

  

					
		 	Confidential	 	Page 21 of 34









  
 DEVIATION means
departure (an action that is planned or unplanned) from an established process or procedure (e.g., approved MASTER BATCH RECORDS, test methods, manufacturing processes, equipment, facilities and/or SOPs). 

DEVICE HISTORY RECORD (BATCH RECORD) means the complete written record of the history of the batch and its production and testing
thereof as required under cGMP and in accordance with the DEVICE MASTER RECORD. 
 DEVICE MASTER RECORD (DMR) means a
compilation of records containing the procedures and specifications for a finished device. The DMR for each type of device may include information such as device specifications, process specifications, quality assurance procedures and
specifications, packaging and labeling specifications, installation, maintenance, and service procedures and methods. 

HEALTH AUTHORITIES mean all governmental and regulatory authorities having jurisdiction over the manufacture, use and/or sale of
the PRODUCT in the TERRITORY, including but not limited to the US Food and Drug Administration (FDA). 
 Manufacturer’s release means the release of
PRODUCT by SUPPLIER. 
 MANUFACTURING AUTHORIZATION means the authorization of SUPPLIER as manufacturer of PRODUCT
according to the applicable regulations. 
 MANUFACTURING Material means any material or substance used in or used to
facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the
manufacturer. 
 OOS means out of specification results. OOS are testing results, which do not meet the approved
SPECIFICATIONS of starting materials, intermediates, PRODUCT, packaging materials, in-process-controls or stability testing, as applicable. 
 PRODUCT means components, manufacturing materials, in- process devices, finished devices, and returned devices. 
 PRODUCTION ORDER means the written communication between COMPANY and SUPPLIER, setting forth the number of units of each PRODUCT to be assembled. 

Quality Tasks and Responsibilities means the quality requirements and obligations placed upon SUPPLIER and COMPANY with respect to
the manufacturing, testing, storage, packaging, labeling, distribution of PRODUCT as listed in Exhibit 1. 
 REPROCESSING:
Introducing materials, in-process intermediates, packaging, labeling, or PRODUCT including one that does not conform to standards or specifications, back into the process and repeating a step or other appropriate chemical or physical manipulation
steps that are part of the established manufacturing process. Continuation of a process step after an in-process control test has shown that the step is incomplete, is considered to be part of the normal process, and is not reprocessing. 

REWORKING: Subjecting materials, in-process intermediates, packaging, labeling or PRODUCT that does not conform to standards or
specifications to one or more processing steps that are different from the established manufacturing process to obtain acceptable quality materials, in-process intermediates, packaging, labeling or PRODUCT. 

  

					
		 	Confidential	 	Page 22 of 34









  
 SOPs mean
written standard operating procedures established, or to be established, by SUPPLIER and employed in the manufacturing, testing, storage, packaging, labeling, certification and delivery of PRODUCT. 

SPECIFICATIONS mean any requirement with which a product, process, service, or other activity must conform. Specifications are
numerical limits, ranges or other acceptance criteria to which the PRODUCT or process of making the PRODUCT must conform. 

TESTING SPECIFICATION means a specific master document that lists the testing parameters, references to analytical procedures and
their SPECIFICATIONS. 
 TSE mean Transmissible Spongiform Encephalopathies, which are characterized as chronic
degenerative nervous diseases. TSE diseases includes in animals e.g. bovine spongiphorm encephalopathy (BSE), and in cattle or in humans e.g. different forms of Creutzfeldt-Jakob disease (CJD). 

