Exhibit
10.11


 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	Page
    1 of 28


 


	1.	Scope




 


	 	1.1.	Lucid
    Diagnostics Inc. (COMPANY) has contracted with Coastline International, Inc. (SUPPLIER), hereinafter referred to individually as
    “Party” and collectively as “Parties”, to perform one or multiple of the following (select as appropriate):


 


	 	☒	Manufacture
    the EsoCheck Cell Collection device (PRODUCT)
	 	☐	Warehousing
    and/or order processing of the Device Name device (PRODUCT) 
	 	☐	Execute
    the Device Name In Vitro Diagnostic (IVD) test (PRODUCT)
	 	☐	Execute
    subset(s) of the Device Name In Vitro Diagnostic (IVD) test (PRODUCT)


 


	 	1.2.	This
    Quality & Manufacturing Master Service Agreement details the responsibilities of each Party regarding the Product(s) listed in
    Appendix A of this Agreement.
	 	 	 
	 	1.3.	If
    selected in paragraph 1.1, COMPANY would like to contract with SUPPLIER to manufacture, including the coordination of contract sterilization
    services, test, release, inventory of raw materials, and storage for WIP Goods for consolidated sterilization in accordance with
    COMPANY product volume requirements.


 


	2.	Effective
  Date & Termination




 


	 	2.1.	

                                                                              This
                                            Agreement shall be effective on the date of the last approval signature. Subject to the terms
                                            of this Agreement, including without limitation Sections 2.2 and 12, the Agreement shall
                                            remain in effect until the earlier of (a) two (2) years from the effective date of this Agreement,
                                            and (b) the date on which the Products listed in Appendix A and/or services are no
                                            longer supplied by SUPPLIER to the COMPANY (provided that this sub-clause (b) shall be deemed
                                            to have occurred on any date on which there are no firm orders outstanding under this Agreement
                                            and on which the PARTIES have mutually agreed to discontinue production of PRODUCT). No less
                                            than one-hundred and twenty (120) days prior to the expiration of the term described in clause
                                            (a) of the immediately preceding sentence, the Parties shall, in good faith, negotiate the
                                            terms for successive renewal of the Agreement, and unless otherwise agreed upon in writing,
                                            the term of this Agreement shall be automatically renewed for successive two (2) year terms.
                                            In the event of a non-renewal of this Agreement, Parties agree to reduce operations in an
                                            orderly fashion. COMPANY or SUPPLIER must provide written notification to other Party of
                                            their intent not to renew no less than ninety (90) days prior to date of termination or the
                                            expiration of any successive terms. The term shall be extended past contract expiration,
                                            if necessary and upon mutual agreement, to accommodate an orderly transition period (and
                                            only for the period of time necessary for such orderly transition). Nevertheless, upon termination
                                            or expiration of the Agreement for any cause, the Parties agree to continue their reasonable
                                            cooperation in order to facilitate an orderly termination of their relationship. Modifications
                                            to this Agreement may only be made in writing and require signature approval by both COMPANY
                                            and SUPPLIER.




 






    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            2 of 28



 


	 	2.2.	Notwithstanding
    the foregoing, and in addition to the termination rights described in Section 12 of this Agreement, COMPANY may terminate this agreement
    without penalty by written notice to the SUPPLIER if the SUPPLIER fails to address, to the COMPANY’s reasonable satisfaction,
    within a minimum of three (3) routine production LOTS, any reasonable requests or complaints made by the COMPANY regarding the quality
    or timeliness of the delivery of any PRODUCT or service or any other material aspects directly related to SUPPLIER’s acts or
    omissions hereunder provided that the COMPANY has given notice to the SUPPLIER of the relevant circumstances, and SUPPLIER has failed
    to cure the same promptly following such notice. Following such notice, the parties will cooperate with each other as reasonably
    necessary for COMPANY to transition the services to be provided hereunder to a new supplier in an orderly fashion.
	 	 	 
	 	2.3.	If
    either Party materially defaults in the performance of any obligation hereunder, the other Party shall have the right to terminate
    the Agreement following a 90 days’ prior written notice to the other Party, or as otherwise agreed upon by both PARTIES.
	 	 	 
	 	2.4.	Further,
    to the extent COMPANY determines that SUPPLIER’s manufacturing of the Product fails to meet the manufacturing requirements
    set forth in the licensing agreement for the Product, including as such requirements pertain to remaining in compliance with the
    Bayh-Dole Act or Patent and Trademark Law Amendments Act (Pub. L. 96-517, December 12, 1980), the COMPANY shall have the right to
    terminate this Agreement upon 90 days’ prior written notice to SUPPLIER, provided that any such termination shall not relieve
    COMPANY from its obligations with respect to any Orders placed prior to the date notice of termination is delivered, including responsibility
    related to excess and obsolete inventory as indicated in Section 9.
	 	 	 
	 	2.5.	Without
    limiting the generality of the foregoing, upon any termination, all hard and digital assets belonging to COMPANY are to be returned
    to the COMPANY within a 2- week period (or if not reasonable practicable, as soon as possible), if so requested by the COMPANY, and
    at a cost to the COMPANY, as mutually agreed upon with SUPPLIER, and the actual reasonable and out-of-pocket cost to SUPPLIER of
    returning such assets. Digital assets include, but are not limited to, editable and pdf versions of documents such as SOP’s,
    protocols, reports, drawings, CAD files, inspection reports, BOMs, emails, and vendor contacts. Hard assets include, but are not
    limited to, fixtures, equipment, inventory of component materials, existing open orders for components or services at vendors and
    finished goods devices.


 


	3.	Definitions




 


	 	3.1.	DEVICE
    HISTORY RECORD (BATCH RECORD) (DHR) means the complete written record of the history of the batch or lot of a finished device and
    its production and testing thereof as required under HEALTH AUTHORITY regulations or requirements and in accordance with the DEVICE
    MASTER RECORD.
	 	 	 
	 	3.2.	COA
    means a Certificate of Analysis, a document listing testing parameters, specifications, and test results.
	 	 	 
	 	3.3.	COC
    means a Certificate of Compliance confirming compliance with quality standards and regulations.
	 	 	 
	 	3.4.	COMPONENT
    means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part
    of the finished, packaged, and labeled device.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            3 of 28



 


	 	3.5.	CUSTOMER
    ORDER means the written communication between COMPANY and SUPPLIER, setting forth the number of units of each PRODUCT, delivery dates,
    and exact shipping instructions for each identified ship to customer of COMPANY.
	 	 	 
	 	3.6.	DEVIATION
    means departure (an action that is planned or unplanned) from an established process or procedure (e.g., approved MASTER BATCH RECORDS,
    test methods, manufacturing processes, equipment, facilities and/or SOPs).
	 	 	 
	 	3.7.	HEALTH
    AUTHORITIES can mean all governmental, regulatory, and certification authorities having jurisdiction over the design, manufacture,
    use and/or sale of the PRODUCT, including but not limited to the US Food and Drug Administration (FDA), and the European Commission
    (EC).
	 	 	 
	 	3.8.	LOT
    or BATCH means one or more components or finished devices that consist of a single type, model, class, size, composition, or software
    version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality
    within specified limits.
	 	 	 
