Document:

Form of Common Stock Purchase Warrant to Certain Investors

 Exhibit 10.16 
 THIS WARRANT AND THE SECURITIES ISSUABLE UPON THE EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY APPLICABLE STATE SECURITIES LAWS AND MAY NOT BE SOLD,
OFFERED FOR SALE, PLEDGED, HYPOTHECATED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT WITH RESPECT TO THE SECURITIES OR AN OPINION OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED.

 COMMON STOCK PURCHASE WARRANT 
 OF 
 TRANSMEDICS, INC. 
  

			
	 Warrant No. 2003-    
	  	December     , 2003

 1. Issuance. This Common Stock Purchase Warrant (this “Warrant”) is issued
to
                                        
by TransMedics, Inc., a Delaware corporation (hereinafter, with its successors, called the “Company”) on December     , 2003. 
 2. Purchase Price; Number of Shares. Subject to the terms and conditions hereinafter set forth, the registered holder of this Warrant (the “Holder”), commencing on the date hereof, is entitled
to purchase from the Company an aggregate of ____________ fully paid and nonassessable shares of the Company’s Common Stock, $0.0001 par value per share (the “Common Stock”) at an exercise price per share (the “Purchase
Price”) of $0.05 until the Expiration Date (as defined below). The shares of Common Stock deliverable upon such exercise, and as adjusted from time to time, are hereinafter sometimes referred to as “Warrant Shares.”

 3. Expiration Date; Automatic Exercise. This Warrant shall expire upon the earlier of (a) ten (10) years from the date
hereof, and (b) the closing of a Qualified Public Offering (as defined below) (the “Expiration Date”), and shall be void thereafter. Notwithstanding the foregoing, unless earlier exercised pursuant to Section 4, this
Warrant shall automatically be deemed to be exercised in full pursuant to the provisions of Section 5 hereof, without any further action on behalf of the Holder, immediately prior to the time this Warrant would otherwise expire pursuant to the
preceding sentence only if, and to the extent that, the fair market value of one share of Common Stock, as determined in good faith by the Board of Directors on the Expiration Date exceeds the Purchase Price then in effect. For purposes hereof, a
“Qualified Public Offering” means the closing of the sale of shares of Common Stock of the Company at a price of at least $5.00 per share (subject to appropriate adjustment for stock splits, stock dividends, combinations and other
similar recapitalizations affecting such shares), in a firm commitment underwritten public offering pursuant to an effective registration statement under the Securities Act of 1933, as amended, resulting in at least $30,000,000 of gross proceeds to
the Company. 
 4. Exercise; Payment of Purchase Price. This Warrant may be exercised by surrender of this Warrant and the tender of
the Notice of Exercise substantially in the form attached hereto as Exhibit A, to the Company at its principal office, or at the office of its stock transfer agent, if any, and accompanied by payment of the Purchase Price for the number of

 
Warrant Shares specified in such form and any applicable taxes. The Purchase Price for any Warrant Shares may be paid (i) in cash, check or by wire
transfer of immediately available funds, (ii) by the surrender by the Holder to the Company of any promissory notes or other obligations issued by the Company, with all such notes and obligations so surrendered being credited against the
Purchase Price in an amount equal to the principal amount thereof plus accrued interest to the date of surrender, (iii) through delivery by the Holder to the Company of other securities issued by the Company, with such securities being credited
against the Purchase Price in an amount equal to the fair market value thereof, as determined in good faith by the Board of Directors, (iv) by surrender of this Warrant pursuant to the Net Issue Election in Section 5 hereof, or (v) by
any combination of the foregoing. 
 5. Net Issue Election. The Holder may elect to receive, without the payment by the Holder of any
additional consideration, shares equal to the value of this Warrant or any portion hereof by the surrender of this Warrant or such portion to the Company, with the net issue election notice annexed hereto duly executed, at the office of the Company
(“Net Issue Election”). Thereupon, the Company shall issue to the Holder such number of fully paid and nonassessable shares of Common Stock as is computed using the following formula: 
  

							
		 	X	 	=	 	Y (A-B)
		 		 		 	     A

  

					
			
	where	 	X=	  	the number of shares of Common Stock to be issued to the Holder pursuant to this Section 5.
			
		 	Y=	  	the number of shares of Common Stock covered by this Warrant in respect of which the net issue election is made pursuant to this Section 5.
			
		 	A =	  	the fair market value of one share of Common Stock, as determined in good faith by the Board, at the time the net issue election is made pursuant to this Section 5.
			
		 	B =	  	the Purchase Price in effect under this Warrant at the time the net issue election is made pursuant to this Section 5.

 The Board shall promptly respond in writing to an inquiry by the Holder as to the fair market
value of one share of Common Stock. 
 6. Partial Exercise. This Warrant may be exercised in part, and the Holder shall, upon
surrender of the Warrant to the Company for cancellation, be entitled to receive a new warrant, which shall be dated as of the date of this Warrant, covering the number of shares in respect of which this Warrant shall not have been exercised.

 7. Issuance of Certificates for Shares; Issuance Date. Upon any exercise of this Warrant, one or more certificates for the number
of shares of Common Stock so purchased shall be issued as soon as practicable thereafter, but not later than ten (10) business days from the date of such exercise (with appropriate restrictive legends, as applicable) registered in the name of
the Holder or the Holder’s designee. The person or persons in whose name or names any certificate representing shares of Common Stock is issued hereunder shall be deemed to have become the holder of record of the shares represented thereby as
at the close of business on the date this Warrant is exercised with respect to such shares, whether or not the transfer books of the Company shall be closed. 
  

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 8. Reserved Shares; Valid Issuance. The Company covenants that it will at all times from and after
the date hereof reserve and keep available such number of its authorized shares of Common Stock, free from all preemptive or similar rights therein, as will be sufficient to permit the exercise of this Warrant in full. The Company further covenants
that such shares as may be issued pursuant to the exercise of this Warrant will, upon issuance, be duly and validly issued, fully paid and nonassessable and free from all taxes, liens and charges with respect to the issuance thereof. 
 9. Subdivision, Combination or Dividends. If after the Original Issue Date (as defined in Section 13 hereof) the Company shall subdivide the
Common Stock, by split-up or otherwise, or combine the Common Stock, or issue additional shares of Common Stock in payment of a stock dividend on the Common Stock, the number of shares of Common Stock issuable on the exercise of this Warrant shall
forthwith be proportionately increased in the case of a subdivision or stock dividend, or proportionately decreased in the case of a combination, and the Purchase Price shall forthwith be proportionately decreased, in the case of a subdivision or
stock dividend, or proportionately increased in the case of a combination. 
 10. Mergers and Reclassifications. If at any time or
from time to time after the exercise of this Warrant the Company shall effect any reclassification, capital reorganization or change of the Common Stock (other than as a result of a subdivision, combination or stock dividend provided for in
Section 9 hereof), or any consolidation of the Company with, or merger of the Company into, another corporation or other business organization (other than a consolidation or merger in which the Company is the continuing corporation and which
does not result in any reclassification or change of the outstanding Common Stock), or any sale or conveyance to another corporation or other business organization of all or substantially all of the assets of the Company, then, as a condition of
such reclassification, reorganization, change, consolidation, merger, sale or conveyance, lawful provisions shall be made, and duly executed documents evidencing the same from the Company or its successor shall be delivered to the Holder, so that
the Holder shall thereafter have the right to purchase, at a total price not to exceed that payable upon the exercise of this Warrant in full, the kind and amount of shares of stock and other securities and property receivable upon such
reclassification, reorganization, change, consolidation, merger, sale or conveyance by a holder of the number of shares of Common Stock which might have been purchased by the Holder immediately prior to such reclassification, reorganization, change,
consolidation, merger, sale or conveyance, and in any such case appropriate provisions shall be made with respect to the rights and interest of the Holder that the provisions hereof (including without limitation, provisions for the adjustment of the
Purchase Price and the number of shares issuable hereunder) shall thereafter be applicable in relation to any shares of stock or other securities and property thereafter deliverable upon exercise hereof. 
 11. Fractional Shares. In no event shall any fractional share of Common Stock be issued upon any exercise of this Warrant. If, upon exercise of
this Warrant as an entirety, the Holder would, except as provided in this Section 11, be entitled to receive a fractional share of Common Stock, then the Company shall, in lieu of delivering such fractional share of Common Stock, shall pay to
the Holder an amount in cash equal to the current fair market value of such fractional share of Common Stock, as determined in good faith by the Board. 
  

