Post-Acquisition
Supply Agreement


 


This
Post-Acquisition Supply Agreement (the “Supply Agreement”) made and entered into effective as of March 18,
2016 (the “Effective
Date”), is between Hancock Jaffe Laboratories, Inc., a Delaware corporation(“HJL”), with its address
at 70 Doppler, Irvine, California 92618, and LeMaitre Vascular, Inc., a Delaware corporation(“LMAT”), with
an address at 63 Second Avenue, Burlington, Massachusetts 01803 (hereinafter sometimes individually or collectively referred to
as a “Party” or the “Parties,” respectively) .
All capitalized terms not defined
herein shall have the meanings ascribed to them in the Asset Purchase Agreement (defined hereinafter).


 


WHEREAS,
pursuant to that certain Asset Purchase Agreement dated of even date between the Parties, LMAT acquired certain assets of
HJL;


 


WHEREAS,
in accordance with the terms of the Asset Purchase Agreement, HJL and LMAT desire to enter into this Supply Agreement, whereby
HJL will be the contract manufacturer of the Products for LMAT post-Closing, all as further set forth in this Supply Agreement.


 


NOW,
THEREFORE, in consideration of the foregoing and the representations, warranties, covenants, and agreements contained herein,
the Parties hereto agree as follows:


 


ARTICLE
1


SCOPE
OF AGREEMENT


 


	1.1.	This
    Supply Agreement applies to the post-Closing supply of Products by HJL to LMAT in accordance with the terms of this Supply
    Agreement.


 


ARTICLE
2


REGULATORY


 


	2.1.	Medical
    Device Establishment Registration. During the term of this Supply Agreement or as required by law, which ever date is
    later, HJL shall continue to maintain a Medical Device Establishment Registration and Listing (as defined under the United
    States Food, Drug and Cosmetic Act and the regulations promulgated thereunder, as amended from time to time (the “Act”))
    as the contract manufacturer.
	 	 
	2.2	Regulatory
    Approvals/Clearances. LMAT shall be responsible, at its sole expense, for filing and obtaining and maintaining (including
    development of and compliance with necessary quality programs) any further authorizations from regulatory authorities worldwide,
    including the FDA and the appropriate competent authority or Notified Body, attendant to or necessary for the commercialization
    of the Products in any jurisdiction. Except as otherwise required by law or agreed by the Parties, LMAT shall be responsible
    for all dealings with the FDA, or the appropriate competent authority or Notified Body, including but not limited to notifications,
    medical device vigilance, and national labeling issues.
	 	 
	2.2.	Registrations/Listings.
    Within a reasonable time post-Closing as agreed to by the Parties, HJL will take all steps reasonably necessary to update
    FURLS (FDA Unified Registration and Listing Systems) regarding the change in HJL’s responsibility for the Products from
    a manufacturer of record to a contract manufacturer. LMAT is responsible for re-listing such Products. Further, on and after
    the Effective Date, LMAT shall be legally responsible for all post-market surveillance activities, customer service, reporting
    and all other regulatory filings and compliance requirements for the Products.
	 	 
	2.3.	Manufacturing
    Compliance. If HJL determines that its manufacturing, quality systems, post-market surveillance activities, or any portion
    thereof, are not in compliance with any Applicable Law, it shall promptly notify LMAT in writing within three business days
    of such determination. In such written notification, HJL shall provide to LMAT an explanation and description of such non-compliance
    and an explanation of the controls that will be implemented or actions that will be or already have been taken to correct
    the non-compliance.
	 	 
	2.4.	Traceability.
    For as long as required by law or to fulfill the obligations under this Supply Agreement, whichever is longer, each Party
    will maintain adequate records to permit the Parties to trace the manufacture of the
    Product     and the distribution and use of the Product. Additionally, within 5 business days of the end of each calendar
    month, HJL shall     prepare and send to LMAT a report listing the following information with respect to any implant
    registration cards received     by HJL during such calendar month: 1) serial number; 2) model number; 3) patient ID #; 4)
    physician last name; 5) Product     implant date; and 6) hospital name, city and state; in each case to the extent that the
    underlying implant cards contain such     information.


 




    	 	 	
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	2.5	Remedial
    Actions. HJL will immediately notify LMAT, and promptly confirm such notice in writing, if it determines or is instructed
    by a regulatory body that any of the Products are or may be subject to recall, field corrective action, stock recovery or
    other post-distribution regulatory action with respect to a Product taken either by virtue of applicable federal, state, foreign,
    or other law or regulation or good business judgment (a “Remedial Action”). LMAT will be responsible for,
    and HJL will assist as requested by LMAT, in gathering and evaluating such information as may be helpful to determine the
    necessity of conducting a Remedial Action; provided that LMAT shall have sole responsibility for collecting information from
    its customers, including customer complaints. LMAT will determine in its sole discretion whether to commence any Remedial
    Action with respect to the Product and HJL shall fully cooperate in such Remedial Action. If LMAT determines in its sole discretion
    that any Remedial Action with respect to the Product should be commenced or if a Remedial Action is required by any governmental
    authority having jurisdiction over the matter, LMAT will control and coordinate all efforts necessary to conduct such Remedial
    Action. If LMAT conducts any Remedial Action related to the Product and HJL is determined by LMAT in its sole discretion to
    be responsible for the issue requiring the Remedial Action (e.g., a problem arises from faulty manufacture), HJL, at LMAT’s
    option, will either issue a credit to LMAT or reimburse LMAT for the sales price of all LMAT devices recalled in such Remedial
    Action and the other reasonable costs incurred by LMAT associated with such Remedial Action. LMAT shall have responsibility
    for managing corrective and preventive action (“CAPA”) as defined in the Act.
	 	 
