SUPPLY AGREEMENT


 


This
Supply Agreement (this “Agreement”), dated as of 15th of September, 2021 (“Effective Date”),
is by and between by and between Quoin Pharmaceuticals, Inc., a Delaware corporation located at 2127 Pleasant Forest Ct., Ashburn,
VA 20148 (“Quoin”) and AFT Pharmaceuticals Ltd., a company incorporated under the laws of New Zealand located
at Level 1, 129 Hurstmere Road, Takapuna, Auckland, 0622, New Zealand (“Licensee”). Quoin and Licensee are sometimes
referred to herein individually as a “Party,” and together as the “Parties.”


 


WITNESSETH:


 


WHEREAS, Quoin
and Licensee are parties to that certain License and Distribution Agreement, dated the date hereof (“License
Agreement”), pursuant to which Quoin granted to Licensee an exclusive license under the Product Technology for Licensee to
obtain the Regulatory Approvals and Exploit the Product in the Territory, subject to the terms of the License Agreement;


 


WHEREAS,
Section 4.4 of the License Agreement provides that the Parties shall enter into a commercial supply agreement pursuant to which
Quoin will manufacture and supply, or have manufactured and supplied, to Licensee the Product for sale in the Territory; and


 


WHEREAS,
the Parties now desire to enter into this Supply Agreement to establish the terms and conditions under which Quoin will have the Product
manufactured and supplied to Licensee for sale in the Territory.


 


NOW,
THEREFORE, in consideration of the premises and mutual covenants contained herein and for other good and valuable consideration,
the receipt and adequacy of which are hereby acknowledged, the Parties hereto agree as follows:


 


Article I


 


DEFINITIONS


 


Section 1.1         Definitions.
Capitalized terms used in this Agreement have the meanings specified in Schedule 1 to this Agreement. As used herein the words “including”
or “includes” shall be deemed to mean “including, without limitation,” or “includes, without limitation.”


 


Article II


 


MANUFACTURE AND SALE OF PRODUCT


 


Section 2.1         Engagement.
During the Term and upon the terms and subject to the conditions set forth herein, Quoin agrees that it will manufacture and supply the
Product to Licensee, and, in turn, Licensee agrees that it will exclusively purchase one hundred percent (100%) of the Licensee’s
requirements of the Product from Quoin for commercialization solely within the Territory. Quoin shall have the right to subcontract its
obligations under this Agreement to a third party with prior notification to Licensee (it being agreed that, wherever Quoin makes a commitment
under this Agreement with respect to the manufacture and supply of Product, such obligation shall be deemed satisfied if performed by
such subcontractor).


 


Section 2.2         Sale
and Distribution. The Licensee will sell the Product only in the Territory and will not directly or indirectly sell or otherwise
distribute the Product outside of the Territory.


 






     


     


    

 


Section 2.3         Packaging
and Labeling. The Licensee will be responsible for ensuring the accuracy of all information contained in the labels or labeling for
Product and the compliance of all such labels and labeling with applicable Law and the Regulatory Approvals. Licensee will approve all
artwork and labeling information necessary for the packaging and labeling of the Product. Quoin will, or will cause its contractors to,
supply all packaging and labels for Product under this Agreement. Such packaging and labels will be in accordance with the Specifications.
Quoin will make any changes to labeling and packaging Specifications required in writing by the Licensee, at the Licensee’s sole
cost and expense (including the cost of any obsolete labeling inventory), within a reasonable timeframe to be agreed upon in writing
by both Parties. The Licensee will be responsible for submitting any such changes to all applicable Governmental Authorities for approval.


 


Section 2.4         Facility
Maintenance; Inspection; Reports.


 


(a)        Quoin
shall, at all times, maintain and operate, or cause its contractors to maintain and operate, all facilities where Product is manufactured,
packaged, tested, stored, warehoused or shipped in compliance with cGMP. Not more than once every twelve (12) months, Quoin shall permit,
or cause its contractors to permit, quality assurance representatives of the Licensee or designated third parties (subject to appropriate
confidentiality obligations) to inspect such facilities, operations, documents, and records directly related to the handling, manufacture,
testing, inspection, packaging, storage, disposal and transportation of the Product by Quoin or the applicable contractor upon reasonable
notice (which shall not be less than ten (10) days), during normal business hours and on a confidential basis. Quoin shall also
permit, and cause its contractors to permit, representatives of the applicable Governmental Authority to inspect such facilities as requested
by the such Governmental Authority.


 


(b)        Quoin
shall maintain adequate and accurate records consistent with the applicable Specifications, including records covering quality control
testing and release of the Product and all other manufacturing services provided hereunder in material compliance with cGMP.


 


(c)        Quoin
shall notify Licensee as soon as reasonably practicable and in any event within five (5) business days following receipt of notice
of any Governmental Authority inspection of the manufacturing facility if such inspection pertains to the Product.


 


Section 2.5         Adverse
Events. Prior to the launch of Product the Parties shall each assign a representative to negotiate in good faith and agree on a process
and procedure for sharing adverse event information which shall be documented in a safety data exchange (SDEA) agreement which the Parties
shall use commercially reasonable efforts to agree upon and execute prior to commercialization of the Product.


 


Article III


 


FORECASTS, ORDERS AND SHIPMENT


 


Section 3.1         Forecasts.
In order to assist in the planning of production runs for the Product, the Licensee will, at least one hundred and eighty (180) days
prior to the commercial Launch of the Product in the Territory, provide Quoin with a non-binding written forecast of estimated
quantities of Product that the Licensee anticipates ordering from Quoin during the next eighteen (18) month period (the
 “Forecast”). This initial Forecast will be updated at least two (2) business days after the first day of the
month following the first calendar quarter after the date hereof, and at least two (2) business days after the first day of the
month for each successive calendar quarter, and each such updated Forecast will be promptly delivered to Quoin by the Licensee. The
first three (3) months of each such Forecast (the “Firm Order Period”) shall be binding on Licensee. The
remaining fifteen (15) months of each such forecast shall be non-binding estimates for planning purposes. No Forecast shall
be required for any period of time that extends beyond the Term (as in effect at the time of such Forecast). The Licensee will
forecast in amounts comprising full batch and in multiples of batch quantities, as such quantities are set forth on Schedule
6.1. Each Forecast will be made by the Licensee in good faith, taking into account reasonable projections of demand for the
Product including, without limitation, allowing for reasonable safety stock of finished Product.