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 12. Notices of Record Date, Etc. In the event of: 
 (a) any taking by the Company of a record of the holders of any class of securities for the purpose of determining the holders thereof who are entitled to
receive any dividend or other distribution, 
 (b) any reclassification of the capital stock of the Company, capital reorganization of the
Company, consolidation or merger involving the Company, or sale or conveyance of all or substantially all of its assets, or 
 (c) any
voluntary or involuntary dissolution, liquidation or winding-up of the Company, 
 then and in each such event the Company will mail or cause to be mailed to
the Holder a notice containing a brief description of the proposed action and stating (i) the date on which any such record is to be taken for the purpose of such dividend, distribution or right, and stating the amount and character of such
dividend, distribution or right, or (ii) the date on which any such reclassification, reorganization, consolidation, merger, sale or conveyance, dissolution, liquidation or winding-up is to take place, and the time, if any is to be fixed, as of
which the holders of record in respect of such event are to be determined. Such notice shall be mailed at least 20 days prior to the date specified in such notice on which any such action is to be taken. 
 13. Other Warrants. This Warrant is one of a series of warrants (collectively, the “Warrants”) that were originally issued by the
Company starting on December     , 2003 (the “Original Issue Date”) pursuant to that certain Securities Purchase Agreement dated as of December ___, 2003 (the “Purchase Agreement”), among
the Company and the other parties thereto. 
 14. Registration Under Securities Act of 1933, as amended. The shares of Common Stock
issuable upon exercise of this Warrant Stock have certain registration rights pursuant to, and as set forth in, that certain Amended and Restated Investor Rights Agreement of even date herewith among the Company and the other parties named therein
(the “Investor Rights Agreement”). 
 15. Amendment. The terms of this Warrant may be amended, modified or waived
only with the written consent of the Company and the Holders of Warrants representing at least a majority of the number of shares of Common Stock then issuable upon the exercise of the Warrants. No such amendment, modification or waiver shall be
effective as to this Warrant unless the terms of such amendment, modification or waiver shall apply with the same force and effect to all of the other Warrants then outstanding. 
 16. Warrant Register; Transfers, Etc. 
 16.1. The Company will maintain a register containing the names and addresses of the registered holders of the Warrants. The Holder may change its address as shown on the 

  

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warrant register by written notice to the Company requesting such change. Any notice or written communication required or permitted to be given to the Holder
may be given by certified mail or delivered to the Holder at its address as shown on the warrant register. 
 16.2. Subject to compliance
with applicable federal and state securities laws, this Warrant may be transferred by the Holder with respect to any or all of the shares purchasable hereunder. Upon surrender of this Warrant to the Company, together with a properly endorsed
Assignment Form in substantially the form attached hereto as Exhibit B (the “Assignment Form”), for transfer of this Warrant as an entirety by the Holder, the Company shall issue a new warrant of the same denomination to the
assignee. Upon surrender of this Warrant to the Company, together with a properly endorsed Assignment Form, by the Holder for transfer with respect to a portion of the shares of Common Stock purchasable hereunder, the Company shall issue a new
warrant to the assignee, in such denomination as shall be requested by the Holder hereof, and shall issue to such Holder a new warrant covering the number of shares in respect of which this Warrant shall not have been transferred. The assignee shall
execute a counterpart signature page attached as Exhibit D to the Stockholders’ Agreement of even date herewith among the Company and the other parties named therein (the “Stockholders’ Agreement”) by which such
transferee agrees to be subject to the rights and obligations under the Purchase Agreement, the Stockholders Agreement and the Investor Rights Agreement in the capacity of a “Purchaser.” 
 16.3. In case this Warrant shall be mutilated, lost, stolen or destroyed, the Company shall issue a new warrant of like tenor and denomination and
deliver the same (i) in exchange and substitution for and upon surrender and cancellation of any mutilated Warrant, or (ii) in lieu of any Warrant lost, stolen or destroyed, upon receipt of evidence reasonably satisfactory to the Company
of the loss, theft or destruction of such Warrant (including a reasonably detailed affidavit with respect to the circumstances of any loss, theft or destruction) and of indemnity reasonably satisfactory to the Company, provided, however, that so
long as the Holder is the registered holder of this Warrant, no indemnity shall be required other than its written agreement to indemnify the Company against any loss arising from the issuance of such new warrant. 
 17. Compliance With Securities Act; Transferability of Shares of Common Stock Issuable Hereto. The Holder, by acceptance hereof, agrees that this
Warrant, and the shares of Common Stock issuable upon exercise of this Warrant, are being acquired for investment and that such Holder will not offer, sell or otherwise dispose of this Warrant, or any shares of Common Stock issuable upon exercise of
this Warrant, except under circumstances which will not result in a violation of the Securities Act, or any applicable state securities laws. This Warrant and all shares of Common Stock issued upon exercise of this Warrant (unless registered under
the Securities Act and any applicable state securities laws) shall be stamped or imprinted with a legend in substantially the following form: 
 THIS WARRANT AND THE SECURITIES ISSUABLE UPON THE EXERCISE HEREOF HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR ANY APPLICABLE STATE SECURITIES LAWS AND MAY NOT BE SOLD,
OFFERED 

  