	 	3.9.	LOT
    NUMBER means any distinctive symbols, such as a distinctive combination of letters or numbers, or both, from which the history of
    the manufacturing, packaging, labeling, and distribution of a unit, lot, or batch of finished devices can be determined.
	 	 	 
	 	3.10.	MANUFACTURING
    AUTHORIZATION means the authorization of SUPPLIER as manufacturer of PRODUCT according to the applicable regulations.
	 	 	 
	 	3.11.	MANUFACTURING
    MATERIALS means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or
    a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or
    impurity not by design or intent of the manufacturer.
	 	 	 
	 	3.12.	OOS
    means out of specification results. OOS are testing results, which do not meet the approved SPECIFICATIONS of starting materials,
    intermediates, PRODUCT, packaging materials, in-process-controls or stability testing, as applicable.
	 	 	 
	 	3.13.	SOPs
    mean written standard operating procedures established, or to be established, used by SUPPLIER in the manufacturing, testing, storage,
    packaging, labeling, certification, and delivery of PRODUCT.
	 	 	 
	 	3.14.	SPECIFICATIONS
    mean any requirement with which a product, process, service, or other activity must conform. Specifications are numerical limits,
    ranges, or other acceptance criteria to which the PRODUCT or process of making the PRODUCT must conform.
	 	 	 
	 	3.15.	PRODUCTS
    mean specific SKUs listed in Appendix A, as amended from time to time by mutual agreement of the Parties.
	 	 	 
	 	3.16.	BUSINESS
    DAYS means any other day than a Saturday, Sunday, or public holiday in the U.S. or Mexico when banks are open for business.
	 	 	 
	 	3.17.	WIP
    means work in process or goods in process inventory, which includes partially finished goods awaiting further processing and/or in-process
    for completion.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            4 of 28



 


	4.	General
  Commitments




 


	 	4.1.	SUPPLIER
    shall manufacture the COMPANY Products according to COMPANY Specifications, applicable HEALTH AUTHORITY requirements and guidelines
    and applicable cGMP rules.
	 	 	 
	 	4.2.	SUPPLIER
    has established and shall continue to maintain a quality system which operates in accordance with ISO 13485:2016 (or, if applicable,
    the most recent revision thereof).
	 	 	 
	 	4.3.	SUPPLIER
    shall be responsible for quality inspection of Products before final release, of which testing and acceptance criteria will be defined
    by COMPANY.
	 	 	 
	 	4.4.	SUPPLIER
    may not engage in any form of reverse engineering of the COMPANY Products, nor may SUPPLIER make copies of the Products, nor misuse
    the COMPANY trademarks or trade names or use such trademarks or trade names in any manner without COMPANY’s prior written approval.
	 	 	 
	 	4.5.	SUPPLIER
    shall be responsible for the routine maintenance of COMPANY and/or SUPPLIER equipment; any required equipment servicing or repairs
    of COMPANY equipment will be notified to COMPANY for prior approval and any approved costs for such servicing will be billed to COMPANY
    with itemized invoice to include details of services completed.
	 	 	 
	 	4.6.	COMPANY
    shall provide SUPPLIER all necessary bill of materials, component specifications, supplier details, and negotiated pricing for required
    materials and componentry.
	 	 	 
	 	4.7.	COMPANY
    shall provide required documentation to perform the assigned work, including but not limited to Standard Operating Procedures, Specifications,
    assembly instructions, packaging configuration, testing requirements, and acceptance criteria.
	 	 	 
	 	4.8.	COMPANY
    shall provide whichever tools are reasonably necessary for SUPPLIER to perform the assigned work, except as may be otherwise agreed
    by the Parties. This includes but is not limited to the following: packaging equipment, manufacturing equipment, leak tester(s),
    dispensers, and necessary replacement parts. COMPANY commits to provide sufficient equipment in acceptable functioning order to support
    the volume demands of the Orders. COMPANY equipment valued in excess of $100 shall be identified by asset tags applied by SUPPLIER.
	 	 	 
	 	4.9.	COMPANY
    shall from time to time provide SUPPLIER a non-binding, rolling 12- month forecast. Based on such forecast, members of the operations
    teams of each of the Parties shall determine what is an appropriate lead-time for firm order commitments (which shall be no less
    than three months) and COMPANY may thereafter provide to SUPPLIER a firm order commitment with such lead-time (which shall be no
    less than three months), provided that COMPANY shall have no obligation to order any specific quantity of units, or to exclusively
    order any units from SUPPLIER. In the event COMPANY order requirements are reduced, excess inventory terms as described in Section
    9 shall apply.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            5 of 28



 


	 	4.10.	In
    the event COMPANY production requirements result in extended lapse of manufacturing, terms of downtime rates shall be charged by
    SUPPLIER, as mutually agreed by the Parties and as described in Appendix B.


 


	5.	General
  Terms




 


The
specified manufacturing activities will take place at the SUPPLIER facility:


Coastline
De Mexico, S.A. De C.V.


Calle
Cipres N4-5 Fraccionamiento Las Brisas


Tijuana,
Baja California, 22117 Mexico


 


Corporate
related activities will take place at the SUPPLIER facility:


Coastline
International, Inc.


1207
Bangor St.


San
Diego, CA 92106


 


Notifications
should be made to the representatives listed below for COMPANY and SUPPLIER. Other communications may be made between various parties
as necessary to complete required activities.


 


	6.	Use
  of Third-Parties




 


SUPPLIER
shall not allow a third party to manufacture, package, label, inspect, test, and release Product unless SUPPLIER has disclosed in writing
to COMPANY the SUPPLIER’s use of a third party, the identity of the third party, and the COMPANY has provided written approval
for the specific use of such third party.


 


If
SUPPLIER employs a third party to perform any or part of the manufacturing, packaging, labelling, inspection, testing, cleaning, sterilization,
release of sample results and/or handling of Product/Sample that is supplied to COMPANY, SUPPLIER shall assure that the third party has
been fully qualified via the SUPPLIER’s third party qualification process prior to performing such activity (ies) unless the COMPANY
is providing the qualification of the third party. In this case, the COMPANY will provide the SUPPLIER written qualification documentation.


 


SUPPLIER
shall, however, retain all obligations under this Agreement in the event a third party is qualified by and employed by SUPPLIER, and
shall be responsible for the third party’s performance in respect hereof. If a third party is used by SUPPLIER to manufacture,
package, label, inspect, test, release and/or handle Products, COMPANY may, upon request, review the list of such third party(ies) during
an on-site visit and/or audit pursuant to paragraph 9.1 of the table set forth in Section 21 below.


 




    	 



    	 



    




 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            6 of 28



 


	7.	Engineering
  and Specification Changes




 


SUPPLIER
shall not change any manufacturing, assembly, or testing process for the Product, or change any documentation, labeling, or specification
of the Product without the prior written consent of COMPANY. If COMPANY determines that an engineering or specification change is desirable
with respect to any Products, including changes required by regulatory authorities, COMPANY may propose such suggestions to SUPPLIER
in writing. SUPPLIER shall advise COMPANY of the feasibility, cost impact, and the amount of time required to implement such change,
as mutually agreed upon by PARTIES. In the event of COMPANY change requests due to engineering changes, component substitutions, or any
other reason (other than reasons related to SUPPLIER’S gross negligence or willful misconduct), COMPANY shall be responsible to
compensate SUPPLIER equal to the out-of- pocket cost incurred by SUPPLIER for the procured components, materials, or other supplies;
provided that any such out-of-pocket costs shall have first been approved by COMPANY.