QUALITY CONTACTS 
 Quality Assurance department contact names and numbers during working hours at each company are: 
  

			
	SUPPLIER Quality Assurance:
	Julianne Huang
	Quality/Operations
	Work Phone:    858-455-4745
	FAX:	  	858-455-4750
	Email:	  	julianne.huang@diazyme.com
	
	COMPANY Quality Assurance:
	Lynne McBride
	Director, RA/QA
	Work Phone:    650-246-6423
	FAX:	  	650-246-6499
	Email:	  	lmcbride@diadexus.com

 In addition to the foregoing, SUPPLIER
and COMPANY shall jointly establish a list of contacts in order to conduct their normal business. 
 CONFIDENTIALITY 

Confidential information disclosed in connection with this Quality Agreement is subject to and shall be protected in accordance with the respective
Section of the AGREEMENT. 
 TERMINATION AND SURVIVAL 
 This Quality Agreement shall terminate contemporaneously with the AGREEMENT. The termination of the Quality Agreement shall not relieve either Party of its obligations regarding (a) confidentiality,
(b) customer complaints, (c) recalls, (d) Inspections by health authorities, (e) storage and destruction of Quality Records and Documentation and (f) storage of retains. 

DISPUTE RESOLUTION 
 ANY DISPUTES ARISING OUT
OF OR IN CONNECTION WITH THIS QUALITY AGREEMENT SHALL BE RESOLVED PURSUANT TO THE RESPECTIVE PROVISIONS OF THE AGREEMENT. 

  

					
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 AMENDMENTS 

Amendments to this Quality Agreement shall be made only in writing duly executed by both PARTIES hereto. 

POWER AND AUTHORITY 
 SUPPLIER represents and warrants to COMPANY that it has all the necessary power and authority to enter into this Quality Agreement on its own behalf and on behalf of all the SUPPLIER entities and shall be legally
bound by this Quality Agreement to the same extent as if they have executed this Quality Agreement and are a party hereto. 
 [signature
page follows] 

  

					
		 	Confidential	 	Page 24 of 34









  
 AGREED TO: 

 

									
	 diaDexus, Inc.
	 		 	 diaDexus, Inc.

					
	 By:
	 	   /s/ Patrick Plewman
	 		 	 By:
	 	   /s/  Lynne
McBride



									
	 Name:
	 	 Patrick Plewman
	 		 	 Name:
	 	 Lynne McBride



									
	 Title:
	 	 President & CEO
	 		 	 Title:
	 	 Director, RA/QA



									
	 Date:
	 	     4/27/09
	 		 	 Date:
	 	     4/27/09

			
	 Diazyme Laboratories Division,
	 		 	 Diazyme Laboratories Division,

			
	 General Atomics
	 		 	 General Atomics

					
	 By:
	 	   /s/ Chong Yuan
	 		 	 By:
	 	     /s/ A.G.
Navarra



									
	 Name:
	 	 Chong Yuan
	 		 	 Name:
	 	 A.G. Navarra



									
	 Title:
	 	 Managing Director
	 		 	 Title:
	 	 Sr VP



									
	 Date:
	 	     4/29/09
	 		 	 Date:
	 	     5/1/09



  

					
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 EXHIBIT 1 – QUALITY TASKS AND
RESPONSIBILITIES 
  

									
	Tasks and Responsibilities	 	  	 	  	 	COMPANY	 	SUPPLIER
	General
Statement
	 The PARTIES shall operate in compliance with cGMP requirements and all
other applicable laws, regulations, and local laws concerning manufacturing, testing, storage, packaging, labeling, and distribution of the PRODUCT.
	 	 	 	X	 	X
	 SUPPLIER shall be responsible for obtaining and maintaining, at its
expense, all permits, licenses, approvals, authorizations and the like required for its performance of the services defined in the AGREEMENT.
	 	 	 	 	 	X
	 SUPPLIER shall ensure that it has not been or uses any persons or
entities debarred under 21 U.S.C. § 335(a) or 335(b), nor disqualified as described in 21 CFR 812.119, nor debarred by any enforcement group associated with a HEALTH AUTHORITY; it will not employ in connection with any services any person who
is not properly qualified by directly applicable training, experience and supervision to carry out the tasks they are assigned in connection with such services; neither it nor any of its officials or employees have been convicted of a felony under
Federal law for conduct relating to the development or approval, including the process for development or approval, of any medical device or regulatory submission; and none of its officials or employees have been convicted of a felony under United
States law for conduct otherwise relating to the regulation of any product or medical device under the Food Drug & Cosmetics Act.
	 	 	 	 	 	X
	 SUPPLIER shall be responsible
for maintaining cGMP compliance of all operations, including but not limited to manufacturing, testing, storage, packaging, labeling, and distribution of PRODUCT. cGMP compliance shall be established and maintained, including but not limited to the
following:
 • Facilities in compliance with cGMP requirements or with any conditions
described in SUPPLIER’s MANUFACTURING AUTHORIZATION, or Device Master Record.
 • All appropriate
equipment, cleaning, utility, and facility qualification and validation activities associated with the PRODUCT.

