Document:

Exhibit
10.55

 

 

September
20, 2021

 

Lannett
Company, Inc.

9000
State Road

Philadelphia,
PA 19136

 

Re:
Letter of Agreement between Elite Pharmaceuticals, Inc. and Lannett Company, Inc. (“Amphetamine Renewal Letter”)

 

Mr.
Block,

 

Lannett
Company, Inc., a Delaware corporation located at 9000 State Road, Philadelphia, PA 19136 and/or its Affiliates (“Lannett”),
and Elite Pharmaceuticals, Inc. a Nevada corporation and Elite Laboratories, Inc. a Delaware corporation (a subsidiary of Elite Pharmaceuticals,
Inc.), located at 165 Ludlow Avenue, Northvale, NJ 07647 (together “Elite”) are parties to a License, Supply and Distribution
Agreement for Mixed Salts for Single Entity Amphetamine Tablets and Mixed Salts for Single Entity Amphetamine Extended Release Capsules
effective as of March 6, 2019 (“Amphetamines Agreement”). Under the Agreement, Elite granted the right to Lannett to sell
and distribute the Mixed Salts for Single Entity Amphetamine Tablets and Mixed Salts for Single Entity Amphetamine Extended Release Capsules
(“Amphetamines”). All capitalized terms used without definition in this Amphetamine Renewal Letter shall have the meanings
provided in the Amphetamines Agreement.

 

Effective
as of the date of execution of this Amphetamine Renewal Letter, the parties agree to the following:

 

Per
Section 8.1 of the Amphetamine Agreement, Elite and Lannett agree to extend the Term of the Amphetamine Agreement for two (2) years.
The Initial Term is for three (3) years, from the Effective Date of March 6, 2019 until March 5, 2022. The First Renewal Term mutually
agreed upon with this letter shall be from March 6, 2022 until March 5, 2024. All terms and conditions of the Amphetamine Agreement shall
remain in full force and effect.

 

If
the foregoing correctly sets forth our agreement and understanding, please execute the enclosed counterpart of this letter agreement
and return the executed counterpart to the undersigned at your convenience.

 

- SIGNATURE
PAGE FOLLOWS -

 

    	1

    	 

    

 

	ELITE
    PHARMACEUTICALS, INC.	 
	 	                               	 
	By	/s/ Nasrat
    Hakim	 
	Name:	Nasrat
    Hakim	 
	Title:	CEO	 

 

Accepted
and agreed as of this September 20, 2021

 

	LANNETT
    COMPANY, INC.	 
	 	 	 
	By	/s/ Michael
    Block	 
	Name:	Michael
    Block	 
	Title:	Vice
    President, Business Development	 

 

    	2Exhibit
10.56

 

 

September
20, 2021

 

Lannett
Company, Inc.

9000
State Road

Philadelphia,
PA 19136

 

Re:
Letter of Agreement between Elite Pharmaceuticals, Inc. and Lannett Company, Inc. for Dantrolene (“Dantrolene Renewal Letter”)

 

Mr.
Block,

 

Lannett
Company, Inc., a Delaware corporation located at 9000 State Road, Philadelphia, PA 19136 and/or its Affiliates (“Lannett”),
and Elite Pharmaceuticals, Inc. a Nevada corporation and Elite Laboratories, Inc. a Delaware corporation (a subsidiary of Elite Pharmaceuticals,
Inc.), located at 165 Ludlow Avenue, Northvale, NJ 07647 (together "Elite") are parties to a License, Supply and Distribution
Agreement for Dantrolene Capsules effective as of April 9, 2019 (“Dantrolene Agreement”). Under the Agreement, Elite granted
a right to Lannett to sell and distribute the product Dantrolene Sodium (“Dantrolene”). All capitalized terms used without
definition in this Dantrolene Renewal Letter shall have the meanings provided in the Dantrolene Agreement.

 

Effective
as of the date of execution of this Letter Agreement, the parties agree to the following:

 

Per
Section 8.1 of the Dantrolene Agreement, Elite and Lannett agree to extend the Term of the Dantrolene Agreement for two (2) years. The
Initial Term is for three (3) years, from the Effective Date of April 9, 2019 until April 8, 2022. The First Renewal Term mutually agreed
upon with this letter shall be from April 9, 2022 until April 8, 2024. All terms and conditions of the Dantrolene Agreement shall remain
in full force and effect.

 

If
the foregoing correctly sets forth our agreement and understanding, please execute the enclosed counterpart of this letter agreement
and return the executed counterpart to the undersigned at your convenience.

  

-
SIGNATURE PAGE FOLLOWS -

 

 

    	1

     

    

 

	ELITE
    PHARMACEUTICALS, INC.	 
	 	                           	 
	By	/s/
    Nasrat Hakims	 
	Name:
    	Nasrat
    Hakim	 
	Title:
    	CEO	 

 

Accepted
and agreed as of this September 20, 2021

 

	LANNETT
    COMPANY, INC. 	 
	 	 	 
	By	/s/
    Michael Block	 
	Name:
    	Michael
    Block	 
	Title:
    	Vice
    President of Business Development	 

 

    	2CONFIDENTIAL
	Exhibit
  10.57

 

EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE
COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

 

SUPPLY
& DISTRIBUTION AGREEMENT

 

This
Supply & Distribution Agreement (“Agreement”) is effective as of the Effective Date by and between:

 

ELITE
PHARMACEUTICALS, INC., with its offices located at 165 Ludlow Avenue, Northvale, New Jersey 07647, United States (“Elite”);
and DEXCEL LTD., with its offices located at 1 Dexcel Street, Or Akiva 3060000, Israel (“Dexcel”). Elite and
Dexcel are each a “Party” and together are the “Parties”.

 

	WHEREAS:	Elite
                                            is a pharmaceutical company engaged in various activities including, but not limited to,
                                            the research, development, manufacture, and marketing of various drugs and pharmaceutical
                                            specialties; and
	 	 
	WHEREAS:	Dexcel
                                            is a pharmaceutical company engaged in various activities including, but not limited to,
                                            the marketing, distribution and sale of pharmaceutical products in the Territory; and
	 	 
	WHEREAS:	Elite
                                            is the owner of the approved ANDA for the Product in the United States and, subject to the
                                            terms and conditions set forth herein, Elite (a) agrees to grant to Dexcel the exclusive
                                            rights to use Elite’s Registration Dossier and to refer to Elite’s ANDA for the
                                            Product, so as to enable Dexcel to obtain one Marketing Authorization per each strength of
                                            the Product in the Territory, and to import, market, sell and distribute the Product in the
                                            Territory, and (b) supply the Product exclusively to Dexcel for sale and distribution by
                                            Dexcel in the Territory; and
	 	 
	WHEREAS:	Subject
                                            to the terms and conditions set forth herein, Dexcel is willing (a) to receive from Elite
                                            the rights to use the Registration Dossier to obtain one Marketing Authorization per each
                                            strength to the Product, and to import, market, sell and distribute the Product in the Territory,
                                            and (b) to purchase, during the Term of this Agreement, all of its requirements for the Product
                                            exclusively from Elite in order to import, market, distribute and sell the Product in the
                                            Territory;

 

NOW
THEREFORE, in consideration of the mutual promises and covenants set forth herein and for good and valuable consideration, the adequacy
and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

	1	Definitions

 

		1.1	“Act”
                                            means the United States Federal Food, Drug and Cosmetic Act, as amended, 21 U.S.C. §301
                                            et seq., and any related or successor federal and/or state law or regulation in the Territory
                                            pertaining to the safety, effectiveness, adulteration, misbranding, mishandling, packaging,
                                            labeling or storage of pharmaceutical ingredients and/or finished pharmaceutical products
                                            that may be applicable to the Product during the Term.
	 	 	 
		1.2	“Affiliate”
                                            shall mean, with regards to a Party, any entity that directly or indirectly (a) is under
                                            Control of such Party, (b) has Control over such Party, or (c) is under common Control with
                                            such Party.
	 	 	 
		1.3	“ANDA”
                                            shall mean Abbreviated New Drug Application A211352, approved by the FDA.
	 	 	 
		1.4	“Anti-Corruption
                                            and Anti-Bribery Laws” shall mean the Bribery Act 2010 (2010 Chapter 23) of the
                                            Parliament of the United Kingdom, the United States Foreign Corrupt Practices Act of 1977
                                            (“FCPA”), as amended any rules or regulations thereunder, and any other
                                            applicable anti-corruption or anti-bribery statutes, laws or regulations in the applicable
                                            country specifically applicable to a Party.
	 	 	 
		1.5	“API”
shall mean the active pharmaceutical ingredients used in the manufacturing of the Product: Amphetamine Aspartate, Amphetamine Sulfate,
Dextroamphetamine Saccharate, and Dextroamphetamine Sulfate.

 

    	 

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

	 	1.6	“Calendar
                                            Quarter” shall mean a three (3) month period ending on March 31, June 30, September
                                            30 or December 31 in any calendar year.

	 	 	 
		1.7	“Change
                                            of Control” shall mean (i) any change, sale, merger, reorganization, or any other
                                            event or action that results in a third party acquiring: (x) all or substantially all of
                                            the business or assets of a Party relating to this Agreement, (y) Control, directly or indirectly,
                                            of such Party (and/or any corporate entity that Controls, directly or indirectly, such Party),
                                            or (ii) any assignment or delegation of, sale or transfer of a Party’s rights and obligations
                                            under this Agreement (or any part hereof) to a third party. Notwithstanding anything in the
                                            immediately preceding sentence to the contrary, where the Party in question is Dexcel, any
                                            of the foregoing events or actions shall not be considered a Change of Control where any
                                            one or more of the relevant third party or parties referred to in clause (i) above is (A)
                                            Mr. Dan Oren’s wife, the lineal descendants (including by adoption and stepchildren)
                                            of Mr. Oren’s ancestors, and the spouses or spousal equivalents of any such lineal
                                            descendants (“Family Member”), or (B) any entity Controlled by Mr. Dan
                                            Oren and/or a Family Member.
	 	 	 
		1.8	“Commercialization
                                            Date” with respect to the Product, shall mean the date on which the Product is
                                            first sold by Dexcel to an unaffiliated Third Party in the Territory (“Launch”).
	 	 	 
		1.9	“Commercially
                                            Reasonable Efforts” means carrying out obligations or tasks consistent with the
                                            efforts and reasonable good practices typically and reasonably exerted in the pharmaceutical
                                            industry for the development, manufacturing, registration, or commercialization (as applicable)
                                            of pharmaceutical products having similar market potential, profit potential or strategic
                                            value as the applicable Product in the Territory, based on conditions then prevailing.
	 	 	 
		1.10	“Confidentiality
                                            Agreement” shall mean the Confidentiality Agreement entered into between the Parties
                                            on the4th day of August, 2021.
	 	 	 
		1.11	“Control,”
                                            as used with respect to any entity, shall mean (a) the possession, directly or indirectly,
                                            of more than fifty (50%) of the outstanding voting security of such entity or other voting
                                            power of such entity, (b) the right to appoint a majority of such entity’s board of
                                            directors, directly or indirectly, or (c) the right to and control the management, affairs
                                            or policies of such entity, directly or indirectly.
	 	 	 
		1.12	“Delivery”
                                            for all Products shall occur, and title and risk of loss and damage to the Product shall
                                            pass to Dexcel, based on the Incoterms® set forth in Section 5.3.7.
	 	 	 
		1.13	“Effective
                                            Date” shall mean the date of the last Party to sign this Agreement.
	 	 	 
		1.14	“Elite’s
                                            IP” shall mean all Intellectual Property Rights invented, developed, derived or
                                            acquired by Elite itself or from a Third Party relating to the manufacture, testing, and/or
                                            use of the Product (including, inter alia, the Registration File). Such information shall
                                            include, but is not limited to, any toxicological, pharmacological, analytical and clinical
                                            data, forms and formulations, control assays and specifications, methods of preparation,
                                            stability data, and any patents, which for all purposes of this Agreement shall be deemed
                                            to include certificates of invention, applications for certificates of invention, and utility
                                            models, and corresponding patents, if any, throughout the world, covering the Product, including
                                            any substitutions, extensions, reissues, re-examinations, renewals, divisions, continuations,
                                            or continuations-in-part, which Elite owns or control.
	 	 	 
		1.15	“FDA”
                                            shall mean the United States Food and Drug Administration, or any successor entity.
	 	 	 
		1.16	“Floor
                                            Price” shall mean the floor prices set forth in Appendix 1.

 

    	2

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

		1.17	“Force
                                            Majeure” shall mean an event beyond a Party’s reasonable control and without
                                            such Party’s fault, which prevents such Party from performing its obligations hereunder;
                                            such events may include, but not be limited to, fire, flood, earthquake, storm, hurricane
                                            or other natural disaster, war, invasion, act of foreign enemies, hostilities (regardless
                                            of whether war is declared), civil war, rebellion, revolution, insurrection, military or
                                            usurped power or confiscation, terrorist activities, pandemic or epidemic which materially
                                            disrupts normal business activities, nationalization, governmental activities relating to
                                            emergency situations, blockage, embargo, strikes or lockouts (except of the personnel of
                                            such Party). The Parties confirm that the current consequences of the SARS-CoV-2 / COVID-19
                                            pandemic do not constitute Force Majeure events hereunder.
	 	 	 
		1.18	“Good
                                            Manufacturing Practice” or “cGMP” shall mean the applicable
                                            regulatory standards and requirements for current good manufacturing practice promulgated
                                            by the FDA under and in accordance with the Act, Parts 210 and 211 of the U.S. Code of Federal
                                            Regulations, and the guidelines and standards published by the FDA relating thereto, as may
                                            be amended from time-to-time, or any successors thereto.
	 	 	 
		1.19	“Gross
                                            Sales” shall mean the contractually-agreed prices for the Product between Dexcel
                                            and the four Israeli health insurance companies (Kupat Holim Clalit, Kupat Holim Maccabi,
                                            Kupat Holim Meuhedet, and Kupat Holim Leumit), the Palestinian sub-distributors, if any,
                                            and any other unaffiliated Third Parties in the Territory, multiplied by the number of Packs
                                            sold during the relevant period.
	 	 	 
		1.20	“Health
                                            Authorities” shall mean the relevant governmental or regulatory entity in the Territory
                                            which is authorized to approve/reject Marketing Authorization applications.
	 	 	 
		1.21	“Intellectual
                                            Property Rights” means all intellectual property rights, including rights in respect
                                            of the following: (i) all inventions, materials, compounds, compositions, substances and
                                            other results of whatsoever nature, whether or not patentable, and whether or not applied
                                            for registration as a patent; (ii) Know-How; (iii) patents, including all reissues, extensions,
                                            renewals, patents of addition, substitution, re-registrations, re-examinations, including
                                            all provisional applications, continuations, continuations-in-part and divisions, but excluding
                                            patents that have been invalidated or cancelled, and patent applications, (iv) copyrights,
                                            proprietary intellectual or industrial rights directly or indirectly deriving therefrom,
                                            whether registered or not; (v) trademarks, trade names, service marks and similar marks,
                                            whether registered or not; (vi) designs, whether registered or not; and (vii) any work of
                                            authorship, regardless of copyrightability and patentability, all compilations and all copyrights.
	 	 	 
		1.22	“Know-How”
                                            means any all technical, scientific and other know-how, information, inventions, trade secrets,
                                            knowledge, technology, means, methods, processes, practices, formulae, instructions, skills,
                                            techniques, procedures, ideas, technical assistance, designs, drawings, assembly procedures,
                                            computer programs, apparatuses, specifications, data, results and other intangible materials,
                                            manufacturing procedures, test procedures and purification and isolation techniques (whether
                                            or not confidential, proprietary, patented or patentable) and all tangible embodiments of
                                            any of the foregoing in written, electronic or any other form or other tangible materials
                                            that are used as research or development tools, such as assays and reference substances.
	 	 	 
		1.23	“Lead
                                            Time” shall mean not less than one hundred and twenty (120) days prior to the requested
                                            delivery date.
	 	 	 
		1.24	“Livery”
                                            shall mean the graphics and text appearing on each Pack of the Product as approved by the
                                            Health Authorities in the Territory.
	 	 	 
		1.25	“Manufacturer”
                                            shall mean Elite, its Affiliates, or any Third Party included as an approved manufacturer
                                            of the Product in the approved Marketing Authorization.

 

    	3

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

		1.26	“Marketing
                                            Authorization” shall mean the authorization of the Health Authorities required
                                            for the sale and marketing of the Product in each country of the Territory.
	 	 	 