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FOR SALE, PLEDGED, HYPOTHECATED OR OTHERWISE DISPOSED OF IN THE ABSENCE OF AN EFFECTIVE REGISTRATION STATEMENT WITH RESPECT TO THE SECURITIES OR AN OPINION
OF COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED. 
 18. Rights of Holder. The Holder shall not, by
virtue hereof, be entitled to any rights of a shareholder in the Company, either at law or equity, and the rights of the Holder are limited to those expressed in this Warrant and are not enforceable against the Company except to the extent set forth
herein. 
 19. Notices. All notices and other communications from the Company to the Holder, or vice versa, shall be in writing and
shall be deemed delivered and effective when given personally, or mailed by first-class registered or certified mail, postage prepaid, or sent via reputable overnight courier service, fee prepaid, at such address as may have been furnished to the
Company or the Holder, as the case may be, by the Company or such holder from time to time. 
 20. No Impairment. The Company will
not, by amendment of its Second Amended and Restated Certificate of Incorporation, as amended from time to time, or through any reclassification, capital reorganization, consolidation, merger, sale or conveyance of assets, dissolution, liquidation,
issue or sale of securities or any other voluntary action, avoid or seek to avoid the observance or performance of any of the terms of this Warrant, but will at all times in good faith assist in the carrying out of all such terms and in the taking
of all such action as may be necessary or appropriate in order to protect the rights of the Holder. 
 21. Remedies. The Company
stipulates that the remedies at law of the Holder of this Warrant in the event of any default or threatened default by the Company in the performance of or compliance with any of the terms of this Warrant are not and will not be adequate, and that
such terms may be specifically enforced by a decree for the specific performance of any agreement contained herein or by an injunction against a violation of any of the terms hereof or otherwise. 
 22. Governing Law. The provisions and terms of this Warrant shall be governed by and construed in accordance with the General Corporation Law of
the State of Delaware as to matters within the scope thereof, and as to all other matters shall be construed and enforced in accordance with and governed by the internal laws of the Commonwealth of Massachusetts, without regard to its principles of
conflicts of laws. 
 23. Successors and Assigns. This Warrant shall be binding upon the Company’s successors and assigns and
shall inure to the benefit of the Holder’s successors, legal representatives and permitted assigns. 
 24. Business Days. If the
last or appointed day for the taking of any action required or the expiration of any right granted herein shall be a Saturday or Sunday or a legal holiday in Massachusetts, then such action may be taken or right may be exercised on the next
succeeding day which is not a Saturday or Sunday or such a legal holiday. 
  

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 IN WITNESS WHEREOF, the undersigned have caused this Warrant to be duly executed as of the date first set
forth above. 
  

			
	 TRANSMEDICS, INC.

		
	 By:
	 	  

		 	Waleed H. Hassanein
		 	President and Chief Executive Officer

  

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 EXHIBIT A 
 NOTICE OF EXERCISE 
 To: TransMedics, Inc. 
 The undersigned hereby elects to [check applicable box]: 
  

	 	 ̈	Purchase                      shares of Common Stock (as defined in the
attached Warrant) of TransMedics, Inc., pursuant to the terms of the attached Warrant and payment of the Purchase Price required under such Warrant accompanies this notice. 

 OR 
  

	 	 ̈	Exercise the attached Warrant for shares of Common Stock issuable under the Warrant pursuant to the net issue election of Section 5 of such Warrant. 

The undersigned hereby represents and warrants that the undersigned is acquiring such shares for its own account for investment purposes only, and not
for resale or with a view to distribution of such shares or any part thereof. 
  

							
	 Date:
	 	  
	  	WARRANTHOLDER:
				
		 		  	By:	 	  

		 		  	Name:	 	
		 		  	Address:	 	

 Name in which shares should be registered:
                                        
                     
  

			
	Address:	 	  

		 	  

 EXHIBIT B 
 ASSIGNMENT FORM 
 TO: TransMedics, Inc. (the “Company”) 
  

					
	The undersigned hereby assigns and transfers
unto                                       
                                        
                                        
                                         

		 	(Type or print name of Assignee)
	of	 	  

	(Type or print address of Assignee)

 the Warrant to purchase shares of Common Stock of the Company, dated as of December
    , 2003, issued by the Company to the undersigned (the “Warrant”) and does hereby irrevocably constitute and appoint
                     as Attorney, to transfer the Warrant on the books of the Company with full power of substitution on the premises. Upon
such transfer, the person named above shall become a “Holder” for the purposes of this Warrant. 
  

					
	 Date:
                    
	  	By:	  	  

		
		  	  

		  	(Print Name of Signatory)
		
		  	  

		  	(Title of Signatory)

 Schedule to Exhibit 10.16 
  

					
	 Name of Warrant Holder
	  	 Issue Date of Warrant
	  	Number of Common
Shares Subject to
Warrant
	 3i Technology Partners L.P.
	  	December 12, 2003	  	1,000,000
	 CB Healthcare Fund II, L.P.
	  	December 12, 2003	  	490,487
	 CB-AH Parallel Fund II, L.P.
	  	December 12, 2003	  	79,513
	 POSCO BioVentures I, L.P.
	  	December 12, 2003	  	400,000
	 Novel BioVentures, LLC
	  	December 12, 2003	  	300,000
	 Sherbrooke Capital Health and Wellness, L.P.
	  	December 19, 2003	  	548,240
	 Sherbrooke Capital Health and Wellness Advisors Fund, L.P.
	  	December 19, 2003	  	1,760OEM Contract between the Registrant and Novalung GmbH

 Exhibit 10.17 
 Confidential Materials omitted and filed separately with the 
 Securities and Exchange Commission. Asterisks
denote omissions. 
 OEM Contract between novalung and TransMedics 
 OEM Contract 
 between 
 Novalung GmbH, 
 Lotzenäcker 3 
 D
- 72379 Hechingen 
 Germany 
 -
“Company” - 
 and 
 TransMedics Inc.,

 200 Minuteman Road, Suite 302 
 Andover, MA 01810

 - “Customer” - 
 CONFIDENTIAL DOCUMENT 
 Preamble 
 The Company is a medical technology company, which, since 2003, has developed, produced and distributed the first extracorporal, interventional lung assist device under the name “iLA”, which provides extra
pulmonary gas exchange to enable lung and remote organ protection. 
 The Customer ensures within its sales network technical and medical training to handle
the OEM product from the Company. The Customer’s sales activities are limited to integration of the product with it’s Organ Care System for sale or distribution to clinical end users or sales or distribution within the Customer’s
distribution network, with final destination of sales to clinical end user. 

			
	OEM Contract between novalung and TransMedics	  	2    

  

 Section 1        Product/Sale of Product/Exclusivity 

  

	(1)	The Company manufactures an OEM device (“Product” or “OEM Product”) of the interventional lung assist “iLA” with the technical specifications as set
out in Exhibit 1.1 (Technical Specifications of Product). 

 The OEM Product is designed for use within
Customer’s Organ Care System (OCS), specifically within a component of the OCS called the Cardiac Disposable Set (CDS). 
  

	(2)	For the avoidance of doubt it is provided that the Customer is only allowed to sell the Product to clinical end users or to sell or distribute the Product within the Customer’s
distribution network, with final destinations of sales to clinical end users. Thus, the sale of the Product by the Customer will be limited to OEM sales in connection with the sale of Customer’s Organ Care System or any component thereof.

  

	(3)	Customer agrees to exclusively include Company’s OEM Product as the sole third party, non-organ “gas exchange device” within any Organ Care System, or component
thereof, that is sold commercially to a clinical end user, within the contract period. Company therefore guarantees special pricing as defined in Exhibit 5. This grant of exclusivity notwithstanding, Customer shall not be prevented from using any
other gas exchange device for research and development, qualification of a backup supplier, or use within a clinical trial that is conducted to gain regulatory approval to sell Customer’s products. 