 


	8.	Ordering
  and Delivery




 


	 	8.1	COMPANY
    shall submit Purchase Orders (the “Order(s)”) for Products to the SUPPLIER electronically. COMPANY shall provide firm
    Orders for no less than three months of PRODUCT (as determined based on the most recent forecast provided by COMPANY). Each Order
    shall contain the following information: (i) a description of the Product by part number, (ii) the quantity of the Product to be
    delivered to the COMPANY for the agreed upon time frame, and (iii) the delivery schedule. Each Order shall provide an order number
    for billing purposes and may include other instructions and terms as may be appropriate under the circumstances.
	 	 	 
	 	8.2	All
    Products shall be delivered in accordance with the specifications provided by COMPANY, marked for shipment to COMPANY destination
    specified in the applicable Order and delivered to a carrier or forwarding agent. All shipments shall be F.O.B. sterilization site,
    unless otherwise agreed by both Parties.
	 	 	 
	 	8.3	SUPPLIER
    at its sole discretion may ship an increase or decrease of up to +/- 10% on any line item of COMPANY Order. SUPPLIER shall invoice
    COMPANY for line items shipped.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            7 of 28



 


	9.	Excess
  and Obsolete Inventory




 


Any
inventory (including finished goods, work-in-process, components, or raw material) or non-cancelable orders for components or raw material
that are rendered excess or obsolete due to (in each case except as a result of SUPPLIER’S gross negligence or willful misconduct)
(a) the cancellation, delay, or reduction by COMPANY of any Orders, (b) a sustained reduction in Orders that impacts any long lead time
parts which SUPPLIER purchased with COMPANY’s advance written authorization in order to meet Order requirements and are non-cancelable
or non-returnable, (c) Specification changes following Order acceptance, (d) minimum quantity purchases of component parts or raw material
required to fill Orders (provided COMPANY was notified of, and approved, such minimum quantity purchases prior to submission of the Order),
(e) the end of a Product’s life, or (f) the termination or expiration of this Agreement (other than due to material breach by SUPPLIER),
will be the financial responsibility of the COMPANY, at SUPPLIER’s total purchase price including proportional freight costs, for
finished goods and for all other items, including, without limitation, documented restocking charges paid by the SUPPLIER to its suppliers;
provided that SUPPLIER uses its commercially reasonable efforts to mitigate any such costs. Notwithstanding the above, COMPANY’s
maximum liability under this Section shall be for the cost paid (as defined above) for all inventories necessary to meet COMPANY issued
Orders (and for raw material and components needed to produce the quantities of Product based on the then current Orders.) In the event
minimum order quantities or long-lead items required to purchase in order to support COMPANY Orders, SUPPLIER will notify COMPANY of
such procurement obligation upon Order acceptance, as excess or obsolete inventory will remain the financial responsibility of the COMPANY
in accordance with this Section 9 (provided COMPANY was notified of, and approved, such procurement obligation, prior to SUPPLIER incurring
such obligation).


 


	10.	Pricing
  and Payment Terms




 


The
cost for contract manufacturing services for COMPANY Products shall be included in Appendix B, as the same may be updated from time to
time by mutual agreement of the Parties. All prices quoted are exclusive of national, state, and local excise, sales, use and similar
taxes, including any duties, and COMPANY shall be responsible for such items. The Parties shall, in good faith, negotiate changes in
the pricing schedule due to changes in the: market price of materials, equipment, labor, process, and other production costs.


 


Except
as otherwise agreed upon by both Parties, payment for any Products, services, or other costs to be paid by COMPANY hereunder is due thirty
(30) days net from the date of issuance of invoice therefore and shall be made in lawful U.S. currency.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            8 of 28



 


	11.	Product
  Warranty




 


	 	11.1	SUPPLIER
    warrants that the Product shall be manufactured to COMPANY’s SPECIFICATIONS, and shall be free from defects in material and
    workmanship; foregoing defects in material are limited to nonconformities caused by SUPPLIER or which should have been identified
    by SUPPLIER by proper compliance with inspection parameters that was provided by COMPANY. In the event any Product does not comply
    with the foregoing, without limiting COMPANY’s rights or remedies, SUPPLIER shall, at COMPANY’s election and at SUPPLIER’S
    expense, repair or replace the Product free from defect. COMPANY bears all design responsibility for
    the Product. Subject in each case to Section 6 herein, matters to which SUPPLIER’s
    warranty will not apply include, without limitation, problems caused in whole or in part by:


 


(a)
Use, operation,
maintenance, assembly, or storage by any party other than
the SUPPLIER that is not in accordance with proper instructions, required specifications, regulatory requirements, or standard industry
practice;


(b)
Alteration by any party other than the SUPPLIER;


(c)
Negligence by any party other than the SUPPLIER;


(d)
Repair or modifications performed by anyone other than the SUPPLIER;


(e)
Use in any manner or procedure other than that for which the Product is labeled;


(f)
Use by any person other than trained medical personnel under order of a physician.


 


In
the event of any defects in material not caused by SUPPLIER and notwithstanding SUPPLIER’s proper compliance with inspection parameters
provided by COMPANY, the Parties shall, at COMPANY’s election and cost, cooperate to (1) as promptly as practicable have delivered
a number of replacement Products equal to up to the number of Products affected by such defects, (2) ensure the defective Products are
segregated from all other Products and appropriately disposed of, (3) conduct an investigation to determine and resolve the underlying
cause of such defects, and (4) recover for the benefit of COMPANY any damages suffered by COMPANY from the third party responsible for
such defects.


 


SUPPLIER
warranty shall extend for a period equal to the shelf life of the product from the date of manufacture, not to exceed two (2) years or
as otherwise agreed by the Parties.


 


	 	11.2	If
    any Product does not materially conform to the warranty stated in Section 11.1 above, the SUPPLIER shall, at the SUPPLIER’s
    option and as the COMPANY’s sole and exclusive remedy, repair or replace such Product at the SUPPLIER’s own expense,
    and ship such repaired or replacement Product back to COMPANY at the SUPPLIER’s own expense, or credit the COMPANY the purchase
    price. The foregoing warranty, and the remedies provided for in this Section 11.2, are expressly conditioned upon (i) COMPANY providing
    SUPPLIER with written notice within five (5) business days after learning of any nonconforming Product and prior to the expiration
    of the warranty period, which notice must identify with particularity the non-conformity, (ii) COMPANY’s full cooperation with
    SUPPLIER in all reasonable respects relating thereto, and (iii) the absence of any alteration or other modification of the Products
    by any person or entity other than SUPPLIER (as set forth by example, but not by limitation above), or in a manner not approved by
    SUPPLIER, in each case subject to Section 6 herein.All
    defective Products which are covered by the foregoing warranty shall be shipped to the SUPPLIER at SUPPLIER’S sole expense
    for such repair or replacement.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            9 of 28



 


	 	11.3	The
    warranty set forth in Section 11.1 above does not include Products that have defects or failures resulting directly from any COMPANY
    supplied components or materials or from COMPANY’s design of Products including, but not limited to, design functionality failures,
    specification inadequacies, failures relating to the functioning of Products in the manner for the intended purpose or in the specific
    end user’s environment or failures resulting from unauthorized modification of the Products. COMPANY bears all responsibility
    directly related to the design of the Product.
	 	 	 