 






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Section 3.2         Orders.


 


(a)        The
Licensee will place firm purchase orders (“Firm Orders”) for Product in writing for delivery at least ninety
(90) days after the Purchase Order Date. A Firm Order shall only be deemed binding on Quoin upon acceptance in writing by Quoin
provided that Quoin shall accept or reject each Firm Order in writing within seven (7) Business Days after Quoin’s
receipt of each valid order which shall require that such order meets the requirements specified below. Each Firm Order will specify
the quantity and description of each Product ordered, the requested delivery date (which delivery dates will not be on a Saturday,
Sunday or holiday), the delivery address, the transportation method and carrier and any special instructions requested; provided
that no Firm Order shall include a quantity of a Product that is greater than 125% of the quantity of such Product set forth in the
Firm Order Period of the most recent Forecast delivered to Quoin by the Licensee. In the event that the Firm Orders exceed 125% of
the most recent forecast, Quoin is not obligated but shall use commercially reasonable efforts to deliver the additional quantities.
The minimum size of any order placed by the Licensee will be a full batch (or multiples of a full batch) in accordance with Schedule
6.1 hereto, except with the prior approval of Quoin and payment of any additional expenses or fees that are required for split
batches. The Product set forth in Firm Orders will be delivered to such location as the Licensee designates in writing to Quoin from
time to time. The date an order will be deemed placed (the “Purchase Order Date”) will be the date that Quoin
actually receives the purchase order form. The Licensee will be fully responsible for any changes to a Firm Order. Orders will be
deemed accepted by Quoin unless Quoin provides notification of rejection to the Licensee within seven (7) Business Days of
receipt of the Firm Order.


 


(b)       Quoin
will use its commercially reasonable efforts to supply the Product in accordance with each Firm Order placed pursuant to the terms of
this Agreement by the Licensee to the extent accepted by Quoin including the quantities and delivery dates in each Firm Order. Each Firm
Order will set forth a delivery date, not less than ninety (90) days after the date of such order.


 


(c)        In
the event that at any time Quoin foresees that it will be unable to supply to Licensee (or its nominee) in whole or in part an ordered
or forecasted quantity of Product by the delivery date for any reason, including a Force Majeure event, Quoin shall notify Licensee of
such inability as soon as possible, the reasons therefor and the date such inability is expected to end, the quantities of Product available
during such period and the proposed amount of the raw materials and/or resources prioritized to Licensee in the event such inability
is caused by a shortage of raw materials and/or resources required for the Manufacture of Product.


 


(d)        Quoin
shall deliver the Product to Licensee with at least 85% (eighty five percent) of remaining shelf life at the shipment date
in accordance with Section 3.2(b).


 


(e)        The
terms of this Agreement shall prevail over any conflicting, inconsistent or additional terms set forth in any Firm Order, invoice, or
acceptance form.


 






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Section 3.3         Delivery.


 


(a)        All
Product shipped under this Agreement will be shipped EXW the facility where the Product is manufactured. The Licensee shall make
necessary arrangements to pick up the shipment and will pay all freight, insurance charges, taxes, import and export duties,
inspection fees and other charges applicable to the sale and transport of Product purchased by the Licensee. Title and risk of loss
and damages to Product purchased by the Licensee will pass to the Licensee upon pickup of the Product by the Licensee’s
carrier at the facility of manufacture. In the event of damage or loss to the Product after delivery, the Licensee will be
responsible to file claims with the carrier. Quoin shall notify Licensee of the following information concurrently with each
shipment of Product: (i) date of shipment, (ii) quantity and type of Product shipped, and (iii) order number or other
identifying information.


 


(b)        Quoin
shall perform quality assurance testing with respect to the Product sold hereunder, including stability testing, so that the Product
conforms with the Specifications. Quoin shall provide Licensee with a Certificate of Analysis (“COA”) and a Certificate
of Compliance (“COC”) confirming that the Product in such shipment has been tested in accordance with the Regulatory
Approval and meets the Specifications via facsimile transmission. Any deviations and investigations related to such Product shall be
completed in compliance with applicable Regulatory Approval and the Quality Agreement (as defined in Section 5.5 hereof).


 


Article IV


 


REPRESENTATIONS AND WARRANTIES


 


Section 4.1         Representations
and Warranties of Quoin. Quoin hereby represents and warrants to the Licensee as follows:


 


(a)        Product
Compliance. All Product delivered pursuant to this Agreement by Quoin (or any sub-contractor thereof) to the Licensee or its designee
during the Term will at shipment be in compliance in all material respects with this Agreement, the Specifications and the Quality Agreement.
At the time Quoin makes each shipment of Product available for pick-up by Licensee (or Licensee’s carrier), the Product shall be
free of any lien or other encumbrance.


 


(b)       Authorization.
This Agreement has been duly executed and delivered by Quoin and, assuming due execution and delivery by the Licensee, constitutes a
valid and binding obligation, enforceable against Quoin in accordance with its terms, except as enforceability may be limited by bankruptcy,
fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to creditors’ rights generally and by general
equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary action on
the part of Quoin and its respective officers and directors.


 


(c)       Absence
of Conflicts. The execution, delivery and performance of this Agreement by Quoin does not conflict with or constitute a default under
any agreement, instrument or understanding, oral or written to which it is a party or by which it may be bound, does not conflict with
any provision of any of its organizational documents and does not conflict with or violate any applicable Law or court order or decree.


 


(d)       Organization
and Standing. Quoin is a corporation, duly organized, validly existing and in good standing under the laws of Delaware.


 


(e)        Power
and Authority. Quoin has the corporate power and authority to execute, deliver and perform this Agreement and to consummate the transactions
contemplated hereby.


 






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(f)        Compliance
With Law. Quoin has and will maintain throughout the Term of this Agreement all permits, licenses, registrations and other forms
of governmental authorization and approval as required in order for Quoin to execute and deliver this Agreement and to perform its obligations
hereunder.


 


(g)       No
Debarment. Quoin is not debarred and has not and will not use in any capacity the services of any person debarred under subsection
306(a) or (b) of the Generic Drug Enforcement Act of 1992. If at any time this representation and warranty is no longer accurate,
Quoin shall promptly notify Licensee of such fact.