	2.6	Complaints
    and Medical Device Reporting. Each Party will comply with applicable provisions of the 21 CFR Part 820 Quality System
    Regulation and 21 CFR Part 803 Medical Device Reporting systems, and each Party will cooperate with the other for the timely
    compliance therewith. HJL agrees to notify LMAT within two business days of receipt of any information that reasonably suggests
    a complaint or Medical Device Report (“MDR”) relating to the Product has occurred. LMAT agrees to notify
    HJL within a reasonable period of time of receipt of any information that reasonably suggests a MOR relating to the Product
    has occurred. HJL will investigate any such complaints or MDRs/Vigilance Reports and forward to LMAT its determinations and
    conclusions relating to the complaint or MOR. HJL shall investigate all instances of an alleged product failure or product
    inadequacy documented by LMAT and forwarded by LMAT for investigation. HJL shall provide a written summary of the findings
    from such investigation and status and ongoing actions to LMAT within seven calendar days following the date that HJL is informed
    of such complaint or MOR and every 14 calendar days thereafter until the complaint or MOR is formally closed. LMAT shall have
    sole responsibility for filing the MOR with the appropriate regulatory agency.
	 	 
	2.7	Vigilance
    Reporting. HJL will notify LMAT in writing if a Vigilance Report is required to be filed with respect to the Product.
    LMAT will be responsible for complying with Vigilance Reporting requirements for the Product.
	 	 
	2.8.	LMAT
    Audits. HJL will give LMAT reasonable access to its manufacturing laboratories, supplier, inventory, shipping, and
    quality     procedures and records and facilities to allow LMAT to conduct full compliance audits relating to the Product,
    its manufacture,     and the Product’s regulatory and quality status, at LMAT’s expense, as reasonably deemed
    necessary by LMAT, but     no more frequently than twice in any 12 month period, unless LMAT determines in good faith that
    exceptional circumstances     require more frequent audits. The audit may include, without limitation, records relating to
    manufacturing compliance with     the Specifications (as defined in the Act), compliance with quality control and inspection
    reports procedures, compliance     with GMP/QSR Regulations and regulatory compliance. Such audits will be conducted during
    HJL’s normal business hours,     with at least three business days’ prior written notice to HJL by LMAT. HJL will
    make its personnel available to LMAT     in connection with such audits. LMAT will provide to HJL the audit findings of
    observations to which HJL will respond within     10 business days with its evaluation of the findings detailing corrective
    actions with follow-up reports every 30 calendar     days until the observations have been formally closed or will inform
    LMAT in writing of the reasons why HJL believes a corrective     action is not required. LMAT will be given access to audit
    all corrective actions.


 




    	 	 	
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	2.9	Regulatory
    Inspections. HJL will promptly notify LMAT of any planned or unannounced inspection of its facilities manufacturing the
    Product or any component part of a Product by the FDA, CE Mark certification organization or other federal, state, local,
    or other regulatory agency which relates to the manufacture, assembly, packaging or regulatory status of the Product and regularly
    provide LMAT with information about the progress and outcome of such inspection, including, without limitation, copies of
    any notice of observations or warnings and copies of HJL responses to these inspection reports or warnings, including, requests
    for Remedial Action, resulting CAPAs, supporting attachments or other related documentation.


 


	2.10	Additional
    Quality Requirements. HJL shall comply with those additional quality requirements set forth in Exhibit A.
	 	 
	2.11	HJL
    Cooperation: HJL shall cooperate with LMAT to the fullest extent possible as reasonably requested by LMAT regarding any
    matter set forth in this Article 2. This shall include, without limitation, cooperation in the following: (a) LMAT’s
    preparation and filing of any regulatory submissions in any jurisdiction, including preparing or providing the documentation
    necessary for all proposed filings with any regulatory agency worldwide, including with the FDA or the appropriate competent
    authority or Notified Body; (b) any clinical trials or investigations or follow-up from such clinical trials or investigations;
    (c) registrations and listings under paragraph 2.2 above; (d) remedial actions and CAPAS, under paragraph 2.3 above; and (e)
    Complaints, Medical Device Reports, Vigilance Reports, Audits and Regulatory Inspections, under paragraphs 2.6 to 2.9 above.


 


ARTICLE
3


SUPPLY
AND ORDERS FOR PRODUCTS


 


	3.1.	Purchase
    Orders. On the Effective Date, LeMaitre shall submit a purchase order to HJL in the form attached as Exhibit B
    (the “Initial Purchase Order”). LMAT shall submit purchase orders to HJL for the Products pursuant to Section
    3.3. Each purchase order shall cover the portion of the forecast that has become a firm order under Section 3.3 of this Supply
    Agreement and shall, at a minimum, include: (a) identification of the Products ordered; (b) quantity; (c) delivery date; and
    (d) shipping instructions and shipping address.
	 	 
	3.2.	Acceptance
    of Orders. Except as otherwise provided in Section 3.4, all purchase orders issued in accordance with this Supply Agreement
    shall be automatically accepted by HJL. Except for the Initial Purchase Order, purchase orders for the Products must be received
    by HJL at least 30 calendar days prior to delivery date requested. Each purchase order shall be deemed to be an offer by LMAT
    to purchase the Products pursuant to the terms of this Supply Agreement and shall give rise to a contract between LMAT and
    HJL for the sale of the Products ordered and shall be subject to and governed by the terms of this Supply Agreement solely
    and to no other terms, including the provisions of the Uniform Commercial Code. The terms and conditions of this Supply Agreement
    shall govern and supersede any additional or contrary terms set forth in LMAT’s purchase order or any HJL or LMAT acceptance,
    confirmation, invoice, or other document, unless the specific additional or contrary terms are stated in writing and duly
    signed by authorized officers of LMAT and HJL. With each lot of Products manufactured by HJL, HJL shall supply to LMAT documentation
    certifying in writing that each shipment of Products complies with (i) the then-current Specifications (as agreed upon by
    the Parties) and with the testing procedures described therein; and (ii) all other documentation required by LMAT.
	 	 
