Document:

Exhibit 4.38

THE SYMBOL “[****]” DENOTES PLACES WHERE CERTAIN IDENTIFIED
INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE
IT IS BOTH (i) NOT MATERIAL, AND (ii) THE TYPE THAT THE REGISTRANT 
TREATS AS PRIVATE OR CONFIDENTIAL
DEVELOPMENT AND SUPPLY AGREEMENT
This Development and Supply Agreement (this “Agreement”) is entered into as of January 13, 2021 by and between TOPCHEM PHARMACEUTICALS LIMITED, a limited company registered in the Republic of Ireland (“Manufacturer”), QUOIN PHARMACEUTICALS LIMITED, a limited company registered in Delaware, USA (“Consumer”).
WHEREAS, the Parties (as hereinafter defined) wish to enter into an agreement pursuant to which Manufacturer will develop the API and sell the API to Consumer;
NOW, THEREFORE, in consideration of the promises and of the mutual covenants and agreements set forth in this Agreement, and other good and valuable consideration the sufficiency of which is acknowledged, the Parties agree as follows:
1.DEFINITIONS
For purposes of this Agreement, the following words and phrases shall bear the respective meanings assigned to them below (and cognate expressions shall bear corresponding meanings):
1.1“Affiliate” means, with respect to any Party, any Person that is Controlled by, Controls, or is under common Control with, that Party.
1.2“Agreement” means this Agreement, as duly amended from time to time.
1.3“API” means [****], which meets the Specifications.
1.4“Business Day” means a day (not being a Saturday or Sunday) on which banks are open for business in the Republic of Ireland.
1.5“cGMP” means current good manufacturing practices in accordance with the rules, regulations and guidances promulgated by the FDA.
1.6 “Control” means, with respect to a Party, the direct or indirect beneficial ownership of more than fifty percent (50%) of the voting interest in, or more than fifty percent (50%) in the equity of, or the right to appoint more than fifty percent (50%) of the directors or management of such Party.
1.7 “Effective Date” means the date on which this Agreement is signed by the later of the Parties to sign this Agreement.
1.8“FDA” means the United States Food and Drug Administration and all agencies under its direct control or any successor organization.
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1.9“Finished Product” means the finished dosage product or products Manufactured by Consumer or its licensee with the API supplied by Manufacturer.
1.10“Force Majeure” has the meaning given such term in Section 12.
1.11“GAAP” means generally accepted accounting principles in the United States.
1.12“Intellectual Property” means any trade secret, know-how and data whether technical or non-technical as well as any development of invention whether or not patentable, concerning the Finished Product or API, its Manufacture, marketing and sale.
1.13“Loss” means any liability, loss, cost, damage or expense, including, without limitation, reasonable attorneys’ fees and expenses.
1.14“Manufacture” means, along with other forms of the word, the manufacturing, handling, packaging, labeling, storage and/or disposal of any API or Finished Products, as the case may be, and of the raw materials and components used in connection with the preparation thereof.
1.15 “Order” shall mean a purchase order issued by Consumer to Manufacturer for delivery of agreed services or for a certain quantity of API specifying the exact quantity of API required, the desired delivery date(s) and shipping instructions, if any.
1.16“Party” means Manufacturer or Consumer and “Parties” means both of them.
1.17“Person” means any individual, partnership, association, corporation, trust or legal person or entity.
1.18“Pre-Existing Intellectual Property” means all Intellectual Property owned, conceived, developed, first reduced to practice or otherwise made or acquired by a Party prior to the Effective Date hereof or outside of the services performed under this Agreement, including all modifications, adjustments or improvements thereto.  For avoidance of doubt, Pre-Existing Intellectual Property may be Manufacturer Pre-Existing Intellectual Property or Consumer Pre-Existing Intellectual Property as the case may be.
1.19“Quality Agreement” means the quality agreement to be entered into by the Parties as required, in form and content to be agreed by all parties.
1.20“Regulatory Approval” means the receipt of approval from any Regulatory Authorities of the acceptance of the use of the API in the Finished Product.
1.21 “Regulatory Authorities” means any and all bodies and organizations, including, without limitation, the FDA, which regulate the Manufacture, importation, distribution, use and sale of API and/or the Finished Products.
1.22“Regulatory Filing” means the preparation, submission and registration of the API to Regulatory Authorities by the either Party or subcontracted third parties.
1.23“Specifications” means the specifications required by Consumer as attached hereto as Annex B or are hereafter provided to Manufacturer.
1.24 “Term” has the meaning given such term in Section 10.1.