 Section 2        Intellectual Property Rights 
  

	(1)	Save as aforesaid, the Customer acknowledges that it has no rights and that this agreement grants no rights in any intellectual property rights (patents, trademarks, logos, know-how
and the like) relating to or in connection with the Product (“Intellectual Property Rights”). Customer is permitted to develop a gas exchange device of its own, provided it does so without the use of any of Company’s confidential
information, and in such a case Customer will acquire any and all intellectual property rights to its own inventions. Customer will not compete with Company in Company’s core business i.e. extrapulmonary ventilation or pulmonary support of
acute and / or chronic patients. 

  

	(2)	If the Customer makes any claims or statements in respect of the Product in its own catalogues, promotional literature, advertisements or the like it shall first obtain the
Company’s written approval. 

  

	(3)	The Customer will promptly comply with any written instructions of the Company with regard to use or identification of the Company’s Intellectual Property Rights.

			
	OEM Contract between novalung and TransMedics	  	3    

  

	(4)	The Customer will at all times comply with the provisions regarding the Company’s patents and trademarks as set out in Exhibit 2.4. 

 Section 3        Quality Terms and Conditions 
 Both, the Company and the Customer will at all times comply with the quality terms and conditions as set out in Exhibit 3. 
 Section 4        Territory and Regulatory Approval 
 The Customer has the unlimited right to sell the OEM Product worldwide solely for OEM purposes as referred to under section 1 subsection 2 (Product/Sale of Product/),
depending on registration status. 
 Section 5        Minimum Purchase Commitment

 The Customer will purchase the following volume of the OEM Product as specified in Exhibit 5 from the Company during the term of this agreement
(“Minimum Purchase Commitment”). For the avoidance of doubt it is provided that if the Minimum Purchase Commitment is not met by the Customer, the Company shall have the right to terminate the agreement with immediate effect. 

Pricing for the Product during the Fixed Term is set out in Exhibit 5 as well. All prices are net and exclusive of shipping. 
 Section 6        Termination and Validity of Contract 
  

	(1)	The contract shall be entered into for a fixed term of 5 (five) years from the date of signing (“Fixed Term”). The contract must be signed by the legal representatives
(General Management - Geschäftsführung) of both parties. 

  

	(2)	If the contract is not terminated 6 (six) months before the end of the Fixed Term by either party, it automatically extends for an indefinite term and may be terminated with a
notice term of 6 (six) months to the end of a calendar month. 

  

	(3)	A termination of the contract has to be given in written form to the other party signed by the legal representative of the terminating party. 

  

	(4)	Irrespective of this provision each of the parties hereto shall always have the right to terminate the agreement with immediate effect, if there is a good reason (wichtiger
Grund). 

			
	OEM Contract between novalung and TransMedics	  	4    

  

	(5)	Customer shall have the right to terminate this contract if Company fails to meet any of the following terms: 

  

	 	a.	Company shall deliver Product which meets the technical specifications of Exhibit 1.1; 

  

	 	b.	Company shall deliver Product which meets the Quality Requirements of Exhibit 3; 

  

	 	c.	Company shall deliver the full quantities of Products ordered according to the delivery schedules specified in a Purchase Order submitted by the Customer. 

Section 7        No Agency 
 The relationship between the Company and the Customer is that of vendor and purchaser and nothing in this agreement shall be construed as giving the Customer authority to enter into obligations on the Company’s
behalf, or to act as the Company’s agent for any purpose; nor shall the Customer hold itself out as having any such authority. The Customer shall make no representations about the Product or the Company’s business which have not been
authorized by the Company. 
 Section 8        Supply of Product/Forecasting/Purchase Orders

  

	(1)	No order shall be effective until approved and accepted in writing by the Company. 

  

	(2)	Forecasting starting with the calendar year 2009: 

 Timing:
Customer will provide Company with a [**] month rolling forecast on a [**] basis. [**] months before the end of each [**], Customer will deliver its forecast for the next [**] months. 
 Content: Each forecast will show Customer’s anticipated [**] requirements for the Product for the next [**] months. 
 Binding Commitment: Each [**]-month forecast will consist of a [**]-month forecast that is binding on Customer and may only be varied by [**]% of the
forecast and a non-binding forecast for the [**] months. If the Company does not notify Customer in writing of its objection to a forecast, then Company is obligated to supply the quantities indicated in Purchase Orders that are in accordance with
the forecasts. 

			
	OEM Contract between novalung and TransMedics	  	5    

  

	(3)	The Customer will issue to the Company specific purchase orders (“Purchase Orders”) for the Product covered by this agreement. Each Purchase Order shall be in the form of
a written or electronic communication and shall contain the following information: (i) a description of the Product by part number; (ii) the quantity of the Product; (iii) the delivery date or shipping schedule; (iv) the location
to which the Product is to be shipped; (v) transportation instructions. Each order shall provide an order number for billing purposes and may include other instructions and terms as may be appropriate under the circumstances. Such Purchase
Orders only shall become binding upon the Company if the Company has accepted and agreed to such Purchase Orders in writing. 

 Section 9        Terms of Payment 
  

	(1)	Irrespective of prices and provided that the parties have not agreed otherwise in writing, the following shall apply: 

  

	 	•	 	 Terms of payment: 30 days net from Customer’s receipt of Company’s Invoice, but in no event earlier than 30 days from Customer’s receipt of the
Product 

  

	 	•	 	 Terms of delivery: ex works Hechingen (Incoterms) 

  

	 	•	 	 Country of origin: Germany 

  

	(2)	Any invoiced amounts that become more than thirty (30) calendar days “past due”, shall be subject to default interest (Verzugszins) of one and one half
(1.5) percent per month from the due date. 

 Section 10        Warranties

  

	(1)	The Company hereby warrants that the Product shall be made of sound materials and good workmanship and shall be fit for purpose when used in accordance with the instructions for use
and any manuals or technical literature supplied by the Company. 

  

	(2)	Without prejudice to any other of its rights the Customer may by notice in writing to the Company reject any or all of the Products that fail to comply with the requirements set out
in subsection 1 above and such notice shall state the reason for the rejection. 

  

	(3)	The Customer shall be deemed to have accepted the Product no later than [**] working days after delivery unless written notice of rejection is served. 

  

	(4)	 If any of the Products do not conform with any of the warranties provided in subsection 1 hereof, the Company shall at its discretion repair or replace such
Product (or the defective 

			
	OEM Contract between novalung and TransMedics	  	6    

  

	 	 
part) or refund the price of such Product provided that, if the Company requests so, the Customer shall at Company’s expense return it to the Company.

  

	(5)	Any other statutory provisions on liability as well as misrepresentations and warranties concerning the Company shall be hereby excluded, except for gross negligence and intent
(grobe Fahrlässigkeit und Vorsatz) of the Company. 