	3.3.	Forecasts.
    Commencing within 10 business days after the Effective Date of this Supply Agreement, LMAT shall provide to HJL a
    written, rolling six-month forecast (with such first forecast to be for less than six months if the first forecast is not
    issued at the beginning of a calendar quarter). HJL shall not be required to deliver to LMAT more than 175 units in any
    thirty day period without HJL’s prior consent. The first three months of each forecast shall constitute a firm order to
    purchase the units of the Products specified in the forecast, and LMAT shall subsequently issue purchase orders consistent
    with these firm orders. The balance of each forecast shall constitute a non-binding good faith estimate of expected orders
    for Products.


 




    	 	 	
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	3.4.	Order
    Limitations. HJL shall maintain an adequate inventory of the Products and shall notify LMAT within two calendar days in
    writing upon becoming aware of any actual or potential interruption in supply. HJL shall not be required to deliver quantities
    in excess of 120% of forecasted requirements unless HJL has been given at least 90 calendar days advance written notice of
    the quantities to be delivered which exceed the forecasted amounts. Notwithstanding the foregoing, HJL shall use all commercially
    reasonable efforts to supply quantities in excess of 120% of forecasted requirements that were given with less than 90 calendar
    days advance notice.
	 	 
	3.5.	Modification
    of Orders. Except as otherwise provided in Section 3.4, no purchase order shall be modified or canceled except upon the
    mutual agreement of the Parties, which agreement shall not be unreasonably withheld by either Party. Mutually agreed upon
    change orders shall be subject to all provisions of this Supply Agreement, whether or not the changed purchase order so states.
    Notwithstanding the foregoing, any purchase order may be canceled by LMAT as to any Products which are not delivered within
    five calendar days of the delivery date requested by LMAT pursuant to a purchase order submitted to HJL under Section 3.1
    and accepted by HJL under Section 3.2 (the “Requested Delivery Date”), and any such cancellation shall
    not limit or affect any contract remedies available to LMAT with respect thereto.
	 	 
	3.6.	Shipment.
    All Products sold by HJL to LMAT shall be shipped by HJL free on board (“F.O.B.”) LMAT’s facility
    (the “Destination”) addressed to LMAT’s address (or such other address as set forth by LMAT). HJL
    shall bear all risk of loss until HJL delivers the Products to the Destination and they are received by LMAT. HJL shall pay
    all loading, freight, shipping, insurance, forwarding and handling charges, fees, storage, and all other charges applicable
    to the Products to facilitate delivery of the Products to the Destination.
	 	 
	3.7.	Inspection.
    HJL will inspect, test and certify the Product to specifications required by the approved device master record and listed
    on the Certificate of Analysis identified in Exhibit C. Upon notification to HJL, LMAT will have the right to reject
    any lot that contains Product that does not meet the Specifications (“Nonconforming Product”). LMAT will
    provide HJL with information as to the reason for the rejection of the Nonconforming Product including a description of the
    test procedure and results, if any, on which the rejection is based (i) within 60 calendar days of receipt therefor with respect
    to nonconformities that can be discovered with reasonable diligence, and (ii) for all other Nonconforming Products, within
    45 calendar days after LMAT discovered or was informed by a third party or should have discovered the nonconformity. HJL will
    instruct LMAT as to the disposal or return of Nonconforming Product. In the event of Nonconforming Product(s), HJL will be
    responsible for return shipping charges. LMAT may issue a debit memorandum to HJL, which HJL will honor promptly for LMAT’s
    benefit, for the purchase price, freight, and related costs of the Nonconforming Product, and HJL will promptly replace the
    Nonconforming Product and invoice LMAT for the Product shipped to replace the Nonconforming Product at the time of shipment
    of the replacement product.
	 	 
	3.8.	Process.
    Material or Labeling Changes.


 


	 	(a)	No
    material changes, modifications, deviations, or exceptions to the Specifications, materials, or fabrication, manufacturing,
    or packaging processes in effect as of the date hereof may be made without LMAT’s prior consent and 60 calendar days’
    prior written notice of the proposed change by HJL to LMAT.
	 	 	 
	 	(b)	Any
    such material, process or labeling changes, modifications, deviations, or exceptions proposed to be implemented by HJL shall
    be subject to prior LMAT regulatory review of HJL’s determination of significance and shall not be implemented for at
    least such 60 day period or longer as required to address LMAT’s concerns, if any, including obtaining any necessary
    regulatory approvals prior to implementing such changes.


 




    	 	 	
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	 	(c)	HJL
    shall provide full cooperation in implementing any changes requested by LMAT.
	 	 	 
	 	(d)	HJL
    shall provide, at its sole cost and expense, a limited number of samples of the Product incorporating the proposed change
    for LMAT’s evaluation in accordance with this paragraph, 3.8.
	 	 	 
	 	(e)	If
    any HJL proposed change would require approval by any governmental authority, LMAT shall be responsible for, and shall bear
    all costs associated with, obtaining such approvals.


 


	3.9.	Labeling.
    HJL, as a contract manufacturer for LMAT, shall be responsible for affixing the labeling on Products purchased under this
    Supply Agreement pursuant to Applicable Laws, including, but not limited to, requirements for unique device identifier (UDI)
    labeling. Product labeling shall read “Manufactured for LeMaitre Vascular, Inc.” unless otherwise agreed to by
    the Parties. HJL shall deliver the text of proposed packaging, labeling, and instructions for use changes to LMAT for regulatory
    review and approval at least sixty (60) calendar days prior to printing. HJL shall prepare labeling and instructions for use
    in all foreign languages that LMAT reasonably requests. LMAT shall be responsible for the costs of translating the labeling
    into any foreign language.
	 	 
	3.10.	Time
    is of the Essence. HJL will advise LMAT in writing within seven calendar days of any delay or anticipated delay in delivery
    or performance under this Supply Agreement.


 


ARTICLE
4


PRICES
AND PAYMENTS


 


	4.1.	Prices.
    The F.O.B. Destination purchase price of all Products sold to LMAT post-Closing hereunder (“Prices”) shall
    be as agreed by the Parties in Exhibit D containing Prices and other miscellaneous terms.
	 	 