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1.25“Territory” means all global countries with no exceptions.
1.26 “Third Party Manufacturer” means any Person (including any Affiliate of Consumer) that Manufactures and supplies Finished Product to Consumer or a Third-Party Seller pursuant to a license or other contractual arrangement with Consumer.
1.27“Third Party Seller” means any Person (including any Affiliate of Consumer) that sells Finished Product to customers pursuant to a license or other contractual arrangement with Consumer.
2.DEVELOPMENT, QUALIFICATION & REGULATORY FILING
2.1Manufacturer shall develop the API as per the scope and costs outlined in Annex A hereto.
2.2Manufacturer shall: (a) provide Consumer with any and all information related to the API which is necessary or advisable for the preparation, prosecution and maintenance of any regulatory filings.
2.3Consumer shall be liable for all Regulatory Filing costs.
2.4Consumer shall use API obtained from Manufacturer in the Finished Product and Manufacturer agrees to supply Consumer with mutually agreed quantities of API for such purposes.
2.5Manufacturer shall not supply or sell the API or provide to any third parties with the exception of such Third-Party Manufacturers or Third-Party Sellers that may be engaged by Consumer to produce the Finished Product.
3.DELIVERY; RISK OF LOSS
3.1API covered by each Order accepted by Manufacturer shall be packed for shipment and stored in accordance with cGMP and the Quality Agreement.  Consumer’s Order number (or other numbers as required and determined) and quantity shipped shall be marked or tagged on each package and bill of lading.
3.2Manufacturer shall ship API to Consumer or a Third-Party Seller or Third-Party Manufacturer as set forth in the respective Orders.  Manufacturer shall (i) conduct quality control tests on the API prior to shipment in accordance with applicable law and the Quality Agreement; (ii) at Consumer’s request furnish samples of the API to Consumer or the Third Party Manufacturer or Third Party Seller; and (iii) deliver with each shipment a certificate of analysis for the API included in such shipment in accordance with the Specifications.
3.3Terms of shipment will be DDU (Incoterms © 2010), Consumer’s specified warehouse or place of operations.  API will be delivered, and title and risk of loss shall pass to Consumer when delivered.  All deliveries from Manufacturer will be made on or before the delivery date specified in each Order confirmed in writing by Manufacturer.
3.4If at any time during the Term, Manufacturer is or expects that it will be unable, in full or in part, to satisfy Consumer’s requirements for API for any reason, Manufacturer shall promptly so notify Consumer, detailing the extent to which it will not
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meet such requirements.  Consumer without limiting any other remedy available to it, may in its discretion meet the shortfall therein from any alternate source or sources.
4.WARRANTY; ACCEPTANCE
4.1Manufacturer warrants that at the time of delivery of API by Manufacturer hereunder, such API (a) shall be free from defects in workmanship and materials; (b) will be in good and merchantable quality and conform to the Specifications; and (c) will have been Manufactured, stored and packaged for shipment in accordance with cGMP in effect at the time thereof and with the Quality Agreement, and in compliance with all applicable laws, regulations and ordinances of any Regulatory Authority having jurisdiction over the Manufacture and delivery of API.
4.2Consumer shall have the right to reject all or part of any shipment of API delivered by Manufacturer if it fails to conform to the warranty contained in Section 4.1 herein, provided that Consumer delivers written notice within thirty (30) days from the date of receipt of such shipment.  If Consumer does not notify within such thirty (30) day period, as applicable, or decides not to test the API prior to use, the API shall be deemed accepted by Consumer.  If Consumer rejects any API, Consumer shall send samples of such allegedly defective API concurrently with or as soon as practicable following Consumer’s written notice pursuant to this Section 4.2 for the purpose of confirming such non-compliance.  Manufacturer shall review such samples as soon as practicable but in no instance more than thirty (30) days following the delivery of the samples pursuant to this Section 4.2.  If a dispute arises as to whether the API conforms to the warranty contained in Section 4.1 which is not resolved within thirty (30) days of the delivery of the samples of the API in question, then the matter (along with related samples, batch records or other evidence, as appropriate) shall be submitted to an independent testing laboratory agreed to by each of Consumer and Manufacturer.  The determination of the independent testing laboratory will be binding upon the Parties.  If it is determined that the API was not in conformance with the warranty in Section 5.1 upon delivery, then Manufacturer will credit Consumer account for the price invoiced for the portion of nonconforming API and the cost of any testing and evaluation by the testing laboratory will be born solely by Manufacturer.  Otherwise, Manufacturer will have no liability to Consumer with respect to such alleged nonconformance and the cost of any testing and evaluation by the testing laboratory will be borne solely by Consumer
5.REPRESENTATIONS, WARRANTIES AND COVENANTS
5.1Consumer hereby represents and warrants to Manufacturer that (a) Consumer is a limited company duly organized and existing under the laws of the Republic of Ireland, (b) it has the requisite authority to enter into this Agreement and to perform its obligations hereunder, (c) this Agreement is a legal, valid and binding agreement of Consumer, enforceable against Consumer in accordance with its terms, except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization, or similar laws in effect which affect the enforcement of creditors’ rights generally and by equitable limitations on the availability of specific remedies (d) Consumer is not aware of any contractual or other restriction, limitation or condition which might affect adversely its ability to perform hereunder, and (e) Consumer is in material compliance with all laws and regulations applicable to the conduct of its business.
5.2Manufacturer represents and warrants that it will develop the API using its commercially reasonable best efforts.  Manufacturer further represents and warrants to
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Consumer that (a) it is a corporation organized and existing under the laws the Republic of Ireland (b) it has the requisite authority to enter into this Agreement and to perform its obligations hereunder, (c) this Agreement is a legal, valid and binding agreement of Manufacturer enforceable against Manufacturer in accordance with its terms except as such enforceability may be limited by applicable bankruptcy, insolvency, moratorium, reorganization, or similar Laws in effect which affect the enforcement of creditors’ rights generally and by equitable limitations on the availability of specific remedies, (d) it is not aware of any contractual or other restriction, limitation or condition which might affect adversely its ability to perform hereunder, and (e) Manufacturer is in material compliance with all applicable laws and regulations.
5.3Each of Consumer and Manufacturer further represents, warrants and covenants:  (i) that it will assign to its performance of this Agreement personnel qualified to perform the activities consistent with the technical requirements of this Agreement; and (ii) that none of such Party’s personnel to be assigned to this Agreement have or shall have been subject to debarment under the United States Generic Drug Enforcement Act or any other penalty or sanction by the applicable Regulatory Authority.
5.4The representations, warranties, covenants and undertakings contained in this Agreement are continuous in nature and shall be deemed to have been given by each Party at execution of this Agreement and at each stage of performance hereunder.
6.REGULATORY INSPECTIONS AND COMMUNICATIONS
6.1Consumer will keep Manufacturer aware of registrations related to API and Manufacturer.  Each of the Parties agrees to cooperate to the extent reasonably requested by the other in connection with any communications with the FDA or any other Regulatory Authority related to API.
6.2Consumer shall have the right, to inspect with those of its representatives, representatives of Consumer’s Affiliates or representatives of any Third-Party Seller those areas of the facilities of Manufacturer where API is Manufactured for Consumer, to meet with personnel knowledgeable with respect to such services and to review the pertinent records relating to the Manufacturing and quality control of the API.  In addition to and not as a part of the foregoing rights, Consumer shall have the right to inspect the facilities of Manufacturer with reasonable advance written notice in the event (a) Manufacturer is in default under this Agreement, (b) in the event of either Party’s receipt of notice of deficiency from any Regulatory Authority regarding the API.
7.COMPLAINT HANDLING AND ADVERSE DRUG REACTION REPORTS
7.1Consumer shall be responsible for reporting all adverse drug events and responding to all adverse drug reports received from third parties regarding the Finished Products.
7.2If Consumer determines, after investigating an adverse event report, that the characteristics or quality of the API supplied under this Agreement may have been a factor in the adverse event, then Consumer shall notify Manufacturer immediately.
7.3Nothing in this Section 7 shall be deemed a waiver of any of Consumer’s rights with respect to indemnity owed by Manufacturer pursuant to Section 9.
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7.4Consumer shall be solely responsible for receiving, recording and responding to all customer inquiries and complaints and all reports of alleged adverse events relating to the Finished Product, and for reporting all such matters to appropriate Regulatory Authorities in accordance with applicable law.  Manufacturer shall provide Consumer with any technical information relating to manufacture or stability of the API reasonably necessary to enable Consumer to perform all such activities and to determine whether the adverse event, customer inquiry or complaint involves nonconformance or defect in the API or necessitates a recall or other corrective or market action.  Should Manufacturer receive any notice or inquiry regarding adverse events, it shall immediately transmit them to Consumer.
8.RECALLS AND WITHDRAWALS
To the extent permitted or required by law, any decision to recall, withdraw or cease distribution of any Finished Product as a result of a violation of applicable law or regulation, or because the Finished Product presents a possible safety risk, shall be made by Consumer.  Consumer will promptly notify Manufacturer of any such decision to recall, withdraw or cease distribution.  Consumer shall indemnify and hold harmless Manufacturer against any and all reasonable Losses (including the value of inventory of API or raw material) which Manufacturer may incur as a result of any recall, withdrawal or cessation of distribution of Finished Products initiated by Consumer but only to the extent that the basis for the recall, withdrawal or cessation is caused solely by Consumer.
9.INDEMNIFICATION AND LIMITATIONS
9.1Manufacturer shall indemnify, defend and hold Consumer, its directors, shareholders, officers, employees and Affiliates, harmless against all losses, damages, third party claims, proceedings, demands and liabilities, including reasonable legal expenses and attorneys’ fees (collectively, “Losses”) arising out of (i) the material breach of any of Manufacturer’s obligations, warranties and representations under this Agreement, or (ii) the death of or injury to any person or any damage to property, resulting from Manufacturer’s operations and provision of Manufacturing services, except to the extent such Losses are caused by Consumer’s gross negligence or willful misconduct or by Consumer’s breach of the Agreement.
9.2Consumer shall indemnify, defend and hold Manufacturer, its directors, officers, employees and Affiliates harmless against all Losses, arising out of (i) the material breach of any of Consumer’s obligations, warranties and representations under this Agreement, or (ii) the death of or injury to any person or any damage to property, resulting from side effects, characteristics or defects of the Finished Product, except to the extent such Losses are caused by Manufacturer’s negligence or willful misconduct, its breach of the Agreement.
9.3Consumer shall indemnify, defend and hold Manufacturer, its directors, officers, employees and Affiliates harmless against all Losses, arising out of any third party claims of patent infringement or other litigation involving the API, except to the extent such Losses are caused by Manufacturer’s negligence or willful misconduct.
9.4Except as expressly set forth in Sections 9.1 through 9.3, above, with respect to amounts payable to third parties, no Party shall be responsible to the other Party for such other Party’s lost profits or indirect, incidental, special, exemplary, punitive or consequential
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damages, including loss or damage to goodwill or reputation, whether foreseeable or not, that are in any way related to this Agreement.