 


Section 4.2         Representations
and Warranties of the Licensee. The Licensee hereby represents and warrants to Quoin as follows:


 


(a)        Authorization.
This Agreement has been duly executed and delivered by the Licensee and, assuming due execution and delivery by Quoin, constitutes a
valid and binding obligation, enforceable against the Licensee in accordance with its terms, except as enforceability may be limited
by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to creditors’ rights generally
and by general equitable principles. The execution, delivery and performance of this Agreement have been duly authorized by all necessary
action on the part of the Licensee and its respective officers and directors.


 


(b)       Absence
of Conflicts. The execution, delivery and performance of this Supply Agreement by the Licensee does not conflict with or constitute
a default under any agreement, instrument or understanding, oral or written to which it is a party or by which it may be bound, does
not conflict with any provision of any organizational documents of the Licensee and does not conflict with or violate any applicable
Law or court order or decree.


 


(c)        Organization
and Standing. The Licensee is a corporation, duly organized, validly existing and in good standing under the laws of New Zealand.


 


(d)       Power
and Authority. The Licensee has the corporate power and authority to execute, deliver and perform this Agreement and to consummate
the transactions contemplated hereby.


 


(e)        Product
Compliance in the Territory. Product delivered by Quoin in accordance with this Agreement is and shall be during the Term consistent
in all respects with all Laws applicable to the manufacture, import, sale, use, storage and commercialization of the Product in the Territory.


 


Section 4.3         Disclaimer.
THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS AGREEMENT ARE THE PARTIES’ ONLY WARRANTIES AND NO OTHER WARRANTY, EXPRESS, IMPLIED
OR STATUTORY, WILL APPLY. EACH PARTY EXPRESSLY DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING
WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. FOR THE AVOIDANCE OF DOUBT, EACH PARTY EXPRESSLY DISCLAIMS ANY AND
ALL WARRANTIES OF NON-INFRINGEMENT THAT ARE NOT EXPRESSLY SET FORTH IN THIS AGREEMENT.


 






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Article V


 


QUALITY ASSURANCE


 


Section 5.1         Quoin’s
Covenants. Quoin hereby covenants during the Term that it will:


 


(a)        manufacture,
fill, package, test, handle, store, warehouse and ship the Product in conformity with this Agreement, Quality Agreement (subject to Section 5.5
of this Agreement) and the Specifications;


 


(b)       promptly
(but in any event no later than five (5) Business Days after becoming aware) inform Licensee of any adverse events related to the
Product and any inspections, communications, or material issues raised by the FDA in connection with the Manufacturing of the Product,
and shall provide Licensee with copies of any correspondence (including emails) relating thereto;


 


(c)       obtain
and maintain all permits reasonably necessary to manufacture and supply Product in accordance with this Agreement; and


 


(d)       if
Quoin becomes aware of any Product supplied to Licensee hereunder that have not been manufactured in accordance with the Specifications,
promptly inform Licensee in writing.


 


Section 5.2         The
Licensee’s Covenants. The Licensee hereby covenants during the Term that it will:


 


(a)        hold,
store, handle, ship, deliver, distribute, offer for sale, and/or sell the Product in accordance with applicable Law and the terms of
the License Agreement, and in compliance with the Specifications;


 


(b)       except
as set forth herein or in the Quality Agreement between the Parties, upon delivery of the Product to the Licensee, the Licensee will
be solely responsible for compliance with all quality control testing and other testing requirements set forth in this Agreement and,
further, all applicable Law with respect to the manufacture, import, sale, use, storage and commercialization of the Product in the Territory;


 


(c)       where
appropriate maintain the Regulatory Approvals for the Product in full force and effect throughout the Term.


 


Section 5.3         Rejection
of Delivered Product. Within thirty (30) days of receipt of any shipment of Product and applicable COA and COC by the Licensee at
its applicable warehouse, the Licensee will inspect the Product, COA and COC and advise Quoin of any defect revealed from such inspection
whereby the Product does not conform to the Specifications. Any Product not refused within thirty (30) days will be deemed accepted.
If the Licensee wishes to refuse acceptance, the Licensee will, within such 30-day period, provide written notice to Quoin of its refusal
to accept the defective Product and the reason(s) therefor. In the event a hidden defect (i.e., one which could not have been reasonably
identified during the initial 30-day Licensee inspection period) is discovered at a later date whereby the Product does not conform to
the Specifications, the Licensee shall inform Quoin within fifteen (15) days after Licensee becomes aware of the alleged hidden defect.
In the event that the Licensee refuses acceptance or rejects the Product due to a hidden defect, Quoin, upon confirmation of the reasons
for refusal or rejection of the Product, will replace within ninety (90) days or as soon as reasonably practicable the defective Product
at Quoin’s sole cost and expense (including the cost of shipping) or refund the Transfer Price and reimburse the shipping expense,
at the Licensee’s option. If Quoin and the Licensee do not agree on the refusal or rejection of Product, then either Party may
refer the matter for final analysis to a specialized laboratory of national reputation acceptable to both Parties for the purpose of
determining the results. Any determination by such laboratory will be final and binding upon the Parties. The cost of any such review
by a laboratory shall be borne by the Licensee if it is determined that the Product conforms to the Specifications, and by Quoin if determined
that it does not. Except as set out in this Section 5.3 and Section 10.1, Quoin shall have no liability to Licensee for any
defect for which it has not received notice from the Licensee as specified herein.


 






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Section 5.4         Recall.
Licensee, in consultation with Quoin, shall have the exclusive right to institute a recall and shall be responsible for managing the
recall and communications with customers and Governmental Authorities. The Parties shall cooperate with each other in connection with
any such efforts. In the event that any Product is quarantined or recalled by Licensee, or is subject to stop-sale action, whether voluntary
or by governmental action, it is agreed and understood that any reasonable and documented expenses, including any out-of-pocket administrative
costs and reasonable and documented fees of any experts or attorneys that may be utilized by either Party, government fines or penalties,
related to such recall, quarantine or stop-sale, will be borne by the Licensee unless it is determined that the reason for the quarantine,
recall or stop-sale action is solely the result of the failure by Quoin to manufacture and supply (or have manufactured and supplied)
Product that meets the Specifications therefor under this Agreement, and in such case such expenses will be the responsibility of Quoin.
If the Parties do not mutually agree on which Party is responsible for the recall or other field action, the responsibility for the recall
or field action shall be determined by a mutually acceptable independent qualified third party whose fees shall be shared equally by
the Parties.