	 	11.4	If
    the SUPPLIER disagrees with a claim by COMPANY that a Product does not conform to the warranty provided in Section 11.1, then the
    Parties agree to submit the dispute to a mutually agreed-upon independent party which has the capability of testing the Product to
    determine whether or not it does so conform. In the event the Parties cannot agree following good faith discussions upon such independent
    party, or in the event it is not possible to acquire the services of such an independent party, then such dispute shall be resolved
    pursuant to Section 18. The cost of the independent testing party shall be borne by the Party against whom the testing party finds,
    as directed by the testing party.


 


	12.	Delays




 


In
the event of a delay in the delivery of any Product that does not constitute an event of force majeure and that is not attributable to
any act or omission of the COMPANY, SUPPLIER shall give written notice to COMPANY stating the reasons for such delay. SUPPLIER shall
take reasonable actions necessary to reduce the period of delay of such production. If any such delay that is directly attributable to
any act or omission of the SUPPLIER causes the delivery to be more than thirty (30) calendar days later than the scheduled delivery date,
of which was confirmed by SUPPLIER, as set forth in the applicable CUSTOMER ORDER, COMPANY shall have the right to terminate this Agreement
pursuant to the terms of Section 2.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            10 of 28



 


	13.	Import
  / Export




 


SUPPLIER
shall provide all necessary administrative services to effect shipment of equipment and material to Mexico, using the information supplied
by COMPANY. Such administrative services shall include, but not be limited to, securing Mexican regulatory import permits or authorizations,
preparation of required customs clearance papers, and all necessary trucking, handling, and storage. SUPPLIER will be the importer of
record for Mexican Customs purposes and will manage payment for all Mexican customs tariffs, duties, bonds, and Mexican customs broker’s
charges, and any all other charges, fees, levies, or permits made pursuant to Mexican law in effect as to the importation to and exportation
from Mexico of COMPANY products and/or equipment, in each case after consultation with COMPANY. Aforementioned costs associated with
COMPANY-specific products, if any, will be subject to approval beforehand by COMPANY, and subsequently itemized and invoiced to CUSTOMER
for reimbursement. COMPANY will be responsible for all customs tariffs, duties, bonds, and customs broker’s charges, and any and
all other charges, fees, levies, or assessments made pursuant to U.S. Customs Code as to the importation to and exportation from the
U.S. of COMPANY product and/or equipment related to and properly incurred pursuant to this Agreement.


 


	14.	Indemnification




 


COMPANY
shall indemnify SUPPLIER and its affiliates against all liabilities and expenses arising out of or in connection with any claim made
by a third party for death, illness, personal injury, damage to property, or infringement of third party’s intellectual property
to the extent that the damage is solely attributable to the acts or omissions of COMPANY, its employees, agents, or subcontractors (other
than SUPPLIER). SUPPLIER shall indemnify COMPANY and its affiliates against all liabilities and expenses arising out of or in connection
with any claim made by a third party for death, illness, personal injury, damage to property, or infringement of third party’s
intellectual property to the extent that the damage is solely attributable to the acts or omissions of SUPPLIER, its employees, agents,
or subcontractors.


 


	15.	Confidentiality




 


The
Parties acknowledge that during the course of this Agreement, each may obtain confidential information regarding the other Party’s
business. Both Parties agree to treat all such information, and the terms of this Agreement, as confidential, to take all reasonable
precautions against disclosure of such information to unauthorized third parties during and after the term of this Agreement and to comply
in all respects with the terms and conditions of that certain Non-Disclosure, Non-Circumvention and Work Product Agreement, dated as
of April 28, 2020, by and between the Parties (the “Confidentiality Agreement”). Upon the written request of any Party, all
documents relating to its confidential information will be promptly returned to such Party.


 


	16.	Non-Solicitation




 


During
the term of this Agreement and ending one (1) year following the Termination Date, the Parties shall not, without each Party’s
prior written consent, directly or indirectly hire, solicit, or encourage any person to leave the employment or other service of either
Party.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            11 of 28



 


	17.	Force
  Majeure




 


Any
delay in the performance of any of the duties or obligations of either Party hereto shall not be a considered a breach of the terms of
the Agreement and the time required for performance shall be extended for a period equal to the period of such delay (not to exceed 90
days, after which the parties shall be entitled to terminate this Agreement), provided that such delay is caused by or the result of
any acts of God, acts of the public enemy, insurrections, riots, labor disputes, including strikes, lockouts or boycotts, fires, explosions,
flood or other unforeseeable causes beyond the control and without the fault or negligence of the Party so affected (including in connection
with the COVID-19 pandemic). The Party so affected shall give prompt notice to the other Party of such cause, and shall take whatever
reasonable steps are necessary to relieve the effect of such cause as rapidly as possible.


 


	18.	Dispute
  Resolution




 


This
Agreement shall be governed by and construed in accordance with the laws of the state of New York, without regard to conflicts of law
principles . In the event of any dispute or disagreement that the parties cannot resolve amicably within 15 days (or such longer period
as they agree to), then as the exclusive means of resolving the dispute either party may require that the matter be settled by binding
arbitration by giving notice of arbitration to the other. Arbitration will take place in the city of the party who receives notice of
arbitration (unless another location is agreed to by the Parties), under the Commercial Rules and auspices of the American Arbitration
Association. The parties will share the costs of the arbitration, though each shall bear its own costs. The arbitrator shall have no
authority to award punitive damages.


 


	19.	Miscellaneous




 


This
Agreement contains the entire agreement between the parties with respect to its subject matter, superseding prior agreements and merging
all prior and contemporaneous negotiations, promises, and arrangements; provided that any confidentiality agreement between the parties
shall remain in full force and effect and is hereby incorporated by reference. This Agreement may be amended or modified only by written
instrument signed by the authorized representatives of both parties. This Agreement shall be binding upon and inure to the benefit of
the parties and their respective heirs, or permitted successors or assigns.


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            12 of 28



 


	20.	Notifications




 


Notifications
to COMPANY


 


	Company
    Name:	Lucid
    Diagnostics Inc.
	 	 
	 

     

    Address:
	Headquarters

    One
    Grand Central Place

    60
    East 42nd Street, Suite 4600

    New
    York, NY 10165

	 	 
	 	Corporate

                                                         Catherine
                                            Howard

	 	Director
    of Manufacturing Operations
	Contact
    Name:	CSH@PAVmed.com

    Quality
    Assurance

    Matthieu
    Ennis

	 	Director
    of Quality
	 	MJE@PAVmed.com


 


Notifications
to SUPPLIER


 


	Supplier
    Name:	Coastline
    International, Inc.
	Address:	1207
                                            Bangor St.