• setting-up, calibrating, cleaning, qualifying and maintaining all equipment associated with the
PRODUCT.
	 	 	 	 	 	X
	MANUFACTURING MATERIALS,
COMPONENTS
	 COMPANY shall define SPECIFICATIONS for MANUFACTURING MATERIALS and COMPONENTS used
in the manufacturing of PRODUCT.
	 	 	 	 	 	X	 	 
	 SUPPLIER shall test and release MANUFACTURING MATERIALS and COMPONENTS purchased by
SUPPLIER and used in the manufacturing of PRODUCT and qualify suppliers for use.
	 	 	 	 	 	 	 	X
	 COMPANY shall approve the MANUFACTURING MATERIAL and COMPONENT quality and
SPECIFICATIONS used in the manufacturing of PRODUCT.
	 	 	 	 	 	X	 	 
	 Company AND SUPPLIER shall ensure that all
MANUFACTURING MATERIALS and COMPONENTS used in the manufacturing of PRODUCT fully comply with the respective SPECIFICATIONS.
	 	 	 	 	 	X	 	X


  

					
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	Tasks and Responsibilities	 	  	 	  	 	COMPANY	 	SUPPLIER
	 COMPANY is responsible for providing SUPPLIER with labels for generation of
finished PRODUCT labeling.
	 	 	 	 	 	X	 	 
	 SUPPLIER is responsible for printing lot numbers and expiration dating, where
needed. Both parties approve label format.
	 	 	 	 	 	X	 	X
	Quality Records and
Documentation
	 SUPPLIER shall draft all necessary PRODUCT documentation (e.g., MASTER
BATCH RECORDS, SPECIFICATIONS and analytical procedures) in accordance with cGMP requirements and provide to COMPANY.
	 	 	 	 	 	X
	 COMPANY and SUPPLIER shall review and approve all PRODUCT
documentation.
	 	 	 	X	 	X
	 SUPPLIER shall store and maintain PRODUCT documents to prevent any
loss or deterioration.
	 	 	 	 	 	X
	 SUPPLIER shall retain all original manufacturing and testing records,
including all raw data, as part of the site BATCH RECORD.
	 	 	 	 	 	X
	 SUPPLIER shall store all paper and electronic documentation for at
least five (5) years following the expiry of PRODUCT.
	 	 	 	 	 	X
	 Upon the expiry of the storage periods of documents, SUPPLIER shall
notify COMPANY in writing and await instructions for three days for the transfer of records to COMPANY or for written authorization for destruction of records.
	 	 	 	X	 	X
	Manufacturing and
Testing
	 COMPANY and SUPPLIER, as applicable, shall provide a unique CONTROL
NUMBER to each batch of PRODUCT.
	 	 	 	X	 	 
	 COMPANY shall provide the Material Safety Data Sheet for the PRODUCT
and inform SUPPLIER of any known hazards associated with the PRODUCT or manufacturing process.
	 	 	 	X	 	 
	 SUPPLIER shall use only PRODUCT documents approved by COMPANY in the
manufacturing and testing of PRODUCT.
	 	 	 	 	 	X
	REWORKING and
REPROCESSING
	 SUPPLIER shall notify COMPANY of any PRODUCT that does not meet
specifications.
	 	 	 	 	 	X
	 SUPPLIER shall define and COMPANY shall approve any rework and
reprocessing protocols or procedures prior to the implementation of any PRODUCT rework or reprocessing.
	 	 	 	X	 	X
	 SUPPLIER shall notify COMPANY of any PRODUCT that requires REWORK or
REPROCESSING.
	 	 	 	 	 	X
	Date of Manufacturing and Date of
Expiration
	 COMPANY will determine assigned date of manufacturing for
COMPONENTS.
	 	 	 	X	 	 
	 COMPANY shall determine the date of expiration of
PRODUCT.
	 	 	 	X	 	 
	Quality Control
Testing
	 SUPPLIER shall conduct release testing on every batch of PRODUCT and
COMPANY will issue a COA.
	 	 	 	X	 	X