 


Section 5.5         Quality
Procedures. Quoin and Licensee shall comply with the terms of the quality requirements set forth in a quality agreement to be negotiated
in good faith by the Parties and entered into by the Parties as soon as practicable after the date hereof (the “Quality Agreement”)
with respect to the manufacture of the Product. To the extent that any inconsistencies or conflicts exist between the Quality Agreement
and this Agreement with regard to quality requirements and compliance with applicable Law, the provisions in this Agreement shall prevail.


 


Section 5.6         Manufacturing
Changes.


 


(a)        Licensee
may unilaterally and in its sole discretion make one or more Required Manufacturing Changes by giving written notice thereof to Quoin,
whereupon the Parties shall cooperate in implementing such Required Manufacturing Changes as promptly as reasonably practicable. Licensee
may request one or more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Quoin, whereupon
if Quoin accepts the requested Discretionary Manufacturing Changes (such acceptance not to be unreasonably withheld or delayed), the
Parties shall cooperate in implementing such Discretionary Manufacturing Changes as promptly as reasonably practicable. Quoin shall promptly
provide to Licensee Quoin’s good faith and detailed estimate of the actual and reasonable costs that will be incurred by Quoin
resulting directly from any such Required or Discretionary Manufacturing Changes, including the cost of any obsolete inventory resulting
from the changes. All such reasonable and documented costs shall be borne by Licensee.


 


(b)       Quoin
shall not in any respect amend, modify or supplement the Specifications or the manufacturing process or any materials or sources of materials
used in connection with manufacturing the Product without the prior written consent of Licensee. Quoin may request or recommend one or
more Discretionary Manufacturing Changes by giving at least ninety (90) days written notice thereof to Licensee and shall provide Licensee
with appropriate documentation relating to any such changes to the Specifications or manufacturing process. If Licensee approves any
such Discretionary Manufacturing Change, Quoin may implement such change in accordance with the specifications provided by Quoin to Licensee.
All costs arising out of any Discretionary Manufacturing Changes requested by Quoin shall be borne by Quoin.


 






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Article VI


 


PRICE AND PAYMENTS


 


Section 6.1         Prices.
The price payable by the Licensee for Product will be the price set forth on Schedule 6.1 and will be adjusted pursuant to Section 6.3
(the “Transfer Price”). The price for the Product set forth on Schedule 6.1 shall be equal to the Manufacturing Costs
of Quoin. The method for calculation of the Transfer Price set forth in this Section 6.1 shall be valid for the Initial Term only,
Transfer Price of any agreed upon Extended Term shall be subject to negotiate between the Parties.


 


Section 6.2         Any
additional costs such as stability costs, scale-up expenses, and additional analytical or testing expenses that may be specifically incurred
at the request of Licensee or as required for the Manufacture of the Product in accordance with the Specifications and/or cGMP compliance
in the Territory will be charged at actual cost to the Licensee. Quoin will provide prior information to the Licensee before incurring
any such costs and/or expenses. A separate invoice will be issued to Licensee for such costs and/or expenses.


 


Section 6.3         Adjustment.
Quoin shall be permitted to increase the Transfer Price of Product to the extent of any documented actual increase in the Manufacturing
Costs.


 


Section 6.4         Invoices.
Quoin will send all invoices in respect of any Product to a single address specified in writing by the Licensee to Quoin following
the date that such Product subject to any Firm Order shall have been made available to the Licensee under Section 3.3(a).
Payments for Product sold hereunder will be made by the Licensee to Quoin within sixty (60) days after the date of the
invoice by electronic funds transmission in United States dollars as specified in any invoice, without any offset or deduction of
any nature whatsoever. All payments will be made to such account as Quoin will have specified in writing to the Licensee with
written confirmation of payment sent by email or facsimile to such address as Quoin will have specified in writing to the Licensee.
Licensee shall advise Quoin within ten (10) calendar days of any disputed invoice. If the Licensee fails to pay any undisputed
invoiced amount when due, a service charge will be imposed by Quoin equal to one percent (1%) per month of the outstanding amount
for each month or portion thereof that such undisputed amount is overdue.


 


Section 6.5         Taxes, etc.
The Licensee will bear solely the cost of any taxes, levies, duties or fees of any kind, nature or description whatsoever applicable
to the sale and transportation of Product sold by Quoin to the Licensee (“Licensee Taxes”), and the Licensee will
forthwith pay to Quoin all such sums upon demand. Quoin and Licensee shall cooperate with each other and use their commercially reasonable
efforts to obtain any certificate or other document from any person as may be necessary to mitigate, reduce or eliminate any such Licensee
Taxes.


 


Section 6.6         Separate
Sale. Each shipment of Product to the Licensee will constitute a separate sale, obligating the Licensee to pay therefor, whether
said shipment is in whole or only partial fulfillment of any order or confirmation issued in connection therewith.


 






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Section 6.7         Deductions.
Except as otherwise required by applicable law, the Licensee agrees not to make any deductions of any kind from any payments becoming
due to Quoin unless the Licensee will have received prior written authorization from Quoin authorizing such deduction.


 


Article VII


 


TERM AND TERMINATION


 


Section 7.1         Term. The provisions of this Agreement will commence on the date hereof and will continue in effect until the License Agreement
is terminated or expires pursuant to its terms, and this Agreement shall terminate simultaneously with such termination or expiration
of such License Agreement, unless earlier terminated in accordance with this Article VII (the “Initial Term”).
This Agreement may be extended in the same manner and for the same duration as, and simultaneously with, any extension of the term of
the License Agreement, subject to a mutually agreed upon price increase at the time of the extension, (the “Extended Term”
and together with the Initial Term, the “Term”).


 


Section 7.2         Termination.
Either Quoin, on the one hand, or the Licensee, on the other hand, as applicable, will have the right to terminate this Agreement with
immediate effect (except as otherwise stated below) upon written notice to the other upon the occurrence of the following:


 


(a)        Quoin,
on the one hand, or the Licensee, on the other hand, files a petition in bankruptcy, or enters into an agreement with its creditors,
or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or becomes
subject to involuntary proceedings under any bankruptcy or insolvency Law;


 


(b)        Quoin,
on the one hand, or the Licensee, on the other hand, fails to cure any noncompliance with any of the terms and conditions hereof within
the time period specified in any prior written notice (which will be at least thirty (30) days) delivered to the non-compliant Party
by another Party; provided; however, that Quoin shall be permitted to terminate immediately upon delivery of written notice to Licensee
in the event that Licensee has failed at least two (2) times in any twelve (12) month period to pay to Quoin any amount invoiced
hereunder when such amount is due, other than where such failure is due to a good faith dispute over the amount owed;


 


(c)        The
termination of the License Agreement.