    San
    Diego, CA 92106

	Contact
    Name:	Bryan
    Blessing
	Title:	Operations
    Director
	Telephone:	(805)
                                            550-0688 (Primary)

    (888)
    748-7177 ext. 103

	Email:	Bryan@coastlineintl.com


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            13 of 28



 


	21.	Responsibilities




 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 
	1.
    General Statement	 	 
	 	 	 
	 	1.1.	The
    PARTIES shall operate in compliance with ISO 13485, FDA 21CFR820, EU MDD 2007/47/EC & EU MDR 2017/745 quality requirements as
    stated herein, environmental, occupational, and health and safety laws, and all other applicable laws, regulations, and local laws
    concerning manufacturing, testing, storage, packaging, labeling, and distribution of the PRODUCT. This also includes medical device
    specific regulatory standards and guidances.	X	X
	 	 	 	 	 
	 	1.2.	SUPPLIER
    shall be responsible for obtaining and maintaining, at its expense, all permits, licenses, approvals, authorizations and the like
    required for its performance of the services defined in the AGREEMENT; in the event of any required COMPANY-specific permit or license,
    SUPPLIER shall give the COMPANY prior written notice of such requirement, and the COMPANY shall be responsible for any reasonable
    and documented out-of-pocket expenses associated with such permit or license.	X	X
	 	 	 	 	 
	 	1.3.	SUPPLIER
    shall ensure that it has not been or does not use any persons or entities debarred under 21 U.S.C. § 335(a) or 335(b), nor disqualified
    as described in 21 CFR 812.119, nor debarred by any enforcement group associated with a HEALTH AUTHORITY; it will not employ in connection
    with any services any person who is not properly qualified by directly applicable training, experience and supervision to carry out
    the tasks they are assigned in connection with such services; neither it nor any of its officials or employees have been convicted
    of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval,
    of any medical device or regulatory submission; and none of its officials or employees have been convicted of a felony under United
    States law for conduct otherwise relating to the regulation of any product or medical device under the Food Drug & Cosmetics
    Act.	 	X


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            14 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	1.4.	SUPPLIER
                                            shall be responsible for maintaining quality compliance of all operations, including but
                                            not limited to manufacturing, testing, storage, packaging, labeling and Sterile Lot Release
                                            of PRODUCT. Quality compliance shall be established and maintained, including but not limited
                                            to the following:

                                                                                                     

    ■
    Facilities in compliance with HEALTH AUTHORITY requirements or with any conditions described in SUPPLIER’s MANUFACTURING
    AUTHORIZATION, or Device Master Record.

    ■ All appropriate equipment, cleaning, utility, and facility qualification and validation activities associated with the
    PRODUCT.

    ■ Setting-up, calibrating, cleaning, qualifying, and maintaining all equipment associated with the PRODUCT.
	 	X
	 	 	 	 	 
	2.
    Design and Development of COMPANY concepts	 	 
	 	 	 
	 	2.1.	COMPANY
    shall provide SUPPLIER with all information pertaining to the design and development of any project concepts.	X	 
	 	 	 	 	 
	 	2.2.	COMPANY
    and SUPPLIER shall create and retain records necessary for the initiation and maintenance of a Design History File according to each
    entity’s respective Design Control requirements and based on the requirements in the Design & Development Plan for each
    project.	X	X
	 	 	 	 	 
	3.
    MANUFACTURING MATERIALS and COMPONENTS	 	 
	 	 	 	 	 
	 	3.1.	COMPANY
    shall provide all documentation for the design, development, qualification, and manufacturing of PRODUCT based on the requirements
    in the Design & Development Plan for each project.	X	 
	 	 	 	 	 
	 	3.2. 	SUPPLIER
    shall test and release MANUFACTURING MATERIALS and COMPONENTS purchased by SUPPLIER or received as COMPANY provided materials and
    used in the manufacturing of PRODUCT. COMPANY maintains the right to increase or modify the sampling plan/parameters of MATERIAL
    and COMPONENTS as determined necessary.	X	X
	 	 	 	 	 
	 	3.3.	SUPPLIER
    shall, subject to COMPANY’s consent, qualify suppliers for the materials, components and services used in the manufacture and
    test of PRODUCT.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            15 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 
	 	3.4.	SUPPLIER
    shall ensure that all MANUFACTURING MATERIALS and COMPONENTS used in the manufacturing of PRODUCT fully comply with the respective
    SPECIFICATIONS provided by COMPANY.	X	X
	 	 	 	 	 
	 	3.5.	COMPANY
    is responsible for communicating to SUPPLIER label specification/drawing for label generation of finished PRODUCT labeling. COMPANY
    supplied label specifications and drawings shall be maintained in SUPPLIER’s document control system and Device Master Record.	X	X
	 	 	 	 	 
	 	3.6.	COMPANY
    and SUPPLIER shall both approve label SPECIFICATIONS of finished PRODUCT labeling prior to use.	X	X
	 	 	 	 	 
	 	3.7.	SUPPLIER
    is responsible for generating components labeling including lot numbers and expiration dating, where needed, which must comply with
    approved label SPECIFICATIONS.	 	X
	 	 	 	 	 
	4.
    Quality Records and Documentation	 	 
	 	 	 	 	 
	 	4.1.	SUPPLIER
    shall draft all necessary DEVICE MASTER RECORDS (DMRs) in accordance with HEALTH AUTHORITIES’ requirements and provide to COMPANY	 	X
	 	 	 	 	 
	 	4.2.	COMPANY
    and SUPPLIER shall review and approve in writing DEVICE MASTER RECORDS as well as device related procedures, work instructions, and
    validations.	X	X
	 	 	 	 	 
	 	4.3.	SUPPLIER
    shall store and maintain DEVICE MASTER RECORDS and DEVICE HISTORY RECORDS to prevent any loss or deterioration. Copies of DEVICE
    MASTER RECORDS and DEVICE HISTORY RECORDS for applicable devices will be made available to COMPANY.	 	X
	 	 	 	 	 
	 	4.4.	SUPPLIER
    shall retain all original manufacturing and testing records, including all raw data, as part of the DEVICE HISTORY RECORD.	 	X
	 	 	 	 	 
	 	4.5.	SUPPLIER
    shall store/retain all paper and electronic documentation and records per the SUPPLIER’s procedures. SUPPLIER is required to
    maintain all documentation and records for a minimum of 10 years from the date of manufacture, unless otherwise mutually agreed upon
    by PARTIES in writing for transfer and storage by COMPANY.	X	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            16 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	4.6.	Upon
    the expiry of the storage periods of DEVICE MASTER RECORDS and DEVICE HISTORY RECORDS, or upon termination of Agreement, SUPPLIER
    shall promptly notify COMPANY in writing and await instructions for the transfer of records to COMPANY or for written authorization
    for destruction of records. COMPANY is required to provide authorization or transfer instructions within 30 days of notification.	X	X
	 	 	 	 	 
	5.
    Manufacturing and Testing	 	 
	 	 	 	 	 
	 	5.1.	COMPANY
    is responsible for authorizing the SUPPLIER to MANUFACTURE PRODUCT by issuing a written request such as a CUSTOMER ORDER.	X	 
	 	 	 	 	 
	 	5.2.	SUPPLIER
    shall use only PRODUCT documents provided by or approved by COMPANY in the manufacturing and testing of PRODUCT.	 	X
	 	 	 	 	 
	 	5.3.	SUPPLIER
    shall provide a unique LOT or BATCH NUMBER for each LOT or BATCH of PRODUCT as well as provide the corresponding manufacturing date
    and expiration date to be used as part of Unique Device Identification for labeling.	 	X
	 	 	 	 	 