9.5Upon the occurrence of an event that requires indemnification under this Agreement, the Party entitled to be indemnified (“Indemnified Party”) will give prompt written notice to the Party obligated to indemnify (“Indemnifying Party”) providing reasonable details of the nature of the event and basis of the indemnity claim.  The Indemnifying Party will then have the right, at its expense and with counsel of its choice, to defend, contest, or otherwise protect against any such action.  The Indemnified Party will also have the right, but not the obligation, to participate, at its own expense in the defense thereof with counsel of its choice.  The Indemnified Party shall cooperate to the extent reasonably necessary to assist the Indemnifying Party in defending, contesting or otherwise protesting against any action, provided that the reasonable cost in doing so will be paid by the Indemnifying Party.  If the Indemnifying Party fails within thirty (30) Business Days after receipt of notice to notify the Indemnified Party of its intent to defend, or to defend, contest or otherwise protect against the action or fails to diligently continue to provide the defense after undertaking to do so, the Indemnified Party will have the right upon ten (10) Business Days’ prior written notice to the Indemnifying Party to defend, settle and satisfy any action and recover the costs of the same from the Indemnifying Party.
9.6In the event that in determining the respective obligations of indemnification under this Section 9, it is found that the fault of the Indemnified Party or its respective Affiliates, contributes to any Losses for which the Indemnifying Party is otherwise liable hereunder, then each Party shall be responsible for that portion of the indemnifiable Losses to which its fault contributed.
9.7Without limiting its obligations hereunder, Consumer shall maintain, commencing with the Effective Date and continuing throughout the Term, sufficient product liability insurance coverage to satisfy its obligations hereunder.  Consumer shall, upon request, provide to Manufacturer certificates of insurance, evidencing such insurance.  Without limiting its obligations hereunder, Manufacturer shall maintain, commencing with the Effective Date and continuing throughout the Term, sufficient product liability insurance coverage to satisfy its obligations hereunder.  Manufacturer shall, upon request, provide to Consumer certificates of insurance, evidencing such insurance.
10.TERM AND TERMINATION
10.1This Agreement shall become effective upon the Effective Date and, unless earlier terminated as provided below, shall remain in full force and effect until the second (2nd) anniversary of the Effective Date (the “Initial Term”).  Thereafter, the Agreement will automatically be extended for successive one (1) year periods (each such period, a “Renewal Term”) unless notice is given six (6) months in advance by either Party of its intent not to renew.  The Initial Term together with all Renewal Terms shall be the “Term.”
10.2Consumer may, but is not required to, terminate the Agreement immediately by providing written notice to Manufacturer upon the occurrence of any of the following events:
10.2.1the liquidation or dissolution of Manufacturer,
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10.2.2The cessation of all or substantially all of Manufacturer’s business operations;
10.2.3The commencement by Manufacturer of insolvency proceedings, or the commencement against Manufacturer of insolvency proceedings that are not dismissed within sixty (60) days from the date of commencement;
10.2.4The failure of the Manufacturer to develop a manufacturing process generating API meeting the Specification.
10.3If a Party breaches a material term or condition of this Agreement, the non-breaching Party shall have the right to terminate this Agreement after thirty (30) days’ prior written notice to the other Party unless any such default or breach is cured within said thirty (30) days.  Termination for breach of a material item under this Section 10.3 shall be in addition to all other rights and remedies available to the non-breaching Party at law or in equity.
10.4Neither the expiration nor the termination of this Agreement shall relieve the Parties of their obligation incurred prior to such expiration or termination.  All provisions that, by their express or implied terms, are meant to survive termination of the Agreement shall continue irrespective of such termination.
10.5The Manufacturer may, but is not required to, terminate the Agreement immediately by providing written notice to the Consumer upon the occurrence of any of the following events:
10.5.1Failure by the Consumer to place any order of the API in a twelve month period.
10.5.2Failure by the Consumer to adhere to the payment terms as set out in Annex A.
11.FORCE MAJEURE
Except for the obligation of a Party to make payments to the other Party pursuant to this Agreement (which will not be deferred or extended for any reason), neither Manufacturer nor Consumer will be responsible to the other for any failure to perform or delay in performing if the failure or delay is due to any strike, riot, civil commotion, sabotage, act of terrorism, embargo, war or act of God or other cause beyond its reasonable control (“Force Majeure”).  Notwithstanding the foregoing, if any delay in the performance by either Party of its obligations under this Agreement shall continue for a period of four (4) months or more, then the Party not suffering the Force Majeure event may terminate this Agreement by written notice to the other Party and each of Manufacturer and Consumer shall be relieved from all duties and obligations under this Agreement, except those duties and obligations accruing prior to such termination.
12.CONFIDENTIALITY; INTELLECTUAL PROPERTY
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12.1In carrying out the terms of this Agreement it may be necessary that one Party disclose to the other certain information, which is considered by the disclosing Party to be proprietary and of a confidential nature.  As used herein “Confidential Information” means any and all information, including Intellectual Property that is disclosed under this Agreement as set forth below and that Consumer or Manufacturer, as the case may be, considers to be and treats as proprietary and confidential.  Confidential Information includes, but shall not be limited to Intellectual Property, plans, processes, compositions, formulations, specifications, samples, systems, techniques, analyses, production and quality control data, testing data, marketing and financial data, and such other information or data relating to any finished drug product or active pharmaceutical ingredient, or its Manufacture, marketing or sale.  Confidential Information also includes the existence and the terms of this Agreement or any license or arrangement with any Third Party Manufacturer or Third Party Seller.
12.2The recipient of any Confidential Information shall not use it for any purpose other than for purposes of performing its obligations under this Agreement.  The Party receiving any Confidential Information will divulge it only to those of its officers, shareholders, directors, employees, advisors, authorized Third Parties and Affiliates (and such Affiliates’ officers, directors, employees and advisors) who have a need to know it as a part of the receiving Party’s obligations hereunder and the receiving Party shall cause said officers, directors, employees, advisors, authorized Third Parties and Affiliates (and such Affiliates’ officers, directors, employees and advisors) shall hold the information in confidence pursuant to this Agreement.  The recipient of any Confidential Information shall not disclose it to any third party, except as otherwise contemplated in this subsection, without the written consent of the disclosing Party.
12.3The obligations of confidentiality and non-disclosure as provided herein will terminate seven (7) years from the expiration or termination of this Agreement; provided, however, that with respect to any Confidential Information constituting proprietary Intellectual Property such as trade secret and know-how, such obligations shall extent until such Confidential Information is made available to the public without restriction and without violating any confidentiality obligations hereunder or otherwise protecting the same.  This Section 12 will impose no obligation upon the recipient of any Confidential Information with respect to any portion of the received information that (a) was known to or in the possession of the recipient prior to the disclosure; or (b) is or becomes publicly known through no fault attributable to the recipient; or (c) is provided to the recipient from a source independent of the disclosing Party that is not subject to a confidential or fiduciary relationship with the disclosing Party concerning the information; or (d) is generated by the recipient independently of any disclosure from the disclosing Party; or (e) is required by law to be disclosed to government officials who shall be informed of the confidential nature of such information.
12.4Upon expiration or earlier termination of this Agreement, the recipient of any Confidential Information shall, as the disclosing Party may direct in writing, either destroy or return to the disclosing Party all Confidential Information disclosed together with all copies thereof, provided, however, the recipient may retain one archival copy thereof for the purpose of determining any continuing obligations of confidentiality, and provided further, however, that any archival copy will remain subject to the obligations of confidentiality and non-disclosure hereunder.
12.5Confidential Information disclosed hereunder shall remain the property of the disclosing Party.  Disclosure of Confidential Information shall not obligate either Party to
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enter into any future agreement relating to such Confidential Information, nor to undertake any other obligation not otherwise set forth in this Agreement.  Subject to the express provisions of this Agreement, neither execution and delivery of this Agreement nor delivery of Confidential Information hereunder shall constitute a grant, by implication, estoppel or otherwise, of any right in or license under any present or future invention, trade secret, trademark, copyright, or patent, now or hereafter owned or controlled by either Party.  This Agreement shall not be construed as a teaming, joint venture, or other similar arrangement.
12.6Manufacturer and Consumer shall respectively own the Manufacturer Pre-Existing Intellectual Property and Consumer Pre-Existing Intellectual Property.
12.7The terms of this Section 13 will survive termination of this Agreement.
13.GENERAL PROVISIONS
13.1Successors and Assigns.  This Agreement shall be binding upon each of the Parties and each of their respective successors and assigns, if any.
13.2Assignment.
13.2.1Except as provided in Section 13.2.2, neither Party may assign or otherwise transfer this Agreement, or any rights or obligations hereunder, by operation of law or otherwise, without the prior written consent of the other Party.
13.2.2Notwithstanding the foregoing:
a.either Party may, without the consent of but upon prior written notice to the other Party, assign this Agreement or its rights or obligations under this Agreement to an Affiliate; provided the assigning Party shall be responsible for such Affiliate’s compliance with the terms and conditions of this Agreement and primary obligor for all or any obligations and liabilities assigned to such Affiliate under the terms of this Agreement;
b.either Party may also make an assignment or transfer of this Agreement (in whole or in part) without the other Party’s prior written consent to (A) any successor to all or substantially all of the business and assets of such Party, whether in a merger, consolidation, sale of stock, sale of all or substantially all of its assets, or other similar transaction, provided that the assigning Party gives thirty (30) days’ prior written notice to the other Party, or (B) in connection with the sale or transfer of all or substantially all of the assets related to this Agreement by Consumer, provided that any such successor or assignee of rights and/or obligations under this subsection (B) shall, in a writing delivered to Manufacturer, expressly assume performance of such rights and/or obligations; and this Agreement shall be binding on, and inure to the benefit of, each Party hereto, its successors, and permitted assigns;
c.In addition, nothing in this Agreement shall preclude Consumer from providing its lenders with a security interest in its rights under this Agreement in accordance with the terms of their security and collateral agreements in connection with any credit facility provided by such lenders to Consumer or preclude such lenders from foreclosing upon such security interest
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in accordance with the terms of such security and collateral agreements (including, without limitation, by means of the sale of the assets or stock of Consumer to a third party including Consumer’s rights and responsibilities under this Agreement), and any such action by such lenders shall not be deemed to be a change of control for purposes of this Agreement; and
d.Consumer shall have the right, by written notice to Manufacturer from time to time, to designate any Affiliate of Consumer that shall be entitled to purchase API directly from Manufacturer pursuant to this Agreement, in which event such Affiliate shall, with respect to such individual orders of API, be deemed the “Consumer” and shall have all rights and obligations of Consumer hereunder.
13.3Notices.  Any notice, request, instruction or other communication required or permitted to be given under this Agreement must be in writing and must be given by sending the notice properly addressed to the other Party’s address shown below (or any other address as either Party may indicate by notice in writing to the other from time to time) (a) by hand or by prepaid registered or certified mail, return receipt requested, , or (b) via nationally recognized overnight courier.
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	If to Manufacturer:
	TopChem Pharmaceuticals Limited