 


Section 7.3         Effects
of Termination.


 


If this Agreement is terminated
pursuant to Section 7.2:


 





(a)               
The Licensee acknowledges and agrees that Quoin will supply the Product for a period of six (6) months following termination
of this Agreement pursuant to Section 7.2(c) hereof, except where such termination of the License Agreement has been by Quoin pursuant
to Section 11.2.3 or 11.2.4 of the License Agreement. In all other cases, Quoin shall be entitled to cancel any Firm Order accepted prior
to the date of termination. Quoin will not be obligated to supply any Product ordered by the Licensee, with respect to any Product to
be delivered after the effective date of the termination. In addition, Quoin may at its election deliver in accordance with the shipping
terms of this Agreement all quantities of components, materials, APIs and work-in-progress, and finished product in Quoin’s or its
Affiliates’ possession, and to the extent such components, materials, API, work-in-progress, and finished product have not already
been paid for by Licensee and are not reasonably allocable to or usable for other activities being carried out by Quoin or its Affiliates,
then the Licensee shall purchase them from Quoin at Quoin’s actual cost, which amount shall be payable no later than thirty (30)
days after receipt thereof by the Licensee.


  






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(b)       Subject
to Section 7.3(a) hereof, termination or expiration of this Agreement for any reason will not relieve the Parties of any obligation
accruing prior to such termination or expiration (including in respect of any Firm Orders). The rights and obligations of the Parties
under Sections 5.3, 5.4, 5.5, 7.3, Article IX, Article X, and Article XI of this Agreement will survive the expiration
or termination of this Agreement.


 


Article VIII


 


FORCE MAJEURE


 


Section 8.1         Force
Majeure. Neither Party will be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing
any term or provision of this Agreement (other than the payment of money) when such failure or delay will be caused (directly or indirectly)
by a circumstance beyond the reasonable control of the affected Party, including, without limitation, pandemic, fire; flood; accident;
explosion; terrorism, sabotage; strike, or any labor disturbance (regardless of the reasonableness of the demands of labor); civil commotions;
riots; invasions; wars (present or future); acts, restraints, requisitions, regulations, or directions of any Governmental Authority,
except where such acts, restraints, requisitions, regulations or directions are the result of a Party’s violation of applicable
Law; shortage of labor, fuel, or power; any failure of a third party supplier of the Product or raw materials to deliver timely; inability
to obtain or delays of transportation facilities; any act of God; any act of the other Party or any cause (whether similar or dissimilar
to the foregoing) beyond the reasonable control of such Party (each a “Force Majeure”). Any Party asserting its inability
to perform any obligation hereunder for any such contingency shall promptly notify the other Party of the existence of any such contingency
and shall use commercially reasonable efforts to mitigate such contingency and re-commence its performance of such obligation as soon
as commercially practicable. Neither Party shall suffer penalty or incur any liability for its inability to perform hereunder by reason
of Force Majeure. If a Party fails to perform any of its obligations under this Agreement by reason of Force Majeure and such non-performance
continues for a period of one hundred and eighty (180) days from the first occurrence of the event of Force Majeure, the other Party
may terminate this Agreement by providing written notice to that effect to the non-performing Party. In the event of such termination,
the provisions contained in Section 7.3 shall apply.


 


Article IX


 


CONFIDENTIALITY


 


Section 9.1         Non-disclosure
and Non-use Obligation. Each Party or its Affiliates or contractors may, from time to time, prior to or after the date hereof, disclose
to the other Party information of a technical or non-technical nature that is not generally known to the trade or public. Each Party
agrees that it will not, and will cause its Affiliates, and will use reasonable best efforts to cause its contractors, not to, use for
any purpose other than as necessary to perform its obligations under this Agreement, and will not disclose to anyone in any manner whatsoever,
any such information including, without limitation, information relating in any way to the products, processes, and services of each
Party or its Affiliates or contractors, which becomes known to the other Party on or prior to the date of the termination or expiration
of this Agreement. The obligations of this Section 9.1 will not apply to information (i) that is known to a Party as shown
by written records prior to its disclosure by Quoin or its contractors; (ii) that becomes public information or is generally available
to the public other than by an unauthorized act or omission of the other Party; or (iii) that is received by a Party from third
parties who are in rightful possession of such information and who are lawfully entitled to disclose such information and did not receive
such information from the other Party. Upon the termination or expiration of this Agreement, each Party will return or destroy (with
written confirmation thereof) to the other Party all documents that include confidential information of each Party or its contractors
including all copies of such documents or extracts therefrom, if any, and will make no further use of such information. This Agreement
shall not be deemed to restrict the receiving Party from complying with a lawfully issued governmental order or any other requirement
of applicable Law to produce or disclose confidential information of the other Party; provided that the receiving Party shall
have complied with the requirements of this Section 9.1. With respect to any such governmental order or requirement of applicable
Law, the receiving Party shall promptly notify the disclosing Party of such order so that the disclosing Party may seek to quash such
order or to obtain an appropriate protective order requiring that the confidential information that is the subject of such order or requirement
of applicable Law be held in confidence or, if disclosed, be used only for the purposes for which such order was issued or such requirement
of applicable Law covers. The receiving Party shall reasonably cooperate with the disclosing Party in any such proceeding. With respect
to any such order that is not quashed or any other requirement of applicable Law to disclose confidential information of the disclosing
Party, the receiving Party shall furnish only that portion of such confidential information that the receiving Party is advised by counsel
is legally required to be disclosed and the receiving Party shall, at the disclosing Party’s cost, exercise its reasonable efforts,
in its sole discretion, to obtain a protective order or other reliable assurance that confidential treatment shall be accorded to the
confidential information so disclosed. The receiving Party’s obligations shall be qualified to the extent it is reasonably able
to comply with the terms of this Section 9.1 depending upon the order or other legal requirement and the timing within which the
receiving Party is obligated to comply therewith.