	4.2.	Payment
    Terms. HJL will invoice LMAT upon delivery of Products. Invoices for Products shall be due and payable in full within
    10 calendar days following the date of the invoice.
	 	 
	4.3.	Taxes.
    The Prices for Products do not include any sales, use, value added, or similar taxes, customs duties, or tariffs imposed by
    any governmental authority or agency on Products or any components thereof that are imposed on LMAT. LMAT shall pay or reimburse
    HJL for all such amounts incurred in connection with LMAT’s purchase of Products; provided, however, that HJL shall
    pay all income, excise, or franchise taxes imposed upon the manufacturing activities or income of HJL.
	 	 
	4.4.	Resale
    Prices. LMAT may resell the Products at such prices, as LMAT, in its sole discretion, shall determine.


 


ARTICLE
5


GENERAL
RIGHTS AND OBLIGATIONS OF HJL


 


	5.1.
    	Manufacture
    and Supply of Products. During the term of this Supply Agreement, HJL shall manufacture the Products in accordance with
    the approved Specifications and Applicable Laws, including FDA Clearance (or Approval as may be required by the FDA), and
    the terms and conditions set forth in this Supply Agreement. HJL shall not sell the Products to, or manufacture the Products
    for, any party except LMAT.


 


ARTICLE
6


TERM
AND TERMINATION


 


	6.1.	Term.
    This Supply Agreement shall take effect as of the date first above written and shall continue in force until the earlier of
    (i) March 18, 2019 and (ii) the date upon which this Supply Agreement is terminated pursuant to Section 6.2 below.


 




    	 	 	
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	6.2.	Termination.
    This Supply Agreement may be terminated by LMAT upon seven calendar days advance written notice to HJL. HJL may terminate
    this Supply Agreement upon 35 calendar days advance written notice to LMAT if LMAT is in material breach of any of its representations,
    warranties or covenants hereunder and, either the breach cannot be cured or, if the breach can be cured, it is not cured by
    LMAT within 30 calendar days after LMAT’s receipt of written notice of such breach.
	 	 
	6.3.	Rights
    and Obligations on Termination. In the event of termination of this Supply Agreement for any reason, the Parties shall
    have the following rights and obligations:


 


	 	(a)	Termination
    of this Supply Agreement shall not release either Party from the obligation to make payment of all amounts then or thereafter
    due and payable.
	 	 	 
	 	(b)	LMAT
    shall have the right, at its option, to cancel any or all purchase orders that provide for delivery after the effective date
    of termination.
	 	 	 
	 	(c)	LMAT’s
    and HJL’s obligations pursuant to Articles 2, 4 and 7-14, and this Section 6.3, shall survive termination of this Supply
    Agreement. All other provisions of this Supply Agreement shall terminate upon termination of this Supply Agreement.


 


ARTICLE
7


PRODUCT
WARRANTIES


 


	7.1	Warranty.
    HJL warrants to LMAT that: (i) the Products delivered to LMAT under this Supply Agreement will be saleable and useable in a
    clinical setting and will conform to the then current and approved Specifications for Products and any documentation
    contained in literature supplied by HJL with that Product; (ii) the Products will be free from defects in design,
    manufacture, materials, and workmanship under normal intended use and service, in accordance with all Applicable Laws and
    requirements including, but not limited to, the Act and GMP/QSR Regulations and not adulterated under the Act; (iii) the
    Products have been manufactured, tested, stored, packaged, labeled, and shipped in compliance with the Specifications and all
    Applicable Laws including, but not limited to, the Act and GMP/QSR Regulations; (iv) the Products shall have a shelf life of
    at least 54 months with a minimum of 48 complete months shelf life remaining when received by LMAT; (v) HJL’s
    manufacturing facility, and manufacturing process for the Products, are,, and at all times during the duration of the Supply
    Agreement, shall be, in compliance with all GMP/QSR Regulations and ISO 13485:2003, EN 46001 requirements; and (vi) the
    Products are free and clear of any liens, security interests, or encumbrances of any nature whatsoever, except for those
    liens, security interests, or encumbrances held by LMAT as contemplated by the Supply Agreement. LMAT shall have available
    any and all remedies available in law or equity in the event any Products do not meet the foregoing warranties. Prior to
    returning any Products alleged to be defective, LMAT shall notify HJL in writing of the claimed defect and, where available,
    shall include the lot and serial number of such Products, as well as the number and date of the invoice therefor. The
    foregoing warranty shall not apply to any Product that has been subjected by LMAT to abuse, misuse, neglect, negligence,
    accident, improper testing, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions
    or use contrary to any written instructions issued by HJL.
	 	 
	7.2.
    	Limited
    Warranty. THE WARRANTIES SET FORTH IN SECTION 7.1 ARE INTENDED SOLELY FOR THE BENEFIT OF LMAT. ALL LOSSES THEREUNDER SHALL
    BE MADE BY LMAT AND MAY NOT BE MADE BY LMAT’S CUSTOMERS.
	 	 
	7.3
    	DISCLAIMER
    OF OTHER REPRESENTATIONS AND WARRANTIES. EXCEPT FOR THE EXPRESS REPRESENTATIONS AND WARRANTIES SET FORTH IN SECTION 8.5
    AND THE PRODUCT WARRANTY SET FORTH IN SECTION 7.1, (A) NEITHER HJL NOR ANY PERSON ON HJL’s BEHALF HAS MADE OR MAKES
    ANY EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY WHATSOEVER, EITHER ORAL OR WRITTEN, INCLUDING ANY WARRANTIES OF MERCHANTABILITY,
    FITNESS FOR A PARTICULAR PURPOSE WHETHER ARISING BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR OTHERWISE,
    ALL OF WHICH ARE EXPRESSLY DISCLAIMED.