		1.27	“Minimum
                                            Order Quantity” shall mean one (1) full batch of the relevant Product. The batch
                                            sizes are:

 

10mg
Product – *** tablets

20mg
Product – *** tablets

30mg
Product – *** tablets

 

		1.28	“Net
                                            Sales” means the Gross Sales of the Product during the relevant computation period
                                            (for purposes of determining whether a given sale occurs during a computation period, such
                                            Product will be considered sold as of the date of shipment to an unaffiliated Third Party
                                            customer of Dexcel in the Territory), less the following items and amounts:

 

		a.	Customs
                                            duties, value added, and similar sales related taxes, if any, imposed on the Product, to
                                            the extent applicable to such sale;
	 	 	 
		b.	Amounts
                                            allowed or credited by reason of rejections, return of goods (including as a result of recalls),
                                            any retroactive price reductions or allowances or rebates, relating to the Product (including
                                            those resulting from inventory management or similar agreements with wholesalers) or quantity
                                            and/or cash discounts actually allowed or taken, whether simultaneously with the sale of
                                            the Product or at any time thereafter;
	 	 	 
		c.	Amounts
                                            incurred resulting from government-mandated rebate programs, including programs mandated
                                            by any agency thereof;
	 	 	 
		d.	Patient
                                            discount programs, administrative fees and chargebacks or similar price concessions related
                                            to the sale of the Product;
	 	 	 
		e.	Any
                                            bad debts due;
	 	 	 
		f.	Any
                                            withholding tax amounts that were actually deducted from the gross sales of the Product by
                                            the Third Party customer provided that a tax return or credit regarding the same was not
                                            credited;
	 	 	 
		g.	Freight,
                                            postage, shipping and applicable insurance charges, to the extent same are separately itemized
                                            on invoices and actually paid; and
	 	 	 
		h.	To
                                            the extent agreed by the Parties in writing, such agreement not to be unreasonably withheld,
                                            any other specifically identifiable appropriate allowances or deductions as may be similar
                                            to those deductions listed above.

 

		1.29	“Net
                                            Selling Price” shall mean, for each relevant computation period during the Term,
                                            the total Net Sales divided by the number of Packs sold during such Calendar
                                            Quarter; provided that the Net Selling Price per Pack shall never be lower than the Floor
                                            Price per Pack.
	 	 	 
		1.30	“Non-Obvious
                                            Defect” shall mean any instance where a batch of a Product fails to conform to
                                            the Specifications or is otherwise defective or fails to conform to the Required Standards,
                                            and such failure would not be discoverable upon reasonable physical inspection or standard
                                            testing.
	 	 	 
		1.31	“Obvious
                                            Defect” shall mean any instance where a batch of the Product fails to conform to
                                            the Specifications or is otherwise defective or fails to conform to the Required Standards,
                                            and such failure is discoverable upon reasonable physical inspection or standard testing
                                            of such Product upon receipt by Dexcel in accordance with its standard operating procedures.
	 	 	 
		1.32	“Pack”
                                            shall mean a bottle containing thirty (30) tablets of the Product in the Livery. Each Pack
                                            will include the batch number, the expiry date, and a patient information leaflet (“PIL”).

 

    	4

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

		1.33	“Packaging”
shall mean all primary containers (including bottles), cartons, and the PIL, and all shipping cases or any other like matter used in
packaging and/or accompanying the Product (including, without limitation, electronic files). 

	 	 	 
		1.34	“Person”
                                            shall mean an individual, corporation, partnership, limited liability company, trust, business
                                            trust, association, joint stock company, joint venture, pool, syndicate, sole proprietorship,
                                            unincorporated organization, governmental authority or any other form of entity not specifically
                                            listed herein.
	 	 	 
		1.35	“Product”
                                            shall mean Dextroamphetamine and Amphetamine combinations containing Amphetamine Aspartate,
                                            Amphetamine Sulfate, Dextroamphetamine Saccharate, and Dextroamphetamine Sulfate, in the
                                            strengths and dosage form approved by the FDA in the ANDA, and as described in Appendix 1.
	 	 	 
		1.36	“Quality
                                            Agreement” shall mean the agreement concerning the manufacturing, packaging and
                                            quality control relating to the Product, to be signed by Elite and Dexcel within ninety (90)
                                            days following the Effective Date in a form substantially similar to the form set forth in
                                            Appendix 2 hereof.
	 	 	 
		1.37	“Recall”
                                            shall mean a voluntary or governmental action to quarantine, stop-sale or withdraw the Product
                                            from the market in the Territory.
	 	 	 
		1.38	“Recall
                                            Costs” shall have the meaning set forth in Section ‎6.5.3 herein.
	 	 	 
		1.39	“Registration
                                            File” shall mean all written pertinent and necessary information regarding the
                                            Product (full approved consolidated dossier modules 2-5), which has been approved by the
                                            FDA (ANDA 211352), and that shall include, inter alia:

 

		●	Elite’s
                                            cGMP certificate;
	 	 	 
		●	Elite’s
                                            manufacturing license;
	 	 	 
		●	Elite’s
                                            QA audits of the API manufacturers;
	 	 	 
		●	Any
                                            bio-studies and/or clinical studies available to Elite on the Effective Date hereof (each,
                                            a “BE Study”);
	 	 	 
		●	A
                                            current, valid US Free Sale Certificate or US Certificate of Pharmaceutical Product (“CPP”)
                                            for the marketed Product;
	 	 	 
		●	Certificate
                                            of compliance with good laboratory practice principles for the laboratories conducting the
                                            analytical tests for the BE Study. The certificate should be from a suitable authority in
                                            a recognized country (US, Canada etc.);
	 	 	 
		●	Dissolution
                                            data of the reference product registered in Israel (Dexcel shall purchase and provide the
                                            samples of the reference product registered in Israel to Elite, at Dexcel’s cost; Elite
                                            shall perform the required studies, at Dexcel’s cost), (see Appendix 4).

 

		1.40	“Representative”
                                            shall mean a Party’s Affiliates, and its and their agents, professional advisors, attorneys,
                                            directors, officers, and employees.
	 	 	 
		1.41	“Required
                                            Standards” shall have the meaning set forth in Section ‎‎‎6.1
                                            herein.
	 	 	 
		1.42	“Safety
                                            Data Exchange Agreement” or “SDEA” shall mean the agreement
                                            to be entered into between the Parties within ninety (90) days following the Effective Date
                                            in a form substantially similar to the form set forth in Appendix 3 hereof, which generally
                                            governs the Parties’ responsibilities related to the safety data and regulatory reporting
                                            requirements for the Products.
	 	 	 
		1.43	“Specifications”
                                            shall mean the pharmaco-chemical, manufacturing, stability and other specifications of the
                                            Product, as defined in the Marketing Authorization and subject to change from time to time
                                            as reasonably required to meet any requirements of the Health Authorities in the Territory.

 

    	5

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

		1.44	“Term”
                                            shall mean the Initial and any Renewal Term, as defined in Section ‎11.1 herein.
	 	 	 
		1.45	“Territory”
                                            shall mean the State of Israel (including all portions of the West Bank under full Israeli
                                            control) and the Palestinian Authority (which shall include the portions of the West Bank
                                            under Palestinian control and Gaza).
	 	 	 
		1.46	“Third
                                            Party” means any Person other than the Parties hereto or their respective Affiliates.
	 	 	 
		1.47	“US
                                            DEA” shall mean the United States Drug Enforcement Agency or any successor entity.
	 	 	 
		1.48	“Working
                                            Day” shall mean a day, excluding a Friday, Saturday or Sunday, on which banks are
                                            open for business, and, for the avoidance of doubt, excluding statutory holidays in the United
                                            States and the Territory.

 

	2	Grant
                                            of Exclusive Rights

 

		2.1	Subject
                                            to Dexcel fulfilling its obligations in accordance with the terms and conditions of this
                                            Agreement, Elite hereby grants to Dexcel the exclusive right, for and during the Term, to
                                            (a) use Elite’s approved Registration File and (b) to allow Dexcel to refer to Elite’s
                                            ANDA for the Product to enable Dexcel to obtain one Marketing Authorization for each strength
                                            of the Product in the Territory and to import into, market, sell and distribute the Product
                                            in the Territory.
	 	 	 
		2.2	During
                                            the Term of the Agreement and subject to the terms and conditions of this Agreement, Dexcel
                                            may designate the following sub-distributors; provided further that Dexcel may designate
                                            other sub-distributors in the Territory with the prior written consent of Elite (not to be
                                            unreasonably withheld):

 

		a.	Within
                                            Israel and Israeli-controlled areas: Chemipal Ltd., 44 Giborei Israel Street, Poleg
                                            Industrial Zone, Netanya 4250432, Israel;
	 	 	 
		b.	In
                                            the areas under Palestinian Authority control: The Al-Ram Drugstore, Qalonia St.,
                                            Jerusalem

 

	3	Regulatory
                                            Affairs

 

		3.1	Elite
                                            shall transmit a complete copy of the Registration File, and such other information included
                                            in the ANDA as Dexcel may reasonable request, to Dexcel using Commercially Reasonable Efforts
                                            to provide within fourteen (14) Working Days after the Effective Date hereof.
	 	 	 
		3.2	Upon
                                            the receipt of the complete Registration File, Dexcel shall audit and review such Registration
                                            File to determine its suitability for submission to the Health Authorities in order to receive
                                            a Marketing Authorization for the Product in the Territory. In the event that, in Dexcel’s
                                            sole discretion, additional information is required in order to submit the Registration File,
                                            Dexcel shall request such information from Elite in writing. Elite shall provide Dexcel with
                                            such information reasonably in its possession using Commercially Reasonable Efforts within
                                            fourteen (14) Working Days from receiving Dexcel’s written request. In the event that,
                                            in Dexcel’s sole and absolute discretion, such additional information provided to Dexcel
                                            is still insufficient to submit the Registration File, such additional information is not
                                            reasonably in Elite’s possession, or in the event that Dexcel’s audit has determined
                                            that the Registration File is not and cannot be made suitable for submission, Dexcel may
                                            terminate this Agreement by providing Elite with a written notification of such decision
                                            with an immediate effect.

 

    	6

    	CONFIDENTIAL
	 
	EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED

    

 

		3.3	Following
                                            Dexcel’s determination that the Registration File is suitable for submission as provided
                                            in Section ‎3.2, Dexcel shall use Commercially Reasonable Efforts to submit the
                                            Registration File to the Health Authorities for the purpose of obtaining a Marketing Authorization
                                            in the Territory within six (6) months after the receipt of the complete Registration File.
	 	 	 
		3.4	Following
                                            Dexcel’s submission of the application for the Marketing Authorization to the Health
                                            Authorities in the Territory, Elite will use Commercially Reasonable Efforts to assist Dexcel
                                            in addressing any issues raised by the Health Authorities and replying to the assessment
                                            or deficiency letter issued by the Health Authority in relation to the application for the
                                            Marketing Authorization in the Territory. Elite shall use Commercially Reasonable Efforts
                                            to provide Dexcel with responses to any such letter, questions or issues requested or raised
                                            by the Health Authorities within the timeframe as required by the Health Authorities, but
                                            Elite shall not be obliged to conduct any new or additional study for any such purpose.
	 	 	 
		3.5	Variations

 

		3.5.1	Elite
                                            will notify Dexcel in writing of any changes which will affect the Registration File and/or
                                            Marketing Authorization for the Product in the Territory, and Dexcel will notify Elite in
                                            writing of any changes requested by Dexcel or required by the Health Authorities which will
                                            affect the Registration File and the Marketing Authorization for the Product in the Territory
                                            (each such change being hereinafter a “Variation”). Elite shall provide
                                            all technical or other documentation reasonably necessary for Dexcel to submit the Variation
                                            for approval to the Health Authorities in the Territory. Elite agrees to use Commercially
                                            Reasonable Efforts to support and assist Dexcel as may be necessary for the Variation to
                                            be approved.
	 	 	 
		3.5.2	The
                                            costs of any Variation shall be borne as follows:
	 	 	 
		a.	For
                                            any Variation requested or required by Elite, Elite shall be responsible for all costs and
                                            fees in the Territory;
	 	 	 
		b.	For
                                            any Variation (i) required by the Health Authorities in the Territory or (ii) requested by
                                            Dexcel and accepted by Elite, Dexcel shall bear all costs and fees in the Territory.
	 	 	 
		3.5.3	Dexcel
                                            shall not have any obligation to accept any Variation to the Registration File if (a) the
                                            Launch or the continuous supply of the Product in the Territory may be affected thereby or
                                            (b) if there will be a material negative impact on the commercialization of the Product in
                                            the Territory (unless Elite can reasonably show that failing to implement the change makes
                                            the continuity of Product supply impracticable).
	 	 	 
		3.5.4	Variations
                                            shall only be implemented after successful completion of the variation procedures in the
                                            Territory. Elite shall continue to supply the Product in conformance with the approved Required
                                            Standards until any Variation is approved by the relevant health authorities.

 

		3.6	During
                                            the Term, Elite undertakes to timely inform Dexcel in writing of any material information
                                            concerning the Registration File and to provide Dexcel with any related documents, provided
                                            that such related document is reasonably in Elite’s possession, free of charge, including
                                            (a) additional three-year ICH stability studies and validation reports on industrial batches
                                            in order to satisfy regulatory requirements, and (b) changes to the Product labeling and/or
                                            the PIL imposed by the FDA or any other regulatory authority.

 

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	4	Marketing
                                            Obligations

 

		4.1	Dexcel
                                            shall be solely responsible, at its own expense, for all activities directly or indirectly
                                            related to the promotion, marketing, sale and distribution of the Product throughout the
                                            Territory, including, inter alia, the importation into, the warehousing, storage,
                                            collection, shipping, order fulfillment, and invoicing of the Product.
	 	 	 
		4.2	Dexcel
                                            shall at all times maintain inventories of the Product, pending sale, in facilities that
                                            are properly equipped (including any required temperature and humidity controls) and in accordance
                                            with the Health Authorities’ regulations for the storage of pharmaceutical products
                                            and the conditions appearing in the Marketing Authorization. Elite shall provide Dexcel with
                                            all relevant information in its possession relating to said storage regulations and conditions.
	 	 	 
		4.3	Dexcel
                                            shall not, without the prior written permission of Elite:

 

		4.3.1	during
                                            the Term of this Agreement, order the Product from any Third Party;
	 	 	 
		4.3.2	use
                                            the Registration File or the Marketing Authorization for any purpose unrelated to this Agreement;
	 	 	 
		4.3.3	use
                                            the Registration File and any information provided pursuant to the provisions hereof for
                                            the purpose of applying for any Marketing Authorization for the Product in countries outside
                                            the Territory and/or additional Marketing Authorizations and/or duplicate Marketing Authorizations
                                            in the Territory;
	 	 	 
		4.3.4	promote,
                                            market, sell or distribute the Product to customers having their place of business, or establish
                                            Product distribution channels, outside the Territory; or
	 	 	 
		4.3.5	maintain
                                            any distribution depot for the Product outside the Territory.

 

	5	Purchase/Supply
                                            of Product

 

		5.1	Subject
                                            to the terms and conditions of this Agreement, throughout the Term, Elite shall manufacture
                                            and supply all Product ordered by Dexcel for sale and distribution in the Territory.
	 	 	 
		5.2	Packaging;
                                            Artwork

 

		5.2.1	Elite
                                            shall acquire all Labeling and Packaging materials for the Products supplied to Dexcel under
                                            this Agreement, such Labeling and Packaging materials to be in accordance with the requirements
                                            of the Marketing Authorization.
	 	 	 
		5.2.2	Dexcel
                                            shall be responsible for providing Elite with the initial artwork for the Livery, which shall
                                            include Dexcel’s trademarks and logos, address, and Label format, not less than one
                                            hundred and twenty (120) days before the requested delivery date for the Launch of the Product.
                                            Elite shall provide Dexcel with printer’s proofs for its review of such initial artwork
                                            and text. Dexcel shall promptly provide Elite with any necessary corrections thereto and/or
                                            notify Elite in writing of its approval of such proofs, such written approval to be maintained
                                            by Elite.
	 	 	 
		5.2.3	Should
                                            Dexcel desire or be required by the Health Authorities to make any change to such Label or
                                            Labeling, Dexcel shall promptly supply approved new artwork and related materials to Elite
                                            not less than one hundred and twenty (120) days before the next requested delivery date for
                                            such Product. Elite shall be responsible for the updating of all artwork and text associated
                                            with such change and for providing Dexcel with printer’s proofs for its review. Dexcel
                                            shall promptly provide Elite with any necessary corrections thereto and/or notify Elite in
                                            writing of its approval of such proofs, such written approval to be maintained by Elite.
                                            Dexcel shall bear the costs for the disposal by Elite of any Packaging materials bearing
                                            the previous Artwork but not exceeding the costs for Packaging materials purchased by Elite
                                            for the next following six (6) months of the current forecast; provided that, if Elite requests
                                            changes to the Artwork, Elite shall assume all costs of such change (which will not be implemented
                                            until any required Variation is approved).

 

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		5.2.4	Dexcel
                                            shall be responsible for ensuring the accuracy of all information contained on the Packaging,
                                            Labels and Labeling for the Product and for compliance with the Marketing Authorization.

 

		5.3	Forecasts,
                                            Orders and Supply

 

		5.3.1	Dexcel
                                            shall provide Elite, two (2) times each calendar year, with a rolling, non-binding and good
                                            faith forecast of its Product requirements (by SKU), for each of the following six (6) months.
	 	 	 