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	Ballymote Business Park

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	Ballymote, County Sligo, F56 RX08

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	Republic of Ireland

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	Email: donal@topchempharma.com

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	with a copy to:
	margaret@topchempharma.com

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	If to Consumer:
	QUOIN PHARMACEUTICALS  

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	42127 Pleasant Forest
Ashburn, VA 20148. USA

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	Attn: Dr Michael Myers

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	Email: mmyers@quoinpharma.com

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	with a copy to:
	dcarter@quoinpharma.com

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All such notices shall be deemed given when received.
13.4Announcements.  Except to the extent required by law, neither Manufacturer nor Consumer will publish, disclose or otherwise announce the existence of this Agreement or the terms hereof without the consent of the other Party, which consent will not be unreasonably withheld; provided however that each of Manufacturer and Consumer may disclose the existence of this Agreement to its officers, shareholders, directors, employees, advisors, Third Party Manufacturers, Third Party Sellers and Affiliates (and such Affiliates’ officers, directors, employees and advisors) in accordance with Section 12.2.
13.5Waiver.  The failure of any Party to terminate or seek redress for a breach of, or to insist upon strict performance of any term, covenant, condition or provision contained
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in this Agreement will not be deemed to be a waiver by such Party of its right to the respective remedy or measure in the future.
13.6Governing Law.  This Agreement will be governed and construed in accordance with the laws of Ireland, except for its conflict of law provisions.  Manufacturer expressly agrees to consent to service of process and personal jurisdiction in all courts located in Ireland and to binding arbitration in Ireland.  Manufacturer also expressly agrees to recognize any final judgment or order stemming from a court or binding arbitration panel.  The Parties shall, before the commencement of any litigation or arbitration proceedings, attempt in good faith to settle their dispute by mediation.
13.7No Partnership of Joint Venture.  Manufacturer and Consumer will at all times act as independent parties without the right or authority to bind the other with respect to any agreement, representation or warranty made with or to any third party.  Except as otherwise stated herein, Manufacturer and Consumer each will be responsible for all costs, expenses, taxes and liabilities arising from the conduct of its own business, as well as from the activities of its officers, directors,  or employees, and each will hold harmless and indemnify the other from those obligations.
13.8Entire Agreement.  With the exception of the Quality Agreement agreed by Consumer and Manufacturer, this Agreement contains the entire and only agreement between the Parties with respect to the Manufacture and sale of the API and no oral statements or representations or written matter not contained in this Agreement will have any force or effect.  This Agreement may not be amended or modified in any way except by writing executed by authorized representatives of both Parties.
13.9Partial Invalidity.  If any portion of this Agreement is determined to be illegal or otherwise unenforceable, that portion, to the extent permitted by law, shall be treated as deleted from this Agreement and the remaining portions of this Agreement will continue to be in full force and effect according to the terms hereof.
13.10Counterparts.  This Agreement may be executed in one or more counterparts, each of which shall constitute an original and all of which, when taken together, shall constitute one agreement.
13.11Section Headings.  Section headings in this Agreement are intended solely for convenience of reference and shall be given no effect in the interpretation of this Agreement.
13.12Annexes and Schedules.  All annexes and schedules to this Agreement, signed by both Parties, whether attached at the time of signature hereof or at any time thereafter, shall be construed as an integral part of this Agreement.
13.13No License.  Except as expressly set forth in this Agreement, nothing herein shall be deemed to constitute a grant to either Party of any license or other right under patents, designs, copyrights or other industrial or intellectual property rights, now or hereafter belonging to the other Party.
[Signature Page to Follow.]
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IN WITNESS WHEREOF, the Parties have executed this Agreement on the date written at the beginning of this Agreement.
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	CONSUMER:
	MANUFACTURER:

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	QUOIN PHARMACEUTICALS LIMITED
	TOPCHEM PHARMACEUTICALS

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	LIMITED

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	By: /s/ Michael Myers
	By: /s/ Donal Coveney

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	Name: Michael Myers
	Name: Donal Coveney

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	Title: President & CEO
	Title: Managing Director

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TopChem Pharma Quoin Pharma Development & Supply Agreement

ANNEX A – SCOPE OF DEVELOPMENT & SUPPLY - API
The Manufacturer will develop a process for the manufacture of the API, analysis of the API and to supply [****].
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		1.
	Basis of Costing

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It is assumed that TopChem purifies commercially available non-GMP grade API via a crystallisation or other purification process. The process will NOT be validated. Analytical methods will be developed to assure the quality of the product. ICH standards will be adhered to in the development of the specification. All analytical methods will be qualified but NOT validated.
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		2.
	Development & Supply Summary & Costs

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The Project deliverables and costs are summarized as follows:
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		3.
	Process Development and Analytical Method Development. Cost €[****] (as detailed in Appendix 1)

		a.
	Deliverables: Develop purification process suitable for scale-up to GMP manufacture. Develop analytical methods and draft specification. Supply lab sample meeting specification.

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		4.
	Dedicated Capital Expenditure: Cost €[****] (as detailed in Appendix 2).

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		5.
	Scale-up, Clinical Trial Batch and Test Methods Qualification. Cost €[****] (as detailed in Appendix 3).

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		a.
	Based on [****] (Pre-validation).

		b.
	Deliverables: [****].

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		6.
	Payment Terms

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Credit terms are strictly 30 days and the following milestone payments apply:
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		1.
	Development – 50% up front, balance on delivery of stated deliverables.

		2.
	Capital - 50% up front, balance on completion of capital equipment qualification.

		3.
	Pre-Validation/Clinical Trial Batch - 50% up front, balance on shipping of the 1kg Clinical Trial Batch.

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VAT at 23% is chargeable to Irish registered customers unless the appropriate VAT exemption is provided. No VAT is chargeable to international customers.
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		7.
	Exclusions

The following are specifically excluded from the scope of this proposal:
​
		a.
	Analytical method validation

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TopChem Pharma Quoin Pharma Development & Supply Agreement

		b.
	Process Validation

		c.
	Stability studies

		d.
	Any additional analytical methods over and above Annex B Specifications as requested by Consumer or any regulatory authority.

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DETAILED COSTING in APPENDICES 1, 2, & 3 – following two pages
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TopChem Pharma Quoin Pharma Development & Supply Agreement

APPENDIX 1 – DEVELOPMENT PHASE ACTIVITIES AND COSTS
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[****]
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APPENDIX 2 – CAPITAL EXPENDITURE
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[****]
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TopChem Pharma Quoin Pharma Development & Supply Agreement

APPENDIX 3 – SCALE-UP, CLINICAL TRIAL BATCH & ANALYTICAL METHODS QUALIFICATION
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[****]
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TopChem Pharma Quoin Pharma Development & Supply Agreement

ANNEX B – SPECIFICATIONS
Appearance:[****]
Identification:[****]
Assay:[****]
Purity:[****]
Loss on Drying:[****]
Residual solvents:  [****]
Residue on Ignition:[****]
pH/acidity:[****]
Microbiological impurities: [****]

​Exhibit 4.39
MASTER SERVICE AGREEMENT
This Master Service Agreement, (“Master Agreement”) effective November 2, 2020 (“Effective Date”), is made by and between Therapeutics, Inc., a Delaware corporation with corporate offices located at 9025 Balboa Avenue, Suite 100, San Diego, CA 92123 (hereinafter “THERAPEUTICS” or “TI”) and Quoin Pharmaceuticals Ltd. with corporate offices located at 42127 Pleasant Forest Ct, Ashburn, VA 20148 (hereinafter “QUOIN”), singly referred to as a “Party” or collectively as the “Parties”.
WHEREAS, QUOIN and THERAPEUTICS desire to enter into this Master Agreement to provide the terms and conditions upon which QUOIN may engage THERAPEUTICS from time-to-time for the purpose of managing the preclinical and clinical development of its new products in the field of dermatology, and other related services or projects, by executing individual Work Orders (as defined below) specifying the details of the service and the related terms and conditions.
NOW THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged by each Party, and intending to be legally bound hereby, QUOIN and THERAPEUTICS agree as follows:
	1.
	Definitions

	(a)
	“Act” means the United States Federal Food, Drug, and Cosmetic Act.