 




    	 	 	
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ARTICLE
8


REPRESENTATIONS,
WARRANTIES, AND INDEMNIFICATION


 


	8.1.	Product
    Liability Indemnification.


 


(a)
By HJL: HJL hereby agrees to defend, indemnify, and hold LMAT and its Affiliates (each a “LMAT Indemnified Party”)
harmless from and against all losses, damages, claims and liability (“Losses”) which arise out of or result
from personal injury or death incident to the use of any Products to the extent resulting from: (i) the failure of the Products
to meet the Specifications, or (ii) the failure of the Products to be manufactured, tested, stored packaged, labeled, or shipped
in compliance with all Applicable Laws, except to the extent resulting from any specific action taken by HJL at the written direction
of LMAT or resulting from any specific action not taken by HJL at the written direction of LMAT.




 


(2)
By LMAT: LMAT hereby agrees to defend, indemnify and hold HJL and its Affiliates (each a “HJL Indemnified Party”)
harmless from and against all Losses which arise out of or result from personal injury incident to the use of any Products
to the extent resulting from the negligent or wrongful acts or omissions of LMAT.


 


(3)
EXCLUSIVE REMEDY. THIS SECTION 8.1 SETS FORTH THE ENTIRE LIABILITY AND OBLIGATION FOR ANY DAMAGES COVERED BY THIS SECTION
8.1.


 


(4)
NO LIABILITY FOR CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL EITHER PARTY OR THEIR REPRESENTATIVES BE LIABLE FOR CONSEQUENTIAL,
INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, PUNITIVE OR ENHANCED DAMAGES, LOST PROFITS OR REVENUES OR DIMINUTION IN VALUE (EXCEPT
FOR LOSSES REQUIRED TO BE PAID TO A THIRD PARTY AS A RESULT OF A THIRD PARTY CLAIM FOR ANY OF THE FOREGOING), ARISING OUT OF OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF (A) WHETHER SUCH DAMAGES WERE FORESEEABLE, (8) WHETHER OR NOT THE OTHER
PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND (C) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT OR OTHERWISE) UPON
WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.




 


	8.2.	Insurance
    Requirements. HJL will carry product liability insurance covering any loss, damage, expense or liability incurred or suffered
    by any party other than HJL arising out of any use of a Product. Such policy or policies, which may include umbrella or excess
    liabilities coverage, shall (i) have aggregate limits of liability of not less than $3,000,000 with respect to any incident
    or occurrence and of not less than $5,000,000 in the aggregate on the Effective Date; and (ii) provide for a deductible or
    retained amount of no greater than $500,000; and (iii) provide that such policy may not be canceled except upon written notice
    in accordance with policy provisions. Upon request, HJL shall provide such evidence of the effectiveness of such insurance
    to LMAT.
	 	 
	8.3.	Cooperation
    as to Indemnified Liability. Each Party hereto shall reasonably cooperate with other parties with respect to access to
    books, records, or other documentation within such Party’s control, if deemed reasonably necessary or appropriate by
    any Party in the defense of any matter which may give rise to indemnification hereunder.
	 	 
	8.4.	LMAT’s
    Representations and Warranties. LMAT hereby represents and warrants to HJL that as of the date hereof:


 


	 	(a)	LMAT
    is a corporation duly incorporated, validly existing and in good standing under the laws of Delaware, and the execution and
    delivery of this Supply Agreement by an officer of LMAT has been duly authorized by all necessary corporate action.


 




    	 	 	
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	 	(b)	This
    Supply Agreement is the legal, valid, and binding obligation of LMAT, enforceable against LMAT in accordance with its terms,
    except as may be limited by any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws and equitable
    principles related to or affecting creditors’ rights generally or the effect of general principles of equity.
	 	 	 
	 	(c)	Neither
    the execution and delivery of this Supply Agreement nor the compliance with the terms and conditions hereof will conflict
    with, result in a breach, violation or failure to perform by LMAT of, or constitute a default under, any of the terms, conditions,
    or provisions of any order, judgment, contract, agreement, certificate of incorporation, bylaws, or other instrument to which
    LMAT is or may be bound or affected.
	 	 	 
	 	(d)	LMAT
    has full right, power, and authority to enter into and perform its obligations under this Supply Agreement.
	 	 	 
	 	(e)	LMAT
    is not under any obligations inconsistent with the provisions of this Supply Agreement.
	 	 	 


 


	8.5.	HJL’s
    Representations and Warranties. HJL hereby represents and warrants to LMAT that as of the date hereof:


 


	 	(a)	HJL
    is a corporation duly organized, validly existing and in good standing under the laws of Delaware, and the execution and delivery
    of this Supply Agreement by an officer of HJL has been duly authorized by all necessary corporate action.
	 	 	 
	 	(b)	This
    Supply Agreement is the legal, valid, and binding obligation of HJL, enforceable against HJL in accordance with its terms,
    except as may be limited by any applicable bankruptcy, insolvency, reorganization, moratorium, or similar laws and equitable
    principles related to or affecting creditors’ rights generally or the effect of general principles of equity.
	 	 	 
	 	(c)	Neither
    the execution and delivery of this Supply Agreement nor the compliance with the terms and conditions hereof will conflict
    with, result in a breach, violation or failure to perform by HJL of, or constitute a default under, any of the terms, conditions,
    or provisions of any order, judgment, contract, agreement, certificate of incorporation, bylaws, or other instrument to which
    HJL is or may be bound or affected.
	 	 	 
	 	(d)	HJL
    has full right, power, and authority to enter into and perform its obligations under this Supply Agreement and to grant to
    LMAT the rights granted and to be granted hereunder.
	 	 	 
	 	(e)	HJL
    is not under any obligations inconsistent with the provisions of this Supply Agreement.


 


ARTICLE
9


CONFIDENTIAL
INFORMATION


 


	9.1.	Confidentiality.
    Section 11(g) of the Asset Purchase Agreement shall apply to all confidential information used by or provided to HJL hereunder.