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall have defined acceptance criteria (i.e. action limit) for each
in-process test performed and each PRODUCT release test shall have an established SPECIFICATION.
	 	 	 	 	 	X
	 COMPANy shall approve all acceptance criteria (i.e. action limit) and
SPECIFICATIONS associated with PRODUCT.
	 	 	 	X	 	 
	 COMPANY shall notify SUPPLIER of any proposed changes to acceptance criteria (i.e.
action limit) and SPECIFICATIONS associated with PRODUCT and such changes shall not be implemented without prior approval from COMPANY.
	 	 	 	X	 	X
	 SUPPLIER shall retain samples of in-process material until FINAL RELEASE by
COMPANY. Samples that would be subject to deterioration if stored until FINAL RELEASE need not be held.
	 	 	 	 	 	X
	 Upon request, SUPPLIER shall forward in-process material samples to COMPANY
according to an approval by both parties.
	 	 	 	X	 	X
	 COMPANY may perform testing to confirm SUPPLIER test results, at COMPANY’s
expense.
	 	 	 	X	 	 
	Supplier and sub-tier
Suppliers
	 SUPPLIER and COMPANY shall ensure the cGMP compliance
of any suppliers or contract suppliers of COMPONENTS and MANUFACTURING MATERIALS used in the PRODUCT.
	 	 	 	X  	 	X
	 SUPPLIER shall notify COMPANY of any changes (additions
or removal) to suppliers or contract suppliers of COMPONENTS and MANUFACTURING MATERIALS used in the PRODUCT.
	 	 	 	 	 	X
	 COMPANY shall approve any changes (additions or
removal) of any suppliers or contract suppliers of COMPONENTS and MANUFACTURING MATERIALS used in the PRODUCT.
	 	 	 	X  	 	 
	 SUPPLIER will provide COMPANY with a list of all
suppliers or contract suppliers of COMPONENTS and MANUFACTURING MATERIALS used in the PRODUCT. With respect to all such suppliers or contract suppliers, SUPPLIER shall ensure that it procures the necessary audit rights so that in the event COMPANY
desires to audit suppliers or contract suppliers of COMPONENTS and MANUFACTURING MATERIALS, it shall have the right (albeit through SUPPLIER) to do so and SUPPLIER will provide the necessary documentation and facilitate COMPANY’s audit of such
suppliers and contract suppliers.
	 	 	 	 	 	X
	PRODUCT RELEASE
	 SUPPLIER shall review and approve its BATCH RECORDS according to its approved
internal procedures.
	 	 	 	 	 	X
	 SUPPLIER shall provide COMPANY the
following PRODUCT documents for review:
 •   BATCH RECORDS, after
completion
 •   DEVIATION REPORTS, investigations associated with the batch