	(b)
	“Active Pharmaceutical Ingredient” as used herein shall mean the active drug or biologic substance or substances contained in the Study Drug.

	(c)
	“FDA” as used herein shall mean the United States Food and Drug Administration.

	(d)
	“IND” as used herein shall mean an Investigational New Drug Application, as defined by the FDA.

	(e)
	“IRB” as used herein shall mean the board(s) established pursuant to 21 CFR Part 56 for the purpose of reviewing clinical investigations.

	(f)
	“Investigator(s)” as used herein shall mean a licensed physician or other licensed medical practitioner who is a qualified clinical investigator willing and able, and engaged to conduct a clinical investigation of the Study Drug as set forth in a Protocol.

	(g)
	“NDA/BLA” as used herein shall mean a New Drug Application or Biologic License Application, respectively, as defined by the FDA, or foreign equivalent.

	(h)
	“Project” as used herein shall mean those specific composite goals, objectives, activities, times, durations, costs and responsibilities described in a Work Order.

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	(i)
	“Protocol” as used herein shall mean particular preclinical or clinical testing procedures and conditions for the clinical evaluation of the Study Drug used from time to time, during the Term (as defined in Section 3(a)).

	(j)
	“Services” as used herein shall mean the services to be provided to QUOIN by THERAPEUTICS pursuant to a Work Order (as defined in Section 2).

	(k)
	“Study” as used herein shall mean the preclinical or clinical research described in a Protocol for which THERAPEUTICS is engaged by QUOIN to perform Services as described on a Work Order.

	(l)
	“Study Drug” as used herein shall be defined in a Work Order and shall mean the drug, biologic, or similar product including any and all of its components, and including related test articles being tested in a Study for which THERAPEUTICS is providing Services as described in a Protocol or product development plan.

	(m)
	Additional terms and conditions are defined in the section indicated in the table below:

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	Defined Term
	Section

	Change Order
	Section 2(b)

	Claims
	Section 11(a)

	Confidential Information
	Section 6(a)

	Discloser
	Section 6(a)

	Initial Term
	Section 3(a)

	QUOIN Indemnitees
	Section 11(a)

	Recipient
	Section 6(a)

	Subsequent Term
	Section 3(a)

	THERAPEUTICS Indemnitees
	Section 11(a)

	Third Party
	Section 11(e)

	Work Order
	Section 2(a)

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	2.
	Work Orders, Nature of Work

	(a)
	Work Orders  The details of each Project under this Master Agreement shall be separately specified in writing in a work order signed by each Party (together with any Change Order with respect thereto, a “Work Order”).  Each Work Order will include, as applicable, the Protocol title or project description, a description of the Services to be performed by THERAPEUTICS, the specifications of the applicable Study Drug including the Active Pharmaceutical Ingredient, the estimated timeline, budget and payment schedule and such other terms as shall be agreed upon by the Parties.  The terms of this Master Agreement shall be automatically incorporated into the terms of any Work Order.  This Master Agreement and each Work Order, independent from other Work Orders, constitute the entire agreement for a Project.  To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this Master Agreement, the terms and provisions of this Master Agreement shall control, unless otherwise expressly set forth in the Work Order.

​

	(b)
	Change Orders  Any material change in a Work Order shall require execution of an amendment to the Work Order (a “Change Order”).  Each Change Order shall set forth the changes to the applicable task, responsibility, duty, budget, timeline or other matters.  A Change Order will only become effective upon the execution of the Change Order by both Parties.

	(c)
	Transfer of Obligations  Notwithstanding any other provision of this Master Agreement, and in addition to any other specific responsibilities of THERAPEUTICS which are set forth herein, pursuant to 21 CFR Part 312.52, QUOIN may, from time to time, transfer to THERAPEUTICS, and if it so agrees THERAPEUTICS may assume, all or some of the specific obligations of QUOIN as '‘Sponsor” under the Act.  A description of such obligations to be transferred to THERAPEUTICS will be provided in each Work Order.  It is agreed that the same description and extent of obligations transferred will be included in Section #13 of any applicable INDs filed on Form FDA 1571.  THERAPEUTICS agrees to cany out diligently all transferred obligations that it agrees to assume.

	(d)
	Performance of Services  THERAPEUTICS agrees to use reasonable efforts to diligently perform, and to cause its employees, officers, permitted subcontractors and representatives to diligently perform the Services in accordance with the terms and conditions of this Master Agreement and each Work Order and with the standard of care customary in the contract research organization industry.  Such efforts may include, without limitation, implementing reasonable procedures such as bonuses and other incentives for timely completion of the Services.  EXCEPT AS SET FORTH IN THIS SECTION 2(d) OR ELSEWHERE IN THIS MASTER AGREEMENT, THERAPEUTICS MAKES NO OTHER COVENANTS, REPRESENTATIONS OR WARRANTIES WITH RESPECT TO THE SERVICES, EXPRESS OR IMPLIED, AND THERAPEUTICS SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE SERVICES TO BE PROVIDED HEREUNDER.

	3.
	Term and Termination

	(a)
	This Master Agreement shall commence on the Effective Date and shall have an initial term of three (3) years (the “Initial Term”), unless earlier terminated as provided herein.  The Initial Term will be automatically renewed for additional one (1) year terms (“Subsequent Term(s)”).  The Initial Term and any Subsequent Terms shall be referred to collectively as the “Term”.

	(b)
	QUOIN may terminate this Master Agreement for any reason upon ninety (90) days prior written notice to THERAPEUTICS.

	(c)
	Either Party may terminate any Work Order and this Master Agreement as it applies to such Work Order, upon written notice to the other Party, if the other Party materially breaches such Work Order and this Master Agreement as it applies to such Work Order.  Both Parties agree to allow the breaching Party a reasonable time, but not more than ninety (90) days, to use reasonable efforts to correct such a breach (other than a breach of payment obligations, as to which this sentence and the next sentence do not apply) and provide

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reasonably satisfactory evidence of corrective actions in a timely manner.  Failure to cure such a breach within such 90-day period shall entitle the non-breaching Party to terminate the applicable Work Order and this Master Agreement as it applies to such Work Order, immediately by written notice to the breaching Party.  In case of any breach in a payment obligation under a Work Order, the non-breaching Party shall be entitled to terminate that Work Order and this Master Agreement as it applies to such Work Order, effective upon the expiration of five (5) business days after notice of such breach from the non-breaching Party to the breaching Party, if the breaching Party fails to cure the breach of such payment obligation within such five (5) business day period.
	(d)
	QUOIN may terminate any Work Order for any reason upon ninety (90) days prior written notice to THERAPEUTICS, subject to Section 3(h).

	(e)
	If either Party believes termination of any Work Order is necessary to protect the safety or welfare of the Study subjects, then such Party shall have the right to terminate the applicable Work Order upon written notice to the other Party; provided, however, that after receipt of such notice of termination, the Parties shall commence any wind-down activities for any on-going Study for which the Parties have any responsibility hereunder in which any Study subject dosing has commenced.  QUOIN shall be responsible for any costs associated with such wind-down activities.

	(f)
	In the event of termination of this Master Agreement or any Work Order, QUOIN and THERAPEUTICS agree to discuss, cooperate and coordinate termination of activities being conducted by THERAPEUTICS.  As soon as reasonably possible after receipt of any written termination notice by either Party, THERAPEUTICS will use commercially reasonable efforts to stop initiation of any tasks or activities not yet started as of the date of termination notice, whether to be conducted by THERAPEUTICS or a third party, unless another plan of termination is agreed to by both Parties.  However, both Parties acknowledge non-cancelable costs may exist and will require payment as detailed in Section 3(h).  In all cases of termination, a reasonable plan of action for cessation of activities will be agreed to by both Parties (such agreement not to be unreasonably conditioned, delayed or withheld) in order to ensure an orderly cessation of on-going tasks and activities and in order to protect the safety and rights of patients, as well as to facilitate compliance with the legal responsibilities of all Parties involved according to applicable local, federal and/or state laws, regulations and ordinances.  THERAPEUTICS will use commercially reasonable efforts to terminate all Work Order associated tasks according to the plan so agreed to by both Parties.