 






     10


     


    

 


Article X


 


INDEMNIFICATION


 


Section 10.1      By Quoin. From and after the Effective Date, Quoin will indemnify, defend and hold harmless, and pay and reimburse, the Licensee,
its Affiliates and their respective officers, directors, employees, agents, advisors, and shareholders from and against any and all liabilities,
losses, claims, damages, costs, and expenses (including reasonable attorneys’ fees) (“Losses”) resulting from
or relating to any claim by a Third Party resulting from or arising out of: (i) Quoin’s or its contractors’ or Affiliate’s
negligence or willful misconduct or violation of applicable laws, or (ii) any breach by Quoin of any of its representations and warranties,
covenants, agreements or obligations contained in this Agreement; except to the extent such Losses arise as a result of the breach of
this Agreement, or the negligence, willful misconduct, violation of applicable laws, or breach of this Agreement by Licensee or its contractors
or Affiliates.


  


Section 10.2       By the Licensee. From and after the Effective Date, the Licensee will indemnify, defend and hold harmless, and pay and reimburse,
Quoin and its Affiliates and their respective officers, directors, employees, agents, advisors and shareholders from and against any
and all Losses resulting from or relating to any claim by a Third Party resulting from or arising out of: (a) the Licensee’s negligence
or willful misconduct or violation of applicable laws, or (b) the Licensee’s breach of any of its representations and warranties,
covenants, agreements or obligations contained in this Agreement; or (c) regarding any Product sold by Licensee or its Affiliates from
and after the Effective Date, including but not limited to (i) any claim for patent infringement, personal injury, death or property
damage or (ii) the use of the Product by any person; provided, however, that the Licensee shall not be liable for any Losses to the extent
arising from Quoin’s or it contractors’ negligence, willful misconduct, violation of applicable laws or breach of its representations
and warranties, covenants, agreements or obligations contained in this Agreement.


 


Section 10.3       Procedures.
With respect to each event, occurrence or matter (an “Indemnification Matter”) as to which Quoin or Licensee, as the
case may be (the “Indemnitee”) is entitled to indemnification from the other Party (the “Indemnitor”)
under this Article X:


 






     11


     


    

 


(a)        Within
ten (10) days after the Indemnitee receives written documents underlying the Indemnification Matter or, if the Indemnification Matter
does not involve a third party action, suit, claim or demand, promptly after the Indemnitee first has actual knowledge of the Indemnification
Matter, the Indemnitee shall give notice to the Indemnitor of the nature of the Indemnification Matter and the amount demanded or claimed
in connection therewith (“Indemnification Notice”), together with copies of any such written documents.


 


(b)        If a third party action, suit, claim or demand is involved, then, upon receipt of the Indemnification Notice, the Indemnitor shall, at
its expense and through counsel of its choice, promptly assume and have sole control over the litigation, defense or settlement (the
 “Defense”) of the Indemnification Matter, except that (i) the Indemnitee may, at its option and expense and through
counsel of its choice, participate in (but not control) the Defense; and (ii) the Indemnitor shall not consent to any Judgment, or agree
to any settlement that does not unconditionally release the Indemnitee, without the Indemnitee’s prior written consent. The Indemnitee
may not consent to the settlement or entry of judgment in any such action, suit, claim or demand without the Indemnitor’s prior
written consent. The Indemnitee shall fully cooperate with the Indemnitor in the Defense as the Indemnitor may request and at its expense.
In any event, the Indemnitor and the Indemnitee shall fully cooperate with each other in connection with the Defense including by furnishing
all available documentary or other evidence as is reasonably requested by the other.





  





Section 10.4       Insurance.
At all times from the Effective Date through that date which is three (3) years after the termination or expiration of this Agreement,
each of the Licensee and Quoin will maintain general liability insurance in the amount of not less than USD $5,000,000 per occurrence
and USD $5,000,000 in aggregate and product liability insurance (or self-insurance), which is reasonable and customary in the USA pharmaceutical
industry for companies of comparable size, provided that in no event shall the product liability insurance amounts be less than USD $5,000,000
per occurrence and USD $5,000,000 in the aggregate limit of liability per year. Each of the Licensee and Quoin shall add the other party
as additional insured in their general liability and product liability policy and provide written proof of such insurance to the other
Party upon request.


 


Section 10.5       Limitations.


 


(a)     In no event shall either Party be liable by reason of any breach of any representation, warranty, condition or other term of this Agreement
or any duty of common law, for any consequential, special, indirect or incidental or punitive loss or damage (whether for loss of current
or future profits, loss of enterprise value or otherwise); provided, however, that the foregoing does not limit any of the obligations
or liability of either Party or its Affiliates under Sections 10.1 and 10.2 with respect to claims of unrelated third parties or liability
arising from fraud or willful misconduct of a Party or its Affiliates or contractors, or damages caused by a Party’s breach of
Article IX.









     12


     


    

 


(b)        In the event that either Party asserts or claims that the other Party has breached any of its obligations hereunder the other Party’s
maximum liability under or in connection with any such claim herein shall be limited to the amounts paid and payable by Licensee to Quoin
hereunder; provided, however, that the foregoing shall not limit any liability or obligations under Sections 10.1 and 10.2 with respect
to claims of unrelated third parties or arising from fraud or willful misconduct of either Party or its Affiliates or contractors.


 


 


Article XI


 


MISCELLANEOUS


 


Section 11.1       Assignment.
Neither Party may assign its rights or obligations under this Agreement without the prior written consent of the other Party ; provided,
however either Party may assign its rights and obligations under this Agreement, without the prior written consent of the other Party,
to an Affiliate or to a successor of the assigning Party by reason of merger, sale of all or substantially all of its assets or the portion
of its business which relates to a Product, or any similar transaction. Any permitted assignee or successor-in-interest will assume all
obligations of its assignor under this Agreement. No assignment will relieve either Party of its responsibility for the performance of
any obligation. This Agreement will be binding upon and inure to the benefit of the Parties hereto and their respective successors and
permitted assigns.


 


Section 11.2       Severability.
If any provision of this Agreement is held to be illegal, invalid or unenforceable by any Law or public policy, the remaining provisions
of this Agreement will nevertheless remain in full force and effect and will not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom as long as the economic or legal substance of the transactions contemplated hereby is not affected
in any manner materially adverse to either Party. Upon such determination that any term or other provision is invalid, illegal or unenforceable,
the Parties will negotiate reasonably and in good faith to modify this Agreement so as to effect the original intent of the Parties as
closely as possible in an acceptable manner in order that the transactions contemplated hereby are consummated as originally contemplated
to the greatest extent possible.