•   Analytical data (in-process and release test data)
	 	 	 	 	 	X


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall provide additional requested documentation and information to
COMPANY in order for COMPANY to complete the disposition of the PRODUCT or to understand and evaluate any deviations, OOS, investigations, or other quality related issues to the PRODUCT.
	 	 	 	 	 	X
	 SUPPLIER shall notify COMPANY on the quantity of PRODUCT
reprocessed.
	 	 	 	 	 	X
	 COMPANY shall notify SUPPLIER of the quantity of PRODUCT reprocessed to retain,
store, or destroy.
	 	 	 	X	 	 
	 COMPANY is responsible for authorizing the SUPPLIER to MANUFACTURE PRODUCT by
issuing SUPPLIER a PRODUCTION ORDER and for drop-shipment of PRODUCT to end-user customer by issuing SUPPLIER a CUSTOMER ORDER.
	 	 	 	X	 	 
	 COMPANY shall notify SUPPLIER of its disposition of the PRODUCT by sending a
notification of inventory release and issuing a COA within (5) business days after Suppliers quality assurance unit notification.
	 	 	 	X	 	 
	Samples and
Retains
	 SUPPLIER shall retain a minimum quantity in order to complete three (3) rounds of
analytical testing of PRODUCT according to the testing protocol, unless otherwise agreed upon in writing by both parties.
	 	 	 	X	 	X
	 For other MANUFACTURING MATERIALS and COMPONENTS used in the PRODUCT, sufficient
samples shall be retained, per SUPPLIER internal procedures.
	 	 	 	 	 	X
	 Upon request, SUPPLIER shall make available PRODUCT retains to
COMPANY.
	 	 	 	 	 	X
	 SUPPLIER shall maintain retained samples and PRODUCT for a period not less than
three months past expiration.
	 	 	 	 	 	X
	Stability
Testing
	 COMPANY shall generate all stability protocols and reports and shall test PRODUCT
according to approved stability protocol.
	 	 	 	X	 	 
	 SUPPLIER may be requested to generate stability data on analyzer platforms not
available to COMPANY at COMPANY’s expense.
	 	 	 	 	 	X
	 Upon request, SUPPLIER shall make available all stability data to
COMPANY.
	 	 	 	 	 	X
	 COMPANY shall determine and approve shelf-life and storage conditions resulting
from stability studies of PRODUCT.
	 	 	 	X	 	 
	Storage and Shipment of PRODUCT and
COMPONENTS
	 SUPPLIER shall store PRODUCT and COMPONENTS safely according to COMPANY approved
procedures and storage conditions for the PRODUCT and COMPONENTS, until further processing or shipment to COMPANY or its designated consignee.
	 	 	 	 	 	X
	 SUPPLIER shall only ship PRODUCT to COMPANY or designated consignee for which it
has received a CUSTOMER ORDER from COMPANY.
	 	 	 	X	 	X


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall continue to store any agreed, remaining quantities of PRODUCT until
receipt of a CUSTOMER ORDER from COMPANY or until product expiration, whichever is sooner.
	 	 	 	 	 	X
	 SUPPLIER shall store all unused COMPONENTS and unshipped PRODUCTS in accordance
with Section 2.9(a) of the AGREEMENT.
	 	 	 	 	 	X
	 SUPPLIER shall notify COMPANY of any events or deviations associated with the
storage and shipment of PRODUCT. SUPPLIER shall determine and document the impact to product quality as a result of any events or deviations.
	 	 	 	 	 	X
	 COMPANY shall review events or deviations and disposition PRODUCT. COMPANY shall
notify the SUPPLIER on the disposition status of PRODUCT.
	 	 	 	X	 	 
	 SUPPLIER shall store and ship PRODUCT according to specified procedures from
COMPANY.
	 	 	 	 	 	X
	DEVIATIONS
	 SUPPLIER shall fully document any DEVIATIONS made during the course of
manufacturing, testing, packaging, labeling, storage and distribution of PRODUCT.
	 	 	 	 	 	X
	 SUPPLIER shall investigate, evaluate and document any potential impact of every
DEVIATION and shall justify any recommendations for further action.
	 	 	 	 	 	X
	 SUPPLIER shall notify COMPANY in writing of any DEVIATIONS related to the
PRODUCT.
	 	 	 	 	 	X
	 COMPANY shall approve all DEVIATIONS related to PRODUCT.
	 	 	 	X	 	 
	OOS, Suspect Test
Results
	 SUPPLIER shall notify COMPANY of any confirmed OOS or suspect test results
obtained for a batch during release or stability testing. SUPPLIER shall notify COMPANY within five (5) business days after confirmation of OOS or suspect test results.
	 	 	 	 	 	X
	 SUPPLIER and COMPANY shall conduct the OOS investigation in accordance with its
approved procedures.
	 	 	 	X	 	X
	 SUPPLIER shall obtain COMPANY approval of all OOS or suspect test results,
including but not limited, to any plans for re-testing and re-sampling unless approved procedure specifies allowance for adjustment and retest.
	 	 	 	 	 	X
	Validation
	 SUPPLIER shall ensure that all process, equipment, cleaning and methods are in
compliance to manufacture, test, package, label, store and distribute PRODUCT according to its approved procedures and shall ensure that processes, equipment, cleaning and methods remain in a validated state for manufacture and testing of
PRODUCT.
	 	 	 	 	 	X
	 Upon request, SUPPLIER shall make all relevant validation records and data
available to COMPANY.
	 	 	 	 	 	X