	(g)
	Upon termination of this Master Agreement or any Work Order, THERAPEUTICS will, at QUOIN’s written request, promptly provide QUOIN with a copy of all records relating to Project performance and all periodic reports and/or patient records, maintaining confidentiality.

	(h)
	Should QUOIN choose to terminate a Work Order prior to completion for any reason other than THERAPEUTICS’ material breach of this Master Agreement or any Work Order or THERAPEUTICS’ insolvency or bankruptcy, QUOIN agrees to pay THERAPEUTICS:

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		(i)
	all reasonable direct fees, including monthly fees for project management, medical monitoring, transfer of records or similar fees earned hereunder for Services performed up to the effective date of termination in accordance with the terms of the Work Order being terminated;

		(ii)
	all non-cancelable costs for third party contracted Services and other expenses, including THERAPEUTICS’s related administrative fees, incurred in connection with any Work Order being terminated to the date of termination; and

		(iii)
	a separate termination fee equal to 10% of the remaining clinical Study Work Order budget,

	(i)
	In the event a Work Order is terminated by QUOIN before conclusion by reason of any uncured material breach by THERAPEUTICS pursuant to Section 3(c) above, any third-party pass-through costs associated with terminating the Work Order, e.g. laboratory costs, etc. will be:

		(i)
	borne by THERAPEUTICS if attributable to THERAPEUTICS’s material breach of its obligations under the Master Agreement or Work Order and previously paid to THERAPEUTICS;

		(ii)
	borne by QUOIN if not previously paid to THERAPEUTICS; or

		(iii)
	borne by and as between QUOIN and THERAPEUTICS as they agree (such agreement not to be unreasonably conditioned, delayed or withheld) if neither of the above (i) and (ii) applies,

	(j)
	Sections 3(f, g, h, and i), 5(b), 6, 7, 8, 10, 11, 12, 13, 15, 16(c), 24, 25 and 27 shall survive any expiration or termination of this Master Agreement to the extent of the terms detailed in each respective Section.

	4.
	Work Order Compensation

	(a)
	Unless otherwise provided for and agreed to in a particular Work Order, the following shall apply with respect to all payments by QUOIN for Services under a Work Order:

		(i)
	THERAPEUTICS will be compensated for its Services, itemized expenses, and pass- through costs, net of discounts, incurred in the performance of the Services pursuant to the budget and payment schedule set forth in each respective Work Order.

		(ii)
	All income related taxes (and penalties thereon) imposed by the United States or any state or locality of the United States on any payment by QUOIN to THERAPEUTICS shall be the responsibility of THERAPEUTICS.  With respect to any other taxes imposed on THERAPEUTICS or required to be withheld by QUOIN from any amount payable to THERAPEUTICS under this Master Agreement or any Work Order (“Other Taxes”), in addition to all other amounts payable to THERAPEUTICS under this Master Agreement or any Work Order,

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QUOIN shall pay to THERAPEUTICS the amount necessary so that THERAPEUTICS will have received all amounts so payable to THERAPEUTICS as if no Other Taxes were imposed on THERAPEUTICS or required to be so withheld from any amount payable to THERAPEUTICS.
		(iii)
	THERAPEUTICS will submit monthly invoices to QUOIN which shall contain sufficient itemizations for fees, expenses and pass-through costs related to a Work Order.

		(iv)
	THERAPEUTICS will invoice QUOIN promptly upon achievement of agreed to milestones (if other than monthly), as set forth in the applicable Work Order, for payment of Services.

		(v)
	Invoices shall be payable in U.S. dollars by QUOIN within thirty (30) days from the date of the invoice (late payments will incur interest at a rate equal to 1.5% for each 30 day period, or part thereof, an invoice remains unpaid after the due date).

	(b)
	If any portion of an invoice is disputed, then QUOIN shall notify THERAPEUTICS in writing and shall pay the undisputed amounts in compliance with Section 4(a)(v) and the Parties shall use good faith efforts to reconcile the disputed amount as soon as practicable.  THERAPEUTICS shall maintain adequate accounting records for all receipts and disbursements of supplies and monies directly related to any Work Order.  QUOIN shall be permitted to audit these records, at QUOIN’s expense, during normal business hours upon reasonable notice to THERAPEUTICS.  THERAPEUTICS will be reimbursed for reasonable expenses, including related labor expenses related to all audit activities.

	(c)
	It is the Parties’ expectation that the budget for any Work Order relating to Services to be provided by THERAPEUTICS will be negotiated by the Parties prior to submitting a formal Work Order for Services.

	5.
	Personnel

	(a)
	The Services with respect to each Project shall be performed by THERAPEUTICS under the direction of a Project Manager.  Subject to the terms and conditions of any Work Order and this Master Agreement as it applies thereto, THERAPEUTICS will perform its Services in a professional and timely manner and will ensure that the personnel or subcontractors it uses to perform the Services are appropriately trained and qualified.  QUOIN shall be entitled in good faith to request that the Project Manager be removed and replaced with a new Project Manager, and THERAPEUTICS shall make reasonable efforts to honor such request.  QUOIN shall, upon request, be entitled to review credentials of all other personnel providing Services as per the Work Order and in good faith may request that any staff member be replaced and THERAPEUTICS shall make reasonable efforts to honor such request.

(a)NON - SOLICITATION
		(i)
	Non-solicitation by QUOIN - QUOIN agrees that during the Term of this Master Agreement, and for a period of two (2) years after the termination of this Master

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Agreement, QUOIN will not directly or indirectly solicit any personnel of THERAPEUTICS or its then current contractors to leave the service of THERAPEUTICS or any such contractor to become employed by QUOIN.
		(ii)
	Non-solicitation by THERAPEUTICS - THERAPEUTICS agrees that during the Term of this Master Agreement, and for a period of two (2) years after the termination of the Master Agreement, THERAPEUTICS will not directly or indirectly solicit any personnel of QUOIN to leave the service of QUOIN to become employed by THERAPEUTICS.

		(iii)
	Enforceability - The provisions of this Non-Solicitation Section shall be construed as enforceable in both law and equity, including by temporary or permanent restraining orders, notwithstanding the existence of any claim or cause of action by either Party against the other Party whether predicated on this Master Agreement or otherwise.

	6.
	Confidentiality

	(a)
	Any confidential and proprietary information (“Confidential Information”) of a Party (“Discloser”) acquired by the other Party (“Recipient”) under this Master Agreement or any Work Order, including, without limitation, the results of any Study or Project, shall not be disclosed to any third party who does not have a need to know such Confidential Information for purposes of performing Recipient’s obligations under this Master Agreement or any Work Order, without the prior written authorization from Discloser.  Recipient shall use the Confidential Information only for the purpose of fulfilling its obligations under this Master Agreement or any Work Order.  Recipient represents and warrants that it has obtained or will obtain agreements with its employees and agents (including subcontractors) to maintain the confidentiality of all Confidential Information as provided herein.

	(b)
	The obligations of Recipient with regard to Confidential Information shall continue for a period of seven (7) years from the date that such Confidential Information is acquired by Recipient.

	(c)
	The obligations of Recipient regarding the confidentiality and nondisclosure of Confidential Information as provided in this section shall not apply to information that:

		(i)
	is already known to Recipient without prior disclosure from Discloser, as shown by Recipient’s prior written records;

		(ii)
	Recipient can demonstrate by written records was developed for or by Recipient, independent of any Confidential Information of the Discloser;

		(iii)
	becomes publicly available through no fault of Recipient;

		(iv)
	is received from a third party that has the legal right to disclose it to Recipient; or

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		(v)
	is required by law to be disclosed; provided that Recipient notifies Discloser in writing of its intention to disclose Confidential Information with sufficient time to allow Discloser to seek a protective order or file an application for confidential treatment as may be permissible.

	(d)
	Recipient acknowledges that the disclosure of Confidential Information without Discloser’s express permission may cause Discloser irreparable harm and that the breach or threatened breach of nondisclosure provisions of this Master Agreement may entitle Discloser to seek injunctive relief, in addition to any other legal remedies that may be available.

	7.
	Ownership and Inventions

	(a)
	THERAPEUTICS shall have no claim to any materials, documents and information, programs and suggestions of every kind and descriptions evidencing Confidential Information of QUOIN that may be provided by QUOIN to THERAPEUTICS, and THERAPEUTICS hereby assigns to QUOIN all data or reports resulting from any Study or prepared by THERAPEUTICS in connection with the Services performed hereunder,.