 Section 11        Confidentiality 
  

	(1)	Scope. The term “Confidential Information” as used herein shall mean any and all information disclosed by a party in written or other tangible form which is clearly
marked as being confidential or proprietary information of the party; or oral information designated as confidential in writing within 30 days after disclosure. The parties acknowledge that all forecasts provided by the Customer hereunder, all
information on orders, purchases, shipping destinations, pricing and the like, shall constitute the Confidential Information of the Customer. 

  

	(2)	Non-Disclosure and Non-Use. The receiving party (“Receiving Party”) shall not disclose any Confidential Information in any form to any third party without the prior
written consents of the disclosing party (“Disclosing Party”) and shall use the same degree of care, but at least reasonable care, in safeguarding such Confidential Information from disclosure as with its own Confidential Information. The
Receiving Party shall use the Confidential Information of the other party only for the purpose of performing its obligations under this agreement. Such restrictions shall not apply to the extent that Confidential Information is required to be
disclosed by the Receiving Party to comply with applicable laws, government regulations, or the rules of a stock exchange, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and takes
reasonable and lawful actions to oppose and minimize the extent of such disclosure. 

  

	(3)	Exceptions. Confidential Information does not include information that (i) is or becomes in the public domain without violation of this agreement by the Receiving Party;
(ii) is known to the Receiving Party, as shown by written or other records, prior the disclosure by the Disclosing Party; (iii) is at any time independently developed by employees of the Receiving Party who have not had access to the
Confidential Information, or (iv) is received by the Receiving Party from a third party having no obligation of confidentiality to the Disclosing Party. 

  

	(4)	 Employees and Others. The Disclosing Party acknowledges that the Receiving Party may need to disseminate Confidential Information to its employees or
authorized third parties. The Receiving Party agrees to cause any such employee or third party to whom Confidential Information is transmitted to be bound to the same obligation of secrecy and confidentiality that the Receiving Party is bound to.
This obligation to maintain confidentiality in accordance 

			
	OEM Contract between novalung and TransMedics	  	7    

  

	 	 
with this section shall survive for five (5) years after termination of this agreement. Within 15 days of termination of this agreement, upon the
Disclosing Party’s request, the Receiving Party shall return all Confidential Information to the Disclosing Party, or certify in writing that is has destroyed all Confidential Information of the Disclosing Party. 

Section 12        Indemnification 
  

	(1)	Subject to the provisions of this subsection 2 below, the Company shall indemnify the Customer against any liability incurred by the Customer in respect of damage to property, death
or personal injury arising from any fault or defect in the materials or workmanship of the Product and any reasonable costs, claims, demands and expenses arising out of or in connection with that liability (“Relevant Claim”), except to the
extent that the liability arises as a result of the action or omission of the Customer. 

  

	(2)	The Customer shall immediately after it becomes aware of a Relevant Claim: 

  

	 	a)	give notice to the Company and provide all information reasonably requested by the Company; 

  

	 	b)	allow the Company to have the exclusive conduct of any proceedings and/or take whatever action the Company may direct to defend the matter, including the use of lawyers specified by
the Company; 

  

	 	c)	not admit liability or settle the matter without the Company’s prior written authorization. 

 Nothing in this agreement shall render either party liable to the other party for any loss of profits or for any indirect, unforeseeable, consequential or
economic loss or damage. 
 Section 13        Product Liability Insurance 
 The Customer and the Company shall maintain a product liability insurance for the duration of this agreement of not less than $5,000,000 per annum and $5,000,000 per
case with a reputable insurer and shall provide a copy of the insurance policy and proof of payment of the current premium to the Customer/Company upon request by the latter. However, it is the mutual understanding between the parties that each of
the product liability insurances of each of the parties shall only be responsible for any product liability damages causes by the respective party’s part used in the organ preservation, maintenance, transport or resuscitation machines. Thus,
the Company shall only be subject to product liability if the OEM Product has caused the product liability damage. 

			
	OEM Contract between novalung and TransMedics	  	8    

  

 Section 14        Limitation of the Company’s
Liability 
 In no event – except for gross negligence and intent (grobe Fahrlässigkeit und Vorsatz) – shall the Company:

  

	a)	be liable to the Customer or any distributor, dealer, purchaser, or user of any of the specified products supplied by the Customer for any damages, claims, or other demands
whatsoever resulting from, by reason of, or arising out of the misapplication, misuse, unauthorized use, or any other use of any of the specified products which is not in strict accordance and compliance with all directions, instructions, cautions,
and warnings provided by the Company in connection with said products; 

  

	b)	be liable to the Customer or any distributor, dealer, purchaser, or user of any of the specified products supplied by the Customer for any damages, claims, or other demands
whatsoever resulting from, by reason of , or arising out of the Product’s modification by a third party other than the Company. 

 Section 15        Jurisdiction and Applicable Law/Arbitration 
 This agreement shall in all
respects be governed by and construed in accordance with German law, excluding its conflict of law rules and excluding the United Nations Convention of Contracts for the International Sale of Goods as of 11 April 1980 or the United Nations
Convention of the Limitation Period for the International Sale of Goods as of 14 June 1974, both as amended. 
 All disputes arising in connection with
the agreement shall be settled under the rules of Conciliation and Arbitration of the International Chamber of Commerce in Paris by three arbitrators appointed in accordance with the said rules. The language of arbitration shall be English and
German language and the place of arbitration is Hechingen, Germany. 
 Section 16        Counterparts 
 This agreement shall be executed in two counterparts, each of
which shall be deemed an original, but all of which together shall constitute one and the same instrument. 
 Section 17        Right of Retention/Set Off 
 The Customer shall not be entitled to make use
of any rights of retention (Zurückbehaltungsrecht) or set off (Aufrechnung) with any claims it may have unless such claims have become binding and unappealable upon a judicial order. 

			
	OEM Contract between novalung and TransMedics	  	9    

  

 Section 18        Miscellaneous Terms 

 

	(1)	All notices, requests, demands and other communications to be given hereafter shall be in writing, and shall be deemed to be sufficiently given if and when mailed by registered
mail, postage prepaid or sent by facsimile to the direct telefax extensions of the management of each of the parties hereto, which are for novalung (+49 (7471) 984 88 15) and for TransMedics (978-685-9562). Telefaxes sent to other telefax
extensions shall not be deemed sufficient. 

  

	(2)	The terms and conditions herein contained constitute the entire agreement between the parties. Any changes in the conditions and rules governing this contract will not be effective
unless signed in writing by duly authorized officers or representatives of the two parties, specifically referring to this agreement. This also applies to this requirement of written form. 

  

	(3)	This agreement shall be binding upon and inure to the benefit of the parties, their legal representatives, successors and assigns. In the event that a provision of this agreement is
void or invalid, the validity of any other provision of this agreement shall not be affected thereby. Rather, the parties shall use best efforts to replace the void or invalid provision by a valid provision which comes as close as possible to the
commercial understanding of the parties expressed in the void or invalid provision. 

  

	(4)	If Novalung or the iLA product line shall be acquired by or its assets otherwise transferred to a third party, Company shall require that any third party acquirer of Novalung or the
iLA product line be bound by all relevant provisions of this Agreement, including, without limitation, this Section 18.4. 