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	Change
Control
	 PARTIES shall make changes to configuration controlled documents in observance of
all notification requirements of any respective HEALTH AUTHORITY.
	 	 	 	X	 	X
	 SUPPLIER shall provide COMPANY with prior written notification of all changes to
MANUFACTURING MATERIALS, COMPONENTS, PRODUCT, equipment and methods that may impact the PRODUCT-regulatory filings or require a regulatory submission and shall not issue a MANUFACTURER’S RELEASE for any batches manufactured under such change
until any needed regulatory approval are obtained.
	 	 	 	 	 	X
	 SUPPLIER shall provide changes to PRODUCT-specific master manufacturing and
testing documentation to COMPANY for review and approval prior to implementing any such changes.
	 	 	 	X	 	X
	 Minor editorial or administrative changes do not need to be reported to COMPANY,
but such changes must be appropriately documented and assessed according to SUPPLIER’s approved internal procedures. If a question arises as to what constitutes a minor editorial or an administrative change, the PARTIES shall discuss a
resolution in good faith.
	 	 	 	 	 	X
	 After implementation of the approved changes at SUPPLIER, SUPPLIER shall use its
best efforts to promptly forward a copy of the relevant revised PRODUCT-specific documents to COMPANY.
	 	 	 	 	 	X
	 COMPANY is responsible for the timely reporting of changes in PRODUCT-specific
documentation to the applicable licensee and/or HEALTH AUTHORITY.
	 	 	 	X	 	 
	Regulatory
Submissions
	 COMPANY shall be responsible for the generation and submission of any regulatory
documents.
	 	 	 	X	 	 
	 SUPPLIER shall assist in providing and compiling information concerning any
relevant parts of any regulatory submissions or supplements required by a HEALTH AUTHORITY. This shall apply to all information necessary to author regulatory submission or correspondence.
	 	 	 	 	 	X
	 COMPANY shall provide SUPPLIER a reasonable period of time in order to review and
provide comments prior to the submission of any regulatory correspondence (this includes the submission or updates thereof) relevant to SUPPLIER’s manufacturing or testing processes or facilities. Such review, possible commenting and release,
respectively, shall be carried out within thirty (30) working days upon receipt of such documentation unless otherwise agreed. This clause shall not be interpreted as to prevent COMPANY from fulfilling their legal obligations if SUPPLIER does not
respond within the mutually agreed timeframe.
	 	 	 	X	 	 
	 COMPANY shall provide copies of all parts of correspondence with HEALTH
AUTHORITIES relating to SUPPLIER’s manufacture of the PRODUCT to SUPPLIER.
	 	 	 	X	 	 
	 SUPPLIER shall file and maintain for its facility a Site Device Master Record
(DMR), or such equivalent, as required by the FDA.
	 	 	 	 	 	X
	 For regulatory purposes, COMPANY shall have the rights to refer to the Site DMR or
to other similar documents.
	 	 	 	X	 	 