	(b)
	THERAPEUTICS shall retain and preserve one (1) copy only of all materials, documents and information, program and suggestions provided by QUOIN to THERAPEUTICS and all data and reports resulting from Services performed hereunder for a period of two (2) years after the NDA has been approved by the FDA or a Project has been discontinued.  At the end of such two (2) year period, THERAPEUTICS shall give QUOIN written notice of its intent to destroy any of such material at least thirty (30) days prior to destruction.  If QUOIN requests such material, THERAPEUTICS shall provide such material to QUOIN at QUOIN’S expense.  Failure of QUOIN to request such material or to respond to such notice within the thirty (30) day period shall constitute QUOIN’s acquiescence to the destruction of such material.

	(c)
	THERAPEUTICS hereby assigns to QUOIN any and all right, title and interest that THERAPEUTICS may have in any discoveries or inventions by THERAPEUTICS directly arising from the Services provided to QUOIN pursuant to this Master Agreement and/or Work Order that are directly related to the Active Pharmaceutical Ingredient, regardless of inventorship, unless otherwise agreed to by the Parties.  THERAPEUTICS will promptly disclose in writing to QUOIN or its nominee any and all such inventions and discoveries of which THERAPEUTICS becomes aware.  Whenever requested to do so by QUOIN, THERAPEUTICS will execute any and all applications, assignments or other instruments and give testimony reasonably necessary for QUOIN to apply for and obtain patent letters in the United States or any foreign country or to otherwise protect QUOIN’s interests, therein, at QUOIN’s sole cost and expense, including the payment of THERAPEUTICS’ standard rates thereof.  These obligations shall continue beyond the termination of this Master Agreement for a period of one (1) year and shall be binding upon THERAPEUTICS’ successors, assignees, administrators and legal representatives.

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	8.
	Access to Records

THERAPEUTICS will permit representatives of QUOIN and/or any authorized regulatory authorities to have access at reasonable times to THERAPEUTICS’s premises for the purpose of observing performance of the Services and/or reviewing resulting data.
	9.
	Adverse Experience Reporting

Pursuant to any Protocol attached to any Work Order, THERAPEUTICS agrees throughout the duration of this Master Agreement, to promptly notify QUOIN of any information concerning any serious or unexpected event or injury, and the severity thereof, associated with the clinical uses, studies, investigations or tests, whether or not determined to be attributable to any Study Drug.
	10.
	Publications

Project results may not be published or publicly disclosed, in whole or in part, by THERAPEUTICS or its affiliates without the prior express written consent of QUOIN.
	11.
	Indemnification

	(a)
	QUOIN agrees to indemnify, defend and hold harmless THERAPEUTICS, its respective officers, trustees, affiliates, agents, servants, employees and successors and (hereafter collectively referred to as “THERAPEUTICS Indemnitees”) from and against any and all losses, costs (including the reasonable costs of providing medical care), expenses (including reasonable attorneys’ fees and charges), claims, actions, liability and/or suits (collectively, “Claims”) by a Third Party (as defined in subsection (e) below) suffered or incurred by a THERAPEUTICS Indemnitee as a result of (i) bodily injury to a patient or Study-related personnel in any Study being conducted pursuant to this Master Agreement or any Work Order directly or indirectly caused by administration of a Study Drag or any procedure under the Protocol or (ii) QUOIN’s gross negligence or any intentional or reckless misconduct by QUOIN, except to the extent that any such Claims are caused by the gross negligence or intentional or reckless misconduct of any THERAPEUTICS Indemnitee.

QUOIN shall further indemnify, defend and hold harmless the THERAPEUTICS Indemnitees from any Claim by a Third Party In contract or tort (including strict liability claims) or based on any other legal theory that relate to the safety or efficacy of the Active Pharmaceutical Ingredient or any component of the Study Drug.
	(b)
	THERAPEUTICS agrees to provide QUOIN with prompt notice of any such Third-Party Claim.  In the event the aforesaid indemnity is invoked, QUOIN shall have the right, but not the obligation, to manage and control the defense and settlement of any and all such actions and lawsuits, and shall have the right to select and engage counsel of its own choice.  THERAPEUTICS shall cooperate reasonably with QUOIN in the defense of any and all actions and lawsuits.  No THERAPEUTICS Indemnitee shall be entitled to compromise or settle any such Third-Party Claim without prior written approval of QUOIN (such approval not to be unreasonably conditioned, delayed or withheld)-

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	(c)
	THERAPEUTICS agrees to indemnify, defend and hold harmless QUOIN, its parents, subsidiaries and affiliates, as well as the officers, directors, employees and agents of each (hereafter collectively referred to as “QUOIN Indemnitees”) against and in respect of any and all Third Party Claims suffered or incurred by any QUOIN Indemnitee resulting from THERAPEUTICS’s gross negligence or intentional or reckless misconduct.

	(d)
	QUOIN agrees to provide THERAPEUTICS with prompt notice of any such Third-Party Claims.  In the event the aforesaid indemnity is invoked, THERAPEUTICS shall have the right, but not the obligation, to manage and control the defense and settlement of any and all such actions and lawsuits, and shall have the right to select and engage counsel of its own choice.  QUOIN shall cooperate reasonably with THERAPEUTICS in the defense of any and all actions and lawsuits.  No QUOIN Indemnitee shall be entitled to compromise or settle any such Third-Party Claim without prior written approval of THERAPEUTICS (such approval not to be unreasonably conditioned, delayed or withheld).

	(e)
	For purposes of these Indemnification provisions, “Third Party” shall mean any person or entity which is neither a Party to this Agreement nor an affiliate of a Party.  For purposes of these Indemnification provisions, an “affiliate” shall mean any person or entity who directly or indirectly controls, is controlled by or is under common control with a Party to this Agreement by means of at least fifty (50%) percent ownership or more of the voting stock or similar interest.  For purposes of this definition, “control,” “controls” or “controlled” means ownership directly or through one or more Affiliates, of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interests in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby a Party appoints or elects or has the right to appoint or elect the majority of the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity.  The Parties acknowledge that in the case of certain entities organized under the laws of certain countries outside of the United States, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and that in such case such lower percentage shall be substituted in the preceding sentence; provided that such foreign investor has the power to direct the management and policies of such entity.

	12.
	Force Majeure and Delays

In the event either Party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, inability to procure materials, failure of power or restrictive government or judicial orders, or decrees, riots, insurrection, war, acts of terrorism, acts of God, inclement weather or other similar reason or cause beyond that Party’s control (not including the inability of a Party’s software to perform data-dependent calculations properly), then performance of such act (except for the payment of money owed) shall be excused for the period of such delay; provided, however, if such delay continues in excess of eight (8) weeks, either Party may terminate the affected Work Order(s) without penalty under any Work Order, except that QUOIN shall be obligated to pay THERAPEUTICS (a) all reasonable direct fees earned under this Master Agreement or the terminated Work Order(s) up to the effective
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date of termination in accordance with the terms of the terminated Work Order(s), as described in subsection (i) of Section 3(h), and (b) all non-cancelable costs incurred in connection with the terminated Work Order(s) to the date of termination, as described in subsection (ii) of Section 3(h).
	13.
	Notices

Whenever any notice is to be given pursuant to this Master Agreement, it must be in writing using postage prepaid first-class certified mail with return receipt requested, delivery prepaid nationally recognized overnight carrier, or facsimile to the addresses set forth below:
		THERAPEUTICS:
	Therapeutics, Inc.
9025 Balboa Avenue, Suite 100
San Diego, CA 92123
Attn:  Daniel J. Piacquadio, M.D., President and CEO

		QUOIN:
	Quoin Pharmaceuticals Ltd.
42127 Pleasant Forest Ct
Ashburn, VA 20148
Attn:  Michael Myers, Ph.D., Chairman & CEO

Such notice shall be effective five days after deposit if sent by mail, the next business day if sent by overnight carrier and upon receipt of electronic confirmation of delivery if sent by facsimile.
	14.
	Legal Compliance