  

					
	 Hechingen, D., 18 Jan 2007
 (Place,
Date)
	 		 	 Andover, MA, 17 Jan 2007
 (Place,
Date)

			
	/s/ Georg Matheis	 		 	/s/ Waleed Hassanein
	 Novalung GmbH
	 		 	 TransMedics Inc.

 Exhibits to OEM Contract between novalung and Transmedics 
 List of Exhibits 
  

			
	Exhibit 1.1	  	Technical Specifications of the Product
		
	Exhibit 2.4	  	Patents and Trademarks
		
	Exhibit 3	  	Quality Requirements
		
	Exhibit 5	  	Minimum Purchase Commitment

 Exhibits to OEM Contract between novalung and Transmedics 
 Exhibit 1.1        Technical Specifications of the Product 
  

			
	Technical specification V 1.0/05	  	TransMedics
		
	General Specifications	  	
		
	Technical specifications	  	“iLA” device [**].
		
		  	[When we update the product with the new connector, we will do a simple amendment to the contract to substitute a new specification]
		
	packing and shipment	  	sterile, adequately packed to maintain sterility and protect product from damage
		
	Changes to Product	  	All product changes in performance or configuration, must be agreed to by both parties. All product changes in process, material, or supplier, and implementation schedules, must be
communicated by Company immediately. In the case of any unsolicited change required by the Company due to unforeseen changes such as a supplier obsoleted part/material, Company will give Customer a [**] month notice of the change and an opportunity
to purchase a supply of product prior to implementation of the change up to the amount forecasted for the following [**] months.

 [**] 

 Exhibits to OEM Contract between novalung and Transmedics 
 Exhibit 2.4        Patents and Trademarks 
  

	(1)	The Customer may use the Company’s trademarks, trade names or symbols within the Territory only for the purpose of exercising its rights and performing its obligations under
this agreement. 

  

	(2)	The Customer shall ensure that each reference to and use of the Company’s trademarks, trade names, any other symbols or patent rights by the Customer is in a manner from time
to time approved by the Company in writing. 

  

	(3)	The Customer shall not 

  

	 	(a)	(a) alter, remove or tamper with any trade names, trade marks and symbols, or numbers, or other means of identification used in relation to the Product;

  

	 	(b)	use any of the Company’s trade names, trade marks and symbols in any way which may prejudice their distinctiveness, validity or goodwill of the Company;

  

	 	(c)	use within the Territory any trade marks or trade names so resembling any trade marks or trade names of the Company as to be likely to cause confusion or deception.

  

	(4)	The Customer shall not acquire any title whatsoever to the Company’s trade names and trade marks or any other symbols or patent rights. 

  

	(5)	The Customer shall neither register, nor have registered, any of the above mentioned trade marks, trade names, symbols or patent rights of the Company (or trade marks or trade names
which are similar to those of the Company) in the Territory or elsewhere. This does not, however, apply to such registration that is required by law or regulation within the Territory, including but not limited to user registration. However, the
Customer shall not execute such registration without the prior written consent of the Company. 

  

	(6)	The Company shall at its own cost defend any claim against Customer or Company from a third party alleging that the Product infringes a third party’s present or future
industrial proprietary rights, including any patent, trademark or copyright or any advertising or promotion material supplied to the Customer by the Company, except in the case when the infringement is the direct result of Customer’s
integration of the Product into its Organ Care System or component thereof. This section is in lieu of and replaces any other express, implied or statutory warranty against infringement. 

 Exhibits to OEM Contract between novalung and Transmedics 
  

	(7)	The Customer shall inform the Company in writing or by facsimile to Company (+49 7471 98488-15)of all claims of infringement of intellectual property rights of the Company, which
come to its notice. The Customer further agrees to cooperate with the Company at the Company’s expense with respect to any legal action which the Company deems necessary to establish and preserve the Company’s rights in and to its trade
marks, trade names, symbols and patent rights. 

  

	(8)	The right to use the Company’s trade marks and trade names or symbols, as provided for under this Exhibit, shall cease immediately for the Customer on the expiration or
termination for any reason of this agreement, provided however that Customer is permitted to continue its use of such trade marks, trade names or symbols until all of Customer’s inventory of Company’s Product is exhausted.

 Exhibit 3 
 QUALITY REQUIREMENTS 
 TransMedics — Novalung GmbH (Company) 
 Supply Agreement – Quality Rider 
  

	
	
	/s/ Georg Matheis, 1/19/07
	 Novalung GmbH
  
 Print/Sign Name and date

	
	/s/ Waleed Hassanein, 1/17/06
	 TransMedics
  
 Print/Sign Name and date

 1.0    Purpose 
 The purpose of Exhibit B is to define the requirements, responsibilities, and goals of Novalung GmbH (Company) with respect to TransMedics, Inc (Customer) product quality. This plan covers the
products manufactured by Novalung GmbH for Customer. This document is necessary to ensure the quality of Customer products and Customer compliance to ISO 13485:2003 Quality System Standard and FDA/QSR (formerly GMP)
21CFR820 regulations. 
 2.0    Order of Precedence 
 In the event that there is a conflict in documentation, the following order of precedence is in effect. 
  

	 	•	 	 Purchase Order 

  

	 	•	 	 Supply Agreement 

  

	 	•	 	 Customer Documentation 

  

	 	•	 	 Novalung GmbH Documentation 

 3.0    References 
 4.0    Definitions 
 FMD: Finished Medical Device 
 HLA: High Level
Assemblies 
 ASL: Approved Company List 
  

	 	Material:	means Raw materials, Material, manufacturing materials, substances, pieces, parts, sub-assemblies, software, firmware, in-process devices, finished devices and labeling (including
literature) which are intended to be included as part of or with the finished, packaged, and labeled device. 

  

	 	Validation:	means confirmation by examination and provision of objective evidence that the particular requirements for a specified intended use can be consistently. As it pertains to a process,
it means that a process consistently produces a result or product meeting its predetermined specifications. 

  

 2 

	 	Verification:	means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 

 5.0    Workmanship 
 All Material and HLA should
be manufactured in accordance with Customer Workmanship Standard, Procedure No. 10060 and the specific controlling Customer Part Number Specifications. 
 6.0    Maintenance and Control 
 Exhibit B, upon agreement of both Customer and Novalung
GmbH, will be a living document that resides in the Customer Company file. Updates must be signed off by both a Quality Assurance Representative from Customer and Company. Any update must be appended in the CONTRACT and
shall be valid only when made in writing and agreed upon by both Customer and Company. 
 7.0    Quality System 

 Company shall establish and maintain a Quality System that will ensure that the quality requirements for Material, HLA and FMD are met. 

Product quality requirements are flowed down to Company through either the Customer specification or P.O. (via special notes). Company shall
establish means to define, document (in writing or electronically) and implement procedures necessary to implement the Quality System. 
 Company
shall identify a Quality System Management Representative who shall be responsible for ensuring that quality system requirements are established and maintained to effectively meet Customer quality requirements. Company management with
executive authority shall periodically review the effectiveness of the Quality System. Results of the review and effectiveness shall be made available to Customer during a Customer audit. 
 The Quality Representative for Company and Customer shall meet on a periodic basis to review the performance of Company’s Quality System.
Internal audits at Company shall be performed to assure that the Quality System can consistently and effectively meet the quality requirements for the products. 
  