 




    	 	 	
8 | Page



    	 



    

 


ARTICLE
10


INTELLECTUAL
PROPERTY AND TRADEMARKS


 


	10.1.	License.
    LMAT hereby grants HJL a limited, non-exclusive and non-transferable license to use the Licensed Intellectual Property, the
    Purchased Intellectual Property and the Purchased Technology (the “Transition IP”), in accordance with
    LMAT’s instructions, solely for purposes of manufacturing in accordance with this Supply
    Agreement and packaging and labeling Products under this Supply Agreement, as long as such Transition IP is used by HJL in
    accordance with LMAT’s standards, specifications, and instructions of which HJL has been advised in writing, but in
    no event beyond the term (or earlier termination) of this Supply Agreement. HJL shall not acquire any right, title, or interest
    under the laws of any nation in such Transition IP or any other intellectual property of LMAT other than the foregoing limited
    license and shall not attempt to assert or register any such right, title, or interest. HJL shall not use any of LMAT’s
    trademarks, trade names, or logotypes as part of HJL’s corporate or trade names or permit any third party to do so without
    the prior written consent of LMAT.
	 	 
	10.2.	Third-Party
    Infringement. HJL shall promptly notify LMAT of any use by any third party of LMAT’s trademarks, trade names, or
    logotypes or any use by such third parties of similar marks which may constitute an infringement or sign off of LMAT’s
    trademarks, trade names, or logotypes, or of any use of any other intellectual property owned by LMAT pursuant to the Asset
    Purchase Agreement or otherwise, of which HJL has knowledge. LMAT reserves the right in its sole discretion to institute any
    proceedings against such third party infringers, and HJL shall refrain from doing so. HJL agrees to provide reasonable cooperation
    to LMAT in any action taken by LMAT against such third parties.
	 	 
	10.3.	Termination
    of Use. HJL acknowledges LMAT’s proprietary rights in and to the Transition IP, and HJL hereby waives all right
    to any trademarks, trade names, and logotypes now or hereafter originated by LMAT. HJL shall not adopt, use, or register any
    words, phrases, or symbols which are identical to or confusingly similar to any of LMAT’s trademarks. Upon termination
    of this Supply Agreement, HJL shall cease using the Transition IP in any manner.
	 	 
	10.4	Protection
    of LMAT Intellectual Property. LMAT shall be responsible for filing and prosecuting all U.S. and foreign patent, copyright
    and trademark applications it deems necessary or appropriate to protect the Transition IP and LMAT’s Intellectual Property.


 


ARTICLE
11


FORUM
SELECTION AND GOVERNING LAW


 


	11.1.	Forum
    Selection and Governing Law. This Supply Agreement and the legal relations among the parties hereto shall be governed
    and construed in accordance with the substantive laws of the Commonwealth of Massachusetts, without giving effect to the principles
    of conflict of laws thereof. Each Party agrees that, in the event such Party elects to initiate litigation against the other
    Party, such Party will file such litigation in the state or federal courts of Massachusetts. Each Party hereby expressly and
    irrevocably waives any claim or defense in any action or proceeding brought in said jurisdictions based on any alleged lack
    of personal jurisdiction, improper venue, forum non conveniens or any similar basis.


 


ARTICLE
12


FORCE
MAJEURE


 


	12.1.	Force
    Majeure Definition. Force Majeure shall mean any of the following events or conditions, not existing as of the date of
    this Supply Agreement, not reasonably foreseeable as of such date and not reasonably within the control of either Party, which
    prevents in whole or in material part the performance by one of the Parties of its obligations hereunder: riots, civil or
    military disturbances, wars, epidemics, fires, floods, hurricanes, typhoons, earthquakes, lightning, and explosions.
	 	 
	12.2.	Notice.
    Upon giving notice to the other Party, a Party affected by an event of Force Majeure shall be released without any liability
    on its part from the performance of its obligations under this Supply Agreement, except for the obligation to pay any amounts
    due and owing hereunder, but only to the extent and only for the period that its performance of such obligations is prevented
    by the event of Force Majeure. Such notice shall include a
    description of the nature of the event of Force Majeure, its cause, and possible consequences. The Party claiming Force Majeure
    shall promptly notify the other Party of the termination of such event.


 




    	 	 	
9 | Page



    	 



    

 


	12.3.	Suspension
    of Performance. During the period that the performance by one of the Parties of its obligations under this Supply Agreement
    has been suspended by reason of an event of Force Majeure, the other Party may likewise suspend the performance of all or
    part of its obligations hereunder, except for the obligation to pay any amounts due and owing hereunder, to the extent that
    such suspension is commercially reasonable.


 


ARTICLE
13


MISCELLANEOUS


 


	13.1.	Audit
    Rights. HJL shall maintain accurate books and records to enable LMAT to monitor compliance by the other with the terms
    of this Supply Agreement. LMAT (or its accountants) shall have the right to inspect such books and records at reasonable intervals
    (but no more frequently than twice in any twelve month period) and upon reasonable prior written notice.
	 	 
	13.2.	Relationship.
    This Supply Agreement does not make either Party the employee, agent, or legal representative of the other for any purpose
    whatsoever. Neither Party is granted any right or authority to assume or to create any obligation or responsibility, express
    or implied, on behalf of or in the name of the other Party. In fulfilling its obligations pursuant to this Supply Agreement
    each Party shall be acting as an independent contractor.
	 	 
	13.3.	Assignment.
    Except as otherwise provided in this Supply Agreement, neither Party may assign or otherwise transfer its rights and obligations
    under this Supply Agreement without the prior written consent of the other Party. Notwithstanding any other provision in this
    Supply Agreement to the contrary, either Party may assign this Supply Agreement to a company controlling, controlled by, or
    under common control with the assigning Party, or to its successor in connection with a change in control of such Party. Any
    prohibited assignment shall be null and void. All terms and conditions of this Supply Agreement shall be binding on and inure
    to the benefit of the successors and permitted assigns of the Parties.
	 	 