 


Section 11.3       Notices.
All notices and other formal or legal communications required or permitted to be given or made pursuant to this Agreement shall be
in writing signed by the sender and shall be deemed duly given (a) on the date delivered, if personally delivered, (b) on
the date sent by telecopier with automatic confirmation by the transmitting machine showing the proper number of pages were
transmitted without error, or (c) on the Business Day after being sent by Federal Express or another recognized overnight mail
service which utilizes a written form of receipt for next day or next Business Day delivery  in each case
addressed to the applicable Party at the address set forth below; provided that a Party may change its address for receiving notice
by the proper giving of notice hereunder:


 






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(a)        if
to the Licensee, to:


 


Attention: Hartley Atkinson


 


Level 1


 


129 Hurstmere Road


 


Takapuna


 


Auckland 0622


 


New Zealand


 


With a copy (which shall not constitute
notice) to:


 


Mintz, Levin, Cohen. Ferris, Glovsky,
and Popeo P.C.


 


One Financial Center


 


Boston MA 02111


 


Phone: +1 617 348 1834


 


Email: TMTuchin@mintz.com


 


Attention: Tali Tuchin


 


(b)       if
to Quoin, to:


 


with a copy (which shall not constitute
notice) to:


 


Blank Rome LLP 


One Logan Square, 130 N 18th St. 


Philadelphia, PA 19103-6998 


Attention: Peter I Tsoflias, Esq. 


Facsimile: 202.379.9021 


Email: PTsoflias@blankrome.com


 


It is understood and agreed that this Section 11.3
is not intended to govern the ordinary course business communications necessary between the Parties in performing their duties, in due
course, under the terms of this Agreement, including the placement of orders and the delivery of Forecasts.


 


Section 11.4       Applicable
Law. THIS AGREEMENT IS MADE UNDER, AND SHALL BE CONSTRUED AND ENFORCED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK, UNITED
STATES OF AMERICA, APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED SOLELY THEREIN, WITHOUT GIVING EFFECT TO PRINCIPLES OF CONFLICTS
OF LAW.


 






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Section 11.5       Arbitration.
If a matter cannot be resolved by the Parties, any said dispute shall be submitted to binding arbitration for final decision, and only
through binding arbitration. Any such arbitration shall be held in New York, New York, in the English language in accordance with the
then-existing Rules of Arbitration of the International Chamber of Commerce (the “ICC Rules”), except where those
rules conflict with this Section 11.5, in which case this Section 11.5 controls. Unless otherwise agreed by the Parties, the tribunal
shall be comprised of one (1) arbitrator agreed to by the Parties. The arbitrator shall decide the merits of any dispute in accordance
with the law governing this Agreement, without application of any principle of conflict of laws that would result in reference to a different
law. Judgment upon the award rendered by the arbitrator may be entered or enforced in any court having jurisdiction thereof. The decision
of the arbitrator shall be final and binding on the Parties and shall be accompanied by a written opinion of the arbitrator explaining
the arbitrator’s rationale for his or her decision. The Parties shall equally share in paying all fees and costs of the arbitrator
and the ICC, but each Party shall bear its own attorney and expert fees, except that the arbitrator may award the prevailing Party its
reasonable attorneys’ fees and legal costs. The Parties agree that, notwithstanding any provision of Applicable Law, they will
not request, and the arbitrators shall have no authority to award, punitive or exemplary damages against either Party. Pending the selection
of the arbitrator or pending the arbitrator’s determination of the merits of any dispute, either Party may seek appropriate interim
or provisional relief from any court of competent jurisdiction as necessary to protect the rights or property of that Party. The intent
of the Parties is that except for seeking appropriate interim or provisional relief or the entering of an arbitration order in a court
of competent jurisdiction, disputes shall be resolved finally in arbitration as provided above, without appeal, and without recourse
to litigation in the courts. The Parties acknowledge that the 1958 United Nations Convention on the Recognition and Enforcement of Foreign
Arbitral Awards (the “New York Convention”) applies to this Agreement and to any arbitral award or order resulting
from any arbitration concluded hereunder.  The award may be made a judgment of a court of competent jurisdiction.





  


Section 11.6       Entire
Agreement. This Agreement and the attached Schedules, which are incorporated herein constitute the entire agreement between the
Parties with respect to the subject matter hereof and all prior agreements with respect hereto are superseded. Each Party confirms
that no representations, warranties, covenants or understandings of any kind, nature or description whatsoever are being made or
relied upon by any Party. No amendment or modifications hereof will be binding upon the Parties unless set forth in a writing
specified to be an explicit amendment to this Agreement duly executed by authorized representatives of each of the Parties. The
Parties recognize that, during the Term of this Agreement, a purchase order, acknowledgement form, invoice or similar routine
document (collectively “Forms”) may be used to implement or administer provisions of this Agreement. Therefore,
the Parties agree that the terms of this Agreement, as it may be amended, will prevail in the event of any conflict between this
Agreement and the printed provision of such Forms, or typed provisions of Forms that add to, vary, modify or are in conflict with
the provisions of this Agreement with respect to the Product sold during the Term of this Agreement.


 


Section 11.7       Headings.
The headings used in this Agreement are intended for convenience only and will not be considered part of the written understanding among
the Parties and will not affect the construction of this Agreement.


 


Section 11.8       Independent
Contractors. The relationship between Quoin, on the one hand, and the Licensee, on the other hand, is solely that of Licensee and
seller. It is expressly agreed that Quoin, on the one hand, and the Licensee, on the other hand, will be independent contractors and
that neither the relationship among the Parties nor this Agreement will be construed as creating a partnership, joint venture or agency.
Neither Quoin, on the one hand, nor the Licensee, on the other hand, will have the authority to make any statements, representations
or commitments of any kind, or to take any action or to incur any liability or obligation which will be binding on the other, without
the prior consent of the other Party to do so. All persons employed by a Party will be employees of such Party and not of the other Party
and all costs and obligations incurred by reason of any such employment will be for the account and expense of such Party.


 






     15


     


    

 


Section 11.9       Waiver.
The waiver by either Party of any right hereunder or the failure to perform or of a breach by the other Party will not be deemed a waiver
of any other right hereunder or of any other or subsequent breach or failure by said other Party whether of a similar nature or otherwise.


 


Section 11.10     Counterparts.
This Agreement may be executed in counterparts, each of which will be deemed an original, and all of which together will constitute one
and the same instrument.