		5.3.2	Dexcel
                                            shall provide Elite with written purchase orders in a form reasonably acceptable to Elite
                                            and which shall specify at least the following: a description of the Product ordered, the
                                            quantity ordered, the relevant Floor Price, the place of delivery and the required delivery
                                            date thereof; provided that (a) all purchase orders shall meet the Minimum Order Quantity
                                            and (b) the required delivery date shall not be less than the Lead Time. Notwithstanding
                                            the aforesaid, in the event of any delay of the obtainment by Elite of an export permit from
                                            the US DEA, the Lead Time will be extended by an additional thirty (30) days; provided, however,
                                            that such delay is not derived from any negligent act or omission of Elite.
	 	 	 
		5.3.3	No
                                            purchase order shall be binding on Elite unless accepted in writing by Elite. Elite shall
                                            have a maximum of ten (10) Working Days from receipt of the purchase order whether to accept
                                            or reject the purchase order. Once the order is confirmed by Elite (which shall not unreasonably
                                            reject or delay such acceptance), it shall be treated as “Confirmed Order,”
                                            the requested delivery date shall be the “Confirmed Delivery Date,” and
                                            the Confirmed Order shall be binding on both Parties.
	 	 	 
		5.3.4	Elite
                                            shall use its best commercial efforts to deliver the Confirmed Orders to Dexcel in full on
                                            the Confirmed Delivery Date. Each shipment shall be accompanied by certificates of analysis,
                                            certificates of compliance and such information required to be included pursuant to the Quality
                                            Agreement, as well as any other documentation required by the relevant authorities for the
                                            export of the Product from the United States and the import of the Product into the Territory.
	 	 	 
		5.3.5	Before
                                            each delivery, Elite will provide Dexcel with a packing list and the invoice for the Product,
                                            by email to Fany.Harry@dexcel.com and to Tammy.Hod@dexcel.com.

 

		a.	Elite
                                            shall obtain and maintain all permits, authorizations, consents, and approvals (including
                                            any special exemptions or approvals), including any release from any quotas or other limitations,
                                            if needed, required to enable it to export the Product from the United States. Elite will
                                            send a scanned copy of its export permit to Dexcel prior to shipment of the Product. Dexcel
                                            shall receive the original export permit by courier.
	 	 	 
		b.	Dexcel
                                            obtain the required import license from the relevant regulatory authority in the Territory,
                                            using such invoice and packing list. As soon as such license is granted to Dexcel, Dexcel
                                            will send an original copy of the license to Elite.

 

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		5.3.6	Elite
                                            will provide Dexcel’s forwarder with all documentation regarding the Product reasonably
                                            requested by Dexcel, as well as that required by the Quality Agreement.
	 	 	 
		5.3.7	All
                                            Product shall be Delivered to Dexcel Incoterms® 2020 FCA Elite’s warehouse, 135
                                            Ludlow Avenue, Northvale, New Jersey USA and/or such other location reasonably designated
                                            by Elite and approved in advance by Dexcel. Elite shall be responsible for obtaining the
                                            export permit for the export of the Product from the United States.
	 	 	 
		5.3.8	Elite
                                            will be responsible for Packaging the Product for appropriate export Product packing, marking
                                            and labelling for shipment (by air or sea, as requested by Dexcel), and including data loggers,
                                            thermal blankets or other special packaging, if requested and provided by Dexcel and as provided
                                            in the Quality Agreement (the cost of which will be paid by Dexcel in accordance with Appendix
                                            1).
	 	 	 
		5.3.9	Nothing
                                            in a purchase order, written order confirmation or acceptance, delivery acceptance or any
                                            other document created or sent by either Party which adds additional or conflicting terms
                                            and conditions to those contained in this Agreement shall be binding on the Parties. The
                                            terms of supply of the Product shall be governed solely by the terms of this Agreement.

 

		5.4	Product
                                            Price

 

		5.4.1	Elite
                                            shall provide Dexcel with an invoice at the relevant Product Floor Price at Delivery. Dexcel
                                            shall pay Elite the total invoiced amount set out in such invoice to Elite in U.S. dollars
                                            by direct bank transfer to the following bank account designated by Elite not more than thirty
                                            (30) days following the date of the invoice, with each Party responsible for its own bank’s
                                            charges:

 

Bank:
***

Routing
Number: ***

Account
Number: ***

Swift:
***

 

		5.4.2	Not
                                            more than thirty (30) days following the end of each Calendar Quarter during the Term, commencing
                                            with the end of the Calendar Quarter during which the Commercialization Date occurred, Dexcel
                                            shall pay Elite an amount equal to ***  percent (***%) of
                                            the Net Selling Price derived from all sales of the Product in the Territory by Dexcel during
                                            such Calendar Quarter, less the total Floor Price paid for such Product, and multiplied by
                                            the number of Product Packs sold, and shall further include a report in an agreed
                                            format setting forth the calculation of the Net Selling Price during such Calendar Quarter.
	 	 	 
		5.4.3	Upon
                                            Elite’s request and not more frequently than annually, Dexcel will provide Elite with
                                            a written confirmation by Dexcel’s external auditors (currently, BDO) with respect
                                            to Dexcel’s Net Selling Price calculations and the amounts payable under this Agreement.
	 	 	 
		5.4.4	Dexcel
                                            shall only use the payment route and payment information set forth in this Section ‎‎‎5.4
                                            for payments to Elite. Dexcel shall only accept changes to such instructions by written Notice
                                            from Elite.

 

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		5.5	Supply
                                            Failure

 

		5.5.1	Elite
                                            will promptly notify Dexcel in writing in the event that Elite is unable, or anticipates
                                            that it will be unable, to supply the Product on the Confirmed Delivery Date (each, a “Supply
                                            Failure”), together with an estimate of the revised collection date of the Product.
                                            In such event, the Parties shall determine a reasonable course of action (including, without
                                            limitation, agreeing to the revised collection date (“Revised Delivery Date”))
                                            to rectify the matter as soon as possible; provided, however, that in the event that Elite
                                            fails to remedy such Supply Failure by the Revised Delivery Date and the actual delivery
                                            date is more than thirty (30) Working Days from the Confirmed Delivery Date, then, unless
                                            such Supply Failure is caused by a Force Majeure event or due to failure by Dexcel to secure
                                            an export permit for the shipment, Dexcel shall be entitled, at its reasonable discretion,
                                            to: (i) suspend payment of any invoices then due, and which may subsequently become due,
                                            to Elite until the delay has been remedied; and/or (ii) to postpone, cancel or modify the
                                            relevant Confirmed Order with respect to the quantities that Elite could not deliver. In
                                            addition, any penalty actually paid by Dexcel to a Third Party customer as a result of the
                                            Supply Failure shall be reimbursed by Elite unless the delay is attributable to (i) action
                                            or controls imposed by the DEA or other governmental agency that that do not result from
                                            Elite’s negligence, gross negligence or willful misconduct or (ii) demonstrable raw
                                            material shortages that are beyond Elite’s control. A Supply Failure shall not apply
                                            to the first lot of each strength ordered and delivered under this Agreement.
	 	 	 
		5.5.2	Except
                                            for Dexcel’s right of termination provided in Section ‎11.2.4 and its rights to
                                            indemnification under Section ‎10.1 for Third Party Claims, the remedies under Section
                                            ‎5.5.1 shall be the sole and exclusive remedy available to Dexcel under the Agreement
                                            with respect to such Supply Failure.

 

	6	Quality;
                                            Recalls

 

		6.1	Elite
                                            warrants and represents that (a) the Product manufactured hereunder shall conform with the
                                            Specifications; (b) the Product shall be manufactured in accordance with all applicable laws
                                            and regulations in the country of manufacture, cGMP, the Quality Agreement, and the Registration
                                            File; (c) to Elite’s knowledge the manufacture of the Product does not infringe the
                                            Intellectual Property Rights of any Person in the country where the Product is manufactured;
                                            (d) all the Product supplied under this Agreement will, upon Delivery, have a shelf life
                                            which is at least 90% of the longest registered shelf life for the Product in the Territory
                                            (as of the Effective Date, the shelf life of the Product is 24 months); (e) for the Term
                                            of this Agreement, it will maintain any license or clearance in respect of cGMP granted to
                                            it under any scheme in the country of manufacture of the Product, and will provide Dexcel
                                            with evidence of any such licenses or clearances when requested by Dexcel to do so; and (f)
                                            the Product will be free of all liens and encumbrances at the time of Delivery (collectively,
                                            the “Required Standards”).
	 	 	 
		6.2	Within
                                            twenty (20) days of receipt the Product at Dexcel’s warehouse in Israel, Dexcel shall
                                            perform appropriate samplings and inspections for the purpose of determining whether the
                                            Product meets the Specifications and contains no Obvious Defects. Dexcel shall be deemed
                                            to have accepted any Product which has not been refused within such twenty (20) day period;
                                            provided that such implicit acceptance shall not be applicable to Non-Obvious Defects of
                                            the Product pursuant to Section 6.3 hereof, below. In the event that Dexcel wishes to refuse
                                            acceptance, Dexcel shall, within such thirty (30) day period, inform Elite in writing of
                                            its rejection and its reasons for such rejection.

 

		6.2.1	If
                                            Elite agrees with Dexcel’s rejection of the defective Product, Elite shall replace
                                            the defective Product as soon as reasonably practicable.
	 	 	 
		6.2.2	If
                                            Elite and Dexcel do not agree upon the rejection of Product, then the matter shall be referred
                                            to a specialized independent laboratory reasonably acceptable to both Parties for the purpose
                                            of final analysis. Any determination by any such laboratory shall be binding upon both Parties.
                                            The cost of any such testing and evaluation by an independent Third Party shall be borne
                                            by Dexcel if it is determined that the Product conforms to the requirements of this Agreement
                                            and by Elite if determined that it does not. If such laboratory determines that the Product
                                            does not conform to the requirements of this Agreement, Elite shall replace the defective
                                            Product as soon as practicable and shall bear and reimburse Dexcel for its actual costs incurred.

 

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		6.3	As
                                            soon as either Party becomes aware of a Non-Obvious Defect, it shall promptly give notice
                                            of such to the other Party. In the event that the Product is found to contain a Non-Obvious
                                            Defect, the Product shall be deemed rejected pursuant to Section 6.2, above, as of the date
                                            of such notice. The rights and obligations of the Parties with respect to the rejected Product
                                            shall thereafter be governed by the testing and replacement provisions of Section 6.2, subject
                                            to the Non-Obvious Defect not being a result of negligence after Delivery, following which
                                            the Product is under Dexcel’ responsibility.
	 	 	 
		6.4	Inspections

 

		6.4.1	Dexcel
                                            and/or any representatives authorized by Dexcel, upon approval by Elite (which shall not
                                            be unreasonably withheld or delayed) and under reasonable confidentiality requirements, shall
                                            have the right, at Dexcel’s sole expense, to audit Elite’s facilities involved
                                            in the manufacturing, packaging, testing, and release of the Product for compliance with
                                            cGMP, on reasonable notice, during normal business hours, and not more than once in each
                                            calendar year. Such audit shall include the right to inspect documents and records relevant
                                            to the manufacture of the Product. Elite shall as promptly as practical respond to issues
                                            raised by Dexcel to Elite in writing as a result of the audit. Elite shall take such actions
                                            as promptly as practical, at its expense, as may be reasonably necessary to address and correct
                                            any such issues.
	 	 	 
		6.4.2	Elite
                                            shall permit the FDA and the Health Authorities to inspect Elite’s facilities involved
                                            in the manufacturing, packaging, testing and release of the Product when so required by the
                                            FDA or such Health Authorities, and shall provide reasonable assistance for such purpose.
                                            Elite shall, as soon as reasonably possible, notify Dexcel of any notice it receives from
                                            the FDA or the Health Authorities requesting an inspection of Elite’s facilities in
                                            relation to the Product.

 

		6.5	Recalls

 

		6.5.1	Each
                                            Party shall promptly provide the other Party with copies of correspondence to or from the
                                            FDA and/or the Health Authorities relating to any corrective action or Recall in the Territory
                                            concerning the Product.
	 	 	 
		6.5.2	If
                                            there is a Recall of the Product in the Territory, then Dexcel agrees to stop shipping Recalled
                                            lots immediately after Dexcel receives written notification of such Recall from Elite. The
                                            Parties shall cooperate fully in any such Recall, including any notice, restriction, change,
                                            corrective act or market action or any Product change requested or ordered by the Health
                                            Authorities or any other governmental agency having jurisdiction in the Territory.
	 	 	 
		6.5.3	In
                                            the event of a Recall, it is agreed and understood that any Recall Costs (defined below)
                                            shall be borne as follows:

 

		a.	if
                                            the Recall arises from Dexcel’s acts or omissions in the marketing, distribution, storage
                                            or handling of the Product following Delivery, the costs and expenses related to the Recall,
                                            including, but not limited to (a) reasonable fees of any experts and/or attorneys that may
                                            be utilized by either Party, (b) government fines or penalties related to such Recall, quarantine
                                            or stop-sale, (c) costs and expenses for notification, (d) transportation, shipping and distribution
                                            expenses attributable to the Product subject to Recall, (e) cost of all replacement Product
                                            and its distribution, (f) the Transfer Price for all Product in Dexcel’s inventory
                                            subject to Recall, and (g) and third party recall expenses (collectively, “Recall
                                            Costs”) shall be borne solely by Dexcel; and
	 	 	 
		b.	if
                                            the Recall arises from the development, manufacturing, testing, handling, storage, or Packaging
                                            of any Product (including but not limited to any latent Product defects) prior to delivery
                                            to Dexcel, the Recall Costs shall be borne solely by Elite.

 

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		6.5.4	If
                                            there is any dispute concerning whether Dexcel or Elite is responsible for the Recall Costs,
                                            such dispute will be referred for decision to an independent expert appointed by agreement
                                            of the Parties with the costs borne equally between them. The decision of such independent
                                            expert must be in writing and, except for manifest error on the face of the decision, will
                                            be binding on both Parties.
	 	 	 
		6.5.5	All
                                            payments for undisputed Recall Costs assessed pursuant to this Section ‎6.5 are due and
                                            payable within thirty (30) days of being invoiced by Elite or Dexcel, as applicable.

 

	7	Warranties

 

		7.1	Each
                                            Party hereby represents and warrants to the other Party:

 

		7.1.1	Such
                                            Party is a corporation duly organized, validly existing and in good standing under the laws
                                            of the jurisdiction in which it is incorporated.
	 	 	 
		7.1.2	Such
                                            Party (a) has the corporate power and authority and the legal right to enter into this Agreement
                                            and to perform its obligations hereunder, and (b) has taken all necessary corporate action
                                            on its part to authorize the execution and delivery of this Agreement and the performance
                                            of its obligations hereunder. This Agreement has been duly executed and delivered on behalf
                                            of such Party, and constitutes a legal, valid, binding obligation, enforceable against such
                                            Party in accordance with its terms.
	 	 	 
		7.1.3	All
                                            necessary consents, approvals and authorizations of all governmental authorities and other
                                            persons required to be obtained by such Party in connection with its performance of this
                                            Agreement have been obtained.
	 	 	 
		7.1.4	Such
                                            Party, on its own behalf and on behalf of its Affiliates (including any of their officers,
                                            directors, or employees) has in place adequate procedures to prohibit, directly or indirectly,
                                            the use any corporate funds for unlawful contributions, gifts, entertainment or other unlawful
                                            expenses relating to political activity, nor has such Party, its Affiliates and their officers,
                                            directors or employees made any unlawful payment to foreign or domestic government officials
                                            or employees or made any bribe, rebate, payoff, influence payment, kickback or other similar
                                            unlawful payment, or taken any action which would cause it to be in violation of or taken
                                            any action which would cause it to be in violation of any Anti-Corruption and Anti-Bribery
                                            Laws.
	 	 	 
		7.1.5	There
                                            is no pending or, to such Party’s knowledge, threatened claims, charges, investigations,
                                            violations, settlements, civil or criminal enforcement actions, lawsuits, or other court
                                            actions against such Party or any of its Affiliates with respect to any Anti-Corruption and
                                            Anti-Bribery Laws.
	 	 	 
		7.1.6	To
                                            such Party’s knowledge, there are no actions, conditions or circumstances pertaining
                                            to such Party’s activities that may give rise to any future claims, charges, investigations,
                                            violations, settlements, civil or criminal actions, lawsuits, or other court actions under
                                            any Anti-Corruption and Anti-Bribery Laws.

 

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	8	Confidentiality

 

		8.1	The
                                            terms of the Confidentiality Agreement are incorporated herein by reference and will apply
                                            to any and all discussions and Confidential Information exchanged by the Parties and/or made
                                            available by a Party or its Affiliates to the other Party or its Affiliates in connection
                                            with or under this Agreement, in any form, whether oral, written, electronic or otherwise
                                            (whether or not marked “confidential”).
	 	 	 
		8.2	For
                                            the purposes of this Agreement, “Confidential Information” shall have
                                            the same meaning as that set forth in the Confidentiality Agreement and shall be deemed to
                                            include the terms of this Agreement; and the “Agreed Purpose” set forth
                                            in the Confidentiality Agreement shall be deemed to include the Parties’ respective
                                            activities hereunder and the implementation of this Agreement.
	 	 	 