	13.4.	Notices.
    Notice permitted or required to be given under this Supply Agreement shall be deemed sufficient if given in writing by commercial
    air delivery service or by registered or certified air mail, postage prepaid, return receipt requested, addressed to the respective
    addresses of the Parties set forth below or at such other address as the respective Parties may designate by like notice from
    time to time. Notices so given shall be effective upon the earlier of: (a) receipt by the Party to which notice is given;
    (b) on the seventh business day following the date such notice was deposited in the mail; or (c) when received. Notices shall
    be given as follows:


 


	 	If
    to HJL:	Hancock
    Jaffe Laboratories, Inc.
	 	 	70
    Doppler
	 	 	Irvine,
    California 92618
	 	 	 
	 	If
    to LMAT:	LeMaitre
    Vascular, Inc.
	 	 	63
    Second Ave.
	 	 	Burlington,
                                         MA 01803

                                                                                Attn:
                                         Legal Dept.

	 	 	With
    a copy by email to: legal@lemaitre.com


 


	13.5.	Entire
    Agreement. This Supply Agreement, including the exhibits attached hereto and incorporated as an integral part of this
    Supply Agreement, and the Asset Purchase Agreement constitutes the entire agreement of the Parties with respect to the subject
    matter hereof, and supersedes all previous proposals, oral or written,and all negotiations, conversations,
    or discussions heretofore had between the Parties related to this Supply Agreement. To the extent this Supply Agreement is
    inconsistent with the terms of the Asset Purchase Agreement, the Asset Purchase Agreement shall control.


 




    	 	 	
10 | Page



    	 



    

 





	13.6.	Amendment.
    This Supply Agreement shall not be deemed or construed to be modified, amended, rescinded, canceled, or waived, in whole or
    in part, other than by written amendment signed by the Parties hereto, except as expressly provided in this Supply Agreement.
	 	 
	13.7.	Severability.
    In the event that any of the terms of this Supply Agreement are in conflict with any rule of law or statutory provision or
    otherwise unenforceable under the laws or regulations of any government or subdivision thereof, such terms shall be deemed
    stricken from this Supply Agreement, but such invalidity or unenforceability shall not invalidate any of the other terms of
    this Supply Agreement, and this Supply Agreement shall continue in force, unless the invalidity or unenforceability of any
    such provisions of this Supply Agreement substantially violates, comprises an integral part of or is otherwise inseparable
    from the remainder of this Supply Agreement.
	 	 
	13.8.	Counterparts.
    This Supply Agreement shall be executed in two or more counterparts, and each such counterpart shall be deemed an original
    hereof.
	 	 
	13.9.	Waiver.
    No failure by either Party to take any action or assert any right hereunder shall be deemed to be a waiver of such right in
    the event of the continuation or repetition of the circumstances giving rise to such right.


 


IN
WITNESS WHEREOF, the Parties have caused this Supply Agreement to be executed on the date first above written.


 


	LEMAITRE
    VASCULAR, INC.	 	HANCOCK
    JAFFE LABORATORIES, INC.
	 	                	 	 	                            
	By:	/s/
    David Roberts	 	By:	/s/
    NORMAN JAFFE
	Name: 	David
    Roberts		Name: 	NORMAN
    JAFFE
	Title:	President	 	Title:	PRESIDENT






 
















    	 	 	
11 | Page



    	 



    

 


EXHIBIT
A


 


ADDITIONAL
QUALITY REQUIREMENTS


 


1.
All Products shall be accompanied by a certification that has been assigned a specific HJL serial number and expiration date and
certifies that the devices have been manufactured and inspected in accordance with all applicable HJL specifications and procedures
with the HJL Order number matching the Packing List HJL Order/Invoice number and the serial number identified on the Packing List.
This number(s) shall be clearly identified on the Product and or its packaging, as well as on traceability records.




 


2.
All Products shall be clearly labeled with the appropriate unique device identifier (UDI) as required by Applicable Laws.




 


2.
HJL shall assign a Products quality representative for the duration of this Supply Agreement. This individual shall be responsible
for overseeing HJL activities that impact the Products and acting on HJL’s behalf in matters associated with Product quality.




 


3.
Product shall be received with no visual signs of damage and one day from “Ship Date” found on the manufacturer’s
packing slip.




 


4.
In all events, HJL shall provide reasonable resources, maintain copies of all documentation, and perform failure investigation
and reasonable corrective and/or preventative actions with respect to any and all complaints.




 


5.
HJL shall retain records as required by Applicable Laws and shall be made available to LMAT upon request.




 


6.
The responsibilities noted in the table below apply to the Parties.




 


	21
    CFR Part 820
	820.20
    Management Responsibility
	820.22
    Quality Audit
	820.25
    Personnel
	820.30
    Design Controls
	820.40
    Document Controls
	820.50
    Purchasing Controls
	820.60
    Identification
	820.65
    Traceability
	820.70
    Production and Process Control
	820.72
    Inspection, Measuring and test equipment
	820.75
    Process validation
	820.80
    Receiving, in process and finished device acceptance
	820.86
    Acceptance Status
	820.90
    Non-conforming product
	820.100
    Corrective and Preventative Action
	820.120
    Device Labeling
	820.130
    Device packaging
	820.140
    Handling
	820.150
    Storage
	820.160
    Asset Purchase
	820.180
    General requirements
	820.181
    Device master record
	820.184
    Device history record






	820.186
    Quality system record
	820.198
    Complaint files
	820.250
    Statistical techniques
	 
	21
    CFR Part 803 Medical device reporting
	21
    CFR Part 806 Recalls
	21
    CFR Part 801 Labeling
	21
    CFR Part 11 Electronic Records



 



    	 	 	
12 | Page



    	 



    




 


EXHIBIT
B


 


INITIAL
PURCHASE ORDER


 




    	 	 	
13 | Page



    	 