 3 

 8.0    Document Controls 
 Company shall control internal documents required by the Quality system. The controls shall ensure that documents are reviewed and approved before distribution and those changes to the documents are reviewed
and approved by personnel comparable to those who reviewed and approved the document. Documents shall be located to be readily available at their point of use. Obsolete documents shall be removed to prevent their unintended use. 
 Company shall only input officially released Customer documentation into its Document Control system. Any other copy is for reference only. Company
should confirm, to Customer, in writing or electronically that they have received documentation from Customer. All Customer controlled documentation should be forwarded to Company Program Manager, or designee. 
 Company Program Manager or designee shall communicate changes to Customer documents to appropriate personnel in a timely manner. Where document
changes might affect the quality of the products such changes shall be communicated to Customer. Records of changes shall be kept and shall include the date the change becomes effective. 
 Customer will inform Company in writing in a timely manner if the Customer product requirements change. Company has 2 business days to review
changes and respond back to Customer with any exceptions, price changes and effectivity date. 
 9.0    Purchasing Controls

 Company shall evaluate Companys, subcontractors and service providers to determine their ability to provide products that conform to the
specified requirements. The evaluation must be documented. The documentation shall include the criteria for acceptance and the extent to which control must be established over the Company. Records of acceptable Companys shall be kept. In the event
that the Company is Customer specific, Customer will evaluate their ability to provide products that meet specified requirements. Company will be responsible for maintaining an acceptable Quality level for all Companys through
production. 
 Purchased products shall be described to the detail necessary to clearly convey the requirements for the products. The specifications and
requirements necessary to ensure the quality of the purchased product must be documented and conveyed to the Company. 
 Company shall maintain the
identity of product during all stages from receiving, to production to delivery to ensure that only the correct, conforming products are delivered. 
 Purchased product shall be bought in accordance with the Customer ASL. There shall be no variance from the ASL unless written authorization is given by Customer. TransMedics shall be responsible for determining whether
verification is required for any changes/additions to ASL. This will be based upon individual form, fit or function criteria, as defined by TransMedics. 
  

 4 

 Purchased product shall be inspected, tested and accepted as conforming to specified requirements. Records of acceptance
or rejection shall be documented. 
 10.0    Production and Process Controls 
 Company shall develop, conduct, control and monitor production processes to ensure that product conforms to its specifications. Company shall establish
approval processes for those processes used in production of the products, and perform Process Validation, where appropriate. 
 The guidelines to be used
for determining whether a process should be validated are as follow, “When a process cannot be fully verified by subsequent inspection and test, then the process shall be validated with a high degree of assurance”. 
 Verification/Validation of processes shall be completed prior to production. There shall be no variance unless written authorization is given by Customer. If
Company elects not to validate a particular process, then a written explanation as to why such process was not validated should be fully documented. 
 Company shall determine the process controls that are suitable. Process controls shall include, but not limited to: 
  

	 	•	 	 Documented instructions and procedures 

  

	 	•	 	 Compliance with reference standards 

  

	 	•	 	 Workmanship criteria expressed in documented standards 

 Company shall implement controls necessary to prevent contamination of manufacturing materials, equipment and product to avoid any adverse affect on the products. 
 Company shall ensure that the equipment used shall be appropriate for the production requirements and be maintained according to a maintenance schedule that ensures the manufacturing specifications are
consistently met. Records of maintenance shall be documented and maintained. Inspections shall be performed to determine that the equipment is maintained as specified in the maintenance schedule. The inspections shall be documented. Where adjustment
of equipment is necessary, the allowable tolerances and limits shall be readily available to those performing the adjustment. 
 Where a material used in the
manufacturing process that might have an adverse effect on the products, Company shall ensure that said material is removed from the products to the extent that the residual material will not harm the product. 
  

 5 

 Software used to automate parts of the manufacturing process or Quality System shall be validated that it is suitable for
the intended use. 
 Company shall provide a process flow map that illustrates all HLA and FMD product delivered to Customer. 
 11.0    Traceability 
 Company shall
maintain the identity of product during all stages from receiving to shipment, in order to ensure that only the correct, conforming products are delivered. 
 In addition, Company will record serial numbers for all HLA and FMD product delivered to Customer. The FMD serial number shall be capable of tracing back to the individual DHR. 
 12.0    Inspection, measuring, and test equipment 
 Company shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.

 Company shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. Records of
calibration shall be maintained. In the event that uncalibrated Test Equipment was used during the processing of product for Customer, Customer should be immediately notified. 
 Test Equipment, used during the acceptance of product for Customer, requires Validation. If test equipment is being developed by Company, then it is the responsibility of Company to create the
Validation Protocol, run the Protocol and document the results. If the test equipment is being transferred to Company from Customer then it will be the responsibility of Customer to provide the necessary documentation, run the
Validation and document the results. Any modification to an already validated piece of Test Equipment will need written approval from Customer. 
 13.0    Acceptance Testing 
 Company shall ensure that in-process product shall be controlled until the required
Quality Assurance measures are completed and necessary approvals are received and documented. 
 Company shall ensure that finished product be held
until acceptance criteria have been met. Release to shipping shall take place after the production activities are complete, the data and documentation is reviewed and release is authorized by signature and date of approval. 
  

 6 

 Company shall maintain the acceptance status of the products throughout manufacturing, packaging, labeling and
shipment of the products, to ensure that only the products that have passed the required acceptance activities is complete. 
 Company shall inspect
products before packaging for delivery to ensure the quality of delivered product. Records of the inspection records shall be sent with each lot. 
 14.0    First Article 
 Company shall perform a First Article inspection with the introduction of a new product to
Company. If requested by Customer, a first article may be performed after an Assembly drawing change. A complete First Article will include a tagged First Article item and evidence that all attributes of that item were inspected and
determined to be acceptable. Where applicable, the item will be verified against attributes consisting of all BOM, labeling, and assembly documentation. First Articles will be recorded on a First Article form Customer generated by
Company. At the request of Customer, Company shall forward a copy of the completed form and/or First Article assembly to Customer for review. 
 Shipment of additional Production assemblies is contingent upon successful acceptance of the First Article assemblies. Company will receive written authorization from Customer once Qualification has been
completed. At the conclusion of this phase, Company will be asked to maintain a “gold sample” that will be retained. 
 Nonconforming First
Articles will not be accepted unless Company has first obtained a Process Deviation Authorization from Customer. 
 15.0    Nonconforming Product 
 Company shall control product that does not meet specifications to ensure that
nonconforming product is not distributed, without explicit approval by Customer. Control of nonconforming product shall include the identification, documentation, evaluation, segregation and disposition of the nonconforming product. The
evaluation shall include the determination of the need for an investigation, corrective action and the notification of the organization responsible for the nonconformance. 
 Company shall identify the persons responsible for the review and disposition of the nonconforming product. The review and disposition of nonconforming product shall be documented. 
  