		8.3	This
                                            Article 8 shall survive the Term for a period of five (5) years.

 

	9	Intellectual
                                            Property Rights; Suspension; Third Party Actions

 

		9.1	Elite
                                            warrants that, as of the Effective Date: (a) to its knowledge Elite is not aware that the
                                            manufacture of the Product as conducted for Elite as of the Effective Date infringes, misappropriates,
                                            or violates any intellectual property rights of any Third Party in the country where the
                                            Product are manufactured, (b) to its knowledge Elite is not aware that the API used in the
                                            manufacture of the Product infringes, misappropriates, or violates any intellectual property
                                            rights of any Third Party in the country where the API and/or the Product are manufactured,
                                            (c) to its knowledge the development of the Product was undertaken by Elite for its own account,
                                            and Elite owns or has the right to provide all relevant rights granted to Dexcel hereunder,
                                            (d) to its knowledge it has not received any communications, in writing and/or oral, alleging
                                            any infringement, misappropriation, or violation by the manufacture or sale of Product (including
                                            any claim that Elite must license or refrain from using any intellectual property rights
                                            of any third party) in the Territory or the place of manufacturing of the API or Product,
                                            and (e) to its knowledge it has not received any notice that any proceedings have been instituted
                                            or are pending which challenge any rights of Elite with respect to the Product or Elite’s
                                            Product intellectual property in the Territory or the place of manufacturing of the API or
                                            Product.
	 	 	 
		9.2	Elite
                                            shall provide Dexcel with all reasonable assistance and co-operation which is reasonably
                                            requested by Dexcel in order for Dexcel to undertake any due diligence review in respect
                                            of Intellectual Property Rights subsisting in the Product; provided that Elite has and shall
                                            not to its knowledge willfully fail or refuse to disclose to Dexcel any relevant information
                                            relating to the Product and any Intellectual Property Rights relating to the Product (unless
                                            such disclosure is prevented or restricted by applicable laws, regulations or any duty of
                                            confidentiality).
	 	 	 
		9.3	Subject
                                            to Elite’s full compliance with the terms of Section ‎‎‎‎‎9.2,
                                            Dexcel hereby undertakes the responsibility of the final verification of the patents and
                                            the status of Intellectual Property Rights for the Product in the Territory and is fully
                                            responsible and liable for possible infringements of any Third Party’s Intellectual
                                            Property Rights which result from the application for Marketing Authorization for the Product
                                            in the Territory, the importation of the Product into the Territory, and the promotion, marketing,
                                            distribution and sale of the Product and all other activities as envisaged under this Agreement
                                            in the Territory.

 

    	14

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		9.4	Suspension.

 

		9.4.1	If,
                                            because of any administrative, arbitral or court decision, or because in a Party’s
                                            reasonable opinion in reference to potential risks related to intellectual property issues,
                                            such Party must refrain from launching, continuing to sell and market the Product in the
                                            Territory, or from manufacturing and supplying the Product for sale in the Territory (as
                                            applicable), such Party shall have the right to suspend the launching, sale, manufacturing
                                            or the supplying of the Product under this Agreement to the extent that and only for so long
                                            as this suspension is reasonably deemed necessary or advisable by that Party to prevent or
                                            limit actual or possible damages, liabilities or injuries.
	 	 	 
		9.4.2	Such
                                            suspension shall be deemed temporary and shall not give a right to either Party to terminate
                                            this Agreement nor shall it be considered to have caused a termination of this Agreement,
                                            unless the Parties agree in writing that termination of this Agreement is reasonably necessary
                                            to prevent or limit such actual or possible damages, liabilities or injuries, and provided
                                            further that if any such suspension lasts for 180 days or more, Elite may terminate the Agreement
                                            on written notice.

 

		9.5	Third
                                            Party Actions. Each Party threatened with suit or sued by a Third Party for intellectual
                                            property infringement because of activities in connection with the Product shall promptly
                                            notify the other Party in writing of such event. In case of an actual suit based on the commercialization
                                            of the Product in the Territory, Dexcel shall have the right (but not the obligation) to
                                            defend such suit in the Territory to the extent that it relates to commercialization of the
                                            Product, and shall have the right to settle with such Third Party (provided that Elite shall
                                            in any event have the right to defend itself against any claims or allegations at its own
                                            cost). Each Party agrees that it shall reasonably cooperate with the other Party in defending
                                            the suit, even if not a party to the suit.

 

	10	Indemnification;
                                            Insurance

 

		10.1	Subject
                                            to the provisions of this Article ‎10, Elite agrees to defend, indemnify and hold
                                            Dexcel, its Affiliates and its and their officers, directors, shareholders, employees, agents,
                                            and other representatives (“Dexcel Indemnitees”) harmless from and against
                                            any and all claims, actions, causes of action, assessments, losses, damages, injuries, liabilities,
                                            costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses)
                                            of the Dexcel Indemnitees, filed, raised, initiated or made by any government authority and/or
                                            third party (collectively, “Claims”) arising from (i) any material breach
                                            by Elite of its representations, warranties, covenants, agreements or obligations under this
                                            Agreement, the Quality Agreement or the SDEA; (ii) negligence or willful misconduct on the
                                            part of Elite, its Affiliates or any of their agents, employees, distributors or subcontractors;
                                            (iii) any product liability claims, whether arising out of warranty, negligence, strict liability
                                            (including manufacturing, storage in Elite’s warehouse or that of any Affiliate or
                                            Manufacturer, or any other product or quality based claims in relation to the Product), and
                                            (iv) any claim for infringement of any Third Party Intellectual Property Rights in the country
                                            where the Product is manufactured, in each case except to the extent that any such damages
                                            give rise to an indemnification claim by Elite under Section 10.2 hereinafter.
	 	 	 
		10.2	Subject
                                            to the provisions of this Article ‎10, Dexcel agrees to defend, indemnify and
                                            hold harmless Elite and its Affiliates, and their respective shareholders, officers, directors,
                                            employees and agents (“Elite Indemnitees”), from and against any Claims
                                            by Third Parties and/or government organizations arising from: (i) the handling, possession,
                                            storing, labeling, use, marketing, distribution, promotion or sale of any Product by Dexcel,
                                            its Affiliates, or any of their distributors, employees, or sub-distributors following Delivery
                                            of the Product to Dexcel; (ii) any material breach by Dexcel of its representations, warranties,
                                            covenants, agreements or obligations under this Agreement, the Quality Agreement or the SDEA;
                                            and (iii) negligence or willful misconduct on the part of Dexcel, its Affiliates or any of
                                            their agents, employees, distributors or subcontractors; or (iv) any claim for infringement
                                            of any third party intellectual property in the Territory (provided that the information
                                            concerning the Product that was provided by Elite is in full and accurate and subject to
                                            Elite’s compliance with the terms of Section ‎‎‎9.1.2 hereinabove),
                                            except to the extent that any such damages give rise to an indemnification claim by Dexcel
                                            under Section 10.1 hereinabove.

 

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		10.3	Unless
                                            and to the extent otherwise specifically provided herein, in the event that the Dexcel Indemnitees
                                            or the Elite Indemnitees intend to claim indemnification under this Article ‎10
                                            with respect to any Claim (such one of the Dexcel Indemnitees or the Elite Indemnitees being
                                            herein referred to as the “Indemnitee”) shall promptly notify the other
                                            Party (“Indemnitor”) of a Claim in respect of which the Indemnitee intends
                                            to claim such indemnification, and the Indemnitor shall assume the defense thereof with counsel
                                            of its own choosing; additionally, an Indemnitee shall have the right to retain its own counsel
                                            with reasonable and documented fees and expenses to be paid by the Indemnitor.

 

		a.	An
                                            Indemnitee shall not be entitled to indemnification under this Section ‎10.3 if
                                            any settlement or compromise of such Claim is concluded by the Indemnitee without the consent
                                            of the Indemnitor, which consent shall not be unreasonably withheld or delayed.
	 	 	 
		b.	An
                                            Indemnitor shall not enter into any settlement or compromise of any Claim or consent to the
                                            entry of any judgment or other order with respect to any Claim which does not contain, as
                                            a part thereof, an unconditional release of the Indemnitee for liability for all loss, cost
                                            or damage that may arise from such Claim or which contains any injunctive or other non-monetary
                                            relief that might in any way interfere with the future conduct of business by the Indemnitee.
	 	 	 
		c.	Any
                                            Indemnitee, and its employees, agents and representatives, shall cooperate fully with the
                                            Indemnitor and its legal representatives, at the Indemnitor’s expense for out-of-pocket
                                            costs, in the investigation of any Claim covered by these indemnification provisions

 

		10.4	Any
                                            breach of warranty, representation or covenant by a Party shall constitute a breach of contract.
	 	 	 
		10.5	Each
                                            Party shall, during the Term and for three (3) years after termination or expiration of this
                                            Agreement, obtain and maintain, at its own cost and expense from a qualified insurance company,
                                            product liability insurance in accordance with the following provisions:

 

		10.5.1	Elite’s
                                            Insurance: Elite’s insurance shall provide protection against any and all claims,
                                            demands, and causes of action arising out of any defects, alleged or otherwise, of the Product(s),
                                            or their use, design, manufacture, Packaging, testing, release, or any material (including
                                            API) incorporated in the Product(s). The amount of coverage shall be a minimum of Ten Million
                                            US Dollars (US$10,000,000) per occurrence and in the aggregate and shall be provided from
                                            an insurance company qualified to write global product liability coverage. Elite shall name
                                            Dexcel as an additional insured on its insurance policies maintained pursuant to this Section
                                            ‎10.5.
	 	 	 
		10.5.2	Dexcel’s
                                            Insurance: Dexcel’s insurance policy shall provide protection against any and all
                                            claims, demands, and causes of action arising out of any defects, alleged or otherwise, of
                                            the Product(s) following Delivery to Dexcel. The amount of coverage shall be a minimum of
                                            Ten Million US Dollars (US$10,000,000) per occurrence and in the aggregate and shall be provided
                                            from an insurance company qualified to write product liability coverage in the Territory.
	 	 	 
		10.5.3	Certificate.
                                            Each Party agrees to furnish the other Party with a certificate of insurance evidencing such
                                            insurance coverage (at the execution of this Agreement and at each anniversary hereof) and
                                            shall provide the other Party with a thirty (30) day written notice of cancellation or non-renewal
                                            of such coverage.

 

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	11	Term
                                            and Termination

 

		11.1	Unless
                                            terminated earlier in accordance with the provisions of this Article 11, this Agreement shall
                                            have an initial term of three (3) years from the Commercialization Date (“Initial Term”);
                                            provided, however, that if, during the third (3rd) year of the Initial Term, Dexcel sells
                                            at least 65,000 bottles of the Product (in any combination of strengths), coupled with a
                                            positive Net Selling Price which shall never be lower than the Floor Price derived from all
                                            sales of the Product in the Territory by Dexcel in such year, then the Initial Term shall
                                            automatically be extended for an additional (4th) year. In the event that, in the fourth
                                            (4th) year of the Initial Term, Dexcel sells at least 65,000 bottles of the Product (in any
                                            combination of strengths), coupled with a positive Net Selling Price which shall never be
                                            lower than the Floor Price derived from all sales of the Product in the Territory by Dexcel
                                            in such year, then the Initial Term shall automatically be extended for an additional (5th)
                                            year. At any time during the Initial Term (including as extended for a 4th or 5th year, as
                                            provided above), the Parties may extend the Initial Term or renew the Agreement following
                                            the end of the Initial Term (each, a “Renewal Term”), by written agreement (the
                                            Initial Term and all Renewal Terms being herein referred to as the “Term”).
	 	 	 
		11.2	This
                                            Agreement may be terminated prior to the end of the Term:

 

		11.2.1	by
                                            either Party, effective immediately with written notice, if (i) a receiver, trustee, or liquidator
                                            of the other Party is appointed for any of properties or assets of the other Party; (ii)
                                            the other Party makes a general assignment for the benefit of its creditors; (iii) the other
                                            Party files a petition under the relevant statute for the bankruptcy, reorganization of the
                                            other Party or any arrangement with its creditors or readjustment of its debt, or its dissolution
                                            or liquidation, or such a petition is filed against the other Party and is not dismissed
                                            within sixty (60) days thereafter; or (iv) the other Party ceases doing business or commences
                                            dissolution or liquidation proceedings;
	 	 	 
		11.2.2	in
                                            the event that a Party is in material breach of a term of this Agreement, the SDEA, or the
                                            Quality Agreement and fails to remedy such breach (in case of a breach which is possible
                                            to be remedied) within thirty (30) calendar days from receipt of written notification (mentioning
                                            the causes and consequences in details) of same, the non-breaching Party shall have the right
                                            to terminate this Agreement upon provision of thirty (30) calendar days’ written notice
                                            to the breaching Party;
	 	 	 
		11.2.3	by
                                            Dexcel, with immediate notice, upon (a) any Manufacturer losing its license, authorization
                                            or approval required by law in order to manufacture and supply the Product to Dexcel, and
                                            such license, authorization or approval was not reinstated within one hundred and eighty
                                            (180) days; (b) Elite notifies Dexcel of any change to, or non-renewal, expiration or withdrawal
                                            by the FDA or any other relevant regulatory authority, of the cGMP status of any Manufacturer
                                            that would prevent Dexcel from importing, marketing or selling the Product in the Territory,
                                            and such cGMP status was not reinstated within one hundred and eighty (180) days; or (c)
                                            an audit or inspection performed by the FDA or the Health Authorities of the facilities involved
                                            in the manufacture of the Product has shown a Critical Finding and the Manufacturer cannot
                                            make or has not made the necessary remedies within the time period requested by such Regulatory
                                            Authority. For the purpose of this provision, “Critical Finding” shall mean that
                                            there is a clear cGMP failure which could materially affect the quality of the relevant Product
                                            and which could, or would, be harmful to the patient;
	 	 	 
		11.2.4	in
                                            the event of two (2) or more Supply Failures within any twelve (12) month period, Dexcel
                                            shall be entitled (but not obligated) to terminate this Agreement upon immediate notice to
                                            Elite; and
	 	 	 
		11.2.5	by
                                            either Party pursuant to Section ‎14.2 hereof.

 

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		11.3	It
                                            is specifically understood by Elite and by Dexcel that, upon termination of this Agreement
                                            for any reason, the only rights of the other Party shall be those specified in Article 12
                                            hereof.

 

	12	Rights
                                            and Obligations upon Termination

 

		12.1	Upon
                                            termination or expiration of this Agreement, Dexcel shall cease distributing the Product
                                            and shall immediately return to Elite, via courier, at Dexcel’ sole cost and expense,
                                            all of Elite’s pharmaceutical and technical Know-how relating to the Product and/or
                                            any Confidential Information (including any and all copies of the Registration File), and
                                            shall provide Elite with written confirmation of the same. Dexcel shall refrain from making
                                            any further use of Elite’s pharmaceutical and technical Know-how relating to the Product
                                            and/or Confidential Information, except as provided in Section ‎12.2 hereof. If
                                            Dexcel terminates the Agreement for any reason other than pursuant to Section ‎11.2.2
                                            or ‎11.2.3, Dexcel shall be excluded from selling the Product (except as allowed
                                            for in Section 12.2) for a period of three (3) years after the date the Agreement terminates.
                                            The obligation to return, as aforementioned, shall not include documentation required to
                                            be kept by Dexcel in accordance with Health Authorities’ instructions or regulations.
	 	 	 
		12.2	Outstanding
                                            Orders; Inventory

 

		12.2.1	Except
                                            in the event that Elite terminates this Agreement pursuant to Section ‎11.2.2 due to
                                            a material breach by Dexcel, any Confirmed Orders made on or before the expiration or termination
                                            of this Agreement but not yet delivered by Elite shall be delivered to Dexcel and Dexcel
                                            shall be liable to pay for the same in accordance with the provisions of the Agreement.
	 	 	 
		12.2.2	Dexcel
                                            may, at its discretion, sell any remaining Product stock then in its possession according
                                            to the terms of this Agreement for a period not exceeding the shelf life of such remaining
                                            Product and shall be liable to pay Net Selling Price adjustments according to Section 5.4.2.
                                            In the event Dexcel determines not to sell the remaining Product stock, it shall return it
                                            to Elite or destroy at its own cost such remaining Product stock as directed by Elite.

 

		12.3	Except
                                            as provided herein, neither Party shall be relieved of its duty to discharge in full all
                                            obligations accrued or due prior to the date of termination or expiration (including, but
                                            not limited to, the obligation to pay all amounts due under any Confirmed Orders which remain
                                            open as of the date of such termination or expiration; provided, however, that Dexcel shall
                                            have no obligation to pay for any Product in the event this Agreement was terminated pursuant
                                            to Section ‎11.2.3); all sums owed by either Party to the other shall become immediately
                                            due and payable on such date.
	 	 	 
		12.4	Each
                                            Party shall remove all reference to the other, if any, from its letterhead, business forms,
                                            advertising literature and place of business, and shall not thereafter use any name or trademark
                                            suggesting that it has any relationship with the other Party.
	 	 	 