	6.
    Reworking And Reprocessing	 	 
	 	 	 	 	 
	 	6.1.	SUPPLIER
    shall promptly notify COMPANY of any PRODUCT that does not meet specifications.	 	X
	 	 	 	 	 
	 	6.2.	SUPPLIER
    shall promptly notify COMPANY of any PRODUCT that requires REWORK or REPROCESSING.	 	X
	 	 	 	 	 
	 	6.3.	SUPPLIER
    shall define and COMPANY shall approve any rework and reprocessing procedures prior to the implementation of any PRODUCT rework or
    reprocessing. Rework procedures shall be approved and released via the same process as original procedures.	X	X
	 	 	 	 	 
	7.
    Date of Expiration	 	 
	 	 	 	 	 
	 	7.1.	COMPANY
    shall determine the date of expiration of PRODUCT based on shelf life studies.	X	 
	 	 	 	 	 
	8.
    Quality Control Testing 	 	 
	 	 	 	 	 
	 	8.1.	SUPPLIER
    shall conduct release testing and/or inspection on every LOT of PRODUCT and issue to COMPANY a COA and/or COC.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            17 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	8.2. 	COMPANY
    shall have defined and provided to SUPPLIER in writing acceptance criteria (i.e. action limit) for each in-process test performed
    and each PRODUCT release test, if required, shall have an established SPECIFICATION.	X	 
	 	 	 	 	 
	 	8.3.
     	SUPPLIER
    shall promptly notify COMPANY of any proposed changes to acceptance criteria (i.e. action limit) and SPECIFICATIONS associated with
    PRODUCT and such changes shall not be implemented without prior written approval from COMPANY.	 	X
	 	 	 	 	 
	9.
    Suppliers and Subcontract Suppliers	 	 
	 	 	 	 	 
	 	9.1.	If
    requested, SUPPLIER will provide COMPANY with a list of all suppliers or subcontract suppliers of COMPONENTS and MANUFACTURING MATERIALS
    used in the PRODUCT. With respect to all such suppliers or subcontract suppliers, SUPPLIER shall ensure that it procures the necessary
    audit rights so that in the event COMPANY desires to audit suppliers or subcontract suppliers of COMPONENTS and MANUFACTURING MATERIALS,
    it shall have the right (albeit through SUPPLIER) to do so and SUPPLIER will provide the necessary documentation and facilitate COMPANY’s
    audit of such suppliers and subcontract suppliers. Audits conducted of subcontractors shall be at direction of, or otherwise authorized
    by, COMPANY and performed by outside auditors at COMPANY’s cost; provided that the Parties agree to reconsider in good faith
    from time to time who will bear the cost of scheduled and unscheduled audits of subcontractors based on, among other relevant factors,
    the then-current volumes of PRODUCTS being manufactured by SUPPLIER for COMPANY.	X	X
	 	 	 	 	 
	 	9.2.	SUPPLIER
    shall ensure the quality compliance to SPECIFICATIONS of any suppliers or subcontract suppliers of COMPONENTS and MANUFACTURING MATERIALS
    used in the PRODUCT.	 	X
	 	 	 	 	 
	 	9.3.	SUPPLIER
    shall promptly notify COMPANY of any changes (additions or removal) to suppliers or subcontract suppliers of COMPONENTS and MANUFACTURING
    MATERIALS used in the PRODUCT.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            18 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	9.4.	COMPANY
    shall approve in writing any changes (additions or removal) of any suppliers or subcontract suppliers of COMPONENTS and MANUFACTURING
    MATERIALS used in the PRODUCT prior to implementation.	X	 
	 	 	 	 	 
	 	9.5.	SUPPLIER
    shall maintain a suitable qualification program for suppliers of COMPONENTS.	 	X
	 	 	 	 	 
	10.
    Product Release	 	 
	 	 	 	 	 
	 	10.1.	SUPPLIER
    shall review and approve its DEVICE HISTORY RECORDS for each LOT according to its approved internal procedures.	 	X
	 	 	 	 	 
	 	10.2.	If
                                            requested, SUPPLIER shall provide COMPANY the following PRODUCT documents for review:

                                                                                                                          

    ■
       Completed LOT HISTORY RECORDS

    ■
           COA and/or COC

    ■
           DEVIATION reports, investigations associated with the batch

    ■
           Analytical data (in-process and release test data)
	 	X
	 	 	 	 	 
	 	10.3.	SUPPLIER
    shall provide additional requested documentation and information to COMPANY in order to understand and evaluate any deviations, out-of-
    specification (OOS) results, investigations, or other quality related issues to the PRODUCT.	 	X
	 	 	 	 	 
	 	10.4.	For
    any LOT of rejected PRODUCT, SUPPLIER shall provide COMPANY with a statement of rejection, specifying the reasons for rejection.
    SUPPLIER shall promptly notify COMPANY of any LOT of PRODUCT aborted during manufacturing. Statements of rejection or notices of
    aborted LOTS shall be forwarded to COMPANY within five (5) business days after SUPPLIER’s Quality Assurance Unit review. Any
    rejected PRODUCT will be disposed of in accordance with industry best practices by SUPPLIER and not used for any other purpose, without
    the consent of COMPANY.	 	X
	 	 	 	 	 
	 	10.5.	SUPPLIER
    shall promptly notify COMPANY of the quantities of PRODUCT aborted, rejected, retained, and released.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            19 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	10.6.	SUPPLIER
    is responsible for authorizing the FINAL RELEASE of PRODUCT with review of DHR, Sterilization Documentation, and any other LOT
    specific records necessary. COMPANY shall provide review and, unless an alternative approval process is agreed by the Parties,
    approval signature on SUPPLIER release Record, and SUPPLIER shall thereafter notify the DISTRIBUTION CENTER via PRE-ALERT FORM of
    the inbound shipment at least twenty-four (24) hours in advance of the expected PRODUCT arrival at the DISTRIBUTION
    CENTER.	X	X
	 	 	 	 	 
	11.
    Shelf-life Testing	 	 
	 	 	 	 	 
	 	11.1.	COMPANY
    or third party shall generate all Shelf-life Testing protocols. SUPPLIER shall support COMPANY by building PRODUCT.	X	X
	 	 	 	 	 
	 	11.2.	COMPANY
    is responsible for the review of all shelf- life data as required in the Design & Development Plan for each project.	X	 
	 	 	 	 	 
	 	11.3.	COMPANY
    shall approve all shelf-life protocols and reports and any amendments as required in the Design & Development Plan for each project.	X	 
	 	 	 	 	 
	12.
    Storage And Shipment Of PRODUCT and Components	 	 
	 	 	 	 	 
	 	12.1.	COMPANY
    shall communicate to SUPPLIER the storage conditions of PRODUCT, which will be included in product specifications.	X	 
	 	 	 	 	 
	 	12.2.	SUPPLIER
    shall handle and store PRODUCT and COMPONENTS safely according to approved procedures and storage conditions for the PRODUCT, maintain
    systems for controlling quarantined, rejected or recalled materials, and maintain storage facilities appropriate for conditions specified
    on PRODUCT label and component SPECIFICATIONS.	 	X
	 	 	 	 	 