 7 

 Rework procedures shall be established that include the processes to be used, the retesting and reevaluation of
nonconforming product after the rework. The rework and reevaluation activities shall be documented. 
 16.0    Corrective and
Preventative Action 
 Company shall establish a system for determining the causes of nonconforming product and correcting those causes to prevent
the nonconformance from recurring. The system shall include the analysis of work, audit reports, returned product, complaints, process metrics and other sources of data to identify the existence of potential causes of nonconforming product. Analysis
applies to both Off-The-Shelf and Customer custom designed Material. In the event that Company is unable to receive timely resolution, from a Customer specific Company, then Company should contact Customer for
assistance. 
 The corrective and preventative action system shall include the investigation of the potential causes of nonconforming product, the
identification of the actions needed to correct and prevent the recurrence of nonconforming product, verification of the effectiveness of the corrective action, changes to processes needed to correct the causes of nonconforming product and ensure
that the information about the quality problem is disseminated to those directly responsible for assuring the quality of the product. 
 Objective evidence demonstrating Corrective/Preventative Action must be present with the response, e.g.
DCO’s, updated method sheets, inspection sheets, 1st article, Company responses, training records, etc. A Company response stating that a document was
updated is not acceptable. The response should also list the affectivity date or P.O. /M.O. or ship date of the Corrective Action. 
 17.0    Customer Returned Goods (CRG) 
 Material/HLA’s/FMD’s returned to Company as a result of a field
complaint will be documented by Customer. 
 Company should process all TransMedics customer complaint Material, HLA or FMD within 5
business days of receiving the material. A written response should be provided to Customer within the 5 days. The failed product will be handled separately. 
 In addition, Company will be required to complete a CAPA Report which lists the Root Cause and Corrective Action. All other returned material should be processed within 30 business days. 
  

 8 

 18.0    Labeling 
 Company shall ensure that label(s), if required, for the products remain legible and affixed during handling. Labels shall be inspected before they are released for use. Labels shall be stored to prevent
mix-ups. Labeling operations shall be controlled to ensure that the correct label is placed in the correct place on the products. 
 19.0    Records 
 The records required by this agreement shall be maintained at Company’s facility. These
records must be made available. 
 Customer requires that all Customer related documents be retained and archived for a period of seven years
after Customer has announced end-of life for the product. Once the seven years has been reached, a decision will be made between Customer and Company on where the documents will be stored. Customer will inform Company
when product end-of-life has been announced. Examples of Customer related documents are: Company audits, training records, and calibration records, test data, Certificate of Conformance (C of C), Rework/Repair Travelers and Device History
Records. If Company has a question as to whether a document should be retained then Company should contact the Customer Quality Representative. No records should be destroyed without written consent from Customer.

 If required by the individual P.O. or Customer documentation, the contents of what is to be recorded on data sheets and Device History Records
(DHR's) will be provided by Customer.  
 If required, by the individual P.O., Customer documentation, Certificates of Conformance,
Acceptance Test Data, should be shipped with the material to Customer. Company is required to keep a copy of the C of C, regardless of whether it was shipped with the product. This applies to both new production or reworked material.

 20.0    Statistical Techniques / Continuous Improvement 
 Company shall use statistical techniques where appropriate to establish, control and verify the acceptability of process capability and product characteristics. This information should be used to monitor
in-house defects as well as to continuously improve Quality of Customer product. A copy of this information will be forwarded to Customer upon request. 
 21.0    Process/Product Yields 
 Product quality targets are defined with WIP 97.5, as calculated
at Customer Incoming /Manufacturing, six months after release of individual Material/HLA’s/FMD’s. If Company does not reach these targets, then every effort should be made by Company to remedy the problem(s) and
correct any in-house deficiencies. 
  

 9 

 22.0    Audits 
 Company’s Quality System is subject to be audited by Customer. The audit will be conducted by Customer, or other authorized, personnel. Company will be given ample advanced notice and
will be provided an agenda as well as the names of the personnel scheduled to be part of the audit. 
 23.0    Approvals

 Company shall maintain a general Quality System in accordance with ISO 9001:2000 and 13485:2003. 
 Company shall immediately notify Customer Quality Assurance Representative of any substantial changes in their Quality System or certification status. 

24.0    Recall 
 In the event of any recall of
any Company Finished Product(s), caused by Company’s sole negligence, whether in or out of warranty, (i) Company shall rework or replace the recalled Finished Product(s) without charge to Customer. 

25.0    Preventive Maintenance 
 Company
shall establish procedures, responsibilities, and instruction for assuring that a Preventive Maintenance (P/M) program is established and to guarantee that all applicable plant maintenance and production equipment is properly maintained. The P/M
plan should ensure that all applicable equipment is maintained to provide optimum operational readiness and that it is capable of meeting its intended use. The P/M program pertains to production equipment, including fixed machinery, tooling (molds,
dies, jigs, fixtures) and plant maintenance. 
 26.0    Packaging 
 All Material/HLA’s/FMD’s shall be packaged in order to prevent from being damaged during normal handling. The outside of the box should include the packing slip and C of C (if required). The outside shipping
box should be marked with Customer P.O., P/N, Revision and Qty, at a minimum. In addition, a list of all the serial numbers shall be included with each ship box, if applicable. 
 27.0    Terms of Exhibit 3 
 Exhibit 3 shall govern all deliveries of products after 01 MAY 2007.

  

 10 

 Exhibits to OEM Contract between novalung and Transmedics 
 Exhibit 5        Minimum Purchase Commitment 
  

					
	 Year
	  	 Number of Units
 Gas Exchanger Device
	  	 Net Price
 (EUR/Unit)

	 2007
	  	[**]	  	[**]
	 2008
	  	[**]	  	[**]
	 2009
	  	[**]	  	[**]
	 2010
	  	[**]	  	[**]
	 2011
	  	[**]	  	[**]
	 2012
	  	[**]	  	[**]

  

	[**](A)	The quantities from 2009 and later are not fixed and will instead be determined by the forecasts according to Section 8 of this Contract. Pricing is valid for a minimum order
quantity and shipment quantity as defined below. 

 (B) Minimum order and shipping quantities: [**] pcs. per order and [**] pcs. per shipment.

 (C) It is contemplated that the Product Specification will be updated to reflect a new TransMedics-specific connector. At that time, the parties will
agree to a simple contract amendment substituting the new specification for the old one, and all Purchase Orders placed after the date of the amendment will be for the new Product with the new connector. 
 Possible future product changes requested by Customer require a contract amendment substituting the new specification for the old one, including changes in pricing.

 Delivery schedule 2007: 
 Immediate delivery of [**]
pcs. to close out Purchase Order P500395 from 07/17/06 
 [**] pcs. by end of May 
 [**] pcs. by end of September 
 [**] pcs. by end of December 

 Exhibits to OEM Contract between novalung and Transmedics 
 Delivery schedule 2008: 
 [**] pcs. by end of March 
 [**] pcs. by end of May 
 [**] pcs. by end of July 
 [**] pcs. by end of September 
 [**] pcs. by end of November 
 quantity / delivery will be defined by TransMedics Purchase Orders.

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