		12.5	Each
                                            Party shall immediately deliver to the other (and cause its Affiliates and its and their
                                            Representatives to so deliver), at such Party’s expense, all Confidential Information
                                            of the other Party, including without limitation any and all copies, duplications, summaries
                                            and/or notes thereof or derived there from, regardless of format.
	 	 	 
		12.6	Except
                                            as specifically set forth herein, all rights granted by each Party to the other Party hereunder
                                            shall be immediately terminated.
	 	 	 
		12.7	The
                                            rights and obligations of the Parties to this Agreement set forth in Sections 5.4, 6.1, 6.3,
                                            6.5, 7, 8, 9, 10, 12, 17, 18, 21 shall survive any termination or expiration of this Agreement.

 

    	18

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	13	No
                                            Assignment

 

		13.1	The
                                            provisions of this Agreement shall be binding upon and inure to the benefit of the Parties
                                            hereto and their respective successors and assigns; provided however, that neither Party
                                            may assign, delegate or otherwise transfer any of its rights or obligations under this Agreement,
                                            whether voluntary or by operation of law, , without first receiving the prior written consent
                                            of the other Party. Any assignment by a Party not in accordance with this Section 13 shall
                                            be null and void. Notwithstanding the foregoing to the contrary, Elite and Dexcel may assign
                                            and delegate their respective rights and duties hereunder, without obtaining the consent
                                            of the other Party, to any Affiliate; provided that the assignee agrees in writing to bound
                                            by the terms and conditions of this Agreement, and the assigning Party likewise agrees to
                                            remain responsible as an obligor hereunder or to the acquirer of all or substantially all
                                            of the business or assets to which this Agreement relates (whether by stock sale, asset sale,
                                            merger, consolidation or otherwise).

 

	14	Force
                                            Majeure

 

		14.1	If
                                            a Party asserts the occurrence of an event of Force Majeure as an excuse for failure to perform
                                            such Party’s obligations, then the obligations of the Parties hereunder shall be suspended
                                            for so long as the Force Majeure event renders performance of the Agreement impossible; provided,
                                            however, that (a) the nonperforming Party shall timely notify the other Party in writing
                                            of the likelihood or actual occurrence of an event of Force Majeure by the nonperforming
                                            Party; (b) the nonperforming Party must reasonably prove that it took all commercially reasonable
                                            steps to minimize delay or damages caused by such event; and (c) the nonperforming Party
                                            substantially fulfilled all non-excused obligations, unless the other Party has notified
                                            the nonperforming Party to the contrary.
	 	 	 
		14.2	In
                                            the event that such Force Majeure continues for a period in excess of ninety (90) days and
                                            the Party which is unable to fulfil its obligations hereunder owing to Force Majeure beyond
                                            such period of ninety (90) days, the other Party shall be entitled to provide written notice
                                            of immediate termination to the Party unable to fulfil its obligations hereunder. The Parties
                                            agree to undertake discussions with a view to reaching some other mutually acceptable and
                                            reasonable arrangement for alleviating the effects of such force majeure.

 

	15	Severability

 

		15.1	If
                                            any provision of this Agreement is found by any court or administrative body of competent
                                            jurisdiction to be invalid or unenforceable, the invalidity or unenforceability of such provision
                                            shall not affect the other provisions of this Agreement, and all provisions not affected
                                            by such invalidity or unenforceability shall remain in full force and effect. The Parties
                                            agree to attempt to substitute for any invalid or unenforceable provision a valid or enforceable
                                            provision which achieves, to the greatest extent possible, the economic objectives of the
                                            invalid or unenforceable provision.

 

	16	Relationship
                                            of the Parties

 

		16.1	The
                                            relationship of the Parties to this Agreement is one of independent contractors.

 

	17	Governing
                                            Law and Jurisdiction

 

		17.1	This
                                            Agreement shall be construed under and exclusively governed by the laws of the State of New
                                            York, United States of America, regardless of any choice of law principles. In the event
                                            of a dispute, the parties will first attempt to resolve the situation amicably. In the event
                                            that the parties are not able to come to an amicable agreement within sixty (60) days, then
                                            each of the Parties irrevocably submits to the sole and exclusive jurisdiction of the Supreme
                                            Court of the State of New York located in the County of New York and the jurisdiction of
                                            the United States Federal District Court located in New York City, for the purpose of any
                                            suit, action or other proceeding arising from this Agreement and agrees that no such suit,
                                            action or proceeding shall be brought by it or its Affiliates except in such courts. Furthermore,
                                            each Party irrevocably waives, to the fullest extent permitted by law, any objection which
                                            it may now or hereafter have to the laying of the venue of such suit, action or proceeding
                                            brought in any such court or any claim that any such suit, action or proceeding brought in
                                            any such court has been brought in an inconvenient forum and agrees not to plead or claim
                                            the same.
	 	 	 
		17.2	The
                                            United Nations Convention on Contracts for the International Sale of Goods shall not apply
                                            to this Agreement and is hereby excluded.

 

	18	Waiver

 

		18.1	The
                                            waiver by either Party of a breach of any of the provisions of this Agreement, the Quality
                                            Agreement or the SDEA by the other Party shall not be construed as a waiver of any succeeding
                                            breach of the same or other provisions; nor shall any delay or omission by either Party in
                                            exercising any right that it may have under this Agreement, the Quality Agreement or the
                                            SDEA operate as a waiver of any breach or default by the other Party.
	 	 	 
		18.2	No
                                            waiver of any right under this Agreement shall be deemed effective unless contained in writing
                                            and signed by the Party charged with such waiver, and no waiver of any right shall be deemed
                                            to be a waiver of any future right or any other right arising under this Agreement. Failure
                                            by a Party to exercise any of its rights under this Agreement, including the right to terminate
                                            this Agreement, shall not constitute a waiver of any of its rights thereafter.

 

	19	Remedies

 

		19.1	All
                                            rights, remedies, undertakings, obligations and agreements contained in this Agreement shall
                                            be cumulative and none of them shall serve to limit any other remedy, right, undertaking,
                                            obligation or agreement which may otherwise arise.

 

	20	Construction

 

		20.1	The
                                            headings in this Agreement and their associated numbers are included for ease of reference
                                            purposes only and shall have no legal, constructive or interpretive effect. This Agreement
                                            shall be construed as if drafted jointly by the Parties and no presumption or burden of proof
                                            shall arise favoring or disfavoring either Party by virtue of the authorship of any of the
                                            provisions of this Agreement.

 

	21	Notices

 

		21.1	Unless
                                            otherwise stated in this Agreement, any and all communications required as provided for in
                                            this Agreement shall be in writing to the addresses noted below and shall be sent by (i)
                                            certified or registered mail, postage prepaid, return receipt requested, (ii) confirmed email
                                            followed by a letter of confirmation sent by any of the methods stated in (i) and/or (iii)
                                            of this clause, or (iii) by an express overnight courier service (for example, Federal Express
                                            or Airborne), postage prepaid, return receipt requested and addressed as set forth below:

 

	Dexcel
                                            Ltd.

    1
    Dexcel Street.

    Or
    Akiva 3060000

    Israel
	Elite
                                            Pharmaceuticals, Inc.

    165
    Ludlow Avenue

    Northvale,
    New Jersey 07647

    United
    States

     

	Attn:
    Vice President & General Manager	Attn:
    CEO & President
	Tel:
    ***	Tel:
    ***
	Email:
    ***	Email:
    ***

 

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	20	Construction

 

		20.1	The
                                            headings in this Agreement and their associated numbers are included for ease of reference
                                            purposes only and shall have no legal, constructive or interpretive effect. This Agreement
                                            shall be construed as if drafted jointly by the Parties and no presumption or burden of proof
                                            shall arise favoring or disfavoring either Party by virtue of the authorship of any of the
                                            provisions of this Agreement.

 

	21	Notices

 

		21.1	Unless
                                            otherwise stated in this Agreement, any and all communications required as provided for in
                                            this Agreement shall be in writing to the addresses noted below and shall be sent by (i)
                                            certified or registered mail, postage prepaid, return receipt requested, (ii) confirmed email
                                            followed by a letter of confirmation sent by any of the methods stated in (i) and/or (iii)
                                            of this clause, or (iii) by an express overnight courier service (for example, Federal Express
                                            or Airborne), postage prepaid, return receipt requested and addressed as set forth below:

 

	Dexcel
                                            Ltd.

    1
    Dexcel Street.

    Or
    Akiva 3060000

    Israel
	Elite
                                            Pharmaceuticals, Inc.

    165
    Ludlow Avenue

    Northvale,
    New Jersey 07647

    United
    States

     

	Attn:
    Vice President & General Manager	Attn:
    CEO & President
	Tel:
    ***	Tel:
    ***
	Email:
    ***	Email:
    ***

 

		21.2	Notices
                                            shall be deemed given three (3) days following mailing by certified or registered mail, and
                                            one (1) day following overnight courier, and if sent by email, upon receipt by the sender
                                            of an acknowledgment of receipt, including, without limitation, an automatically-generated
                                            emailed read receipt (provided that a Party shall still comply with the additional requirements
                                            set forth in Section ‎‎‎21.1(ii), above).

 

	22	Entire
                                            Agreement; Amendments; Preamble and Appendices

 

		22.1	This
                                            Agreement, together with all the Appendices, the Confidentiality Agreement, the Quality Agreement
                                            and the SDEA, sets forth and constitutes the entire agreement and understanding between the
                                            Parties with respect to the subject matter hereof, and supersedes any and all prior agreements,
                                            understandings, promises and representations between the Parties, whether written or oral,
                                            with respect to the subject matter hereof.
	 	 	 
		22.2	This
                                            Agreement may not be amended, modified, released, or discharged in any manner except by a
                                            written instrument, referring to this Agreement and signed by both Parties.
	 	 	 
		22.3	Any
                                            preamble and appendix to the Agreement is incorporated herein and forms an integral part
                                            hereof.

 

IN
WITNESS WHEREOF the Parties have caused this Agreement to be executed by their respective duly authorized representatives as of the
Effective Date.

 

	ELITE PHARMACEUTICALS, INC.	 	DEXCEL LTD.
	 	                                        	 	 	 
	By: 	/s/
    Nasrat Hakim	 	By:	/s/
    Ilan Oren
	Name:	Nasrat Hakim	 	Name:	 Ilan Oren
	Title:	CEO	 	Title:	Co-Chief Executive Officer
	Date:	12/06/2021	 	Date:	12/05/2021

 

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Appendix
1 – Products, Floor Prices, Batch Sizes, PQR

 

Products:

 

Dextroamphetamine
and Amphetamine combinations of the API in the following dosages and Pack sizes:

 

10mg
(2.5mg x 4API) – Packs of 30 tablets

20mg
(5mg x 4API) – Packs of 30 tablets

30mg
(7.5mg x 4API) – Packs of 30 tablets

 

The
5mg (1.25 x 4 API), 7.5mg (1.875mg x 4 API), 12.5mg (3.125mg x 4 API), 15mg (3.75mg x 4API) approved in the US, will not initially be
marketed in the Territory

 

Floor
Prices:

 

10mg
/ Pack of 30 tablets - $***

20mg
/ Pack of 30 tablets - $***

30mg
/ Pack of 30 tablets - $***

 

Pricing
for Incoterms® set forth in Section 5.3.7

 

Elite
shall prepare a periodic Product Quality Review for the Product (“PQR”) in accordance with the provisions of the Quality
Agreement and shall provide Dexcel with a copy of the PQR, upon request.

 

Costs
for items in Section 5.3.8 are included in the Floor Price.

 

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Appendix
2 – Form of Quality Agreement 

 

TEMPLATE
– DO NOT SIGN

 

TECHNICAL
AGREEMENT

 

This
TECHNICAL AGREEMENT (“Agreement”) is entered into as of the date of the last Party to sign this Agreement (“Effective
Date”) by and between DEXCEL ENTITY, with its registered address at [DEXCEL ENTITY ADDRESS] (“Dexcel”),
and OTHER PARTY, with its registered address at _______________ (“Company”). Dexcel and Company hereinafter sometimes
referred to as the “Parties” or individually as a “Party.”

 

PREAMBLE

 

	 	A.	Dexcel and
    Company have entered into a [Name of Commercial Agreement], dated [Date] (“Main Agreement”), pursuant to which
    Company shall manufacture for and supply certain medicinal products to Dexcel for sale and distribution in the Territory;
	 	 	 
	 	B.	The manufacturer of pharmaceutical
    products is responsible for manufacturing and controlling the products it provides in accordance with cGMP, in accordance with the
    Marketing Authorization in the Territory, and to comply with the requirements of “The Rules Governing Medicinal Products in
    the European Community,” Chapter 7;
	 	 	 
	 	C.	Company has a manufacturing
    authorization in accordance with the laws of [country where facility is located] and is subject to the ongoing monitoring
    by the relevant health authorities in such country, and further has provided Dexcel with copy of its certificate of cGMP issued by
    the relevant health authorities in [country where facility is located], indicating that Company’s Facility complies
    with local cGMP requirements; and
	 	 	 
	 	D.	The Marketing Authorization holder for the Product
    in the Territory is Dexcel.

 

NOW,
THEREFORE, THE PARTIES AGREE AS FOLLOWS:

 

	23	DEFINITIONS

 

	 	23.1	“Active
    Pharmaceutical Ingredient” or “API” shall mean that part of the Product ingredients intended to furnish
    pharmacological activity or to otherwise have a direct and intended effect on the patient; for the purpose of this Agreement, the
    API is [Name of API].
	 	 	 
	 	23.2	“ALCOA Standard”
    means, with respect to data integrity, that all data is Attributable, Legible, Contemporaneous, Original, and Accurate, as well as
    complete, durable, corroborated, version- based, accessible, and consistent.

 

Attributable
– data must be able to be attributed to an individual, and the identity of the person performing the activity must be clearly
documented.

 

Legible
– data must be clearly legible whether it is handwritten, images or electronic formatting viewed as a printed page or in the
electronic system, with no ambiguity regarding the clarity of the data.

 

Contemporaneous
– data must be recorded as the event happens (in real time).

 

Original
– raw or source data must be retained appropriately, and subject to review and approval.

 

Original
data is not a copy.

 

Accurate
– fully correct and representative of the event recorded.

 

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	 	23.3	“Certificate
    of Analysis” shall mean the document for the relevant batch of the Product signed by Company’s Qualified Person or
    produced by a computer system which provides a degree of control equivalent to that given by a signature, which states that such
    batch is suitable for release and includes a description of the Specifications for, and results of testing applied by Company to
    the Product and the other details set forth in Exhibit E hereof. A sample of a Certificate of Analysis is attached
    hereto as Exhibit E1.
	 	 	 
	 	23.4	“Certificate of
    Conformity” shall mean the document for the relevant batch of the Product signed by Company’s Qualified Person or
    produced by a computer system which provides a degree of control equivalent to that given by a signature, which certifies that such
    batch of the Product was manufactured and tested in compliance with the Specifications therefor, the Marketing Authorization and
    cGMP and includes the details set forth in Exhibit F hereof. A sample of a Certificate of Conformity is attached hereto
    as Exhibit F1 .
	 	 	 
	 	23.5	“Change Control
    Form” shall mean the document prepared by Company to document any change from the defined production processes of the Product.
	 	 	 
	 	23.6	“Complaints”
    shall mean defects observed and communicated to Company or Dexcel related to the use of the Product.
	 	 	 
	 	23.7	“Deviation”
    shall mean (i) an incident that occurs during bulk manufacture, packaging, storage, transportation, sampling, or testing of a batch
    of Product, which is OOS with regard to components, materials, in-process controls, Product, and/or stability; and/or (ii) a variation
    or departure from processes, procedures, predefined critical parameters, specifications, or cGMP and/or Health Authority requirements,
    during bulk manufacture, packaging, transportation, storage, sampling, or testing of a batch of Product.
	 	 	 
	 	23.8	“Deviation Report”
    shall mean the report compiled by Company to document any Deviations.
	 	 	 
	 	23.9	“Facility”
    shall mean the approved facilities of Company where the production, packaging, in- process controls, storage, testing, and release
    of the Products takes place, as set forth in Exhibit A hereof.
	 	 	 
	 	23.10	“Good Distribution
    Practice” or “GDP” shall mean the applicable guidelines for the proper distribution of medicinal products
    for human use.
	 	 	 
	 	23.11	“Good Manufacturing
    Practices” or “cGMPs” shall mean the current good manufacturing practices for pharmaceutical substances
    or products as adopted in the relevant country/ies in the Territory and in the country in which the Products are manufactured, as
    may be amended or supplemented from time to time, including (i) as specified in [21 Code of Federal Regulations (“CFR”)
    Parts 210 and 211 [cGMP for Finished Pharmaceuticals] and 21 CFR Parts 1301, 1304, 1307, 1312 (“FDA cGMP”)][ the
    EC Guide to Good Manufacturing Practices for Medicinal Products v.4, and in the European Community Directive 2017/1752/EC GMP Guidelines,
    as amended from time to time (“[EU cGMP Guidelines][FDA cGMP]”)], and, if applicable, the International Conference
    of Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) Guidance for Industry Q7
    Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients; and (ii) as required by applicable laws and regulations
    and/or the Health Authorities in the relevant country/ies in the Territory and in the country in which the Products are manufactured.