    

 





 





	Vendor
    ID;	HAN005	 	PO#:27716
	Company:	HANKCOCK
    JAFFE LABORATORIES, INC. 	 	LeMaitre
    Vascular
	Address:	70
    DOPPLER	 	 
	.	 	 	 
	City,
    State, Zip:	IRVINE,
    CA 92618	 	63
2nd Avenue

         Burlington, MA 01803-441

	 	 	 	 
	 	Tel:
                                         (949)261-2900 Fax: (949)261-2992 
	 	Tel:
    781-425-1690 Fax: 781-425-6295
	 	 	 	 
	Contact:	 	 	From:

                                                          

        www.lemaitre.com 



 


	Date:
    03/16/2016	Terms:
    NET 30	Ship
    Via: UPS Acct# 86X953


 


	Line
    #	 	Catalog
    # / Vendor #	 	Product
    Description	 	QTY	 	Unit
    Price 	 	Line
    Total
	1	 	HJL016-10-N	 	ProCol®
                                         Vascular Bioprosthesis 6 mm X 10 cm 
	 	25	 	$400.00	 	$10,000.00
	 	 	 	 	Requested
    by: 4/15/16 Promised by: 4/15/16
	 	 	 	 	 	 	 	 	 	 	 
	2	 	HJL016-25-N	 	ProCol®
                                         Vascular Bioprosthesis 6 mm X 25 cm 
	 	18	 	$400.00	 	$7,200.00
	 	 	 	 	Requested
    by: 4/15/16 Promised by: 4/15/16
	 	 	 	 	 	 	 	 	 	 	 
	3	 	HJL016-30-N	 	ProCol®
                                         Vascular Bioprosthesis 6 mm X 30 cm 
	 	66	 	$400.00	 	$26,400.00
	 	 	 	 	Requested
    by: 4/15/16 Promised by: 4/15/16
	 	 	 	 	 	 	 	 	 	 	 
	4	 	HJL016-40-N	 	ProCol®
                                         Vascular Bioprosthesis 6 mm X 40 cm 
	 	66	 	$400.00	 	$26,400.00
	 	 	 	 	Requested
    by: 4/15/16 Promised by: 4/15/16


 


	Subtotal	$70,000.00
	Trade
    Discount	$0.00
	Freight	$0.00
	Miscellaneous	$0.00
	Tax	$0.00
	Total	$70,000.00

 




    	 	 	
14 | Page



    	 



    

 


EXHIBIT
C


 


Certificate
of Conformity


 


Date:
_________


 


Invoice
#:____________


 


The
following products are manufactured per the current GMP standard, passed all final inspections and have met the product specifications.
We, Hancock Jaffe Laboratories, Inc. confirm the sterility of these products and hereby release them in accordance to the applicable
standards (ISO 10993, ISO 11607, ISO 11135, ISO 14160 and ISO 17665), our Quality system Manual and FDA regulations.


 


The
following products were sterilized at:


 


	 	 	 	 	 	 	 	 	Sterilization	 	 
	Catalogue Number	 	Product Description	 	Quantity	 	Product Lot Number	 	Order

Number	 	Process

Date	 	Expiration Date
	 	 	 	 	 	 	 	 		 		 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 



 


	Prepared
    By:	(Name)	 
	 	(Title)	 






 




    	 	 	
15 | Page



    	 



    

 





EXHIBIT
D


 


PRICE
PER UNIT OF PRODUCT (APPLIES TO ALL UNIT LENGTHS)


 


	Price
    Per Unit	Units
    Covered
	$400	First
    660 units of Product, regardless of when ordered or delivered
	$600	Units
    ordered after the first 660 units of Product



 






    	 	 	
16 | Page



    	 



    




 


Lemaitre
Vascular Forecast for ProCol units


March
15, 2016


 


	month:

        period
        start date:

        period
        end date:
	 	1

        3/16/2016

        4/15/2016
	 	2

        4/16/2016

        5/15/2016
	 	3

        5/16/2016

        6/15/2016
	 	4

        7/16/2016

        8/15/2016
	 	5

        7/16/2016

        8/15/2016
	 	6

        8/16/2016

        9/15/2016
	 	Price

        Per
        Unit

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	HJL016-10-N	 	25	 	25	 	25	 	25	 	25	 	25	 	TBD
	HJL016-25-N	 	18	 	18	 	18	 	18	 	18	 	18	 	TBD
	HJL016-30-N	 	66	 	66	 	66	 	66	 	66	 	66	 	TBD
	HJL016-40-N	 	66	 	66	 	66	 	66	 	66	 	66	 	TBD
	Total	 	175	 	175	 	175	 	175	 	175	 	175	 	 


 




    	 	 	 



    	 



    

 


EXHIBIT
F





 


March
18, 2016


 


PMA
Amendment


U.S.
Food and Drug Administration


Center
for Devices and Radiological Heath


Document
Mail Center - W066-G609


10903
New Hampshire Avenue


Silver
Spring, MD 20993-0002


 


	RE
    :	PMA
    #P020049 Amendment
	 	ProCol®
                                         Vascular Bioprosthesis for Vascular Access

                                                         

	 	Notification
    of Sponsor Change


 


This
letter is to provide notification that effective March 18, 2016 all rights of PMA
#P020049 were transferred to LeMaitre Vascular, Inc. 63 Second Avenue, Burlington, MA 01803.


 


The
enclosed eCopy is an exact duplicate of the paper copy.


 


Regards,


 


/s/
Sue Montoya 


 


Sue
Montoya


Vice
President of Operations and QA/RA


Hancock
Jaffe Laboratories


70
Doppler, Irvine, CA 92618


Phone:
949-261-2900


Fax:
949-261-2992


e-mail:
suemontoya@hjlinc.com


 


Hancock
Jaffe Laboratories - 70 Doppler, Irvine, California 92618 USA


Phone
(949) 261 2900 Fax (949) 261 2992