THERAPEUTICS shall perform all work under this Master Agreement and any Work Order in conformity in all material respects with all applicable federal, state and local laws and regulations including but not limited to the Act and the regulations promulgated pursuant thereto, as amended from time to time.  For purposes of QUOIN providing the FDA with certification pursuant to Section 306(k) of the Act, THERAPEUTICS warrants that no person working under the supervision of THERAPEUTICS that will be performing Services pursuant to this Master Agreement or any Work Order has been debarred or convicted of crimes pursuant to Sections 306(a) and (b) of the Act and under the U.S. Generic Drug Enforcement Act of 1992, 21 U.S.C. §§335(a) and (b), as amended.  THERAPEUTICS agrees to notify QUOIN as soon as practicable upon THERAPEUTICS’ learning of the occurrence of any such debarment, conviction, or inquiry relating to a potential debarment, of any person performing Services pursuant to this Master Agreement or any Work Order and agrees that said person shall be immediately prohibited from performing Services under this Master Agreement or any Work Order.
QUOIN covenants and represents that it shall not request THERAPEUTICS to perform assignments or tasks that violate any applicable law or regulation.
	15.
	Regulatory Inspections

	(a)
	Responsibilities of THERAPEUTICS:  If any governmental or regulatory authority conducts or gives notice to THERAPEUTICS of its intent to conduct an inspection of THERAPEUTICS or any study site or take any other regulatory action with respect to the Services provided under this Master Agreement or any Work Order, THERAPEUTICS

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shall (a) cooperate with QUOIN and reasonably act to obtain the cooperation of any Investigator(s); (b) provide QUOIN prior notice of any inspection or other regulatory action; and (c) allow QUOIN the right to be present at any such inspection at THERAPEUTICS.  QUOIN shall have primary responsibility of preparing and THERAPEUTICS shall cooperate in the preparation of any responses which may be required by any governmental or regulatory authority with regard to any such inspection or regulatory action, and any required follow-up actions.  QUOIN shall have the sole opportunity to challenge any order of a regulatory or governmental activity affecting its IND, NDA or any Project.  If THERAPEUTICS has attempted to comply with the provisions of this Section 15 but is nevertheless required by a governmental or regulatory authority to comply with its demand or request, then compliance by THERAPEUTICS shall not cause a breach of this Master Agreement.  THERAPEUTICS will be reimbursed reasonable expenses by QUOIN, including daily labor rate expenses related to all regulatory inspections.
	(b)
	THERAPEUTICS Support of Study Site for Audit:  In the event that a clinical site is notified by any governmental or regulatory authority of an inspection or audit of a study under any prior completed or current Work Order, upon QUOIN’s consent, THERAPEUTICS will provide audit assistance to that site in preparation for the inspection.  THERAPEUTICS will be reimbursed for reasonable expenses, including travel reimbursement and labor expenses at daily rates, related to all regulatory inspections.  Inspection/audit fees charged by the sites will be billed directly to QUOIN, if applicable.

	16.
	Insurance

	(a)
	THERAPEUTICS and QUOIN each represents that it maintains and will continue in force during the Term of this Master Agreement, at its sole cost and expense, the minimum insurance coverage listed below.  Each Party shall provide to the other certificates of insurance evidencing the insurance required hereunder and will provide prompt written notice to the other Party prior to any cancellation of such coverage or material change in such coverage.

		(i)
	Comprehensive automobile liability insurance for vehicles furnished by such Party or used by such Party in the performance of this Master Agreement or any Work Order with bodily injury and property damage limits of at least $1,000,000 each occurrence, combined single limit;

		(ii)
	Commercial general liability insurance with bodily injury and property damage minimum limits of $1,000,000 each occurrence, with an aggregate combined single limit of at least $2,000,000;

		(iii)
	Excess liability insurance with minimum limits of $1,000,000 per occurrence/aggregate combined single limit which shall be excess of the coverage described in Section 16(a)(i) and Section 16(a)(ii) above; and

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		(iv)
	With respect to QUOIN only, product and clinical trials liability insurance in the amount of at least $5,000,000 combined single limit with the obligation to continue for a minimum of three (3) years beyond the termination of the Study.

	(b)
	To the extent permitted by law, the insurance set forth above as well as any other coverage agreed to be purchased hereunder shall contain waivers of subrogation and/or rights of recovery as to claims against the other Party.  This waiver shall not apply if the responsible Party was grossly negligent.

	(c)
	THERAPEUTICS shall be identified as an additional insured under QUOIN’s product and clinical trials liability insurance described in Section 16(a)(iv) above.

	(d)
	THERAPEUTICS and QUOIN agree that with regard to this Master Agreement, the insurance coverage to be provided hereunder shall be considered as primary insurance and not contributory with any similar instance which the other Party and/or its employees and agents may maintain on their own behalf.

	17.
	Assignment

Other than to a successor to all or substantially all its assets, this Master Agreement and each Work Order may not be assigned by either Party without the other Party’s prior written consent, which consent shall not be unreasonably conditioned, delayed or withheld.
	18.
	Independent Contractors

For purpose of this Master Agreement, the relationship between the Parties is that of an independent contractor and neither Party shall have the authority to bind or act on behalf of the other Party without its prior written consent.  Nothing contained in the Master Agreement shall be construed to create the relationship of principal and agent or employer and employee between QUOIN and THERAPEUTICS, or their respective employees, servants, agents or independent contractors.
	19.
	Relationship with Investigators

If a particular Work Order obligates THERAPEUTICS to contract with an Investigators) or investigative site, then any such contract shall be on a form mutually acceptable to THERAPEUTICS and QUOIN, and any material changes to such form shall require prior written approval by QUOIN.  QUOIN will be responsible for promptly reviewing, commenting on and/or approving such form contracts and proposed changes.
	20.
	Advertising

THERAPEUTICS shall not issue any information or statement to the press or public relating to the results of any Study without the prior written consent of QUOIN.  Neither Party shall use the name or trademarks of the other Party in any announcement, publication or promotional material or in any form of public distribution, including file Party’s website or any social networking media without the prior written consent of the other Party except as required by applicable law, any court or administrative order or any Work Order.
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Notwithstanding the foregoing provisions of this Section 20, THERAPEUTICS shall have the right to include the name of QUOIN in any listing of clients, the type of services provided and the respective fees charged or forecasted to be charged for the sole purpose of providing such information to board members, financial institutions, accounting firms and prospective equity or debt investors in THERAPEUTICS.
21.Mutual Representations
Each Party represents that:  (a) it has the right and authority to enter into this Master Agreement and to perform its obligations hereunder and required pursuant to each Work Order; (b) the person executing this Master Agreement has the authority to do so; and (c) it is not a party to any existing agreement or arrangement that would prevent it from entering into this Master Agreement or would adversely affect its performance under this Master Agreement.  These representations will also apply with respect to the execution of each Work Order by such Party.
22.Severability
If any provision of this Master Agreement or any Work Order shall be deemed void in whole or in part for any reason whatsoever, the remaining provisions shall remain in full force and effect.
23.Estoppel
The waiver or forbearance by either Party or the failure by either Party to claim a breach of any provision of this Master Agreement or any Work Order shall not be deemed to constitute a waiver or estoppel with respect to any subsequent breach or with respect to any provision thereof.
24.Applicable Law
This Master Agreement shall be governed by and construed in accordance with the laws of the State of California, without regard to the conflicts of law principles thereof.  Each Party hereby irrevocably consents to submit to the exclusive jurisdiction of the state and federal courts located in Cook County, Illinois relating to any claim, dispute or disagreement arising out or in any way related to this Master Agreement or the legal relationships established herein or any Work Order, and each Party consents to the personal jurisdiction of such courts.
25.Descriptive Heading
The descriptive heading of the Master Agreement sections are inserted for convenience only and shall not control or affect the meaning or construction of any provision hereof.
26.Binding Effect
The Master Agreement shall be binding upon and inure to the benefit of the Parties hereto and their successors and assigns.
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27.Entire Understanding
This Master Agreement and each Work Order represents the entire understanding of the Parties with respect to the subject matter hereof.  Any modification to this Master Agreement or any Work Order must be in writing and signed by both Parties.
28.Multiple Counterparts
This Master Agreement may be executed in multiple counterparts, each of which shall be deemed an original and all of which, taken together, shall constitute one and the same instrument.  In the event that any signature is delivered by facsimile transmission or by e-mail delivery of a “.pdf' format data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile or “.pdf' signature page were an original thereof.
IN WITNESS WHEREOF, the Parties hereto have executed this Master Agreement as of the Effective Date.
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	THERAPEUTICS, INC.
	    
	QUOIN PHARMACEUTICALS LTD.

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	By:
	/s/ Daniel J. Piacquadio
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	By:
	/s/ Michael Myers

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	Name:
	Daniel J. Piacquadio, M.D.
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	Name:
	Michael Myers, Ph.D.

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	Title:
	President and CEO
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	Title:
	Chairman & CEO

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