 

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	 	23.12	“Health
    Authorities” shall mean any applicable federal, state or local government authority, quasi-governmental authority, regulatory
    or administrative agency, authority, body, court, commission or tribunal in the relevant country/ies in the Territory or in the country
    of manufacture of the Product with jurisdiction or authority in such country over the development, manufacture, supply, storage,
    import, export, marketing, sale or commercialization (including approval of Marketing Authorizations) and/or reimbursement of pharmaceutical
    products, including [the FDA] [the UK Medicines and Healthcare Products Regulatory Agency][the Bundesinstitut für Arzneimittel
    und Medizinprodukte] [the European Medicines Agency].
	 	 	 
	 	23.13	“Marketing Authorization”
    shall mean the marketing authorization granted by the Health Authorities in order to permit the importation, promotion, distribution
    and sale of the Product in the Territory.
	 	 	 
	 	23.14	“Marketing Authorization
    Dossier” shall mean the package of technical and clinical information, processes, techniques and data relating to the Product
    (and the relevant manufacturing site) as may be required for the purposes of obtaining and/or varying a Marketing Authorization in
    the Territory.
	 	 	 
	 	23.15	“OOS”
    shall mean a test result that shows that the Product, after an initial investigation, was determined not to have a clear obvious
    error due to external circumstances, does not comply with the predetermined acceptance criteria, or has fallen outside of acceptance
    criteria which have been established in official compendia and/or by documentation included in the Product’s approved Marketing
    Authorization Dossier.
	 	 	 
	 	23.16	“Packaging Materials”
    shall mean the components used in both the primary and secondary packaging of the Product.
	 	 	 
	 	23.17	“Product(s)”
    shall mean the finished form pharmaceutical product(s) described in Exhibit A.
	 	 	 
	 	23.18	“PQR”
    shall mean the annual Product review and report, in English, prepared by Company for Dexcel and meeting the requirements of the [EU
    cGMP Guidelines][FDA cGMP].
	 	 	 
	 	23.19	“Qualified Person”
    or “Responsible Pharmacist” or “QP” shall mean a person named on the Manufacturing Authorization
    and recognized by the relevant Health Authorities applicable to the Product as having the necessary scientific and technical background
    and experience to allow such person to be responsible for the release of batches of Product for sale and distribution and/or supply.
	 	 	 
	 	23.20	“Quality Defects”
    refers to Critical and Major Quality Defects:

 

	 	 	23.20.1	Critical
    – These are quality defects which are potentially life-threatening or could cause serious risk to patient health, including,
    but not limited to: wrong Product (label and contents are different products); correct Product but wrong strength, with serious medical
    consequences; microbial, physical or chemical contamination, with serious medical consequences; mix up of products (‘rogues’)
    within a pack (for example, two different blister strips within one carton or two different tablets within one blister strip); wrong
    active pharmaceutical ingredient in a multi-component Product with serious medical consequences; or non-compliance with Specifications
    (for example, assay, stability, fill/weight).
	 	 	 	 
	 	 	23.20.2	Major –
    These are quality defects which could cause illness or mistreatment but not to a life-threatening extent, including, but not limited
    to: mislabeling – wrong or missing text or figures; missing or incorrect information – leaflets or inserts; microbial,
    physical or chemical contamination, with medical consequences; or insecure closure with serious medical consequences (for example,
    lack of child-resistant containers, potent product, sterile product).

 

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	 	23.21	“Recall”
    shall mean (i) a voluntary or governmental action to quarantine, stop-sale or withdraw the Product from the market in the Territory;
    and (ii) all field actions with respect to the Product in the Territory, product recalls, market withdrawals, stock recoveries, corrections
    (repair, modification, adjustment, relabeling, destruction, or inspection, including patient monitoring), safety alerts, and press
    releases. This definition does not apply to the retrieval or return of samples of the Product from the distribution network to facilitate
    an investigation into a possible Quality Defect.
	 	 	 
	 	23.22	“Reference Samples”
    shall mean the samples of all starting materials and the Product which are collected and retained in order to investigate any Deviations,
    OOS results, Quality Defects, or Complaints concerning the Products.
	 	 	 
	 	23.23	“Responsible Contact
    Persons” shall mean the key personnel of Company and Dexcel listed in Exhibit D hereof.
	 	 	 
	 	23.24	“Sharing of Pharmaceutical
    Responsibilities” shall mean the allocation of the relevant pharmaceutical responsibilities for the Products between Company
    and Dexcel as described in Exhibit C hereof.
	 	 	 
	 	23.25	“Specifications”
    shall mean all written product, regulatory, manufacturing, quality control and quality assurance procedures, processes, practices,
    standards, instructions and specifications, including, manufacturing process, analytical procedures and acceptance criteria, as set
    forth in the registered Marketing Authorization Dossier and the Marketing Authorization the Product, from time to time.
	 	 	 
	 	23.26	“Standard Operating
    Procedures” or “SOP’s” shall mean the written set of instructions compiled by a Party for any
    process or system that is followed during the operation of any activities, system or equipment, including, inter alia, quality
    assurance, quality control, maintenance, utilities, human resources, etc.
	 	 	 
	 	23.27	“Subcontractor”
    shall mean a third Party or an affiliate of Company which has a contract or other relationship with Company to provide some portion
    of the work or services related to the manufacture, packaging, storage, sampling, or testing of a Product which Company is obliged
    to perform under this Agreement. A list of all approved Subcontractors as of the Effective Date of this Agreement is set forth in
    Exhibit B.
	 	 	 
	 	23.28	“Territory”
    shall have the meaning set forth in the Main Agreement.

 

	24	GENERALLY

 

	 	24.1	Company agrees
    to manufacture the Products for Dexcel according to the Specifications, cGMP, and the Marketing Authorization of the Product.
	 	 	 
	 	24.2	Company shall have and
    maintain adequate facilities and equipment, knowledge and experience, and competent personnel, to satisfactorily supply the Products
    to Dexcel in accordance with the provisions of this Agreement and the Main Agreement.
	 	 	 
	 	24.3	Company and Dexcel agree
    to the Sharing of Pharmaceutical Responsibilities as described in Exhibit C.
	 	 	 
	 	24.4	Company shall timely notify
    Dexcel of any change or restriction to Company’s cGMP manufacturing authorization certificate, where such change is specifically
    relevant to any one or more of the Products.

 

	25	RESPONSIBLE CONTACT
    PERSONS; PERSONNEL; TRAINING

 

	 	25.1	Company and
    Dexcel have appointed the key personnel listed in Exhibit D as Responsible Contact Persons.
	 	 	 
	 	25.2	Any change of the Responsible
    Contact Persons must be notified by one Party to the other, in writing, sent to the address first set out above, or to such other
    address as the other Party has provided in writing.

 

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	 	25.3	Company’s
    (and all of Company’s Subcontractors’) personnel shall receive initial and continuing training relevant to their tasks,
    including data integrity, based on written standard operating procedures (SOPs) and in accordance with a written training program.
	 	 	 
	 	25.4	A record of all training
    should be kept by Company, and the practical effectiveness of training shall be periodically assessed and documented. Such record
    and assessments shall be available for review by Dexcel during any audit of Company’s Facility as provided in Section 35.1.

 

	26	STARTING MATERIALS

 

	 	26.1	Suppliers of
    API and Excipients

 

	 	 	26.1.1	Company shall
    be responsible for the procurement and testing of the API and for auditing the API supplier, which audit shall be performed at least
    once every three (3) years. On request, an executive summary of the most recent audit of the API supplier shall be provided to Dexcel
    by Company. Company shall provide Dexcel with a QP declaration of cGMP compliance of the API supplier relating to the use of the
    API in the manufacturing of the Product.
	 	 	 	 
	 	 	26.1.2	Company shall sign a technical
    agreement with all of its API suppliers relevant to any Product, and shall, on request, provide Dexcel with a declaration that a
    technical agreement has been concluded with each such API supplier.
	 	 	 	 
	 	 	26.1.3	Company shall be responsible
    for the procurement and testing of the raw materials (excipients). Company shall be responsible for the cGMP compliance of the raw
    material suppliers. Documentation showing cGMP compliance of the raw materials shall be provided to Dexcel by Company upon request.

 

	 	26.2	Packaging Materials

 

	 	 	26.2.1	The information
    for the artwork necessary for the preparation of the Packaging Materials for the Product shall be provided by Dexcel to Company.
    Dexcel is responsible for ensuring that the text in the artwork is accurate, correct and in compliance with the approved Marketing
    Authorization.
	 	 	 	 
	 	 	26.2.2	Company is responsible
    for the procurement and quality of all Packaging Materials in accordance with the approved artwork.
	 	 	 	 
	 	 	26.2.3	Company is responsible
    for evaluation of suppliers of Packaging Materials for cGMP compliance and to make available the relevant documentation to Dexcel
    upon request. An executive summary of the most recent audit of the Packaging Materials’ suppliers shall be provided to Dexcel
    by Company.
	 	 	 	 
	 	 	26.2.4	Company shall be responsible
    for compliance with Transmissible Spongiform Encephalopathy (“TSE”) and Bovine spongiform encephalopathy (“BSE”)
    risk regulations based on the API supplier’s TSE/BSE Declarations and the Packaging Material supplier’s TSE/BSE Declarations.
    Updated TSE/BSE declarations must be issued after any change to the manufacturing process which involves new raw materials that have
    been sourced from a different supplier. All relevant TSE/BSE declarations shall be provided by Company to Dexcel.

 

	 	26.3	Company shall
    be responsible for performing a risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal
    products for human use according to [guideline EU-2015/C 95/02].
	 	 	 
	 	26.4	Company shall be responsible
    for performing a risk assessment for nitrosamine in all relevant active ingredients, excipients and other raw materials in accordance
    with EMA/189634/2019.

 

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	27	PRODUCTION AND
    QUALITY CONTROL; FACILITY

 

	 	27.1	Company shall
    arrange the production, the packaging, the in-process controls, and the storage of the Products at its Facility according to cGMP
    and in compliance with the requirements of the Marketing Authorization Dossier. Company is responsible for ensuring that all Product
    batches are manufactured under cGMP conditions and as required by the Marketing Authorization Dossier.
	 	 	 
	 	27.2	Company will not use an
    alternate facility for, or transfer at a later date, any of the manufacturing, bulk packaging, packaging, processing, testing, storage
    or release operations for any of the Products without the prior written approval of Dexcel. Such approval by Dexcel of any new facility
    shall not be unreasonably withheld or delayed, but will also be contingent upon approval of the new facility by the Territory’s
    Health Authorities.
	 	 	 
	 	27.3	Company warrants that it
    does not handle specified risk materials, hazardous or potentially hazardous materials such as penicillins, cephalosporins, betalactams,
    hormones (including androgens, estrogens, progestins), steroids and cytotoxic products in the same building or buildings where the
    manufacturing of the Products takes place.
	 	 	 
	 	27.4	Company warrants that there
    are segregated areas in the Facility designated for the storage of products awaiting further decision, including, without limitation,
    any products suspected of falsification, returned products, rejected products, products awaiting disposal, and recalled products.
    Company further warrants that these items are kept separate from saleable stock.
	 	 	 
	 	27.5	The respective responsibilities
    of the parties are set forth in Appendix C.

 

	28	DEVIATIONS

 

	 	28.1	Company’s
    Qualified Person is responsible for reviewing the Deviation Reports relating to all Deviations involving the sampling and testing
    of the API, excipients and primary Packaging Materials and to the production of the bulk Product, before approval of the Product.
	 	 	 
	 	28.2	Company shall inform Dexcel
    in the Certificate of Compliance about any Deviation and provide a Deviation Report summary in English for each batch that is included
    with each shipment of the Product to Dexcel. In the event that the Product has already been received by Dexcel when such Deviation
    is noted by Company, Company shall immediately notify Dexcel by electronic mail.

 

	29	DOCUMENTATION

 

	 	29.1	Company undertakes to deliver to
    Dexcel together with every batch of Products the following documents:

 

	 	 	a.	Certificate of Analysis of the Product
    (Exhibit E).
	 	 	b.	Certificate of Compliance (Exhibit F).
	 	 	c.	Certificate of Analysis of the API from the API supplier.
	 	 	d.	A Deviation Report summary, in English, of any Deviation
    that may adversely affect the Product’s quality, safety, efficacy, stability and/or purity.
	 	 	e.	Packing list for delivery from Company’s site
    to the relevant Dexcel Party.

 

	30	RELEASE

 

	 	30.1	Company will deliver only Products
    manufactured in compliance with the Specifications and cGMP.
	 	 	 
	 	30.2	Dexcel is responsible for release of the Products to
    the market based on the documents provided by Company in Section 29.1.

 

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	31	STORAGE CONDITIONS
    & SHIPPING

 

	 	31.1	All starting materials (API, excipients
    and Packaging Materials) held by Company shall be stored within prescribed storage conditions at all times from the receipt thereof.
    In addition, the Products covered by the Agreement must be stored and transported in accordance with the storage and transport conditions
    set forth in Exhibit A and the Incoterms® agreed to in the Main Agreement.
	 	 	 
	 	31.2	Temperature data loggers
    shall be used to record temperature conditions during transit.

 

	 	 	31.2.1	Company is
    responsible for (i) providing the data loggers, (ii) including at least two (2) dataloggers with each shipment of Product to Dexcel,
    and (iii) providing the temperature specifications for the Product during shipment. [One (1) data logger shall be used per pallet
    of each shipment.] [Shipment documentation will indicate the placement location of all data loggers.]
	 	 	 	 
	 	 	31.2.2	Dexcel is responsible for
    (i) reviewing the temperature data from the data loggers upon receipt of each shipment of Product, (ii) immediately notifying Company
    in the event of any OOS results, and (iii) promptly returning the data loggers to Company, unless single-use data loggers are used.

 

	32	REFERENCE SAMPLES

 

	 	32.1	Company is
    responsible for ensuring that Reference Samples of (a) all relevant starting materials and (b) Product (each batch) are kept for
    at least the Product shelf life plus one (1) year.
	 	 	 
	 	32.2	The number of Reference
    Samples of the Product must be sufficient to perform at least two (2) full quality control analyses (including microbiological testing).

 

	33	STABILITY REPORTS
    & PQR

 

	 	33.1	Company shall
    provide ongoing stability summaries at the request of Dexcel in accordance with ICH guidelines. In the event of a confirmed stability
    OOS, Dexcel must be notified immediately.
	 	 	 
	 	33.2	In case stability concerns
    are raised during the review of a PQR or for any other reason (e.g. a Complaint), the Qualified Persons of the Parties shall agree
    upon the steps to be taken to address the concern.
	 	 	 
	 	33.3	Company undertakes to prepare
    an annual PQR (in English) for the Product supplied to Dexcel. The PQR will be for a twelve (12) month period and contain, at the
    minimum, the contents required by the [EU cGMP Guidelines][FDA cGMP]. On request, a copy of the completed and approved PQR will be
    provided by Company to Dexcel within three (3) months of its completion.

 

	34	COMPLAINTS AND
    RECALL

 

	 	34.1	Complaints

 

	 	 	34.1.1	Any non-medical
    / technical Complaint regarding the quality of the Product received by Dexcel in the Territory shall be communicated by Dexcel to
    Company in accordance with the notice provisions set forth in the Main Agreement (“Notice”).
	 	 	 	 
	 	 	34.1.2	Company shall be responsible
    for performing an investigation concerning the Complaint and for sending a report containing the results of the investigation and
    any corrective actions taken or to be taken to solve the problem that originated the Complaint to Dexcel within thirty (30) calendar
    days following Company’s receipt of the Notice.
	 	 	 	 
	 	 	34.1.3	All complaints of a medical
    nature and all adverse drug event reporting shall be done in accordance with the safety data exchange agreement signed by Company
    and Dexcel.

 

	 	34.2	Recall

 

	 	 	34.2.1	The Parties
    agree to contact each other immediately as soon as they become aware of the potential for a Recall caused by a Quality Defect concerning
    the Products, including a Recall by the Company or its distributors of the same product in another country. Twenty-four (24) hour
    contact details are set out in Exhibit E.

 

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	 	 	34.2.2	Dexcel is responsible
    for the management of any Recall of the Products in the Territory. Company must cooperate fully in ensuring a fast and effective
    recall.
	 	 	 	 
	 	 	34.2.3	Nothing stated herein shall
    prevent, constrain or delay any unilateral action which either Party, in its sole discretion, reasonably deems to be necessary to
    protect the public, comply with the law or to protect its business interests or reputation, provided that no such action will be
    taken without reasonable prior written notice by mail or electronic mail to the applicable contact for the other Party as set forth
    in Exhibit E.

 

	 	34.3	Suspected Counterfeit
    Goods

 

	 	 	34.3.1	If either Party
    becomes aware of any suspicion that Products could be counterfeit, actual counterfeit incidents, or incidents relating to illegal
    handling with respect to the Product, such Party will inform the other Party immediately (within twenty-four (24) hours).
	 	 	 	 
	 	 	34.3.2	Dexcel will inform the
    Health Authorities in the Territory of the suspicion or incident in accordance with local law or regulation.