 


Section 11.11     No
Benefit to Third Parties. The representations, warranties, covenants and agreements set forth in this Agreement are for the sole
benefit of the Parties and their successors and permitted assigns, and nothing herein, express or implied, is intended to or will confer
upon any person or entity any legal or equitable rights, benefits or remedies, other than to the extent set forth in Sections 10.1 and
10.2.


 


[signature page follows]


 






     16


     


    

 


IN WITNESS WHEREOF, the Parties hereto have caused
this Agreement to be signed by their respective representatives thereunto duly authorized, all as of the date first written above.


 


	By:	 /s/ Hartley Atkinson 	 




Name: Hartley Atkinson 


Title: Managing Director


 


	Witnessed	 
	By:	 /s/ Louise Clayton 	 




Name: Louise Clayton 


Title: Director Internal Business


 


	By:	 /s/ Michael Myers 	 




Name: Michael Myers 


Title: CEO


 


	Witnessed	 
	By:	 /s/ Denise Carter 	 




Name: Denise Carter 


Title: Chief Operating Officer


 









     


     


    

 


Schedule 1.1


 


DEFINITIONS


 


As used in this Agreement,
the following terms will have the meanings ascribed to them below:


 


(a)           “Active
Pharmaceutical Ingredient” or “API” means the active pharmaceutical ingredient for Product.


 


(b)           “Affiliate”
of a Person means any other Person that directly or indirectly, through one or more intermediaries, controls, is controlled by, or is
under common control with, such Person. The term "control" (including the terms "controlled by" and "under common
control with") means the possession, directly or indirectly, of the power to direct or cause the direction of the management and
policies of a Person, whether through the ownership of voting securities, by contract or otherwise.


 


(c)           “cGMPs”
means current good manufacturing practice requirements of the FDA as promulgated under the Federal Food Drug and Cosmetics Act at 21
C.F.R. (parts 11, 210 and 211), and the European Medicines Agency as set forth in Regulation No. 1252/2014 and Commission Directive
91/356/EEC, as amended by Directive 2003/94/EC.


 


(d)           “COA”
has the meaning set forth in Section 3.3(b).


 


(e)           “COC”
has the meaning set forth in Section 3.3(b).


 


(f)            “Discretionary
Manufacturing Change” means change to the Specifications or manufacturing processes that is not a Required Manufacturing Change.


 


(g)           “Extended
Term” has the meaning set forth in Section 7.1.


 


(h)           “FDA”
means the United States Food and Drug Administration and any successor agency thereto


 


(i)            “Firm
Order” has the meaning set forth in Section 3.2.


 


(j)            “Firm
Order Period” has the meaning set forth in Section 3.1.


 


(k)           “Force
Majeure” has the meaning set forth in Section 8.1.


 


(l)            “Forecast”
has the meaning set forth in Section 3.1.


 


(m)          “Forms”
has the meaning set forth in Section 12.6.


 


(n)           “Governmental
Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other instrumentality of
(i) any government of any country, or (ii) a federal, state, province, county, city or other political, administrative or regulatory
subdivision thereof; in each case, in the jurisdiction where the Product is manufactured and/or in the Territory.


 


(o)           “Initial
Term” has the meaning set forth in Section 7.1.


 


(p)           “Law”
means each federal, state, provincial, municipal, local, or foreign law, statute, ordinance, order, determination, judgment, common law,
code, rule, official standard, or regulation, enacted, enforced, entered, promulgated, or issued by any Governmental Authority.


 






     


     


    

 


(q)           “Manufacturing”
or “Manufactured” means the manufacture and packaging of Product, including, without limitation, mix, fill and finish.


 


(r)            “Manufacturing
Costs” means, with respect to a Product, (x) where Quoin is the actual manufacturer of such Product, the actual cost of
manufacturing the Product (expressed on a per unit manufactured basis), which consists of (i) actual direct cost of any raw
materials, intermediates, packaging materials and labor utilized in such Manufacturing, (ii) an appropriate share of factory overhead
costs allocated to Manufacture of the Product, but excluding any costs related to under-utilized capacity, all calculated in accordance
with GAAP, and (iii) any transportation, freight expenses actually incurred by Quoin to ship the material along with any costs paid
to third parties with respect to any portion of manufacturing or testing the Product, or (y) where Product is manufactured by any
subcontractor for any of the foregoing, the aggregate amount paid to such subcontractor and any other third parties with respect to any
portion of manufacturing or testing the Product.


 


(s)           “Party”
or “Parties” means Quoin and/or the Licensee, as applicable.


 


(t)            “Person”
means any individual, corporation, partnership, limited liability company, limited liability partnership, syndicate, person, trust, association,
organization or other entity, and including and successor, by merger or otherwise, of any of the foregoing.


 


(u)           “Product”
means pharmaceutical product QRX003 in finished dosage form for human use.


 


(v)           “Purchase
Order Date” has the meaning set forth in Section 3.2(a).


 


(w)          “Licensee”
has the meaning set forth in the preamble.


 


(x)           “Licensee
Taxes” has the meaning set forth in Section 6.4.


 


(y)           “Licensee
Trademark” has the meaning set forth in Section 11.1.


 


(z)            “Quality
Agreement” has the meaning set forth in Section 5.6.


 


(aa)         “Regulatory
Approval” shall mean the licenses, registrations, clearances, consents, authorizations, and approvals required to have manufactured,
store, import, transport, market, promote, sell, place on the market, and distribute the Product (including, without limitation, pricing
approvals and labeling approvals) in the Territory, and all amendments thereto or supplements thereof.


 


(bb)        “Required
Manufacturing Change” means a change to the Specifications or manufacturing process that is required by a Governmental Authority
or applicable Law.


 


(cc)         “Specifications”
means the requirements and standards for the manufacture, packaging, storage and shipment of the Product set forth in the Quality Agreement,
as amended or supplemented in accordance with this Agreement.


 


(dd)        “Term”
has the meaning set forth in Section 7.1.


 


(ee)         “Territory”
means Australia and New Zealand.


 


(ff)          “Third
Party” means any Person, other than Licensee and its Affiliates, and other than Quoin and its Affiliates.


  


(gg)         “Transfer
Price” means the amount to be paid by the Licensee to Quoin pursuant to Section 6.1 and as may be adjusted from time to
time pursuant to Section 6.2.





 






     


     


    

 


Schedule
6.1 


Transfer
Price and Batch Quantities


 


TRANSFER PRICES AND BATCH QUANTITIES FOR DOSAGES AS OF EFFECTIVE DATE:


 


To be confirmed prior to regulatory submission.