	 	12.3.	SUPPLIER
    shall notify COMPANY of any adverse conditions or events or DEVIATIONS associated with the storage of PRODUCT, within two (2) business
    days of becoming aware. SUPPLIER shall evaluate and document the potential impact to product quality as a result of any events or
    DEVIATIONS and submit a written report, preliminary or final, to COMPANY within 5 business days of becoming aware. SUPPLIER shall
    take all action reasonably necessary to address any such adverse conditions or events or DEVIATIONS.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            20 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	12.4.	COMPANY
    shall review the SUPPLIER’s report and shall notify the SUPPLIER in writing of the disposition of PRODUCT.	X	 
	 	 	 	 	 
	13.
    DEVIATIONS	 	 
	 	 	 	 	 
	 	13.1.	SUPPLIER
    shall fully document any DEVIATIONS made during the course of manufacturing, testing, packaging, labeling, storage and distribution
    of PRODUCT.	 	X
	 	 	 	 	 
	 	13.2.	SUPPLIER
    shall notify COMPANY in writing within two (2) business days of becoming aware of any DEVIATIONS related to the PRODUCT.	 	X
	 	 	 	 	 
	 	13.3.	SUPPLIER
    shall investigate, evaluate and document any potential impact of every DEVIATION and shall justify any recommendations for further
    action. SUPPLIER shall provide a written report of investigation, preliminary or final, to COMPANY within five (5) business days
    of becoming aware of any DEVIATION related to the PRODUCT.	 	X
	 	 	 	 	 
	 	13.4.	COMPANY
    shall approve all DEVIATIONS related to PRODUCT.	X	 
	 	 	 	 	 
	14.
    OOS, Suspect Test Results	 	 
	 	 	 	 	 
	 	14.1.	SUPPLIER
    shall promptly notify COMPANY of any confirmed OOS or suspect test results obtained for a LOT during release or stability testing.
    SUPPLIER shall notify COMPANY in writing within two (2) business days after confirmation of OOS or suspect test results.	 	X
	 	 	 	 	 
	 	14.2.	SUPPLIER
    shall conduct the OOS investigation in accordance with its approved procedures and provide company a written report, preliminary
    or final, within five (5) business days after confirmation of OOS or suspect test results.	 	X
	 	 	 	 	 
	 	14.3.	SUPPLIER
    shall obtain written COMPANY approval of all OOS or suspect test results, including but not limited to, any plans for re-testing,
    re-sampling, and disposition.	X	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            21 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	15.
    Validation	 	 
	 	 	 	 	 
	 	15.1.	SUPPLIER
    shall ensure that all processes, equipment, computer systems, cleaning and methods to manufacture, test, package, label, and store
    PRODUCT are in compliance according to its approved procedures and shall ensure that processes, equipment, computer systems, cleaning
    and methods are validated and remain in a validated state for manufacture and testing of PRODUCT. This may include sterilization
    of product or oversite of sterilization process through a third party supplier. Validation records shall be provided to CUSTOMER
    upon request.	 	X
	 	 	 	 	 
	 	15.2.	SUPPLIER
    shall ensure that all software used in their Quality Management System is evaluated for validation and validated appropriately per
    SUPPLIER procedure. Validation records shall be provided to CUSTOMER upon request.	 	X
	 	 	 	 	 
	 	15.3.	SUPPLIER
    shall provide PRODUCT process, cleaning/sterilization, or method validation protocols and reports to COMPANY for approval as required
    in the Design & Development Plan for each project.	 	X
	 	 	 	 	 
	 	15.4.	SUPPLIER
    shall provide a copy of all approved PRODUCT-related validation protocols and reports to COMPANY.	 	X
	 	 	 	 	 
	 	15.5.	Upon
    request, SUPPLIER shall make all relevant validation records and data available to COMPANY.	 	X
	 	 	 	 	 
	16.
    Change Control	 	 
	 	 	 	 	 
	 	16.1.	Both
    PARTIES shall make changes to controlled documents in observance of all notification requirements of any respective HEALTH AUTHORITY.	X	X
	 	 	 	 	 
	 	16.2.	SUPPLIER
    shall promptly provide COMPANY with prior written notification of all changes to MANUFACTURING MATERIALS, COMPONENTS, PRODUCT, validated
    processes, facilities, utilities, equipment and methods that may impact the PRODUCT regulatory filings or require a regulatory submission,
    prior to implementation of such changes and shall not issue a MANUFACTURER’S RELEASE for any LOTS manufactured under such change
    until any needed regulatory approvals are obtained.	 	X
	 	 	 	 	 
	 	16.3.	SUPPLIER
    shall provide changes to PRODUCT- specific master manufacturing and testing documentation to COMPANY for review and approval in writing
    prior to implementing any such changes. COMPANY will control labeling and packaging content and review final device packaging and
    labeling as part of DMRs.	X	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            22 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	16.4.	After
    implementation of the approved changes at SUPPLIER, SUPPLIER shall forward a copy of the relevant revised PRODUCT-specific documents
    to COMPANY within two (2) business days.	 	X
	 	 	 	 	 
	 	16.5.	COMPANY
    is responsible for the timely reporting of changes in PRODUCT-specific documentation to the applicable licensee and/or HEALTH AUTHORITY.	X	 
	 	 	 	 	 
	17.
    Audits and Compliance	 	 
	 	 	 	 	 
	 	17.1.	Upon
    reasonable notice to SUPPLIER, SUPPLIER shall permit COMPANY or its appointed representatives (hereinafter “Auditors”)
    to conduct audits of all documents, processes, procedures, materials, supplies, equipment, packaging and facilities of SUPPLIER (or
    any third party engaged by SUPPLIER) applicable to PRODUCT for the purposes described herein (hereinafter an “Audit”).	 	X
	 	 	 	 	 
	 	17.2.	COMPANY
    or its Auditors may have access to SUPPLIER for routine compliance audit purposes once a year. Such Audits shall be conducted with
    reasonable notice during regular business hours.	X	 
	 	 	 	 	 
	 	17.3.	In
                                            addition to the compliance audits, COMPANY and its Auditors shall be entitled to conduct
                                            “For Cause” investigative Audits, to address significant PRODUCT quality or safety
                                            problems.