 

	35	INSPECTIONS

 

	 	35.1	During normal
    working hours and upon reasonable notice, Company agrees that Dexcel will be entitled to audit the Facilities where the Product is
    manufactured, packed, tested, stored, and released.
	 	 	 
	 	35.2	Company will inform Dexcel
    within five (5) days following notice of any regulatory inspection that relates to the manufacturing, bulk packaging, packaging,
    processing, testing, storage and/or release of the Product.
	 	 	 
	 	35.3	A copy of any reports,
    summaries or notices issued by a regulatory authority that relate to a Product shall be provided to Dexcel within three (3) days
    of receipt by Company. Company shall be responsible for responding to the inspection and shall provide Dexcel with a copy of its
    submitted responses. Company must consult with Dexcel regarding any proposed corrective and preventative actions (“CAPA”)
    that may affect the Products and reach a mutual agreement regarding regulatory responses prior to Company’s submission of the
    responses to the relevant regulatory authority. Dexcel shall not unreasonably withhold its prior written approval of the proposed
    CAPA response.

 

	36	DATA
    INTEGRITY

 

	 	36.1	Company agrees
    to have procedures in place to ensure quality-relevant data meets the ALCOA Standard. The data should be able to be traced to its
    source and be readily available during regulatory inspections.
	 	 	 
	 	36.2	Company further agrees
    to notify Dexcel of any breach to the integrity of the data affecting the quality or the safety of any Product batches already shipped
    to Dexcel, as soon as possible, but not to exceed two (2) days after becoming aware of the event.

 

	37	CHANGE
    CONTROL 

 

	 	37.1	Both Parties
    shall inform each other in advance of any relevant quality-related regulatory changes (“Change”) affecting the
    Product’s manufacturing, testing or release procedures, equipment, or materials or any other items affecting Product quality
    or the Marketing Authorization Dossier of the Products.

 

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	 	 	37.1.1	All major Changes,
    as defined by Company’s change control SOPs as a change that will require a formal variation to the Marketing Authorization
    Dossier, shall be sent, before implementation, for approval by Dexcel. It is the responsibility of Dexcel to perform the proper variation
    procedures at the Health Authorities in the Territory according to the requirements of such country’s variation guidelines.
	 	 	 	 
	 	 	37.1.2	The implementation of any
    Changes can only be carried out after Company receives the written approval of Dexcel and, if required, the Health Authorities in
    the Territory.
	 	 	 	 
	 	 	37.1.3	It is the responsibility
    of Company to transfer these changes to its internal documentation.
	 	 	 	 
	 	 	37.1.4	All minor changes, as defined
    by Company change control procedures as a change that will not require a formal variation to the Marketing Authorization Dossier,
    shall be approved by Company’s Quality department before implementation.

 

	38	SUBCONTRACTORS

 

	 	38.1	Company is
    allowed to subcontract any work related to the manufacture, quality control and/or release of the Product only with the prior written
    approval of Dexcel. It is the responsibility of Company to perform quality audits of such Subcontractors in order to assure the quality
    system and cGMP compliance of such Subcontractors. Company shall enter into a technical agreement with each such Subcontractor, a
    copy of which shall be provided to Dexcel upon request.
	 	 	 
	 	38.2	Subcontractors must meet
    the same quality requirements as Company. No subcontracting shall release Company from its responsibilities or its obligations under
    this Agreement. Company is responsible for auditing its Subcontractors. Company’s audit reports will be made available to Dexcel
    upon request.

 

	39	FINAL
    PROVISIONS

 

	 	39.1	This Agreement
    shall become effective upon its signature by the authorized representatives of both Parties and shall be reviewed by Company and
    Dexcel every three (3) years to assure its efficiency and accuracy.
	 	 	 
	 	39.2	In the event of a conflict
    between this Agreement and the Main Agreement with respect to quality-related activities, including compliance with cGMPs and all
    other regulatory obligations regarding the Product, the provisions of this Agreement shall govern and with respect to all other matters,
    the provisions of the Main Agreement shall govern.
	 	 	 
	 	39.3	Any alteration or amendment
    of this Agreement and its Exhibits requires the written consent of the Parties. New versions of Appendices become valid only after
    signature by the authorized representatives of both Parties and may be added to this Agreement without the need for updating the
    entire Agreement.
	 	 	 
	 	39.4	Upon request, this Agreement
    (or part thereof) may be forwarded or disclosed to the relevant Health Authorities in order to comply with applicable regulations.
	 	 	 
	 	39.5	The term of this Agreement
    and its termination is subordinated to the term and termination of the Main Agreement; provided, however, that this Agreement shall
    remain in effect until the last expiry date of all Products supplied to Dexcel by Company. In addition, regulatory obligations or
    other obligations which expressly or by implication are intended to survive the termination or expiration hereof, shall survive the
    termination of this Agreement.
	 	 	 
	 	39.6	The validity, construction,
    interpretation and effect of this Agreement and the respective rights and obligations of the Parties hereunder shall be governed
    and determined by and in accordance with the choice of law and jurisdiction clauses in the Main Agreement.
	 	 	 
	 	39.7	This Agreement may be executed
    in any number of counterparts, each of which shall be deemed an original but all of which together shall constitute one and the same
    instrument.
	 	 	 
	 	39.8	Signatures to this Agreement
    transmitted by electronic mail in “portable document format” (“pdf”), or by any other electronic means which
    preserves the original graphic and pictorial appearance of the Agreement, shall have the same effect as physical delivery of the
    paper document bearing the original signature.

 

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IN
WITNESS WHEREOF, this Agreement has been executed by the duly authorized representatives of the Parties hereto, effective as provided
above.

 

	DEXCEL ENTITY	 	Company
	 	 	 	 
	TEMPLATE	 	 	 
	 	          	 	 	     
	By: 	 	 	By: 	 
	Name:	 	 	Name:	 
	Title:	 	 	Title:	 
	Date:	 	 	Date:	 

 

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LIST
OF EXHIBITS

 

	 	DESCRIPTION
	A	Products,
    Storage/Transportation, Facilities
	B	Approved
    Subcontractors
	C	Sharing
    of Pharmaceutical Responsibility
	D	Responsible
    Contact Persons
	E	Certificate
    of Analysis Requirements
	F	Certificate
    of Conformity Requirements
	G	Change
    History

 

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EXHIBIT
A

 

Product,
Storage/Transportation Conditions & Facilities

 

	PRODUCT	 	STORAGE/TRANSPORTATION
    CONDITIONS	 	FACILITY
    ADDRESS
	 	 	 	 	 
	 	 	 	 	 

 

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EXHIBIT
B

 

Approved
Subcontractors

 

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EXHIBIT
C

 

Sharing
of Pharmaceutical Responsibilities between Company and Dexcel

 

	RESPONSIBILITY
    OF	 	Company	 	Dexcel
	Compliance
    of manufacturing and control SOPs with EU GMP Guidelines and with Marketing Authorization and Specifications	 	X	 	 
	ACTIVE
    INGREDIENTS	 	 
	Procurement	 	X	 	 
	Control
    and compliance with Specifications	 	X	 	 
	Reserve
    Samples	 	X	 	 
	Technical
    Agreement with API Supplier	 	X	 	 
	EXCIPIENTS
    AND MATERIALS
	Definition
    of Specifications	 	X	 	 
	Procurement	 	X	 	 
	Control
    and compliance with Specifications	 	X	 	 
	Reserve
    Samples	 	X	 	 
	ELEMENTAL
    IMPURITIES AND NITROSAMINES RISK ASSESSMENT	 	 	 	 
	Perform
    a risk assessment to identify and mitigate the risk of nitrosamines presence in API and finished product manufacturing process in
    accordance with EMA/189634/2019.	 	 

    X
	 	 
	Re-evaluate
    the risk assessment if there are any changes to API manufacturer or the finished product manufacturing process that may impact the
    risk assessment.	 	 

    X
	 	 
	Provide
    a copy of the risk assessment upon request.	 	X	 	 
	Perform
    a risk assessment to consider the elemental impurities of the finished products according to ICH Q3D.	 	X	 	 
	Re-evaluate
    the risk assessment if there are any changes to equipment, starting materials, manufacturing process, packaging materials or any
    other changes that may impact the risk assessment.	 	 

    X
	 	 
	Provide
    a copy of the risk assessment upon request.	 	X	 	 
	PACKAGING
    MATERIALS
	PRIMARY
    PACKAGING MATERIALS
	Definition
    of Specifications	 	X	 	 
	Preparation
    of artwork	 	X	 	 
	Artwork
    Text	 	 	 	X
	Release
    of artwork	 	X	 	 
	Approval
    of artwork	 	 	 	X
	Procurement	 	X	 	 
	Control
    and compliance with Specifications	 	X	 	 
	Reserve
    Samples	 	X	 	 
	SECONDARY
    PACKAGING MATERIALS
	Definition
    of Specification	 	X	 	 
	Preparation
    of artwork	 	X	 	 
	Artwork
    Text	 	 	 	X

 

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	RESPONSIBILITY
    OF	 	Company	 	Dexcel
	Release
    of artwork	 	X	 	 
	Approval
    of artwork	 	 	 	X
	Procurement	 	X	 	 
	Control
    and compliance with Specifications	 	X	 	 
	Reserve
    samples	 	X	 	 
	INTERMEDIATE
    AND BULK PRODUCTS
	Definition
    of Specifications	 	X	 	 
	Manufacturing
    instructions	 	X	 	 
	In-process
    controls	 	X	 	 
	Production/manufacturing
    records	 	X	 	 
	Testing
    instructions	 	X	 	 
	Quality
    controls/test records	 	X	 	 
	Batch
    Record	 	X	 	 
	FINISHED
    PRODUCTS	 	 	 	 
	Definition
    of Specifications	 	X	 	 
	Primary
    packaging instructions	 	X	 	 
	Primary
    packaging/packaging records	 	X	 	 
	Testing
    instructions for packaged Cartridges	 	X	 	 
	Quality
    controls/test records	 	X	 	 
	Secondary
    packaging instructions	 	X	 	 
	Secondary
    packaging records	 	X	 	 
	Certificate
    of Analysis	 	X	 	 
	Certificate
    of Compliance including Deviations	 	X	 	 
	Issue
    of batch numbers	 	X	 	 
	Definition
    of shelf-life	 	X	 	 
	Issue of
    expiry date	 	X	 	 
	Reserve
    samples	 	X	 	 
	Release
    for dispatch	 	X	 	 
	Transport
    of the Product from Company’s Facility to Dexcel’s premises	 	 	 	X
	Inclusion
    of data loggers during shipping	 	X	 	 
	Reading
    of data loggers; communicating temperature excursions or other transport condition non-compliances to Company	 	 	 	X
	Communicating
    OOS results to Company	 	 	 	X
	Release
    for marketing in the Territory	 	 	 	X
	On-going
    stability studies	 	X	 	 
	Communication
    of complaints to Company	 	 	 	X
	Investigation
    and resolution of Product complaints	 	X	 	 
	Management
    of any recall of the Products in the Territory	 	 	 	X
	Product
    recall – Product quality	 	X	 	 
	Informing
    the other Party about Product recall situation (within or outside the Territory)	 	X	 	X
	Process
    Deviations Reports	 	X	 	 
	Change
    Control Forms	 	X	 	 
	Product
    Quality Reports	 	X	 	 

 

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EXHIBIT
D

 

Responsible
Contact Persons

 

Dexcel:

 

	Title	 	Name	 	Contact
    Information
	 	 	 	 	 
	Vice
    President, Quality	 	***	 	***@dexcel.com
	 	 	 	 	***
	 	 	 	 	 
	Responsible
    Pharmacist	 	***	 	***@dexcel.com
	 	 	 	 	***
	 	 	 	 	 
	QP
    Pharmacist	 	***	 	***@dexcel.com
	 	 	 	 	***
	 	 	 	 	 
	QP
    Pharmacist	 	***	 	***@dexcel.com
	 	 	 	 	***
	 	 	 	 	 
	Vendors
    QA Manager	 	***	 	***@dexcel.com
	 	 	 	 	***
	 	 	 	 	 
	Pharmacovigilance
    Unit Manager	 	***	 	**@dexcel.com
	 	 	 	 	***

 

Company:

 

	Title	 	Name	 	Contact
    Information
	 	 	 	 	 
	 	 	 	 	 

 

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EXHIBIT
E

 

Certificate
of Analysis Requirements

 

The
Certificate of Analysis must contain at least the following information:

 

Product
Name

Product
Code

Batch
No

Batch
Size

AR
No

Mfg
Date

Expiry
Date

Specification
No

Revision
No

Name
and test methods of the Test

Specification
of the Test

Result

Remarks

Comments

Prepared
by

Checked
by

QP
Sign/Date

 

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EXHIBIT
E1

 

Sample
Certificate of Analysis

 

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EXHIBIT
F

 

Certificate
of Conformity Requirements

 

The
Certificate of Conformity must contain at least the following information:

 

Product
Name and Strength

Company

Batch
Number

Manufacturing
Date

No
of Packs Released

MA/PL
Number

Pack
Size

Expiry
Date

Total
Number of packs sent for Analysis/Retained Samples

Check
List for Review of the documents

Deviations
/ Comments

QP
Sign/Date

 

Statement
required on CoC:

 

It
is hereby certified that the above information is authentic and accurate. This batch has been manufactured, packaged and quality controlled,
at MANUFACTURER’S site, in accordance with the original and current version of the Batch Record and in full compliance with cGMPs
requirements and with the specifications of the above license.

 

	 	☐	No
    deviation occurred during batch processing, packaging and analysis which could adversely affect product quality.
	 	 	 
	 	☐	Deviation
    number:
	 	 	 
	 	☐	Deviation
    Classification: ☐ Minor ☐ Major ☐ Critical

 

The
batch processing, packaging, in-process controls and final analysis records were reviewed by me and found to be in compliance with cGMPs.

 

I
hereby approve the batch for shipment. 

 

[Signed
by releasing QP]

 

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EXHIBIT
F1

 

Sample
Certificate of Conformity

 

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EXHIBIT
G

 

Change
History

 

	Rev.
    No.	 	Reason	 	Date
	1.0	 	Initial
    Issue	 	 
	 	 	 	 	 

 

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Appendix
3 – Form of SDEA

 

TEMPLATE
– NOT FOR SIGNATURE

 

SAFETY
DATA EXCHANGE AGREEMENT

 

This
Safety Data Exchange Agreement (“SDEA”) is entered into as of the date on which this document has been signed by both
parties (“Effective Date”), by and between DEXCEL LTD., with its registered address at 1 Dexcel Street, Or
Akiva 3060000, Israel (“Dexcel”) and OTHER PARTY NAME, with its registered address at [Company Address] (“Company”).

 

	1	Scope

 

	 	1.1	As the holder
    of approved marketing authorizations (each, a “Marketing Authorization”) in [the State of Israel (including the
    areas of the West Bank under Israeli control) and the Palestinian Authority (including the areas of the West Bank under Palestinian
    Authority control and Gaza)] (“Territory”) for the pharmaceutical products listed in Appendix –PV1
    (“Products”), Dexcel, as the holder of the Marketing Authorization in the Territory (“MAH”)
    has local responsibilities for pharmacovigilance reporting and monitoring in the Territory. Company has responsibility for the global
    database for the Products; therefore, Company is responsible for oversight of pharmacovigilance for the all the markets for which
    it has outsourced distribution and marketing rights for the Products, including the Territory.
	 	 	 
	 	1.2	This SDEA is a supplement
    to the [__________] Agreement between Dexcel and Company, dated ___________ (“Commercial Agreement”), and describes
    the pharmacovigilance and exchange of safety information responsibilities of the parties for the Products, overrides any conflicting
    provisions regarding pharmacovigilance, safety issues and/or exchanges of safety information in any other agreement between the parties
    with respect to the Products (including, without limitation, the Commercial Agreement), and it supersedes any previous procedure
    that existed between the parties with respect to the exchange of pharmacovigilance information for the Products.
	 	 	 
	 	1.3	This Agreement, with the
    exception of Article 6 (Confidentiality), will be automatically terminated on the date that the final batch of any Product
    supplied by Company to Dexcel has reached its expiry. For the avoidance of doubt, the latest possible date based on product expiry
    for all Products supplied by Company to Dexcel shall be used as the automatic termination date of this SDEA.
	 	 	 
	 	1.4	All exchanges of information
    pursuant to this SDEA between Company and Dexcel and with the relevant health authorities in the Territory (“Health Authorities”)
    shall use the current rules, terms and definitions as stated in the Good Pharmacovigilance Practices [as published by the European
    Medicines Agency (EMA), and the equivalent] rules, regulations and guidelines applicable in the Territory (“Israeli
    Rules”), as all such may be amended from time to time.
	 	 	 
	 	1.5	The guidelines stated herein
    shall apply only as a minimum, it being understood by the parties that the Israeli Rules relating to pharmacovigilance applicable
    in the Territory shall be abided by and prevail to the extent the Israeli Rules are more restrictive than the provisions of this
    SDEA.