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall upon reasonable request and prior notice, give COMPANY access
during normal business hours to information in the Site DMR, and other similar documents which are necessary to complete regulatory documentation related to PRODUCT and its manufacture in SUPPLIER’s facility.
	 	 	 	 	 	X
	 SUPPLIER shall co-operate with the FDA or other such regulatory body, as requested
by COMPANY and in response to matters concerning or impacting the PRODUCT.
	 	 	 	 	 	X
	 SUPPLIER shall notify COMPANY of any communication with the FDA (or other such
agency) concerning the PRODUCT or impacting the PRODUCT and shall co-operate with COMPANY in the scheduling of any planned inspection concerning the PRODUCT.
	 	 	 	 	 	X
	 Each Party shall promptly notify the other PARTY of new regulatory requirements,
which it may become aware with respect to the manufacture, testing, packaging, labeling, certifications, and storage of the PRODUCT and shall confer with each other about the best means to comply with such requirements.
	 	 	 	X	 	X
	 If a manufacturing process change or release requirement is required by a HEALTH
AUTHORITY, each party shall provide reasonable technical and regulatory assistance to support any necessary regulatory filings that the filing party will make to obtain regulatory approval.
	 	 	 	X	 	X
	Audits and
Compliance
	 Upon reasonable notice to SUPPLIER, SUPPLIER shall permit COMPANY or its appointed
representatives (hereinafter “Auditors”) to conduct audits of all documents, processes, procedures and facilities of SUPPLIER applicable to PRODUCT for the purposes described herein (hereinafter an “Audit”).
	 	 	 	 	 	X
	 COMPANY or its Auditors may have access to SUPPLIER for routine Audit purposes
once a year. Such Audits shall be conducted during regular business hours.
	 	 	 	X	 	 
	 In addition to the compliance, Annual
audits, COMPANY and its Auditors shall be entitled to (a) conduct “For Cause” investigative Audits to address significant PRODUCT quality or safety problems, and (b) perform on-site reviews of completed PRODUCT BATCH RECORDS.

 
 For Cause Audits shall relate to significant operational concerns
at SUPPLIER, and may include but are not limited to lot rejection by COMPANY, unresolved OOS investigations, an FDA Warning Letter or any deficiency letter issued by a Health Authority, as they pertain to systems or observations associated with the
testing of PRODUCT. Such inspections or Audits, to the extent reasonably practical, shall be conducted in a manner that shall not materially interrupt or impair any significant operations at SUPPLIER.
	 	 	 	X	 	 
	 An exit meeting shall be held between representatives from SUPPLIER and COMPANY
and/or its Auditors to discuss Audit observations.
	 	 	 	X	 	X
	 COMPANY shall provide a written report of all Audit observations to
SUPPLIER.
	 	 	 	X	 	 


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall correct all noted deficiencies as soon as practicable, and shall
provide COMPANY with a written response to Audit observations within thirty (30) days of receipt of Audit report.
	 	 	 	 	 	X
	 If, within forty (40) business days after receiving an Audit report, SUPPLIER
cannot remedy an Audit observation involving non-compliance the PARTIES shall use good faith efforts to agree upon a reasonable written plan and timetable for such remedy.
	 	 	 	X	 	X
	Inspections by HEALTH
AUTHORITIES
	 COMPANY shall inform SUPPLIER (and vice versa) with as much advance notice as
possible, but at least within five (5) business days of notification, of any regulatory activities of which they become aware that could reasonably be expected to prompt an inspection at SUPPLIER involving the PRODUCT (e.g. pre-approval or for cause
Inspections).
	 	 	 	X	 	X
	 SUPPLIER shall allow COMPANY or its Auditors to participate in PRODUCT-related
pre-approval, For Cause, or post-approval inspections if deemed necessary by COMPANY. COMPANY shall be available for consultation during the Inspection but shall not participate during the inspection unless requested by SUPPLIER or a HEALTH
AUTHORITY representative.
	 	 	 	X	 	X
	 SUPPLIER shall not discuss with any HEALTH AUTHORITY any activities relating to
the PRODUCT not actually performed by SUPPLIER, or sub-contracted by SUPPLIER.
	 	 	 	 	 	X
	 SUPPLIER shall inform COMPANY daily of potential issues identified during an
inspection.
	 	 	 	 	 	X
	 SUPPLIER shall allow COMPANY or its Auditors to attend the inspection closeout to
address any PRODUCT-related observations. SUPPLIER is responsible for addressing manufacturing, testing, packaging, labeling, facility and compliance observations.
	 	 	 	 	 	X
	 For regulatory observations that specifically involve the PRODUCT, SUPPLIER shall
hold discussions with COMPANY sufficiently in advance of any commitment to a regulatory agency. COMPANY shall prepare and/or comment on SUPPLIER proposed responses specific to PRODUCT within time commitments needed to address regulatory concerns.
COMPANY and SUPPLIER have joint final approval for the PRODUCT responses related to SUPPLIER to be submitted.
	 	 	 	X	 	X
	 For regulatory observations that involve any quality, production, material,
laboratory, facilities, equipment or packaging system-related cGMP issues that are not specific to the PRODUCT, SUPPLIER has final approval for the responses to be submitted.
	 	 	 	 	 	X
	 Prior to filing regulatory inspection reports and responses, SUPPLIER shall
provide COMPANY with copies of completed regulatory inspection reports and responses, in each case purged only of trade secret or other confidential or proprietary information of SUPPLIER that is unrelated to its obligations under this Quality
Agreement or is unrelated to PRODUCT.
	 	 	 	 	 	X