     

    For
Cause Audits shall relate to significant operational concerns at SUPPLIER (or applicable third party), and may include but are not limited
to lot rejection by COMPANY, unresolved OOS investigations, Warning Letter or any deficiency letter issued by a HEALTH AUTHORITY, as
they pertain to systems or observations associated with the testing of PRODUCT. Such inspections or Audits, to the extent reasonably
practical, shall be conducted in a manner that shall not materially interrupt or impair any significant operations at SUPPLIER (or applicable
third party).
	X	 



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            23 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	17.4.	If
    requested, an exit meeting shall be held between representatives from SUPPLIER and COMPANY and/or its Auditors to discuss Audit nonconformances.	X	X
	 	 	 	 	 
	 	17.5.	COMPANY
    shall provide a written report of all Audit nonconformances to SUPPLIER within thirty (30) calendar days. COMPANY shall communicate
    all expected nonconformances to SUPPLIER at the conclusion of the audit.	X	 
	 	 	 	 	 
	 	17.6.	SUPPLIER
    (or applicable third party) shall correct all noted deficiencies as soon as practicable, and shall provide COMPANY with a written
    Corrective Action Plan to Audit observations within fifteen (15) calendar days of receipt of Audit report.	 	X
	 	 	 	 	 
	 	17.7.	If,
    within forty (40) business days after receiving an Audit report, SUPPLIER (or applicable third party) cannot remedy an Audit nonconformance
    the PARTIES shall use good faith efforts to agree upon a reasonable written plan and timetable for such remedy.	X	X
	 	 	 	 	 
	18.
    Inspections by HEALTH AUTHORITIES	 	 
	 	 	 	 	 
	 	18.1.	SUPPLIER
                                                                              shall inform COMPANY with as much advance notice as possible, but at least within two (2) Business Days of notification, of any
                                                                              regulatory activities of which they become aware that could reasonably be expected to prompt an inspection at SUPPLIER involving the
                                                                              PRODUCT (e.g. pre- approval, for cause, post approval, or other inspections). SUPPLIER shall promptly notify COMPANY in writing of
                                                                              any unannounced audits or inspections involving the PRODUCT.
	X	X
	 	 	 	 	 
	 	18.2.	SUPPLIER
    shall allow COMPANY or its Auditors to participate in any PRODUCT-related inspections if deemed necessary by COMPANY. COMPANY shall
    be available for consultation during the Inspection but shall not participate during the inspection unless requested by SUPPLIER
    or a HEALTH AUTHORITY representative.	X	X
	 	 	 	 	 
	 	18.3.	SUPPLIER
    shall not discuss with any HEALTH AUTHORITY any activities relating to the PRODUCT not actually performed by SUPPLIER, or sub-contracted
    by SUPPLIER.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            24 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	18.4.	SUPPLIER
    shall inform COMPANY in writing daily of potential issues identified during an inspection.	 	X
	 	 	 	 	 
	 	18.5.	SUPPLIER
    shall allow COMPANY or its Auditors to attend the inspection closeout to address any PRODUCT-related observations. SUPPLIER is responsible
    for addressing process qualifications, manufacturing, testing, packaging, labeling, facility, and compliance observations as applicable.	 	X
	 	 	 	 	 
	 	18.6.	For
    regulatory observations that specifically involve the PRODUCT, SUPPLIER shall hold discussions with COMPANY sufficiently in advance
    of any commitment to a regulatory agency. COMPANY shall prepare and/or comment on SUPPLIER proposed responses specific to PRODUCT
    within time commitments needed to address regulatory concerns. COMPANY and SUPPLIER have joint final approval for the PRODUCT responses
    related to SUPPLIER to be submitted.	X	X
	 	 	 	 	 
	 	18.7.	For
    regulatory observations that involve any quality, production, material, laboratory, facilities, equipment, or packaging system-related
    quality issues that are not specific to the PRODUCT, SUPPLIER has final approval for the responses to be submitted.	 	X
	 	 	 	 	 
	 	18.8.	Prior
    to filing regulatory inspection reports and responses, SUPPLIER shall provide COMPANY with copies of completed regulatory inspection
    reports and responses, in each case purged only of trade secret or other confidential or proprietary information of SUPPLIER that
    is unrelated to its obligations under this Quality Agreement or is unrelated to PRODUCT.	 	X
	 	 	 	 	 
	 	18.9.	SUPPLIER
shall promptly correct any site-related violations or deficiencies. SUPPLIER shall promptly notify COMPANY and discuss solutions in good
faith to reach written agreement on such issue within thirty (30) days of initiating discussions.
	 	X
	 	 	 	 	 
	 	18.10.	If
    any HEALTH AUTHORITY or any entity representing such an authority requests access to SUPPLIER’s records, facilities, equipment
    and/or personnel, or conducts an unannounced inspection, or takes any other regulatory action (including without limitation any warning
    letters and FDA-483s), in each case relating to a COMPANY PRODUCT, then SUPPLIER will notify COMPANY by email within twenty-four
    (24) hours. COMPANY shall have the right to be present at any Audit or inspection by a HEALTH AUTHORITY that relates to the PRODUCT,
    and, where time permits, to conduct a pre-Audit inspection, so long as audit is announced with detailed notification prior to inspection.	 	X



 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            25 of 28



 


	TASKS
    AND RESPONSIBILITIES	COMPANY	SUPPLIER
	 	 	 	 	 
	 	18.11.	SUPPLIER
    shall promptly provide COMPANY copies of all relevant communications between SUPPLIER and any HEALTH AUTHORITY relating to PRODUCT.
    Where SUPPLIER is required or intends to respond to any such communication, SUPPLIER will provide COMPANY with a copy of such communication
    and SUPPLIER’s proposed response sufficiently in advance of the date that such response is to be submitted, in order to permit
    COMPANY to review and comment upon such response. COMPANY and SUPPLIER shall jointly agree on any written response relating to PRODUCT.	X	X
	 	 	 	 	 
	19.
    Complaints and PRODUCT Recalls	 	 
	 	 	 	 	 
	 	19.1.	COMPANY
    is responsible for complaint handling, including the receipt, collection, management, and reporting activities for customer complaint
    events. This includes notification of recall/field action to HEALTH AUTHORITIES, regulatory bodies, distributors, and end user communications.	X	 
	 	 	 	 	 
	 	19.2.	COMPANY
    or other sub-supplier shall receive and deliver to SUPPLIER all relevant PRODUCT identified as having defects related to PRODUCT
    complaints.	X	 
	 	 	 	 	 
	 	19.3.	SUPPLIER
    shall assess and promptly notify COMPANY of any PRODUCT defects or complaints that may be a result of SUPPLIER’s or other sub-
    supplier’s manufacturing of the PRODUCT.	 	X
	 	 	 	 	 
	 	19.4.	When
    reasonably requested by COMPANY, SUPPLIER shall promptly perform investigations and shall provide COMPANY with any necessary documentation.	X	X
	 	 	 	 	 
	 	19.5.	If
    COMPANY determines a recall may be necessary, then COMPANY shall inform SUPPLIER in writing specifying the details of the recall
    within twenty-four (24) hours of initial notification.	X	 
	 	 	 	 	 
	 	19.6.	If
    SUPPLIER receives any non-PRODUCT related complaints or recalls which may impact the quality of COMPANY’s PRODUCT, SUPPLIER
    shall notify COMPANY in writing of any non-PRODUCT complaints or recalls received directly from an investigator site or consumer
    within 48 hours of complaint receipt.	 	X


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            26 of 28



 


Approvals


	Coastline International, Inc.	 	Lucid Diagnostics Inc.
	 	 	 	 	 
	Signature:	/s/
    Bryan Blessing	 	Signature:	/s/
    Lishan Aklog
	Name:	Bryan
    Blessing	 	Name:	Lishan
    Aklog
	Title:	Director,
    Operations	 	Title:	Executive
    Chairman
	Date:	9/1/2021
    | 1:24:16 PM PDT	 	Date:	9/1/2021
    | 4:13:56 PM EDT


 



    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            27 of 28



 


Appendix
A


 




    	 



    	 



    

 


	 	Quality
                                            & Manufacturing Master Service

                                                                     Agreement
	

                                                                                Revision#:
                                            A

                                                                                Page
                                            28 of 28



 


Appendix
B