 

	2	Pharmacovigilance
    Terms and Definitions

 

	 	2.1	‘Adverse
    Drug Reaction’ (‘ADR’) concerns noxious and unintended or undesirable responses to a medicinal product.
    This means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse
    reactions may arise from use of a medicinal product within or outside the terms of the medicinal product’s marketing authorization
    or from occupational exposure, including, inter alia, off-label use, overdose, misuse, abuse and medication errors.

 

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	 	2.2	‘Adverse
    Event’ (‘AE’) is any untoward medical occurrence in a patient administered a medicinal product and which
    does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and
    unintended sign (e.g. an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product,
    whether or not considered related to the medicinal product.
	 	 	 
	 	2.3	‘Serious
    Adverse Drug Reaction’ (‘SADR’) shall mean any untoward medical occurrence that, at any dose:

 

	 	a.	results in death,
	 	b.	is life-threatening,
	 	c.	requires in-patient hospitalisation or prolongation
    of existing hospitalisation,
	 	d.	results in persistent or significant disability/incapacity,
	 	e.	is a congenital anomaly/birth defect, and/or
	 	f.	is a medically (or clinically) important event or reaction.

 

	 	2.4	‘Unexpected
    Adverse Drug Reaction’ shall mean an adverse reaction, the nature or severity of which is not consistent with the applicable
    product information (e.g. Investigator’s Brochure for an unapproved investigational medicinal product).
	 	 	 
	 	2.5	‘ICSR’
    is an individual case safety report in the form required by the Health Authorities in the Territory.
	 	 	 
	 	2.6	‘Product Complaint’
    is a report of product deficiency which can stem from any source in the product distribution chain once the product has been placed
    in commercial distribution (including samples), excluding reports classified as or containing adverse reactions/adverse events.
	 	 	 
	 	2.7	‘Date of First
    Receipt’ (‘DFR’) shall mean the calendar date when the first person at either party is notified of a
    suspected adverse drug reaction.
	 	 	 
	 	2.8	‘Healthcare Professional’
    for the purposes of reporting suspected adverse reactions, healthcare professionals are defined as medically qualified persons, such
    as physicians, dentists, pharmacists, nurses and coroners or as otherwise specified by local regulations.

 

	3	Correspondence

 

	 	3.1	Dexcel, as
    the MAH for the Products in the Territory, shall be responsible for all correspondence relating to the Product with the Health Authorities
    in the Territory, as required.
	 	 	 
	 	3.2	All correspondence, communications
    and reports between Dexcel and Company pursuant to this SDEA will be in English. English translations of reports, data, or other
    documents within the scope of this SDEA shall be the responsibility of the party that is sending the report, data or other documents.

 

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	 	3.3	Dexcel, as
    the MAH for the Products in the Territory, is also responsible for responding to any safety-related inquiries received from Healthcare
    Professionals, consumers or the Health Authorities regarding the Products in the Territory.

 

	4	Safety
    Information Exchange

 

	 	4.1	Dexcel shall
    be responsible for the following with respect to all suspected Adverse Drug Reactions associated with the Products (including all
    spontaneous serious and non-serious reports, both expected and unexpected), occurring in the Territory:

 

	 	4.1.1	Investigation
    and follow-up of ADRs reported in the Territory shall be the responsibility of Dexcel. Company shall provide Dexcel, upon request,
    with reasonable assistance to ensure that appropriate investigations or testing is carried out on any Products thought to be associated
    with an ADR.
	 	 	 
	 	4.1.2	Dexcel shall be responsible
    for reporting suspected ADRs relating to the Products to the relevant Health Authority in the Territory in line with current legislation.
	 	 	 
	 	4.1.3	ADR reports should contain
    at least the following minimum information. However, the reports with any of the below information missing should also be forwarded
    to Company:

 

	 	a.	An identifiable reporter / source
    (e.g. Healthcare Professional or consumer) with contact details for the reporter / source;
	 	b.	An identifiable patient (e.g. gender / age or age group);
	 	c.	The suspected ADR; and
	 	d.	The suspect medicinal product (with an active ingredient
    the same as that used in the Product).

 

	 	4.1.4	Dexcel will
    forward all reports (initial and follow-up, serious and non-serious, unlisted and listed) occurring in the Territory to Company within
    five (5) calendar days of DFR (including, but not limited to, Spontaneous, Competent Authority, and Solicited reports). In addition,
    the following shall be forwarded to the Company:

 

	 	a.	Knowledge of any Adverse Event or
    Adverse Drug Reaction;
	 	b.	Details of any publication reporting any Adverse Event
    or Adverse Drug Reaction identified from its review of scientific literature;
	 	c.	Details of any reported lack of Efficacy, change in
    reported efficacy of the product, abuse, misuse, medication error or overdose.
	 	d.	Details of any pregnancy / report or exposure (including
    paternal exposure)
	 	e.	Details of any occupational exposure
	 	f.	Details of the product use during lactation
	 	g.	Adverse reaction related to product use outside the
    terms of the marketing authorization (off-label use);
	 	h.	Adverse reactions related to counterfeit product;
	 	i.	Adverse reaction related to transmission via a medicinal
    product of an infectious agent;
	 	j.	Adverse reaction data from class action lawsuits;

 

Company,
as owner of the global safety database for the Product, will capture all suspected ADRs forwarded by Dexcel and include such reports
in periodic safety update reports (“PSURs”) that are generated in association with the Product. For reports forwarded
by Dexcel, Company shall be ultimately responsible for assessing the seriousness, causality of each report that is added to the global
safety database.

 

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	 	4.1.5	All Communications
    between the Parties themselves shall be in English and, where possible, in writing. Any required translation into English of a Communication
    will be the responsibility of the Informing Party.
	 	 	 
	 	4.1.6	As an absolute minimum,
    Dexcel will provide information outlined in Section 4.1.4 in English to enable case processing for Adverse Events or Adverse Drug
    Reaction or Other Pharmacovigilance information. A full English translation of the source document and translation date will be provided
    as a follow-up report.
	 	 	 
	 	4.1.7	Company will provide Dexcel
    with Company’s evaluation of reports occurring in the Territory following assessment as specified in Section 4.1.4:

 

	 	a.	For serious ADR reports, Company
    will provide its evaluation within twelve (12) calendar days of DFR,
	 	 	 
	 	b.	For non-serious ADR reports, Company will provide its
    evaluation within thirty (30) calendar days of DFR.

 

	 	4.1.8	ADR reports
    occurring in the Territory which were received during the first twelve (12) months of the marketing of any new formulation of the
    Product will be expedited to the local Health Authority within a fifteen (15) day period, as per local legislation. In order to be
    in line with reporting timeframes, the case exchange will be according to time frames of serious case reports as specified in Section
    4.1.4 and Section 4.1.7 0.
	 	 	 
	 	4.1.9	If Company receives a spontaneous
    ICSR associated with the Products in the Territory, Company will immediately (within two (2) business day, as defined in the Territory)
    forward the ICSR to Dexcel for processing as defined above.
	 	 	 
	 	4.1.10	ICSRs shall be sent electronically
    (e.g. as a PDF attachment, via email) between the contacts defined in Appendix PV-II to this SDEA. Facsimile transmission or telephone
    may be used in circumstances where the usual email mode of transmission is not available.
	 	 	 
	 	4.1.11	Format: All ICSRs received
    from spontaneous notification shall be transmitted in a format agreed by both parties. This can be any of the following forms: CIOMS
    I or E2B files consistent with the ICH E2B/M2 Guideline on the Data Elements for Electronic Transmission of ICSR or other agreed
    form in English.

 

	 	4.2	Literature Searches.

 

	 	4.2.1	Dexcel is responsible
    for local literature search in the Territory for articles that include reports of suspected adverse drug reactions possibly associated
    with a Product. Dexcel is subsequently responsible for processing (including requests for additional information from the authors
    where appropriate) and reporting to the relevant Health Authorities any ICSRs identified where required to do so by current legislation.
    Such reports identified by Dexcel from local literature search should be forwarded to Company according to the timelines defined
    in section 5.1.5.
	 	 	 
	 	4.2.2	Company is responsible
    for global literature search.

 

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	 	4.3	Signal Detection.

 

	 	4.3.1	Company shall
    be responsible for identifying new risks of the product and for informing Dexcel immediately any safety concern or any change in
    risk- benefit balance of the product. Company will inform Dexcel about a validated signal within 10 days of validation. Dexcel will
    inform Company of any safety concerns identified by Dexcel within 10 calendar days. Dexcel will inform the national Health Authority
    with this information, if applicable.
	 	 	 
	 	4.3.2	Each party shall notify
    the other party within five (5) business days regarding any Health Authorities actions or enquiries regarding the Product, including,
    without limitation:

 

	 	a.	Restrictions on distribution or
    recall actions due to safety issues;
	 	b.	Clinical trial suspension or protocol amendment for
    safety and/or efficacy reasons;
	 	c.	Dosage modification for safety reasons;
	 	d.	Changes in target population or indications for safety
    reasons;
	 	e.	Formulation changes for safety reasons; or
	 	f.	Modification of the investigator brochure and/or core
    safety data sheet and/or labelling for safety reasons.

 

	 	4.4	Periodic Safety Update Reports (PSURs).

 

Company,
as owner of the global safety database for the Product, will prepare PSURs based on the European Union reference date (EURD) list. These
reports will be made available to Dexcel to support their submissions relating to maintenance of the marketing authorisation in the Territory.

 

	 	4.5	Risk management Plans

 

	 	4.5.1	If a Risk Management
    Plan (RMP) for the Product is required by Regulatory Authorities in the Territory as a post-authorization commitment, Dexcel will
    inform Company within (2) two business days in order to allow an adequate timeframe for preparation of such a document. RMPs will
    be prepared and updated by Company and provided to Dexcel in a timely manner.
	 	 	 
	 	4.5.2	Dexcel is responsible for
    implementing any risk minimization activities for the Product in the Territory.

 

	 	4.6	Training of employees

 

The
parties are both responsible for instituting systems, procedures and training (including training records) within their company (including
affiliate companies where necessary) to appropriately collect, document, submit all pharmacovigilance data consistent with the procedures
set forth in this Article 4.

 

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	 	4.7	Reconciliation

 

	 	4.7.1	Where information
    has been exchanged between the parties, an e-mail or fax acknowledging receipt of the information must be sent to the other party
    within three (3) calendar days. If information has been forwarded but an acknowledgement is not received, the discrepancy must be
    investigated and resolved by both parties.
	 	 	 
	 	4.7.2	Quarterly reconciliation
    listing will be set up so that the case transmissions to each party are verified. Dexcel will send a line listing of all cases received
    at Dexcel for the Product. Company shall review the line listing and notify Dexcel of any cases not received at Company. Dexcel shall
    provide further information that Company reasonably requests in order to complete the quarterly reconciliation. Reconciliation of
    the prior quarter shall be completed by the beginning of the following month e.g. Reconciliation for the quarter January to March,
    must be completed by end of April.

 

	 	4.8	Medical Information

 

	 	4.8.1	Each party
    shall be responsible for providing medical information scientific services to consumers and healthcare professionals in their Territories
    for the Product. Dexcel may use only the Product labelling to answer directly enquiries it receives from either health care professionals
    or consumers, but in instances where this data does not provide a suitable response, the enquiry may be forwarded to Company for
    its help with responding to the enquirer. The contact information for Company Medical information is provided in Appendix PV-2.
	 	 	 
	 	4.8.2	If a medical information
    inquiry involves an ICSR, such ICSR should be reported by Dexcel to Company in accordance with the instructions and timeframes specified
    in this Article 4.

 

	5	Product
    Quality Complaints

 

	 	5.1	Quality complaints concerning the
    Product will be handled in the manner described in the Technical Agreement signed by and between the parties.
	 	 	 
	 	5.2	For Product quality complaints that also have an associated
    suspected ADR, the ICSR must be reported between the parties as defined in section 5.1 of this SDEA.

 

	6	Confidentiality

 

Both
parties agree that the information exchanged under this SDEA is Confidential Information as defined in the Commercial Agreement and shall
not be disclosed to any third party other than for the purposes described in this SDEA (i.e. for compliance with international and local
pharmacovigilance legislation).

 

	7	Audit

 

Upon
reasonable written notice, either party may initiate an audit of the other Party’s relevant activities to monitor compliance with
this SDEA and applicable laws and regulations. An audit may be performed by internal personnel with reasonable qualifications and experience
or both Parties may agree upon a third party auditor who will be performing the audit. The audit will relate only to the scope of and
compliance with this SDEA and applicable laws and regulations, and will be performed during normal business hours on dates to be agreed
between the parties. All audit-related out-of- pocket expense shall be borne by the Party seeking the audit. Neither Party may require
an audit more than once in one calendar year.

 

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	8	Miscellaneous

 

	 	8.1	Neither party
    may assign this SDEA or any rights or obligations hereunder in any manner without the prior written consent of the other party.
	 	 	 
	 	8.2	The parties agree to update
    this SDEA according to any changes made in regulatory requirements. Dexcel will inform Company in the event of any updates or changes
    in the national regulatory requirements in the Territory concerning pharmacovigilance.
	 	 	 
	 	8.3	Failure or breach by either
    party to comply with any of the obligations and conditions hereof, unless such failure is caused by applicable laws or regulations,
    shall entitle the other party to give to the party in default notice requiring it to remedy such failure or breach. If such failure
    or breach is not remedied within thirty (30) days after receipt of such notice (or in the case of a failure or breach not capable
    of being remedied within such thirty (30) days period, the party in default has failed within such period to commence and diligently
    continue actions to cure such failure or breach), the notifying party shall be entitled to terminate this SDEA and/or the Commercial
    Agreement between the parties relating to the Product, by giving notice to take effect immediately.
	 	 	 
	 	8.4	The provisions of this
    SDEA shall be deemed separate. Therefore, if any part of this SDEA is rendered void, invalid or unenforceable, such rendering shall
    not affect the validity and enforceability of the remainder of this SDEA unless the part or parts which are void, invalid or unenforceable
    shall substantially impair the value of the whole SDEA to either party.
	 	 	 
	 	8.5	The headings used in this
    SDEA are for the convenience of the parties only, and shall not be considered in interpreting or applying the provisions of this
    SDEA.
	 	 	 
	 	8.6	This SDEA may be executed
    in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be one and the same
    agreement. Counterparts may be delivered via electronic mail (including pdf or electronic signatures) and any counterpart so delivered
    shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.

 

IN
WITNESS WHEREOF, the Parties have executed this SDEA as of the Effective Date.

 

	DEXCEL
    LTD.	 	OTHER
    PARTY NAME
	 	 	 	 	 
	Signature: 
    		 	Signature: 
    	
	Name:	***	 	Name:	 
	Position:	Vice
    President, Quality 	 	Position:	 
	Date:	_____________,
    202__	 	Date:	_____________,
    202__

 

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Appendix
PV-1

 

Products

 

	Trade
    name	 	Active
    ingredient (INN)	 	MA
    NUMBER
	 	 	 	 	 
	 	 	 	 	 

 

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Appendix
PV-2

 

Contact
List

 

Dexcel:

 

	Name	 	Title	 	Contact
    Details
	***	 	***	 	T:
    ***

    M:
    *** T

    ***@dexcel.com

	 	 	 	 	 
	***	 	***	 	T:
    ***

    M:
    ***

    ***@dexcel.com

 

Company:

 

	Name	 	Title	 	Contact
    Details
	 	 	 	 	 
	 	 	 	 	 

 

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Appendix
4 – Comparative dissolution requirements

 

Qualification
of use of EU/US reference product

 

To
justify the use of the biostudy conducted with US reference product a comparison should be made to Israeli reference product. The comparison,
including the dissolution study, physical characterization and qualitative composition, as described below should include all strengths
from the bio study.

 

Comparative
dissolution study:

 

Comparative
dissolution study reports should include a 12 unit dissolution profile of the Israeli reference product, in the following media: 0.1N
HCl, pH 4.5 and pH 6.8 with no addition of surfactant (unless justified), and QC medium.

 

All
dissolution profile studies should be done using the QC dissolution method parameters (volume, stirring rate and temperature).

 

In
case USP monograph for the drug product is available, 12 units of dissolution profile of the Israeli reference product at dissolution
conditions described in the monograph should be provided.

 

Comparative
dissolution data on the US Bio reference product vs. test product should be provided. In case comparative dissolution of original reference
vs. test product were not performed at 0.1N HCl, pH 4.5, pH 6.8, QC medium and/or USP dissolution conditions, then these tests should
be completed using 12 units of each product. Use of new batches different than the bio-batches is allowed.

 

Results
of all dissolution studies shall be presented in tabulated format including individual results, average and RSD, and on charts.

 

F2
calculations between the US reference vs. the Israeli reference and between the Israeli references vs. test product shall be provided.
Please also include the list of values that used for the F2 calculations.

 

Physical
characterization

 

Physical
characterization of the IL RLD, US RLD such as description (i.e., shape, color, debossing, presence of film coating), dimensions and
weight should be provided by the partner as part of the study using 12 units of each product.

 

Qualitative
composition

 

A
tabulated comparison of the qualitative composition of Israeli reference product and of the US reference product used in the bio study
should be provided.

 

    	52

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