  

					
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	Tasks and Responsibilities	 	  	 	COMPANY	 	SUPPLIER
	 SUPPLIER shall promptly correct any site-related violations or deficiencies.
SUPPLIER shall notify COMPANY and discuss solutions in good faith to reach written agreement on such issue within thirty (30) days of initiating discussions.
	 	 	 	 	 	X
	 If any HEALTH AUTHORITY or any entity representing such an authority requests
access to SUPPLIER’s records, facilities, equipment and/or personnel, or conducts an unannounced inspection, or takes any other regulatory action (including without limitation any warning letters and FDA-483s), in each case relating to a
COMPANY PRODUCT then SUPPLIER will promptly notify COMPANY by telephone followed by hard copy confirmation. COMPANY shall have the right to be present at any Audit or inspection by a HEALTH AUTHORITY that relates to the PRODUCT, and, where time
permits, to conduct a pre-Audit inspection.
	 	 	 	 	 	X
	 SUPPLIER shall promptly provide COMPANY copies of all relevant communications
between SUPPLIER and any HEALTH AUTHORITY relating to PRODUCT. Where SUPPLIER is required or intends to respond to any such communication, SUPPLIER will provide COMPANY with a copy of such communication and SUPPLIER’s proposed response
sufficiently in advance of the date that such response is to be submitted, in order to permit COMPANY to review and comment upon such response. To the extent permitted by law SUPPLIER shall incorporate all such reasonable comments into such response
prior to submission.
	 	 	 	 	 	X
	Complaints and PRODUCT
Recalls
	 COMPANY shall receive and initially assess all PRODUCT defects and
complaints.
	 	 	 	X	 	 
	 COMPANY shall promptly notify SUPPLIER of any PRODUCT defects or complaints that
may be a result of SUPPLIER’s manufacturing of the PRODUCT.
	 	 	 	X	 	 
	 When reasonably requested by COMPANY, SUPPLIER shall promptly perform
investigations and shall provide COMPANY with any necessary documentation.
	 	 	 	X	 	X
	 COMPANY shall notify SUPPLIER of any PRODUCT recall that may be a result of
SUPPLIER’s manufacturing of the PRODUCT.
	 	 	 	X	 	 
	 If COMPANY determines a recall may be necessary, then COMPANY shall inform
SUPPLIER in writing specifying the details of the recall within twenty-four (24) hours of initial notification.
	 	 	 	X	 	X
	 If SUPPLIER receives any non-PRODUCT related complaints or recalls which may
impact the quality of COMPANY’s PRODUCT, SUPPLIER shall notify COMPANY in writing of any non-PRODUCT complaints or recalls received directly from an investigator site or consumer within 48 hours of complaint receipt.
	 	 	 	 	 	X


  

					
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